Responsive Documents - CREW: FDA: Regarding FOIA Logs: 6/19/2012 - CREWLog Response

Disclosure FOI Request Log Range from 03/01/2011 Report
Total Records: 12455 Control # 2011-1571 2011-1572 Recd Date / Due Date 03/01/2011 03/29/2011 03/01/2011 03/29/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ANWAR, A J GAMMON, TIM FEDERAL LAWS THE PROHIBIT DOCTORS FROM PRESCRIBING MEDICATIONS TO PATIENTS WITH EXISTING CONDITIONS WITH SYMPTOMS THAT ARE THE SAME AS SIDE EFFECTS OF THOSE MEDICATIONS LIFESCAN INC - ONETOUCH VERIO RECS INDAPAMIDE, PERINDOPRIL - AERS 12/15/10 TO PRESENT Signature/ Requester Subject 2011-408 - DELETED RECS
2011-1573 2011-1574
03/01/2011 03/29/2011 03/01/2011 03/29/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
MAURA MARTIN NORDEN SIDLEY AUSTIN LLP MARY B SZALKOWSKI PRISMA CORP
2011-1575 2011-1576
03/01/2011 03/29/2011 03/01/2011 03/29/2011
FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/
CHRISTINE FORGUES MORGAN LEWIS & BOCKIUS LLP RYAN S PATTERSON QUARLES & BRADY LLP
FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS; FORMIC ACID - RECS, CORR MICHAEL FOODS INC, MINNETONKA, MN; ABBOTSFORD FARMS INC, MG WALDBAUM CO, WAKEFIELD, NE, ETC PASTEURIZATION OF SHELL EGGS RECS AMGEN INC, THOUSAND OAKS,CA - EIR BTWN 12/10 & 2/11
2011-1577 2011-1578 2011-1579
03/01/2011 03/29/2011 03/01/2011 03/29/2011 03/01/2011 03/29/2011
DE ANGELIS, KATE ORA/NE-FO/NWE-DO/NWECB/ ORT, GLENNA CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ARLENE MORALES BURDOCK GROUP RHYTEC INC - PORTRAIT PSR 3 EIRS, ATTACHMENTS, EXHIBITS FLOUR, FIBER, LENTILS, CHICKPEAS, ETC - REGULATORY STATUS, CONSUMPTION, SAFETY RECS, ETC
2011-1580
03/01/2011 03/29/2011
ORA/SW-FO/KAN-DO/COMP/
TAMARA STIER ICON DEVELOPMENT SOLUTIONS
ALAN S MARION MD - EIRS LAST 5 YRS
2011-1581 2011-1582
03/01/2011 03/29/2011 03/01/2011
FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E FDA/OMPT/CDER/ORP/DIDP/ GABRIEL B SHERMAN
SENOMYX INC - SENOMYX S263, S336, S807, ETC ANIMAL SAFETY TEST RECS RANBAXY LABORATORIES LTD , HIMACHAL PRADESH,
Page 1 of 1132
Monday June 18 2012 10:41 AM

Total Records: 12455 Control # Recd Date / Due Date 03/29/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1583 2011-1584 2011-1585 2011-1586 2011-1587 03/01/2011 03/29/2011 03/01/2011 03/29/2011 03/01/2011 03/29/2011 03/01/2011 03/29/2011 03/01/2011 03/29/2011 2011-1588 03/01/2011 03/29/2011 2011-1589 03/01/2011 03/29/2011 2011-1590 2011-1591 03/01/2011 03/29/2011 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1592 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1593 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MOSS, DEMETRIUS MEDICINES THAT TREAT SARCOIDOSIS - AERS; CDC ADDRESS WYCKOFF, MATTHEW G BARR PHARMA - NIMODIPINE ANDA 77-811 MODULE 2, SEC P.1, P.2, P.3 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E ME.ANIE MUHLSTOCK PARKER WAICHMAN ALONSO LLP JASON GROTO CHICAGO TRIBUNE AVRIL G LOVE TUCKER ELLIS & WEST LLP PHENYTONIN & FOSPHENYTOIN - AERS, TRIAL RESULTS, LITERATURE ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E LEE RANON TAG MEDICAL PRODUCTS CORPORATION LTD ORA/CE-FO/BLT-DO/CB/ FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E ALI AJDARI SIERRA INTERNATIONAL INC SENOMYX INC - FOOD FLAVOR ENHANCER ADDITIVES CMPLNTS INNOVASIVE DEVICES INC - INNOVASIVE 2.8 MMX 6.4MM ROCLET K970423 RECS SENOMYX INC - SUSPENSION OF NORMAL REQUIREMENTS FOR HUMAN SAFETY TESTING OF FLAVOR ENHANCER ADDITIVES GLAXOSMITHKLINE -SUPER POLIGRIP DENTURE ADHESIVE CREAM 510K RECS, CORR, LBLG ETC FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E SENOMYX INC - NANOTECHNOLOGY MFG TECHNIQUES RECS SENOMYX INC - FOOD FLAVOR ENHANCER ADDITIVES RANGE OF CONCENTRATION RECS CMPLNT 113896 Signature/ Requester Hyman, Phelps & McNamara, P.C. Subject INDIA - APPLICATION INTEGRITY POLICY MEMO 2/25/09
K914972, K926138, K923367 ETC - APRVLS
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Total Records: 12455 Control # 2011-1594 Recd Date / Due Date 03/01/2011 03/29/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1595 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-1596 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1597 03/01/2011 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1598 2011-1599 2011-1600 2011-1601 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 2011-1602 03/02/2011 03/30/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/CHI-DO/CCB/ SEWRAZ, CHETANAND APRIL HOLLIS FDA NEWS MARY A PAWLOWSKI MERCKLER BULGER TILSON MARICK & PEARSON LLP DR GAYATRI SABERWAL INSTITUTE OF BIOINFORMATICS AND APPLIED BIOTECHNOLOGY PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC, FOOD MFG FACILITIES, ETC (INSIDE & OUTSIDE THE US) - 483S 2/11 ROLF'S PATISSERIE INC, LINCOLNWOOD, IL - DESSERT RECALL 12/24/10 BIOLOGICS-RELATED PATENTS - RECS TOSHIHIRO HIGUCHI GEORGETOWN UNIVERSITY NATIONAL ADVISORY COMMITTEE ON RADIATIONS (NACOR) - RECS INDIVIDUAL RECS RICHARD YOUNGSTROM NYCOMED US INC WATSON PHARMA PRIVATE LTD, DOMBIVLI, AMBERNATH, THANE, INDIA - EIRS, 483S 3/08 TO 4/08 KEVIN TUCKER EXPONENT, INC. FLUORIDE IN TOOTHPASTE - APRVL RECS CHRISTOPHER FREDRIC MSC CANGENE CORP HEPAGAM B HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN) BLA STN:125237 - CLNCL RVWS PAUL B EPISCOPE LLC Signature/ Requester Subject TERBUTALINE (BRETHINE) - FDA LTRS TO HEALTH CARE PROVIDERS, ENTITIES, MFRS
Page 3 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1603 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1604 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1605 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1606 2011-1607 03/02/2011 03/30/2011 03/02/2011 03/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1608 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1609 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1610 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1611 03/02/2011 FDA/OMPT/CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) OTSUKA - ABILIFY (ARIPIPRAZOLE) NDA 21-436/S002 APVL CHLOE BIRD PCCA LIST OF FOREIGN IMPORTED DRUGS JEN FERANIL KM PHARMACEUTICAL CONSULTING LLC NEXAVAR (SORAFENIB) NDA 21-923/S007 - APRVL RECS WILLIAM VAN NOSTRAN CHILDREN'S HOSPITAL MEDICAL CENTER OF AKRON CLINDAMYCIN IV FORMULATIONS - AERS ANTOINE JEFFREY JEFFERIES & CO LIZ CURTIS LYBECK MURPHY LLP PROPOXYPHENE - AERS NUMBER OF IND APPLICATIONS 2009, 2010 CHRISTOPHER SEYMOUR CHANGE TO WIN TARO PHARMACEUTICAL INDUSTRIES LTD, HAIFA BAY, ISRAEL 5/28/10, 9/10/09; TARO PHARMACEUTICALS INC, BRAMPTON, ONTARIO 7/31/08 - 483S JILL S HALL AAIPharma Services Corp. NUMBER OF 505(B)(2) NDA APPLICATION APRVLS GUISE, ELISE NDC #61577 - RECS Signature/ Requester Subject
Page 4 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/30/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1612 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1613 2011-1614 03/02/2011 03/30/2011 03/02/2011 03/30/2011 2011-1615 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1616 2011-1617 2011-1618 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1619 03/02/2011 04/21/2011 2011-1620 03/02/2011 03/30/2011 2011-1621 03/02/2011 03/30/2011 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LUCAS M WATSON ESQ LUCAS M WATSON LLC LUNESTA - CMPLNTS 1/1/05-2/23/11 FDA/OMPT/CDRH/OCER/DFOI/ M ELIZABETH BIERMAN MORGAN LEWIS & BOCKIUS LLP CHRISTOPHER SEYMOUR CHANGE TO WIN PATIENT & HEALTH CARE PROVIDER EXPERIENCES WITH NEGATIVE PRESSURE WOUND THERAPY - SURVEY RESULTS DYNAMIC PHARMACEUTICALS INC, BROOKSVILLE, FL - 483 12/3/10 REICH, EUGENIE LUCAS M WATSON ESQ LUCAS M WATSON LLC ETHEX CORP, KV PHARM - ISOSORBIDE MONONITRATE CMPLNTS 1/1/07-2/23/11 FDA/OMPT/CDRH/OCER/DFOI/ MONSTES CHARLES-HARRIS NEOS SURGERY BIOMET INC, WARSAW, IN - PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP K911802 FOIA LOG - 2010 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RANDAR, DIANE LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LUCAS M WATSON ESQ LUCAS M WATSON LLC ROCK HILL OB/GYN, ROCK HILL, SC - IMPLANON MDRS 1/10 TO PRESENT FRESENIUS MEDICAL CARE - FRESENIUS 2008K @ HOME HEMODIALYSIS SYS K070049 PAXIL - CMPLNTS 1/1/05-2/23/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. ABBOTT LABS - HUMIRA (ADALIMUMAB) BLA 125057/S0062 APRVL LTR, PI, RVWS Signature/ Requester MERCK & CO., INC. Subject LTR, RVWS
Page 5 of 1132

Total Records: 12455 Control # 2011-1622 2011-1623 2011-1624 2011-1625 2011-1626 2011-1627 2011-1628 2011-1629 Recd Date / Due Date 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1630 03/02/2011 03/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1631 2011-1632 2011-1633 2011-1634 2011-1635 2011-1636 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ ALEXANDER, JUDY . JOAN STITT (UG2CD-16) MERCK & CO., INC. KIMBERLY ARENDS G&W LABORATORIES INC WISCONSIN PHARMACAL COMPANY LLC, JACKSON, WI EIRS, 483S, CO RESP LAST 3 YRS CENTER FOR FOOD SAFETY & APPLIED NUTRITION - FOIA 2011-354 JULIE B MASTER DEVON INTERNATIONAL GROUP JOAN STITT (UG2CD-16) MERCK & CO., INC. ASTHMARX - ALAIR RPTS, CORR 6/10 TO PRESENT BRIGHAM & WOMEN'S HOSPITAL - CYTOCARE MACHINE MDRS, RPTS, COMM, ETC 4/10 2010-9333 LUCAS M WATSON ESQ LUCAS M WATSON LLC PAXIL, LUNESTA COMBINATION - CMPLNTS 1/1/05-2/23/11 Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. NATE MORABITO NEWS - WJHL-TV JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. LUCAS M WATSON ESQ LUCAS M WATSON LLC PAXIL, LUNESTA, PREDNISONE COMBINATION - CMPLNTS 1/1/05-2/23/11 2010-8634 2010-8513 2010-8474 2010-8373 JAMES H QUILLEN MOUNTAIN HOMVE, VA MEDICAL CENTER, JOHNSON CITY, TN - CITATIONS LAST 10 YRS 2010-5896 Subject 2010-4798
Page 6 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/30/2011 2011-1637 2011-1638 03/02/2011 03/30/2011 03/02/2011 03/30/2011 2011-1639 2011-1640 2011-1641 2011-1642 2011-1643 2011-1644 2011-1645 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/02/2011 03/30/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1646 03/03/2011 03/31/2011 2011-1647 2011-1648 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1649 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1650 03/03/2011 03/31/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ KIRK A HORNBECK HUNTON & WILLIAMS LLP HENTGES DAIRY FARM, ADDY, WA - INVESTIGATION RECS, RPTS, CORR, ETC 1/04 TO PRESENT FRANKLIN, THAILIA OM/OMP/DODM/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC GARY HAIGHT PUTNEY INC DAVID TIMLIN MEDTRONIC USA INC BLAINE A NORRIS WIGGINS NORRIS COFFEY EDDIE TOMS POLYEXCEL LLC WILLIAM J SKINNER MUSCATATUCK PUBLISHERS INC XOMED INC - MODIFIED IMPLANT FOR XOMED AUDIANT BONE K884056, AUDIANT BONE CONDUCTOR K881382, AUDIANT BONE CONDUCTOR AT THE EAR K872168, ETC DJO INC, ENCORE MEDICAL LP - HIP PROSTHESES REGULAR SHELL K974093, FLARED SHELL K974095, METAL INLAY K003250, ETC POLYDIMETHYLSILOXANE (PDMS) - MAMMAILIAN TOXICOLOGICAL RECS DIETARY SUPPLEMENTS MFRS - 75-DAY PREMARKETING NOTICES 1/08 TO PRESENT SUPRAX 400 - AERS PFIZER ANIMAL HEALTH - TEMARIL-P NADA 12-437 RECS FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ Action Office OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester BEVERIDGE & DIAMOND PC DIANNE L CHAMBERS HOGAN LOVELLS US LLP COURTNEY FREDRICKSON TOXICOLOGY REGULATORY SERVICES MARILYN WHITNEY COVINGTON & BURLING LLP MARILYN WHITNEY COVINGTON & BURLING LLP MARILYN WHITNEY COVINGTON & BURLING LLP KEITH A BARRITT FISH & RICHARDSON PC METHACRYLONITRILE USE IN PVDC RESINS - CORR, RECS PHYSIO-CONTROL - LIFENET SYS K102757 DKT FDA-2010-P-0491 DKT LOG 1988N-0004, NDAC TRANS 1/13/95 DKT LOG 1988N-0004, NDAC TRANS 1/13/95 Subject REQUESTS 1/26/11 TO PRESENT SECTION 912 OF THE FDA AMENDMENTS ACT 2007 CORR, MEMOS NOTES, ETC 10/25/10 TO PRESENT MELATONIN - GRAS OR FAP
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Total Records: 12455 Control # 2011-1651 Recd Date / Due Date 03/03/2011 03/31/2011 2011-1652 2011-1653 2011-1654 03/03/2011 04/07/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1655 2011-1656 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1657 03/03/2011 03/31/2011 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1658 2011-1659 2011-1660 03/03/2011 03/31/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1661 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1662 2011-1663 03/03/2011 03/31/2011 03/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DOBSON, DONALD MARK AARON L HARRAH MEDTRONICS - PEEK-PREVAIL SPACER MDRS, CORR, SANCTIONS, ETC 2007 TO PRESENT INDIVIDUAL RECS CHRISTOPHER SEYMOUR CHANGE TO WIN GRANULES, HYDERABAD INDIA - 483 3/6/09 FDA/OMPT/CDRH/OCER/DFOI/ Doe J HENRY WU INNOTICS INC FDA/OMPT/CDRH/OCER/DFOI/ DOBSON, DONALD MARK MEDTROINCS - PRESTIGE ST ARTIFICIAL DISC MDRS, CORR, APRVL RECS, ETC MEDTRONICS - INFUSE HUMAN BONE RECOMBIENT MDRS, MEMOS, SANCTIONS, ETC KETOTIFEN FUMARATE DATABASE 7/2/99-12/31/06 FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ DOBSON, DONALD MARK LINUS GAARN JOHANSEN ORIFARM GENERICS A/S AARON L HARRAH HILL PETERSON CARPER, ET AL MEDTRONICS - INFUSE HUMAN BONE RECOMBIENT, PEEL-PREVAIL SPACE, PRESTIGE ARTIFICIAL DISC MDRS, CORR, MINS, ETC GENERAL CHEMICAL, MIDLOTHIAN, TX - EIR MOST RECENT INDIVIDUAL RECS Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ FADER, ALEXANDER JEFF STACHEWICZ FOIA GROUP INC FOI SERVICES INC Signature/ Requester KEN REID WASHINGTON INFORMATION SOURCE WELLMONT HOLSTON VALLEY MEDICAL CTR, KINGSPORT, TN - EIRS, 483S, CORR, ETC 8/3-6/10 FOOD FACILITIES IN CHINA - EIRS, 483S 6/16/09 TO PRESENT CONTRACT #HHSF223200630254G Subject CLOSED 483S & EIRS REQUESTS 9/1/10 - 2/15/11
Page 8 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/31/2011 2011-1664 2011-1665 03/03/2011 03/31/2011 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1666 03/03/2011 03/31/2011 2011-1667 03/03/2011 03/31/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1668 03/03/2011 03/31/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1669 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1670 03/03/2011 03/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1671 03/03/2011 03/31/2011 CTP/OD/ CTP/OD/ OC/COS/OES/ ERIC LIPTON NEW YORK TIMES FAMILY SMOKING PREVENTION AND CONTROL ACT CORR 9/10 TO PRESENT MIA NGUYEN ORLANDO HEALTH MULTAQ (DRONEDARONE) - AERS DELANA S SANDERS THE SANDERS LAW FIRM ATTORNEYS & COUNSELORS AT LAW FOSAMAX - MUCCI RPT, EFFICACY RECS MATT MEZVINSKY RIDGEBACK CAPITAL MANAGEMENT LLC AMR101 - SPECIAL PROTOCOL ASSESSMENTS (SPAS) MARINE & ANCHOR TRIAL RICK TOMLLINSON CALIFORNIA STRAWBERRY COMMISSION MARY HANSON COLORADO MENTAL HEALTH INSITUTE FOR LOGAN IMPORTED & DOMESTIC STRAWBERRIES - MICROBIAL TESTING 2000-2010 ANTIPSYCHOTICS - AERS, CLNCL TRIAL RECS 2/11 Action Office ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/ATL-DO/ACB/ Signature/ Requester HILL PETERSON CARPER, ET AL WILLIAM R PFISTER SONAR PRODUCTS INC ERIC M BERMAN DRINKER BIDDLE REATH LLP RIVER'S EDGE PHARMACEUTICALS LLC, SUWANEE, GA EIRS, 483S 2009, 2010 COMPARATIVE EFFECTIVENESS CLAIMS GENERALLY MUST BE BASED ON AT LEST TWO ADEQUATE & WELLCONTROLLED STUDIES - FDA LTR Subject
Page 9 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OES/ OC/COS/OL/ 2011-1672 2011-1673 2011-1674 03/03/2011 03/31/2011 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1675 2011-1676 03/03/2011 03/31/2011 03/03/2011 03/31/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1677 2011-1678 03/03/2011 03/31/2011 03/03/2011 03/31/2011 2011-1679 2011-1680 2011-1681 2011-1682 2011-1683 2011-1684 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 CBER/OCTMA/DDOM/ALFB/ Doe J OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MERCK & CO., INC. ROBERT F VAAGE ROBERT VAAGE LAW OFCS NUVASIVE INC - NEUROVISION JJB APRVL RECS, LBLG, CLNCL TRIALS; INDIVIDUAL RECS H1NI VACCINE - VAERS MERCK & CO., INC. FOI DAILY LOG 2/7-11/11 MERCK & CO., INC. FOI DAILY LOG 2/14-18/11 MERCK & CO., INC. FOI DAILY LOG 2/21-25/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ JARED MACCLEARY CROWELL & MORING KYLE OBERENDER PERISHABLE DISTRIBUTORS OF IOWA LTD CLOSED FOIA REQUESTS 2/1-28/11 SHRIMP SAMPLE #645023 - LAB RESULTS CVM REQUESTS - 2/11 OC/COS/OL/ OC/COS/OL/ ERIC LIPTON NEW YORK TIMES ERIC LIPTON NEW YORK TIMES ELYSSA M FRIED ELLIS LAW PC AARON L HARRAH HILL PETERSON CARPER, ET AL JOANNE S HAWANA ARENT FOX LLP ISRS 6835639, 3860818, 686223 ETC 2011-1405, 2011-1120, 2011-980, ETC - CONGRESSIONAL CORR LAST 6 MONTHS FAMILY SMOKING PREVENTION AND CONTROL ACT CONGRESSIONAL CORR 6/09 TO PRESENT FRESHWAY FOOD, SIDNEY, OH - REPORTABLE FOOD REGISTRY NOTICE 5/7/10; E COLI OUTBREAK INVESTIGATION - INDIVIDUAL RECS, ETC INDIVIDUAL RECS Signature/ Requester Subject
Page 10 of 1132

Total Records: 12455 Control # 2011-1685 2011-1686 2011-1687 2011-1688 2011-1689 Recd Date / Due Date 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 2011-1690 03/04/2011 04/01/2011 2011-1691 03/04/2011 04/01/2011 2011-1692 2011-1693 2011-1694 2011-1695 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ WITHROW, MICHAEL DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS SHERI M BENSON PFIZER INC RICHARD KAPLAN CONSOLIDATED RESEARCH INC DONALD N BLUE ZETETIC THEODORE SULLIVAN BUCHANAN INGERSOLL & ROONEY PC ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SHARON R LEIPPI JOHN C FARR LAW OFCS AMANDA SWEARENGEN CELERION ANNE ANDREWS ANDREWS & THORNTON EZVILLE LTD - SOLOSLIM, SIBUTRAMINE AERS, ADULTERATION EVEREST BIOMEDICAL INSTRUMENTS CO, CHESTERFIELD, MO - K060997 SIEMENS HEALTHCARE DIAGNOSTICS - ENTRY #AV30023106-3 IMPORT REFUSAL RECS STEAM STERILIZERS OCR II & OCM II - K942989; SDS DENTAL INC (DBA SUMMIT DENTAL SYSTEMS) - ZIPCLAVE STEAM STERILIZER CLASS 2 DVC APRVL LTR, LBLGL, NONCLNCL STUDIES, CLNCL STUDIES, ETC IRWIN NATURALS (NATURE'S SECRET) - DUAL ACTION CLEANSE CMPLNTS CELERION, TEMPE, AZ - EIRS 10/12-21/10 GILEAD SCIENCES INC, SAN DIMAS, CA - EIR 1/25/10-2/12/10 CLOSED FOIA REQUESTS 2/28/11-3/4/11 CLOSED FOIA REQUESTS 2/21-27/11 FOI SERVICES INC WITHROW INC, SOUHEGAN MGMT CORP, SALEM, NH EIRS 11/1-2/06, 10/5-6/09 CLOSED FOIA REQUESTS 2/14-20/11 FOI SERVICES INC CLOSED FOIA REQUESTS 2/28/11-3/6/11 FOI SERVICES INC CLOSED FOIA REQUESTS 2/21-27/11 Signature/ Requester Subject CLOSED FOIA REQUESTS 2/14-20/11
2011-1696 2011-1697 2011-1698
03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011
Page 11 of 1132

Total Records: 12455 Control # 2011-1699 Recd Date / Due Date 03/04/2011 04/01/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1700 03/04/2011 04/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1701 03/04/2011 04/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1702 03/04/2011 04/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1703 03/04/2011 04/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1704 2011-1705 03/04/2011 04/01/2011 03/04/2011 04/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1706 2011-1707 03/04/2011 04/01/2011 03/04/2011 04/01/2011 2011-1708 03/04/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ LILLIAN C BECKER COSMETIC INGEDIENT REVIEW LILLIAN C BECKER COSMETIC INGEDIENT REVIEW LILLIAN C BECKER SILICA SILYLATE, SILICA DIMETHYL SILYLATE, TRIMETHYLSILOXYSILICATE, ETC - TOXICOLOGY STUDIES PENTAERYTHRITYL TETRAACETATE, PENTAERYTHRITYL TETRALAURATE, PENTAERYTHRITYL TETRAOLEATE, ETC TOXICOLOGY STUDIES CALCIUM TARTRATE, POTASSIUM SODIUM TARTRATE, FDA/OMPT/CDRH/OCER/DFOI/ M ELIZABETH BIERMAN MORGAN LEWIS & BOCKIUS LLP JODY L GREEN DENVER HEALTH ROCKY MOUNTAIN POISON & DRUG CENTER NEGATIVE PRESSURE WOUND THERAPY - SURVEY RESULTS 2009-2010 COUGH & COLD PREPARATIONS - ISR 61-4, 6812638-2, 6813451-2, ETC AERS MICHAEL R COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 2/1/113/1/11 DECKER, MONICA DILANTIN-125 - ISR 672978-4; DILANTIN PHENYTOIN - ISR 6726185-X; DILANTIN, DILANIAN-125 - 6651091-9, ETC ROBIN PAYNTER Oregon Health and Science University TERBUTALINE - AERS PATRICIO ABAIZUA VASADE BIOSCIENCES INC PARENTERAL VIRA-A (VIDARABINE) - IND 8014 Signature/ Requester ANDREA KEAN SHIRE HUMAN GENETIC THERAPIES Subject RENTSCHLER BIOTECHNOLOGIES GMBH & CO, LAUPHEIM, GERMANY - EIRS 11/2607-12/4/07
Page 12 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/01/2011 2011-1709 03/04/2011 04/01/2011 ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ 2011-1710 03/04/2011 05/16/2011 2011-1711 2011-1712 2011-1713 2011-1714 2011-1715 2011-1716 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1717 2011-1718 2011-1719 2011-1720 2011-1721 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 2011-1722 03/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ALISON SASTHE ELLMAN INTERNATIONAL INC WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTSER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY PEGGY ANN GARJIAN, BROOKLYN, NY - EIRS, 483S, CO RESP 1/22/08-2/25/08 JAMIE KAPNER, SCOTTSDALE, AZ - EIRS, 483, CO RESP 2/16/05-4/6/05 SANOFI-AVENTIS US LLC, BRIDGEWATER, NJ - EIRS, 483S, CO RESP 4/16/10-5/13/10 JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT, RARITAN, NJ - EIRS, 483S, CO RESP 7/11/10 ELI LILLY, GREENFIELD, IN - EIRS, 483S, CO RESP 1/1/093/31/09 THERMAGE INC - THERMACOOL SYS K053365 LUBOW, BARBARA R ORA/SW-FO/DALDO/COMPLIANCE/ OC/COS/OL/ RON SIMON SIMON & LUKE LLP MICHAEL WERESCHAGIN PITTSBURGH TRIBUNE-REVIEW AARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL ENDO PHARMS - LIDODERM (LIDOCAINE PATCH) AERS CTA SCAN - INDIVIDUAL RECS CTA SCAN - INDIVIDUAL RECS CTA SCAN - INDIVIDUAL RECS SANGAR FRESH CUT PRODUCE LLC - CHOPPED CELERY LISTERIA MONOCYTOGENES OUTBREAK INVESTIGATION, EIR 1/05 TO 1/10, 483, RECALL RECS, ETC CONGRESSIONAL TESTIMONY, HEARINGS, INVESTIGATIONS - LEGAL EXPENSES 2000 TO PRESENT CTA SCAN - INDIVIDUAL RECS Action Office Signature/ Requester COSMETIC INGEDIENT REVIEW RON SIMON SIMON & LUKE LLP Subject TARTARIC ACID, ETC - TOXICOLOGY STUDIES HILLANDALE FARMS OF IOWA INC, QUALITY EGG LLC, WRIGHT COUNTY EGG - SALMONELLA OUTBREAK INVESTIGATION, 483, CORR, RECALL RECS, ETC 2010
Page 13 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/04/2011 2011-1723 2011-1724 2011-1725 2011-1726 2011-1727 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 2011-1728 2011-1729 2011-1730 2011-1731 2011-1732 2011-1733 2011-1734 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 2011-1735 03/07/2011 04/04/2011 2011-1736 2011-1737 03/07/2011 04/04/2011 03/07/2011 04/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER EL CHALKLEY THOMSON REUTERS WALTER E CHALKEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS KIMBERLY ARENDS G&W LABORATORIES INC STEPHANIE BERNARD TORNIER ELENA EKIN MEMORIAL SLOAN KETTERING CANCER CENTER SUSAN P D'ARAY I-SMART CNSULTING VAL MOORE ZYMOGENETICS INC BOVINE THROMBIN/THROMBIN NOS/THROMBON LOCAL SOL - IRS 7314092, 7568466, 7006005, ETC PAUL A OVERLIE (TEXAS CARDIAC CENTER), LUBBOCK, TX - EIRS, 483S, CO RESP 10/17-20/06 BURTON L REED, VISALIA, CA - EIRS, 483S, CO RESP 6/26/03 EMAD DEAN NUKTA, CLEVELAND, OH - EIRS, 483S, CO RESP 7/29/02-9/9/02, 1/27/03-2/6/03 MEDIMMUNE, LIVERPOOL, UK - EIRS, 483S, CO RESP 2009, 2010 LEON C LAHAYE (LAHAYE CSENTER FOR ADVANCED EYE CARE), LAFAYETTE, LA - EIRS, 483S, CO RESP 3/14/014/18/01 SANOFI AVENTIS DEUTSCHLAND GMBH, FRANKURT, GERMANY - EIRS, 483S, CO RESP 9/6-16/10 SANOFI PASTEUR, MARCY L'ETOILE, FRANCE - EIRS, 483S, CO RESP 3/15/10-4/2/10 GENETICS & IVF INSTITUTE, IRB, FAIRFAX, VA - EIRS, 483S, CO RES 9/24/09-10/1/09 TODD V SWANSON, LAS VEGAS, NV - EIRS, 483S, CO RESP 4/11/03-5/13/03 RICHARD R BRIGGS, LAS VEGAS, NV - EIRS, 483S, CO RESP 5/2-21/03 BIO-PHARM INC, LEVITTOWN, PA - EIRS, 483S, CO RESP LAST THREE YRS HOWMEDICA OSTEONICS CORP - AVON PATELLOFEMORAL JOINT PROSTHESIS K010100, K020841, K041160, ETC MAMMOGRAPHY FACILITIES CERTIFIED BY FDA 12/08 TO PRESENT VIRULITE LLC - ELECTRONIC COLD SORE DVC K083767 Subject
Page 14 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-1738 03/07/2011 04/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1739 2011-1740 2011-1741 2011-1742 2011-1743 2011-1744 2011-1745 2011-1746 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/07/2011 04/04/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1747 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1748 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1749 03/08/2011 04/05/2011 ORA/CE-FO/PHI-DO/PCB/ KURT R WEBER OCULAR SYSTEMS INC CENTER FOR ORGAN RECOVERY & EDUCATION, PITTSBURGH, PA - EIRS 2008-2011 FRANCIS, JUDY VELCADE (BORTEZOMIB) - AERS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS PURDUE - BUTRANS NDA 21-306 APRVL LR, LBLG, RVWS, ETC OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ TOBIAS D, SUMMERS BERNARD J ROBINS BERNARD J ROBINS ATTY JOHN L BRANUM CARR & CARR MARILYN WHITNEY COVINGTON & BURLING LLP MICHELLE JACKSON VENABLE LLP ANGELA SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ASTRAZENECA - NEXIUM NDA 21-153/S008 APRVL LTR, LBLG, RVWS, ETC DKT 2004N-0050, FDA-1995-S-0039 ANTIMICROBIAL 1 RPT, 7/24/74 COSTCO, BROOKLYN, NY - PRE-SLICED SALAMI RPTS, CMPLNTS, STATEMENTS, ETC HOV INFUDYTIRD, INC, DOLLAR GENERAL CORP, DOLLAR GENERAL, ETC - TORCH FUEL RPTS, EMAIL,S VIDEO, ETC DKT FDA-2010-N-0621 OM/OMP/DODM/ JASON GROTTO CHICAGO TRIBUNE FDA TRIALS DKT 1999N-003 GABRIEL B SHERMAN Hyman Phelps and McNamara PC RANBAXY LABORATORIES LTD, HIMACHAL PRADESH, INDIA - RECS, CORRR, MEMOS 2/25/11-3/4/11 Signature/ Requester Subject
Page 15 of 1132

Total Records: 12455 Control # 2011-1750 2011-1751 Recd Date / Due Date 03/08/2011 04/05/2011 03/08/2011 04/05/2011 2011-1752 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1753 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1754 2011-1755 03/08/2011 04/05/2011 03/08/2011 04/05/2011 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1756 2011-1757 2011-1758 2011-1759 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 2011-1760 03/08/2011 04/05/2011 2011-1761 2011-1762 03/08/2011 04/05/2011 03/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INFORMATION ACCESS FOI DAILY LOG 2/24-28/11, 1/31/11-2/4/11 VALUE OF INSIGHT CONSULTING INC FOI LDAILY LOG 1/10-14/11, 1/18-20/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 2/21-25/11 CanReg, Inc. FOI DAILY LOG 2/21-25/11 FOI SERVICES INC FOI DAILY LOG 2/21-25/11 KENDLE REGULATORY AFFAIRS CLOSED FOIA REQUESTS 2/21-25/11 FOI DAILY LOGS 3/3/11 ANGELIA D SLAYTON KENDLE INTERNATIONAL INC JOANIE JUNG WATSON LABORATORIES INC SMITHKLINE BEECHAM BIOLOGICS - ENGERIX-B APRVL LTR, RVWS, ETC RAPAFLO (SILODSIN - ISR 6671386, 56161078, 6689388, ETC JESSICA HEALEY HARDISON COCHRAN ZYLOPRIM, ALLOPURINOL - APRVL LTRS, LBLG FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/CE-FO/PHI-DO/PCB/ Signature/ Requester KURT R WEBER OCULAR SYSTEMS INC MANOJ ZACHARIAS LIBERTY MANAGEMENT GROUP LTD DAYLE CALLAGHAN ROUSE LEGAL Subject NORTHEAST PENNSYLVANIA LIONS EYE BANK, BETHLEHEM, PA - EIRS 2008-2011 HANUJIN DIGI-X CO LTD, SALT LAKE CITY, UT - PORTABLE X-RAY SYS MODEL HAND-RAY K092772 INACTIVE INGREDIENT GUIDE 1996
Page 16 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/05/2011 2011-1763 2011-1764 2011-1765 2011-1766 2011-1767 2011-1768 2011-1769 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/27/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CVM/OCD/ OC/OCC/ 2011-1770 03/08/2011 04/05/2011 2011-1771 2011-1772 03/08/2011 04/05/2011 03/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ REGINA CAJIGAS LANDMAN CORSI BALLAINE & FORD PC ERON Z CANNON MCCORMICK BARSTOW ET AL E C GILBREATH LUMINGAN OPHTHALMIC SOL - APRVL RECS PREVNAR 13 - CLNCL TRIALS, APRVL, INVESTIGATION, ETC POLY-MVA - FINDINGS, RECOMMENDATIONS, APPLS, ETC Center for Regulatory Services, Inc. DARCI BOLGER LEXIS NEXIS COURTLINK INC DARCI BOLGER LEXIS NEXIS COURTLINK INC DARCI BOLGER LEXIS NEXIS COURTLINK INC DAVID M BARRON COMMONWEALTH OF KENTUCKY, DEPARTMENT OF PUBLIC ADVOCACY CORRECTHEALTH, STOCKBRIDGE, GA, WILSON'S PHARMACY, GA, RAINBOW PHARMS OR RAINBOW MEDICAL ASSOCIATES, GA - SODIUM THIOPENTAL OR SODIUM PENTOTHAL RECS 3/09 TO PRESENT 2010-8097 2010-8076 2011-443 INFORMATION ACCESS FOI DAILY LOG 2/21-25/11 INFORMATION ACCESS FOI DAILY LOG 2/21-25/11 Signature/ Requester INFORMATION ACCESS FOI DAILY LOG 2/7-11/11, 2/14-18/11 Subject
Page 17 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/05/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1773 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1774 03/08/2011 04/05/2011 2011-1775 2011-1776 03/08/2011 05/02/2011 03/08/2011 04/05/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-1777 03/08/2011 04/05/2011 2011-1778 2011-1779 03/08/2011 04/05/2011 03/08/2011 04/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ ORA/CE-FO/CHI-DO/CCB/ 2011-1780 2011-1781 03/08/2011 04/05/2011 03/08/2011 04/05/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC K920637 K914148 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ Doe J SELENA KYLE NATURAL RESOURCES DEFENSE COUNCIL KEN REID WASHINGTON INFORMATION SOURCE TOXICOLOGY, FOREIGN, UNIV LABS - ADRESSES, EMAILS, PHONE NUMBERS, ETC BABY FOOD, INFANT FORMULA CONTAMINATED BY MERCURY - RECS MORTON GROVE PAHRMS, WOCKHARDT USA - LINDANE CORR, MINS, RPTS, ETC CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ JOHN D CONNER JR MCKENNA LONG & ALDRIDGE LLP MAHLON M WILKES PHD HYGEIA ASSOCIATES SARAH L BREW NILAN JOHNSON LEWIS PA MON-87708-9 SOYBEAN, FG-72 SOYBEAN, MON-87705-6 SOYBEAN, ETC - RECS, CORR LEV PHARMACEUTICALS INC - CINRYZE C1 ESTERASE INHIBITOR VAERS, USAGE, TESTS, ETC GREAT AMERICAN APPETIZERS INC, FOOD SOURCE LLP LISTERIA MONOCYTOGENES INVESTIGATION, CORR, RECALL RECS, RPTS, ETC DR FRANK DEHNER IMMATICS BIOTECHNOLOGIES GMBH BERLEX LABS - LEUKINE (SARGRAMOSTIM) BLA 103362 APRVL RECS, RVWS Signature/ Requester GILBREATH LAW FIRM Subject
Page 18 of 1132

Total Records: 12455 Control # 2011-1782 2011-1783 2011-1784 Recd Date / Due Date 03/08/2011 04/05/2011 03/08/2011 04/05/2011 03/08/2011 04/05/2011 2011-1785 03/08/2011 04/05/2011 2011-1786 03/08/2011 04/05/2011 2011-1787 03/08/2011 04/05/2011 2011-1788 03/08/2011 04/05/2011 2011-1789 03/08/2011 04/05/2011 2011-1790 03/08/2011 04/05/2011 2011-1791 03/09/2011 04/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1792 03/09/2011 04/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Doe J 911 EMERGENCY PHONE CALL TRANS JENNIFER D NEWBERGER Hyman Phelps and McNamara PC GENERIC INHALED NITRIC OXIDE BIOEQV - REQUESTS, GUIDANCE DARCI BOLGER LEXISNEXIS COURTLINK INC K042405 DARCI BOLGER LEXISNEXIS COURTLINK INC K043466 DARCI BOLGER LEXISNEXIS COURTLINK INC K031249 DARCI BOLGER LEXISNEXIS COURTLINK INC K030661 DARCI BOLGER LEXISNEXIS COURTLINK INC K014091 DARCI BOLGER LEXISNEXIS COURTLINK INC K030885 FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester AMY KINCANON LEXISNEXIS COURTLINK INC DARCI BOLGER LEXIS NEXIS COURTLINK INC DARCI BOLGER LEXIS NEXIS COURTLINK INC K003543 K982256 Subject K971844
Page 19 of 1132

Total Records: 12455 Control # 2011-1793 2011-1794 Recd Date / Due Date 03/09/2011 04/06/2011 03/09/2011 04/06/2011 Action Office ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ 2011-1795 03/09/2011 04/06/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ 2011-1796 2011-1797 2011-1798 2011-1799 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/09/2011 04/06/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1800 03/09/2011 04/06/2011 2011-1801 03/09/2011 04/06/2011 2011-1802 03/09/2011 04/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ RAVID KATCHALSKI RADIANCY PALOMAR MEDICAL PRODUCTS INC - LOI SYS K090525 WILLIAM A OLSON Center for Regulatory Services, Inc. WILSON-COOK MEDICAL - OASIS BILIARY STENT INTRODUCTION SYS K040151 WILLIAM A OLSON Center for Regulatory Services, Inc. BOSTON SCIENTIFIC CORP - BILIARY ENDOPROSTHESIS STENT SYS K965147 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ JOHN FOLEY Keller and Heckman LLP RON SIMON SIMON & LUKE LLP SUZANNE LA SCALZA OCULAR THERAPEUTIX INC LISA R TRENT SAFC PHARMA SANOFI AVENTIS DEUTSCHLAND, FRANKFURT,GERMANY EIR, 483, CO RESP 9/6-16/10 WHOLE BLACK PEPPER FROM VIETNAM (ISOLATE PCF 390620) - RPTS, LAB RESULTS, NOTES, ETC CAP 5C0190 FORMIC ACID - FAP 2262 MARILYN WHITNEY COVINGTON & BURLING LLP ENERGY DRINKS - RECS 1/08 TO PRESENT Doe J QUESTER, BRNADON INDIVIDUAL RECS Signature/ Requester Subject IMPORT REFUSALS 10/01 TO PRESENT
Page 20 of 1132

Total Records: 12455 Control # 2011-1803 Recd Date / Due Date 03/09/2011 04/06/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1804 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1805 2011-1806 03/09/2011 04/06/2011 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1807 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1808 2011-1809 2011-1810 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/09/2011 04/06/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-1811 03/09/2011 04/06/2011 ORA/NE-FO/NWE-DO/NWECB/ LOGAN WORSLEY INTERNATIONAL BROTHERHOOD OF TEAMSTERS US FOODSERVICE, NORWICH, CT, PEABODY, MA - LTRS, NOTES, EXHIBITS, ETC FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ WOOD, MARC EDWARD J PETRUS EDWARD J PETRUS MD MARK C TANENBAUM MARK C TENENBAUM ATTY MEDTRONIC MINIMED INC - PARADIGM QUICK-SET INFUSION SETS CORR, TESTING 12/1/07 TO 6/18/09 SPARKLE SPRING WATER INC, CHATSWORTH, GA - RESP TO WARNING LTR 7/1/09 WARNING LTR 2011-DAL-WL-001 - RESP TO WARNING LTR 10/21/10 NEWBOLD, ELIZABETH YAZ - RPTS, AERS OM/OMP/DODM/ JAMES R CARTER CARTER LAW OFCS ROBIN GAIL OSHMAN ROBIN GAIL OSHMAN MD PHD LATISSE (BIMATOPROST) - AERS DKT 1998P-1291 SUZANNE CHAMBERS ONCONOVA THERAPEUTICS INC ZYDUS (CADILA HEALTHCARE), AHMEDABAD, INDIA - 483 1/17/11-2/9/11 Signature/ Requester FRAN DAUGHTRIDGE PFIZER Subject EMBEDA - ISR 6920792
Page 21 of 1132

Total Records: 12455 Control # 2011-1812 2011-1813 2011-1814 Recd Date / Due Date 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/09/2011 04/06/2011 2011-1815 03/09/2011 04/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-1816 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1817 03/09/2011 04/06/2011 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-1818 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1819 03/09/2011 04/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1820 2011-1821 2011-1822 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/09/2011 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 2/128/11 MERCK & CO INC - ROTATEQ (ROTAVIRUS) VAERS 2/128/11 MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 414480-1, 414481-1 JOHN F RESEK PHD KENYON & KENYON LLP MOBILE STUDY - A STUDY OF BONVIVA (IBANDRONATE) REGIMENS IN WOMEN WITH POST-MENOPAUSAL OSTEOPOROSIS 1/03 MICHAEL A CAROME MD PUBLIC CITIZEN ALNARA PHARMS - SOLLPURA (LIPROTAMASE) STUDY RECS LOGAN WORSLEY INTERNATIONAL BROTHERHOOD OF TEAMSTERS C&S WHOLESALE GROCERS, SUFFIELD, CT; HATFIELD, MA; ABERDEEN, MD, ETC - CORR, FINDINGS, INVESTIGATIONS, ETC MAURICE KLAPWALD NEW YORK PUBLIC LIBRARY NUMBER OF ORIGINAL & ACTIVE INDS RECEIVED 2009, 2010 Action Office ORA/CE-FO/BLT-DO/CB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester DALE MCGREGOR CELLBEE FARM KATHLEEN L NASWTRI KOSKOFF KOSKOFF & BIEDER CHRISTINE FORGUES MORGAN LEWIS COUNSELORS AT LAW DIANE MENGERSEN SCHREIBER FOODS NTERNATIONAL INC FAIRBANK FARMS, ASHEVILLE, NY - GROUND BEEF ECOLI OUTBREAK INVESTIGATION 9/9, 10/9 ACTELION PHARMACUTICALS US INC - WARNING LTR 9/14/10 CANNED TUNA - ENTRY #241-8274323-7 LAB ANALYSIS Subject CMPLNT 116454
Page 22 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/06/2011 2011-1823 2011-1824 2011-1825 2011-1826 2011-1827 2011-1828 2011-1829 2011-1830 2011-1831 2011-1832 2011-1833 2011-1834 2011-1835 2011-1836 2011-1837 2011-1838 03/09/2011 04/06/2011 03/09/2011 04/06/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ Action Office Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SUSAN DAMRON BRINKS HOFER GILSON & LIONE JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-1185 - REQUEST LTR 2011-1164 - REQUEST LTR 2011-1163 - REQUEST LTR 2011-1145 - REQUEST LTR 2011-1126 - REQUEST LTR 2011-1116 - REQUEST LTR 2011-1424 REQUEST LTR 2011-1433 REQUEST LTR 2011-1434 REQUEST LTR 2011-1094 - REQUEST LTR 2011-1515 REQUEST LTR 2011-1518 REQUEST LTR 2011-1519 REQUEST LTR 2011-1522 REQUEST LTR MERCK & CO INC - PROQUAD (MEASLES, MUMPS, RUBELLA & VARICELLA VIRUS VACCINE) VAERS 2/1-28/11 DKT 1996N-0048 Subject
Page 23 of 1132

Total Records: 12455 Control # 2011-1839 Recd Date / Due Date 03/10/2011 04/07/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1840 2011-1841 03/10/2011 04/07/2011 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-1842 03/10/2011 04/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL HOSPIRA INC - VANCOMYCIN WARNING LTRS, EIRS, 483S, ETC JOAN STITT (UG2CD-16) MERCK & CO., INC. SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL QUALITEST PHARMACEUTICALS INC, WATSON LABORATORIES INC - ALLOPURINOL WARNING LTRS, EIRS, 483S, ETC 2011-1200 - REQUEST LTR Signature/ Requester SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL Subject PFIZER INC, SUN PHARMACEUTICALS INDUSTRIES, TARO PHARMACEUTICALS USA INC, ETC - DILANTIN LBLG CHANGES, WARNING LTRS, EIRS, 483S, ETC
Page 24 of 1132

Total Records: 12455 Control # 2011-1843 Recd Date / Due Date 03/10/2011 04/07/2011 2011-1844 2011-1845 03/10/2011 04/07/2011 03/10/2011 04/07/2011 Action Office ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1846 03/10/2011 04/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ 2011-1847 2011-1848 2011-1849 2011-1850 2011-1851 2011-1852 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SUE CARLSON CARGILL ANIMAL NUTRITION JOAN STITT (UG2CD-16) MERCK & CO., INC. SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL MYLAN PHARMACEUTICALS INC - PHENYTOIN WARNING LTRS, EIRS, 483S, ETC CARGILL ANIMAL NUTRITION, MINEOLA, TX - FORM 2481 RPT & ENDORSEMENT PG 7/19/10 2010-5898 2010-5899 2010-6924 2010-8619, 2010-8620 SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL TEVA PHARMACEUTICALS USA INC, TARO PHARMACEUTICALS USA INC - TEGRETOL WARNING LTRS, EIRS, 483S, ETC AMGEN FRANCE SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL JOHNSON & JOHNSON - LEVAQUIN WARNING LTRS, EIRS, 483S,E TC GOOD GUIDANCE PRACTICES 2/97 Signature/ Requester LARA N SIMMONS MEDLINE INDUSTRIES INC Subject SPLS 642089, 642090, 642091, ETC - LAB ANALYSIS
Page 25 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ 2011-1853 03/10/2011 04/07/2011 OC/OM/OSS/ORPS/DFO/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ 2011-1854 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1855 2011-1856 2011-1857 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1858 2011-1859 2011-1860 2011-1861 2011-1862 2011-1863 2011-1864 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 OC/OM/OMP/DDM/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OF/CFSAN/OCD/EOS/ OC/OM/OEO/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ OC/OM/OMP/DDM/ AARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL JOHANNAH DRERUP COLLINS LAW FIRM AARON L HARRAH HILL PETERSON CARPER, ET AL ELIZABETH COLLINS HUNTON & WILLIAMS LLP SUE CARLSON CARGILL ANIMAL NUTRITION BOBBY SCHOCHET CARGILL ANIMAL NUTRITION, LITTLE CHUTE, WI - FORM 2481 RPT, ENDORSEMENT PG 8/10/10 DKT LOG 1985N-0214 DKT LOG 1996N-0417 MEAD JOHNSON - INFANT FORMULA E SAKAZAKII INFECTION RECS INDIVIDUAL RECS INDIVIDUAL RECS INDIVIDUAL RECS ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC SUE CARLSON CARGILL ANIMAL NUTRITION DR SANJUKTA BHADURI UPSHER-SMITH LABORATORIES INC ST JUDE, SYLMAR CA - EIRS, 483S, LTRS, ETC 1/1/09 TO 3/1/11 CARGILL ANIMAL NUTRITION, NEW RICHLAND, MN - FORM 2481 RPT, ENDORSEMENT PG 7/21/10 DIASTAT (DIAZEPAM) - SBA ANIL SACHDEVA STRIDES INC APP PHARMS - FLUOROURACIL INJ ANDA 40-279 RLD LBLG FOI SERVICES INC 2002-1586 Signature/ Requester Subject
Page 26 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/07/2011 2011-1865 03/10/2011 04/29/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-1866 2011-1867 2011-1868 2011-1869 2011-1870 2011-1871 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1872 03/10/2011 04/07/2011 2011-1873 2011-1874 03/10/2011 04/07/2011 03/10/2011 04/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1875 03/10/2011 04/07/2011 ORA/CE-FO/PHI-DO/PCB/ SUE CARLSON CARGILL ANIMAL NUTRITION CARGILL ANIMAL NUTRITION, LEBANON, PA - FORM 2481 RPT, ENDORSEMENT PG 11/18/10 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ MANOJ ZACHARIAS LIBERTY MANAGEMENT GROUP LTD SUE CARLSON CARGILL ANIMAL NUTRITION SOFIA BRUERA BLIZZARD MCCARTHY & NABERS LLP ALOKA CO LTD, WALLINGFORD, CT - SD-3500 ULTRASOUND SYS K060059 Doe J ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION CHRISTINE M HUMPHREY ESQ C HUMPHREY & ASSOCS PA KYLE 0'CONNOR CONVATEC E CARLSON CARGILL ANIMAL NUTRITION CARGILL ANIMAL NUTRITION, MENTONE, IN - FORM 2481 RPT, ENDORSEMENT PG 8/20/10 CARGILL ANIMAL NUTRITION, LECOMPTE, LA - FORM 2481 RPT, ENDORSEMENT PG 8/25/10 PHARMANETICS, MORRISVILLE, NC - RAPIDPOINT ENOXPARIN TEST CARD K013305 INSP CONVA TEC - SENSI-PREMA NEONATAL BCG ELECTRODES WITH LEAD WIRES K003804 CARGILL ANIMAL NUTRITION, AMARILLO, TX - FORM 2481 RPT, ENDORSEMENT PG 10/20/10 AMIDATE, ETOMIDATE - AERS Action Office Signature/ Requester OLSSON FRANK WEEDA TERMAN BODE MATZ ANEET PANESAR BURDOCK GROUP CHLORELLA PROTOTHECOIDES, CHLORELLA PYRENOIDOSA, CHLORELLA REGULARIS, ETC REGULATORY STATUS, CONSUMPTION, SAFETY RECS Subject
CARGILL ANIMAL NUTRITION, KANSAS CITY, KS - FORM 2481 RPT, ENDORSEMENT PG 11/8/10 TOPAMAX (TOPIRAMATE, TOPIRAGEN) - AERS 1/1/97-3/4/11
Page 27 of 1132

Total Records: 12455 Control # 2011-1876 Recd Date / Due Date 03/10/2011 04/07/2011 2011-1877 2011-1878 2011-1879 2011-1880 2011-1881 2011-1882 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1883 2011-1884 2011-1885 2011-1886 2011-1887 2011-1888 2011-1889 2011-1890 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ PURSELL, LAURA JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. DAVID MOSER BIOVEST INTERNATIONAL NORTHWESTERN UNIV, ROBERT H LURIE COMPREHENSIVE CANCER CENTER, CHICAGO, IL - EIRS, 483S, 482S, ETC 5/1/00 TO PRESENT 2011-957 - REQUEST LTR 2011-947 - REQUEST LTR 2011-940 - REQUEST LTR ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ JONEL ALECCLA MSNBC.COM HOWARD, JULIE AINGARAN SRISKANDARAJAH LIVING ON EARTH CZIMER FOODS INC, GLEN, IL - EIRS, WARNING LTRS, EMAILS, ETC 2001 TO PRESENT ALLOSTIM RESEARCH, CARLSBAD, CA - 483 5/10 H&P INDUSTRIES (TRIAD GROUP), HARTLAND, WI - EIRS 1/11, 2/11 MICOR (ZACHS SPICE CO), DEER PARK, TX - EIR 6/3/10 ORA/CE-FO/PHI-DO/PCB/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JAN LL ROLLER DAVIS & YOUNG JASON MILLMAN THE HILL NEWSPAPER GABRIEL B SHERMAN Hyman Phelps and McNamara PC SUE CARLSON CARGILL ANIMAL NUTRITION WANGYANG ANDON HEALTH CO LTD JOAN STITT (UG2CD-16) MERCK & CO., INC. FRAN DAUGHTRIDGE PFIZER EMBENDA - ISR 6920792 2011-917 - REQUEST LTR Subject NUMBER OF BI-V ICD VENTRICULAR IMPLANTED CARDIOVERTER-DEFIBRILLATOR PACEMAKERS IMPLANTED BY DR BRIAN S SWIRSKY COMMISSIONER MARGARET HAMBURG - SCHEDULES, DAY CALENDARS, APPOINTMENTS, ETC 1/09 TO PRESENT FRASER SWEATMAN INC - FIRST NITROONOX BLENDER K760766 CARGILL ANIMAL NUTRITION, MARTINSBURG, PA - FORM 2481 RPT, ENDORSEMENT PG 12/7/10 K030358, K030359
Page 28 of 1132

Total Records: 12455 Control # 2011-1891 2011-1892 2011-1893 2011-1894 2011-1895 Recd Date / Due Date 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/10/2011 04/07/2011 03/11/2011 04/08/2011 03/11/2011 04/08/2011 2011-1896 03/11/2011 04/08/2011 2011-1897 03/11/2011 04/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1898 2011-1899 2011-1900 2011-1901 2011-1902 2011-1903 03/11/2011 04/08/2011 03/11/2011 04/08/2011 03/11/2011 04/08/2011 03/11/2011 04/08/2011 03/11/2011 04/08/2011 03/11/2011 05/25/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ ORA/OE/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SEA-DO/SCB/ LATHAM, IAN CARLOS LEON TWIN TAILS SEAFOOD CORP MARILYNN WHITNEY COVINGTON & BURLING LLP CANNED CRAB MEAT ENTRY JF7-OO85620-2 - SPL ANALYSES RESULTS CAFFEINATED ALCOHOLIC BEVERAGES - RPTS, MINS, MEMOS, ETC 1/08 TO PRESENT CLAY, PATRICK BIG DADDY'S CREAMERY - 483 2/25/11 ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/NJ-DO/NJCB/ CAROLINA M HEAVNER K&L GATES ROBERT A KAATZ CARDELLI LANFEAR & BUIKEMA ACUPAC PACKAGING INC, MAHWAH, NJ - EIRS, 483S WARNING LTRS, ETC 1/07 TO 3/11 SOFT LENS TECHNOLOGY - WARNING LTR 06-ATL-08 9/27/06 KANSAS CITY FREE HEALTH CLINIC - 483 6/7-12/06 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVIS, MARTIN PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC DANIEL A GOFMAN SERRADO CAPITAL LLC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. KAVANAUGH LIVINGSTON GOODWILL PROCTER LLC BIOJECT INC, TUALATIN, OR - ZETAJET NEEDLE-FREE INJ THERAPY SYS K090003; BYRNE MEDICAL INC, CONROE, TX - ERBELIFT HAND PUMP & FLEXIBLE PROBE K092090 WIPRO GE HEALTHCARE PRIVATE LTD, BANGALORE, INDIA - EIR MOST RECENT IND SUBMISSION FOR DRUGS - 1982 TO 2010 DKT FDA-2009-M-0101 2011-1013 - REQUEST LTR 2011-991 - REQUEST LTR Subject 2011-978 - REQUEST LTR
Page 29 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OE/ 2011-1904 2011-1905 03/11/2011 04/08/2011 03/11/2011 04/08/2011 2011-1906 03/11/2011 04/08/2011 2011-1907 03/11/2011 04/08/2011 2011-1908 03/11/2011 04/08/2011 2011-1909 03/11/2011 04/08/2011 2011-1910 03/11/2011 04/08/2011 2011-1911 03/11/2011 04/08/2011 2011-1912 03/11/2011 04/08/2011 2011-1913 03/11/2011 04/08/2011 2011-1914 03/11/2011 04/08/2011 2011-1915 03/11/2011 04/08/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC VASCULAR SOLUTIONS INC, MAPLE GROVE, MN - EIR MOST RECENT ZONARE MEDICAL SYSTEMS INC, MOUNTAIN VIEW, CA EIR MOST RECENT PLEXUS MANUFACTURING SDN BHD, BAYAN LAPAS, MALAYSIA - EIR MOST RECENT SONOSCAPE COMPANY LTD, SHENZHEN, CHINA - EIR MOST RECENT SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO LTD, SHENZHEN, CHINA - EIR MOST RECENT SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO LTD, BAIMANG XILI TOWN, SHENZHEN, CHINA - EIR MOST RECENT SHENZHEN HITACHI CABLE CO LTD, SHENZHEN, CHINA EIR MOST RECENT SONOWAND AS, TRONDHEIM, NORWAY - EIR MOST RECENT SUPERSONIC IMAGINE, AIX-EN-PROVENCE, FRANCE - EIR MOST RECENT U-SYSTEMS INC, SUNNYVALE, CA - EIR MOST RECENT FDA/OF/CFSAN/OCD/EOS/ MOTEN, LA VEETA JOSETTE MOORE FRANKFORD CANDY LLC CFSAN OVERTIME PAYMENTS/COMPENSATORY TIME PAYMENTS - 1/1/10 TO 2/25/11 GUMMY CANDY - HEAVY METAL TESTING RECS Signature/ Requester Subject
Page 30 of 1132

Total Records: 12455 Control # 2011-1916 Recd Date / Due Date 03/11/2011 04/08/2011 2011-1917 03/11/2011 04/08/2011 2011-1918 03/11/2011 04/08/2011 2011-1919 03/11/2011 04/08/2011 2011-1920 03/11/2011 04/08/2011 2011-1921 03/11/2011 04/08/2011 2011-1922 03/11/2011 04/08/2011 2011-1923 03/11/2011 04/08/2011 2011-1924 03/11/2011 04/08/2011 2011-1925 03/11/2011 04/08/2011 2011-1926 03/11/2011 04/08/2011 2011-1927 03/11/2011 04/08/2011 2011-1928 03/11/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/MIN-DO/MCB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC MICHLLAEL CULHANE SHENZHEN DELICATE ELECTRONICS CO LTD, CHENZHEN , CHINA - EIR MOST RECENT SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO LTD, SHANTOU, CHINA - EIR MOST RECENT GRASP 1G0371 - WHEY PROTEIN ISOLATE & DAIRY PRODUCTS JUST RIGHT INC, MINNETONKA, MN - EIR MOST RECENT TOSHIBA MEDICAL SYSTEMS CORP, TOCHIGI, JAPAN - EIR MOST RECENT USCOM LTD, SYDNEY, AUSTRALIA - EIR MOST RECENT SANMINA-SCI CORP, HUNTSVILLE, AL - EIR MOST RECENT SENORX INC, IRVINE, CA - EIR MOST RECENT SERTECH AMERICA CORP, DORAL, FL - EIR MOST RECENT SPENCER TECHNOLOGIES, SEATTLE, WA - EIR MOST RECENT SONOSITE INC, BOTHELL, WA - EIR MOST RECENT ST JUDE MEDICAL, ST PAUL, MN - EIR MOST RECENT Subject TERATECH CORP, BURLINGTON, MA - EIR MOST RECENT
Page 31 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/08/2011 2011-1929 03/11/2011 04/08/2011 2011-1930 03/11/2011 04/08/2011 2011-1931 03/11/2011 04/08/2011 2011-1932 03/11/2011 04/08/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ 2011-1933 2011-1934 03/11/2011 04/08/2011 03/11/2011 04/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1935 03/11/2011 04/08/2011 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ 2011-1936 03/11/2011 04/08/2011 ORA/P-FO/LOS-DO/LACB/ LISA R TRENT SAFC PHARMA MCGUFF PHARAMACEUTICALS, SANTA ANA, CA 5/18/10 TO 7/16/10; IRISYS, SAN DIEG, CA 3/16/10 TO 6/15/10; GILEAD ERIC ABDULLAYEV INTERNATIONAL SIGHT RESTORATION INC ARKANSAS LIONS EYE BANK & LAB, LITTLE ROCK, AR; BATON ROUGE REGIONAL EYE BANK, BATON ROUGE, LA; CINCINNATI EYE BANK FOR SIGHT RESTORATION INC, CINCINNATI, OH, ETC - WARNING LTRS, 483S LAST TEN YRS ORA/SE-FO/FLA-DO/FCB/ GABRIEL RODRIQUEZ CUSTOMS BROKERAGE BARBARA J WAGNER BARNWELL WHALEY ET AL CHEWING LEATHER STRIPS (DOG TOYS) ENTRY #MH90089620-9 - LAB RESULTS ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS INC, JOHNSON & JOHNSON - LEVAQUIN (LEVOFLOXACIN) AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester DH BUSINESS CONSULTING & ASSOCIATES PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC ANDRES RESTREPO NATURAL RESOURCES DEFENSE COUNCIL Subject PRODUCTS SOLIDS SHANGHAI APEX ELECTRONICS TECHNOLOGY CO LTD, SHANGHAI, CHINA - EIR MOST RECENT SASET (CHENGDU) INC, CHENGDU, CHINA - EIR MOST RECENT SANMINA-SCI SYSTEMS SINGAPORE PTE LTD, SINGAPORE - EIR MOST RECENT BP/DEEPWATER HORIZON GULF OF MEXICO OIL SPILL RECS
Page 32 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject SCIENCES, SAN DIEGO CA 1/25/10 TO 3/2/10, ETC - EIRS, 483S, CO RESP 2011-1937 2011-1938 03/11/2011 04/08/2011 03/11/2011 04/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1939 03/14/2011 04/11/2011 2011-1940 03/14/2011 04/11/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ 2011-1941 03/14/2011 04/11/2011 2011-1942 2011-1943 2011-1944 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 2011-1945 03/14/2011 04/11/2011 2011-1946 03/14/2011 04/11/2011 FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ ARLENE MORALES BURDOCK GROUP MALTOSE OLIGOSACCHARIDES, OLIGOMALTOSE, ALTERNANSUCRASE, SURCOMALT, ALTERNAN REGULATORY STATUS, CONSUMPTION, USES, ETC TRICIA WILDEY FEDSOURCES INC JAMES FERNANDO - CONTRACT #HHSF223200630019C ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TARO KAMAI MIC INTRNATIONAL CORP CRAIG ROUSH ROCKLINE INDUSTRIES AARON MEHTA TOTAL AMOUNT SPENT ON PRINT, BILLBOARD, INTERNET, CENTER FOR PUBLIC INTEGRITY RADIO & TV ADVERTISING BY THE FDA 1/07 TO 1/11 INSTRUMENTARIUM DENTAL, PALODEX GROPU OY ORTHOPANTOMOGRAPH K093683 HYDRITE CHEMICAL CO, MILWAUKEE, WI - EIR 9/28-30/10 KIM R JESSUM STRADLEY RONON ET AL K922817, K944479 PAUL R MAGUFFEE UNIV OF MISSOURI OFC OF THE GENERAL COUNSEL ELOISE W KAILIN MD PROTECT THE PENINSULA'S FUTURE UNIV OF MISSOURI HEALTH CARE - EIR ATTACHMENTS, TEST SPLS, FOIA REQUESTS, ETC FDA/OF/CFSAN/OCD/EOS/ AMY MOZINGO BURDOCK GROUP ROBERT BENINCASA NPR ISRS 4716351, 4762142, 4765304, ETC ACACIA GUM, POLYDEXTROSE - CALORIC VALUE
COLD AND ALLERGY MEDICATIONS - APRVL ENFORCEMENTS RECS; POLICY WHICH REGULATES CONTENT LIMIT FOR LEAD, ARSENIC, CADMIUM, ETC IN PHARMACEUTIALS & FOODS
Page 33 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-1947 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1948 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1949 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1950 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1951 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1952 03/14/2011 04/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1953 2011-1954 03/14/2011 04/11/2011 03/14/2011 04/11/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ LAYTON SHURTLEFF GLOBE MEDICAL TECH INC GAIL LESSICK LACHMAN CONSULTANT SERVICES, INC. REVOLUTIONS MEDICAL CORP - AUTO RETRACTABLE SAFETY SYRINGE K083193 DOMESTIC & FOREIGN DRUG COMPANY INSPS, BIORESEARCH MONITORING (BIMO) INSPS 2/1-28/11 CHRIS W HAAF SCHNADER HARRISON SEGAL & LEWIS GENENTECH INC, BIOGEN IDEC - RITUXAN (RITUXIMAB) APRVL RECS LISA GIRION LOS ANGELES TIMES SEROQUEL (QUIETAPINE) - AERS LEE D COPE PETERS MURDAUGH PARKER ELTZROTH & DETRICK CYTOTEC (MISOPROSTOL) - DEAR HEALTHCARE PROFESSIONAL LTR; LIST OF HEALTHCARE PROFESSIONALS SENT LTR IN SOUTH DAKOTA IMM, HANK LIST OF KOREAN GENERIC DRUG MFRS, MOST RECENT FOREIGN DRUG APPL Doe J PROPYLENE GLYCOL & ETOMIDATE/AMIDATE - ISRS 3073161, 4078297, 6924136, ETC CARRI A REMILLARD FOLIART, HUFF, OTTAWAY, & BOTTOM ULTRAM (TRAMADOL) - AERS Signature/ Requester Subject
Page 34 of 1132

Total Records: 12455 Control # 2011-1955 Recd Date / Due Date 03/14/2011 04/11/2011 Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/SAN-DO/SFCB/ 2011-1956 2011-1957 03/14/2011 04/11/2011 03/14/2011 04/11/2011 2011-1958 2011-1959 2011-1960 2011-1961 2011-1962 2011-1963 2011-1964 2011-1965 2011-1966 2011-1967 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/14/2011 04/11/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1968 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHRISTINE WARNER DECHERT LLP PACO - METOCLOPRAMIDE HCL ANDA 71-665 APRVL LTR, CORR ORA/P-FO/LOS-DO/LACB/ AISEN, MARC DONALD J FARBER DONALD J FARBER ATTY APOTEX CORP - PAROXETINE HCL TABS REVISED LBLG 6/06 OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SATOHIKO TAKANASHI KOWA COMPANY LTD SATOHIKO TAKANASHI KOWA COMPANY LTD SATOHIKO TAKANASHI KOWA COMPANY LTD SATOHIKO TAKANASHI KOWA COMPANY LTD BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC GABRIEL SHERMAN Hyman Phelps and McNamara PC MARILYNN WHITNEY COVINGTON & BURLING LLP KABBALAH CENTRE, LOS ANGELES, CA - RECS DKT FDA- 2010-P-0491 DKT 1992D-0345 FOI DAILY LOG 1/1/08-12/31/08 FOI DAILY LOG 1/1/09-12/31/09 FOI DAILY LOG 1/1/11-3/7/11 MARCHER ENTERPRISES LTD - DISCAM DIGITAL IMAGING SYS K974535 CARL ZEISS MEDITEC INC - CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER (RNFL) AND MACULAR NORMATIVE DATABASES K08291 TOPCON CORP - IMAGENET PROFESSIONAL PC SOFTWARE SYS K082364 TALIA TECHNOLOGY LTD - RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYSER K082364 FOI DAILY LOG 1/1/10-12/31/10 Signature/ Requester DOUG L PFEIFER BOWMAN AND BROOKE LLP Subject BOLTHOUSE FARMS INC - CARROT JUICE RECALL, INVESTIGATION 9/06
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1969 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1970 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1971 03/15/2011 05/18/2011 2011-1972 2011-1973 03/15/2011 04/12/2011 03/15/2011 04/12/2011 2011-1974 03/15/2011 04/12/2011 2011-1975 2011-1976 2011-1977 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 2011-1978 03/15/2011 04/25/2011 2011-1979 2011-1980 03/15/2011 04/12/2011 03/15/2011 04/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ CTP/OD/ CTP/OD/ OC/OM/OFM/ HAMILTON, LEROY L ROBERT V PRONGAY GLANCY BINKOW & GOLDBERG ORA/SE-FO/ATL-DO/ACB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/MIN-DO/MCB/ GAITHER, LEVUN MARGARET M GROVES DUKE UNIV/SCHOOL OF MEDICINE JOHN B DUBECK Keller and Heckman LLP SRILAXMI BEARELLY MD, DUKE UNIV EYE CENTER, DURHAM, NC - EIR, 483 11/11/0-12/10/10 STAR SCIENTIC INC - ARIVA-BDL, STONEWALL-BDL DISSOLVABLE TOBACCO LOZENGES MODIFIED RISK TOBACCO PROD APPLS SECTIONS 8-11 DIAPULSE CORPORATION OF AMERICA - PAYMENTS OF FEES FOR DVC REGISTRATION 2006 TO 2011 HANSEN MEDICAL INC - SENSEI X ROBOTIC CATHETER SYS, ARTISAN EXTEND CONTROL CATHETER, ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NYK-DO/NYDCB/ CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ SUSAN MALCHER JAMES J REAM LAW OFC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC ANDREW HAN PHD IMMUNETICS INC CELLEX-C INTERNATIONAL INC - CELLEX-C ADVANCED EYE FIRMING CREAM CMPLNTS, WARNINGS MULTIGON INDUSTRIES INC, YONKERS, NY - EIR MOST RECENT NORTH AMERICAN MEDICAL CORP, MARIETTA, GA - EIR MOST RECENT VERAX BIOMEDICAL INC - BK070044, BK090028 TEST METHODS & PROCEDURES SURGITEK, RACINE, WI - INSP 1988 RECS ROGER H HOOLE HOOLE & KING LC BACTERIN INC, BACTERIN INTERNATIONAL INC, BACTERIN INTERNATIONAL HOLDINGS INC - PRICE OF STOCK, FUNDING, CORR, ETC PATTI GASDEK MANOLAKIS PHARM D PMM CONSULTING BROMPHENIRAMINE - ISRS 4390491-7, 5263518-8, 5269020-1, ETC PATTI GASDEK MANOLAKIS PMM CONSULTING COUGH & COLD PRODS CONTAINING BROPHENIRAMINE AERS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-1981 03/15/2011 04/12/2011 2011-1982 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-1983 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-1984 2011-1985 2011-1986 2011-1987 2011-1988 2011-1989 2011-1990 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ Ryan, Charles ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS MARTIN O'CONNOR GERMAINE LABORATORIES INC MARTIN O'CONNOR GERMAINE LABORATORIES INC CHILD SUPPORT STATUTES, ADMINISTRATIVE POLICIES,GUIDELINES FOR NEBRASKA HOLOPACK, COLUMBIA, SC - EIRS, 483S, CO RESP 8/10 TO 1/11 DOW CHEMICAL CO, MIDLAND, MI - EIRS, 483S, CO RESP 8/10 TO 1/11 3M DRUG DELIVERY SYSTEMS DIVISION, NORTHRIDGE, CA - EIRS, 483S, CO RESPS 8/1/10 TO 1/31/11 ABC LABS, COLUMBIA, MO - EIRS. 483S, CO RESP 8/10 TO 1/11 BIONIME CORP - RIGHTTEST BLOOD GLUCOSE MONITORING SYS K092052 PRINCETON BIOMEDTECH CORP - BIOSIGN FLU A+B K083746 ASHLEY A PIGGOTT ESQ MORRIS POLICH & PURDY LLP VINTAGE PHARMACEUTICALS LLC, HUNTSVILLE, AL METOCLOPRAMIDE AERS, EIRS, 483S, ETC FDA/OMPT/CDRH/OCER/DFOI/ PATRICIA S RITTER RN FRANK L BARNSON LAW OFFICES AHSLEY A PIGGOTT ESQ MORRIS POLICH & PURDY LLP QUALITEST PHARMACEUTICALS INC, HUNTSVILLE, AL METOCLOPRAMIDE AERS, EIRS, 483S, ETC PROLIFT MESH - MDRS, WARNINGS Signature/ Requester LLP Subject INTELLISENSE FINE FORCE TECHNOLOGY, ETC RECALL, CLEARANCE, TRAINING RECS
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Total Records: 12455 Control # 2011-1991 Recd Date / Due Date 03/15/2011 04/12/2011 2011-1992 2011-1993 2011-1994 2011-1995 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1996 2011-1997 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1998 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-1999 2011-2000 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2001 2011-2002 2011-2003 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON J KNIPPER & COMPANY INC, LAKEWOOD, NJ - EIRS, 483S, CO RESPS 8/1/10 - 1/31/11 LANCASTER LABS, LANCASTER, PA - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 DYNAMIT NOBEL GMBH, KALKSTRASSE, LEVERKUSEN, ORA/SW-FO/KAN-DO/COMP/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS CELSIS LABORATORY GROUP, ST LOUIS, MO - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 LABOR L&S AG, BAD BOCKLET GROSSENBRACH, GERMANY - 483, CO RESP 8/10 TO 1/31/11 ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS MICRONISIERUNGS KONTOR OBERROT GMBH, OBEROTT GERMANY - 483, CO RESP 8/10 TO 1/31/11 ORA/CE-FO/PHI-DO/PCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS ALMAC CLINICAL SERVICES, AUDUBON, PA - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 BESPAK EUROPE LTD, NORFOLK, ENGLAND - 483, CO RESP 8/10 TO 1/31/11 ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/CIN-DO/CCB/ Action Office ORA/CE-FO/CHI-DO/CCB/ Signature/ Requester ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS AQNGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS Subject CATALENT PHARMA SOLUTIONS (CARDINAL HEALTH PACKAGING SERVICES, STERILE TECNOLOGIES), WOODSTOCK, IL - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 PATHEON, CINCINNATI, OH - EIRS, 483S, CO RESP 8/1/10 1/31//11 PPD LABS, MIDDLETON, WI - EIRS, 483S, CO RESP - 8/1/101/31/11 PATHEON (MOVA PHARMACEUTICAL CORP), MANATI, PR EIRS, R83S, CO RESP 8/1/10 - 1/31/11 PATHEON, MISSISSAUGA, ONTARIO CANADA - 483, CO RESP 8/10 TO 1/31/11
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Total Records: 12455 Control # Recd Date / Due Date 04/12/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2004 2011-2005 2011-2006 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2007 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2008 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2009 2011-2010 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2011 2011-2012 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2013 03/15/2011 04/12/2011 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS PFIZER INC, KALAMAZOO, MI - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 ORA/CE-FO/MIN-DO/MCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS PACE ANALYTICAL LIFE SCIENCES LLC, OAKDALE, MM EIRS, 483S, CO RESP 8/1/10 - 1/31/11 SHASUN PHARMA SOLUTIONS, NORTHUMBERLAND, ENGLAND - 483, CO RESP 8/10 TO 1/31/11 ORA/NE-FO/NYK-DO/NYDCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS NORWICH PHARMACEUTICALS INC, N0RWICH, NY - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 PATHEON INC, BOURGOIN JALLIEU, CEDEX FRANCE - 483, CO RESP 8/10 TO 1/31/11 ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS PATHEON INC, BURLINGTON, ONTARIO CANADA - 483, CO RESP 8/10 TO 1/31/11 ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS PATHEON, INC, WHITBY, ONTARIO CANADA - 483, CO RESP 8/10 TO 1/31/11 ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/SAN-DO/SFCB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS MEDCOMM SOLUTIONS, EMERYVILLE, CA - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 NEXT BREATH LLC, BALTIMORE, MD - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 NYCOMED GMBH, SINGEN, GERMANY - 483, CO RESP 8/10 TO 1/31/11 Signature/ Requester KENDLE REGULATORY AFFAIRS Subject GERMANY - 483, CO RESP 8/10 TO 1/31/11
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Total Records: 12455 Control # 2011-2014 2011-2015 Recd Date / Due Date 03/15/2011 04/12/2011 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2016 2011-2017 2011-2018 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 2011-2019 03/15/2011 04/12/2011 2011-2020 03/15/2011 04/12/2011 2011-2021 03/15/2011 04/12/2011 2011-2022 03/15/2011 04/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2023 03/15/2011 04/12/2011 2011-2024 03/15/2011 04/12/2011 2011-2025 03/15/2011 04/12/2011 2011-2026 03/15/2011 ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC ANGELIA D SLAYTON UNIV OF IOWA, PHARMACETUICAL SERVICES DIV, COLLEGE OF PHARMACY, IOWA CITY, IA - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 OLYMPUS MEDICAL SYSTEMS CORP, HACHIOJI SHI, JAPAN - EIR MOST RECENT PARALLEL DESIGN SAS, SOPHIA ANTIPOLIS CEDEX, FRANCE - EIR MOST RECENT UPS SUPPLY CHAIN SOLUTIONS, LOUISVILLE, KY - EIRS, FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/BLT-DO/CB/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICIA S RITTER RN FRANK L BARNSON LAW OFFICES PHARMACEUTICS INTERNATIONAL INC, HUNT VALLEY, MD - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 PHARMAGISTICS LLC, SOMERSET, NJ - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 MEDISON CO LTD, HONGCHEON GUN, REPUBLIC OF KOREA - EIR MOST RECENT PANASONIC HEALTHCARE CO LTD, SAIJO, JAPAN - EIR MOST RECENT PANASONIC HEALTHCARE CO LTD, YOKOHAMA, JAPAN EIR MOST RECENT OLYMPUS MEDICAL SYSTEMS CORP, NISHITAMA GUN, JAPAN - EIR MOST RECENT SEPTOCAINE (ARTICAINE HCL) - AERS Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS Subject 3M HEALTH CARE LTD, LOUGHBOROUGH LEICESTERSHIRE UK - EIRS, 483, CO RESP 8/10 TO 1/31/11 AEROCAN FRANCE SAS, (ALCAN CEBAL), BELLEGARDE FRANCE - 483, CO RESP 8/10 TO 1/3/11
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Total Records: 12455 Control # Recd Date / Due Date 04/12/2011 2011-2027 03/15/2011 04/12/2011 2011-2028 2011-2029 2011-2030 03/15/2011 04/12/2011 03/15/2011 04/12/2011 03/15/2011 04/12/2011 2011-2031 03/15/2011 04/12/2011 2011-2032 03/15/2011 04/12/2011 2011-2033 03/15/2011 04/12/2011 2011-2034 03/15/2011 04/12/2011 2011-2035 03/15/2011 04/12/2011 2011-2036 03/15/2011 04/12/2011 2011-2037 03/15/2011 04/12/2011 2011-2038 03/15/2011 04/12/2011 2011-2039 03/15/2011 ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester KENDLE REGULATORY AFFAIRS PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH PARKS MEDICAL ELECTRONICS, INC, ALOHA, OR - EIR MOST RECENT NEUSOFT MEDICAL SYSTEMS IMPORT & EXPORT CO LTD, SHENYANG, CHINA - EIR MOST RECENT PHILIPS ULTRASOUND INC, REEDSVILLE, PA - EIR MOST MEDI-STIM ASA, OSLO, NORWAY - EIR MOST RECENT PJ ELECTRONICS CO LTD, PUCHEON, REPUBLIC OF KOREA - EIR MOST RECENT PENTAX SOUTHERN REGION SERVICE CTR, GRIDIRON, TX - EIR MOST RECENT MAQUILAS TETA KAWI SA DE CV, DEPARTMENTO PREC, GUADALAJARA, MEXICO - EIR MOST RECENT MEDI-STIM ASA, HORTEN, NORWAY - EIR MOST RECENT PENTAX MEDICAL CO, MONTVALE, NJ - EIR MOST RECENT Subject 483S, CO RESP 8/1/10 - 1/31/11 PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO LTD, SHENYANG LIAONING CHINA - EIR MOST RECENT UPS SUPPLY CHAIN SOLUTIONS (UNIT C&D), RENO, NV EIRS, 483S, CO RESP 8/1/10 - 1/31/11 WEST ANALYTICAL SERVICES LLC, MAUMEE, OH - EIRS, 483S, CO RESP 8/1/10 - 1/31/11 PLEXUS CORP LTD, KELSO, UK - EIR MOST RECENT
Page 41 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/12/2011 2011-2040 03/15/2011 04/12/2011 2011-2041 03/15/2011 04/12/2011 2011-2042 03/15/2011 04/12/2011 2011-2043 03/15/2011 04/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OCIO/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2044 03/15/2011 04/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2045 2011-2046 2011-2047 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2048 03/16/2011 04/13/2011 CBER/OCTMA/DDOM/ALFB/ CVM/OCD/ NOELLE CALLAHAN PHYSICIANS COMMITTEE FOR RESPONSI PHOTOGRPAPHS, VIDEO FOOTAGE OF CHIMPANZEES CURRENTLY OR FORMERLY OWNED BY THE FDA KENDLE REGULATORY AFFAIRS FRAN KOCH INFORMATION ACCESS KATHERYN PATTERSON SHINN GORDON & REES LLP IOVATE HEALTH SCIENCES USA INC - HYDROXYCUT REGULAR RAPID RELEASE CAPLETS, CAFFEINE-FREE RAPID RELEAASE CAPLETS, LIQUID SHOTS, ETC RECS FOI DAILY LOG 2/28/11 - 3/4/11 FOI DAILY LOG 2/28/11 - 3/4//11 JIM M. PERDUE, Jr. PERDUE & KIDD LLP TRIAD GROUP INC - MEDWATCH FORM 10/11 TO 3/1/11 HAMILTON PHD, LEROY L ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CHI-DO/CCB/ Action Office Signature/ Requester SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC PHILIPS ULTRASOUND INC, BOTHELL, WA - EIR MOST RECENT PHILIPS MEDICAL SYSTEMS, ANDOVER, MA - EIR MOST RECENT RECORDS RETENTION POLICY FOR BACKUP FILES Subject RECENT PLEXUS CORP, BUFFALO GROVE, IL - EIR MOST RECENT
Page 42 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ 2011-2049 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/ATL-DO/ACB/ CVM/OCD/ OC/OCC/ 2011-2050 03/16/2011 04/13/2011 ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ 2011-2051 03/16/2011 04/13/2011 CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ERIC LIPTON NEW YORK TIMES REP ANNA ESHOO - CORR 2005 TO PRESENT RICK TOMLINSON CALIFORNIA STRAWBERRY COMMISSION FOODBORNE DISEASE OUTBREAKS ASSOCIATED WITH STRAWBERRIES - RECS 1998-2007 WILLIAM R MONTROSS JR LAW OFFICE OF THE SOUTHERN CENTER FOR HUMAN RIGHTS DR CARLO MUSSO, CORRECTHEALTH, RAINBOW MEDICAL ASSOCS, GEORGIA DEPT OF CORRECTIONS SODIUM THIOPENTAL USED FOR THE PURPOSE OF EXECUTION RECS, CORR 1/10 Signature/ Requester Subject
Page 43 of 1132

Total Records: 12455 Control # 2011-2052 Recd Date / Due Date 03/16/2011 04/13/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2053 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2054 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2055 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2056 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2057 03/16/2011 04/13/2011 2011-2058 2011-2059 2011-2060 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ SOLER, ALBERTO ORA/CE-FO/PHI-DO/PCB/ WOLKOFF, JERRY ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ MICHAEL MCKITTERICK SAFE FOOD NOW HICKMAN'S EGG RANCH INC, BUCKEYE, AZ - RECS 1/00 TO PRESENT INSTRUMENTATION INDUSTRIES INC, BETHEL PARK, PA EIR 3/11 STEPHAN CHEMICAL CO - NATURAL FLAVOR DISTRIBUTION TO OTHER COMPANIES IN FOOD PRODS NIKI LEE TLC BIOPHARMACEUTICALS INC APUTIT INC, MO; COLDSTREAM LABORATORIES INC, KY; XENOBIOTIC LABORATORIES INC, NJ - GMP INSP; PHARMANET, NJ - GCP INSP BARBARA A BINZAK BUCHANAN INGERSOLL & ROONEY PC WARFIN (COUMADIN) NDA 09-218/S101 - POSTMARKETING SAFETY RVWS CRAMER #426488, TIMOTHY POLY-VI-FLOR/IRON - AERS LIEU, HSIAO D EISAI PHARMACEUTICALS INC - QUININE DERIVATIVE (E3330) RECS MINTONG GUO YISCON TECH CO LTD GD SEARLE LLC - COVERA-HS (VERAPAMIL HCL) NDA 20552 CMC QUALITY & CLNCL RVWS Signature/ Requester BRENDA SOUZA ONO PHARMA USA INC Subject XALATAN - SBA
Page 44 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/NJ-DO/NJCB/ 2011-2061 2011-2062 2011-2063 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 2011-2064 2011-2065 2011-2066 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2067 2011-2068 03/16/2011 04/13/2011 03/16/2011 04/13/2011 2011-2069 2011-2070 03/16/2011 04/13/2011 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ 2011-2071 03/16/2011 04/13/2011 FDA/OF/CFSAN/OCD/EOS/ WILBUR JOHNSON JR COSMETIC INGEDIENT REVIEW DISODIUM LAURETH SULFOSUCCINATE, TRISODIUM SULFOSUCCINATE, MAGNESIUM LAURETH-3 SULFOSUCCINATE, ETC - CHEMISTRY, METABOLISM, TOXICITY RECS, ETC BAYER HEALTHCARE - BEYAZ NDA 22-532 APRVL 9/10 FOI SERVICES INC ORA/CE-FO/BLT-DO/CB/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ PATTI WALLER MARLER CLARK ATTYS LIBBY CAMPBELL ELLIS LAWHORNE & SIMS PA LIBBY CAMPBELL ELLIS LAWHORNE & SIMS PA WILBUR JOHNSON JR COSMETIC INGEDIENT REVIEW TINY GREENS SPROUTS - SALMONELLA OUTBREAK 11/10 TO 12/10, 1/11 TO 2/11 CORR, TEST RESULTS, RPTS, ETC R THOMAS STANLEY, DAVID E STANLEY, 7 OAKS PHARMACEUTICAL CORP - OATHS, AFFIDAVITS, RPTS, ETC MARK SZCZAWINSKI, JESTOR TECHNOLOGY PARTNERS INC - OATHS, AFFIDAVITS, RPTS, ETC BENZYL ALCOHOL, BENZOIC ACID, SODIUM BENZOATE, ETC - CHEMISTRY, METABOLISM, TOXICITY RECS FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS TIM LAWTON C-REG MEDICAL TIM LAWTON C-REG MEDICAL IMAGING THERAPEUTICS INC - OSDX HIP BMD SYS K082402 MOEHS CATALANA SL RUBI PLANT, BARCELONA, SPAIN EIR, 483, WARNING LTR, CO RESP 2/10 MICROMRI INC, LANGHORNE - BONE VUE K083691 CLOSED FOI REQUESTS 3/14-20/11 FOI SERVICES INC CLOSED FOI REQUESTS 3/14-21/11 FOI DAILY LOG 2/28/11 - 3/4/11 Signature/ Requester Subject
2011-2072
03/16/2011 04/13/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
Page 45 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2073 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2074 03/16/2011 04/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2075 03/16/2011 04/13/2011 2011-2076 2011-2077 2011-2078 2011-2079 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/16/2011 04/13/2011 2011-2080 2011-2081 03/16/2011 04/13/2011 03/16/2011 04/13/2011 2011-2082 2011-2083 03/16/2011 04/13/2011 03/16/2011 04/13/2011 2011-2084 03/16/2011 04/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC LAURA HERR JONES NATURAL CHEWS ERIC ROSSMAN ROSSMAN LAW GROUP ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC CHRISTOPHE LELONG MED-IMAPS ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC CHRISTOPHE LELONG MEDIMAPS ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC ZIMMER INC - DIRECT CURRENT BONE BROWTH STIMULATOR P790008 SS&E IMAGING THERAPEUTICS INC - OSDX HIP BMD SYS K082402 ORTHOFIX INC - PHYSIO-STIM P850007 SS&E BIOMET INC - ORTHOPAK P850022 SS&E MICROMRI INC, LANGHORNE - BONEVUE K083691 DJ ORTHOPEDICS LLC - ORTHOLOGIC P910066 SS&E 2011-1206 (CERTIFIED) FDA/OMPT/CDRH/OCER/DFOI/ ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC OSTEOSTIM ORTHOFUSE MODEL - SS&E DATA RECS P850035 VENOUS HEALTH SYSTEMS - VASCULAIRE COMPRESSION SYS K103113 CMPLNT 119584 JOAN STITT (UG2CD16) MERCK & CO., INC. MYLAN - ALENDRONATE SODIUM ANDA 76-584 APRVL LTR, RVWS, PI JOAN STITT (UG2CD-16) MERCK & CO., INC. DR REDDY'S LABS INC - ALENDRONATE SODIUM ANDA 79049 APRVL LTR, RVWS, PI Signature/ Requester Subject
Page 46 of 1132

Total Records: 12455 Control # 2011-2085 Recd Date / Due Date 03/16/2011 04/13/2011 2011-2086 03/16/2011 04/13/2011 2011-2087 03/16/2011 04/13/2011 2011-2088 03/16/2011 04/13/2011 2011-2089 2011-2090 03/16/2011 04/13/2011 03/16/2011 04/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-2091 2011-2092 2011-2093 03/16/2011 04/13/2011 03/16/2011 04/13/2011 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2094 2011-2095 2011-2096 2011-2097 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ HALLBERG, CHRIS KEITH A BARRITT FISH & RICHARDSON PC ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ MICHAEL C BILL ADVANCED VISION RESEARCH BRENDA M GARTZ ELI LILLY & CO HORIZON PHARMACEUTICALS INC, RIVIERA BEACH, FL EIR 7/09 AMYLIN PHARMACEUTICALS INC, WEST CHESTER, OH EIR 10/13-15/10 DEVILBISS 3655 SERIES PULMO-AIDE COMPACT COMPRESSOR - K020932 MIM SOFTWARE - MOBILE MIM PACS K103785 ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ MICAHEL McKITTERICK SAFE FOOD NOW MICAHEL McKITTERICK SAFE FOOD NOW BRENDA M GARTZ ELI LILLY & CO COLORADO EGG LLC, GRAND JUNCTION, CO - CORR, CMPLNTS, RPTS, ETC 1/00 TO PRESENT ARMSTRONG EGG RANCH, VALLEY CENTER, CA - CORR, CMPLNTS, RPTS, ETC 1/00 TO PRESENT ORION CORP, ESPOO, FINLAND - EIRS 9/10 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC ERELA DANA MUSCULOSKELETAL CLINICAL REGULATORY ADVISORS LLC BRIAN P. SHARKEY PORZIO BROMBERG & NEWMAN PC LINDA TOWLER, CPA AVERY BIOMEDICAL DEVICES BRENT H. JORDAN THE LAW FIRM OF JORDAN & GREER IMPLUS FOOTCARE LLC - LITTLE HOTTIES HAND AND BODY WARMERS CMPLNTS, LAWSUTIS, INVESTIGATIONS, ETC; INDIVIDUAL RECS NEURX DIAPHRAGM PACING SYS - 510K RIVERS EDGE PHARMACEUTICALS LLC - CMPLNTS, CORR EBI LP - BIO OSTEOGEN SYS 204 P790002 SS&E SMITH AND NEPHEW CO - EXOGEN P900009 SS&E Subject EBI LP - OSTEOSTIM SS&E P790005
Page 47 of 1132

Total Records: 12455 Control # 2011-2098 2011-2099 2011-2100 2011-2101 2011-2102 2011-2103 Recd Date / Due Date 03/17/2011 04/14/2011 03/17/2011 05/10/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2104 03/17/2011 04/14/2011 2011-2105 2011-2106 03/17/2011 04/14/2011 03/17/2011 04/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2107 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2108 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2109 03/17/2011 04/14/2011 ORA/ORO/DIOP/ ORA/ORO/DIOP/ BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & IMPORT REFUSALS 10/01 TO 8/06 VALERIA SENA-WELTIN WEINBERG GROUP INC DOCETAXEL INJ NDA 22-234 - APRVL RECS WILLIAM YOUNGBLOOD JOHNSON MATTHEY ENDO PHARMACEUTICALS HOLDINGS INC - OPANA ER NDA COMPLETE RESP LTR 1/7/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester BOBBY SCHOCHET OLSSON FRANK & WEEDA WYNNE CATHCART ERICKSON MORRISON & FOERSTER LLP FATIMA ASLAM Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP KEEVE E NACHMAN PHD Johns Hopkins Bloomberg School of Public Health SHAWN P KELLY CITY AND COUNTY OF SAN FRANCISCO CITY ATTORNEY DAYLE CALLAGHAN ROUSE LEGAL BARBARA J WAGNER BARNWELL WHALEY ET AL SANOFI PASTEUR SA - ACTHIB VACCINE APRVL LTRS, PI, RECS, ETC BEFORE 2000 RANBAXY PHARMACEUTICALS INC - SIMVOR, SIMVOTIN, SIMVASTATIN AERS MELENGESTROL ACETATE RESIDUE IN CATTLE - FOOD SAFETY TESTING; NADA034-254, NADA 039-402 - FOI SUMMARY, ETC F ALIOTO COMPANY INC - CORR, INSP 2001 TO PRESENT RICE BRAN FIBER - GRN 373 GLUCOAMYLASE (GA) ENZYME - GRN 372 GI DYNAMICS INC, SEEDLING ENTERPRISES - INTESTINAL SLEEVE DVC RECS KRILL OIL - GRN 371 Subject SOCK IT ORAL PAIN GEL - K063148
Page 48 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester ASSOCIATES LLC 2011-2110 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2111 2011-2112 2011-2113 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2114 2011-2115 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2116 03/17/2011 04/14/2011 2011-2117 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2118 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2119 03/17/2011 04/14/2011 2011-2120 03/17/2011 04/14/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ APRIL HOLLIS FDA NEWS APRIL HOLLIS FDANEWS CEREBRAL HEALTH, JUPITER, FL; CARDIOPULMONARY INSTRUMENTATION, DORAL, FL; QUASAR BIO-TECH (DBA SILVER BAY), SARASOTA, FL, ETC - 483S 2/1-28/11 ACTIVE MEDICAL SUPPORT, GRETNA, LA; CROWN HEALTH CARE LAUNDRY SERVICES, SELMA, AL - 483S 2/1-28/11 PARTHA BASUMALLIK LANNETT COMPANY INC KADIAN (MORPHINE SULFATE ER CAPS) NDA 20-616 - SBA ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DEN-DO/COMP/ APRIL HOLLIS FDA NEWS KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. FRESENIUS MEDICAL CARE, OGDEN, UT; CEDARBURG HAUSER PHARMACEUTICALS, DENVER, CO; CODY LABS, CODY, WY, ETC - 483S 2/1-28/11 ISOXSUPRINE HCL - DESI FINDING & RVW ORA/SE-FO/ATL-DO/ACB/ APRIL HOLLIS FDA NEWS MICHAEL TSAY KPC PRODUCTS INC TRANSENTERIX, DURHAM, NC; BD DIAGNOSTICS, MEBANE, NC - 483S 2/1-28/11 TESTUDINIS (CHINEMYS NIGRICANS) ENTRY #D520941897-4; MANTIS COCOON, SANG PIAO XIAO ENTRY #D52-0936622-3 - ANALYTICAL RESULTS CBER/OCTMA/DDOM/ALFB/ RYDER, CHERYL APRIL HOLLIS FDA NEWS FDA/OF/CFSAN/OCD/EOS/ ANNE ANDREWS ANDREWS & THORNTON CVD 103-HGR (TRAVELER'S DIARRHEA VACCINE) - ANIMAL STUDIES, RESULTS TEVA PHARMACEUTICALS FINE CHEMICALS, BULCIAGO, COMO, IT; CADILA HEALTHCARE LTD, AHMEDABAD CITY, IN; STRIDES ARCOLAB LTD, BANGALORE, IN, ETC - 483S 2/1/-28/11 HYDROXYCUT - AERS, CORR, RECALL RECS 2009 YAEL JULIE FISCHER KIRKLAND & ELLIS LLP MUTUAL PHARMACEUTICALS CO - QUININE SULFATE NDA 21-799 TELECONFERENCE TRANS, MINS 6/13/05 Subject
Page 49 of 1132

Total Records: 12455 Control # 2011-2121 Recd Date / Due Date 03/17/2011 04/14/2011 2011-2122 03/17/2011 04/14/2011 2011-2123 03/17/2011 04/14/2011 2011-2124 2011-2125 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2126 03/17/2011 04/14/2011 2011-2127 03/17/2011 04/14/2011 2011-2128 2011-2129 2011-2130 2011-2131 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2132 2011-2133 2011-2134 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2135 03/17/2011 04/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/SAN-DO/SFCB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDANEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDANEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDANEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS R IAN KLUGE Hyman Phelps and McNamara PC UNITED THERAPEUTICS, SILVER SPRING, MD; 3CPM CO, TOWSON, MD - 483S 2/1-28/11 UPSHER SMITH LABS, PLYMOUTH, MN; CAMBRIDGE MAJOR LABS, GERMANTOWN, WI; AD-TECH MEDICAL INSTRUMENT CORP, RACINE, WI - 483S 2/1-28/11 FORFEITURE OF 180-DAY EXCLUSIVITY UNDER FDC ACT (FAILURE TO OBTAIN TENTATIVE APPROVAL) - MEMOS ET MEDICAL DEVICES, CAVARENO, IT; SAGAMI RUBBER INDUSTRIES, ATSUGI CITY, JP; INION, TAMPERE, FL, ETC 483S 2/1-28/11 GERITREX CORP, MOUNT VERNON, NY; NYCOMED, HICKSVILLE, NY; SONOMED, NEW HYDE PARK, NY, ETC 483S 2/1-28/11 HOFFMAN LA ROCHE, NUTLEY, NJ; JACOBUS PHARMACEUTICAL CO, PLAINSBORO, NJ; CATALENT PHARMA SOLUTIONS, SOMERSET, NJ, ETC - 483S 2/1-28/11 INNOVATIVE MEDICAL EQUIPMENT, LYNDHURST, OH 483S 2/1-28/11 LEHIGH VALLEY TECHNOLOGIES, ALLENTOWN, PA; OTOVATION, KING OF PRISSIA, PA - 483S 2/1-28/11 LONE STAR MEDICAL PRODUCTS, STAFFORD, TX - 483S 2/1-28/11 PRIMAPHARM, SAN DIEGO, CA; PYRAMID LABS, COSTA MESA, CA; BRENNTAG PACIFIC, CHANDLER, AZ, ETC - 483S 2/1-28/11 STANDING CO, SAGINAW, MI - 483S 2/1-28/11 Subject APLICARE, MERIDEN, CT; ALEXION PHARMS, SMITHFIELD, RI; CHASMA SCIENTIFIC, CAMBRIDGE, MA, ETC - 483S 2/128/11 AVINGER, REDWOOD CITY, CA; STARION INSTRUMENTS, SUNNYVALE, CA; XEMAX SURGICAL PRODUCTS, NAPA, CA, ETC - 483S 2/1-28/11 BUCKEYE INTERNATIONAL, MARYLAND HEIGHTS, MO; PETNET SOLUTIONS, ST LOUIS, MO; KV PHARM, MARYLAND HEIGHTS, MO, ETC - 483S 2/1-28/11 CARDINAL HEALTH, ANASCO, PR - 483S 2/1-28/11
Page 50 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2136 03/17/2011 04/14/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DFI/ ORA/ORO/DFI/ ORA/ORO/DFS/ ORA/ORO/DFS/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-2137 03/17/2011 04/14/2011 2011-2138 2011-2139 2011-2140 2011-2141 2011-2142 2011-2143 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2144 2011-2145 03/17/2011 04/14/2011 03/17/2011 04/14/2011 2011-2146 03/18/2011 04/15/2011 ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/DET-DO/DCB/ BRENDA M GARTZ ELI LILLY & CO BAXTER PHARMACEUTICAL SOLUTIONS, BLOOMINGTON, IN - EIR 9/10 ORA/NE-FO/NWE-DO/NWECB/ BECK, ROBERT. PAUL W. TRIPP LINCARE INC MRB ACQUISITION CORP, FL; TN - EIR, 483, WARNING LTRS 3/03 TO PRESENT ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/SJN-DO/SJCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ Doe J ONA SCANDURRA COUNTRY LIFE LLC KATHLEEN PORUPSKI MYLAN INC HOGAN LOVELLS US LLP IMPAC MEDICAL SYSTEMS - MOSAIC SOFTWARE RECALL #Z-1027-2011 RECS SANTA CRUZ NUTRITIONALS, SANTA CRUZ, CA; RHG & CO INC, MIDDLETOWN, CT - 483, EIR 6/09 TO PRESENT PHARMACEUTICAL INSPS DONE BY SAN JAN DISTRICT OFFICE - WARNING LTRS, 483S, DATES, ETC 2005 TO PRESENT ARMSTRONG PHARMS, ROXBURY, MA; CANTON, MA - 483S OC/COS/OL/ ANJAN MUKHEJEE DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE AARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL 2011-1382 INDIVIDUAL RECS INDIVIDUAL RECS SEN SCOTT BROWN - CORR 2/4/10 TO PRESENT RICK TOMLINSON CALIFORNIA STRAWBERRY COMMISSION RASPBERRY CYCLOSPORA OUTBREAK 1996, 1997, 2000, 2001 - RECS Signature/ Requester Subject
Page 51 of 1132

Total Records: 12455 Control # 2011-2147 2011-2148 2011-2149 2011-2150 2011-2151 Recd Date / Due Date 03/18/2011 04/15/2011 03/18/2011 04/15/2011 03/18/2011 04/15/2011 03/18/2011 04/15/2011 03/18/2011 04/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2152 03/18/2011 04/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2153 03/18/2011 04/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2154 03/18/2011 04/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2155 2011-2156 03/18/2011 04/15/2011 03/18/2011 04/15/2011 2011-2157 03/18/2011 04/15/2011 2011-2158 03/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ ORA/OE/ ORA/OE/ FDA/OMPT/CDRH/OCER/DFOI/ ROBIN LL ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY ALFREDA TILLMAN BESTER MAKO SURGICAL CORP, FT LAUDERDALE, FL - ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS HIP (RIO-HIP) K091998 MEDTRONIC - SATELLITEL SPHERE COCR SPACER APRVL, RECALL DAY, LIZ FDA/OMPT/CDRH/OCER/DFOI/ CHARLOTTE BAKER COVIDIEN NELLCOR (COVIDIEN) - OXIMAX N-600X PUSE OXIMETER K060576 RECALLS AND FIELD CORRECTIONS, BIOLOGICS CLASS II, III 1/1/06-3/15/11 R IAN KLUGE Hyman Phelps and McNamara PC APPVD DRUG PRODS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS - LIST OF 3-YEAR MARKETING EXCLUSIVITY 1984 TO 2010; LIST OF NDA APRVLS WITHDRAWN FOR SAFETY OR EFFECTIVENESS ELIZABETH K BARBENHEN PUBLIC CITIZEN ARICEPT NDA 20-690 5 & 10 MG TABS - APRVL LTR, RVWS JOANN DAWSON ELI LILLY & CO STAXYN NDA 20-179 - APRVL HISTORY, LTRS RVWS, ETC ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO JOANN DAWSON ELI LILLY & CO REMEL INC, THERMO FISHER SCIENTIFIC, LENEXA, KS EIR 3/18/10 FORTESTA NDA 21-463 - APRVL HISTORY, LTRS RVWS, ETC Subject BOEHRINGER INGELHEIM PHARMS, RIDGEFIELD, CT - EIR 9/10 AVID RADIOPHARMACEUTICALS, PHILADELPHIA, PA - EIR 11/10 ICON CLINICAL RESEARCH, PA - EIR 6/9-15/10
Page 52 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/15/2011 2011-2159 03/18/2011 04/15/2011 2011-2160 03/18/2011 04/15/2011 2011-2161 03/18/2011 04/15/2011 2011-2162 2011-2163 03/18/2011 04/15/2011 03/18/2011 04/15/2011 2011-2164 03/18/2011 04/15/2011 2011-2165 03/18/2011 04/15/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/OCI/ ORA/OCI/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/NE-FO/NWE-DO/NWECB/ Doe J GREGORY W WHEELER LAW OFC OF GREGORY W WHEELER DOUGLAS N BLUE ZETETIC DOUGLAS N BLUE ZETETIC INC RECKITT BENCKISER, MYSORE, INDIA; UTTARAKHAND, INDIA - DETTOL ANTISEPTIC LIQUID AND HANDWASH ENTRY #AFQ-0026287-1 IMPORT REFUSAL RECS RECKITT BENCKISER, MYSORE, INDIA; KESHAV EXPORTS PVT LTD, BANGALORE, INDIA - DETTOL LIQUID ENTRY KM6-0048439-8/6/1, KM6-0048439-8/6/2, KM6-004839-8/6/3 IMPORT REFUSAL RECS TALECRIS BIOTHERAPEUTICS INC - GAMUNEX-C) BLA 125046 VAERS 6926338, 6952381, 7386776, ETC HONEYDEW & CANTALOUPE MELONS ENTRY DM40305253-1 ANALYTICAL RPTS, W/S FROZEN FOOD - EIR 4/5/10 CMPLNT 117247 FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester TILLMAN BESTER & ASSOCIATES LLC NED FEDER PROJECT GOVRRNMENT OVERSIGHT ALFREDA TILLMAN BESTER TILLMAN BESTER & ASSOCIATES LLC YUO-LING CHOU TLC BIOPHARMACEUTICALS INC ICAD INC - SECONDLOOK COMPUTER-AIDED DETECTION SYS P010038 APRVL LTR 4/4/08 MEDICAL PROCEDURE, MEDICAL PROD OR MEDICAL DVC SEEKING APRVL 1/00 TO PRESENT APTUIT, KANSAS CITY, MO; COLDSTREAM LABORATORIES INC, LEXINGTON, KY; XENOBIOTIC LABORATORIES INC, PLAINSBORO, NJ, ETC - GMP INSP RPT Subject
2011-2166 2011-2167
03/18/2011 04/15/2011 03/18/2011 04/15/2011
CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/ ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ CVM/OCD/
MARY ANN LAMB Talecris Biotherapeutics, Inc. DANIEL G JARCHO MCKENNA LONG & ALDRIDGE LLP
2011-2168
03/18/2011 04/15/2011
DONNER, BARBARA
CANIDAE, TASTE OF THE WILD, WELLNESS, ETC - OMEGA 3 SOURCES (FISH) IN DRY DOG FOOD RPTS
2011-2169
03/18/2011 04/15/2011
OC/OM/OMP/DDM/
MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION
DKT FDA-1995-S-0039
Page 53 of 1132

Total Records: 12455 Control # 2011-2170 2011-2171 2011-2172 2011-2173 2011-2174 Recd Date / Due Date 03/21/2011 04/18/2011 03/21/2011 04/18/2011 03/21/2011 04/18/2011 03/21/2011 04/18/2011 03/21/2011 04/18/2011 2011-2175 03/21/2011 04/18/2011 2011-2176 03/21/2011 04/18/2011 2011-2177 03/21/2011 04/18/2011 2011-2178 03/21/2011 04/18/2011 2011-2179 2011-2180 2011-2181 03/21/2011 04/18/2011 03/21/2011 04/18/2011 03/21/2011 04/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2182 03/21/2011 04/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ MATTHEW D RIFAT LAW OFFICES OF MATTHEW D RIFAT LLP EXELINT INTERNATIONAL - NON-CORING (HUBER) NEEDLES SAFETY INVESTIGATION, LTR TO MFG, CORR, ETC 2009 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/ATL-DO/ACB/ Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO PETER JORDAN OLYMPUS BUILDING SERVICES INC PETER JORDAN OLYMPUS BUILDING SERVICES INC PETER JORDAN OLYMPUS BUILDING SERVICES INC PETER JORDAN OLYMPUS BUILDING SERVICES INC PETER JORDAN OLYMPUS BUILDING SERVICES INC AMY L GOERSS HODGSON RUSS LLP AARON W GARCIA WALKUP MELODIA ET AL AARON W GARCIA WALKUP MELODIA ET AL MUIRKIRK ROAD COMPLEX, LAUREL, MD - CONTRACT FDA-SOL-06-00132 JOHNSON RESEARCH, PARMA, ID - EIR 4/19/10 MPI RESEARCH, MATTAWAN, MI - EIRS 6/28/10-7/7/10 TRA LABS, ATHENS, GA - EIRS 3/23-25/10 Subject CHERI-HILL, STARWOOD, MI - EIR 5/12/10
MUIRKIRK ROAD COMPLEX, LAUREL, MD - CONTRACT FDA-SOL-06-0032 CONTRACT MODIFICATIONS MUIRKIRK ROAD COMPLEX, LALUREL, MD - CONTRACT FDA -SOL-06-0032 SOURCE EVALUATION BOARD NOTES MUIRKIRK ROAD COMPLEX, LAUREL, MD - CONTRACT FDA-SOL-06-0032 CURRENT CONTRACTOR & ANNUAL PRICE MUIRKIRK ROAD COMPLEX, LAUREL, MD - CONTRACT FDA-SOL-06-0032 SOURCE EVALUATION BOARD INSTRUCTIONS IMAGING THERAPEUTICS INC - OSDX HIP BMD SYS K082402 DEPUY ORTHOPAEDICS (JOHNSON & JOHNSON) - ASR HIP RESURFACING SYS 510K DEPUY ORTHOPAEDICS (JOHNSON & JOHNSON) - ASR XL ACETABULAR SYS 510K
Page 54 of 1132

Total Records: 12455 Control # 2011-2183 2011-2184 Recd Date / Due Date 03/21/2011 04/18/2011 03/21/2011 04/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2185 03/21/2011 04/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2186 03/21/2011 04/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2187 03/21/2011 04/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2188 03/21/2011 04/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2189 03/21/2011 04/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2190 03/21/2011 04/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2191 03/21/2011 04/18/2011 ORA/SE-FO/ATL-DO/ACB/ MATTHEW S KNOOP ASHE RAFUSE & HILL LLP RIVER'S EDGE PHARMACEUTICALS LLC, SUWANEE, GA RESP TO WARNING LTR ATTACHMENTS 2,3,4,5,8 6/10/10 ASHLEY GARGOUR BERG & ANDROPHY ASTRAZENECA PLC, ASTRAZENCA PHARMACEUTICALS PLC - CRESTOR APRVL APPL, CLNCL STUDIES, ETC NOELLE C LETTEN BERG & ANDROPHY EISAI CO LTD - ARICEPT CORR, CLNCL STUDIES 2002 TO 2010 ROBERT T BURNS PUTNAM INVESTMENTS SANOFI AVENTIS DEUTSCHLAND GMBH - RESP TO WARNING LTR WL 320-11-09 2/9/11, 1/11, OBSERVATION RPTS, 9/6,10,13-16/10, ETC ROBERT R FREEDMAN WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE YOHIMBINE - IND 25104 1989 FOI SERVICES INC AUROBINDO PHARMA LTD (UNIT VI, IV), HYDERABAD, ANDHRA PRADESH, INDIA - 483 12/10 ANDY GRAGOVIC LAW OFC SOMMERS SCHWARTZ THORATEC - HEARTMATE II LEFT VENTRICULAR SYS (LVAS) MDRS 1/08 TO PRESENT Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CHRISTINE M HUMPHREY C. Humphrey & Associates PETER SAMBERG WEITZ & LUXEMBERG PC Subject PREMD INC, ROCKVILLE, MD - LDI & VDI PRECIPITATION CHOLESTEROL VIA ESTERASE-OXIDASE HDL K062092 ZIMMER HOLDINGS - METASUL DUROM ACETABULAR COMPONENT 510KS, MDRS, CLNCL TRIALS, ETC
Page 55 of 1132

Total Records: 12455 Control # 2011-2192 2011-2193 Recd Date / Due Date 03/21/2011 04/18/2011 03/21/2011 04/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ 2011-2194 2011-2195 03/21/2011 04/18/2011 03/21/2011 04/18/2011 CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DEN-DO/COMP/ CTP/OD/ CTP/OD/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ CTP/OD/ CTP/OD/ 2011-2196 03/21/2011 04/18/2011 2011-2197 2011-2198 2011-2199 03/21/2011 04/18/2011 03/21/2011 04/18/2011 03/21/2011 04/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-2200 03/21/2011 04/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC CLOSED FOIA REQUESTS 3/7-11/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ GEOFFREY MILLISOM ADLER POLLOCK & SHEEHAN PC MARK YOUNG MARK YOUNG PA ANDI POULSON LEXIS NEXIS COURTLINK INC EVAN MOSS BARTHCO INTERNATIONAL INC ENTRY 1113-5228945-5 - LAB RESULTS 2011-680 FCN 935 2010-4281 - REDACTED RECS CONNIE J QUINTERO SCHERR & LEGATE ATTY MICHAEL GIVEL UNIV OF OKLAHOMA POLITICAL SCIENCE DEPT DCI BIOLOGICAL INC/LAS CRUCES BIOLOGICALS LLC CMPLNTS, INVESTIGATIONS, EVALUATIONS, ETC TOBACCO PRODUCT SCIENTIFIC A/C - POLICY & LEGAL DETERMINIATIONS, PUBLIC RELATIONS RECS, FINANCIAL RECS, ETC Action Office ORA/CE-FO/BLT-DO/CB/ SENTEMENTES, GUS G CHRISTINA WADE PERRONE ROSE WALKER LLP Signature/ Requester Subject MEDIFAST INC, OWINGS MILLS, MD - EIRS, WARNING LRTS, CONSUMER CMPLNTS, ETC LAST 3 YRS WMI ENTERPRISE, LLC; WMI ENTERPRISES INC, WABASH MEDICAL LLC, ETC - COMM
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Total Records: 12455 Control # 2011-2201 2011-2202 Recd Date / Due Date 03/21/2011 04/18/2011 03/21/2011 04/18/2011 2011-2203 2011-2204 03/21/2011 04/18/2011 03/21/2011 04/18/2011 ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-2205 2011-2206 03/21/2011 04/18/2011 03/22/2011 04/19/2011 CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ 2011-2207 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2208 03/22/2011 04/19/2011 2011-2209 2011-2210 03/22/2011 04/19/2011 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2211 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ RENE SIEWCZYNSKI ARZNEI-TELEGRAMM FOREST LABS - MONUROL (FOSFOMYCIN TROMETHAMINE) PI 1997 FDA/OF/CFSAN/OCD/EOS/ OC/OSHC/OPD/ PAUL KETTERIDGE PD REGULATORY CONSULTING LLC MEGAN S BAZURTO ESQ KLINEDINST PC GARY E MILLER MD ALTERNATIVE SERVICES NETWORK IMMUNEX CORP - NOVANTRON E/MITOXANTRONE NDA 19297, NDA 21-120 ORPHAN DRUG DESIGNATION WELLA BLONDOR LIGHTENING POWDER, WELLA KOLESTON PERFECT CREME DEVELOPER - RECS TRILEPTAL (OXCARBAZEPINE) COMBINED WITH MONOAMINE OXIDASE INHIBITORS - AERS SCOTT269681-B/638141, EDWARD J ASTRAZENENCA - SEROQUEL AERS, RECS OC/OM/OMP/DDM/ BONNIE CHARPENTIER METABOLEX, INC. ANEET PANESAR BURDOCK GROUP ANITOX CORP - FAP 2237 EMDAC TRANS 2/5/75 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ FOI SERVICES INC JUNE K GHEZZI JONES DAY BELINDA O' BOBANY HOLLINGSWORTH LLP EVAN MOSS BARTHCO INTERNATIONAL INC ENTRY 113-5279431-4 - LAB RESULTS HUGGINS & MAXWELL LTD, LAS VEGAS, NV - LUPRON DEPOT LTRS, RESP TO LTRS; PHARMA GENSIS INC, ROCKVILLE, MD - LTRS, RESP TO LTRS DKT FDA-1996-P-0153, 1998P-0150, 1998P-0218, ETC. Signature/ Requester Subject CLOSED FOIA REQUETS 3-14-18/11
Page 57 of 1132

Total Records: 12455 Control # 2011-2212 Recd Date / Due Date 03/22/2011 04/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2213 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2214 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2215 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2216 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2217 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2218 03/22/2011 04/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2219 03/22/2011 ORA/SE-FO/NOL-DO/NOCB/ MICHELLE HOLBROOK DR TIMOTHY MELSON, HELLEN KELLER HOSPITAL, CAMPBELL, MATTHEW AMBIEN CR - AERS ERIC LIPTON NEW YORK TIMES REP ANNA ESHOO - CORR 2007 TO PRESENT ALEX VEIZIS FDALIVE.COM CDER A/C MTGS - COSTS, ANNUAL FEES, WEBCAST FEES, ETC IMRE SZENTPETERI MD EGIS PLC EFFIENT (PRASUGREL) NDA 22-307/S001 - BIOEQV RECS BETHANY FARMER INFOTRIEVE INC DESI: CURRENT STATUS AND UNAPPROVED DRUGS (PRESENTATION) 10/22/03 CATHERINE LEOMY KOHLER PHARM D ACTELION CLINICAL RESEARCH INC ZYRTEC (CETIRIZINE TABS) NDA 19-835 - SBA Signature/ Requester BARBARA JONES DOMINION GROUP INC Subject TEVA PHARMS - ALMOTRIPTAN MALATE ANDA 78-027 APRVL LTR
Page 58 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/19/2011 2011-2220 2011-2221 2011-2222 2011-2223 03/22/2011 04/19/2011 03/22/2011 04/19/2011 03/22/2011 04/19/2011 03/22/2011 04/19/2011 2011-2224 2011-2225 03/22/2011 04/19/2011 03/22/2011 04/19/2011 2011-2226 2011-2227 03/22/2011 04/19/2011 03/22/2011 04/19/2011 2011-2228 2011-2229 2011-2230 2011-2231 03/22/2011 04/19/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 CTP/OD/ CTP/OD/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-2232 03/23/2011 04/20/2011 2011-2233 03/23/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ OM/OMP/DODM/ OC/COS/OES/ COLEEN KLASMEIER PROFESSIONAL SOCIETIES OF PHYSICIANS, NURSES, DR PAVEL NOVAK STORZ MEDICAL DKT 2009P-0023 ORA/NE-FO/NWE-DO/NWECB/ OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ NATIONAL MEDICAL ASSOCIATION MARILYNN WHITNEY COVINGTON & BURLING LLP ROSS RENDELMAN HOGAN LOVELLS US LLP JAMES W STEARNS MOUNTAIN DAIRY STORMY POWELL C/O HARRY POWELL YUKON CHARLIE'S TOBACCO PRODUCTS PROCEDURE FOR IMPORTATION & CONSUMPTION OF CHEMICAL-FREE ORGANIC TOBACCO LEAVES FROM THE PHILLIPINES CMPLNT #117691 DKT LOG FDA-2004-D-0500 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/CHI-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ MCCANN, JOE CHARLOTTE VALLAEYS CORNUCOPIA INSTITUTE CHARLOTTE VALLAEYS CORNUCOPIA INSTITUTE MARTEK BIOSCIENCES CORP - INFANT FORMULAS CONTAINING DHASCO & ARASCO GRAS RECS 6/09 TO PRESENT INFANT FORMULAS CONTAINING DHA & ARA - CAERS 11/08 TO PRESENT FDA HEALTH PROFESSIONAL BRIEFING FOR BENLYSTA TRANS 3/14/11 DKT FDA-2010-N-0621, FDA-2010-P-0491 MYLAN INC, WV, IL, TX, ETC - EIRS, 483S 1/11 TO PRESENT ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester RHO INC AMY L GOERSS HODGSON RUSS LLP CHRISTOPHER LEONIENCO CANGENE CORP JOHNDA L CRITES BAKER & BOTTS, L.L.P. AMY L FRIEDMAN MD UPSTATE MEDICAL UNIV JEAN-PAUL CLOZEL MD, ACTELION PHARMACEUTICALS US INC - WARNING LTR CORR 1/5/11 (CERTIFIED) TELEFLEX MEDICAL - HEM-O-LOK LIGATING CLIP K062914 CLASS II RECALLS, RECS ORTHO BIOTECH - EIRS, 483S 2007-2010 Subject SHEFFIELD, AL - EIRS, 483S 10/29/96 TO PRESENT MICROMRI INC - BONEVUE K083691
Page 59 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/20/2011 2011-2234 2011-2235 2011-2236 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2237 03/23/2011 04/20/2011 2011-2238 03/23/2011 04/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ ORA/CE-FO/CHI-DO/CCB/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2239 2011-2240 03/23/2011 04/20/2011 03/23/2011 04/20/2011 2011-2241 2011-2242 2011-2243 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 2011-2244 2011-2245 03/23/2011 04/20/2011 03/23/2011 ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ HELLEN A OKETCH PHD USP PHARMACOPEIA MARILYNN WHITNEY COVINGTON & BURLING LLP BRIJ GUPTA PHD RIJ PHARMACEUTICAL CORPORATION LINDA HIBBS PREMIER RESEARCH GROUP MELINDA F LEVITT ESQ ZEAXANTHIN TRADE ASSN - CORR, RECS 1/10 TO PRESENT RIJ PHARMACEUTICAL CORP, MIDDLETOWN, NY - 483 5/2427/10 SENSORMEDICS - MODEL 3100 HIGH-FREQUENCY OSCILLATORY VENTILATOR P890057 SS&E DR KAREN K WINER MD, NICHD - EIR 1/12/10-2/3/10 CAERS DATABASE 1/05 TO 2/11 CBER/OCTMA/DDOM/ALFB/ brady, james CARLOS LEON TWIN TAILS SEAFOOD CORP CANNED CRAB MEAT - ENTRY JF7-0085620-2 ANALYSIS RESULTS MSM BLOOD DONATION DEFERRAL - RECS DEJESUS, JUDITH ELECTRONIC CIGARETTES - RECS WOLF WORMS WORMS & HIRSCH INC BAXTER HEALTHCARE CORP - COLLEAGUE INFUSION PUMPS CONSENT DECREE 6/29/06, CORR, RECALLS, ETC RUST, ROBERT FDA/OMPT/CDRH/OCER/DFOI/ Action Office OC/COS/OES/ ORA/SW-FO/DEN-DO/COMP/ CRAM, GREGORY B THOMAS J QUINN Medical Resource Alliance RECKITT BENCKISER - SUBOXONE (BUPRENOPHINE) AERS INITIAL RPT - 8411702 Signature/ Requester SIDLEY AUSTIN LLP Subject PHARMACOLOGISTS - UNAPPROVED OFF-LABEL USES OF APRVD DRUGS LTR 4/27/93 AMERICAN BIOTECH LABS LLC, ALPINE, UT - 483S
Page 60 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/20/2011 2011-2246 2011-2247 2011-2248 2011-2249 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 2011-2250 2011-2251 03/23/2011 04/20/2011 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2252 2011-2253 03/23/2011 04/20/2011 03/23/2011 04/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2254 2011-2255 2011-2256 2011-2257 2011-2258 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TINA MAYER LUMENIS INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SUZAN ONEL K & L GATES LINDA HIBBS PREMIER RESEARCH GROUP APP PHARMS - DIPRIVAN (PROPOFOL) NDA 19-627 INTEGRATED SUMMARY OF SAFETY ESWALLOW USA - DYSPHAGIA THERAPY KIT K092202 FOI DAILY LOG 3/14-18/11 FOI DAILY LOG 3/7-11/11 LUMENIS LTD, YOKNEAM, ISRAEL - EIRS 5/25-28/09 ERIKA MORKEVICH Cerner Galt JUHI SINGH INNOPHARMA LLC ETON - EDECRIN ETHACRYNATE SODIUM POWDER INJ NDA 16-093 SBA FOI DAILY LOG 1/1/11 TO 3/17/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ Action Office Signature/ Requester FOLEY & LARDNER LLP W PATRICK NOONAN W PATRICK NOONAN W PATRICK NOONAN W PATRICK NOONAN W PATRICK NOONAN W PATRICK NOONAN CRAIG NELSON MD COUNTY OF SAN DIEGO OFFICE OF THE MEDICAL EXAMINER W PATRICK NOONAN W PATRICK NOONAN SATISH PEJAVER INNOPHARMA LLC NBTY MANUFACTURING, SOUTH PLAINFIELD, NJ - EIRS, 483S, CO RESP, ETC LAST 5YRS APP PHARMS - FLUPHENAZINE DECANOATE INJ ANDA 71413 SBA NBTY MANJFACTURING LLC, ANAHEIM, CA - EIRS, 483S, CO RESP, ETC LAST 5YRS NBTY MANUFACTURING, BOHEMIA, NY - EIRS, 483S, CO RESP, ETC LAST 5YRS NBTY MANFACTURING LLC, BOHEMIA, NY - EIRS, 483S, CO RESP LAST 5YRS CMPLNT #117488 Subject
Page 61 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-2259 2011-2260 03/23/2011 04/20/2011 03/23/2011 04/20/2011 2011-2261 03/23/2011 04/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2262 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2263 03/23/2011 04/20/2011 2011-2264 03/23/2011 04/20/2011 2011-2265 03/23/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/NJ-DO/NJCB/ 2011-2266 03/23/2011 04/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-2267 03/23/2011 04/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC CARDIOPULMONARY CORP BERNOULLI VENTILATOR MANAGEMENT SYS K011861 TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC CARDIOPULMONARY CORP - VENTURI VENTILATOR K 943412 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC JAMES A WELLS HAINES & ASSOCIATES CARDIOPULMONARY CORP - MODIFICATION TO BERNOULLI VENTILATOR MAN K0220018 OCTAPHARMA USA INC - OCTAGAM (IMMUNE GLOBULIN INTRAVENOUS HUMAN) LIQUID PREPARATION EIRS, RPTS LTRS, ETC 10/20/10, 9/23/10 ALLAN BOYE JENSEN INTERACOUSTICS A/S K946229 INNA PENDRAK JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT, LLC ISR 1710316-5, 1768678-9 JOAN STITT (UG2CD-16) MERCK & CO., INC. JAN MARIE EBERTH UNIV OF TEXAS MD ANDERSON CANCER CENTER LAVENIA FORD CARDINAL HEALTH MAMMOGRAPHY FACILITIES CERTIFIED IN THE USA ANNUAL INSP 2000 TO 2010 ADVANCED STERILIZATION PRODUCTS, IRVINE, CA STERRAD STERILIZATION POUCH K951295 FOI DAILY LOGS 2/28/11-3/4/11 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-2268 Recd Date / Due Date 03/23/2011 04/20/2011 2011-2269 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ 2011-2270 03/23/2011 04/20/2011 2011-2271 03/23/2011 04/20/2011 2011-2272 03/23/2011 04/20/2011 2011-2273 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2274 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2275 03/23/2011 04/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2276 03/23/2011 04/20/2011 OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J LEVAQUIN - BOXED WARNINGS, STUDIES Doe J LEVOTHYROXINE - AERS 2007, 2008, 2009, 2010, 2011 Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC JOHNDA L CRITES BAKER & BOTTS, L.L.P. CARDIOPULMONARY CORP - BERNOULLI MANAGEMENT SYS (MS) SOFTWARE K061932 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester TRACEY MOYER DRAAGER MEDICAL SYSTEMS INC JOSE M BIAGGI JUNQUERA BIAGGI & BIAGGI PSC ATTY AT LAW Subject CARDIOPULMONARY CORP - VENTURI VENTILATOR K982174 MCNEIL PPC INC - TYLENOL EXTRA STRENGTH EIRS, CMPLNTS, RPTS, ETC
CARDIOPULMONARY CORP - MODIFICATION TO BERNOJULLI VENTILATOR MAN K051283 CARDIOPULMONARY CORP - BERNOULLI MANAGEMENT SYS OXINET Iii K091461 FASUDIL DATA FAFETY & MONITORING BOARD TELECONFERENCE - MINS 11/23/04; BERLEX LABS FASUDIL HCL ORAL MINS 9/21/01; BERLEX LABS INC FASUDIL NDA, IND, PRE-IND MTGS 12/10-12/01, ETC (CERTIFIED) TEVA - PRAVASTATIN 10 MG CMPLNTS
Page 63 of 1132

Total Records: 12455 Control # 2011-2277 Recd Date / Due Date 03/23/2011 06/02/2011 2011-2278 03/24/2011 04/21/2011 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2279 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2280 2011-2281 2011-2282 2011-2283 2011-2284 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 2011-2285 03/24/2011 05/19/2011 2011-2286 03/24/2011 04/21/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2287 03/24/2011 04/21/2011 2011-2288 03/24/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ CHRISTOPHER HO GUANGZHOU GALAXY FOOD PRODUCTS CO LTD MICHELE SINOWAY PHD GUANGZHOU GALAXY FOODS PRODUCTS CO LTD, HONG KONG, CHINA - EIR 1/25/11 SANOFI-WINTHROP INDUSTRIES, MAISONS, FRANCE INSP 12/10 RECS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ CBER/OCTMA/DDOM/ALFB/ DAYLE CALLAGHAN ROUSE LEGAL DR GAYATRI SABERWAL INSTITUTE BIOINFORMATICS & APPLIED BIOTECHNOLOGY LEDERLE/WYETH - HIBTITER; MERCK - PEDVAXHIB (LIQUID FORM, LYOPHILISED FORM), ETC SBA, PI, APRVL LTRS, ETC US PATENTS ON BIOLOGICS - RECS YOUNG, DARRYL MAURICE BARBARA JONES DOMINION GROUP INC SUSAN BROWN MCCORMICK & COMPANY INC ENTRY #EGA-0002817-4 - LAB RESULTS FOI DAILY LOG 1/1-31/07 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ GARY LAZER BUC & BEARDSLEY MARILYN WHITNEY COVINGTON & BURLING LLP FOI GUIDE, SAMPLE REQUEST, FAQ, ETC DKT 1991N-0326 DKT 1988P-0365, 1994P-0387 ART SPIVY TETRADIGM GROUP PEPTAVLON NDA 017-048 - APRVL LTRS, SUMMARY RVWS, APRVL RECS Signature/ Requester JAMES K REUSS CARPENTER LIPPS & LELAND LLP TERRY J ENFIELD KLEINFELD, KAPLAN & BECKER Subject THE KROGER CO OR INTER-AMERICAN PRODUCTS, SPRINGFIELD, TN - CONTAMINATED PET FOOD PRODS CORR, RPTS, NOTES, ETC 10/23/10 SUPREP BOWEL PREP KIT NDA 22-372 - ACTION PKG
Page 64 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/21/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2289 2011-2290 2011-2291 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 2011-2292 2011-2293 2011-2294 2011-2295 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 2011-2296 2011-2297 2011-2298 2011-2299 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ CORTES, DAVE FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC GROTON LABS, PFIZER INC, GROTON,CT 10/27/10; PFIZER INC, PEARL RIVER, NY 1/10/10; PHARMACIA, UPJOHN CO, KALAMAZOO, MI 9/28/10, ETC - 483S ORA/NE-FO/NWE-DO/NWECB/ FOI SERVICES INC FAP OBO125 FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC PHUSION PROJECTS LLC (DRINK FOUR BREWING CO) FOUR LOKO CAERS 2005 TO PRESENT CHARLES RIVER, SHREWSBURY, MA - 482 2/22/10-3/3/10 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC JEFF STACHEWICZ FOIA GROUP INC CONTRACT #HHSF223200630254G FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FRESENIUS MEDICAL - 2008K AT HOME WITH WIRELESS WETNESS DETECTOR K070049 DADE BEHRING - DIMENSION VISTA INTEGRATED SYS K051087 LIFECELL CORP - LTM WOUND DRESSING K082103 FDA/OMPT/CDRH/OCER/DFOI/ DIERINGER, CHARLES CHEYENNE JOHNSON FEDSOURCES INC GLOBAL NET SERVICES INC - CONTRACT #HHSF223201000054I FDA/OF/CFSAN/OCD/EOS/ JIM HUANG BEMIS COMPANY, INC INTER OCULAR LENSES - STUDY RECS, APRVL RECS FCN 1018 Signature/ Requester LACHMAN CONSULTANT SERVICES, INC. Subject
Page 65 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2300 03/24/2011 04/21/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ 2011-2301 2011-2302 2011-2303 2011-2304 2011-2305 2011-2306 2011-2307 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2308 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2309 03/24/2011 FDA/OMPT/CDER/ORP/DIDP/ SATISH PEJAVER APP PHARMS - FLUPHENAZINE DECANOATE INJECTABLE MICHELE SINOWAY LACHMAN CONSULTANT SERVICES, INC. RP SCHERER GMBH & KG, EBERBACH, GERMANY - EIR 3/10 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ABULHAJ, RAMZI SATOHIKO TAKANASHI KOWA COMPANY LTD MICHELE SINOWAY LACHMAN CONSULTANT SERVICES, INC. MACCO ORGANIQUES, SALABERRY-DE-VALLEYFIELD, CANADA - EIR 4/10 CANON INC - CX-1 K092565 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MCCANN, JOE PEGGY WALLACE PEGGY WALLACE ATTY AT LAW PEGGY WALLACE PEGGY WALLACE ATTY AT LAW K050906 SUMMIT ACETABULAR SYS - K983014 FDA/OMPT/CDRH/OCER/DFOI/ TRACEY MOYER DRAGER MEDICAL INC CARDIOPULMONARY CORP - MODIFICATION TO VENTURI VENTILATOR K990429 KCI - ACTIVAC, VAC FREEDOM2; CONVATEC - ENGENEX, ETC NPWT SYS MDRS 2000 TO PRESENT PINNACLE ACETABULAR SYS - K000306 CORTES, DAVE BAXTER HEALTHCARE CORP, CHERRY HILL, NJ 10/29/10; BAXTER HEALTHCARE (BAXTER HEALTHCARE OF PR), GUAYAMA, PR 9/3/10; BAXTER HEALTHCARE CORP, LOS ANGELES, CA, 8/27/10, ETC - 483S Signature/ Requester Subject
Page 66 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/21/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2310 2011-2311 2011-2312 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 2011-2313 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2314 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2315 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2316 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2317 03/24/2011 04/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2318 2011-2319 03/24/2011 04/21/2011 03/24/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC ALLERGAN - ZYMAXID NDA 22-548 APRVL RECS UNTITLED LTR 10-SJN-UTL-03 FOI SERVICES INC B BRAUM - CEFAZOLIN & DEXTROSE NDA 50-779 SUPPLEMENTAL APRVL MOST RECENT FOI SERVICES INC WATSON LABS - NICOTINE POLACRILEX GUM ANDA 79-038 APRVL RECS FOI SERVICES INC GUANFACINE - ISRS 3030429, 3091287, 3115085, ETC FOI SERVICES INC ISTA - BROMDAY NDA 21-664/S013 APRVL RECS DIERINGER, CHARLES ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/FLA-DO/FCB/ POBANZ, BEN MICHELE SINOWAY LACHMAN CONSULTANT SERVICES, INC. NEULASTA (PEGFILGRASTIM) - AERS, CMPLNT PROTOCOLS, ONLINE DATABASE, ETC ORA/SE-FO/FLA-DO/FCB/ BRADLEY S CLANTON BAKER DONELSON ET AL NORTH MIAMI RESEARCH INC, NORTH MIAMI, FL - 483S, WARNING LTRS 7/14/08 LIST OF LICENSED SEAFOOD & SEAFOOD PROCESSING FACILITIES IN FLORIDA ELI LILLY & CO, INDIANAPOLIS, IN - EIRS 9/09 Signature/ Requester INNOPHARMA LLC Subject 25MG/ML INJECTION SBA ANDA071413
Page 67 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/21/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2320 03/24/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-2321 2011-2322 2011-2323 2011-2324 2011-2325 2011-2326 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 03/24/2011 04/21/2011 2011-2327 03/24/2011 04/21/2011 2011-2328 2011-2329 2011-2330 03/24/2011 04/21/2011 03/25/2011 04/22/2011 03/25/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ DOMINION GROUP INC GLADYS B TONKIN Center for Regulatory Services, Inc. KENNETH REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS SUZANNE M VOGEL SIMILAC HUMAN MILK FORTIFIER CONCENTRATED LIQUID - RECS 2009 TO PRESENT HOLOGIC INC - P920048/S006; ADEZA BIOCHEMICAL FOI DAILY LOG 3/7-11/11 FOI DAILY LOG 3/7-11/11 FOI DAILY LOG 3/7-11/11 FOI DAILY LOG 3/7-11/11 FOI SERVICES INC FOI DAILY LOG 3/7-11/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 3/7-11/11 FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 3/7-11/11 FOI DAILY LOG 3/7--11/11 FOI SERVICES INC COVANCE LABS, HARROGATE, UK 1/09; VIENNA, VA 7/09; COVANCE RESEARCH PRODUCTS, DEDHAM, MA 9/09, ETC - EIRS, 483S, CO RESP Signature/ Requester FOI SERVICES INC Subject
Page 68 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/22/2011 2011-2331 2011-2332 2011-2333 2011-2334 2011-2335 2011-2336 2011-2337 2011-2338 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 2011-2339 2011-2340 2011-2341 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2342 03/25/2011 04/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2343 03/25/2011 04/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LI, FENG NAPROXCINOD NDA 22-478 - LIST OF OFFICERS OR EMPLOYERS, SUMMARY RWV FOR REGULATORY ACTION, TEAM LEADER RVW, ETC 7/20/10, 6/1/10 LI, FENG OFIRMEV NDA 22-450 - LIST OF OFFICERS OR EMPLOYERS, SUMMARY RVW FOR REGULATORY ACTION, TEAM LEADER RVW, ETC 2/9/10, 2/10/10, 10/14/09 LI, FENG FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ OC/OSHC/OPD/ FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ ORA/ ORA/ OC/OM/OMP/DDM/ MCCANN, JOE ROSS RENDELMAN HOGAN LOVELLS LLP MARIE KUKER KUKER REGULATORY CONSULTING SUSAN B MILLS WEINBERG WHEELER ET AL KYLE O'CONNOR CONVATEC EURAND PHARMACEUTICALS INC - FLUTICASONE PROPIONATE ORPHAN PROD DESIGNATION SHEPHERD POULTRY FARMS LLC, SPANISH FORK, UT SALMONELLA OUTBREAK RECS 9/10 TO 12/10 DISPOSABLE ECG MONITORING ELECTRODES - K990112, K990110, K990111 SPRIX NDA 22-382 - LIST OF OFFICERS OR EMPLOYERS, CLNCL SUMMARY RVW, TEAM LEADER RVW, ETC 5/14/10, 9/27/09, 8/10/09 DKT FDA-2004-D-0500 ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester ALERE SCARBOROUGH INC PETS HESS HOME HEARTH GRAINS SYBIL SHAINWALD ATTY SYBIL SHAINWALD LAW OFCS SYBIL SHAINWALD ATTY SYBIL SHAINWALD LAW OFCS DAVID G PERKINS ABBOTT LABORATORIES, INC. PREEYA M NORONHA LATHAM & WATKINS LLP LIST OF HIGH-RISK PHARMACEUTICAL MFG COMPANIES RESINOUS AND POLYMERIC COATINGS - RECS Subject P920048/S003 HESCO ENTERPRISES INC (DBA HOME HEARTH GRAINS) REGISTRATION, PIN NUMBER BIOSPHERE MEDICAL INC - MDRS, APRVL RECS, LBLG CHANGES, ETC DERMIK LABS/SANOFI-AVENTIS US LLC - MDRS, APRVL RECS, LBLG CHANGES, ETC CELLAY INC, CAMBRIDGE, MA - EIR 6/10
Page 69 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-2344 03/25/2011 04/22/2011 2011-2345 2011-2346 03/25/2011 04/22/2011 03/25/2011 04/22/2011 2011-2347 2011-2348 2011-2349 2011-2350 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ Ranteesi, Simon FRAN KOCH INFORMATION ACCESS SUSAN B MILLS WEINBERG WHEELER ET AL ESSBENSHADE FARMS INC, MOUNT JOY, PA, MARIETTA PA, HILLSIDE POULTRY FARMS INC, CHAMBERSBURG, PA, SHIPPENSBURG, PA ETC - SALMONELLA OUTBREAK 9/10 TO 12/10 RECS 2010-8876 2010-8940 2010-8934 2010-8933 DOROTHY EGG FARMS LLC, WINTHROP, TURNER, ME, MAINE CONTRACT FARMING LLC, TURNER, ME, MOUNTAIN HOLLOW FARMS LLC, LEEDS, ME, ETC - SALMONELLA OUTBREAK 9/10 TO 12/10 RECS ZOLOFT (SERTRALINE) - AERS 2010-9469 ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ SUSAN B MILLS WEINBERG WHEELER ET AL NELSON LOPEZ GRIFOLS BIOLOGICALS INC SUSAN B MILLS WEINBERG WHEELER ET AL FRAN KOCH INFORMATION ACCESS PAXIL - AERS BEAVERDAM FARM, MOUNTVILLE, SC, GAINES & ANDY JOHNSON FARM, TROY, SC, GIBSON POULTRY, SALUDA, SC ETC - SALMONELLA OUTBREAK 9/10 TO 12/10 RECS 2010-9135 NEW DAY FARMS LLC, RAYMOND, OH, WEST MANSFIELD, OH; OHIO FRESH EGGS LLC, CROTON, OH, JOHNSTOWN, OH, ETC - SALMONELLA OUTBREAK 9/10 TO 12/10 RECS RUGER CHEMICAL, LINDEN, NJ - EIRS, 483S 1/1/07-3/1/11 Signature/ Requester Subject
2011-2351 2011-2352 2011-2353 2011-2354 2011-2355
03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/25/2011 04/22/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/
FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS SUSAN B MILLS WEINBERG WHEELER ET AL
2011-2356
03/25/2011 04/22/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
SOFIA BRUERA BLIZZARD MCCARTHY & NABERS LLP
2011-2357
03/25/2011
ORA/CE-FO/PHI-DO/PCB/
BRADLEY BAKER
ENVIRONMENTAL TECTONICS CORP - EIRS 7/31/08-8/27/08
Page 70 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/22/2011 2011-2358 03/25/2011 04/22/2011 ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester ENVIROMENTAL TECTONICS CORP SUSAN B MILLS WEINBERG WHEELER ET AL NATIONAL FOOD CORP HQ, EVERETT, WA, NATIONAL FOOD CORP HILLTOP, STANWOOD, WA, NATIONAL FOOD CORP STANWOOD FARM, STANWOOD, WA, ETC - EIRS, 483S, RPTS 9/10-12/10 MILBAR LABS, EAST HAVEN, CT - EIRS 1/22-27/10 VIVITROL NDA 21-897 - LIST OF OFFICERS OR EMPLOYERS, SUMMARY RVW FOR REGULATORY ACTION, TEAM LEADER RVW, ETC 9/24/10, 9/27/10, 10/12/10 Subject
2011-2359 2011-2360
03/25/2011 04/22/2011 03/25/2011 04/22/2011
ORA/NE-FO/NWE-DO/NWECB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
JAMES LL KADOW OBAGI MEDICAL PRODUCTS LI, FENG
2011-2361 2011-2362 2011-2363
03/25/2011 04/22/2011 03/25/2011 04/22/2011 03/28/2011 06/20/2011
CTP/OD/ CTP/OD/ FDA/OO/OFBA/OAGS/ OM/OMP/DODM/ ORA/CE-FO/DET-DO/DCB/
ANDREW ZAJAC TRIBUNE NEWSPAPERS FLECHSIG, NATALIE HELENA BOTTEMILLER FOOD AND ENVIRONMENT REPORTING NETWORK INC
STAR SCIENTIFIC INC - ARIVA-BDL, STONEWALL-BDL PRODS FDA NOTICES DIRECT-TO CONSUMER GENETIC TESTS PUBLIC MTG TRANS 3/8-9/11 DOUGLAS L FELLER DVM, ELANCO ANIMAL HEALTH, GREENFIELD, IN - 483 3/12-22/02, 6/4/02 ELI LILLY, AVID PHARMS - AMYVID (FLORBETAPIR F18 INJ) NDA RESP LTR
2011-2364
03/28/2011 04/25/2011
MICHAEL A CAROME MD PUBLIC CITIZEN
2011-2365
03/28/2011 04/25/2011
HELEN GUTGARTS SYBIL SHAINWALD LAW OFCS
ROCHE THERAPEUTICS INC - BONIVA AERS, LBLG CHANGES, APRVL RECS, ETC
2011-2366 2011-2367
03/28/2011 04/25/2011 03/28/2011 04/25/2011
FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
MOLLY SHUBERT HANN VERMONT LAW SCHOOL FOI SERVICES INC
RAW MILK CHEESEMAKERS - 60-DAY AGING RULE 2009 DR MARTHA HAGAMAN - NIDPOE RESP & CONSENT AGREEMENT 1/9/06
2011-2368
03/28/2011
CVM/OCD/
PFIZER ANIMAL HEALTH - RIMADYL INDIVIDUAL RECS
Page 71 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/25/2011 2011-2369 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2370 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2371 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2372 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2373 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-2374 03/28/2011 04/25/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2375 03/28/2011 FDA/OMPT/CDER/ORP/DIDP/ MICHELE SINOWAY PHD INSTITUTE FOR ENERGY TECHNOLOGY, KJELLER, ERIC A NORMAN LYBECK MURPHY LLP DEPUY - PINACLE HIP REPLACEMENT SYS MDRS, 510K APPL, CERTIFCATIONS, ETC FOI SERVICES INC HEMORRHOIDAL DRUG PRODUCTS ADVISORY REVIEW PANEL - RPT 1/24/78; STERLING DRUG INC, NEW YORK, NY - PHENYLEPHRINE RECS PURSUANT TO 38 FR 10307 4/26/73; OTC VOLS 120013, 120014 FOI SERVICES INC DR LOUIS FABRE - NIDPOE RESP & CONSENT AGREEMENT 6/23/08 FOI SERVICES INC DR DANIEL BERGER - NIDPOE RESP & CONSENT AGREEMENT 9/11/10 FOI SERVICES INC DR JACQUES CALDWELL - NIDPOE RESP & CONSENT AGREEMENT 5/11/06 FOI SERVICES INC Action Office Signature/ Requester Doe J DR PRAMOD RAVAL - NIDPOE RESP & CONSENT AGREEMENT 8/25/08 Subject
Page 72 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2376 2011-2377 03/28/2011 04/25/2011 03/28/2011 04/25/2011 2011-2378 03/28/2011 04/25/2011 CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2379 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2380 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2381 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2382 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2383 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2384 03/28/2011 04/25/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ KRISTIE M CARTER SIDNEY P COMINSKY LLC ADVANCED BIONICS, SYLMAR, CA - 483S, CO RESP 2001, 2004 MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM OXYCODONE, ACETAMINOPHEN - AERS 2009 TO PRESENT MICHAEL J LASZLO LASZLO & ASSOCIATES LLC MERCK & CO INC - PROSCAR WARNING LTRS, AERS, COMM, ETC PRASANNA SUNTHANKER REVOGENEX INC CADENCE PHARM - OFIRMEV IV ACETAMINOPHEN NDA 22-450 SBA MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM FENTANYL - AERS 2009 TO PRESENT MICHAEL J LASZLO LASZLO & ASSOCIATES LLC MERCK & CO INC - PROPECIA WARNING LTRS, AERS, COMM, ETC LAUREN R SILVIS SIDLEY AUSTIN LLP LAUREN R SILVIS SIDLEY AUSTIN LLP KEVIN CWAYNA URBAN APPS STAR SCIENTIFIC INC - MODIFIED RISK TOBACCO PROD CORR STAR SCIENTIFIC INC - CENTER FOR TOBACCO PRODUCTS RESP CONCERNING APPL TO MARKET A MODIFIED RISK TOBACCO PROD SANOFI AVENTIS - DRONEDARONE AERS Signature/ Requester LACHMAN CONSULTANT SERVICES INC Subject NORWAY - INSP 2/10
Page 73 of 1132

Total Records: 12455 Control # 2011-2385 Recd Date / Due Date 03/28/2011 04/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2386 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2387 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2388 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2389 03/28/2011 04/25/2011 CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SEA-DO/SCB/ ELIZABETH M QUICK LAW OFFICES OF ELIZABETH QUICK PLLC MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM SEATTLE CANCER CARE ALLIANCE, FRED HUTCHINSON CANCER RESEARCH CENTER, UW MEDICINE - STEM CELL PRODS AERS, CMPLNTS, AUDITS, EIRS, ETC 1/02 TO PRESENT KETOROLAC - AERS 2009 TO PRESENT MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM PROPOFOL - AERS 2009 TO PRESENT MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM DESFLURANE - AERS 2009 TO PRESENT MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM MIDAZOLAM - AERS 2009 TO PRESENT Signature/ Requester MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM Subject CEFAZOLIN - AERS 2009 TO PRESENT
2011-2390
03/28/2011 04/25/2011
2011-2391 2011-2392 2011-2393 2011-2394
03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011
ORA/CE-FO/NJ-DO/NJCB/ BUTLER, MARIE ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ STEPHEN RUETHER MEDTRONIC ANDREW JACOB PANDOL PANDOL BROS INC PAIGE SAVITZ BEAVER STREET FISHERIES INC MELISSA FOSS PHARM D
CLEMENT PAPPAS & CO INC, SEABROOK, NJ - 483S 9/1/10 TO 3/21/11 THERMO FISHER SCIENTIFIC REMEL, LENEXA, KS - OXIOD PRODS 483 3/18/10 DAVY COLD STORAGE, VINELAND, NJ - EIRS 2/10/11 FROZEN FROG LEGS ENTRY 595-4767194-7 - ANALYTICAL RESULTS
2011-2395
03/28/2011
BUPIVACAINE, LIDOCAINE, ROPIVACAINE - AERS 2009 TO
Page 74 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2396 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2397 03/28/2011 04/25/2011 2011-2398 03/28/2011 04/25/2011 2011-2399 03/28/2011 04/25/2011 2011-2400 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ 2011-2401 03/28/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-2402 2011-2403 2011-2404 2011-2405 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DR MARK WHOLEY - CONSENT AGREEMENT 7/19/06, NIDPOE RESP 11/05 DR STEPHEN RAPER - WARNING LTR RESP 12/00, CONSENT AGREEMENT 2/9/05 DR MARK BATSHAW - WARNING LTR RESP 12/00, ANALOGIC - ANATOM K944131 BENAVENTE, MARIA LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, MIAMI, FL - PROTEINEX RECALL RECS 11/10; EIR MOST RECENT BENAVENTE, MARIA CVM/OCD/ CVM/OCD/ ORA/CE-FO/DET-DO/DCB/ FOOD AND ENVIRONMENT REPORTING NETWORK INC HELENA BOTTEMILLER FOOD AND ENVIRONMENT REPORTING NETWORK INC HELENA BOTTEMILLER FOOD AND ENVIRONMENT REPORTING NETWORK INC ELANCO ANIMAL HEALTH, GREENFIELD, IN - RESP TO 9/12/02 WARNING LTR LLORENS PHARMACEUTICAL CORP, SAN JUAN, PR PROTEINEX RECALL RECS 11/10; EIR MOST RECENT DOUGLAS L FELLER DVM, ELANCO ANIMAL HEALTH, GREENFIELD, IN - 483 3/12-22/02 PAYLEAN, TOPMAX (RACTOPAMINE HCL) - RECS MELISSA FOSS PHARM D MEMORIAL HEALTH SYSTEM ONDANSETRON - AERS 2009 TO PRESENT Signature/ Requester MEMORIAL HEALTH SYSTEM Subject PRESENT
Page 75 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/25/2011 2011-2406 2011-2407 2011-2408 2011-2409 2011-2410 2011-2411 2011-2412 03/28/2011 04/25/2011 03/28/2011 05/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/28/2011 04/25/2011 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2413 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2414 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2415 03/29/2011 04/26/2011 2011-2416 2011-2417 03/29/2011 04/26/2011 03/29/2011 04/26/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SYBIL SHAINWALD ATTY LAW OFFICES OF SYBIL SHAINWALD DEBRA COGAN ARSTASIS INC ROBERT Z PHILLIP TELEFLEX MEDICAL C R BARD INC, BARD ACCESS SYSTEMS INC - IMPLANTED PORT WITH OPEN-ENDED CATHETER POST-MARKETING SURVEILLANCE RPTS, MDRS, APRVL, ETC ARSTASIS ACCESS SYS RECALL Z-0993-2011 - HEALTH HAZARD EVALUATION FORM ARROW INTERVENTIONAL, EVERETT, MA - INTRA-AORTIC BALLOON (IAB) CLASS I RECALL Z-0790-2001 THROUGH Z0793-2011, Z0969-2011 HEALTH HAZARD EVALUATION FORM JOSUE GOSS HARVARD SCHOOL OF ENGINEERING & APPLIED SCIENCES ST GOBAIN PERFORMANCE PLASTICS CORP - TYGON 2775 HIGH PURITY TUBING & TYGON 2275 IB PURITY PRESSURE TUBING DMF 19787 9/19/06 JOSUE GOSS HARVARD SCHOOL OF ENGINEERING & APPLIED SCIENCES ST GOBIAN PERFORMANCE PLASTICS CORP - SANIPURE BDF BIOPHARMACEUTICAL TUBING DMF 19732 8/31/06 OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC CHRIS CELESTE EAS Consulting Group, LLC JOSUE GOSS HARVARD SCHOOL OF ENGINEERING & APPLIED SCIENCES ST GOBAIN PERFORMACE PLASTICS CORP - SANIPURE 60 BIOPHARMACEUTICAL TUBING DMF 19464 5/22/06 DKT LOG FDA-1995-S-0039 CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC JUSTIN VARD SIDLEY AUSTIN LLP OC/OM/OMP/DDM/ Action Office Signature/ Requester FOI SERVICES INC ROSS RENDELMANN HOGAN LOVELLS LLP DR JAMES WILSON - NIDPOE LTR RESP 12/00, CONSENT AGREEMENT 2/9/05 DKT FDA-2007-D-0369, FDA-2007-D-0433, FDA-2007-P0111 DR ALFRED CHANG - NIDPOE LTR RESP 12/02, CONSENT AGREEMENT 1/9/07 DYEON LLC - FCN 736 Subject CONSENT AGREEMENT 2/9/05 DKT FDA-2004-D-0500
Page 76 of 1132

Total Records: 12455 Control # 2011-2418 Recd Date / Due Date 03/29/2011 04/26/2011 2011-2419 2011-2420 03/29/2011 06/22/2011 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2421 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2422 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ 2011-2423 2011-2424 03/29/2011 04/26/2011 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2425 2011-2426 2011-2427 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 2011-2428 03/29/2011 ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ ROBERT Z PHILLIPS TELEFLEX MEDICAL ROBERT Z PHILLIPS TELEFLEX MEDICAL DANIEL G JARCHO MCKENNA LONG & ALDRIDGE LLP ARROW INTERVENTIONAL INC, EVERETT, MA - EIR 2/1718/11, 2/22/11, 2/24/11, ETC ARROW INTERVENTIONAL INC, EVERETT, MA - EIRS 1/1415/10, 1/20-22/10, 1/25/10, ETC DEL MONTE FRESH PRODUCE N A INC - HONEYDEW & CANTALOUPE MELONS ENTRY DM4-0305253-1 ANALYTICAL RPTS RICERCA BIOSCIENCES, CONCORD, OH - EIRS, 483S, CO ORA/NE-FO/NWE-DO/NWECB/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO SANDOZ, KUNDL, AUSTRIA - EIR 7/10 FORMATECH, ANDOVER, MA - 483 10/10 STERLING BOCAGE JR NO STUDENT LEFT BEHIND EDUCATION & WELLNESS INSTITUTE FLUORIDE - YEAR APRVD, SAFETY RECS; THIMEROSAL, ALUMINUM - APRVD IN VACCINES, ETC SAMUEL DESKIN DESKIN LAW FIRM ELI LILY - CYMBALTA SBA, WARNING LTRS, AERS, ETC SHANNON 290938, DANIEL FDA/OMPT/CDRH/OCER/DFOI/ FOLTA, TIMOTHY B Action Office FDA/OMPT/CDRH/OCER/DFOI/ RABINOWITZ, JOSH Signature/ Requester Subject MURRAY ELECTRONIC, HUNT VALLEY, MD - STIMULATOR NERVE TRANSCUTANEOUS FOR PAIN RELIEF K7717875; BIONICARE STIMULATOR SYS K971437 ESTABLISHMENTS & PROD LISTINGS ACTIVE & INACTIVE RPTS OF REGISTRATION DATE, PMAS PLAXIL, COCAINE, NOVACAINE - RECS
Page 77 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/26/2011 2011-2429 2011-2430 03/29/2011 04/26/2011 03/29/2011 04/26/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OCC/ 2011-2431 03/29/2011 04/26/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/ORO/DFS/ ORA/ORO/DFS/ ORA/OE/ ORA/OE/ ORA/SE-FO/ATL-DO/ACB/ OC/OCC/ OC/OCM/EMOPS/ OC/OER/OPA/ 2011-2432 03/29/2011 04/26/2011 ORA/ ORA/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ 2011-2433 03/29/2011 FDA/OMPT/CDER/ORP/DIDP/ ANDI POULSON ISR M00349768 EDWARD FEIGEN AMERICAN FEDERATION OF LABOR CONGRESS OF INDUSTRIAL ORGANIZATIONS LIST OF AMERICAN RED CROSS CLASS II RECALLS & ASSOCIATED FINES 4/15/03, 9/30/08 TONY CORBO Food & Water Watch FOOD PRODS BEING IMPORTED FROM JAPAN & THE MONITORING OF US FOOD PRODS FOR RADIOLOGICAL CONTAMINATION 3/11/11 TO PRESENT Action Office Signature/ Requester LYNN, MARY E ELYSSA M FRIED Finkelstein and Partners DANIEL G JARCHO MCKENNA LONG & ALDRIDGE LLP Subject RESP 8/10-14/09, 8/27/09-9/9/09, 1/5-14/10 LISTERIA OUTBREAK - EIRS, FOOD REGISTRY NOTICE, CMPLNTS, ETC 4/15/10, 2/10, 6/10 DEL MONTE - CANTALOUPE SALMONELLA PANAMA INFECTIONS OUTBREAK RECALL CASE QUESTIONAIRES, RPTS, ANALYTICAL STUDIES, ETC 3/22/11
Page 78 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/26/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2434 03/29/2011 04/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2435 2011-2436 2011-2437 2011-2438 2011-2439 2011-2440 2011-2441 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 03/29/2011 04/26/2011 2011-2442 2011-2443 03/29/2011 04/26/2011 03/29/2011 04/26/2011 2011-2444 03/29/2011 04/26/2011 2011-2445 2011-2446 03/29/2011 04/26/2011 03/30/2011 04/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC ANDI POULSON LEXISNEXIS COURTLINK INC 2009-581 WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 3/21-27/11 CLOSED FOI REQUESTS 3/21-27/11 DOMINION GROUP INC KENNETH REID WASHINGTON INFORMATION SOURCE CECELIA FRENCH CanReg, Inc. FOI DAILY LOG 3/14-18/11 FOI DAILY LOG 3/14-18/11 FOI DAILY LOG 3/14-18/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 3/14-18/11 FOI SERVICES INC GLADYS B TONKIN Center for Regulatory Services, Inc. FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 3/14-18/11 FOI DAILY LOG 3/14-18/11 FOI DAILY LOG 3/14-18/11 STEPHANIE COHEN SCHOLER, KAYE FOI DAILY LOG 3/14-18/11 2010-6322 & 2010-6894 ANDI POULSON LEXISNEXIS COURTLINK INC ISR M00349768 (CERTIFIED) Signature/ Requester LEXISNEXIS COURTLINK INC Subject
Page 79 of 1132

Total Records: 12455 Control # 2011-2447 2011-2448 2011-2449 2011-2450 2011-2451 2011-2452 2011-2453 2011-2454 2011-2455 2011-2456 2011-2457 2011-2458 2011-2459 2011-2460 2011-2461 2011-2462 2011-2463 Recd Date / Due Date 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 05/13/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ANDI POULSON LEXISNEXIS COURTLINK INC ANDI POULSON LEXISNEXIS COURTLINK INC ANDI POULSON LEXISNEXIS COURTLINK INC KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP KAREN CHEN MASIMO CORP PATRICIA MILBANK MASIMO CORP PATRICIA MILBANK MASIMO CORP KAREN CHEN MASIMO CORP PAUL LOFTNESS QUANTUM CATCH LLC PAUL LOFTNESS QUANTUM CATCH LLC CENTERVUE SPA, PADOVA , ITALY - DIGITAL RETINOGRAPHY SYS DRS K101935 VISUAL PATHWAYS INC, PRESCOTT, AZ - FUNDUS AUTOIMAGER K020888 2009-2864 ULTRACRIT HEMATOCRIT MEASUREMENT DVC - BK050056 HEMOCUE HB 301 SYS - K061047 HEMOCUE HEMOGLOBIN 201DM ANALYZING SYS - K041234 HEMOCUE B-GLUCOSE SYS - K962415 HEMOCUE B-HEMOGLOBIN SYS - K961312 HEMOCUE B-GLUCOSE SYS - K961311 HEMATASTAT C-70B - K913128 HEMATASTAT H-70 - K890849 HEMOCUE HB 201+ SYS - K032203 HEMATASTAT H-70 - K890849 HEMATASTAT C-70B - K913128 2008-8598 2008-1597 Subject 2005-13795
Page 80 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/27/2011 2011-2464 2011-2465 2011-2466 2011-2467 2011-2468 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 05/18/2011 Action Office OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ ORA/ ORA/ ORA/ ORA/ ORA/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/KAN-DO/COMP/ 2011-2469 03/30/2011 04/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ 2011-2470 2011-2471 03/30/2011 04/27/2011 03/30/2011 04/27/2011 2011-2472 03/30/2011 04/27/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JONATHAN WERNER COFACTOR TECHNOLOGIES NORBERT GLAESKE KALTENBACH & VOIGT GMBH ANNA LIS AKNAFO DANIELS FINE ISRAEL ET AL KAVO AMERICA - KAVO POLYLUX II K013500; KAVO CORUND HANDPIECE 2013 K002708; KAVO KEY LASER 1242 K00805, ETC MEDTRONIC INC, MEDTRONIC MINMED INC - PARADIGM INSULIN PUMP APRVL AERS, RPTS, ETC PSORIA-SHIELD INC - MODEL PS1000 K103540 CORTES, DAVE NOVARTIS PHARMACEUTICALS CORP, SUFFERN, NY 12/21/10, 9/16/10; NOVARTIS VACCINE & DIAGNOSTICS INC, EMERYVILLE, CA 7/15/10; NOVARTIS PHARMACEUTICALS CORP, EAST HANOVER, NJ 4/20/10, ETC - 483S CORTES, DAVE Signature/ Requester INFORMATION ACCESS PAIGE SAVITZ BEAVER STEET FISHERIES INC PAIGE SAVITZ BEAVER STEET FISHERIES INC PAIGE SAVITZ BEAVER STEET FISHERIES INC PAIGE SAVITZ BEAVER STEET FISHERIES INC FROZEN FROG LEGS ENTRY 595-476193-9 - ANALYTICAL RESULTS 1/15/11 FROZEN FROG LEGS ENTRY 595-476195-4 - ANALYTICAL RESULTS 1/15/11 FROZEN FROG LETS ENTRY 595-476191-3 - ANALYTICAL RESULTS 1/15/11 FROZEN FROG LEGS ENTRY 595-4768497-3 - ANALYTICAL RESULTS 1/20/11 SANOFI AVENTIS US LLC, KANSAS CITY MO 1/16/00; SANOFI AVENTIS, SINGAPORE 7/15/10; SANOFI AVENTIS US LLC, BRIDGEWATER, NJ 5/13/10 - 483S Subject
Page 81 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-2473 03/30/2011 04/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2474 2011-2475 2011-2476 03/30/2011 04/27/2011 03/30/2011 04/27/2011 03/30/2011 04/27/2011 2011-2477 03/30/2011 04/27/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2478 2011-2479 03/30/2011 04/27/2011 03/30/2011 04/27/2011 OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ MOSS, MICHAEL KATHI LOHMANN EXPONENT EVALUATION OF THE HEALTH ASPECTS AS A FOOD INGREDIENT FDA 223-75-2004 1976 WORST CASE CANCER RISK ASSESSMENT FOR 1,3 DICHLOROPROPANOL 8/4/98; EXPEDITED RISK ASSESSMENT FOR 1,3 DICHLOROPROPANOL MEMO OF 8/24/98 ACCEPTING RISK ESTIMATE FOR REGULATION OF FAP 9A4175 3/25/99 HOPE PHARMS - ACID JELLY NDC 60267-125-85 PRODUCT REGISTRATION DOSSIER ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ CAROLYN LARREGUI CLAUSEN MILLER PC JONEL ALECCIA NSNBC.COM CHRISTOPHER KENDRIC GOLDBERG SEGALLA THOMAS J. KEEGAN, Jr. KEEGAN & KEEGAN ROSS & ROSNER LLP OXFORD FROZEN FOODS, PORTLAND, ME - RPTS INVESTIGATIONS, STATEMENTS, ETC H&P INDUSTRIES (TRIAD GROUP), HARTLAND, WI - EIRS, 483S 3/21-28/11 SEAFOOD ATLANTIC INC, EMERALD SEA FOOD CO INC, KING FISH CORP - CIGUATERA POISIONING INVESTIGATION RECS 8/6/10 ACTONEL - INVESTIGATIONS, DATA SUMMARIES, COMPUTER PRINTOUTS, ETCDAR LINDA GELFIN INTEGTRATED RESEARCH COMMUNICATIONS LLC GILENYA - AERS Signature/ Requester Subject
2011-2480
03/30/2011 04/27/2011
LOUISE GALANOS EVERETT LABORATORIES INC
2011-2481
03/30/2011 04/27/2011
LOUISE GALANOS EVERETT LABORATORIES INC
LACLEDE INC - LUVENA PRODUCT REGISTRATON DOSSIER
2011-2482 2011-2483
03/30/2011 04/27/2011 03/30/2011 04/27/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/
KYOKO ASAMI ASO LLC ARLENE MORALES BURDOCK GROUP
HEBEI FAVOR PLASTIC CO LTD - K102613 ENZYME TECHNICAL ASSN (ETA) - EVALUATION OF PROCESSING AIDS OR INDIRECT FOOD ADDITIVES & DEFOAMING OR ANTIFOAMING AGENTS 2003
Page 82 of 1132

Total Records: 12455 Control # 2011-2484 Recd Date / Due Date 03/30/2011 04/27/2011 Action Office CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ 2011-2485 03/30/2011 04/27/2011 2011-2486 03/30/2011 04/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OO/OFBA/OAGS/ 2011-2487 03/31/2011 04/28/2011 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2488 03/31/2011 04/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2489 03/31/2011 04/28/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2490 03/31/2011 04/28/2011 2011-2491 03/31/2011 04/28/2011 2011-2492 03/31/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ OM/OMP/DODM/ ALEJANDRA VASQUEZ MCCULLOUGH GINSBERG MONTANO & PARTNERS ALEJANDRA VASQUEZ MCCULLOUGH GINSBERG MONTANO & PARTNERS ANEET PANSAR INTERNATIONAL SPECIALTY PRODUCT, CALVERT CITY, KY - PERMITS, REGISTRATION INTERNATIONAL SPECIALTY PRODUCT, ASSONETT, MA PERMITS, REGISTRATION DKT FDA-1995-S-0039 ALEJANDRA VASQUEZ MCCULLOUGH GINSBERG MONTANO & PARTNERS INTERNATIONAL SPECIALTY PRODUCT, TEXAS CITY, TX PERMITS, REGISTRATIONS BRENDA M GARTZ ELI LILLY & CO SIEGFRIED LTD, ZOFINGEN, SWITZERLAND - 483 7/26-29/10 BRENDA M GARTZ ELI LILLY & CO ISO-TEX DIAGNOSTICS INC, FRIENDSWOOD, TX - 483 5/4/10-6/2/10 ANNA EDNEY BLOOMBERG NEWS BRAND NAME AND GENERIC ANTI-EPILEPSY DRUGS UNIV OF MD SCHOOL OF PHARMACY GRANT 2010; AMERICAN EPILEPSY SOCIETY PROPOSED STUDY RECS STEPHEN L. LACEY ABBOTT LABORATORIES, INC. DR JOSE SAAVEDRA, NESTLE NUTRITION - LTR 11/8/10 Signature/ Requester CAROLINE JOYCE LEGACY Subject LTR FROM LAWRENCE DEYTON TO STAR SCIENTIFIC REGARDING ARIVA BDL & STONEWALL BDL 3/23/11
Page 83 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/28/2011 2011-2493 2011-2494 03/31/2011 04/28/2011 03/31/2011 04/28/2011 2011-2495 03/31/2011 04/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-2496 03/31/2011 04/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2497 03/31/2011 04/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2498 2011-2499 2011-2500 03/31/2011 04/28/2011 03/31/2011 04/28/2011 03/31/2011 04/28/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ OC/OPPL/OPL/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/CE-FO/MIN-DO/MCB/ KATHY J JONES lAW OFFICE OF RICHARD BAKER JOE YERADI NEWS21 BEN MOSCOVITCH INSIDE WASHINGTON PUBLISHERS DRUG IMPORTATION EVALUATION - PROPOSALS, CORR, MINS, ETC MASTER LIST OF ALL FOOD RELATED DATABASES H & P INDUSTRIES (TRIAD GROUP) - 483 MOST RECENT DARIA MARI POLICHEM SA LAMISIL TERBINAFINE HCL CREAM NDA 20-192 PHARMACOLOGY & TOXICOLOGY RVWS RONALD G JACOB NORTHSTAR RX LLC, AUROBINDO PHARMA LTD VALACYCLOVIR HCL TABS AERS FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ Action Office Signature/ Requester BURDOCK GROUP ANEET PANSAR BURDOCK GROUP STANLEY J ROGASKI CONTACT LENS INSTITUTE ALIVIA CHUDHURI KVK-TECH INC 15TH SYMPOSIUM ON MATERIAL SCIENCE AND CHEMISTRY OF CONTACT LENSES - DR TINA KIANG, DR MOLLY GHOSH PRESENTATION SLIDES 3/18/10 MIKART INC - BENZPHETAMINE HCL TABS - LBLG DKT FDA-1995-S-0039 - RPTS #89, 174, 479, ETC Subject
Page 84 of 1132

Total Records: 12455 Control # 2011-2501 2011-2502 Recd Date / Due Date 03/31/2011 04/28/2011 03/31/2011 04/28/2011 2011-2503 03/31/2011 04/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2504 04/01/2011 04/29/2011 2011-2505 04/01/2011 04/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2506 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2507 04/01/2011 04/29/2011 OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2508 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2509 2011-2510 2011-2511 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ STEINFELD, ADAM COATS INTERNATIONAL HOLDINGS INC - 483 9/1-8/10 GERHARDT, NATHAN REED TECKENBROCK INTERBODY INNOVATIONS LLP, MIDLAND, TX - PEEK DKT 2005P-0498 (CERTIFIED) RAFAEL L ARRIBAS JR PHARMACEUTICAL GENERIC DEVELOPERS INC ADVANCED GENERIC CORP, DORAL, FL - LABELER CODE 45737, OTC DRUGS MFR LICENSE, REGISTRATION AS A PRIVATE LABEL DISTRIBUTOR, ETC STEINFELD, ADAM BUPROPION HCL - DRAFT GUIDANCE KIM FASULLO PFIZER INC GRALISE (GABAPENTIN) TABS NDA 22-544 - SBA ANNE L WEISMANN Citizens for Responsibility and Ethics in Washington MARIA ROETHKE B&H CONSULTING SERVICES INC NIMOTOP CPAS NDA 18-869 - SBA FOI DAILY LOG 1/10 TO PRESENT TRAN, DAVID VAN ORA/CE-FO/MIN-DO/MCB/ Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester JOE YERADI NEWS21 RICK BARRETT MILWAUKEE JOURNAL SENTINEL Subject MASTER LIST OF ALL DATABASES FOR CENTER FOR FOOD SAFETY H & P INDUSTRIES (TRIAD GROUP), HARTLAND, WI - EIRS MOST RECENT ROCHE - TAMIFLU (OSELTAMIVIR) IND
Page 85 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/29/2011 2011-2512 04/01/2011 04/29/2011 2011-2513 04/01/2011 04/29/2011 2011-2514 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2515 04/01/2011 04/29/2011 2011-2516 04/01/2011 04/29/2011 2011-2517 04/01/2011 04/29/2011 2011-2518 04/01/2011 04/29/2011 2011-2519 04/01/2011 04/29/2011 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2520 04/01/2011 04/29/2011 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2521 04/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ JOSEPH O MAGLIOZZI SEIKAGAKU CORP - GEL 200 LBLG MITCHELL ZELLER PINNEY ASSOCIATES STAR SCIENTIFIC - ARIVA-BDL, STONEWALL-BDL PRODS MODIFIED RISK APRVL APPL; FSPTCA LTR 3/23/11 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP ALLISON M ZIEVE PUBLIC CITIZEN HEALTH RESEARCH GROUP BIOMET ORTHOPEDICS INC - SPINAL STABILIZING SPHERE SYS K063139 LIFE SPINE - INTERVERTABRAL FUSION DVC WITH BONE GRAFT SOLID SPHERE LUMBAR K073274 MEDTRONIC SOFAMOR DANSK INC, MEMPHIS, TN SATELLITE SPINAL SYS K051320 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP JONATHAN P ROBELL AKIN GUMP ET AL INTERBODY INNOVATIONS LLP, MIDLAND, TX - ORTHOSIS SPINAL SPHERE K062992 TEVA PHARMACEUTICAL INDUSTRIES LTD, JERUSALEM, ISREAL - EIR, 483, WARNING LTR, ETC 9/10 Action Office Signature/ Requester LAW OFFICES WINCKLER & HARVEY LLP SUSAN B MILLS WEINBERG WHEELER ET AL Subject SPINAL SPHERES K073105 SALMONELLA HARTFORD, SALMONELLA BAILDON OUTBREAK - CORR, TRACEBACK DATA, TESTING, ETC 2010
MEDTRONIC SOFAMOR DANCK, MEMPHIS, TX - SATELLITE SPINAL SYS K060415/S1 STAR SCIENTIFIC - DISSOLVABLE TOBACCO LOZENGES LTR 3/11
Page 86 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/29/2011 2011-2522 2011-2523 2011-2524 2011-2525 2011-2526 2011-2527 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ALEXANDER, JUDY . KYLE O'CONNOR CONVATEC REINFORCED ENDOTRACHEAL TUBES - K962389, PEDIATRIC EUROPHILLIC SLIPPERY COATED FOLEY CATHETER - K954752, SILICONE COATED CATHETERS K770256, ETC DENDREON, MORRIS PLAINS, NJ - PROVENGE (SIPULEUCEL-T) BLA 12-5197, EIR 1/11-26/11 DEL MONTE, GALVESTON, TX - CANTALOUPE MELONS ENTRY DM4-0299780-1 ANALYTICAL RPTS FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ GERHARDT, NATHAN LAURA M SHAMP LAURA M SHAMP LLC MENTOR - MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS P030053 CONDITIONS FOR APRVL ASTHMARX - ALAIR P-080032, QT-00332 STUDY RESULTS ORA/NE-FO/NYK-DO/NYDCB/ GERHARDT, NATHAN HAIN CELESTIAL GROUP - 483 3/31/10 & 4/1,5,7-9,14/10 ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN PHARMLINE INC - 483 1/14,15,20,21/10 & 2/3/10 Action Office Signature/ Requester GENZYME CORP VITA-HERB NUTRICEUTICALS INC - 483 5/18/10-6/29/10 Subject
2011-2528 2011-2529
04/01/2011 04/29/2011 04/01/2011 04/29/2011
ORA/CE-FO/NJ-DO/NJCB/ CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/
KATHLEEN S PICKA DENDREON CORP DANIEL G JARCHO MCKENNA LONG & ALDRIDGE LLP
2011-2530 2011-2531 2011-2532
04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/
BAIZURA ABDUL RASHID KHAN UNOMEDICAL SDN BHD GERHARDT, NATHAN
HAEMATURIA CATHETERS - K973076, ADULT HYDROPHILIC - K954752, TRACHEOSTOMY TUBES - K945874, ETC RHG & COMPANY INC (VITAL NUTRIENTS) - 483S 8/12,13,17-19/10, 9/1-2/10 FLUOXETINE - AERS
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ VERNILLE, SUSAN M
2011-2533 2011-2534
04/01/2011 04/29/2011 04/01/2011 04/29/2011
OC/OM/OMP/DDM/ OC/OM/OMP/DDM/
MARILYN WHITNEY COVINGTON & BURLING LLP RACHAEL COTNER K & L GATES
DKT FDA-2010-P-0491 DKT & DKT LOG OF 1976N-0052N
Page 87 of 1132

Total Records: 12455 Control # 2011-2535 Recd Date / Due Date 04/01/2011 04/29/2011 2011-2536 2011-2537 04/01/2011 04/29/2011 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2538 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-2539 2011-2540 04/01/2011 04/29/2011 04/01/2011 04/29/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2541 04/01/2011 04/29/2011 2011-2542 04/01/2011 05/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2543 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DR. SANJUKTA BHADURI, MBBS, MFPM ROCHE - VERSED PEDIATRIC EXCLUSIVITY STUDIES ORA/NE-FO/NWE-DO/NWECB/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS TOM'S OF MAINE INC, SANFORD, ME - CLEAN & GENTLE WITH FLUORIDE PEPPERMINT FLAVOR RECALL, EIRS, 483S, CO RESP 2/8/11 ZOSTAVAX BLA 125123/0 - APRVL LTR, LBLG, RVWS, ETC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS MATHIL M. KALAORA CLINQUEST INC BENEV COMPANY INC, MISSION VIEJO, CA - BENEV ACNE SPOT TREATMENT RECALL, EIRS, 483S, CO RESP 12/14/10 WHO SIGNAL REPORT ON HORMONAL CONTRACEPTIVES & HEARING DISORDERS ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS DAINIPPON SUMITOMO PHARMA, SUZUKA, MIE, JAPAN EIRS, 483S, CO RESP 2008 Action Office ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ SHELIA S. STEVENS BAROSENSE INC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS USGI MEDICAL - G-CATH TISSUE ANCHOR DELIVERY CATHETER K100251 DAINIPPON SUMITOMO PHARMA, SUZUKA, MIE, JAPAN EIRS, 483S, CO RESP 8/10 TO 1/11 GERHARDT, NATHAN Signature/ Requester Subject ATLAS OPERATIONS INC - 483 10/28/09-11/16/09
Page 88 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2544 2011-2545 2011-2546 2011-2547 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 04/01/2011 04/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2548 2011-2549 04/01/2011 04/29/2011 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SEA-DO/SCB/ FDA/OF/CFSAN/OCD/EOS/ DAVID MONK GLASS FLAKE LIMITED AMY GONZALES AMGEN INC SANOFI-AVENTIS US LLC, KANSAS CITY, MO 8/18/10; ELI LILLY & CO, INDIANAPOLIS, IN 7/28/10; MERCK & CO INC, UNION, NJ 7/30/10. ETC - EIRS, 483S, CO RESP CAP 7C0251 Signature/ Requester UPSHER-SMITH LABORATORIES INC BRIAN E. FRITZ SALTZ MONGELUZZI ET AL BRIAN E. FRITZ SALTZ MONGELUZZI ET AL BRIAN E. FRITZ SALTZ MONGELUZZI ET AL MOIRA H. PIETROWSKI ROETZEL & ANDRESS AIRSEP CORP - NEW LIFE OXYGEN CONCENTRATOR MODEL ASOO5-1 MDRS TINY GREENS; FLATLAND HYDROPONICS INC - RECS AIRSEP CORP - OXYGEN CONCENTRATORS MODEL AS006 XX, AS005 XX RECALL Z-010/011-0 RECS AIRSEP CORP - CMPLNTS, CORR, INVESTIGATIONS Subject
Page 89 of 1132

Total Records: 12455 Control # 2011-2550 2011-2551 Recd Date / Due Date 04/01/2011 04/29/2011 04/01/2011 04/29/2011 2011-2552 2011-2553 04/01/2011 04/29/2011 04/01/2011 04/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/MIN-DO/MCB/ 2011-2554 04/04/2011 05/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2555 04/04/2011 05/02/2011 2011-2556 04/04/2011 05/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2557 04/04/2011 05/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2558 04/04/2011 05/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2559 04/04/2011 05/02/2011 ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DALCHANDLER, KAY M CMPLNT 118806 MAIRE O'DONNELL BIONICHE PHARMA GROUP LTD ROCHE PALO - CYTOVENE (GANCICLOVIR SODIUM INJ) NDA 19-661 SBA NAZ ALI SANTEN INC ALLERGAN - OZURDEX (DEXAMETHASONE INTRAVITREAL IMPLANT) NDA 22-315/S003 APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ MANAL GABRIEL DDS PHD CIBA VISION CORP VERN DUBA UNIV OF IOWA COLLEGE OF PHARMACY 15TH SYMPOSIUM ON THE MATERIAL SCIENCE AND CHEMISTRY OF CONTACT LENSES - DR MOLLY GHOSH, DR TINA KIANG PRESENTATIONS MERCK - DECADRON-LA (DEXAMETHASONE ACETATE) NDA 16-675 LBLG BRIAN BOSTON AMBIOPHARM INC REGENERX PHASE 2 CLNCL TRIAL - CONTRACT MFR, COMPLIANCE ISSUES ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANN M. BEGLEY K & L GATES WILLIAM D. HARE MCNEELY HARE & WAR LLP DENISON PHARMACEUTICALS INC - NASAL GUARD K053625, CORR 12/29/05 INO THERAPEUTICS INC - INOMAX (NITRIC OXIDE) NDA 20845 6/16/97, NDA 20-845 AERS, FIELD ALERT RPTS, PROMOTIONAL LBLG, ETC Action Office OM/OSS/OPILS/FDAHO/ MARTIN, BARBARA ELAINE DUNCAN PALADIN MEDICAL INC VILEX INC, MCMINNVILLE, TN - EIR, CORR 1/10 TO 3/30/11 Signature/ Requester Subject ELIXIR OF SULFANILAMIDE 1937 - LTRS, RPTS
Page 90 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office DO/COMPLIANCE/ 2011-2560 04/04/2011 05/02/2011 ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2561 04/04/2011 05/02/2011 ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DEN-DO/COMP/ 2011-2562 2011-2563 04/04/2011 05/02/2011 04/04/2011 05/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2564 04/04/2011 05/02/2011 2011-2565 2011-2566 2011-2567 2011-2568 04/04/2011 05/02/2011 04/04/2011 05/02/2011 04/04/2011 05/05/2011 04/05/2011 06/21/2011 2011-2569 2011-2570 04/05/2011 05/03/2011 04/05/2011 05/03/2011 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ FOI SERVICES INC ERIKA MORKEVICH Cerner Galt JEFF KELLY LOWENSTEIN HOY CHICAGO KAM PATEL Basic Food Flavors, Inc. BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO COVANCE, MADISON, WI - EIR 8/10 BASIC FOOD FLAVORS INC, NORTH LAS VEGAS, NV HYDROLYZED VEGETABLE PROTEIN (HVP) RECALL STATUS, TEST RESULTS, RPTS, ETC COVANCE, MADISON, WI - 483 8/10 FDA DATABASES 2008 TO PRESENT FOI DAILY LOG 1/1/07-7/1/11 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 3/28/11-4/3/11 CLOSED FOI REQUESTS 3/28/11-4/3/11 FDA/OF/CFSAN/OCD/EOS/ ANN M OXFORD ALBEMARLE CORP KRISTIN DAVENPORT GOODWIN PROCTER LLP DIPRIVAN (PROPOFOL) NDA 19-627 - APRVL RECS ROBERT P GIACALONE RPH JD CARDINAL HEALTH THERMO FISHER SCIENTIFIC (ASHEVILLE) LLC, MARIETTA, OH; PATTERSON DENTAL SUPPLY INC, RALEIGH, NC; HENRY SCHEIN DENTAL INC, ETC - EIRS, 483S, WARNING LTRS 1/09 TO PRESENT FCN 1036 MEYER, JEFFREY W CMPLNT 117488 Signature/ Requester Subject
Page 91 of 1132

Total Records: 12455 Control # 2011-2571 2011-2572 2011-2573 2011-2574 2011-2575 2011-2576 2011-2577 2011-2578 2011-2579 Recd Date / Due Date 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 2011-2580 2011-2581 04/05/2011 05/03/2011 04/05/2011 05/03/2011 ORA/OE/ ORA/OE/ MAY, SAMMUEL ORA/CE-FO/CHI-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/KAN-DO/COMP/ CLAY, PATRICK CARDINAL HEALTH - ARANESP (DARPEPOETIN ALFA) NDC 55513-021-04, RECALL D-258-2010, NDC 55513-027-04, RECALL 259-2010, NDC 55513-023-04 RECALL D-2602010, ETC HEAD AND SHOULDERS CONDITIONER NDA 19-412 - RECS ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/BLT-DO/CB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/MIN-DO/MCB/ Action Office ORA/CE-FO/MIN-DO/MCB/ Signature/ Requester BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO JOHN WALSH JAMES ALEXANDER CORP TONY CHEN FDAZILLA JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JIM M PERDUE JR PERDUE & KIDD LLP PATRICIA C GRACE BLOODSOURCE HEAMONETICS SOFTWARE SOLUTIONS, BRAINTREE, MA; INFORMATION DATA MANAGEMENT (IDM), ROSEMONT, IL EIRS, 483S, CO RESP 2006-2010 KANSAS CITY FREE HEALTH CLINIC - DR LEIN LTR 1/20/04 ATLANTIC SCALE COMPANY INC, NUTLEY, NJ - 483S 10/08 TO PRESENT OLIVER-TOLAS HEALTHCARE PACKAGING, FEASTERVILLE, PA - 483S 10/08 TO PRESENT H&P INDUSTRIES INC (TRIAD GROUP) - 483S 3/11 MICROBIOLOGICAL CONSULTANTS INC, HUNTINGTON, WV - 483S 11/08 TO PRESENT LIST OF 483S 1/11 TO 3/11 ABC LABS, COLUMBIA, MO - 483 11/10 COVANCE, MADISON, WI - EIR 3/09 Subject COVANCE, MADISON, WI - 483 3/09
2011-2582
04/05/2011 05/03/2011
JILL DAINTON UNILEVER
2011-2583
04/05/2011 05/03/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MEHTA, JAYESH
COMBINATION BISPHOSPHONATE AND ANTIANGIOGENESIS THERAPY WITH PAMIDRONATE AND THALIDOMIDE - STUDY RECS
2011-2584
04/05/2011 05/03/2011
WILLIAM STAHOVEC AVEMA PHARMA SOLUTIONS
ADVENT PHARMACEUTICAL INC - IBUPROFEN TABS ANDA 76-460 RECS, CORR, SUPPLEMENTS, ETC
Page 92 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2585 04/05/2011 05/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2586 04/05/2011 05/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ KIM KRACKE ALCON RESEARCH LTD MORROW, LEN W DEPUY - SUMMIT ACETABULAR SYS K983014, PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS K002883; ULTIMA UNIPOLAR HEAD AND ADAPTOR SLEEVES K965156, ETC 15TH SYMPOSIUM ON THE MATERIAL SCIENCE AND CHEMISTRY - UPDATING THE CONTACT LENS CLASSIFICATION SYS, LENS SOLUTION INTERATIONS: IMPACT ON BIOCOMPATIBILTY SLIDES INDIVIDUAL RECS - VAERS Signature/ Requester Subject
2011-2587
04/05/2011 08/01/2011
CBER/OCTMA/DDOM/ALFB/
KIMBERLY A GRABBE MAGLIO CHRISTOPHER & TOALE LAW FIRM
2011-2588 2011-2589 2011-2590 2011-2591 2011-2592
04/05/2011 07/20/2011 04/05/2011 05/20/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011 04/05/2011 05/03/2011
CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/
ERICA SABLAN ROCHE MOLECULAR SYSTEMS ERICA SABLAN ROCHE MOLECULAR SYSTEMS YAMADA, LAURA
SIEMENS HEALTHCARE DIAGNOSTICS INC - TRUGENE HIV-1 GENOTYPING KIT BK110007 QAGEN - HLA TYPING KIT BK080022 MICROVENTION - MICROPLEX COIL SYS (MCS), HYDROCOIL EMBOLIC SYS (HES) K032590 PENUMBRA - COIL SYS K03305
FDA/OMPT/CDRH/OCER/DFOI/ YAMADA, LAURA FDA/OF/CFSAN/OCD/EOS/ PHILLIPS, SUSAN D OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ LAURA FARLEY LAURA FARLEY MARCIA D. HOWARD CONSUMER HEALTHCARE PRODUCTS ASSOCIATION OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ VON LINDSEY LINDSEY RESEARCH SERVICES ROBERT WAGNER AEGIS REGULATORY INC ROBERT WAGNER AEGIS REGULATORY INC
BENZENESULFONIC ACID, TRETASODIUM SALT FCS NO 15 - ANALYTICAL METHODS, EXTRACTION PROCEDURES, ETC DKT 1997N-0103, DKT LOG FDA-1997-N-0020 DKT 1981N-0033
2011-2593 2011-2594
04/05/2011 05/03/2011 04/05/2011 05/03/2011
2011-2595 2011-2596
04/06/2011 05/04/2011 04/06/2011 05/04/2011
DKT 1997M-0460 SALTON'S REJUVENIQUE - K011935
2011-2597
04/06/2011 05/04/2011
NERO RESOURCES GROUP INC - INTERX 1000/DERMA 200 STIMULATOR K070217
Page 93 of 1132

Total Records: 12455 Control # 2011-2598 2011-2599 Recd Date / Due Date 04/06/2011 05/04/2011 04/06/2011 05/04/2011 2011-2600 04/06/2011 05/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2601 2011-2602 2011-2603 2011-2604 2011-2605 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 06/09/2011 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ 2011-2606 2011-2607 2011-2608 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 05/04/2011 2011-2609 2011-2610 04/06/2011 05/11/2011 04/06/2011 05/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ JILL SCHWEIGER MEDASYS INC ANDI POULSON LEXISNEXIS COURTLINK INC LALITH GOONATILAKE UNITED NATIONS INDUSTRIAL DEVELOP JORDAN M KAPLAN ZWERDLING PAUL KAHN ET AL CHRISTINE CHENG PHARM D UNIV OF CALIFORNIA SAN FRANCISCO LIST OF NEW MOLECULAR ENTITIES (NME) AND BIOLOGIC LICENSE (BLA) APRVD 1980 TO 1998 BORDER REJECTION DATA FOR COMPARATIVE ANALYSES OF TRADE CHALLENGES BTWN US AND EU MARKETS 2008 TO 2010 JAMES SIDNEY - BAR ORDER 12/14/10 CODMAN & SHURTLEFT INC - 3000 SERIES IMPLANTABLE INFUSION PUMP P890055/S026 12/17/10 2011-1807 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OL/ FDA/OMPT/CDRH/OCER/DFOI/ JESSIE VERNA CONMED CORP SCOTT GREENBERG WALL STREET JOURNAL JESSIE VERMA CONMED CORP VIVIAN KESSLER AMICUS THERAPEUTICS KEVIN MOCOGNI SALVI SCHOSTOK & PRITCHARD PC MOUNT SINAI SCHOOL OF MEDICINE, NEW YORK, NY - 483, CO RESP 9/22/05 INDIVIDUAL RECS CHAIRMAN DARRELL ISSA - FOI DAILY LOG LAST 5 YRS, CORR, RECS EXPECT ENDOSCOPIC ASPIRATION NEEDLE - K100712 EXPECT ENDOSCOPIC ASPIRATION NEEDLE - K11030 FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ROBERT WAGNER AEGIS REGULATORY INC ROBERT F VAAGE ROBERT VAAGE LAW OFCS VIVIAN KESSLER AMICUS THERAPEUTICS INC Subject FACEMASTER OF BEVERLY HILLS - FACIAL TONING SYS K040871 NUVASIVE INC - INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYS, NEUROVISION JJB, SPHERX SYS, ETC LBLG, PROMOTIONAL MATERIALS, INSTRUCTIONS, ETC HOPITAL EUROPEEN GEORGES POMPIDOU, PARIS, FRANCE - 483S, CO RESP 9/22-26/00
Page 94 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2611 04/06/2011 05/04/2011 2011-2612 04/06/2011 05/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2613 04/06/2011 05/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2614 04/06/2011 05/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2615 2011-2616 2011-2617 2011-2618 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 05/04/2011 04/06/2011 05/04/2011 2011-2619 04/07/2011 05/05/2011 2011-2620 04/07/2011 05/05/2011 2011-2621 04/07/2011 ORA/SW-FO/DEN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ OC/OCC/ CBER/OCTMA/DDOM/ALFB/ BIOMERIEUX - BACT/ALERT SYS BK030075, BS030076 LISA ALLEN ROTHWELL, FIGG, ERNST & MANBECK, P.C. MOIRA H PIETROWSKI ROETZEL & ANDRESS TINY GREENS, FLATLAND HYDROPONICS INC - RECS LEGITSCRIPT - SOLICITATION #FDA-SOL-10-1068201-02 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ BEACHAM, NEFERTITI VIVIAN KESSLER AMICUS THERAPEUTICS VIVIAN KESSLER AMICUS THERAPEUTICS SUSAN B MILLS WEINBERG WHEELER ET AL BIO BLOOD COMPONENTS, GARY, IN - VIOLATIONS 9/10 TO 3/11 RAPHAEL SCHIFFMAN, NATIONAL INSITUTES OF HEALTH, BETHESDA, MD - 483S, CO RESP 10/20-00-11/3/00 COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD (COMIRB) - RESP TO WARNING LTR 4/5-15/99 SALMONELLA OUTBREAK ASSOCIATED WITH EGGS INVESTIGATION RECS 2010 BILL LOOMER WOIO-TV HGC - AERS GEORGE KRESSLER JR FMI SUPER BUMP RELIEF (BENSOYL PEROXIDE, SALICYLIC ACID) NDC 65840 - RECS TOM MYERS AIDS HEALTHCARE FOUNDATION GILEAD SCIENCES INC - TRUVADA (TENOFOVIR.EMTRICITABINE) CORR 1/10 TO PRESENT WILLIAM D LOUGHEED BIOCEPTA CORP OTC VOLS 070032, 070165, 070267, ETC Signature/ Requester Subject
Page 95 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/05/2011 2011-2622 2011-2623 04/07/2011 05/05/2011 04/07/2011 05/19/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2624 2011-2625 2011-2626 04/07/2011 05/05/2011 04/07/2011 05/05/2011 04/07/2011 05/05/2011 2011-2627 2011-2628 2011-2629 2011-2630 2011-2631 04/07/2011 05/05/2011 04/07/2011 05/05/2011 04/07/2011 05/05/2011 04/07/2011 05/05/2011 04/07/2011 05/05/2011 2011-2632 2011-2633 2011-2634 04/07/2011 05/05/2011 04/07/2011 05/05/2011 04/07/2011 05/05/2011 2011-2635 04/07/2011 CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ PROSCAR LONG TERM EFFICACY & SAFETY STUDY (PLESS) - CLNCL TRIAL RECS KARASEK, MELISSA LONGO, FREDERICK C JARED MACCLEARY CROWELL & MORING CMPLNT 119442 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ CVM/OCD/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ WILSON, TERRY M ESTEBAN SIERRA CITRUSOURCE. LLLC STUART RICHARDS ALLFARM ANIMAL HEALTH RONNIE SUE GOLDFARB GELSTAT CORP RON DHILLON BRITISH FOOD CENTRES LTD MAURA M NORDEN SIDLEY AUSTIN LLP PAUL J LARKIN II PAUL J LARKIN ASSOCIATES INC KEVIN O'ROURKE FDANEWS PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG & CLNCL TRIAL FACILITIES IN & OUT OF THE US - 483S 3/131/11 HOFFMAN-LA ROCHE INC - ACCUTANE CLOSED FOI REQUESTS 1993 TO 1998 CVM - FOI DAILY LOG 3/11 STAR SCIENTIFIC - STONEWALL MOIST BDL MODIFIED RISK TOBACCO PRODS CORR SEA MAMA'S SEAFOOD SAUCE - RECS DENTAL PRODS, DENTURES, PROSTHETICS, ETC CMPLNTS LAST 5 YRS JUICEHEADS INC, SAN BERNARDINO, CA - EIR 9/10 TO 10/10 OXYTETRACYCLINE DIHYDRATE 005-028; OXYTETRACYCLINE HCL 005-667, ETC - PUBLIC MASTER FILE HILLESTAD PHARMACEUTICALS, WOODRUFF, WI - EIRS, 483S 7/13-14/10 LIST OF LACF AND ACIDIFIED FOOD MFRS IN THE UK Doe J ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester SULLIVAN PhD, NADINE LAROY SALINE II DOUBLE RC GREEN INC FOOD MFRS, BLAINE, BANNOCK, BONNIVILLE COUNTIES, ID, ETC - INSPS AVENTIS - VAERS LOT NUMBERS W0869, W1440, X0800, ETC LIST OF INGREDIENTS Subject
Page 96 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/05/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2636 04/07/2011 05/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2637 04/07/2011 05/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2638 04/07/2011 05/05/2011 FDA/OMPT/CDRH/OCER/DFOI/ CHUCK RYAN CONVATEC INC COLOPLAST - SELF-CATH CS CLOSED URINARY CATHERTERIZATION SYS K070939; SELF-CATH CATHETER K100878; CONVEEN INTERMITTENT CATHETERS K895548 510KS, RVWS, CORR, ETC APOGEE - CLOSED SYSTEM INTERMITTENT CATHETERIZATION KIT K032710 510KS, RVWS, CORR, ETC CROS (CONTRACT RESEARCH ORGANIZATIONS) - EIRS DRUG MFRS, REPACKERS/PACKERS, LABELERS ETC, FOREIGN & DOMESTIC 1/1/11 TO PRESENT FOI DAILY LOG 3/21-25/11 FOI DAILY LOG 3/21-25/11 FOI DAILY LOG 3/21-25/11 ELIZAABETH CUSACK CAHILL GORDON & REINDEL ORTHO MCNEIL JANSSEN - ORTHO EVRA (ETHINYL ESTRADIOL; NORELGESTROMIN) NDA 021180 AERS PRINCETON UNIVERSITY BRISTOL MYERS SQUIBB - ONGLYZA AERS 2009 TO PRESENT Signature/ Requester MEISEL, LEE B Subject
2011-2639 2011-2640
04/07/2011 05/05/2011 04/07/2011 05/05/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
CHUCK RYAN CONVATEC INC DAVID P JORDAN BARBARA JONES DOMINION GROUP INC GLADYS B TONKIN Center for Regulatory Services, Inc. KENNETH REID WASHINGTON INFORMATION SOURCE CECELIA FRENCH CanReg, Inc.
2011-2641 2011-2642 2011-2643
04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011
2011-2644 2011-2645 2011-2646 2011-2647
04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011
FOI DAILY LOG 3/21-25/11 FOI DAILY LOG 3/21-25/11
FOI SERVICES INC FOI DAILY LOG 3/21-25/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 3/21-25/11 INFORMATION ACCESS
Page 97 of 1132

Total Records: 12455 Control # 2011-2648 2011-2649 2011-2650 2011-2651 2011-2652 2011-2653 2011-2654 Recd Date / Due Date 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 2011-2655 2011-2656 04/08/2011 05/06/2011 04/08/2011 05/06/2011 2011-2657 2011-2658 04/08/2011 05/06/2011 04/08/2011 05/06/2011 2011-2659 2011-2660 04/08/2011 05/06/2011 04/08/2011 05/06/2011 ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ 2011-2661 04/08/2011 05/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ NATASHA MINSKER AMERICAN CIVIL LIBERTIES UNION OF NORTHERN KOHLER, ELIZABETH FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ ORA/NE-FO/NYK-DO/NYDCB/ BLACKMORE, JENNIFER US NONWOVENS, BRENTWOOD, NY - EIR, 483, CO RESP, ETC 11/29/10 GREAT LENGTHS INTERNATIONAL SRL, DAVID ANTHONY GOLD INDORATA SERVICES GESTAO SDTC EXPORTS,GREAT LENGHTS HAARVERTREIBS, ETC - HAIR EXTENSIONS PRODS, KERATIN POLYMER BOND PRODS EIRS, LBLG, CMPLNTS, ETC 2011-319 ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ XU, ZHIPING DEBORAH HASTINGS THE DAILY NEWS CORP NATIONAL ASSN OF THEATER OWNERS - CORR 1/1/104/7/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ JOHN WALSH JAMES ALEXANDER CORP HELENA KRAMER RUBEZAHL SCHOKOLADEN GMBH GIBRALTAR LABS, FAIRFIELD, NJ - EIRS, 483S, RECALLS 10/08 TO PRESENT WHOLE MILK CHOCOLATE EGGS, MILK CHOCOLATE EASTER FIGURINES - LAB RPTS VINYL PATIENT EXAMINIATION GLOVES - 510K Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC JOHN WALSH JAMES ALEXANDER CORP HELLEN A OKTECH PHD USP PHARMACOPEIA FOI SERVICES INC Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-167) MERCK & CO., INC. MEAD JOHNSON - ENFAMIL PROD LINE EIRS, 483S 1/11 TO PRESENT WYETH - S-26 SMA, WYSOY, NURSOY & PROMIL PROD LINE EIRS, 483S 1/11 TO PRESENT POREX TECHNOLOGIES, FAIRBURN, GA - EIRS, 483S, RECALLS 10/08 TO PRESENT DIETARY SUPPLEMENTS - CAERS 2011-1655 - REQUEST LTR 2011-1613 - REQUEST LTR Subject 2011-1599 - REQUEST LTR
Page 98 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester CALIFORNIA 2011-2662 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2663 2011-2664 04/08/2011 05/06/2011 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2665 2011-2666 2011-2667 2011-2668 2011-2669 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SUSSMAN, MARVIN L JEREMY GRAZIANO EYE PHOTO SYSTEMS INC HARMON S GRAVES HARMON S GRAVES ATTY ANDREW LUK COOPERVISION SYMPOSIUM ON THE MATERIAL SCIENCE & CHEMISTRY OF - UPDATING THE CONTACT LENS CLASSIFICATION SYS; LENS SOL INTERACTIONS: IMPACT ON BIOCOMPATIBILITY SLIDES 3/18/11 MACROPRO GEL (BETTA GLUCAN GEL) - K002078 FCN 944, FCN 1036 ABBOTT LABS (ROSS PRODS DIV) - TELEPHONE CONFERENCE 1/12/05; INFANT FORMULA TEST RESULTS; INDIVIDUAL RECS, ETC ORA/SE-FO/ATL-DO/ACB/ Doe J LEVENTON SAU, BARCELONA, SPAIN - EIRS, 483S, WARNING LTRS, ETC OPHTHALMIC IMAGING SYSTEMS, SACRAMENTO, CA - OIS EYESCAN PORTABLE MODULALR IMAGING SYS K092374 ALCON LABS - ACRYSOF TORIC IOL P930014/S016 PI CMPLNT 119591 ORA/NE-FO/NYK-DO/NYDCB/ KIMBERLY ARENDS G&W LABORATORIES INC MICHAEL R COHEN RPH MS SCD INSTITUTE FOR SAFE MEDICATION PRACTICES E FOUGERA & CO (NYCOMED US INC), MELVILLE, NY EIRS, 483S, CO RESP 2008 TO PRESENT MEDWATCH RPTS CODED AS MEDICATION ERRORS 3/1/114/1/11 PATRICK SHAFFER LEXISNEXIS COURTLINK INC OXYCONTIN (OXYCODONE HCL ER) TABS NDA 22-272 RECS Subject
2011-2670 2011-2671 2011-2672
04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/CIN-DO/CCB/
ALYSON L WOOTEN KILPATRICK TOWNSEND ATTY JIM FALLER PHD ZEE COMPANY INC STEPHEN H MEYER NICK STEIN LAW OFC
2011-2673
04/08/2011 05/06/2011
FDA/OMPT/CDRH/OCER/DFOI/
NITYA NARAYANNAN MAQUET CARDIOVASCULAR
COVIDIEN, BOULDER CO - LIGASURE CURVED SMALL JAW OPEN SEALER/DIVIDER K102470
Page 99 of 1132

Total Records: 12455 Control # 2011-2674 Recd Date / Due Date 04/08/2011 05/06/2011 2011-2675 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OER/OPA/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ 2011-2676 2011-2677 04/08/2011 05/06/2011 04/08/2011 05/06/2011 2011-2678 04/08/2011 05/06/2011 2011-2679 04/08/2011 05/06/2011 ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2680 2011-2681 04/08/2011 05/06/2011 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2682 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2683 04/08/2011 ORA/CE-FO/BLT-DO/CB/ JOHN WALSH FILTRONA FIBERTEC, COLONIAL HEIGHTS, VA - EIRS, 483S, MCCANN, JOE AUXILIUM PHARMS - ZIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) AERS FDA/OMPT/CDRH/OCER/DFOI/ SHANE M HAM OSBORN MALEDON PA DR FRANK DEHNER IMMATICS BIOTECHNOLOGIES GMBH BERLEX LABS - LEUKINE (SARGRAMOSTIM) BLA 103362 APRVL LTRS, SUMMARY RVWS THORATEC VAD SYS P870072/S002,S003,S004, ETC - RECS Doe J ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ JOHN FOLEY Keller and Heckman LLP GARY A FOLLMAN FOLLMAN REALL ESTATE SERVICES LLC RAQUEL RUTTLEDGE MILWAUKEE JOURNAL SENTINEL R&G ENTERPRISES LLC, DAN LUIS TORTILLA, MARYLAND HEIGHTS, MO - EIRS 2/16/11 H&P INDUSTRIES (TRIAD GROUP), HARTLAND, WI - EIRS, CORR 2001 TO PRESENT ENVIRON - FAP 3A4749 Action Office ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP ERICA R ARONSON Hyman Phelps and McNamara PC Subject DCI MANAGEMENT GROUP INC, NORTHPORT, NY - EIRS, 483S, CO RESP LAST 5 YRS CRITICS SLAM COST OF FDA-APPROVED DRUG TO PREVENT PRETERM BIRTHS - WASHINGTON POST ARTICLE DISCUSSION 3/25/11, RECS
LEVAQUIN - AERS
Page 100 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/06/2011 2011-2684 2011-2685 04/08/2011 05/06/2011 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2686 2011-2687 2011-2688 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2689 04/08/2011 05/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2690 04/08/2011 05/06/2011 2011-2691 04/08/2011 05/06/2011 2011-2692 04/08/2011 05/06/2011 2011-2693 04/08/2011 05/06/2011 2011-2694 04/08/2011 05/06/2011 2011-2695 04/08/2011 ORA/SW-FO/DALORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS DCI BIOLOGICALS SAN MARCOS LLC, SAN MARCOS, TX EIR, 483, CO RESP LAST 5 YRS DCI BIOLOGICALS AUSTIN LLC, AUSTIN, TX - EIR, 483, CO RESP LAST 5 YRS STILLWATER PLASMA CENTER LLC, STILLWATER, OK - 483, EIR, CO RESP LAST 5 YRS DCI BIOLOGICALS GREENVILLE LLC, GREENVILLE, NC EIR, 483, CO RESP LAST 5 YRS DCI BIOLOGICALS LLC, GALLUP, NM - EIR, 483, CO RESP LAST 5 YRS WESTGATE BIOLOGICALS LLC, COLLEGE STATION, TX JOHNDA L CRSITES BAKER & BOTTS, L.L.P. GUIDANCE FOR INDUSTRY: ESTIMATING THE MAXIMUM SAFE STARTING DOSE IN INITIAL CLNCL TRIALS FOR THERAPEUTICS IN ADULT HEALTHY VOLUNTEERS 7/05, ETC (CERTIFIED) WEHRMAUN, DAVID CVM/OCD/ CVM/OCD/ KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. KRISTI O SMEDLEY Center for Regulatory Services, Inc. FEED INGREDIENT DERIVED FROM BIOLOGICAL TREATMENT OF WASTE PULP FROM PAPER PROCESSING POTATO WASTEWATER SLUDGE AS A FEED INGREDIENT SAFETY ASSESSMENT SYNTHROID, LEVOTHYROXINE, POTASSIUM IODINE AERS; SPICE K2, MEPHODRONE, ETC - RECS FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester JAMES ALEXANDER CORP AARON L HARRAH HILL PETERSON CARPER, ET AL RICK HAWKINS LUMOS PHARMA LUMOS PHARMA, AUSTIN, TX - CYCLOCREATINE IND 43, 267 RECS Subject RECALLS, ETC 2008 TO PRESENT INDIVIDUAL RECS
Page 101 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/06/2011 2011-2696 04/08/2011 05/06/2011 2011-2697 04/08/2011 05/06/2011 2011-2698 04/08/2011 05/06/2011 2011-2699 04/08/2011 05/06/2011 2011-2700 04/08/2011 05/06/2011 2011-2701 04/08/2011 05/06/2011 2011-2702 04/08/2011 05/06/2011 2011-2703 04/08/2011 05/06/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2704 2011-2705 2011-2706 2011-2707 2011-2708 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. DIANA RUSK COHEN ARNALL GOLDEN GREGORY LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2011-1794 - REQUEST LTR 2011-1705 - REQUEST LTR 2011-1676 - REQUEST LTR DISPOSABLE HAND SWITCHING ESU PENCIL K925619 2011-1669 - REQUEST LTR ORA/SW-FO/DEN-DO/COMP/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ Action Office DO/COMPLIANCE/ ORA/SE-FO/FLA-DO/FCB/ Signature/ Requester MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP JUNE K. GHEZZI JONES DAY ATTYS Subject EIR, 483, CO RESP LAST 5 YRS DCI BIOLOGICALS ORLANDO LLC, GAINESVILLE, FL - EIR, 483, CO RESP LAST 5 YRS DCI BIOLOGICALS TEMPLE TERRACE LLC, TEMPLE TERRACE, FL - EIR, 483, CO RESP LAST 5 YRS DCI BIOLOGICALS CARBONDALE LLC, CARBONDALE, IL EIR, 483, CO RESP LAST 5 YRS BOWLING GREEN BIOLOGICALS LLC, BOWLING GREEN, KY - 483, EIR, CO RESP LAST 5 YRS PORTLAND BIOLOGICALS LLC, LEWISTON, ME - EIR, 483, CO RESP LAST 5 YRS LAS CRUCES BIOLOGICALS LLC, LAS CRUCES, NM - 483, EIR, CO RESP LAST 5 YRS DCI BIOLOGICALS WICHITA FALLS LLC, WICHITA FALLS, TX - EIR, 483, CO RESP LAST 5 YRS LUPRON DEPOT - SAFETY RVW 1/09 TO PRESENT
Page 102 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/06/2011 2011-2709 2011-2710 2011-2711 2011-2712 2011-2713 2011-2714 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/08/2011 05/06/2011 2011-2715 2011-2716 2011-2717 2011-2718 04/08/2011 05/06/2011 04/08/2011 05/06/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 2011-2719 04/11/2011 05/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2720 04/11/2011 05/09/2011 2011-2721 04/11/2011 05/09/2011 2011-2722 04/11/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ NORINGTON #138726, LAKESHA JENNIFER SHARKEY LIST OF APPROVED AND UNAPPROVED FOOD, SOAP, TOOTHPASTE, ETC FOR THE INDIANA DEPT OF CORRECTIONS 9/11/03 TO PRESENT UROSURGE INC - PERCUTANEOUS SANS DVC K992069 CHRISTOPHER WAHI MICROPHARMA VITAPATCH PIN PROTECTION DVC - K895920 JEREMY BORDEN CENTER FOR PUBLIC INTEGRITY LEXAPRO, CELEXA - AERS 2000 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ WOLTERS KLUWER LAW & BUSINESS MARCY SUSSMAN GlaxoSmithKline ANGELIA SLAYTON KENDLE REGULATORY AFFAIRS CHRISTOPHER WAHI MICROPHARMA CHRISTOPHER WAHI MICROPHARMA AMC ANTIMICROBIAL PIN/WIRE SLEEVE - K012193 TEGADERM CHG - K080620 OTC VOLS. 130134, 130151, ETC. OTC VOL 210263 Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. FOI DAILY LOG 3/21-25/11 2011-2106 - REQUEST LTR 2011-1970 - REQUEST LTR 2011-1969 - REQUEST LTR 2011-1940 - REQUEST LTR 2011-1938 - REQUEST LTR Subject
Page 103 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/09/2011 2011-2723 04/11/2011 05/09/2011 2011-2724 04/11/2011 05/09/2011 2011-2725 04/11/2011 05/09/2011 2011-2726 2011-2727 04/11/2011 05/09/2011 04/11/2011 05/09/2011 2011-2728 04/11/2011 05/09/2011 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2729 2011-2730 04/11/2011 05/09/2011 04/11/2011 05/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ 2011-2731 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2732 04/11/2011 05/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS K093775 PATRICIA L REGENYE Celgene Corporation RICHARD GREIL, LKH SALZBURGH/LANDESLKINIK FUR INNERE MEDIZIN III, SALZBURG, AUSTRIA - 483S 7/10 TO 4/11 AARON L HARRAH HILL PETERSON CARPER, ET AL PATRICIA L REGENYE Celgene Corporation MICHELLE PETRI, JOHNS HOPKINS UNIV SCHOOL MEDICINE, BALTIMORE, MD - 483S 2/01 TO 4/11 INDIVIDUAL RECS PATRICIA L REGENYE Celgene Corporation SERGIO ACCHIARDO, UNIV TENNESSEE HEALTH SICENCE CTR, MEMPHIS, TN - 483S 3/90 TO 4/11 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ GARY C COOPER GARY C COOPER LAW OFC PATRICIA L REGENYE Celgene Corporation CUSTOMS AND BORDER PROTECTION SEIZURE CASE #2011-2809-000224-01 - INVESTIGATION RPT GILBERT WEINER, MIAMI GARDENS, FL - 483S 3/05 T0 4/11 JENNIFER SHARKEY EMKINETICS INC UROPLASTY INC - URGENT PC NEUROMODULATION SYS K052025 JENNIFER SHARKEY EMKINETICS INC UROPLASTY INC - URGENT PC NEUROMODULATION SYS K071822 JENNIFER SHARKEY EMKINETICS INC UROPLASTY INC - URGENT PC NEUROMODULATION SYS K061333 Signature/ Requester EMKINETICS INC Subject
Page 104 of 1132

Total Records: 12455 Control # 2011-2733 Recd Date / Due Date 04/11/2011 05/09/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2734 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2735 2011-2736 2011-2737 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 2011-2738 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-2739 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2740 2011-2741 2011-2742 04/11/2011 05/09/2011 04/11/2011 05/18/2011 04/11/2011 05/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2743 04/11/2011 05/09/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ PATRICIA L REGENYE Celgene Corporation GHODRAT SIAMI, VA MED CTR NASHVILLE/VANDERBILT UNIV, NASHVILLE, TN - 483S 2/01 TO PRESENT FDA/OF/CFSAN/OCD/EOS/ ROACH, ALICE JUDITH SCOLNICK SCOTT & SCOTT LLP RICHARD V WOLFE KIMBERLY-CLARK CORP MONSANTO CO - MON 87705 HIGH OLEIC SOYBEAN SAFETY & NUTRIONAL ASSESSMENT BAXTER INTERNATIONAL INC - HEPARIN 483S, WARNING LTRS, CORR, ETC 1/08 TO 12/09 KIMBERLY-CLARK CORP - LABELER CODE 55118 LIST LEWIS B HOLMES MASSGENERAL HOSPITAL FOR CHILDREN GABAPENTIN - ANIMAL STUDIES FDA/OMPT/CDRH/OCER/DFOI/ CASCIO III, PAUL J MATTHEW S KNOOP ASHE RAFUSE & HILL LLP OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ROACH, ALICE BRIAN P SULLIVAN SEARCY DENNEY ET AL PIONEER HI-BRED INTERNATIONAL INC - HIGH OLEIC 305423 SOYBEAN GRAS FILINGS, FORM FDA 3665, ETC IMAGING DIAGNOSTIC SYSTEMS INC, FORT LAUDERDALE, FL - COMPUTER TOMOGRAPHY LASER BREAST IMAGING DVC RESP LTR RIVER'S EDGE PHARMACEUTICALS LLC, SUWANEE, GA PHOSENAMINE DRUG REGISTRATION FORMS, CORR, RECS 1/08 TO PRESENT TEVA PHARMS - PROPOFOL AERS SUSAN TODD WEST-WARD PHARMACEUTICAL CORP TEVA - GLYBURIDE TABS ANDA 74-388 BIOAVL, RVWS, DISSOLUTION RECS, ETC Doe J Signature/ Requester Subject ETOMIDATE - ISRS 3502684, 3656609, 3821456, ETC
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Total Records: 12455 Control # 2011-2744 2011-2745 2011-2746 2011-2747 2011-2748 2011-2749 2011-2750 Recd Date / Due Date 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2751 04/11/2011 05/09/2011 2011-2752 2011-2753 04/11/2011 05/09/2011 04/11/2011 05/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2754 2011-2755 2011-2756 2011-2757 04/12/2011 05/10/2011 04/12/2011 05/10/2011 04/12/2011 05/10/2011 04/12/2011 05/10/2011 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2D-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK & CO INC - ROTATEOQ (ROTAVIRUS) VAERS 3/131/11 MERCK & CO INC - PROQAD (MEASLES, MUMPS, RUBELLA, ETC) VAERS 3/2-31/11 MERCK & CO INC - GARDASIL VAERS 3/1-31/11 FOI DAILY LOG 3/28/11-4/1/11 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION MARILYNN WHITNEY COVINGTON & BURLING LLP DR. DARIA MARI POLICHEM SA PHARMACOLOGY & TOXICOLOGY RVW - LAMISIL (TERBINAFINE HCL) CREAM NDA 020192 DKT FDA-2010-P-0491 DKT FDA-1997-S-0039 BUHLES, WILLIAM C ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ Action Office ORA/P-FO/LOS-DO/LACB/ Signature/ Requester PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation JEFFREY CALLEN, UNIV ASSOC DERMATOLOGY, LOUISVILLE, KY - 483S 3/90 TO PRESENT MARSHALL NASH, DEKALB NEUROLOGY ASSOC, DECATUR, GA - 483S 3/03 TO PRESENT ABE MARCADIS, CLNCL STUDIES BOYNTON BEACH, BOYNTON BEACH, FL - 483S 1/06 TO PRESENT OTSUKA AMERICA PHARMACEUTICAL INC - OPC 8212 (VESNARINONE) PRIOR INVESTIGATION & MARKETING EXPERIENCES RPTS Subject CHARLES KAUPKE, UNIV CALIFORNIA IRVINE MED CTR, ORANGE, CA - 483S 2/98 TO PRESENT ELISE OLSEN, DUKE UNIV MED CTR, DURHAM, NC - 483S 3/98 TO PRESENT LEE NESBITT, NEW ORLEANS, LA - 483S 11/92 TO PRESENT
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Total Records: 12455 Control # 2011-2758 2011-2759 2011-2760 Recd Date / Due Date 04/12/2011 05/10/2011 04/12/2011 05/10/2011 04/12/2011 05/10/2011 2011-2761 2011-2762 04/12/2011 05/10/2011 04/12/2011 05/10/2011 2011-2763 2011-2764 04/12/2011 05/10/2011 04/12/2011 05/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ CVM/OCD/ OC/OCC/ 2011-2765 2011-2766 04/12/2011 06/03/2011 04/12/2011 05/10/2011 2011-2767 04/12/2011 05/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2768 04/12/2011 05/10/2011 ORA/ ORA/ MELISSA M NICHOLS WILKES BOWERS PA RECALL OF POWDERED INFANT FORMULA CONTAMINATED BY ENTEROBACTER SAKAZAKI - RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KELLY, ED CHRISTINE M HUMPHREY ESQ HUMPHREY MIRKIN PA MERCE CANOVAS LESVI LABORATORIOS SL ENDYMED LTD - FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR K101510; EMERGO GROUP - EXILIS, EXILIS 500 K092191 ALEMBIC RESEARCH CENTRE, GUJARAT, INDIA - EIRS LAST TWO DOMINIAN SCANNER K093147 - NOTES, E-MAILS, FAXES SHAPIRO, MEGHAN FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ JOHN NEUMANN HICKEY JOHN NEUMANN HICKEY ATTY NATASCIA AYERS JAROSLAWICZ & JAROS LAW OFCS JOHN NEUMANN HICKEY JOHN NEUMANN HICKEY ATTY BARD PERIPHERAL VASCULAR INC (BARD INTERNATIONAL & CR BARD LTD) - VENA CAVA FILTER MDRS, CO RESP VIRGINIA DEPT OF CORRECTIONS, GREENSVILLE CORRECTIONAL CENTER - SODIUM THIOPENTAL, SODIUM PENTOTHAL, PAVULON, ETC EXPIRATION DATES RECS BARD PERIPHERAL VASCULAR INC, CR BARD LTD - G2 INFERIOR VENA CAVA FILTER RECS INDIVIDUAL RECS MCCANN, JOE Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester KEVIN S FRIES COSMETIC INGREDIENT REVIEW JOAN STITT (UG2CD-16) MERCK & CO., INC. QUALITEST PHARMS, HUNTSVILLE, AL; CHARLOTTE, NC EIRS, 483S LAST 2 YRS FOI DAILY LOG 3/21-25/11 Subject HAIR SMOOTHING PRODS - CAERS
Page 107 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/OE/ ORA/OE/ 2011-2769 2011-2770 04/12/2011 05/10/2011 04/12/2011 05/10/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2771 04/12/2011 05/10/2011 2011-2772 04/12/2011 05/10/2011 2011-2773 2011-2774 2011-2775 2011-2776 04/12/2011 05/10/2011 04/12/2011 05/10/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 2011-2777 2011-2778 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2779 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BARNES MELOXICAN, WELLBUTRIN (BUPROPION HCI XL) - CLNCL TRIALS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ HUBER, MATTHEW ROSS RENDELMAN HOGAN LOVELLS US LLP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP JEFFREY A MILMAN HODES MILMAN LLP JOSEPH CAPRIOTTI JOSEPH A CAPRIOTTI MD ALLEGIANCE HEALTHCARE - POVIDONE IODINE NDA 19522 LBLG, MICROBIOLOGY RVWS, MEDICAL RVWS 3/31/89 MEDTRONIC INC - MINIMED CONTINUOUS GLUCOSE P980022/2090,S092 XOFT - AXXENT FLEXISHIELD MINI K090471 ORA/CE-FO/DET-DO/DCB/ ORA/OCI/ ORA/OCI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ MELISSA M NICHOLS WILKES BOWERS PA BP GULF OIL SPILL - HEALTH EFFECTS OF EXPOSURE TO COREXIT DISPERSANT FORMULA RECS DKT 1976N-0056 POWDERED INFANT FORMULA FIELD SURVEY 2002 - RECS MELISSA M NICHOLS WILKES BOWERS PA ABBOTT LABS, INTERNATIONAL FORMULA COUNCIL SIMILAC POWDERED INFANT FORMULA RECALL RECS, CORR 2010 BRIDGET BODNAR MICHIGAN RADIO LELA WARREN, GLITTERSNIFFER COSMETICS, DEARBORN HEIGHTS, MI - RECS FDA/OO/OFBA/OAGS/ CHRISTOPHER K JACKSON AAJ TECHNOLOGIES KRISTI O SMEDLEY Center for Regulatory Services, Inc. HYPERION/OBIEE SUPPORT SERVICES - CONTRACT FDA11-223-SOL-00024 NORTH AMERICAN BIOPRODUCTS CORP - FAP 2268 Signature/ Requester Subject
Page 108 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-2780 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2781 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2782 04/13/2011 05/11/2011 2011-2783 2011-2784 2011-2785 2011-2786 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2787 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2788 2011-2789 2011-2790 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SHAPIRO, MEGHAN ORA/SW-FO/DALDO/COMPLIANCE/ OM/OMP/DODM/ CRAIG ROUSH ROCKLINE INDUSTRIES CLAUDIA BERGER LIB4RI VIRGINIA DEPT OF CORRECTIONS, GREENSVILLE CORRECTIONAL CENTER - SHIPMENT OF SODIUM THIOPENTAL INTO THE US POLICY RECS ROCKLINE INDUSTRIES, SPRINGDALE, AK - EIRS 1/1/06, 12/31/06 DKT 1996N-0057 ANDI POULSON LEXISNEXIS COURTLINK INC ISR M00185096 (CERTIFIED) ORA/CE-FO/NJ-DO/NJCB/ JAMES P MCCARTHY QUADEX PHARMACEUTICALS LLC AARON L HARRAH HILL PETERSON CARPER, ET AL SHARI WRIGHT REICH & BINSTOCK LLP BALKE A EUDY MORRIS POLICH & PURDY LLP RAFAEL L ARRIBAS JR PHARMACEUTICAL GENERIC DEVELOPERS INC IOVATE HEALTH SCIENCES - HYDROXYCUT CAERS, CMPLNTS, WARNINGS, ETC PHYGEN LLC, ALLEZ SPINE LLC - LAGUNA PEDICLE SCREW SYS K103748, K050060 EIRS, 483S, CO RESP, ETC ADVANCED GENERIC CORP (AGC), DORAL,FL- OTC MFR LICENSE, REGISTRATION UNDER LABELER CODE 45737, LIST OF PRODS, ETC H&P INDUSTRIES (HH&P LLC), HARTLAND, WI - EIRS, 483S, CO RESP 10/30/09, 11/10/10 INDIVIDUAL RECS BRADFORD L JEFFERSON BRADFORD JEFFERSON PA SKELLAXIN (METAXALONE) - AERS Doe J PFIZER PHARM - GABAPENTIN AERS Signature/ Requester Subject
Page 109 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-2791 2011-2792 04/13/2011 08/12/2011 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2793 2011-2794 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-2795 04/13/2011 05/11/2011 2011-2796 2011-2797 04/13/2011 05/11/2011 04/13/2011 05/11/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2798 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANNA-LIISA NIXON CAPITAL COLLATERAL REGIONAL COUSNEL - SOUTH SODIUM THIOPENTAL - IMPORT TO THE US, TEST RESULTS, CHAIN OF CUSTODY, ETC ORA/ORM/ ORA/ORM/ ORA/CE-FO/NJ-DO/NJCB/ GASTELU, DANIEL RICHARD R SCHLUETER CHILDERS SCHLUETER & SMITH LLC DEPUY ORTHOPAEDICS INC, WARSAW, IN - DEPUY ASR XL ACETABULAR SYS, ASR HIP RESURFACING PLATFORM MDRS, CORR, CMPLNTS, ETC GAIL LESSICK LACHMAN CONSULTANT SERVICES, INC. LIST OF DOMESTIC AND FOREIGN INSPS FOR DRUG COMPANIES, BIORESEARCH MONITORING (BIMO) INSPS 3/1-31/11 NUTRISPORT PHARMACAL, FRANKLIN, NJ - EIRS, 483S ORA/CE-FO/BLT-DO/CB/ SCHARBERG, DAVID L MATTHEW K ITO OREGON HEALTH & SCIENCE UNIV/ SCHOOL OF PHARMACY BIORELIANCE, ROCKVILLE, MD - 483S 9/8-29/08, 8/16/109/2/10, 1/23/11-2/4/11 RED YEAST RICE PRODS - EIRS, TESTING, WARNING OR ENFORCEMENT LTRS, ETC BARAK, NIR FDA/OF/CFSAN/OCD/EOS/ THOMAS C MCENTEE EI DU PONT DE NEMOURS & CO OXYMETAZOLINE NASAL DROPS NDA 14-717 - RECS NATIONAL FOOD PROCESSORS ASSN (NFPA) - FAP 4A4415 Signature/ Requester Subject
Page 110 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ CVM/OCD/ OC/OCC/ 2011-2799 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2800 2011-2801 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2802 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2803 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2804 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2805 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Ranteesi, Simon PAXIL - AERS CHRIS RENZ PRS INC AMNEAL - IBUPROFEN TABS ANDA 71-334 APRVL LTR CHRIS RENZ PRS INC WOCKHARDT - CAPTOPRIL TABS ANDA 74-532 APRVL LTR CHRIS RENZ PRS INC AMNEAL - METFORMIN HC TABS ANDA 77-880 APRVL LTR ORA/SE-FO/ATL-DO/ACB/ PENINNAH WANJERI BD BIOSCIENCES ALISON M MICKLE WARNER CHILCOTT BECTON DICKINSON BIOSCIENCES DISCOVERY LABWARE, DURHAM, NC - EIR 1/08 TO 6/08 WARNER CHILCOTT CO LLC - ENABLEX (DARIFENACIN) ER TABS IND 45,457 AMENDMENTS GAYLE DOUGLAS HENINGER GARRISON DAVIS LLC MEDS IV LLC, ADVANCED SPECIALTY PHARMACY LLC TOTAL PATENTERAL NUTRITION (TPN) INSPS, LBLG CHANGES, AERS, ETC Signature/ Requester Subject
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Total Records: 12455 Control # 2011-2806 Recd Date / Due Date 04/13/2011 05/11/2011 2011-2807 2011-2808 2011-2809 2011-2810 2011-2811 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2812 2011-2813 2011-2814 2011-2815 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 04/13/2011 05/11/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2816 2011-2817 2011-2818 2011-2819 04/13/2011 05/11/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & CLOSED FOIA REQUESTS 4/4-8/11 FOI SERVICES INC CLOSED FOIA REQUESTS 4/11-15/11 OC/OM/OMP/DDM/ MARILYNN COVINGTON & BURLING LLP CLOSED FOIA REQUESTS 4/4-8/11 OTC VOL 04TTFM ELENA HOWELL HOGAN LOVELLS US LLP ELENA HOWELL HOGAN LOVELLS US LLP AARON L. HARRAH HILL PETERSON CARPER, ET AL JOAN STITT MERCK & CO., INC. MERCK & CO - ISENTRESS (RALTEGRAVIR) MEDWATCH INDIVIDUAL RECS 2011-2135 2011-2360 ORA/NE-FO/NYK-DO/NYDCB/ Action Office ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ HOGAN LOVELLS US LLP MEAGAN THEROUX OLYMPUS BIOTECH CORP MEAGAN THEROUX OLYMPUS BIOTECH CORP KELLIE B. COMBS ROPES & GRAY LLP DULERA (FORMOTEROL FUMORATE & MOMETASONE FUROATE) RVW, APRVL 22-518 BIONIQUE TESTING LABS INC, SARANAC, NY - EIR 2/10 STRYKER BIOTECH, HOPKINTON, MA - EIR 5/14/09- 6/8/09 Signature/ Requester BENJAMIN L. ENGLAND, Esq. BENJAMIN L ENGLAND & ASSOCIATES LLC THOMAS J QUINN Medical Resources Alliance 2011-2242 Subject ZHANJIANG EVERGREEN AQUATIC PRODUCT - IMPORT ALERT #16-131 EXEMPTION LIST
SD1200 RENAME - RECS
Page 112 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester BUSINESS 2011-2820 04/14/2011 05/12/2011 2011-2821 2011-2822 2011-2823 2011-2824 2011-2825 2011-2826 2011-2827 2011-2828 2011-2829 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ CVM/OCD/ OC/OCC/ 2011-2830 04/14/2011 05/12/2011 ORA/SE-FO/FLA-DO/FCB/ DARLA C CHEW ORTHOFIX INC. NANOTHERAPEUTICS INC, ALACHUA, FL - EIR MOST RECENT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CHRISTOPHER J WORKMAN WORKMAN LEASURE LLP MARC BOOKMAN ATLANTIC CENTER FOR CAPITAL REPRESENTATION PENNSYLVANIA DEPT OF CORRECTIONS - IMPORTATION OF SODIUM THIOPENTAL, PANCURONIUM BROMIDE, POTASSIUM CHLORIDE, ETC USED FOR CARRYING OUT EXECUTIONS CORR 9/09 TO PRESENT INDIVIDUAL RECS CLOSED FOIA REQUESTS 3/7-11/11 CLOSED FOIA REQUESTS 2/28/11-3/4/11 CLOSED FOIA REQUESTS 3/14-18/11 CLOSED FOIA REQUESTS 3/21-25/11 CLOSED FOIA REQUESTS 3/28/11-4/1/11 CLOSED FOIA REQUESTS 4/11-15/11 CLOSED FOIA REQUESTS 4/4-8/11 CLOSED FOIA REQUESTS 4/4-8/11 Subject
Page 113 of 1132

Total Records: 12455 Control # 2011-2831 2011-2832 Recd Date / Due Date 04/14/2011 05/12/2011 04/14/2011 05/12/2011 Action Office ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/PHI-DO/PCB/ Signature/ Requester KONI CROSSAN ISTA PHARMACEUTICALS CHARLES J BEAVER PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES INC ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ 2011-2834 2011-2835 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2836 2011-2837 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2838 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ JESSICA JOHNSON FEDERAL DEFENDER SERVICES OF EASTERN TENNESSEE INC SODIUM THIOPENTAL ENTRY #112-9247186-3, #1127818637-8 - IMPORTATION RECS FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ MITCHELL S FUERST FUERST ITTLEMAN PL JANSSEN PHARMACEUTICA, GEEL, BELGIUM - EIR 12/10 NORTHEAST SCIENTIFIC INC - K090661 PATHOLOGY RPT FDA/OF/CFSAN/OCD/EOS/ Caranchini, Benjamin CLARK G SULLIVAN ARNALL GOLDEN GREGORY LLP PURDUE PHARMS - FDA FORMS 3542 FOR US PATENT #6,589,960 TRANS FATS - CAERS SCHARBERG, DAVID L Subject STATISTICS & DATA CORP, TEMPE, AZ; ORA CLINICAL, ANDOVER, MA - EIRS, 483S MOST RECENT OXYMORPHONE HCI TRF FILM COATED TABS NDA 20-1665 - EIR 2/9/11
2011-2833
04/14/2011 05/12/2011
BIORELIANCE CORP 2/4/11, VA-MD REGIONAL COLLEGE OF VETERINARY MEDICINE 1/19/11, SALISAW EQUINE CLINIC 1/6/11, ETC - 483S
Page 114 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CVM/OCD/ OC/OCC/ 2011-2839 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2840 2011-2841 2011-2842 2011-2843 2011-2844 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 06/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ 2011-2845 2011-2846 2011-2847 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KRISTI O SMEDLEY Center for Regulatory Services, Inc. TOLMAR INC - DICLOFENAC SODIUM PARAGRAPH IV CERTIFICATIION AMSINO INTERNATIONAL - AMSINO IV ADMINISTRATION SET & EXTENSION SETS K101958 AMERICAN BIOPRODUCTS - ERYTHROMYCIN FAP 2263 FOI SERVICES INC PAULA MELLEMA BIOLIFE PLASMA SERVICES PLASMA BIOLOGICAL SERVICES INC, ELGIN, IL 3/24/10; PLASMA CARE INC, RICHMOND, VA 3/28/10; CSL PLASMA, COLUMBUS, OH 7/9/10, ETC - EIRS FOI SERVICES INC ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC LINDA BOWEN SANOFI AVENTIS JEROME STEVENS PHARMS, BOHEMIA, NY - EIR, 483, WARNING LTR, CO RESP 4/13 TO 5/6/09; 2/13 TO 3/10/10 GENERAMEDIX INC - SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE ANDA 78-215 SBA STAR SCIENTIFIC INC - STONEWALL BDL MODIFIED RISK TOBACCO PRODUCT (MRTP) APPL STAR SCIENTIFIC INC - ARIVA BDL TM DOCS 2/19/10 FOI SERVICES INC TEVA PRARMACEUTICAL INDUSTRIES LTD, JERUSALEM, ISRAEL OSD - EIR 9/10 Signature/ Requester Subject
Page 115 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-2848 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2849 2011-2850 2011-2851 2011-2852 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2853 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2854 2011-2855 2011-2856 2011-2857 2011-2858 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2859 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC TEVA PARENTERALS - METHYLPREDNISOLONE ACETATE ANDA 40-620 APRVL LTR, LBLG, RVWS, ETC FOI SERVICES INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC ORA/P-FO/SEA-DO/SCB/ FOI SERVICES INC GREER LABS, LENOIR, NC - EIR, 483, WARNING LTR, CO RESP 3/1/07 TO PRESENT ALLERGAN, SANTA BARBARA, CA - EIR, 483, WARNING LTR, CO RESP 2005 TO PRESENT STAR SCIENTIFIC - ARIVA-BDL, STONEWALL-BDL MODIFIED RISK TOBACCO PRODS APPL NOTICES SANDOZ - METHYLPREDNISOLONE ACETATE ANDA 40-794 APRVL LTR, RVWS QUORUM IRB, SEATTLE, WA - 483 1/08 TO PRESENT FOI SERVICES INC ALLERGAN JUVEDERM, PRINGY, FRANCE - EIR, 483, WARNING LTR, CO RESP 5/10 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FOI SERVICES INC DPT LABS, SAN ANTONIO, TX - QUALITY ASSURANCE PROFILE (QAP) MOST RECENT NONIM MEDICAL - MODEL 7600 REGIONAL OXIMETER SYS K090807 WL GORE & ASSOCS - GORE-TEX DUALMESH PLUSE BIOMEDICAL K9461606 BRISTOL MYERS SQUIBB - YERVOY BLA 125377 APRVL RECS FOI SERVICES INC SCHERING - DULERA NDA 22-518 APRVL RECS Signature/ Requester Subject
Page 116 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2860 2011-2861 2011-2862 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2863 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ 2011-2864 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2865 04/14/2011 05/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-2866 2011-2867 2011-2868 2011-2869 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ OC/OM/OMP/DDM/ ORA/P-FO/SEA-DO/SCB/ ED PATT GREER LABORATORIES INC AUDREY RISLEY FIRST ASIAN INC JOYCE RIDLEY WOLTER KLOWER AMANDA WEST IMPORTING ROCK SALT FROM THE PHILIPPINES REGULATIONS, REQUIREMENTS DKT & DKT LOG OF FDA-1997-S-0039, FDA-1995-S-0039, ETC. CONTRACTING OFFICER LIST HOLLISTER STIER LABS LLC, SPOKANE, WA - 483 12/10 ADRIAN CHOWDHARY BIO PRODUCTS LABORATORY BIO PRODUCTS LABS, ELSTREE, UK - EIR 5/15-22/09 ADRIAN CHOWDHARY BIO PRODUCTS LABORATORY GAMMAPLEX - AERS ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ZOSTAVAX BLA 125123/0 - APRVL LTR, SBA FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC SANDOZ - METHYLPREDNISOLONE ACETATE ANDA 04-719 APRVL LTR, LBLG, RVWS, ETC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC PARE SURGICAL - ENDOSCOPIC SUTURING DVC K003102 VIOPTIX - ODISSEY TISSUE OXIMETER K042657 Signature/ Requester Subject
Page 117 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/12/2011 2011-2870 2011-2871 2011-2872 2011-2873 2011-2874 2011-2875 2011-2876 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/14/2011 05/12/2011 04/15/2011 05/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2877 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2878 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2879 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2880 2011-2881 04/15/2011 05/13/2011 04/15/2011 05/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JEREMY GRAZIANO EYE PHOTO SYSTEMS INC PATRICK J KINNEY LYNCH BREWER HOFFMAN & RIGHTMEDICAL PRODUCTS LLC - BIOMICROSCOPE SLIT-LAMP AC-POWERED K060869 OMEGA LABORATORIES INC - PHENCYCLIDINE K105979 NAVEEN SHARMA BA RESEARCH INDIA LIMITED BA RESEARCH INDIA LTD, GUJARAT, INDIA - ETHINYL ESTRADIO/LEVONORGESTREL TABS EIRS 10/18-22/10 NAVEEN SHARMA BA RESEARCH INDIA LIMITED BA RESEARCH INDIA LTD, GUJARAT, INDIA - NABUMETON TABS EIRS 6/17-18/10, 6/21/23/10 NAVEEN SHARMA BA RESEARCH INDIA LIMITED BA RESEARCH INDIA LTD, GUJARAT, INDIA RISEDRONATE SODIUM TABS EIRS 10/25-27/10 BEVERIDGE & DIAMOND PC OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ Action Office OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Signature/ Requester CENTRE CONSULTING RACHEL COTNE K & L GATES RACHAEL COTNER K & L GATES RACHAEL COTNER K & L GATES R. COTNER K & L GATES KATHY MCGOWN FOXKISER JULIA COOKE WESTLAW.COURTEXPRESS CFSAN FOI REQUESTS 3/2/11 TO 4/13/11 DKT 1992N-0434 DKT FDA-2011-P-0213 DKT 1976N-0052 DKT 1976N-0052 DKT 1976N-0052 DKT & DKT LOG OF 1976N-0052 Subject
Page 118 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester FINK LLP 2011-2882 2011-2883 04/15/2011 05/13/2011 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2884 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2885 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2886 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2887 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-2888 2011-2889 2011-2890 2011-2891 04/15/2011 05/13/2011 04/15/2011 05/13/2011 04/15/2011 05/13/2011 04/15/2011 05/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ CHRISTOPHER SEYMOUR CHANGE TO WIN ADIL D BILLIMORIA USV LTD VIK BAJNATH ARTHREX INC JULIE C BRAIN OFFICE OF THE FEDERAL PUBLIC DEFENDER FOR THE DISTRICT OF DELAWARE IMPORTATION OF SODIUM THIOPENTAL, PENTOBARBITAL, PANCURONIUM BROMIDE, ETC - PRE-APRVL INSPECTION 9/09 TO PRESENT MDR 5019523 ACETAL (1,1 DIETHOXYETHANE) - TOXICOLOGICAL RECS L PERRIGO CO - 483 MOST RECENT STEVE R PRESS BAKER DONELSON ET AL STEWART-JACKSON, ATLANTA, GA - UTA CAPS APRVL RECS, 483S, FINAL OPINIONS, ETC DORA GAUL MEDISCA INC UPDATED FOREIGN IMPORTED DRUG PROD LIST (FIDP) MICHELE SINOWAY LACHMAN CONSULTANT SERVICES INC OXALIPLATIN INJ ANDA 78-815 - SBA SHERI WEBB CETERO RESEARCH CETERO RESEARCH (ALLIED CLINICAL RESEARCH INC), MISSISSAUGA, CANADA - EIRS 4/29/02 TO 5/1/02 Doe J FDA/OMPT/CDRH/OCER/DFOI/ LISA HESSABI SYBRON DENTAL SPECIALTIES PENTRON CLINICAL TECHNOLOGIES LLC - DENTIN CONDITIONING & ADHESIVE SYS (BOND 1) K013542 PANTOPRAZOLE - AERS Subject
Page 119 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ CVM/OCD/ OC/OCC/ 2011-2892 2011-2893 04/15/2011 05/13/2011 04/18/2011 05/16/2011 ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/OCI/ ORA/OCI/ 2011-2894 04/18/2011 05/16/2011 2011-2895 2011-2896 04/18/2011 05/16/2011 04/18/2011 05/16/2011 2011-2897 2011-2898 2011-2899 2011-2900 2011-2901 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC SHERI WEBB CETERO RESEARCH SHERI WEBB CETERO RESEARCH SHERI WEBB CETERO RESEARCH CHRISTOPHER GARTEN CELSION CORP CETERO RESEARCH MISSISSAUGA (ALLIED RESEARCH INT'L) - EIRS 2/19/21/08 SYNBIAS PHARM LLC, DONETSK, UKRAINE - EIRS, 483S, CO RESP FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CONMED - ABC DISSECTING BLADE ELECTRODE MODEL 139330; BLUNT NEEDLE ELECTRODE MODEL 139331 K062082 NUORTHO SURGICAL - CERULEAU ELECTROSURGICAL PROBE K101711 ETHICON ENDO-SURGERY - ECHELON FLEX 45/60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER K110385 ETHICON ENDO-SURGERY - REUSABLE LINEAR STAPLER HANDLE K110049 CETERO RESEARCH MISSISSAUGA (ALLIED RESEARCH INT'L INC) - EIRS 6/7-8/04 CETERO RESEARCH MISSISSAUGA - EIRS 9/20-22/09 Doe J OM/OMP/DODM/ KATHLEEN HDGES ROCKLINE INDUSTRIES METHODS FOR CONDUCTING RECALL EFFECTIVENSS CHECK CMPLNT 26058 Signature/ Requester Subject
Page 120 of 1132

Total Records: 12455 Control # 2011-2902 2011-2903 2011-2904 Recd Date / Due Date 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2905 04/18/2011 05/16/2011 2011-2906 04/18/2011 05/16/2011 2011-2907 04/18/2011 05/16/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS BLUEFIELD ASSOCIATES, ONTIARIO, CA; IRENDA, LOS ANGELES, CA; CARIBIA, STANTON, CA, ETC - 483S 3/131/11 DIVERSIFIED MANUFACTUIRNG CORP, NEWPORT, MN; ATHEA LABS, MILWAUKEE, WI; APEX INTERNATIONAL MFG, CHASKA, MN, ETC - 483S 3/1-31/11 ANESTHETIC GAS RECLAMATION, NASHVILLE, TN; ELECTRO MEDICAL EQUIPMENT, BATON ROUGE, LA; EATON MANUFACTURING CORP, MEMPHIS, TN - 483S 3/131/11 FSC LABS, CHARLOTTE, NC; PFEIFFER PHARMS, ATLANTA, GA; STERIMED, CARTERSVILLE, GA, ETC -N 483S 3/1-31/11 REGIS TECHNOLOGIES, MORTON GROVE, IL; BAXTER HEALTHCARE, ROUND LAKE, IL; ABBOTT LABS, NORTH CHICAGO, IL, ETC - 483S 3/1-31/11 ORGANON TEKINIKA CORP, DURHAM, NC - TOF-WATCH SX K992598 ACS DOBFAR, TRIBIANO, MILAN, ITALY - EIRS, 483S 5/10 FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MELISSA WALKER STEREOTAXIS INC MELISSA WALKER STEREOTAXIS INC ANDI POULSON LEXISNEXIS COURTLINK INC ISRS M00174642, M00345865, M00349838, ETC (CERTIFIED) Subject PERKINS HEALTHCARE TECHNOLOGIES - MD VISION SYS K101474 ST JUDE MEDICAL - VANTAGE VIEW SYS K110085
2011-2908 2011-2909
04/18/2011 05/16/2011 04/18/2011 05/16/2011
ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/
KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS
2011-2910 2011-2911
04/18/2011 05/16/2011 04/18/2011 05/16/2011
HERBERT VAN DYK PHILIPS MEDIZIN SYSTEME REBECCA A BERTONE HANFORD PHARMS
2011-2912
04/18/2011 05/16/2011
ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
KEVIN O'ROURKE FDA NEWS CARLA R SCARMAZZI KING & SPALDING CLARK, MAGGIE
PETNET SOLUTIONS, DALLAS, TX; DREW SCIENTIFIC, DALLAS, TX; BETA BIOMED SERVICES, ROWLETT, TX, ETC - 483S 3/1-31/11 JONATHAN SPROUTS INC, ROCHESTER, MA - EIRS, 483S, CMPLNTS, ETC 1/08 TO PRESENT, 9/27/10, 10/13/10 FARM FACILITIES IN GUATEMALA - EIRS, 483S LAST 10 YRS
2011-2913 2011-2914
04/18/2011 05/16/2011 04/18/2011 05/16/2011
Page 121 of 1132

Total Records: 12455 Control # 2011-2915 Recd Date / Due Date 04/18/2011 05/16/2011 2011-2916 04/18/2011 05/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2917 04/18/2011 05/16/2011 2011-2918 2011-2919 04/18/2011 05/16/2011 04/18/2011 05/16/2011 ORA/SW-FO/DEN-DO/COMP/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KEVIN O'ROURKE FDA NEWS ALEXANDER I SHAPOVAL ESQ ALEXANDER I SHAPOVAL LAW OFCS SIESTA MEDICAL - PRELUDE TONGUE SSPENSION SYS K101060 NEOTERIC COSMETICS DENVER, CO; GALLOWAY TECHNOLOGIES, SARATOGA SPRINGS, UT; INTERNATIONAL MEDICAL DEVELOPMENT CORP, HUNSTSVILLE, UT, ETC - 483S 3/1-31/11 P J NOYES CO, LANCASTER, NH; SAFECOR HEALTH, WOBURN, MA; LYNE LABS, BROCKTON, MA, ETC - 483S 3/1-31/11 BUDESONIDE - AERS Doe J INDIVIDUAL RECS SHAW, LORI Action Office OC/COS/OL/ Signature/ Requester BEN MOSCOVITCH INSIDE WASHINGTON PUBLISHERS Subject CONTAMINATED HEPARIN INVESTIGATION CONGRESSIONAL CORR 7/10 TO PRESENT EFFEXOR - AERS
2011-2920
04/18/2011 05/16/2011
ORA/NE-FO/NWE-DO/NWECB/
KEVIN O'ROURKE FDA NEWS
2011-2921
04/18/2011 05/16/2011
2011-2922
04/18/2011 05/16/2011
ORA/CE-FO/DET-DO/DCB/
RUSH & HEBBLE CO, EDINBURGH, IN; KING PHARM INC, ROCHESTER, MI; L PERRIGO, ALLEGAN, MI, ETC - 483S 3/131/11 CETERO RESEARCH MISSISSAUGA (ALLIED CLINICAL RESEARCH INC) - EIRS 7/18-22/03 CETERO RESEARCH MISSISSAUGA (ALLIED RESEARCH INT'L-CETERO) - EIRS 9/10-12/07 SMITH KLINE & FRENCH - THALIDOMIDE CLNCL TRIAL RECS 1962
2011-2923 2011-2924 2011-2925
04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/
SHERI WEBB CETERO RESEARCH SHSERI WEBB CETERO RESEARCH REEVES, KAY GUNDERSON
Page 122 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/PHI-DO/PCB/ 2011-2926 2011-2927 2011-2928 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2929 04/18/2011 05/16/2011 2011-2930 04/18/2011 05/16/2011 2011-2931 2011-2932 2011-2933 04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011 2011-2934 04/18/2011 05/16/2011 2011-2935 2011-2936 04/18/2011 05/16/2011 04/18/2011 05/16/2011 2011-2937 04/18/2011 05/16/2011 2011-2938 04/18/2011 05/16/2011 ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS PAUL H HARDIMAN IRIDEX CORP LUCY GARCIA DAMCO CUSTOMS SERVICES INC HERBERT VAN DYK PHILIPS MEDIZINE SYSTEME BOBLINGEN GMBH KEVIN O'ROURKE FDA NEWS BIOMETER INTL A/S - TOF-GUARD TRANSMISSION MONITOR K925159 LUITPOLD PHARMS, SHIRLEY, NY; AXON SYSTEMS, HAUPPAUGE, NY; IMMCO DIAGNOSTICS, BUFFALO, NY 483S 3/1-31/11 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OLA RICKARDSSON LUND UNIV DEPT OF OPHTHALMOLOGY LAURA STORMS-TYLER OLYMPUS AMERICA INC HERBERT VAN DYK PHILIPS MEDIZIN SYSTEME KINETICS CONCEPTS INC - ABTHERA ABDOMINAL DRESSING K090489 FUJIMON - FUJIMON EPX-440 ENDOSCOPIC VIDEO PROCESSOR AND/OR FUJIMON INTELLIGENT CHROMO ENDOSCOPY (FICE) IMGAGING SYS CORR BIOMETER INTL A/S - ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR K893485 SIESTA MEDICAL - PRELUDE II TONGUE SUSPENSION SYS K103179 CPAC, GREAT BEND, KS; MARCUS RESEARCH LAB, ST LOUIS, MO; APOTHECA, WOODBINE, IA, ETC - 483S 3/131/11 JUBILANT CADISTA PHARMS, SALISBURY, MD; MICRO/AIRE SURGICAL INSTRUMENTS, CHARLOTTESVILLE, VA - 483S 3/1-31/11 ISRS MW5015543 - 8-11-10; MW5017084 - 8-11-10; MW 5017755 - 10-1-10 ETC LA ENTRY 59A5-4781705-2 - LAB RESULTS IWASHIMA, FUMIYOSHI FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ DON SASEK WATSON INC MELISSA WALKER STEREOTAXIS INC ROXPRO PHARMA INC - SPRIX (KETROLAC TROMETHAMINE) NDA 22-382; ROCHE PALO - TORADOL (KETROLAC TROMETHAMINE) NDA 19-645, NDA 19-698 APRVL RECS CURLVIEW IGT LLC - CARDIO-VIEW K083321 WATSON FOODS INC, WEST HAVEN, CT - 483 1/10/02 Signature/ Requester Subject
Page 123 of 1132

Total Records: 12455 Control # 2011-2939 Recd Date / Due Date 04/18/2011 05/16/2011 2011-2940 04/18/2011 05/16/2011 2011-2941 04/18/2011 05/16/2011 2011-2942 04/18/2011 05/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2943 2011-2944 04/18/2011 05/16/2011 04/18/2011 05/16/2011 2011-2945 04/18/2011 05/16/2011 2011-2946 2011-2947 04/18/2011 05/16/2011 04/18/2011 05/16/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/COS/OES/ OC/COS/OES/ 2011-2948 04/18/2011 05/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2949 04/18/2011 05/16/2011 ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ DEBORAH FERNANDEZ VANERGRIFT FORWARDING CO INC FROZEN SKATEWINGS & FILLETS ENTRY 316-1912520-1 ANALYTICAL RESULTS SHERI WEBB CETRO RESEARCH CETERO RESEARCH MISSISSAUGA (ALLIED RESEARH INTL-CETERO) - EIR 8/18-22/08 Doe J CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS INDIVIDUAL RECS ADVANCED SKIN TECHNOLOGIES, BERNVILLE, PA; AVID RADIOPHARMACEUTICALS, PHILADELPHIA, PA; LANNETT CO,PHILADELPHIA, PA, ETC - 483S 3/1-31/11 DIAGAST, LOOS CEDEX, FR - 483S 3/1-31/11 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KEVIN O'ROURKE FDA NEWS INTERLACE MEDICAL - MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS K100559 J MORITA MFG CORP, KYOTO-SHI, JP; AXIS-SHIELD POC AS, OSLO, NO - 483S 3/1-31/11 KEVIN O'ROURKE FDA NEWS DAIICHI FINE CHEMICAL CO, TOYAMA, JP; NTP RADIOISOTOPES, PRETORIA, SA, SMITHKLINE BEECHAM LTD, WORTHING, UK, ETC - 483S 3/1-31/11 FOI SERVICES INC ORA/CE-FO/CIN-DO/CCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester HERBERT VAN DYK PHILIPS MEDIZINE SYSTEME BOBLINGEN GMBH KEVIN O'ROURKE FDA NEWS COSMED LABS, LOUISVILLE, KY; PATHEON PHARMS, CINCINNATI, OH; PIEZOSURGERY,COLUMBUS, OH, ETC 483S 3/1-31/11 INFLUENCE - REPOSE BONE SCREW SYS K981677 Subject ORGANON TEKNIKA CORP - TOF WATCH K972698
Page 124 of 1132

Total Records: 12455 Control # 2011-2950 Recd Date / Due Date 04/18/2011 05/16/2011 2011-2951 04/18/2011 05/16/2011 ORA/SE-FO/SJN-DO/SJCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS Subject SORIN CRM, SALUGGIA, VC, IT; COMMAND MEDICAL PRODUCTS, NICARAGUA, MANAGUA, NI; GPC MEDICAL, NEW DELHI, IN, ETC - 483S 3/1-31/11 SCHERING-PLOUGH PRODUCTS, LAS PIEDRAS, PR; PFIZER CONSUMER HEALTHCARE, GUAYAMA, PR; ABBOTT PHARMACEUTICALS, BARCELONETA, PR ETC - 483S 3/131/11 SOUND OXYGEN SERVICE, AUBURN, WA - 483S 3/1-31/11 DERMARITE INDUSTRIES, PATERSON, NJ; IGI, BUENA, NJ; JUNE JACOBS LABS, MOONACHIE, NJ ETC - 483S 3/1-31/11 PETNET SOLUTIONS, JACKSONVILLE, FL; CARDINAL HEALTH 414, ORLANDO, FL; PHARMACREAMS CORP, DORAL, FL ETC - 483S 3/1-31/11 PETNET SOLUTIONS, PALO ALTO, CA; AMPAC FINE CHEMICALS, RANCHO CORDOVA, CA; ANGIOSCORE, FREMONT, CA ETC - 483S 3/1-31/11 LIFESCAN - ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYS K093745 DKT FDA-2010-P-0491 INTERNATIONAL MEDSURG CONNECTION - PISTON SYRINGE & HYPODERMIC NEEDLE K022159 SYNERGETICS INC - ADJUSTABLE GAS PRESSURIZED INFUSION TUBE SET K091441 SURGICAL DESIGN INC - CIRCUMCISION CLAMP K043533 EFFEXOR - AERS SHAW, LORI LYNN
2011-2952 2011-2953 2011-2954
04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/18/2011 05/16/2011
ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/FLA-DO/FCB/
KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDANEWS KEVIN O'ROURKE FDANEWS
2011-2955
04/18/2011 05/16/2011
ORA/P-FO/SAN-DO/SFCB/
KEVIN O'ROURKE FDANEWS
2011-2956 2011-2957 2011-2958 2011-2959 2011-2960 2011-2961
04/18/2011 05/16/2011 04/18/2011 05/16/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011
FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
LONNA DENDOOVEN ARKRAY FACTORY USA INC MARILYN WHITNEY COVINGTON & BURLING LLP TIFFANY M SISLER DEROYAL CORPORATE TIFFANY M SISLER DEROYAL CORPORATE TIFFANY M SISLER DEROYAL CORPORATE
2011-2962
04/19/2011 05/17/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SHAW, LORI LYNN
CONCERTA - AERS
2011-2963
04/19/2011
FDA/OMPT/CDER/ORP/DIDP/
TRAZADONE - AERS
Page 125 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/17/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2964 04/19/2011 05/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2965 04/19/2011 05/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2966 04/19/2011 05/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2967 04/19/2011 05/17/2011 2011-2968 04/19/2011 05/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2969 04/19/2011 07/05/2011 2011-2970 04/19/2011 05/17/2011 ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ JAMES KIMMEL ABRAMS GORELICK FRIEDMAN ET AL SUSAN B. MILLS WEINBERG WHEELER ET AL THERMOTEX THERAPY SYSTEMS LTD - THERMOTEX HEATING PAD CMPLNTS MAHI MAHI, AMBERJACK, ORANGE COUNTY, FL CIGUATERA POISONING INVESTIGATION RECS 1999 FDA/OF/CFSAN/OCD/EOS/ VIRUNYA BHAT NSF International CHARLES CELESTE EAS Consulting Group, LLC SAFEPHARM LABORATORIES LTD 1993 BENZOGUANAMINE NINETY DAY REPEAT DOSE ORAL TOXICITY STUDY IN THE RAT PROJECT - STUDY ACTAVIS MID ATLANTIS - CLOBETASOL PROPIONATE ANDA 78-223 APRVL, LBLG, CHEMISTRY RVW MATTHEW CHAYES NEWSDAY REJECTED DRUG BRAND NAMES PAST 2 YRS THOMAS SAMUELSON ANALYSIS GROUP NICOTINE TRANSDERMAL PATCH - AERS THOMAS SAMUELSON ANALYSIS GROUP CHANTIX, CHAMPIX (VARENICLINE) - AERS Signature/ Requester SHAW, LORI LYNN Subject
Page 126 of 1132

Total Records: 12455 Control # 2011-2971 2011-2972 2011-2973 2011-2974 2011-2975 Recd Date / Due Date 04/19/2011 05/17/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011 04/19/2011 05/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2976 2011-2977 04/20/2011 05/18/2011 04/20/2011 05/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SANDRA REIS MIRACULINS INC SANDRA REIS MIRACULINS INC PREMD INC (IMI INTERNATIONAL MEDICAL INNOVATIONS) PREVU LAB TEST (LT) SKIN STEROL TEST K063314 PREMD INC (INTERNATIONAL MEDICAL INNOVATIONS) PREVU POINT OF CARE (POC) SKIN STEROL TEST (CHOLESTREROL 123 TEST) K011760, K014018, K062092, ETC HAAG-STREIT AG - BIOMICROSCOPE SLIT-LAMP AC POWERED K982057 HAAG-STREIT AG - BIOMICROSCOPE SLIT-LAMP ACPOWERED K100202 OMRON DALLAN CO LTD, DALIAN, CHINA - EIR 1/19-21/09 EC09044/E001 ABIOMED INC - PROTECT II IMPELLA RECOVER SYS CLNCL TRIAL STUDY ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC RISPERDAL NDA 20-272/S036, NDA 20-588/S024, NDA 21444/S008 MEDICAL RVWS, STATISTICAL RVWS, APRVL 1/06 TO 12/06 ACUTE INNOVATIONS LLC, HILLSBORO, OR - STERNAL FIXATION SYS K101170 MONICA HEALTHCARE - MONICA AN24 UTERINE ELECTROMYOGRAPHIC MONITOR DVC K101801 SHERID, MUHAMMED FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ LIANG, JOSEPH ISRS 6525604, 6532569, 6532573 Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ SAMANIEGO, JAMES KAREN L. TAILLON CUMMINS & WHITE Signature/ Requester ELENA HOWELL HOGAN LOVELLS US LLP Subject GENERAL MILLS INC - CHEERIOS TOASTED WHOLE GRAIN OAT CEREAL WARNING LTR RESP, MINS, CORR SMITHS MEDICAL INTL LTD - CO RESP, EIR, WARNING LTR 12/19/05 XOFT INC - AXXENT FLEXISHIELD MINI K090417 RECALL Z1865-2011, MDRS, CORR, ETC INDMIE INSTANT NOODLES, INDONESIA - CMPLNT 10/10/10
2011-2978 2011-2979 2011-2980 2011-2981 2011-2982
04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
JEREMY GRAZIANO EYE PHOTO SYSTEMS INC JEREMY GRAZIANO EYE PHOTO SYSTEMS INC JOSEPH CONSOLI OMRON HEALTHCARE INC ROBERT DICKSON CARDIACASSIST INC ARTHUR ROSENTHAL AVANIR
2011-2983 2011-2984
04/20/2011 05/18/2011 04/20/2011 05/18/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/
KIM REED BIOMET MICROFIXATION KEITH A BARRITT FISH & RICHARDSON PC
Page 127 of 1132

Total Records: 12455 Control # 2011-2985 Recd Date / Due Date 04/20/2011 05/18/2011 Action Office ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ 2011-2986 04/20/2011 05/18/2011 ORA/ ORA/ ORA/OE/ ORA/OE/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OCM/EMOPS/ ORA/SW-FO/DEN-DO/COMP/ 2011-2987 04/20/2011 05/18/2011 2011-2988 2011-2989 04/20/2011 05/18/2011 04/20/2011 05/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-2990 04/20/2011 05/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2011-2991 04/20/2011 ORA/P-FO/SAN-DO/SFCB/ MELANIE COTE MEDISCA INC, LAS VEGAS, NV - EIRS 9/13-14/10 RICHARD WILSON UNIV OF READING/SCIENCE & TECHNOLOGY CENTRE ENAMEL FLUORIDE UPTAKE TESTING PROCEDURES METHOD #40 - RECS BALDY, PATRICIA S OM/OMP/DODM/ OC/COS/OL/ SHAWN HILS DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE NANCY LEIGH RYAN SORIN GROUP PROVERA (MEDROXYPROGESTERONE ACETATE) TABS, PREMARIN (CONJUGATED ESTROGEN) TABS - RECS 1996 DEAN HELLER - HOUSE LTRS, RPTS, PHONE LOGS, ETC 1/4/06 TO PRESENT DKT 1993M-0383 CLAIRE LUGO LINDOW STEPHENS TREAT LLP FRONTERA PRODUCE LTD - SALMONELLA SAINTPAUL OUTBREAK RECS 8/08 Signature/ Requester GLORIANN MCLENNAN CANNON COCHRAN MANAGEMENT SERVICES INC Subject TAYLOR FARMS - POPEYE SPINACH CMPLNT 120239
Page 128 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/18/2011 2011-2992 2011-2993 2011-2994 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/ORO/ ORA/ORO/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ CVM/OCD/ OC/OCC/ 2011-2995 2011-2996 2011-2997 2011-2998 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-2999 2011-3000 2011-3001 2011-3002 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 05/18/2011 04/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CLOSED FOIA REQUESTS 2/22-25/11 CLOSED FOIA REQUESTS 2/14-18/11 CLOSED FOIA REQUESTS 2/7-11/11 CLOSED FOIA REQUESTS 1/31/1-2/4/11 CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOIA REQUESTS 1/24-28/11 CLOSED FOIA REQUESTS 1/17-21/11 CLOSED FOIA REQUESTS 1/10-14/11 CLOSED FOIA REQUESTS 1/3-7/11 ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ Action Office Signature/ Requester MEDISCA INC BRENDA M GARTZ ELI LILLY & CO SATISH M SOOD SHANTI CLINICAL TRIALS W. MICHAEL CHICK, Jr. SHANTI CLINICAL TRIALS, COLTON, CA - EIRS 12./15/10 TO 1/7/11 GENZYME, RIDGEFIELD, NY - 483 11/10/10-12/21/10 Subject
VIRGINIA DEPARTMENT OF CORRECTIONS, GREENSVILLE CORRECTIONAL CENTER IN VIRGINIA - SODIUM COMMONWEALTH OF VIRGINIA OFFICE OFFICE OF THE CAPITAL THIOPENTAL, THIOPENTAL SODIUM, SODIUM PENTOTHAL, ETC EXPIRATION DATES, CORR, IMPORTATION RECS, ETC DEFENDER
Page 129 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/18/2011 2011-3003 04/21/2011 05/19/2011 2011-3004 2011-3005 2011-3006 04/21/2011 05/19/2011 04/21/2011 05/19/2011 04/21/2011 05/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3007 2011-3008 04/21/2011 06/01/2011 04/21/2011 05/19/2011 2011-3009 2011-3010 2011-3011 2011-3012 04/21/2011 05/19/2011 04/21/2011 05/19/2011 04/21/2011 05/19/2011 04/21/2011 05/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3013 2011-3014 04/21/2011 05/19/2011 04/21/2011 05/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3015 04/21/2011 ORA/NE-FO/NWE-DO/NWECB/ TIMOTHY BURTON INTEGRA BURLINGTON MA INC, BURLINGTON, MA - EIR ORA/SW-FO/KAN-DO/COMP/ TROPF, DOUGLAS M CHARLES CELESTE EAS Consulting Group, LLC AMERICAN CONTRACT SYSTEMS INC, KANSAS CITY, MO 483, WARNING LTR 8/27/09 SANDOZ - DICLOFENAC DR TABS ANDA 74-376 APRVL LTR, LBLG, BIOEQV RVWS, ETC IWASHIMA, FUMIYOSHI ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ Linder, David CALVIN Y ZHOU SCHROER CAPITAL, L.P. ACORDA - AMPYRA (DALFAMIPRIDINE) TABS NDA 22-250 AERS ALLERGAN - ACULAR (KETROLAC TROMETHAMINE) NDA 19-700 APRVL RECS CTP/OD/ CTP/OD/ OM/OMP/DODM/ MAURA M NORDEN SIDLEY AUSTIN LLP MICHAEL A CAROME MD PUBLIC CITIZEN HEALTH RESEARCH GROUP PAUL W TRIPP LINCARE INC SENIOR RESPIRATORY SOLUTIONS INC, TX - EIRS, 483S, WARNING LTRS 1/04 TO PRESENT ENZYTE - ACTIVE INGREDIENT LIST DKT 1998N-0862 TOBACCO PRODUCTS SCIENTIFIC A/C - CORR EHRENPREIS MD, ELI D HOPPER ADC#115793, CARL M ACCUTANE - ISRS 6525604,6532569, 6533975, ETC Action Office OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CanReg, Inc. RICK ALEXANDER SOUTHEASTERN TECHNOLOGY INC JEREMY GRAZIANO EYE PHOTO SYSTEMS INC SOUTHEASTERN TECHNOLOGY INC, MURFREESBORO, TN - EIR 4/7/08 KARL SRORZ IMAGING INC - OPTRONICS EPIC COLOR TELEVISION CAMERA SYS K963333 LARRY DAVID, CHERYL HINES - CONTACT INFO Subject
Page 130 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/19/2011 2011-3016 04/21/2011 05/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3017 2011-3018 04/21/2011 05/19/2011 04/21/2011 05/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ 2011-3019 2011-3020 04/21/2011 05/19/2011 04/21/2011 05/19/2011 2011-3021 04/21/2011 05/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3022 04/22/2011 05/20/2011 2011-3023 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-3024 04/22/2011 05/20/2011 2011-3025 04/22/2011 05/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ REED TECKENBROCK WINCKLER & HARVEY LLP LANX SPINAL FIXATION SYS MODIFICATION - K090252 REED TECKENBROCK WINCKLER & HARVEY LLP ORTHOSIS SPINAL PEDICLE FIXATION - K071877 OC/OM/OMP/DDM/ MICHAEL CAROME PUBLIC CITIZEN HEALTH RESEARCH GROUP JASON R MCCLITIS BROWN LAW OFC LC AMERICAN REGENT, LUITPOLD PHARMS - SODIUM BICARBONATE INJ RECALL RECS DKT 1998N-0313 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JUANG WANG BIO-RAD LABS CHUCK RYAN CONVATEC INC FRAN DAUGHTRIDGE PHARM D PFIZER INC AQUACEL HYDROFIBER WOUND DRESSING - K063271, ABSORBENT ANTIMICROBIAL WOUND DRESSING K013814, AQUACEL AG SURGICAL - K091034, ETC EMBEDA - ISRS 7621399, 7654485, 7659389, ETC DIAZYME 25-OH VITAMIN D ASSAY - K102432 FDA/OMPT/CDRH/OCER/DFOI/ STEVE A KAMEL STEVE A KAMEL PC JOSHUA K BROWN PETERSON & MYERS PA TREMETRICS - TREMETRICS RA500 AUDIOMETER RISK, FAILURE MODE ANALYSES, WARNING LTRS, ETC PENTEC HEALTH INC - IPN THERAPY, INTRAPERITONEAL NUTRITION SOL IN DIALYSATE BAGS RECALL #D-039-2008 RECS Action Office Signature/ Requester INTEGRA BURLINGTON MA INC TOM PIKE AIR LIQUIDE HEALTHCARE AMERICA CORP Subject 11/30/09-12/2/09 LIST OF REGISTERED PACKAGERS/RE-PACKAGERS OF MEDICAL OXYGEN
Page 131 of 1132

Total Records: 12455 Control # 2011-3026 2011-3027 Recd Date / Due Date 04/22/2011 05/20/2011 04/22/2011 05/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3028 04/22/2011 05/20/2011 2011-3029 2011-3030 2011-3031 2011-3032 2011-3033 2011-3034 2011-3035 2011-3036 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 2011-3037 2011-3038 2011-3039 2011-3040 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ KENDLE REGULATORY AFFAIRS BARBARA JONES DOMINION GROUP INC GLADYS B TONKIN Center for Regulatory Services, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. KEN SCHIRADO PENUMBRA INC J MICHAEL TAYLOR KING & SPALDING PENUMBRA INC, ALAMEDA, CA - EIRS 7/29/09-8/28/09, 8/1014/10 PHARMACEUTICALS IMPORTED INTO THE US - RECS 1/07 TO PRESENT CHINESE-MADE SPECIALTY FOODS - RECALL RECS 1980 FOI DAILY LOG 4/4-8/11 FOI DAILY LOG 4/4-8/11 FOI DAILY LOG 4/4-8/11 FOI DAILY LOG 4/4-8/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC ALISON TRADO HILL DERMACEUTICALS INC FOI DAILY LOG 4/4-8/11 HILL DERMACEUTICALS INC, SANFORD, FL - EIR 9/15-28/08 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ KENNETH REID WASHINGTON INFORMATION SOURCE MICHAEL KEITH WHITE THOMAS J HENRY FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 4/4-8/11 LOST MOUNTAIN TISSUE BANK - RECALL #B-0549-007 RECS FOI DAILY LOG 4/4-8/11 FOI DAILY LOG 4/4-8/11 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester RACHEL BUTT SEBALY SHILLITO & DYER KARON DUNAVAN BSN MBA ST JOHN'S MERCY MEDICAL CENTER IDEV - SUPERA TRANSHEPATIC BILIARY SELF-EXPANDING STENT SYS K071646 Subject BTL INDUSTRIES LTD - EXILIS MODEL 5000 K092191
Page 132 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/20/2011 Action Office ORA/ ORA/ ORA/OE/ ORA/OE/ 2011-3041 2011-3042 04/22/2011 05/20/2011 04/22/2011 05/20/2011 2011-3043 2011-3044 2011-3045 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 2011-3046 04/22/2011 05/20/2011 CTP/OD/ CTP/OD/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3047 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3048 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3049 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3050 04/22/2011 ORA/SE-FO/NOL-DO/NOCB/ CARLA R. SCARMAZZI INTERNATIONAL SPECIALTY SUPPLY, COOKEVILLE, TN OBIEN, KATHLEEN NIMODIPINE - AER Doe J INDIVIDUAL RECS P BRIAN SMITH, MD MPH MHS DUKE CLINICAL RESEARCH INSTITUTE ACYCLOVIR IND 106153 - RECS MEEK, JUSTIN TRENT CVM/OCD/ KROGMAN, LAURA JOHN B DUBECK Keller and Heckman LLP FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ SHARON A CENTER DVM CORNELL UNIVERSITY JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC LORI VIVIAN RN BSN OURIEL GROUP GERANIUM ROBERTIANUM, RED ROBIN, CRANESBILL, ETC - CAERS WL GORE & ASSOCIATES - GORE ACUSEAL VASCULAR GRAFT FOR HEMODIALYSIS ACCESS IDE SUBMISSION AMOUNT OF LEGAL HORMONES THAT CAN BE GIVEN TO CATTLE FOR DAIRY & MEAT PURPOSES STAR SCIENTIFIC INC - STONEWALL MOIST-BDL SMOKELESS TOBACCO MODIFIED RISK TOBACCO PROD APPL TARGET ACTION DATES FOR NDA, ANDA, BLA SUBMISSIONS 2011 SULFONAMIDE ANTIMICROBIALS - AERS Signature/ Requester BURKETT, ERIC S Subject TO 2005
Page 133 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/20/2011 2011-3051 2011-3052 2011-3053 2011-3054 2011-3055 2011-3056 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 04/22/2011 05/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3057 04/22/2011 05/20/2011 2011-3058 04/22/2011 05/20/2011 ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3059 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3060 04/22/2011 05/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DR IRINA KLYATSKAYA PHARM HOLDING GENENTECH - LUCENTIS (RANIBIZUMAB) BLA 125156; AVASTIN (BEVACIZUMAB) BLA 125085 RECS CHARLES CELESTE EAS Consulting Group, LLC SANDOZ - DICLOFENAC DR ANDA 74-394 LBLG, APPRVL LTR, CHEMISTRY RVWS, ETC VAL MOORE ZYMOGENTICS INC BOVINE THROMBIN - MEDWATCH HUIZHEN ZHANG AM TODD ENTRY NO 231-5373876-2 ORA/NE-FO/NWE-DO/NWECB/ Action Office ORA/SE-FO/NOL-DO/NOCB/ CTP/OD/ CTP/OD/ ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester KING & SPALDING JOHN B DUBECK Keller and Heckman LLP BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO ARON L HARRAH HILL PETERSON CARPER, ET AL AARON L HARRAH HILL PETERSON CARPER, ET AL SURYA C NAMBURI EISAI PHARMATECHNOLOGY & MANUFACTURING PVT LTD DIETHYL CARBAMAZINE CITRATE - NON-CLNCL PHARMACOLOGY, TOXICITY STUDIES INDIVIDUAL RECS INDIVIDUAL RECS BOEHRINGER INGELHEIM, RIDGEFIELD, CT - EIR 9/15-27/10 Subject SPROUTING SEED PRODUCT CMPLNTS, EIR, 483 1/08 TO PRESENT STAR SCIENTIFIC INC - ARIVA-BDL, STONEWALL-BDL MODIFIED RISK TOBACCO PROD APPL BOEHRINGER INGELHEIM, RIDGEFIELD, CT - 483 9/15-27/10
Page 134 of 1132

Total Records: 12455 Control # 2011-3061 Recd Date / Due Date 04/22/2011 05/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3062 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ 2011-3063 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3064 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ 2011-3065 2011-3066 2011-3067 2011-3068 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3069 04/25/2011 06/09/2011 2011-3070 04/25/2011 05/23/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC ABBOTT, BARCELONETA, PR, WORCESTER, MA - EIRS, 483S CO RESP, ETC 2010 FOI SERVICES INC BIOGEN IDEC/GENETECH, SOUTH SAN FRANCISCO, SAN DIEGO, VACAVILLE, CA; RESEARCH TRIANGLE PARK, NC EIRS, 483S CO RESP, ETC 2010 FOI SERVICES INC ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC ORA/NE-FO/NWE-DO/NWECB/ FOI SERVICES INC PFIZER, NEW LONDON, CT - EIRS, 483S, CO RESP, ETC 5/4/09 TO 6/3/09 KFORCE CLINICAL RESEARCH, TAMPA, FL - EIRS, 483S, CO, ETC 6/09 RESEARCH PHARMACEUTICAL SERVICES, FORT WASHINGTON, PA - EIRS 3/10 OXYBUTYNIN CHLORIDE ER ORAL TABS ANDA 76-702, ANDA 76-644, ANDA 78-293, ETC - APRVL RECS FOI SERVICES INC CENTOCOR ORTHO BIOTECH, MALVERN, PA - EIR, 483S, WARNING LTR, ETC 1/10 TO 12/10 KATIE KANE PULMATRIX INC PULMOZYME BLA 103532 - SBA FOI SERVICES INC FIRECREST CLINICAL, LIMERICK, IRELAND; PRINCETON, NJ - EIRS, 483S 1/01 TO PRESENT Signature/ Requester ALLEN DICKENSON FORMULATED RESEARCH GROUP Subject LICENSES, PERMITS FOR MEDICINAL CANNABIS - RECS
Page 135 of 1132

Total Records: 12455 Control # 2011-3071 Recd Date / Due Date 04/25/2011 05/23/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3072 2011-3073 04/25/2011 05/23/2011 04/25/2011 05/23/2011 2011-3074 2011-3075 2011-3076 2011-3077 2011-3078 2011-3079 2011-3080 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 07/11/2011 04/25/2011 07/11/2011 04/25/2011 07/11/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ ORA/P-FO/SAN-DO/SFCB/ 2011-3081 04/25/2011 05/23/2011 2011-3082 2011-3083 04/25/2011 05/23/2011 04/25/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ CBER/OCTMA/DDOM/ALFB/ TIMOTHY MASON CONWAY HOMER & CHINCAPLAN PC SUSAN B MILLS WEINBERG WHEELER ET AL ANDI POULSON AMBERJACK, MAHI MAHI CIGUATERA CASES IN ORANGE COUNTY, FL - INVESTIGATION RECS 1999 ISRS M00151179, M00328000, M00151520, ETC INDIVIDUAL RECS - VAERS RPT FDA/OO/OFBA/OAGS/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC SATISH M SOOD PHD SHANTI CLINICAL TRIALS SCOTT C BYRD BYRD LAW FIRM SCOTT C BYRD BYRD LAW FIRM SCOTT C BYRD BYRD LAW FIRM BILL HRANCHAK NEAL R GROSS & CO JULIAN PECQUET HILL NEWSPAPER FREE STATE REPORTING INC - CONTRACT #HHSF223200831138P US PRO CYCLING TEAM - PERFORMANCE ENHANCING DRUG USE INVESTIGATION RECS INDIVIDUAL RECS INDIVIDUAL RECS CAUDILL SEED & WAREHOUSE CO INC - RECS LAST 5 YRS FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS AMGEN, JUNCOS, PR, WEST GREENWICH, RI - EIRS, 483S, CO RESP, ETC 2010 SHANTI CLINICAL TRIALS, COLTON, CA - EIR 12/15/10-1/7/11 CLOSED FOI REQUESTS 4/18-22/11 CLOSED FOI REQUESTS 4/18-22/11 Signature/ Requester LINDA HIBBS PREMIER RESEARCH GROUP Subject ZOFRAN NDA 20-007 - PEDIATRIC PHARMACOKINETIC STUDY RPTS
Page 136 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/23/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3084 2011-3085 2011-3086 2011-3087 2011-3088 2011-3089 2011-3090 2011-3091 2011-3092 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/25/2011 05/23/2011 2011-3093 2011-3094 04/25/2011 05/23/2011 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3095 04/25/2011 05/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3096 04/25/2011 ORA/NE-FO/NWE-DO/NWECB/ JENNIFER BURKE AGENUS INC, LEXINGTON, MA - EIRS 8/11/10 EMILY DORNBLASER UNIV OF NEW ENGLAND COLLEGE OF PHARMACY ELI LILY - VANCOCIN (VANCOMYCIN) NDA, TOXICOLOGY RECS, GENERIC VERSIONS, ETC 1958 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ NYROBIA FREEMAN CONMED LINVATEC CORP CHARLES GILVARG PRINCETON UNIVERSITY BIOMET SPORT MEDICINE INC, WARSAW, IN JUGGERKNOT SOFT ANCHOR K110145 NOVO NORDISK - VICTOZA AERS 2009 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ BARBARA RICH STERIS CORP ANDI POULSON LEXISNEXIS COURTLINK INC BARBARA RICH STERIS CORP BARBARA RICH STERIS CORP JOHN B DUBECK Keller and Heckman LLP DEVON WM HILL Keller and Heckman LLP NYROBIA FREEMAN CONMED LINVATEC CORP JAN HOLLINGWORTH DEACONESS BILLINGS CLINIC NYROBIA FREEMAN CONMED LINVATEC CORP TELEFLEX MEDICAL, FALL RIVER, MA - FORCE FIBER K033654 AUGUSTINE BIOMEDICAL & DESIGN - HOT DOG PATIENT WARMING MATTRESS SYS K092807 TALLEY MEDICAL - TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS K080763 STAR SCIENTIFIC INC - STONEWALL MOIST-BDL APPL 2/1/11 EASTMAN CHEMICAL CO - FCN 1056 CHEMISTRY & TOXICOLOGY MEMO BIOMET SPORT MEDICINE INC, WARSAW, IN - SLEEVE & BUTTON SOFT TISSUE DVC K071704 MEDTRONIC - QUICK SET MEDICAL DVC PROD RPT SMITHS MEDICAL ASD INC - LEVEL 1 SNUGGLE WARM WARMING BLALNKET K083336 2009-5197 Signature/ Requester LEXISNEXIS COURTLINK INC Subject
Page 137 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/23/2011 2011-3097 2011-3098 2011-3099 2011-3100 04/25/2011 05/23/2011 04/25/2011 05/23/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3101 2011-3102 2011-3103 2011-3104 2011-3105 2011-3106 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3107 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3108 2011-3109 04/26/2011 05/24/2011 04/26/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-2379, 2011-2382 REQUEST LTR 2011-2285 REQUEST LTR ASHLIE ADAMS CORNERSTONE THERAPEUTICS INC PAMINE (METHSCOPOLAMINE BROMIDE) - AERS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ASHLIE ADAMS CORNERSTONE THERAPEUTICS INC METHSCOPOLAMINE NITRATE - AERS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC TECO DIAGNOSTICS - UTI DETECTION STRIPS K100024 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ACCURAY INC - ROBOCOUCH PATIENT SUPPORT SYS K042146 BARD PERIPHERAL VASCULAR - ATLAS PTA BALLOON DILITATION CATHETER K052236 SPECTRAGENICS - TRIA HAIR REMOVAL LASER SYS K090820 HOME SKINOVATIONS - SILK'N FLASH N GO K103184 FOI SERVICES INC FOI SERVICES INC CECELIA FRENCH CanReg, Inc. TRIS PHARMA - HYDROCODONE POLISTIREX & CHLORPHENIRAMINE POLISTIREX ANDA 91-632 APRVL RECS 10/1/10 CLOSED FOIA REQUESTS 4/18-22/11 OC/OM/OMP/DDM/ Action Office Signature/ Requester AGENUS PATRICIA EVANS PATRICIA EVANS CLOSED FOI REQUESTS 4/18-22/11 DKT & DKT LOG OF 1985N-0214 Subject
Page 138 of 1132

Total Records: 12455 Control # 2011-3110 2011-3111 2011-3112 2011-3113 Recd Date / Due Date 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3114 04/26/2011 05/24/2011 2011-3115 04/26/2011 05/24/2011 2011-3116 04/26/2011 05/24/2011 2011-3117 2011-3118 2011-3119 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 2011-3120 2011-3121 04/26/2011 05/24/2011 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ CVM/OCD/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ PAUL D LAWLESS HAMMILL O'BRIEN CROUTIER ET AL JOANA RUSU CONSUMERS UNION RYAN P ATKINSON STRONG & HANNI LAW OFCS DOUGLAS N BLUE II ZETETIC ERICA R ARONSON Hyman Phelps and McNamara PC FRANK CARTER CHEK MED SYSTEMS INC DAVID L GREBEL ONDER SHELTON O'LEARY & PETERSON LLC THERMOTEX THERAPY SYSTEMS LTD, SUAREZ CORPORATION INDUSTRIES - THERMOTEX HEATING PAD CMPLNTS, WARNINGS, CORR, ETC MERCURY LEVELS IN COMMERCIAL FISH & SHELLFISH TEST RESULTS, CONCENTRATIONS, ANALYSIS, ETC 2004 TO PRESENT PRECISION FORMULATIONS LLC, COPPELL, TX - INSPS, CORR 1/07 TO PRESENT (CERTIFIED) PET SUPPLIES LTD - LUFENURON TAB AEK-8638081-9 RECS HI-PRO FEEDS, FRIONA, LUBBOCK, TX; DEXTER, NM, CHEYENNE, OK, ETC - EIRS, CORR, MINS, ETC 3/17/09 TO PRESENT CHEK-MED SYSTEMS INC - SPOT ENDOSCOPIC MARKER K993951 ORAJEL, ANBESOL, ORABASE, ETC - WARNING LTRS, AERS, APRVL RECS, ETC BILL HRANCHAK NEAL R GROSS & CO FREE STATE REPORTING INC, ANNAPOLIS, MD; COURT REPORTING & STENOTYPE SERVICES HHSF223200831138P Doe J R IAN KLUGE Hyman Phelps and McNamara PC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ Signature/ Requester ADELE MK GILPIN HUNTON & WILLIAMS LLP RENA REVIVO Spa De Soleil FROZEN TILAPIA FILLETS SPL 595-4784183-9 ANALYTICAL RESULTS LYNE - TRIAMCINOLONE ACETONIDE ANDA 40-771; VINTAGE PHARMS - RANITIDINE HCL ANDA 78-890; WATSON LABS - TACROLIMUS ANDA 90-402, ETC APRVL LTRS 7/10 SPA DE SOLEIL, SUN VALLEY, CA - EIR Subject 2010-3791
Page 139 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/OCI/ ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ 2011-3122 04/26/2011 05/24/2011 ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ BARRY M BORDETSKY BARRY M BORDETSKY LAW OFCS PEANUT CORPORATION OF AMERICA, GEL SPICE CO, CUISINE INNOVATION LLC - PEANUT RECALL RECS, CORR Signature/ Requester Subject
Page 140 of 1132

Total Records: 12455 Control # 2011-3123 Recd Date / Due Date 04/26/2011 05/24/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ 2011-3124 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3125 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3126 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3127 2011-3128 04/26/2011 05/24/2011 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3129 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3130 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3131 04/26/2011 05/24/2011 ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ KIM N NGUYEN SEGAL MCCAMBRIDGE SINGER R LAN KLUGE Hyman Phelps and McNamara PC CONCORD LABS, NJ - CARISOPRODOL & ASPIRIN ANDA 40-832, ANDA 40-860; UPSHER SMITH - TOPIRAMATE ANDA 78-499; PHARMACHEMIE BV - METHOTREXATE SODIUM PRESERVATIVE FREE ANDA 40-843, ETC APRVL LTRS ARTIMPLANT AB, ARTIMPLANT USA INC - ARTELON CMC SPACER RECS R IAN KLUGE Hyman Phelps and McNamara PC TARO - LEVETIRACETAM ANDA 78-960; ACTAVIS MID ATLANTIC - CETIRIZINE HYDROCHLORIDE ANDA 78-617; SAGENT STRIDES - LABETALOR HYDROCLORIDE ANDA 79-134, ETC APRVL LTRS ORA/P-FO/LOS-DO/LACB/ PAULA EICHMAN EURAND R IAN KLUGE Hyman Phelps and McNamara PC BARR - TEMOZOLOMID ANDA 78-879; IMPAX LABS TAMSULOSIN HYCROCHLORIDE ANDA 90-377; WOCKHARDT - LEVETIRACETAM ANDA 90-028, ETC APRVL LTRS NATIONAL VITAMIN - EIR R IAN KLUGE Hyman Phelps and McNamara PC KUDCO IRLAND - ANASTROZOLE ANDA 91-331; MYAN ACARBOSE ANDA 91-053; WATSON LABS - FENTANYL CITRATE ANDA 79-075, ETC APRVL LTRS R IAN KLUGE Hyman Phelps and McNamara PC SUN PHARMA GLOBAL - GALANTAMINE HYDROBROMIDE ANDA 90-178; TARO - RISPERIDON ANDA 90-347; ACTAVIS TOTOWA - PANTOPRAZOLE SODIUM ANDA 90-797, ETC APRVL LTRS TINA M BABOS IPD ANALYTICS LLC CYCLOBENZAPRINE HCL ANDA 90-738 - APRVL LTR 4/18/11 Signature/ Requester ADAM REILLY WGBH-TV Subject GENZYME, FARMINGHAM, MA - UNSAFE MFG PRACTICES CMPLNT 8/23/09
Page 141 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3132 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3133 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3134 2011-3135 04/26/2011 05/24/2011 04/26/2011 05/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3136 2011-3137 2011-3138 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3139 04/26/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3140 2011-3141 04/26/2011 05/24/2011 04/26/2011 05/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CR BARD - ATLAS PTA BALLON DILITATION CATHETER K040243 HOME SKINOVATIONS - FLASH N GO K082298 ALLISON M ZIEVE PUBLIC CITIZEN 2011-2519 - DELETED RECS FDA/OMPT/CDRH/OCER/DFOI/ WANGYANG ANDON HEALTH CO LTD ANDI POULSON LEXISNEXIS COURTLINK INC NINA MOORE TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC XGEVA (DENOSUMAB) BLA 125320/S007 - PROPRIETARY NAME RVW 2011-2632 FDA/OMPT/CDRH/OCER/DFOI/ LYNNE SMART KUMETRIX INC ALTHEA BURTON PATH MICRONJET 600 HYPODERMIC SINGLE LUMEN NEEDLE K092746 TAMPONADE UTERINE BALLOON CATHETER SET K013597; BT CATH (INTRAVASCULAR CATHETER) K862480; BELFORT-DILDY OBSTETRIC TAMPONADE SYS K091958, ETC K030358, K030359 JEFFREY PETRUCELLY PETRUCELLY NADLER & NORRIS PC CLONIDINE - RECS R LAN KLUGE Hyman Phelps and McNamara PC VISTAPHARM - NYSTATIN ANDA 65-422; AMNEAL PHARM FLUCONAZOLE ANDA 78-423; DR REDDYS LABS LTD DESLORATADINE ANDA 78-365, ETC APRVL LTRS Signature/ Requester ET AL Subject
Page 142 of 1132

Total Records: 12455 Control # 2011-3142 2011-3143 2011-3144 2011-3145 Recd Date / Due Date 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 04/26/2011 05/24/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3146 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3147 04/26/2011 05/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3148 2011-3149 04/27/2011 05/25/2011 04/27/2011 05/25/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3150 04/27/2011 05/25/2011 2011-3151 2011-3152 2011-3153 04/27/2011 05/25/2011 04/27/2011 05/25/2011 04/27/2011 CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ APTSIAURI, K KRISTI O. SMEDLEY, Ph.D. OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ MCCANN, JOE TENSPRODUCTS INC, GRAND LAKE, CO - BAKWEL SYS 501K FERM SOLUTIONS INC - ERYTHROMYCIN THIOCYANATE PATRICIA L. REGENYE Celgene Corporation HELLMUT SAMONIGG, UNIV KLINIK GRAZ/KLINSCHE ABTEILUNG FUR ONKOL, GRAZ, AUSTRIA - 483 5/10 TO PRESENT LUITPOLD PHARMS, SHIRLEY, NY - EIR, 483 LAST 2 YRS OC/OM/OMP/DDM/ ANGELIA SLAYTON KENDLE REGULATORY AFFAIRS PATRICIA L. REGENYE Celgene Corporation WENDY STOCK, CHICAGO, IL - 483 6/09 TO 4/11 OTC VOLS. 020074, 020075, 020076, ETC. R IAN KLUGE Hyman Phelps and McNamara PC MIKART - CHLORZOXAZONE ANDA 40-861 6/1/10; LUPIN LTD - LAMOTRIGINE ANDA 78-691 6/1/10; MATRIX LABS LTD - SIMVASTATIN ANDA 90-868 6/8/10, ETC - APRVL LTRS R IAN KLUGE Hyman Phelps and McNamara PC ACS DOBFAR - CEFOXITIN SODIUM ANDA 65-415 5/19/10; WATSON LABS FLORIDA - ALPRAZOLAM ANDA 77-198 5/13/10; SAGENT STRIDES - BACITRACIN ANDA 90-211 5/11/10, ETC - APRVL LTRS BROWN, CHELSEY R IAN KLUGE Hyman Phelps and McNamara PC UPSHER SMITH - LOSARTAN POTASSIUM ANDA 90-544 4/6/10; MYLAN - BUPROPION HCL ANDA 90-325 4/8/10; MATRIX LABS LTD - DIDANOSINE ANDA 90-788 4/8/10, ETC - APRVL LTRS Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. TYSON FOODS INC - WARNING LTR 11/13/09 FOI DAILY LOG 4/4-8/11 Subject FOI DAILY LOG 4/11-15/11
Page 143 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/25/2011 2011-3154 2011-3155 04/27/2011 05/25/2011 04/27/2011 05/25/2011 2011-3156 04/27/2011 05/25/2011 2011-3157 2011-3158 04/27/2011 05/25/2011 04/27/2011 05/25/2011 2011-3159 04/27/2011 05/25/2011 CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ OC/COS/OES/ OC/COS/OES/ 2011-3160 04/27/2011 05/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3161 04/28/2011 05/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/OCI/ ORA/OCI/ 2011-3162 2011-3163 04/28/2011 05/26/2011 04/28/2011 05/26/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ANNA DEMKOVICH ABBOTT LABORATORIES, INC. ERIC F GREENBERG ERIC F GREENBERG PC NESTLE, BISSENHOFEN, GERMANY - INFANT FORMULA CORR, MINS, NOTIFICATIONS, ETC SABIC INNOVATIVE, BASF CORP - FCN 429 MARC J LANE MARC J LANE LAW OFCS INDIVIDUAL RECS TODD E. FARKAS JAFFE LAW FRIM WARNING LTR RESPONSE FROM DR HENRY LIN DAVID B. RIVKIN, Jr. BAKER & HOSTETLER, LLP ONCOLOGIC DRUGS A/C - NOMINATION PROCESS, AVASTIN CORR, CONFLICT OF INTEREST RECS, ETC ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ BRAD SCHONHOFT BALYASNY ASSET MANAGEMENT ERIN N. POPLAR ERIN POPLAR LAW LLC LORRI K. CHAVEZ FARNAM COMPANIES INC KALMBACH FEEDS INC, UPPER SANDUSKY, OH - WARNING LTRS, CO RESP, INVESTIGATIONS 1/95 TO PRESENT FARNAM COMPANIES INC - TRYPZYME AEROSOL NADA 31-555 LUITPOLD PHARMS, SHIRLEY, NY - 483 1/1/10-4/25/11 Action Office Signature/ Requester Center for Regulatory Services, Inc. KRISTI O. SMEDLEY, Ph.D. Celgene Corporation BRENDA M. GARTZ ELI LILLY & CO NORTHERN BIOMEDICAL, MUSKEGON, MI - 483 6/13/08 Subject FAP 2271 ENVIROTECH - HYPOBROMOUS ACID FCN 944 RVW
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Total Records: 12455 Control # 2011-3164 2011-3165 2011-3166 2011-3167 2011-3168 2011-3169 2011-3170 2011-3171 Recd Date / Due Date 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 07/05/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 2011-3172 2011-3173 04/28/2011 05/26/2011 04/28/2011 05/26/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3174 04/28/2011 05/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3175 2011-3176 2011-3177 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ MARK A FINKELSTEIN JONES DAY MARK A FINKELSTEIN JONES DAY LISA HESSABI SYBRON DENTAL SPECIALTIES DISCUS DENTAL LLC - DISCUS NV, NV ORTHO DENTAL LASERS INVESTIGATION RECS, RVWS, CORR, ETC ZAP LASERS LLC - STYLA, STYLA ORTHO DENTAL LASERS INVESTIGATION RECS, CORR, RVWS, ETC KERR CORP (PENTRON) - COMPSEAL K952500 ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS CONTROLLED THERAPEUTICS - CERVIDIL NDA 20-411 APRVL LTR, CHEMISTRY RVWS, PHARMACOLOGY RVWS, ETC ANDI POULSON LEXIS NEXIS COURTLINK INC JOAN STITT (UG2CD-16) MERCK & CO., INC. SANOFI-AVENTIS US INC - APIDRA SOLOSTAR (INSULIN GLULISINE) NDA 21-629/S008 APRVL LTR, PI, RVWS 2/24/09 2010-8076 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/ATL-DO/ACB/ GAUL, FRAN JAMES F LABOE ESQ ORR & RENO PA JOSEPH CONSOLI OMRON HEALTHCARE INC ERIC F GREENBERG ERIC F GREENBERG PC AFTAB AHMAD NEUROWAVE MEDICAL UROSURGE INC - STOLLER AFFERENT NERVE STIMULATOR DVC K992069; UROPLASTY INC - URGENT PC NEUROMODULATION K101847 SOUHEGAN MANAGEMENT CORP, SALEM, NEW HAMPSHIRE - INSP, LBLG, PHOTOGRAPHS 11/17-23/10 OMRON MATSUSAKA CO LTD, MATSUSAKA-CITY, JAPAN EIR 12/6-9/09 KANEKA TEXAS CORP - FCN 1053 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester FATIMA ASLAM Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP SPARKLE SPRING WATER INC - RECS MILK MINERAL CONCENTRATE - GRN 376 ENZYME MODIFIED STEVIOL GLYCOSIDES - GRN 375 Subject MALEATED ISOPRENYL POLMYER - GRN 374
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Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester INC 2011-3178 04/28/2011 05/26/2011 2011-3179 04/28/2011 05/26/2011 2011-3180 04/28/2011 05/26/2011 2011-3181 04/28/2011 05/26/2011 ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3182 04/28/2011 05/26/2011 2011-3183 2011-3184 2011-3185 2011-3186 2011-3187 2011-3188 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 04/28/2011 05/26/2011 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3189 04/28/2011 05/26/2011 CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ JEFFREY BROWN PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS SANOFI PASTEUR INC - MENACTRA (MENINGOCOCCAL POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE VACCINE) LOT RELEASE PROTOCOL, SAFETY TESTS FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ LYNN, MARY E PETER SHAH HARRIS SPICE COMPANY INC JEFF STACHEWICZ FOIA GROUP INC PETER SHAH HARRIS SPICE COMPANY INC CAROLINA M HEAVNER K & L GATES STAR SCIENTIFIC INC, GLEN ALLEN, VA - MODIFIED RISK TOBACCO APPL FOR TONEWALL-BDL & ARIVA-BDL PRODS LTRS, MTG, MINS, ETC VKL VIETNAM LTD, BINH DUONG, VIETNAM - EIR, 483 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP ANREW TIMMONS HEALTHCOR MANAGEMENT LP LUITPOLD PHARMACEUTICALS INC, SHIRLEY, NY - 483S, WARNING LTRS 4/14/11 MDS PHARMS SERVICES, BOTHELL, WA - EIRS, 483S 8/09, 9/09 PHUC SINH CORP (VIETSPICES COMPANY LTD), BINH DUONG PROVINCE, VIETNAM - EIR, 483 ANTIVIAL DRUG A/C - TRANS, MINS 1989-1996 ARC MEDICAL SUPPLIES (BEJING) CO LTD - EIR 12/6-14/10 JASON F CONATY HOGAN LOVELLS US LLP NDA 20-622/S026 - LBLG, PI Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LISA HESSABI SYBRON DENTAL SPECIALTIES INC LISA HESSABI SYBRON DENTAL SPECIALTIES INC VITARROZ - CMPLNT KERR CORP (PENTRON) - FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL K021457 KERR CORP (PENTRON) - HEMA-BENZ K953405 Subject
Page 146 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-3190 04/28/2011 05/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3191 2011-3192 2011-3193 2011-3194 2011-3195 2011-3196 2011-3197 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 06/23/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3198 04/29/2011 05/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3199 04/29/2011 05/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ZHOU, CALVIN Y ACORDA - AMPYRA TABS, ER, ORAL - AERS 1/22/10 TO PRESENT CHU, GLORIA BACTRIM - AERS GRANDE, DOMINICK FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ LEXIS NEXIS COURTLINK INC lAUREN HONG KAREWAY PRODUCT INC LAUREN HONG KAREWAY PRODUCT INC LAUREN HONG KAREWAY PRODUCT INC LAUREN HONG KAREWAY PRODUCT INC MOST RECENT LIST OF COMPANIES THAT MADE ELECTONIC COMMON TECHNICAL DOCUMENT (ECTD) SUBMISSIONS OPTICS LABORATORY INC - EYE-CEPT REWETTING DROPS K041008 CACHET PHARMACEUTICAL PVT LTD - STERILE SALINE SOL K102165 SAUFLON PHARMACEUTICALS LTD - MULTIPURPOSE SOL K030278 BAUSCH & LOMB - MULTI-PURPOSE SOL NRCO3 K031646 OC/OM/OMP/DDM/ GABRIEL SHERMAN Hyman Phelps and McNamara PC 2010-7448 DKT FDA-1998-D-0005 SUE ANN MCAVOY SENSIENT COLORS INC LCW 2009-10143, 2009-10144 Signature/ Requester Subject
Page 147 of 1132

Total Records: 12455 Control # 2011-3200 2011-3201 2011-3202 2011-3203 2011-3204 2011-3205 Recd Date / Due Date 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3206 04/29/2011 05/27/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ 2011-3207 04/29/2011 05/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3208 04/29/2011 05/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3209 2011-3210 2011-3211 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS 2011-1194 2011-1547 2011-1521 BRENDA M. GARTZ ELI LILLY & CO BOEHRINGER INGLEHEIM, VIENNA, AUSTRIA - EIR MOST RECENT BRENDA M. GARTZ ELI LILLY & CO BOEHRINGER INGLEHEIM, VIENNA, AUSTRIA - 483 MOST RECENT ELENA HOWELL HOGAN LOVELLS LLP FLOWERS FAMILY BAKERIES INC, FLOWERS FOODS NATURE'S OWN WHITEWHEAT BRAND BREAD CORR, MINS, MEMOS 1/90 TO PRESENT ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ Action Office ORA/SE-FO/ATL-DO/ACB/ SCHONHOFT, BRAD LESLIE PAUL PERRIGO PLANT 5 MEGAN M LEWIS WILSON ELSER ET AL GARNET FEE EXPEDITORS FATIMA ASLAM Keller and Heckman LLP ANDREW KODESCH THE FRANKEL GROUP Signature/ Requester Subject HOSPIRA INC, ROCKY MOUNTAIN, NC - 483S, WARNINGS 1/1/09 TO 4/27/11 RECKITT BENCKISER INC, FORT WORTH, TX - EIRS, 483S 1/5/11 DOUGLAS P LEHER, DR DOUG'S TOTAL BODY WLLNESS INC - REISH PLEX DIETARY SUPPL, CAERS EXPEDITORS - ENTRY DECLARATIONS RPT 1/10 TO PRESENT NATIONAL STARCH & CHEMICAL CORP - FAP438, FAP 9A4136 LIST OF ORIGINAL BLA APPL - 2006 TO PRESENT
Page 148 of 1132

Total Records: 12455 Control # 2011-3212 Recd Date / Due Date 04/29/2011 05/27/2011 2011-3213 2011-3214 2011-3215 04/29/2011 05/27/2011 04/29/2011 05/27/2011 04/29/2011 05/27/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-3216 2011-3217 04/29/2011 05/27/2011 04/29/2011 05/27/2011 ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3218 2011-3219 04/29/2011 05/27/2011 04/29/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-3220 2011-3221 2011-3222 2011-3223 04/29/2011 05/27/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ SHERI O. COVINGTON K&L GATES KAILIE MACMASTER PRAGMA CORP COLLEEN M EVALE Keller and Heckman LLP ANDREW J THOMPSON QUORUM REVIEW IRB, SEATTLE, WA - EIR, 482S, 483S LAST 3 YRS SILLIKER LAB - NATIONAL PASTEURIZED EGGS (NPE) IN SHELL PASTEURIZATION VALIDATION PROCESS RECS 5/95 RECYCLED PLASTICS #135 - NO OBJECTION LTR 5/11/10 RECS FDA/OF/CFSAN/OCD/EOS/ SANJAY NARAYAN ABBOTT LABORATORIES, INC. SUE ANN McAVOY SENSIENT COLORS LLC UPSHER SMITH; NATURES BOUNTY; SUNDOWN NATURALS - NIACIN DIETARY SUPPLEMENT CAERS MICA BASED PEARLESCENT PIGMENTS AS COLOR ADDITIVE IN FOODS OR DRUGS - CAP 8C0262; 8C0257 TAMI L. WAHL Traditional Medicinals, Inc. JOAN STITT MERCK & CO., INC. HIGH QUALITY ORGANICS, RENO, NV - 483, RECALL, EIRS 1/10 TO PRESENT SANOFI AVENTIS - LANTUS (INSULIN GLARGINE) NDA 21081/S-024 APRVL LTR, LBLG, RVWS CanReg, Inc. ANDI POULSON LEXISNEXIS COURTLINK INC ICU BED - MW5008512 FOI SERVICES INC DAILY LOG 4/25-29/11 WOLTERS KLUWER LAW & BUSINESS DAILY LOG 4/25-29/11 Signature/ Requester Subject DAILY LOG 4/25/11-5/1/11
MEDTRONIC INC - TWO-PIECE INTRATHECAL CATHETER DUBYAK CONNICK THOMPSON & MODEL 8711 RPT BLOOM LLC
Page 149 of 1132

Total Records: 12455 Control # 2011-3224 2011-3225 2011-3226 2011-3227 2011-3228 2011-3229 Recd Date / Due Date 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3230 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3231 2011-3232 2011-3233 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3234 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3235 2011-3236 05/02/2011 05/31/2011 05/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS BRENDA M. GARTZ VIANEX PLANT C, GREECE - EIR MOST RECENT FOI DAILY LOG 4/11-15/11 BRENDA M. GARTZ ELI LILLY & CO VIANEX PLANT B, GREECE - EIR MOST RECENT GLADYS B TONKIN Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC BRENDA M. GARTZ ELI LILLY & CO SUN PHARMACEUTICAL INDUSTRIES LTD, GUJURAT, INDIA - EIR MOST RECENT FOI DAILY LOG 4/11-15/11 FOI DAILY LOG 4/11-15/11 BRENDA M GARTZ ELI LILLY & CO UBE, YAMAGUCHI, JAPAN - EIR 4/08 TO PRESENT FDA/OF/CFSAN/OCD/EOS/ MOTEN, LAVEETA BRENDA M GARTZ ELI LILLY & CO Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ MOTEN, LAVEETA Signature/ Requester KRISTIAN RASMUSSEN CORY WATSON ET AL BETHANY S FRENCH BEVERIDGE & DIAMOND PC MATTHEW WHITAKER WESTLAW COURTEXPRESS CFSAN SUPERVISORY BUDGET ANALYST DETAIL ANNOUNCEMENT - RESUME PKG, SELECTING OFFICIALS CFSAN SUPERVISORY TEAM LEADER DETAIL ANNOUNCEMENT - RESUME PKG, SELECTING OFFICIALS XEILLIA, COPENHAGEN, DENMARK - EIR MOST RECENT TOBACCO TRANSITION PAYMENT PROGRAM ASSESSMENT CALCULATIONS - RECS FOI DAILY LOG 12/06 TO PRESENT Subject 2010-7820 - DELETED RECS
Page 150 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/31/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3237 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3238 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3239 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3240 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3241 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3242 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3243 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3244 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BRENDA M. GARTZ ELI LILLY & CO CATALENT, SWINDON, UK - EIR 2009 TO PRESENT BRENDA M. GARTZ ELI LILLY & CO ROTTENDORF PHARMA GMBH, GERMANY - EIR 2009 TO PRESENT BRENDA M. GARTZ ELI LILLY & CO CILAG, SWITZERLAND - EIR 2009 TO PRESENT BRENDA M. GARTZ ELI LILLY & CO PATHEON, FRANCE - EIR MOST RECENT BRENDA M. GARTZ ELI LILLY & CO CATALENT, BRUSSELS, BELGIUM - EIR 2010 BRENDA M. GARTZ ELI LILLY & CO MEFAR, TURKEY - EIR MOST RECENT BRENDA M. GARTZ ELI LILLY & CO TAKEDA, KILRUDDERY, IRELAND - EIR MOST RECENT BRENDA M. GARTZ ELI LILLY & CO VIANEX PLANT D, GREECE - EIR MOST RECENT Signature/ Requester ELI LILLY & CO Subject
Page 151 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3245 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3246 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3247 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3248 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3249 05/02/2011 05/31/2011 2011-3250 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3251 2011-3252 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3253 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BRENDA M GARTZ ELI LILLY & CO ANSAN, GYEONGGI-DO, KOREA - EIR MOST RECENT FDA/OMPT/CDRH/OCER/DFOI/ ASHLEA RICCI, RAC CONMED LINVATEC CORP BRENDA M GARTZ ELI LILLY & CO BUSHU PHARMACEUTICALS, KAWAGOE-SHI, SAITAMA, JAPAN -EIR MOST RECENT DEPUY MITEK - GRYPHON T & P BR ANCHORS K100012 FDA/OF/CFSAN/OCD/EOS/ CLARK, MAGGIE BRENDA M GARTZ ELI LILLY & CO GENEXSA (GENERADOA DE EXPORTACIONES SA) 4/22/02; FRUITICA DE GUATEMALA 4/22/02; PRODUCTICOS DE LA TIERRA SA 4/23/02, ETC - INSPS HIZON, ANTIPOLO CITY, PHILIPPINES - EIR MOST RECENT FOI SERVICES INC DR REDDYS LABS LTD - OMEPRAZOLE MAGNESIUM ANDA 78-878 APRVL RECS FOI SERVICES INC WATSON LABS - MICROGESTIN 1.5/30; MICROGESTIN FE 1.5/30 ANDA 75-548 APRVL RECS FOI SERVICES INC WATSON LABS - MICROGESTIN 1/20, MICROGESTIN FE 1/20 ANDA 75-647 APRVL RECS BRENDA M GARTZ ELI LILLY & CO JANSSEN BIOLOGICS, LEIDEN, NETHERLANDS - EIR MOST RECENT Signature/ Requester Subject
Page 152 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3254 2011-3255 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3256 2011-3257 2011-3258 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3259 2011-3260 2011-3261 2011-3262 2011-3263 2011-3264 2011-3265 2011-3266 2011-3267 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BEAM ONE, LIMA, OH - EIR MOST RECENT BEAM ONE, SAN DIEGO, CA - EIR MOST RECENT PHILLIPS PLASTICS CORP, MENOMONIE, WI - EIR MOST RECENT NYPRO, CLINTON, MA - EIR MOST RECENT PATHEON, CINCINNATI, OH - EIR MOST RECENT SHARP, CONSHOHOCKEN, PA - EIR MOST RECENT CATALENT, WOODSTOCK, IL - EIR MOST RECENT DSM PHARMS, GREENVILLE, NC - EIR MOST RECENT HOSPIRA, MCPHERSON, KS - EIR MOST RECENT ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ASHLEA RICCI CONMED LINVATEC CORP BRENDA M GARTZ ELI LILLY & CO BR4NDA M GARTZ ELI LILLY & CO DAITO PHARMACEUTICAL COL LTD, TOYAMA-CITY, JAPAN - EIR MOST RECENT SMITH & NEPHEW INC - OSTEORAPTOR SUTURE ANCHOR K082215 AMYLIN PHARM, SAN DIEGO, CA - EIR MOST RECENT FDA/OMPT/CDRH/OCER/DFOI/ ASHLEA RICCI CONMED LINVATEC CORP BRENDA M GARTZ ELI LILLY & CO BONUTTI RESEARCH INC - MULTITAK SUTURE SYS K973015 KOWA PHARM, TOKYO, JAPAN - EIR MOST RECENT Signature/ Requester Subject
Page 153 of 1132

Total Records: 12455 Control # 2011-3268 Recd Date / Due Date 05/02/2011 05/31/2011 2011-3269 2011-3270 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3271 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3272 2011-3273 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3274 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3275 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3276 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3277 05/02/2011 05/31/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ STEVE KUNITAKE REAMETRIX INC GUAVA EZCD4 SYS K053497 PURGED COPY NELLIE E. STALEY CHOATE HALL & STEWART CEPHALON - TREANDA NDA 22-249; NDA 22-303 PEDIATRIC EXCLUSIVITY DETERMINATION RECS SINGER, MICHAEL S XALATAN NDA 20-597 - MEDICAL, PHARMACOLOGY RVW Doe J LEVORA; NORDETTE - AERS, LBLG 1996 TO PRESENT ORA/SW-FO/KAN-DO/COMP/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO XEILLIA, COPENHAGEN S, DENMARK - EIR MOST RECENT COVIDIEN, ST LOUIS MO - EIR MOST RECENT BRENDA M GARTZ ELI LILLY & CO REXAM, OFFRANVILLE, FRANCE - EIR MOST RECENT ORA/P-FO/SEA-DO/SCB/ Action Office ORA/SE-FO/FLA-DO/FCB/ Signature/ Requester TREVI PIES NUTRITIONAL LABORATORIES INTL BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO REXAM, LE TREPOT, FRANCE - EIR MOST RECENT HOLLISTER-STIER, SPOKANE, WA - EIR MOST RECENT Subject KANEC USA INC, DAVIE, FL - EIR 3/31/10-4/19/10
Page 154 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-3278 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3279 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3280 2011-3281 05/02/2011 05/31/2011 05/02/2011 05/31/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3282 05/02/2011 05/31/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DEN-DO/COMP/ 2011-3283 2011-3284 2011-3285 05/02/2011 05/31/2011 05/02/2011 05/31/2011 05/02/2011 05/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3286 2011-3287 05/02/2011 05/31/2011 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC OC/OM/OMP/DDM/ MINDY B. DUQUE INFOTECH DATA RESEARCH DAIICHI SANKYO, TAKYO, JAPAN - 483 7/26/07 DKT FDA-1995-S-0039 FDA/OMPT/CDRH/OCER/DFOI/ Doe J SAMIIT DEB PHARMACEUTICS INTERNATIONAL INC FDA/OMPT/CDRH/OCER/DFOI/ JASON R. McCLITIS BROWN LAW OFC LC ETHICON - GYNECARE PROLIFT MESHES 501K, INVESTIGATIONS, APRVL ZOLEDRONIC ACID INJ NDA 21-223 CLNCL STUDIES, BIOEQUIV, LOT NUMBERS, ETC SUN MED - ENDOTRACHEAL TUBE INTRODUCER MDRS BRAD SCHONHOFT BALYASNY ASSET MANAGEMENT WATSON PHARMS INC, CORONA, CA; DAVIE, FL; COPIAGUE, NY; SALT LAKE CITY, UT - 483S 1/110-4/27/10 STUART M. COBERT UNILEVER ANN GUPTA PEOPLE FOR INTEGRITY IN MEDICAL RESEARCH PENDING DRUG APPLS FOR ALZHEIMER DISEASE UNILEVER COVINGTON, COVINGTON, TN - EIR 12/3-11/09 THOMAS MARRIOTT PHD ZARS PHARMA INC ZARS PHARMA - SYNERA TOPICAL PATCH NDA 21-623 APRVL NATHAN P. CHANEY CHANEY LAW FIRM PA LASIX INJ NDA 16-363 - LBLG Signature/ Requester Subject
Page 155 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3288 2011-3289 2011-3290 2011-3291 2011-3292 05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 06/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC LAUREN HONG KAREWAY PRODUCT INC LAUREN HONG KAREWAY PRODUCT INC LAUREN HONG KAREWAY PRODUCT INC RICK GODDARD ROCHE DIAGNOSTICS COBAS INTEGRA CYCLOSPORIN SAMPLE PRETREATMENT REAGENT Z-1998-2011, RES 56636; ACETAMINOPHEN TEST SYS Z-1679/1680-11, RES 57513, ETC HEALTH HAZARD EVALUATION HARVARD APPARATUS - HARVARD 2 SYRINGE PUMP K952794 KERR/PENTRON - FLEX SPAN TEMPORARY CROWN & BRIDGE K021457 ALLERGAN MEDICAL, PRINGY, FRANCE - POST-PMA JUVEDERM XE EIR 5/3-7/10 MEDTRONIC SOFAMOR DANEK - PRESTIGE CERVICAL DISC P060018 MDRS, PAS RPTS 2007 STRYKER CORP/STRYKER HOWMEDICA OSTEONICS CORP - MDRS 9/14/07 NCT00735475 CSLCT-USF-07-41 (CSL'S AFLURIA) IMMUNOGENICITY & SAFETY COMPARISON TO US INFLUENZA VIRUS VACCINE RECS, RVWS, ACTIONS ETC OPTICS LABORATORY INC - EYE-CEPT REWETTING DROPS K041008 SLEEP DEVICES INC - SONA PILLOW K040161 CACHET PHARMACEUTICALL PVT LTD - STERILE SALINE SOL K102165 SAUFLON PHARMACEUTICALS LTD - MULTIPURPOSE SOL K030278 BAUSCH & LOMB - MULTI-PURPOSE SOL NRCO3 K031646 FEMSUITE - FEMEYE TWO K093218 Signature/ Requester Subject
2011-3293 2011-3294
05/03/2011 06/01/2011 05/03/2011 06/01/2011
FRANK HARRINGTON HARVARD APPARATUS LISA HESSABI SYBRON DENTAL SPECIALTIES INC
2011-3295 2011-3296 2011-3297 2011-3298
05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 06/01/2011
ROSE CHAN ALLERGAN INC. Doe J
FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/
PETER F BURNS BURNS CUNNINGHAM ET AL PAUL EFFLER, MD DEPARTMENT OF HEALTH WESTERN AUSTRALIA
2011-3299 2011-3300
05/03/2011 06/01/2011 05/03/2011
LAUREN HONG KAREWAY PRODUCT INC BENJAMIN L ENGLAND
Page 156 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/01/2011 2011-3301 05/03/2011 06/01/2011 2011-3302 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3303 05/03/2011 06/01/2011 2011-3304 05/03/2011 06/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ RONALD G VAN VALEN NOVARTIS PHARMACEUTICAL CORP PAUL EFFLER, MD DEPARTMENT OF HEALTH WESTERN AUSTRALIA CBER/OCTMA/DDOM/ALFB/ PAULEFFLER, MD DEPARTMENT OF HEALTH WESTERN AUSTRALIA FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3307 05/03/2011 06/01/2011 2011-3308 05/03/2011 06/01/2011 OM/OSS/OPILS/FDAHO/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3309 2011-3310 2011-3311 05/03/2011 06/01/2011 05/03/2011 06/01/2011 05/03/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ Doe J WILLIAM MESTRANDREA PFIZER INC AMERICAN RED CROSS GREATER OZARKS REGION RECS PROCESS VALIDATION FOR DRUG MANUFACTURING OPERATIONS - FDA TRAINING PROGRAM DAIICHI-SANKYO, TOKYO, JAPAN - EIR, WARNING LTR, CO RESP ETC 7/26/07 JOHN AUBEUF ROCHESTER PHARMS G & W LABS - NDA 775-49 APRVL LTR 12/9/97 SOPHIA PASEDIS AMERIDOSE LLC AMERIDOSE LLC, FRAMINGHAM, MA & WESTBOROUGH, MA - REQUESTERS OF INFO FOR SITES ANGELIA D SLAYTON KENDLE INTERNATIONAL INC MYFORTIC MYCOPHENOLIC ACID DELAYED-RELEASE TABS NDA 50-791 APRVL PKG NCT00959049 CSLCT-USF-07-36 - A NON-INFERIORITY IMMUNOGENICITY & SAFETY STUDY WITH CSL LIMITED'S AFLURIA & US LICENSED TRIVALENT INACTIVATED SPLITVIRION INFLUENZA VACCINE NCT00825162 CSLCT-USF-06-29 - UNCONTROLLED, OPEN-LABEL, SAFETY & TOLERABILITY STUDY OF CSL LIMITED'S AFLURIA ANALYSES OF ANDAS CONTAINING PARAGAPH IV CERTIFICATION OR SECTION VIII STATEMENT 2010, 2011 CBER/OCTMA/DDOM/ALFB/ Action Office Signature/ Requester BENJAMIN L ENGLAND & ASSOC LLC PAUL EFFLER, MD DEPARTMENT OF HEALTH WESTERN AUSTRALIA ART ROSENTHAL AVANIR PHARMS NCT00562484 CSLCT-USF-06-28 (CSL'S AFLURIA) EFFICACY, SAFETY & TOLERABILITY OF CSL LIMITED'S INFLUENZA VIRUS VACCINE AVANIR PHARMS - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE & QUINIDINE SULPHATE) CAPS NDA 21-87 MOR, STATISTICAL RVW, APRVL RECS, ETC Subject
2011-3305
05/03/2011 06/01/2011
2011-3306
05/03/2011 06/01/2011
Page 157 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/01/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3312 2011-3313 05/03/2011 06/01/2011 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3314 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3315 05/03/2011 06/01/2011 2011-3316 2011-3317 05/03/2011 06/01/2011 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-3318 2011-3319 05/03/2011 06/01/2011 05/03/2011 06/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3320 05/03/2011 06/01/2011 MADISON HARBOUR & MROZ PA 2011-3321 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ R. IAN KLUGE Hyman Phelps and McNamara PC SYNERX PHARMA - TESTOSTERONE ENANTHATE ANDA 40-647; AMNEAL PHARMS - CETIRIZINE HYDROCHLORIDE ANDA 90-766; ROXANE - BUPRENORPHINE ORA/SW-FO/DEN-DO/COMP/ KELLY S STREET LAS CRUCES BIOLOGICALS LLC - EIRS 2001 TO PRESENT CROWELL & MORING R. IAN KLUGE Hyman Phelps and McNamara PC MYLAN - SUMATRIPTAN SUCCINATE ANDA 77-163; AUROBINDO PHARMA - LAMOTRIGINE ANDA 90-401; AUROBINDO PHARMA - CEFOTAXIME SODIUM ANDA 65516 APRVL LTR 11/09 CVM FOIA REQUESTS LOGGED IN 4/11 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FATIMA ASLAM Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP ANGELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC NUTRINOVA NUTRITION SPECIALTIES & FOOD INGREDIENTS GMBH, LONZA LTD - MICRO-ALGAL OIL GRN160, GRN 319 RECS NIKKEN SOBONSHA CORP - DUNALIELLA BARDAWIL GRN 276, GRN 351 RECS IOVATE, HYDROXYCUT, SMARTBURN PRODUCTS ETC CAERS, RECS 1/31/11 TO PRESENT FOI SERVICES INC SICOR, BIOTECH, VILNIUS, LITHUANIA - 483, 5/10 TO 6/10 FOI SERVICES INC ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC LUITPOLD PHARMS, SHIRLEY, NY - 483, 1/2011 TO PRESENT SICOR BIOTECH, VILNIUS, LITHUANIA - EIR, WARNING LTR, CO RESP ETC 5/10 TO 6/10 Signature/ Requester FOI SERVICES INC Subject
Page 158 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3322 2011-3323 05/03/2011 06/01/2011 05/03/2011 06/01/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3324 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3325 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3326 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3327 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3328 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3329 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3330 05/03/2011 FDA/OMPT/CDER/ORP/DIDP/ R. IAN KLUGE GLENMARK GENERICS - LITHIUM CARBONATE ANDA 79R. IAN KLUGE Hyman Phelps and McNamara PC APP PHARMS - SUMATRIPTAN SUCCINATE ANDA 79-242; AUSTARPHA RMA LLC - SERTRALINE HYDROCHLORIDE ANDA 78-677; SANDOZ - METHYLPREDNISOLONE ACETATE ANDA 40-794 APRVL LTR 3/09 R. IAN KLUGE Hyman Phelps and McNamara PC EBEWE PHARMA - METHOTREXATE SODIUM PRESERVATIVE FREE ANDA 90-029; IPCA LABS LTD HYDROCHLOROTHIAZIDE ANDA 79-237; SILARX LEVETIRACETAM ANDA 90-263 APRVL LTR R. IAN KLUGE Hyman Phelps and McNamara PC HIKMA FARMACEUTICA - BUTORPHANOL TARTRATE ANDA 78-400; ZYDUS PHARMS USA - RISPERIDONE ANDA 78516; ACCORD HEALTHCARE - MYCOPHENOLATE MOFETIL ANDA 65-433 APRVL LTR 5/09 R. IAN KLUGE Hyman Phelps and McNamara PC NOVEL LABS INC - PEG 3350 & ELECTROLYTES ANDA 90186; NOVEL LABS INC - PEG 3350 & ELECTROLYTES ANDA 90-231; ZYDUS PHARMS USA INC - ROPINIROLE HYDROCHLORIDE ANDA 90-411 APRVL LTR 6/09 R. IAN KLUGE Hyman Phelps and McNamara PC ORCHID HEALTHCARE - AMLODIPINE BESYLATE ANDA 78453; TEVA - BICALUTAMIDE ANDA 76-932; SYNTHON PHARMS - BICALUTAMIDE ANDA 77-973 APRVL LTR 7/09 R. IAN KLUGE Hyman Phelps and McNamara PC WATSON LABS FLORIDA - METOPROLOL SUCCINATE ANDA 76-862; WATSON LABS FLORIDA - METOPROLOL SUCCINATE ANDA 77-118; TEVA PHARMS - DIVALPROEX SODIUM ANDA 78-700 APRVL LTR 8/09 MITCHELL ZELLER PINNEY ASSOCIATES R. IAN KLUGE Hyman Phelps and McNamara PC AUROBINDO PHARMA - RISPERIDONE ANDA 78-452; MUTUAL PHARM - TEMAZEPAM ANDA 78-581; DR REDDYS LABS LTD - NATEGLINIDE ANDA 77-461 APRVL 9/09 2011-2520 - DELETED RECS Signature/ Requester Subject HYDROCHLORIDE ANDA 78-633 APRVL LTR 10/09
Page 159 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/01/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3331 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3332 05/03/2011 06/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3333 2011-3334 2011-3335 2011-3336 05/03/2011 06/01/2011 05/04/2011 06/02/2011 05/04/2011 06/02/2011 05/04/2011 06/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3337 05/04/2011 06/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3338 2011-3339 05/04/2011 06/09/2011 05/04/2011 06/02/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ 2011-3340 05/04/2011 06/02/2011 OM/OMP/DODM/ WILLIAM J SKINNER MUSCATATUCK PUBLISHERS DKT 1997S-0006 JUDITH C GALLANT FOLEY HOAG LLP R ASHBY PATE LIGHTFOOT FRANKLIN & WHITE LLC SMITH & NEPHEW INC, MEMPHIS, TN - EIRS 1/10-12/06 (CERTIFIED) HILL ROM - AFFINITY I,II,III, IV BIRTHING BEDS RECALLS, URGENT MEDICAL DVC CORRECTION LTRS KRISTI R SIMS MURTY PHARMACEUTICALS INC SIMS, FLORENCE, ITALY - EIRS, 483S, CORR 1/08, 10/10 BEVERIDGE & DIAMOND PC DAVID PALLING DAVID PALLING LLC MESTINON TABS, SYRUP, TIMESPAN TABS (PYRIDOSTIGMINE BROMIDE) - APRVL, RVWS BEVERIDGE & DIAMOND PC 2011-2740 ORA/P-FO/LOS-DO/LACB/ HAROLD L. SLATORE ACON LABORATORIES INC 201-2736 MICRO DETECT INC, TUSTIN, CA - EIR, 483 R. IAN KLUGE Hyman Phelps and McNamara PC HIKMA FARMACEUTICA - FOSPHENYTOIN SODIUM ANDA 78-765; IPCA LABS LTD - CHLOROQUINE PHOSPHATE ANDA 90-249; IPCA LABS LTD - CHLOROQUINE PHOSPHATE ANDA 90-610 APRVL LTR 12/09 R. IAN KLUGE Hyman Phelps and McNamara PC STRIDES ARCOLAB LTD - ETOMIDATE ANDA 78-289; MATRIX LABS LTD - STAVUDINE ANDA 78-775; PADDOCK CICLOPIROX ANDA 78-266 APRVL LTR 1/09 Signature/ Requester Hyman Phelps and McNamara PC Subject 139; IMPAX LABS INC - MINOCYCLINE HYDROCHLORIDE ANDA 900-24; UPSHER SMITH - LAMOTRIGINE ANDA 78310 APRVL LTR 2/09
Page 160 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester INC 2011-3341 05/04/2011 06/02/2011 2011-3342 05/04/2011 06/02/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3343 05/04/2011 06/02/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ 2011-3344 2011-3345 05/04/2011 06/02/2011 05/04/2011 06/02/2011 2011-3346 05/04/2011 06/03/2011 ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-3347 2011-3348 2011-3349 05/04/2011 06/02/2011 05/04/2011 06/02/2011 05/04/2011 06/02/2011 2011-3350 2011-3351 2011-3352 05/04/2011 06/02/2011 05/04/2011 06/02/2011 05/04/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ LYNNE SMART KUMETRIX INC OLA RICKARDSSON LUND UNIVERSITY LOIS ZIEBOL MICRONJET 600 HYPODERMIC SINGLE LUMEN NEEDLE K092746 WL GORE & ASSOCIATES INC - PRECLUDE PERICARDIAL MEMBRANE K012098 SS&E CATHETER REPAIR KIT W/REPLACEMENT CONNECTOR ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ SHARLENE EDMONDS PPD LUCY CERDA ANITA'S MEXICAN FOODS CORP CHRISTOPHER C O9KOROEGBE CARGILL TANDEM LABS, SALT LAKE CITY, UT - EIRS, 483S, CORR, ETC 2010 TO PRESENT ANITA'S MEXICAN FOODS CORPM SAN BERNARDINO, CA EIR, 11/5/09 WILBLUR CHOCOLATE CO INC (DBA CARGILL COCOA & CHOCOLATE) - EIR 3/23-26/10. Doe J INDIVIDUAL RECS Doe J FDA/OF/CFSAN/OCD/EOS/ PONDER, MARY A ANEET PANSAR BURDOCK GROUP INSTITUTE OF MEDICINE FOOD FORUM - ENHANCING THE REGULATORY DECISION MAKING PROCESS FOR DIRECT FOOD INGREIDENT TECHNOLOGIES WORKSHOP FINAL RPT 5/6-7/97 FOOD HANDLERS CLASS - LIST OF MATERIALS & SUPPLIES CMPLNT 119416 ROBIN L ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY (IMT) GRAHAM WHITAKER WHITAKER, GRAHAM INTEGRATED SURGICAL SYSTEMS INC, SACRAMENTO, CA - DIGIMATCH ROBODOC SURGICAL SYS K072629 Subject
OFLOXACIN OTIC SOL NDA 20-799 - PROTOCOLS 8280APRT004, 8280A-PRT005
Page 161 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/02/2011 Action Office Signature/ Requester PERSUIIT VASCULAR Subject K011015; MODIFIED VAS-CATH CATHETER REPAIR KITK890099; BAXTER HEALTH CARE - DUAL LUER LOCK LOCK CAP K101385 PRIME DENTAL MANUFACTURING INC, CHICAGO, IL - FDA 3613 SUPPLEMENTARY INFORMATION CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS HAWS CORP, SPARKS, NV; BBC BIOCHEMICAL, MOUNT VERNON, WA - EIRS, 483S, CO RESPS, ETC 2010, 2011 LETAIRIS( AMBRISENTAN) NDA 22-081/S017 - APRVL SUMMARY & ASSESSMENT
2011-3353
05/04/2011 06/02/2011
STEPHEN ERICKSON DENTAL TECHNOLOGIES INC
2011-3354 2011-3355
05/04/2011 06/02/2011 05/04/2011 06/02/2011
ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
DAVID L ROSEN FOLEY & LARDNER LLP FRANCES DUFFY-WARREN ACTELION CLINICAL RESEARCH INC
2011-3356
05/04/2011 06/02/2011
DON J MIZERK HUSCH BLACKWELL LLP
MYLAN - CYCLOBENZAPRINE ER CAPS ANDA 90-738 APRVL LTR 4/18/11
2011-3357 2011-3358
05/05/2011 06/03/2011 05/05/2011 06/03/2011
ORA/P-FO/LOS-DO/LACB/ ROSE, HAL A FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ NAPIER, JO ANN T
GAR LABS - WARNING LTR 12/6/10, CORR, INSP NOTES, ETC TOPAMAX (TOPIRAMATE) NDA 20-505, NDA 20-844 - AERS, MEMOS, RVWS, ETC
2011-3359
05/05/2011 06/03/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
JOHNA HOEY OPEN SOCIETY INSTITUTE
VIVITROL - AERS
2011-3360
05/05/2011 06/03/2011
CHRISTY MENG INNOPHARMA LLC
ACETADOTE (ACETYLCYSTEINE INJ) NDA 21-539 - AERS
2011-3361
05/05/2011 06/03/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LEAVER, RICHARD
MULTAQ (DRONEDARONE HCL) - AERS
Page 162 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3362 05/05/2011 06/03/2011 2011-3363 05/05/2011 06/03/2011 2011-3364 2011-3365 05/05/2011 06/03/2011 05/05/2011 06/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3366 05/05/2011 06/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3367 05/05/2011 06/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3368 05/05/2011 06/03/2011 2011-3369 2011-3370 2011-3371 2011-3372 2011-3373 05/05/2011 06/03/2011 05/05/2011 06/03/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANGELIA SLAYTON KENDLE REGULATORY AFFAIRS DEB FLEETHAM MEDTRONIC DEB FLEETHAM SURGIFROST XL CRYOSURGICAL DVC & CRYSOURGICAL LAAX INC - TIGERPAW SYS K101961 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC HYDROCISION - ARTHROJET SYS WITH CAUTERY, TURBOBURR & CURETTE K032529 HYDROCISION - ARTHROJET SYS WITH CAUTERY & BURR K002764 DESI 11287 FOI SERVICES INC HYDROCISION - ATHROJET XT K041233 L ANDREW HOLLIS HOLLIS WRIGHT & COUCH PC MERCK & CO INC - PROSCAR (FINASTERIDE) AERS (CERTIFIED) L ANDREW HOLLIS HOLLIS WRIGHT & COUCH PC MERCK & CO INC - PROPECIA (FINASTERIDE) AERS (CERITIFED) FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ RUTH LAMLEY BAYER HEALTHCARE ANIMAL HEALTH DIVISION DAVID LOHMAN ACCIPITER CAPITAL MANAGEMENT LLC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS L ANDREW HOLLIS HOLLIS WRIGHT & COUCH PC ELANCO ANIMAL HEALTH - MICOTIL 300 (TILMICOSIN PHOSPHATE) NADA 140-929 FOI SUMMARY LUITPOLD PHARMS, SHIRLEY, NY - EIR, 483, CORR 3/11, 4/11 SOLAZYME INC - ALGAL FLOUR GRN 330, ALGAL OIL GRN 331 GLAXOSMTIHKLINE - AVODART (DUTASTERIDE) AERS Signature/ Requester Subject
Page 163 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/06/2011 2011-3374 2011-3375 2011-3376 2011-3377 2011-3378 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 2011-3379 2011-3380 05/06/2011 06/06/2011 05/06/2011 06/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3381 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3382 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3383 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3384 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANDREA DALTON LAW OFC OF ANDREA DALTON LLC GENENTECH - TAMIFLU (OSELTAMIVIR) LBLG, AERS, CLNCL TESTING, ETC COBY TURNER GLANCY BINKOW & GOLDBERG LLP MANNKIND CORP - AFREZZA (AFRESA) AERS THOMAS J MULDOON ESQ TAKEDA PHARMACEUTICAL NORTH AMERICA INC BOEHRINGER INGELHEIM PHARMACEUTICALS INC & ELI LILLY & CO - TRADJENTA (LINAGLIPTIN) SBA YUKIO FUJINO FUJINO, YUKIO TOKYO CLINL RES ORGANIZATION MED CLIN, SHINJUKU, TOKYO, JAPAN - EIRS, 483S CO RESP 11/8/10 FUJINO, YUKIO MANDEL, IAN FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester MEDTRONIC DEB FLEETHAM MEDTRONIC DEB FLEETHAM MEDTRONIC DEB FLEETHAM MEDTRONIC DEB FLEETHAM MEDTRONIC CHRIS BOES MEDTRONIC ENDOCARE INC - CRYOCARE CARDIAC SURGICAL SYS K011040 CRYOCATH SURGIFROST & CRYOSURGICAL DVC PLUS FROSTBYTE CLAMP & CRYOSURGICAL CONSOLE K053436 MAYOR PATRICK "PAT" MCCRORY - CORR 1/1/96 TO 12/31/08 MED CORP HEISHINKAI OCROM CLINIC, KASUGA SUITA CITY, OSAKA, JAPAN - EIRS, 483S, CO RESP 11/1/10 Subject CONSOLE - K062140 SURGIFROST CRYOSURGICAL DVC PLUS FROSTBYTE CLAMP & CRYOSURGICAL CONSOLE - K040690 SURGIFROST CRYOSURGICAL DVC PLUS FROSTBYTE CLAMP & CRYOSURGICAL CONSOLE - K053436 ATRICURE INC - ATRICLIP LAA EXCLUSION SYS K093679
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Total Records: 12455 Control # 2011-3385 2011-3386 Recd Date / Due Date 05/06/2011 08/25/2011 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3387 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-3388 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3389 2011-3390 05/06/2011 06/06/2011 05/06/2011 06/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3391 05/06/2011 06/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3392 2011-3393 05/06/2011 06/06/2011 05/06/2011 06/06/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ HUA, MIN MAX BUSETTI THOMPSON PUBLISHING GROUP CHINA BEJING ZHIMINGE QUANTUM BIOLOGY SCIENCE CO LTD - CERTIFICATE OF FREE SALE GENERAL MILLS - CHEERIOS HEALTH CLAIMS CORR 3/15/11 - 4/30/11 SARA DITTA INSIDE WASHINGTON PUBLISHERS ADMINISTRATIVE CONTROLS & PROCEDURES FOR STAFF SELECTION AT THE FDA'S CENTER FOR DEVICES & RADIOLOGICAL HEALTH - INVESTIGATION Doe J MARILYNN WHITNEY COVINGTON & BURLING LLP AMOXICILLIN DURING PREGNACY - DEVELOPMENTAL PROBLEMS IN BABIES 2009-7667, 2009-7731, 2009-7729, ETC JESSICA C NEUMANN NEW ENGLAND LIFE CARE FLUOROURACIL (5-FU) - AERS 1/1/01 TO 5/5/11 SABRINA K CUNNINGHAM HARE WYNN NEWELL & NEWTON LLP MEDS IV PHARMACY - COMPOOUNDED PRODS RECALL SERRATIA MARCESCENS BACTEREMIA OUTBREAK IN ALABAMA HOSPITALS 3/30/11 Action Office CBER/OCTMA/DDOM/ALFB/ Signature/ Requester CHARLES H KY;PER KYPER & ASSOCIATES IRINA KLYATSKAYA PHARM-HOLDING CJSC Subject CIRCLE BIOLOGIC LLC, KAYLIGHT CORP - MYCELLS AUTOLOGOUS PLATELET PREPARATION KIT BK080057 GENENTECH CO - LUCENTIS (RANIBIZUMAB) BLA 12-5156; AVASTIN (BEVACIZUMAB) BLA 12-5085 RECS
Page 165 of 1132

Total Records: 12455 Control # 2011-3394 Recd Date / Due Date 05/06/2011 06/06/2011 2011-3395 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3396 2011-3397 05/06/2011 06/06/2011 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OL/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/OCI/ ORA/OCI/ ORA/OE/ ORA/OE/ OC/COS/OES/ OC/COS/OES/ 2011-3398 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3399 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3400 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOE GRAEDON GRAEDON ENTERPRISES TACROLIMUS (GENERIC PROGRAF) - AERS JOE GRAEDON GRAEDON ENTERPRISES BUDEPRION XL - AERS JOE GRAEDON GRAEDON ENTERPRISES TEVA, IMPAX - BUDEPRION XL 300 BIOEQUV STUDY CORR ORA/SW-FO/DEN-DO/COMP/ PAUL W TRIPP LINCARE INC KIMBERLY R LAMBERT LEVIN PAPANTONIO THOMAS ET AL WIND RIVER HOME OXYGEN, LLC, WY - EIRS, 483S, WARNING LTRS ETC 1/1/04 TO PRESENT ZOLOFT (SERTRALINE) - CMPLNTS, CORR, INVESTIGATIONS, ETC Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester PAUL W TRIPP LINCARE INC SAMUEL K ROSEN HARWOOD FEFFER, LLP Subject WRIGHT & FILIPPIS INC, OCTPHARMACY LLC, W&F HIGH TECH SYSTEMS LLC, MMOC LLC, MI - EIRS, 483S, WARNING LTRS ETC 1/1/04 TO PRESENT HORIZANT (GABAPENTIN ENCARBIL) TABS - NDA AMENDMENTS10/6/10 TO PRESENT
Page 166 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3401 2011-3402 2011-3403 2011-3404 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3405 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3406 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3407 05/06/2011 06/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3408 05/09/2011 06/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3409 05/09/2011 06/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FIORE, MICHAEL C APRVD PRESCRIPTION DRUG PRODS WITH THERAPEUTIC EQUIVALENCE EVALUATION - ORANGE BOOK 1981 FIORE, MICHAEL C APRVD PRESCRIPTION DRUG PRODS WITH THERAPEUTIC EQUIVALENCE EVALUATION - ORANGE BOOK 1980 ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC SANOFI AVENTIS - PRIFTIN (RIFAPENTINE) NDA 21024/S008 APRVL LTR, RVWS THUMANN, ANTHONY AZT (AZIDOTHYMIDINE, ZIDOVUDINE, RETROVIR) CMPLNTS 1995 TO 2002 AMY MITCHELL GLAXO SMITH KLINE SHENZHEN HEPALINK PHARMACEUTICAL CO LTD, GUANDONG, PR CHINA - EIR MOST RECENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TERRENCE E. SULLIVAN GYRUS ACMI INC TERRENCE E. SULLIVAN GYRUS ACMI INC TERRENCE E. SULLIVAN GYRUS ACMI INC AMY MITCHELL GLAXO SMITH KLINE ASCENT HEALTHCARE SOLUTIONS - PKS PLASMA SPATULA DVC 501K SHENZHEN HEPALINK PHARMACEUTICAL CO LTD, GUANDONG, PR CHINA - EIR 2008 ASCENT HEALTHCARE SOLUTIONS - PKS PLASMASORD DVC 510K ASCENT HEALTHCARE SOLUTIONS - PKS OMNI DVC 510K Signature/ Requester Subject
Page 167 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3410 2011-3411 05/09/2011 06/07/2011 05/09/2011 06/07/2011 2011-3412 05/09/2011 06/07/2011 2011-3413 05/09/2011 06/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3414 05/09/2011 06/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3415 05/09/2011 06/07/2011 2011-3416 05/09/2011 06/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3417 2011-3418 05/09/2011 06/07/2011 05/09/2011 06/07/2011 ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-3419 05/09/2011 06/07/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ LOUISE E KING TROPICAL FRUIT GROWERS OF SOUTH FLORIDA LYCHEE IMPORTED FROM ASIA - INVESTIGATION RECS 2010 ALLAN COUKELL PEW CHARITABLE TRUSTS DANIEL G JARCHO MCKENNA LONG & ALDRIDGE LLP ALTEC MEDICAL INC, EASLEY, SC - AFFADAVIT IN SUPPORT OF SEARCH WARRANT 7/9/09 DEL MONTE FRESH PRODUCE NA INC, PHILADELPHIA, PA, HOLT TERMINAL, GLOUCESTER CITY, NJ - CANTALOUPE MELONS ENTRY 113-5554438-5 SPL COLLECTION RPTS, LAB RPTS HAMZA CHAUDARY ADLER POLLOCK & SHEEHAN PC WILLIAM A LAKE MARCUS RESEARCH LABORATORY INC NANHANG INDUSTRIAL CO LTD, HANGZHOU, CHINA - EIR, 482, 483 MOST RECENT 2011-338 - MINOR DELETIONS TO DETROIT RECS JACKSON, EVA JO PROETHAZINE, PERPHENZAINE, PROMETHAZINE ETC AERS, WARNINGS, LBLG, ETC MICHAEL R CHOHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 4/1/11 TO 5/1/11 MARIA KEELAN GAMBRO RENAL PRODUCTS NXSTAGE MEDICAL INC - PUREFLOW-B SOL K053286 FDA/OMPT/CDRH/OCER/DFOI/ LAM, NELSON ANDI PULSON LEXISNEXIS COURTLINK INC PAIN CONTROL INFUSION PUMP K990101 - RVWS, APRVL, K093745 Signature/ Requester Subject
Page 168 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ 2011-3420 2011-3421 2011-3422 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 2011-3423 2011-3424 2011-3425 2011-3426 2011-3427 2011-3428 2011-3429 2011-3430 2011-3431 2011-3432 2011-3433 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ MERCK & CO., INC. FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FATIMA ASLAM Keller and Heckman LLP ALK-ABELLO, PORT WASHINGTON, NY - EIRS, WARNING LTRS, CO RESPS 1/09 TO PRESENT MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 4/130/11 NEVADA ALLIANCE AGAINST DIABETES, RUBIN H SAAVEDRA, LAS VEGAS, NV - EIRS, 483S, CORR 3/9-25/09 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ERBE USA - MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20239-094 K062712 ALPHA-LIPONIC ACID - ANIMAL FOOD GRN #3 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ BROOKS, KENNETH C ERBE USA - HYBRID KNIFE K083608 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ OC/OSHC/OPD/ ROBERT K MERRELL LIPOCINE INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. H1N1 VACCINE - LIST OF INGREDIENTS FOI CLOSED REQUESTS 4/1-30/11 CLOSED FOI REQUESTS 3/1-31/11 FOI DAILY LOG 4/25-29/11 KV PHARMACEUTICAL CO - MAKENA NDA 21-945 ORPHAN DESIGNATION RVWS, SBA (ROTAVIRUS VACCINE LIVE ORAL PENTAVALENT MERCK & CO INC) ROTATEQ - VAERS 4/1-30/11 (MEASLES, MUIMPS, RUBELLA & VARICELLA VIRUS VACCINE LIVE MERCK & CO INC ) PROQUAD - VAERS 4/130/11 FOI DAILY LOG 4/18-22/11 Signature/ Requester Subject
Page 169 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3434 2011-3435 05/09/2011 07/05/2011 05/09/2011 06/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3436 2011-3437 2011-3438 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 2011-3439 2011-3440 05/09/2011 06/07/2011 05/09/2011 06/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-3441 2011-3442 2011-3443 05/09/2011 06/07/2011 05/09/2011 06/07/2011 05/09/2011 06/07/2011 2011-3444 2011-3445 2011-3446 05/09/2011 06/07/2011 05/10/2011 06/08/2011 05/10/2011 OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ SAGONA, MARIAN N WILLIAM H. GRADY PAUL, HAUSTING, JANOFSKY & WALKER LLP DAVID SELL PHILADELPHIA INQUIRER ANGELIA SLAYTON KENDLE REGULATORY AFFAIRS MARILYNN WHITNEY SYNTHES INC, NORIAN INC, WEST CHESTER, PA - EIRS, 483S 5/4, 6/04 DKT & DKT LOG OF 1978N-0021, 1978N-0021P, OTC VOL 160069, ETC. DKT FDA-2010-P-0491 DKT 1985D-0108 ORA/P-FO/SAN-DO/SFCB/ STEVE MILLER AIR LIQUIDE USA LLC COCA-COLA - WARNING LTR RESP 10/10/08 AIR LIQUIDE, RICHMOND, CA - EIRS, 3/25-30/11 ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC QI JIA PHD UNIGEN ORA/SE-FO/SJN-DO/SJCB/ ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC BRAD SCHONHOFT BALYASNY ASSET MANAGEMENT ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC ALK-ABELLO, PORT WASHINGTON, NY - 483S, CORR 1/09 TO PRESENT LUIPOLD PHARMS, SHIRLEY, NY - EIRS, WARNING LTRS, CO RESP 2/9/11-3/15/11 BRISTOL MYERS SQUIBB CO, MANATI, PR - 483 1/1/104/27/11 LUITPOLD PHARMS, SHIRLEY, NY - 483S, CORR 2/9/113/15/11 ACACIA CATECHU - CAERS, AERS FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ KRYSTYLLE L RICHARDSON GMSBIOTECH PIPERACILLIN/TAZOBACTAM - IRS 6512804; 667151 LABTYPE VISUAL - BK040049 Signature/ Requester Subject
Page 170 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/08/2011 2011-3447 2011-3448 2011-3449 2011-3450 05/10/2011 06/08/2011 05/10/2011 06/08/2011 05/10/2011 06/14/2011 05/10/2011 06/08/2011 2011-3451 2011-3452 05/10/2011 06/08/2011 05/10/2011 06/08/2011 2011-3453 2011-3454 05/10/2011 06/08/2011 05/10/2011 06/08/2011 2011-3455 05/10/2011 06/08/2011 2011-3456 05/10/2011 06/08/2011 2011-3457 05/10/2011 06/08/2011 2011-3458 2011-3459 05/10/2011 06/08/2011 05/10/2011 06/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ DOUGLAS N BLUE ZETETIC W NELSON HARDIN ELECTRO-CAP INTERNATIONAL INC DOUGLAS N BLUE ZETETIC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC SALMA JETHA VQ CONSULTING GROUP SANJUKTA BHADURI UPSHER-SMITH LABORATORIES INC ROCHE - VERSED SBA NOVARTIS, EAST HANOVER, NJ - ENTRY KG2-0527460-1 PHOTOGRAPHS, RECS INDIANA BLOOD CENTER, INDIANAPOLIS, IN 3/14/11; ADVANCED REPRODUCTIVE MEDICNE & SURGERY PC, BLOOMFIELD HILLS, MI - 483S ATLANTA BLOOD SERVICES, ATLANTA, GA 3/1/11; BLOOD CONNECTION INC, PIEDMONT, SC 3/23/11 - 483S CLEVLAND CLINIC, CLEVELAND, OH 1/14/11; CLEVELAND EYE BANK INC, CLEVELAND, OH 3/25/11; LIFECENTER ORGAN DONOR NETWORK, CINNCINNATI, OH 2/4/11 - 483S COMMUNITY BLOOD CENTER OF GREATER KANSAS CITY, KANSAS CITY, MO - 483 2/11/11 CANDULOR USA - DIRECT CROWN NATURAL 1 K101814 NOVARTIS, EAST HANOVER, NJ - ENTRY KG2-057650-7 PHOTOGRAPHS, RECS K780045 VELASQUEZ-MANOFF, MOISES ORA/SE-FO/FLA-DO/FCB/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ Action Office Signature/ Requester COVINGTON & BURLING LLP MARILYNN WHITNEY COVINGTON & BURLING LLP MARILYNN WHITNEY COVINGTON & BURLING LLP DOUGLAS N BLUE ZETETIC NOVARTIS, EAST HANOVER, NJ - ENTRY KG2-0527528-5 PHOTOGRAPHS, RECS JASPER LAWRENCE, AUTOIMMUNE THERAPIES INC, SANTA CRUZ, CA - WARNING LTRS, VIOLATIONS, INJUNCTIONS, ETC DKT FDA-2010-P-0491 DKT FDA-2010-N-0621 Subject
Page 171 of 1132

Total Records: 12455 Control # 2011-3460 Recd Date / Due Date 05/10/2011 06/08/2011 2011-3461 05/10/2011 06/08/2011 2011-3462 05/10/2011 06/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-3463 2011-3464 05/10/2011 06/08/2011 05/10/2011 06/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-3465 05/10/2011 06/08/2011 2011-3466 2011-3467 05/10/2011 06/08/2011 05/10/2011 07/11/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3468 2011-3469 2011-3470 05/10/2011 06/08/2011 05/10/2011 06/08/2011 05/10/2011 06/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ ANDRE MINNAAR CHAMPION PETFOODS LP ELENA HOWELL HOGAN LOVELLS LLP NICK PALMER KEYSTONE INDUSTRIES ENTRY #144-4376281-3 - LAB METHODS, SPL SIZE, COLLECTION, ETC MARTEK BIOSCIENCES - INFANT FORMULAS CONTAINING DHASCO & ARASCO CAERS 1/1/10 TO PRESENT K994357, K012882 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ LAURA H MCKASKLE MORGAN LEWIS COUNSELORS AT LAW DOUGLAS N BLUE II ZETETIC DAMINAN JONES PACIFIC STRATEGY GROUP F ALIOTO CO INC, SAN FRANCISCO, CA - CONTAMINATION OF FOOD PRODS COMM,CMPLNTS, WARNINGS, ETC 2000 TO PRESENT NOVARTIS CONSUMER HEALTH INC - ENTRY #AM10169992-5 NUMBER OF INDS, DENIALS, ACCEPTANCES, ETC PAST 10 YRS FDA/OF/CFSAN/OCD/EOS/ ASBJORN LEIRVAG TV 2 AS NICHOLAS M DEPALMA ARNOLD & PORTER RIVER'S EDGE PHARMACEUTICALS LLC - WARNING LTR, FINAL INVESTIGATION RPTS, RESP TO LTR, 5/20/10, 10/27//10, 11/10/10; KYLEMORE PHARMACEUTICALS LLC ACTION OR INVESTIGATION RPT, ETC FDA FOREIGN FOOD INSP PROGRAM Action Office ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SEA-DO/SCB/ Signature/ Requester DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ANTHONY SDSCIA ATLANTIC PHARMACEUTICALS INC Subject GULF COAST REGIONAL BLOOD CENTER, HOUSTON, TX 483 2/2/11 NORTHWEST BIOMET INC 1/17/11; OREGON REPRODUCTIVE MEDICINE LLC 3/1/11; IDAHO CENTER FOR REPRODUCTIVE MEDICINE PC 1/24/11 - 483S DKT 2007P-0399
Page 172 of 1132

Total Records: 12455 Control # 2011-3471 2011-3472 Recd Date / Due Date 05/10/2011 06/08/2011 05/10/2011 06/08/2011 ORA/ ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ 2011-3473 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3474 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3475 2011-3476 05/11/2011 06/09/2011 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3477 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-3478 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ TATIANA OUSSOVA LEE B MEISEL MD MERCK SHARP & DOHME CORP - PROPECIA NDA 20788/S017 AMENDMENTS, CORR 9/15/10 KIM KEYSER LONZA BIOLOGICS, INC NINGXIA QIYUAN PHARMACEUTICAL CO LTD, YINGCHUAN, NINGXIA, CHINA - EIRS, 483S SHEPHERD, KEN FDA/OMPT/CDRH/OCER/DFOI/ PERRY GRABRECK GRABRECK CEFTRIAXONE - AERS HEALTH CONCEPTS INC - K871292 DUSTIN BLOCK IPD ANALYTICS LLC LANSOPRAZOLE ANDA 78-730 - APRVL LTR 10/15/10 DUSTIN BLOCK IPD ANALYTICS LLC FLUTICASONE PROPIONATE ANDA 90-759 - APRVL LTR 5/2/11 RYAN, PAUL Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester APRIL HOLLIS FDA NEWS KRAFT FOODS - BOCA BURGER HEXANE TESTING RESULTS Subject GENZYME, CAMBRIDGE, MA - 483 6/2/10
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Total Records: 12455 Control # 2011-3479 Recd Date / Due Date 05/11/2011 06/09/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3480 2011-3481 05/11/2011 06/09/2011 05/11/2011 06/09/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3482 2011-3483 05/11/2011 06/09/2011 05/11/2011 06/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ ORA/CE-FO/DET-DO/DCB/ ORA/OCI/ ORA/OCI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3484 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC AKORN - LIDOCAINE HCL ANDA 40-433, APRVL LTR ORA/SE-FO/FLA-DO/FCB/ Doe J ANNESLEY H DEGRAIS CORY WATSON ET AL DEPUY INC, DEPUY ORTHOPAEDICS, JOHSNON & JOHNSON, ETC - PINNACLE HIP IMPLANT DVC RECOMMENDATIONS, TRANS, MIN, ETC WATSON - RIVASTIGMINE RPT JW AUGUST 10NEWS AZTECA AMERICA DAVID E OUTWATER OUTWATER & PINCKES LLP ETHOS ENVIRONMENTAL INC - REGENERECT COMM, INVESTIGATION, TESTING, ETC 1/09 TO PRESENT HUMAN TISSURE BANKS & LABS, CA - EIRS LEE B MEISEL MD Signature/ Requester Subject MERCK SHARP & DOHME CORP - PROPECIA 20-788/S018 CORR, RVW 12/9/10
Page 174 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3485 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3486 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3487 2011-3488 05/11/2011 06/09/2011 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ 2011-3489 05/11/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3490 2011-3491 2011-3492 2011-3493 2011-3494 05/11/2011 06/09/2011 05/11/2011 06/09/2011 05/11/2011 06/09/2011 05/11/2011 06/09/2011 05/11/2011 06/09/2011 2011-3495 05/11/2011 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ OM/OMP/DODM/ Orton, Sharyn KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. ASTHIKA GOONEWARDENE BLOOMBERG LLP SAMI J. HIJAB ANCHOR GLASS CONTAINER DUFFY MACKAY COUNCIL FOR RESPONSIBLE NUTRITION PATRICK ENGLISH, Esq. ASIA BIOTECH CORP - TELOMERES DIETARY SUPPLEMENT NOTIFICATIONS DIETARY SUPPLEMENT FIRMS - GMP INSP 9/9 TO PRESENT 2010-3972 - DELETED RECS DRUG MFR INSPS LAST 10 YRS DOCKET 85C-0415 BLOOD PRODUCT ADVISORY MTG 9/89, 10/95 THOMAS, DONALD E ASPIRIN - APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ KEITH A. BARRITT FISH & RICHARDSON PC E. KIRK WOOD WOODLAW FIRM LLC MOBISANTE INC - MOBIUS ULTRASOUND IMAGING SYS K102153 IDS SPORTS - MASS TABS INVESTIGATIONS DAVID ZUCHERO CHESAPEAKE REGULATORY GROUP INC NEUREN PHARMACEUTICALS LTD, FREEMANS BAY AUCKLAND, NEW ZEALAND - NEFIRACETAM IND 55-988 CORR 12/02 TO PRESENT FOI SERVICES INC HI TECH PHARMA - LIDOCAINE HCL ANDA 40-837, APRVL RECS Signature/ Requester Subject
Page 175 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/09/2011 2011-3496 05/11/2011 06/09/2011 ORA/ORM/ ORA/ORM/ ORA/OE/ ORA/OE/ 2011-3497 2011-3498 05/11/2011 06/09/2011 05/11/2011 06/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3499 2011-3500 05/11/2011 06/09/2011 05/11/2011 06/09/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3501 05/11/2011 06/09/2011 2011-3502 05/11/2011 06/09/2011 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-3503 2011-3504 2011-3505 2011-3506 05/11/2011 06/09/2011 05/11/2011 07/19/2011 05/11/2011 06/09/2011 05/12/2011 06/10/2011 ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/DET-DO/DCB/ OC/OM/OMP/DDM/ Doe J LISA COCKRELL TETRA CORE DKT 1980N-0208 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ BEN WEST LUCE FORWARD ATTY RICHARD W SIERGIEJ BAYER MATERIAL SCIENCE LLC INDIVIDUAL RECS UNITED BRANDS CO INC - JOOSE CAFFEINATED ALCOHOLIC BEVERAGE RECS VALSPAR CORP - FCN 1039 GAILL LESSICK LACHMAN CONSULTANT SERVICES, INC. PETER S HERRICK PETER S KERRICK PA ATTY AT LAW LIST OF ALL DOMESTIC & FOREIGN INSP FOR DUG CO & BIORESEARCH MONITORING - 4/1-30/11 T & SALES CO LLC - BULLETINS, MANUALS, WARRANTS, ETC CARTER DILLARD ANIMAL LEGAL DEFENSE FUND JONATHAN WILLIAMS UNIV OF GEORGIA DEPT OF ECONOMICS EGG LAYING HENS IN COMMERCIAL PRODUCTION FACILITIES, TX - EIRS 1/09 TO PRESENT APRVL LTRS CONTAINING PARAGRAPH IV PATENT CERTIFICATION 1985 TO 2011 FDA/OMPT/CDRH/OCER/DFOI/ KEITH A BARRITT FISH & RICHARDSON PC RAJKUMAR VINNAKOTA SHORE CHAN BRAGALONE LLP WELLDOC INC - DIABETESMANAGER SYS, DIABETESMANGER-RX SYS K1000666 TYRX PHARMA INC - K052864, K053656, K063091, ETC Action Office Signature/ Requester LATHAM & WATKINS CORI SCHRADER BIOQUALITY VACCINE, BIOLOGICS, DRUG MFRS, ETC - 483S 9/10 TO PRESENT Subject
Page 176 of 1132

Total Records: 12455 Control # 2011-3507 2011-3508 Recd Date / Due Date 05/12/2011 06/10/2011 05/12/2011 06/10/2011 2011-3509 05/12/2011 06/10/2011 2011-3510 2011-3511 2011-3512 2011-3513 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3514 05/12/2011 06/10/2011 2011-3515 05/12/2011 06/10/2011 2011-3516 05/12/2011 06/10/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ CBER/OCTMA/DDOM/ALFB/ CVM/OCD/ ORA/OCI/ ORA/OCI/ ORA/P-FO/SAN-DO/SFCB/ 2011-3517 05/12/2011 06/10/2011 CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MICHAEL REY CBS NEWS CHARLES E RUNELS JR MD, WEST MOBILE, AL - 483S 5/12/06, 9/21/06, 8/2/06 DAVID DEKOK VIN NETWORK NEWS SERVICES EVERGLO NATURAL VETERINARY SERVICES - WARNING LTR WEST NILE VIRUS CORR ORA/NE-FO/NYK-DO/NYDCB/ SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP THOMAS J HERTEN ARCHER & GREINER ATTY DCI MANAGEMENT GROUP LLC, QUEENS VILLAGE, NY EIRS, 483S, CO RESP PAST 5 YRS T&M IMPORTS LLC - SICILIAN LIME JUCIE & SICILIAN LEMON JUCE PRODS INVESTIGATION 6/3/10 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ WILSON, ROBERT R REBECCA MOCK GILEAD SCIENCES INC ASHLEA RICCI CONMED LINVATEC CORP JEFF BARRUS VESTAN MEDICAL IMAGING FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OC/OM/OMP/DDM/ Signature/ Requester STACEY STOVER LATHAM & WATKINS LLP GERALD T DONOGHUE LAW OFC OF GERALD T DONOGHUE GERALD T DONOGHUE LAW OFC OF GERALD T DONOGHUE SENTINELLE - VANGUARD BREAST MRI AUXILIARY TABLE/TABLETOP CHANNEL COIL ARRAY FOR GE MRI SYS K100113 SENTINELLE VANGUARD BREAST MRI AUXILIARY TABLE WITH 8 CHANNEL COIL FOR GESIGNA SYS - K060873 PROCTOR & GAMBLE DOG FOOD PLANT, LOUISBURG, OH EIRS, 483S, 484, 6/29/10 TO 83/10, ETC HOSPIRA PTY AUSTRLIA LTD, MULGRAVE, AUSTRALIA 483S TWO MOST RECENT BIOMET SPORTS MEDICINE, WARSAW, IN - SLEEVE WITH ZIPLOOP FIXATION DVC K101063 COVIDIEN - LYMPHAZURIN NDA 18-310 APRVL HISTORY, LTRS, RVWS, ETC 7/29/81 Subject DKT FDA-1997-S-0039
Page 177 of 1132

Total Records: 12455 Control # 2011-3518 2011-3519 Recd Date / Due Date 05/12/2011 06/10/2011 05/12/2011 06/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-3520 05/12/2011 07/25/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ 2011-3521 2011-3522 2011-3523 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ OC/OER/OPA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/OCI/ ORA/OCI/ 2011-3524 05/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ LIANE LaROCHELLE APEX BIOTECHNOLOGY CORP - AUTOSURE VOICE 3 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ STEVENSON, RICHARD MICHAEL A FERRARA JR FERRARA LAW FIRM TIM SANDLER NBC NEWS AVEENO - ACTIVE NATURALS SKIN BRIGHTENING DAILY SCRUP CMPLNTS MALUM KINETICS - LTRS, MEMOS, MINS 1/24/11, 1/6/11, 12/15/11, ETC FOOD DEFECT HANDBOOK MARGARET A KING WICKER SMITH ET AL REALIZE ADJUSTABLE GASTRIC BAND - MDRS, MEDICAL LITERATURE, RECALLS, ETC Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester JEFFERY C LOWE Mayer Brown LLP JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC TOVATE - "JACKED OR JACKED 3D OR JACK 3D", "1-MR OR 1 MR OR 1.M.R", "CELLUCOR C4 EXTREME" OR "CELLUCOR CR". AERS Subject FCN 342
Page 178 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/10/2011 2011-3525 05/12/2011 06/10/2011 2011-3526 2011-3527 2011-3528 2011-3529 2011-3530 2011-3531 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP PATRICIA L. REGENYE Celgene Corporation JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP MARIA K. LETELLIER WINSTON AND STRAWN LLP ROBERT HOLMES, FORSYTH MED SPEC, WINSTON SALEM, NC - 483, EIRS, RECALL RECS 9/05 TO PRESENT KLOCKER PENTAPLAST OF AMERICA INC, GORDONSVILLE, VA - 483, RECALL, EIR 10/08 TO PRESENT FLUOROSEAL, ALLENTOWN, PA - EIR, 483, RECALL 10/08 TO PRESENT WHITEHOUSE ANALYTICAL LABS, WHITEHOUSE, NJ - EIRS, 483S, RECALL RECS 10/08 TO PRESENT PERFECSEAL A (BEMIS CO), PHILADELPHIA, PA - RECALL, EIR, 483 10/08 TO PRESENT DIAMOND FOODS; BEN & JERRYS; BREYERS; KENS FOODS; NESTLE JUICY JUICE; SUNSWEET ANTIOXIDANT BLEND DRIED FRUIT MIXES - WARNING LTRS, PETITIONS 2001 TO PRESENT PHENYTOIN - PATIENT RX INFORMATION, AER MINEGAR, LARRY Subject BLOOD GLUCOSE MONITORING SYS & TEST STRIP K102481 MEDX SET LTD - LIGHTLY DD INFUSION SET K110282
2011-3532
05/12/2011 06/10/2011
2011-3533
05/12/2011 06/10/2011
KRISTA E. BIANCO FINNEGAN HENDERSON ET AL
JIANGSU HANSOH PHARMACEUTICAL CO LTD, PEOPLES REPUBLIC OF CHINA - GEMCITABINE HCL 483 1/06 TO PRESENT
2011-3534
05/12/2011 06/10/2011
DAVID P. LOWE Jacquart and Lowe
XOLAIR - SAFETY RVW 7/16/09
2011-3535 2011-3536
05/12/2011 06/10/2011 05/12/2011 06/10/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WOLTERS KLUWER LAW & CanReg, Inc.
DAILY LOG WEEK 4/18-22/11 DAILY LOG WK 4/18-22/11
Page 179 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester BUSINESS 2011-3537 2011-3538 2011-3539 2011-3540 2011-3541 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 05/12/2011 06/10/2011 2011-3542 2011-3543 2011-3544 2011-3545 2011-3546 05/12/2011 06/10/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3547 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3548 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3549 05/13/2011 CBER/OCTMA/DDOM/ALFB/ JEFFREY PETROZZINO WARFARIN REVERSAL - FRESH FROZEN PLASMA (FFP) ADMINISTRATION RECS MARIE ALLEN HADGE GTC BIOTHERAPEUTICS INC SANOFI-CHIMIE, VRAMON, FRANCE - EIRS MARIE ALLEN HADGE GTC BIOTHERAPEUTICS INC SANOFI-CHIMIE, CEDEX, FRANCE - EIRS FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ KENDLE REGULATORY AFFAIRS LYNNE SKELLEY FEDSOURCES INC LYNNE SKELLEY FEDSOURCES INC LYNNE SKELLEY FEDSOURCES INC MARIE ALLEN HADGE GTC BIOTHERAPEUTICS INC BOOZ-ALLEN & HAMILTON INC - CONTRACT HHSF223200950002I, TASK ORDER #HHSF22301002T BOOZ-ALLEN & HA MILTON INC - CONTRACT HHSF223200950002I TASK ORDER #HHSF22301003T GLOBAL NET SERVICES INC - CONTRACT HHSF223200950015I, TASK ORDERR #HHSF22301002T SANOFI-AVENTIS, ANAGNI , ITALY - EIRS WASHINGTON INFORMATION SOURCE DAILY LOG WK 4/18-2/11 DOMINION GROUP INC DAILY LOG WK 4/18-22/11 INFORMATION ACCESS DAILY LOG WK 4/18-22/11 FOI SERVICES INC DAILY LOG WK 4/18-22/11 Center for Regulatory Services, Inc. DAILY LOG WK 4/18-22/11 DAILY LOG WK 4/18-22/11 Subject
Page 180 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/13/2011 2011-3550 2011-3551 2011-3552 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 2011-3553 2011-3554 05/13/2011 06/13/2011 05/13/2011 06/13/2011 2011-3555 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3556 2011-3557 05/13/2011 06/13/2011 05/13/2011 06/13/2011 2011-3558 2011-3559 05/13/2011 06/13/2011 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3560 2011-3561 05/13/2011 06/13/2011 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WIEBE, PATRICK FDA/OF/CFSAN/OCD/EOS/ GREGORY SOWER ENVIRON INTERNATIONAL CORP DUPONT CHEMICAL SOLUTIONS ENTERPRISE - FCN 206, FCN 311 & FCN 338 INTELGENX CORP - CPI-300 COMPLETE RESP LTR 1/10 TO 2/10 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ AARON TVEDT PIVOTAL HEALTH SOLUTIONS MARY B SZALKOWSKI PRISMA CORP INDAPAMIDE; PERINDOPRIL - AERS 2/3/11 TO PRESENT ATT-300 DVC - K944699 FDA/OMPT/CDRH/OCER/DFOI/ SHERI O COVINGTON K&L GATES MICHAEL REY CBS EVENING NEWS CYTORI THERAPEUTICS INC - CYTORI LIPOPLASTY SYS WITH CELASE REAGENT K063235 CORR, MINS, RVWS, ETC PATIENT ADVOCACY COUNCIL IRB, MOBILE AL - EIR, 483, COMM 9/18-21/06 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ KAREN MUNOZ DOLAN LAW OFCS LINDA LORETZ PHD PERSONAL CARE PRODUCTS COUNCIL ANNEMIEKE M TENMIS KANNER & WHITELEY LLC ANIMAL PLACENTAL PROTEIN, COAL TAR, MORPHOLINE, ETC - COMPANY NAME, TYPE OF PROD, RPT DATE, ETC ABBOTT LABS - DEPAKOTE TABS (DIVALPROEX SODIUM) NDA 18-723, NDA 21-168 RESP TO DDMAC LTR 1/22/09 STROGER HOSPITAL RADIOLOGY DEPT - CMPLNTS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ HUDAK, JOHN JIN KEE NG AL MEDICAL SHER S KUNG PERKINS COIE MULTI-PURPOSE HEALTH DVC QUALITY STANDARDS K093322 1/1/08 TO 12/30/10 NEUROCOM INTERNATIONAL INC - EQUITEST K851744, DUAL FORCEPLATE K863443, BALANCE MANAGER K946229, ETC Action Office Signature/ Requester COMPARA BIOMEDICAL 2010 REQUESTS INVOLVING POLITICAL APPOINTEES Subject
Page 181 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3562 2011-3563 2011-3564 2011-3565 2011-3566 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-3567 05/13/2011 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3568 2011-3569 2011-3570 2011-3571 2011-3572 2011-3573 2011-3574 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 05/13/2011 06/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOI REQUESTS 5/9-13/11 CLOSED FOI REQUESTS 5/2-6/11 FOI SERVICES INC FOI CLOSED REQUESTS - 5/2-6/11 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ Doe J PAUL TRUJILLO SYNERON INC CLOSED FOI REQUESTS 5/9-13/11 REACTION SYS - K090221 FDA/OMPT/CDRH/OCER/DFOI/ DIANA RUSK COHEN ARNALL GOLDEN GREGORY LLP CMPLNT 119014 STEMPRO MSC SFM MEDIUM - K103302 JASON M KANE MD MS RUSH UNIVERSITY MEDICAL CTR FENOLDOPAM, CORLOPAM (FENOLDOPAM MESYLATE) AERS FERNALD, KENNETH LEWIS, SASKIA C LIST OF DRUGS APRVD WITH PRIORITY RVW STATUS 2000-2009 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ CORONADO, RICHARD KIMBERLY BAXTER AFFYMAX INC KIMBERLY BAXTER AFFYMAX INC MAMMOGRAPHY FACILITIES - ACCREDITATION OR RENEWAL APPL RECS NEKTAR THERAPEUTICS, HUNTSVILLE, AL - EIRS 2003 TO 2010 SENTRY BIOPHARMA SERVICES INC, INDIANAPOLIS, IN EIRS 2003 TO 2010 2010 FOI REQUESTS Signature/ Requester Subject
Page 182 of 1132

Total Records: 12455 Control # 2011-3575 Recd Date / Due Date 05/13/2011 06/13/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3576 2011-3577 05/16/2011 06/14/2011 05/16/2011 06/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3578 05/16/2011 06/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3579 2011-3580 05/16/2011 06/14/2011 05/16/2011 06/14/2011 2011-3581 2011-3582 05/16/2011 06/14/2011 05/16/2011 06/14/2011 2011-3583 2011-3584 2011-3585 2011-3586 05/16/2011 06/14/2011 05/16/2011 07/13/2011 05/16/2011 06/14/2011 05/16/2011 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC ARUN K CHOPRA ABH NATURES PRODUCTS INC, FARMINGDALE, NY - EIRS, CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MEDTRONIC VASCULAR - MEDTRONIC AVE BRIDGE EXTRA SUPPORT OVER THE WIRE RENAL STENT SYS P020007 APRVL RECS COOK MEDICAL INC - FORMULA BALLOON-EXPANDABLE RENAL STENT SYS P100028 APRVL RECS FENWAL - AMICUS SEPARATOR SYS BK100044 POST SUBMISSION CORR CIBA EXPERT SERVICES - FCN 914 CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC NATHANIEL ENOS CONWAY HOMER & CHINCAPLAN PC IMAGYN MEDICAL - MICROSPAN HYSTEROSCOPE K961688 COCA-COLA CO, COLORMATRIX CORP, KOSA ANTHRANILAMIDE - FCN 137 INDIVIDUAL RECS FOI SERVICES INC APOTEX, TORONTO, ONTARIO, CANADA - EIRS, 483S, CO RESP, ETC 8/1-31/09 BRUNO 05-A-2947, MICHAEL DR GILBERT R WEINER ADVANCED PHARMA CO LTD SFBC INTERNATIONAL - EIR 3/9/05-5/2/05 PLAVIX - AERS BALDY, PATRICIA S Signature/ Requester Subject ESTRATEST HS (ESTERIFIED ESTROGENS & METHYLTESTOSTERONE) TABS - LABL AS IN PHYSICIANS DESK REFERENCE 1995 EDITION
Page 183 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/14/2011 2011-3587 05/16/2011 06/14/2011 2011-3588 2011-3589 2011-3590 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/16/2011 06/24/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/OCI/ ORA/OCI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-3591 2011-3592 2011-3593 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/16/2011 06/14/2011 CTP/OD/ CTP/OD/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ MATTHEW M HULL CONSENSUS ORTHOPEDICS ALISON MACPHERSON FISH VET GROUP GREGORY N CONNOLLY DMD MPH HARVARD SCHOOL OF PUBLICH HEALTH 2011-3594 05/16/2011 06/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-3595 05/16/2011 06/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3596 05/16/2011 06/14/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC EGON FAULHABER SURGICAL INSTRUMENTS PINZETTEN NON STICK BIPOLAR FORCEPS, BIPOLAR FORCEPS, MONOPOLAR FORCEPS K101080 CATHERINE LARKIN BLOOMBERG NEWS ACTEMRA (TOCILIZUMAB) - AERS JOHN GILLINGS COLLINS STEWART LLC LUITPOLD - GEM21S CORR 2009 TO PRESENT MODIFIED RISK TOBACCO PRODS - NUMBER OF APPLS RECEIVED FOR RVW 4/11 CONSENSUS ORTHOPEDICS INC - CORTICELLOUS BONE SCREW K953198 AZAMETHIPHOS SUMMARY RPT 1999 CVM/OCD/ ORA/NE-FO/NWE-DO/NWECB/ Action Office Signature/ Requester TISHCON CORP BRUCE W FELMLY MCLANE GRAF RAULERSON & MIDDLETON KRISTI O SMEDLEY Center for Regulatory Services, Inc. DEBORAH C ATTWOOD Keller and Heckman LLP STANLEY R GOODMAN GOODMAN & SAPERSTEIN JOHNSON & JOHNSON, LIFESCAN INC - - BLOOD GLUCOSE TEST STRIPS MDRS 1/04 TO 4//30/08; H&H, DOOR TO DOOR MEDICAL SUPPLY INC - AFFIDAVITS, ATTACHEMTS, PHOTOGRAPHS 3/7/05, ETC Subject 483S MOST RECENT SOUHEGAN MANAGEMENT CORP, SALEM, NH - EIR 10/56/09, EXHIBITS 1-8, ATTACHMENTS 1-6; EIR 11/17-23/10, EXHIBITS 1-7, 2 ATTACHMENTS SHANDONG SHENGLI, JINAN CITY, SHANDONG, CHINA EIRS, 483S TELLES LLC - FCN 943
Page 184 of 1132

Total Records: 12455 Control # 2011-3597 2011-3598 2011-3599 2011-3600 2011-3601 2011-3602 2011-3603 2011-3604 2011-3605 Recd Date / Due Date 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/16/2011 06/14/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3606 05/17/2011 06/15/2011 2011-3607 05/17/2011 06/15/2011 2011-3608 2011-3609 05/17/2011 06/15/2011 05/17/2011 06/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-3610 05/17/2011 06/15/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ CAITRONA RYAN BAYLOR UNIV MEDICAL CENTER ETANERCEPT, INFLIXIMAB, ADALIMUMAB, ETC - AERS ORADELL ANIMAL HOSPITAL INC ORA/SW-FO/KAN-DO/COMP/ ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/DEN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ GUTTING, RICHARD E DAN PADEN PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS ALEXANDER SHAPOVAL LAW OFC OF ALEXANDER L SHAPOVAL FW BRYCE CO, IAN W MOORES - FOREIGN FOOD FACILITIES REGISTERED IN THE US MERRICK INC - JR TEXAS TAFFY PET TREAT ANALYTICAL RESULTS, COLLECTION RPTS 1/28/11 FARM WORKERS APPLICATION OF BLU-KOTE TO PIGS INVESTIGATION RECS ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC AMANDA W BRIDGES E PONENT JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP PAUL HARDMAN IRIDEX CORP JUDY F GORDON CLINREG CONSULTING SERVICES INC TRUSOPT - CHEMISTRY & PHARMACOLOGY RVWS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CORDIS CORP - PALMAZ BALLOON-EXPANDABLE STENT P890017/S010 BOSTON SCIENTIFIC CORP - EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYS P060006 MOLTENO GLAUCOMA IMPLANT - K890598, K902489; BAERVELDT GLAUCOMA IMPLANT - K905129, K955455 PLASTICS TECHNOLOGY LABORATORIES INC, PITTSFIELD, MA - EIRS, 483S, RECALLS 10/08 TO PRESENT STERIS ISOMEDIX SERVICES INC, SOUTH PLAINFIELD, NJ EIRS, 483S, RECALLS 10/08 TO PRESENT MDRS MW5015543, MW5017084, MW5017755, ETC Action Office FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC Signature/ Requester Subject COCA-COLA CO, CLARIANT LIFE SCIENCE MOLECULES (AMERICA) INC, INVISTA SAR 1 - FCN 465 GYRUS ACMI - INVISIO DIGITAL HYSTEROSCOPE K092278
SIMILASAN - EYE DROPS TESTING, INVESTIGATION
Page 185 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3611 05/17/2011 06/15/2011 2011-3612 2011-3613 2011-3614 2011-3615 2011-3616 2011-3617 2011-3618 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/17/2011 06/15/2011 2011-3619 05/17/2011 06/15/2011 2011-3620 2011-3621 2011-3622 2011-3623 05/17/2011 06/15/2011 05/17/2011 06/15/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MITCHELL G21465, PAUL STEVEN F WALTER RTU PHARMACEUTICALS LLC NOVARTIS - TRANSDERM SCOP (SCOPOLAMINE) NDA 17874 - SBA DOMINION GROUP INC ARTIFICIAL TRANS FATS - RECS CanReg, Inc. FOI DAILY LOG 4/25-29/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 4/25-29/11 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 4/25-29/11 ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Center for Regulatory Services, Inc. CARLA SCARMAZZI KING & SPALDING FOI DALY LOG 4/25-29/11 DKT 1985G-0335 KENDLE REGULATORY AFFAIRS FOI DAY LOG 4/25-29/11 FOI SERVICES INC FOI DAILY LOG WK 4/25-29/11 INFORMATION ACCESS FOI DAILY LOG 4/25-29/11 MICHAEL O. BRADLEY BRADLEY KOUNTRY ACRES FOI DAILY LOG 4/25-29/11 HARMONY CHEMICAL ON STRAWBERRY CROPS MIKE HUGHLETT MINNEAPOLIS STAR TRIBUNE B & M CO - TURMERIC RECALL 4/15/11 Signature/ Requester AT DALLAS Subject
Page 186 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3624 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3625 05/18/2011 07/05/2011 2011-3626 2011-3627 2011-3628 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3629 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3630 2011-3631 05/18/2011 06/16/2011 05/18/2011 06/16/2011 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3632 05/18/2011 06/16/2011 2011-3633 2011-3634 05/18/2011 06/16/2011 05/18/2011 06/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KIMBERLY JESSICA ROY ARTICLE ONE PARTNERS DONNA DESHIELDS MORROW ROMINE & PEARSON LAW OFCS BAILEY MEDICAL ENGINEERING - NATURE III BREAST PUMP RECS 1987 KONE INSTRUMENTS INC - BURDICK MEDIC 4 DEFIBRILLATOR KK853354 HAMILTON, LEROY L ERCHONIA MEDICAL - K082609 Doe J VASSILIOS CHRISTODOULOPOULOS SANDOZ CANADA INC. NDA 22-359 - RECS INDIVIDUAL RECS Doe J PLAVIX, CRESTOR, COUMADIN, ETC - AERS DOMINION GROUP INC FDA/OMPT/CDRH/OCER/DFOI/ WIEBE, PATRICK FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ REED TECKENBROCK WINCKLER & HARVEY LLP JILLIAN AVERY REVISION MILITARY LTD CARDIUM THERAPEUTICS INC - RESP TO FORM FDA 3541 MOST RECENT IMPAX LABS - DOXYCYCLINE ANDA 20-065 SBA LASER EQUIPMENT INSTALLED, REGISTERED IN 2010 EMINENT SPINE - K090064 MEISEL, LEE B MERCK - PROSCAR, PROPECIA AERS 1998 TO 2010 Signature/ Requester Subject
Page 187 of 1132

Total Records: 12455 Control # 2011-3635 2011-3636 2011-3637 2011-3638 2011-3639 Recd Date / Due Date 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 2011-3640 05/18/2011 06/16/2011 2011-3641 2011-3642 2011-3643 2011-3644 2011-3645 2011-3646 2011-3647 2011-3648 2011-3649 2011-3650 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 CVM/OCD/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SEA-DO/SCB/ CVM/OCD/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester HELLEN A OKETCH PHD USP PHARMACOPEIA HELLEN A OKETCH PHD USP PHARMACOPEIA HELLEN A OKETCH PHD USP PHARMACOPEIA HELLEN A OKETCH PHD USP PHARMACOPEIA SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES SHI PANG UNIV OF HOUSTON DEPT OF PURE ENCAPSULATIONS INC, SUBBURY, MA - EIR, 483 1/08 TO 5/11 DAWE'S LABORATORIES LTD - PRYFERM RECS ARIZONA NUTRITIONAL SUPPLEMENTS, CHANDLER, AZ EIR, 483 1/05 TO 5/11 NATURAL FACTORS, EVERETT, WA - EIR, 483 1/05 TO 5/11 STANDARD PROCESS INC, PALMYRA, WI - 483, EIR 1/05 TO 5/11 VITANICA INC, TUALITIN, OR - EIR, 483 1/05 TO 5/11 GAIA HERBS, BREVARD, NC - 483, EIR 1/05 TO 5/11 NEW CHAPTER, BRATTLEBORO, VT - EIR, 483 1/07 TO 5/11 CADCO INC - AUREOMYCIN, BACITRACIN SINCE, TYLOSIN, ETC RECS AL LABORATORIES INC (ALPHARMA INC) - SOLU-TRACIN 50, BMD (BACCITRACIN METHYLENE DISALICYLATE) RECS BIOTICS RESEARCH CORP, ROSENBERG, TX - EIR, 483 1/07 TO 5/11 AYUSH HERBS INC, REDMOND, WA - EIR, 483 1/1/07-5/5/11 CHINESE SALVIA - CAERS 1/05 TO 5/11 ZEAXANTHIN - CAERS 1/05 TO 5/11 KRILL OIL - CAERS 1/05 TO 5/11 Subject BLACK PEPPER - CAERS 1/05 TO 5/11
Page 188 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester HISTORY 2011-3651 2011-3652 2011-3653 2011-3654 2011-3655 2011-3656 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 05/18/2011 06/16/2011 2011-3657 2011-3658 05/18/2011 06/16/2011 05/18/2011 06/16/2011 2011-3659 05/18/2011 06/16/2011 2011-3660 05/18/2011 06/16/2011 2011-3661 05/18/2011 06/16/2011 2011-3662 05/18/2011 06/16/2011 2011-3663 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ GROH, TERRY CVM/OCD/ CVM/OCD/ CVM/OCD/ CVM/OCD/ CVM/OCD/ ORA/P-FO/SEA-DO/SCB/ CVM/OCD/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES SHI PANG UNIV OF HOUSTON DEPT OF HISTORY MICHAEL D. LEVIN HEALTH BUSINESS STRATEGIES SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY HOFFMAN-LA ROCHE INC (ROCHE CHEMICAL DIVISION) OPTIMUM VITAMIN NUTRITION RECS MERCK & CO INC (MERCK ANIMAL HELATH DIVISION) CLEAN CUTS RECS SENSA - AER HERCULES INC - HERCULES CELLULOSE GUM RECS THORNE RESEARCH INC, DOVER, ID; SANDPOINT, ID - 483, EIR 1/08 TO 5/11 ELI LILY & CO (ELANCO PRODUCTS) - RUMENSIN, TYLAN RECS FLAVINE INTERNATIONAL INC - FLAVINE RECS ENZYMATIC THERAPY INC, GREEN BAY, WI - EIR, 483 1/09 TO 5/11 DEGUSSA CORP - DL-METHIONINE RECS WISE WOMAN HERBALS, CRESWELL, OR - EIR, 483 1/07 TO 5/11 JHS NATURAL PRODUCTS LLC, EUGENE, OR - EIR, 483 1/05 TO 5/11 RHG & CO INC, MIDDLETOWN, CT - EIR, 483 1/05 TO 5/11 METAGENICS INC, GIG HARBOR, WA - EIR, 483 1/07 TO 5/11 Subject
Page 189 of 1132

Total Records: 12455 Control # 2011-3664 Recd Date / Due Date 05/18/2011 06/16/2011 2011-3665 05/18/2011 06/16/2011 2011-3666 05/18/2011 06/16/2011 2011-3667 05/18/2011 06/16/2011 2011-3668 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3669 05/18/2011 06/16/2011 2011-3670 05/18/2011 06/16/2011 2011-3671 05/18/2011 06/16/2011 2011-3672 2011-3673 05/18/2011 06/16/2011 05/18/2011 06/16/2011 2011-3674 05/18/2011 06/16/2011 2011-3675 2011-3676 05/18/2011 06/16/2011 05/18/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ CVM/OCD/ CVM/OCD/ ORA/CE-FO/BLT-DO/CB/ CVM/OCD/ CVM/OCD/ CVM/OCD/ SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY JOHN WALSH JAMES ALEXANDER CORP SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY JOHN WALSH JAMES ALEXANDER CORP MICHAEL D. LEVIN TECTUBES USA, VINELAND, NJ - RECALL, EIR, 483 10/08 TO PRESENT DOUGLAS LABS, PITTSBURGH, PA - EIR, 483 1/07 TO 5/11 ZINPRO CORP - ZINPRO RECS APLICARE, PRICHARD, WV - RECALL, EIR, 483 10/08 TO PRESENT WMB CORP - SUPER KMS RECS VPO INC - CLTC (CHLORTETRACYCLINE) RECS SMITHKLINE ANIMAL HEALTH PRODUCTS - STAFAC (VIRGINIAMYCIN) FOX CO - FAVOMYCIN RECS Doe J CVM/OCD/ CVM/OCD/ CVM/OCD/ Action Office CVM/OCD/ Signature/ Requester SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SHI PANG UNIV OF HOUSTON DEPT OF HISTORY SCHERING CORP - GARASOL (GENTAMICIN SULFATE0, ASL RECS ISR 2011027903 SALSBURY LABS - 3-NITRO RECS PREMIER MALT PRODUCTS INC - ZYMO-BEST RECS Subject PFIZER INC - BANNINTH RECS
Page 190 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/16/2011 2011-3677 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3678 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3679 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3680 2011-3681 05/18/2011 06/16/2011 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3682 05/18/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ 2011-3683 2011-3684 2011-3685 05/19/2011 06/17/2011 05/19/2011 06/17/2011 05/19/2011 06/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MILLICORE AB - DIGIVENTCHEST DRAINAGE SYS K062302 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MAUNA KEA TECHNOLOGIES - CELLVIZIO WITH CONFOCAL MINIPPROBE K061666 PENTAX - CONFOCAL LASER SYS K042740 LINDA TURLEY TURLEY LAW FIRM JOHNSON & JOHNSON INC, SANDOZ INC, ALZA CORP FENTANYL PATCH WARNINGS, RECALLS, AERS, ETC ORA/CE-FO/DET-DO/DCB/ RONALD F. DeNARDIS DENARDIS & MILLER PC GEORGE R. THOMPSON THOMPSON & ONEIL AMARYL NDA 20-496 - APRVL, LBLG INDIVIDUAL RECS JOAN STITT MERCK & CO., INC. MERCK & CO - ISENTRESS (RALTEGRAVIR) ISRS 61329654, 61897672 ROBERT M. KLEIN, MD ASTHMA & ALLERGY MEDICAL ASSOCIATES LIST OF NON-NARCOTIC COUGH, COLD, ALLERGY PRODS APRVD BY THE FDA Action Office Signature/ Requester HEALTH BUSINESS STRATEGIES ALEXANDER MIRONOV TIGRIS PHARMACEUTICALS INC PROVENTIL HFA (ALBUTEROL SULFATE) SBA NDA 20-503 Subject
Page 191 of 1132

Total Records: 12455 Control # 2011-3686 2011-3687 2011-3688 Recd Date / Due Date 05/19/2011 06/17/2011 05/19/2011 06/17/2011 05/19/2011 06/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3689 05/19/2011 06/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ RICHARD PATTERSON OWEN PATTERSON & OWEN CEDARS SINAI MEDICAL CENTER, LOS ANGELES COUNTYUSC MEDICAL CENTER, GELENDALE AVENTIST MEDICAL CENTER, ETC - GE LIGHTSPEED RT 4-8-16-SLICE CT MATCHINE, GE LIGHTSPEED VCTZ 64-SLICE CT MACHINE, GE DISCOVERY ST 16-SLICE SYS TECHNICAL & SAFETY RECS, VENDOR QUALITY ASSURANCE, ETC CHARLES E RUNELS JR MD (LIFESTREAM MEDICAL), MOBILE, AL - EIRS 5/8-12/06, 9/11-21/06 MYLAN INC, WV, IL, TX, ETC - EIRS, 483S 1/11 TO PRESENT MCCANN, JOE SEAN PARK JOHNSON & JOHNSON CONSUMER COMPANIES EMANUELLE LEMAIRE SOGEVAL LABORATORIES INC MICHAEL L DIAMOND ASBURY PARK PRESS INC MCNEIL HEALTHCARE LLC, LAS PIEDRAS, PR - 10/22/09 TO 1/8/10 MCNEIL PPC INC, FORT WASHINGTON, PA - 5/19/10 TO 4/30/10 JOHNSON & JOHNSON MERCKK CONSUMER, LANCASTER, PA - EIRS, TRANS, INTERVIEW MEMOS, 6/22/10 TO 7/9/10 PHARMACEUTICAL CO - WARNING LTRS 1/01 TO PRESENT AGRICOLA ZARAGOZA, ALLENDE, MEXICO - EIRS, 483S 7/08 RHYTEC INC - PORTRAIT PLASMA SKIN RESURFACING SYS RPTS, LTRS, TESTING, ETC APPLIED LABORATORIES INC, COLUMBUS, IN - EIRS, 483S, CO RESP 1/03 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DAVID E VARIO FOSTER DAVID E VARIO FOSTER LOIS ZIEBOL PURSUIT VASCULAR BAXTER - CLEARLINK ANTIMICROBIAL LUER ACTIVATED SYS K072576; ICU MEDICAL - TEGO NEEDLE FREE ACCESS DVC K040710; MEDEX - STOPCOCK & LUER LOCK PLUG K954970, ETC BAXTER HEALTHCARE - DUAL LUER LOCK CAP K981318 Subject CATHETER CONNECTIONS INC - DUALCAP K093229
2011-3690 2011-3691
05/19/2011 06/17/2011 05/19/2011 06/17/2011
ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
MICHAEL REY CBS EVENING NEWS
2011-3692
05/19/2011 06/17/2011
2011-3693 2011-3694
05/19/2011 06/17/2011 05/19/2011 06/17/2011
CMPLNT 120483
2011-3695 2011-3696 2011-3697
05/19/2011 06/17/2011 05/19/2011 06/17/2011 05/19/2011 06/17/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/
MICHAEL L DIAMOND ASBURY PARK PRESS INC CLAIRE LUGO LINDOW STEPHENS TREAT LLP LAWRENCE J SMITH BENSON ERTOLDO BAKER ET
Page 192 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester AL 2011-3698 2011-3699 05/19/2011 06/17/2011 05/19/2011 06/17/2011 2011-3700 05/19/2011 06/17/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3701 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3702 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-3703 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3704 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3705 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3706 05/19/2011 06/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ EHRENPREIS MD, ELI D ACCUTANE - ISRS 5821094, 5821088, 5821084 ETC MATTHEW WHITAKER WESTLAW COURTEXPRESS SR AHMAD - FLUOROQUINOLONE SAFETY RVW MATTHEW WHITAKER WESTLAW COURTEXPRESS CITIZEN PETITION 2005P-0205/CPI 11/23/05 MATTHEW WHITAKER WESTLAW COURTEXPRESS M TIERNE - FLUOROQUINOLONE LBLG RVW P.R. NOBELS VITAL SCIENTIFIC, N.V. VITAL SCIENTIFIC BV, THE NETHERLANDS - EIR 6/28/047/1/04 CLARK G. SULLIVAN ARNALL GOLDEN GREGORY LLP PURDUE PHARMA - DILAUDID, DILAUDID HP FORM 3542, 3542A FOR US PATENT 6,589,960 NGUYEN, THOMAS ORA/CE-FO/BLT-DO/CB/ Doe J KEVIN O'ROURKE FDANEWS LIST OF PHARMACEUTICAL BIOLOGICS, MEDICAL DVC MFG, FOOD MFG & CLNCL TRIAL FACILITIES IN THE US & OUSIDE THE US - 483S 4/1-30/11 CONDYLOX (PODOFILOX) NDA 19-795 MEDICAL RVW, SUMMARY RVW LTR, NCE (NEW CHEMICAL ENTITY) DETERMINATION LTR CMPLNT 119564 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3707 05/19/2011 06/17/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-3708 2011-3709 2011-3710 2011-3711 05/19/2011 06/17/2011 05/19/2011 06/17/2011 05/19/2011 06/17/2011 05/20/2011 06/20/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-3712 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3713 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3714 2011-3715 2011-3716 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CESIDIO TEMPESTA NOVA BIOMEDICAL CESIDIO TEMPESTA NOVA BIOMEDICAL LISA HESSABI DIAZYME LABS - MODIFICATION TO DIRECT ENZYMATIC HBA1C ASSAY KIT K070734 CORRECT PLUS - K001218 GENERAL ATOMICS - HBA1C ENZYMATIC ASSAY K050178 PATTY HU TARO PHARMACEUTICALS U.S.A., INC DOW PHARM SCIENCES - CLINDAMYCIN PHOSPHATE & BENZOLY PEROXIDE GEL 10% NDA 65-443 SBA, CHEMISTRY RVW, ETC PATTY HU TARO PHARMACEUTICALS U.S.A., INC DOW PHARM SCIENCES - CLINDAMYCIN PHOSPHATE & BENZOYL PEROXIDE GEL 5% NDA 65-443 SBA, MOR, CHEMISTRY RVW, ETC ORA/CE-FO/CIN-DO/CCB/ SCOTT, LAUREN ANNA DEMKOVIC ABBOTT LABORATORIES, INC. PATTI WALLER MARLER CLARK ATTYS DAVID DION CARDINAL HEALTH OMEGA LABS INC, MOGADORE, OH - WARNING LTRS, CMPLNTS ZEZEX INTERNATIONAL INC/MOOG INC - 483 12/29/10 CORR, MINS, EMAILS, ETC SAN GAR FRESH CUT PRODUCE, TX - LISTERIA MONOCYTOGENES OUTBREAK 2010 ELASTIC BANDAGE ENTRY #BJV-0238029-4 - TEST RESULTS Doe J CMPLNT 118593 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 06/20/2011 2011-3717 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3718 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3719 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3720 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3721 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3722 05/20/2011 06/20/2011 2011-3723 2011-3724 05/20/2011 06/20/2011 05/20/2011 06/20/2011 2011-3725 2011-3726 05/20/2011 06/20/2011 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ FABIO E TARUD PROSKAUER ROSE LLP RAYMOND P ROOS UNIV OF CHICAGO/DEPT OF NEUROLOGY GUANABENZ - AERS TROJAN LATEX CONDOM - K912901 ORA/CE-FO/DET-DO/DCB/ BEACHAM, NEFERTITI HEALTHER E BORLASE BAYER & BORLASE ORA/SE-FO/ATL-DO/ACB/ MIKE GORMAN GORBEC PHARMACEUTICAL SERVICES RIVER'S EDGE PHARMACEUTICALS LLC, SUWANEE, GA EIRS 5/21/10 TO PRESENT BIO BLOOD COMPONETS INC, GARY, IN - 483, ETC 4/2529/11 JOHNSON & JOHNSON - MISSING, TAINTED, THEFT OF LEVAWUIN, ACIPHEX RPTS 2010 Doe J ZITHROMAX - AERS KRISTA E BIANCO FINNEGAN HENDERSON ET AL JIANGSU HANSOH PHARMACEUTICAL CO LTD, LIANYUNGANG HANSEN PHARMACEUTICAL CO LTD, LIANYUNGANG HAOSEN PHARMACEUTICAL CO LTD, ETC EIRS, APRVL LTRS1/06 TO PRESENT (CERTIFIED) JAMES EWING SHIRE DEVELOPMENT INC INTUNIV (GUANFACINE) EX TABS NDA 222-037 - ISR 6739254, 69222368, 6435393, ETC MARK MANSOUR AKIN GUMP STRAUSS HAUER & FELD, LLP QINGDAO JIULONG BIOPHARMACEUTICAL CO LTD, QINGDAO, CHINA - EIRS, EXHIBITS, RPTS, ETC 1/11 TO PRESENT FRATTI, JOHN Action Office Signature/ Requester SYBRON DENTAL SPECIALTIES LEVAQUIN, CIPRO & AVELOX - AERS Subject
Page 195 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3727 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3728 2011-3729 05/20/2011 06/20/2011 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3730 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3731 2011-3732 05/20/2011 06/20/2011 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3733 05/20/2011 06/20/2011 2011-3734 05/20/2011 07/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-3735 05/20/2011 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CATHERINE LARKIN BLOOMBERG NEWS MISLEADING DRUG ADS - CONSUMER CMPLNTS ANNE DAVIS SMITH BROOKS MASTERSON BUECHEL-PAPPAS ANKLE REPLACEMENT DVC - RECALL RECS NEIL R EULIANO PHD CONVERGENT ENGINEERING GIVEN DIAGNOSTIC IMAGING SYS - K010312; OLYMPUS CAPSULE ENDOSCOPE SYS - K063259 ORA/SE-FO/FLA-DO/FCB/ RUFFINI, JOSEPH MARY ANDERSON SHIRE INC SIX L'S PACKING CO - GRAPE TOMATO SALMONELLA RECALL RECS LILY - PROZAC PULVULES NDA 18-936 APRVL LTR, MOR, STATISTICAL RVW, ETC JOAN STITT (UG2CD-16) MERCK & CO., INC. SCHERING-PLOUGH (SINGAPORE) PTE LTD, SINGAPORE EIR 7/1-31/10 ORA/SE-FO/ATL-DO/ACB/ STEINFELD, ADAM DENISE RIEKER SANOFI PASTEUR DAINIPPON SUMITOMO PHARMA LTD, OITA CITY, JAPAN 483S 2005 TO PRESENT SANDOZ INC - EIR, 483, 482, ETC 3/31/08 DENISE RIEKER SANOFI PASTEUR PIRAMAL HEALTHCARE LTD, ANDHRA PRADESH, INDIA 483S 2005 TO PRESENT Signature/ Requester Subject
Page 196 of 1132

Total Records: 12455 Control # 2011-3736 Recd Date / Due Date 05/20/2011 06/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3737 2011-3738 2011-3739 2011-3740 2011-3741 2011-3742 2011-3743 2011-3744 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/20/2011 06/20/2011 05/23/2011 06/21/2011 2011-3745 2011-3746 05/23/2011 06/21/2011 05/23/2011 06/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3747 05/23/2011 06/21/2011 2011-3748 2011-3749 05/23/2011 06/21/2011 05/23/2011 OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ SHAWN H HUBER PROFESSIONAL HOSPITAL SUPPLY INC FORREST L PEPPER DEVAUGHN MITCHELL & DECLERCK PLLC LEN BRUZZESE REQUESTS FROM JOURNALISTS - CORR 2/10 PROFESSIONAL HOSPITAL SUPPLY INC, TEMECULA, CA EIRS 10/30/00-11/3/00, 1/3101-2/1/01, 4/20-29/11 RECENTLY APRVD DVCS DATABASE 2000 TO 2011 JOE R NEEL NPR NEWS SEAN HIGGINS ESQ ANDREWS & THORNTON ISRS 4816951, 4873869, M00321204, ETC FOI DAILY LOG FY 2010 TO PRESENT ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP RICK HENEGHAN RN MSN BCATV CENTURION STERILIZATION SERVICES, HOWELL, MI EIRS, 483S, RECALLS 3/09 TO PRESENT STONE INDUSTRIAL INC, COLLEGE PARK, MD - EIRS, 483S, RECALL RECS 3/09 TO PRESENT STERIPRO LABS, ITASCA, IL - EIRS, 483S, RECALL RECS 3/09 TO PRESENT MOCON INC, MINNEAPOLIS, MN - EIRS, 483S, RECALL RECS 3/09 TO PRESENT TMP TECHNOLOGIES, BUFFALO, NY - EIRS, 483S, RECALL RECS 10/08 TO PRESENT MIDWEST FILTRATION CO, CINCINNATI, OH - EIRS, 483S, RECALL RECS 10/08 TO PRESENT STERIGENICS, WILLOWBROOK, IL - EIRS, 483S, RECALL RECS 10/08 TO PRESENT DIRECTED ENERGY WEAPONS - RECS Signature/ Requester CATHERINE LARKIN BLOOMBERG NEWS Subject BAD AD PROGRAM - RECS
Page 197 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/21/2011 2011-3750 05/23/2011 06/21/2011 Action Office OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3751 05/23/2011 06/21/2011 2011-3752 05/23/2011 06/21/2011 ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-3753 05/23/2011 06/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/SJN-DO/SJCB/ 2011-3754 2011-3755 2011-3756 05/23/2011 06/21/2011 05/23/2011 06/21/2011 05/23/2011 06/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3757 2011-3758 05/23/2011 06/21/2011 05/23/2011 06/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LI, XINQUIANG FDA/OMPT/CDRH/OCER/DFOI/ ALEXANDER, JUDY ELLAONE (ULIPRISTAL ACETATE) - INVESTIGATIONAL NEW DRUG (IND) FILINGS, QUALITY ASSURANCE, PHARMACOKINETICS, ETC ASTHMARX - ALAIR P080032 FDA/OMPT/CDRH/OCER/DFOI/ GRABRECK, PERRY GEORGE R THOMPSON THOMPSON & ONEIL AMARYL NDA 20-496 - APRVL PKG, RECS, LBLG ETC (CERTIFIED) FDA/OMPT/CDRH/OCER/DFOI/ KAY GOZELSKI LBR RESEARCH INC K871292 MEDICAL BEDS - 510K SUBMISSIONS Doe J FLUOROURACIL CREAM - CMPLNT BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & ASSOCIATES LLC MARIA F MUNOZ SEADCO USA CORP ENTRY #594-0216008-5 - LAB RESULTS ENTRY #581-7519828-0 - RECS MEISEL, LEE B Signature/ Requester ASSOCIATION OF HEALTH CARE JOURNALISTS MERCK - PROSCAR ISRS 3016700-4, 3055449-9, 30767133, ETC Subject
Page 198 of 1132

Total Records: 12455 Control # 2011-3759 Recd Date / Due Date 05/23/2011 06/21/2011 2011-3760 2011-3761 05/23/2011 06/21/2011 05/23/2011 06/21/2011 2011-3762 05/23/2011 06/21/2011 2011-3763 2011-3764 2011-3765 2011-3766 2011-3767 05/23/2011 06/21/2011 05/23/2011 06/21/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ Action Office CBER/OCTMA/DDOM/ALFB/ Doe J CHRIS CELESTE EAS Consulting Group, LLC LINDA LORETZ PERSONAL CARE PRODUCTS COUNCIL MARGRET KAMEL EMORY UNIVERSITY DIVISION OF PEDIATRIC NEPHROLOGY GILBERT SCHLEIER BASE SE GILBERT SCHLEIER BASE SE PATRICIA L REGENYE Celgene Corporation PATRICIA REGENYE Celgene Corporation CYNDI A TREMBLEY HARRIS BEACH LLP NICHOLAS LOWE (CLINCIAL RESEARCH SPECIALISTS), SANTA MONICA, CA - 483S 4/02 TO 5/11 JOHN MCCARTY (MEDICAL COLLEGE OF VIRGINIA), RICHMOND, VA - 483S 12/01 TO 5/11 CIBA VISION - EXTENDED WEAR SOFT CONTACT LENSES P010019/S010 6/10/08; CIBA VISION LOTRAFILCON B&A SOFT CONTACT LENSES P010019/S010 8/6/08 APPLICATION, ATTACHMENTS MEDICAL BEDS - 510K REQUIREMENT TO REGISTER DVCS LTRS 1/01 TO 6/01 BIOSENSE WEBSTER - NAVISTAR CELSIUS THEROCOOL DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETERS P030031 INDIVIDUAL RECS FCN 1046 - FORM 3480, APPENDICES, MEMOS VOLUNTARHY COSMETIC REGISTRATION PROGRAM (VCRP) - COS USING 40 LISTED INGREDIENTS DONALD BATISKY, NATIONWIDE CHILDREN'S HOSPITAL, COLUMBUS, OH - EIR, 483 FCN 1020 - FORM 3480, APPENDICES, MEMOS Signature/ Requester Subject AVENTIS - DTAP & HIB VACCINE LOT NOS 1,2,3,4 ; MERCK VZV VACCINE SINGLE DOSE, MULTI DOSE VIALS 1998 TO PRESENT DKT LOG FDA-1995-S-0039
2011-3768 2011-3769 2011-3770
05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/
KAY R GOZELSKI LBR RESEARCH INC DAVID B RAISTRICK EN-VISION AMERICA GEORGENE WATERMAN CATHEFFECTS INC
2011-3771
05/24/2011 06/22/2011
WILLIAM E PIERSON JR LAW OFC OF WILLIAM E PIERSON JR
2011-3772
05/24/2011 06/22/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SUNG, CYNTHIA
IND 44,158 - PHARMACOLOGY & TOXICOLOGY RVWS
Page 199 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3773 05/24/2011 06/22/2011 2011-3774 05/24/2011 06/22/2011 2011-3775 05/24/2011 06/22/2011 2011-3776 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3777 05/24/2011 06/22/2011 2011-3778 2011-3779 05/24/2011 06/22/2011 05/24/2011 06/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/P-FO/LOS-DO/LACB/ 2011-3780 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3781 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-3782 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MARK MANSOUR AKIN GUMP ET AL AMPHASTAR PHARMACEUTICALS INC, SOUTH EL MONTE, CA - EIRS, COVERSHEET, EXHIBITS, ETC 1/11 TO PRESENT KRISTEN STEWART DEUTSCHE BANK RISK MITIGATION STRATEGIES IN IMMUNE GLOBULIN PRODS WORKSHOP - TRANS, SLIDES 5/17-18/11 BRETT H PIZER AON RISK SOLUTIONS HORMONE REPLACEMENT THERAPY/HRT PRODS - 483, WARNING LTR, LABEL CHANGE LTR 1/8/03 ORA/CE-FO/BLT-DO/CB/ CULLEN B CASEY ESQ ANDERSON COE & KING LLP ELIZABETH TEIXEIRA ESQ ROBERT VAAGE LAW OFCS NICHOLE D PODGURSKI ESQ DONAHUE & HORROW LLP BAUGHER ENTERPRISES INC, WESTMINSTER, MD - E COLI OUTBREAK INVESTIGATION 10/10 TO 11/10; E COLI VIOLATION INVESTIGATION 2006 NUVASIVE INC - NEUROVISION JJB K013215, K032083, K040543, ETC TRIMAX GROUP INC - ENTRY M42-772660001, MA41772436001, M41-77245001, ETC SOBEL, EVE FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J JENNIFER KAVALLIERATOS AARONSON RAPPAPORT ET AL CVM/OCD/ AMY WADE NOVARTIS ANIMAL HEALTH POSATEX (ORBIFLOXACIN MOMETASONE FUROATE MONOHYDRATE & POSACONAZOLE) OTIC SUSPENSION NADA 141-266 - FOI SUMMARY HEALTH PLAN OF NEVADA, LAS VEGAS, NV; GENERAL SURGERY ASSOCIATES, LAS VEGAS, NV - LTRS OF CMPLNTS 8/23/10, 1/5/11 ALLERGAN - BAND ADJUSTABLE GASTRIC BANDING SYS SAFETY ALERTS, ADVISORIES, MEMOS, ETC 2007 TO PRESENT FLOMAX - AERS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ 2011-3783 05/24/2011 06/22/2011 2011-3784 05/24/2011 06/22/2011 2011-3785 2011-3786 05/24/2011 06/22/2011 05/24/2011 06/22/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ 2011-3787 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3788 05/24/2011 06/22/2011 2011-3789 05/24/2011 06/22/2011 2011-3790 05/24/2011 06/22/2011 2011-3791 2011-3792 05/24/2011 06/22/2011 05/24/2011 06/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ NORMAN F ESTRIN PHD ESTRIN CONSULTING GROUP INC DR GEORGE GAGNEJA BIOTRON DIAGNOSTICS INC DR GEORGE GAGNEJA BIOTRON DIAGNOSTICS INC DR GEORGE GAGNEJA BIOTRON DIAGNOSTICS INC TIM LAWTON C-REG MEDICAL STERLING BIOCHEMICALS - LIPASE REAGENT SET K831874, URIC ACID K834045, CREATINE KINNASE K830672, ETC STERLING BIOCHEMICALS INC - ALKALINE PHOSPHATASE REAGENT SET K843332, GLUCOSE HEXOKINASE K844998, ALT/GPT (UV) K844251/A, ETC STERLING BIOCHEMICALS INC - AMYLASE K781248, HDL CHOLESTEROL K781249, TRIGYLCERIDES K823341, ETC TOPCON CORP - NON-MYDRIATIC RETINAL CAMERA K100207 NTI-TSS INC - NTI TENSION SUPPRESSION SYS K010876 NORMAN F ESTRIN PHD ESTRIN CONSULTING GROUP INC IVY BLOCK NDA 20-532 - RECS HERRERA, MICHELLE JUSTIN MCCARTHY JUDICIAL WATCH MCDONALDS CORP - MARKETING DIRECTED TO CHILDREN COMM 1/3/11-5/23/11 ORA/CE-FO/CIN-DO/CCB/ SHAWN H HUBER PROFESSIONAL HOSPITAL SUPPLY INC DJUNA E PERKINS BRODY HARDOON PERKINS LLP ET AL ROBERT GERTIE, B & B PHARMS - MEMO OF INTERVIEW AMERICAN CONTRACT SYSTEMS, TIFFIN, OH - EIRS 1/514/11 OUTBREAKS OF SALMONELLA INGANDA - RECS 4/10 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-3793 Recd Date / Due Date 05/24/2011 06/22/2011 2011-3794 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3795 05/24/2011 06/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3796 2011-3797 2011-3798 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3799 2011-3800 05/24/2011 06/22/2011 05/24/2011 06/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3801 2011-3802 2011-3803 2011-3804 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ TREGLIA T66950, DANIEL JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. NAPROXEN - LBLG, WARNINGS, AERS 2011-2605 - REQUEST LTR 2011-2587 - REQUEST LTR 2011-2951 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. KATE PETERSON ONCONOVA THERAPEUTICS INC DACOGEN NDA 21-790 - SBA 2011-2635 - REQUEST LTR JOAN STITT (UG2CD-17) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. KATE PETERSON ONCONOVA THERAPEUTICS INC DOXIL NDA 50-718 - SBA 2011-2556 - REQUEST LTR 2011-2549 - REQUEST LTR KATE PETERSON ONCONOVA THERAPEUTICS INC TARCEVA NDA 21-743 - SBA Action Office ORA/CE-FO/CIN-DO/CCB/ Signature/ Requester MARGRET KAMEL MSPH EMORY UNIVERSITY DIVISION OF PEDIATRIC NEPHROLOGY KATE PETERSON ONCONOVA THERAPEUTICS INC Subject DR DONALD BATISKY, NATIONWIDE CHILDREN'S HOSPITAL, COLUMBUS, OH - 483 9/12/06 GEMZAR NDA 20-509 - SBA
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Total Records: 12455 Control # 2011-3805 2011-3806 2011-3807 2011-3808 2011-3809 2011-3810 2011-3811 2011-3812 2011-3813 2011-3814 2011-3815 2011-3816 2011-3817 2011-3818 2011-3819 2011-3820 2011-3821 Recd Date / Due Date 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MERCK & CO., INC. 2011-3077; 2011-3078 MERCK & CO., INC. 2011-3054; 2011-3055 MERCK & CO., INC. 2011-3048 MERCK & CO., INC. 2011-2975 MERCK & CO., INC. 2011-2947 MERCK & CO., INC. 2011-2939 MERCK & CO., INC. 2011-2935 MERCK & CO., INC. 2011-2917 MERCK & CO., INC. 2011-2910 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CE-16) MERCK & CO., INC. JOSH HART SIDLEY AUSTIN LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-2904 2011-2891 - REQUEST LTR DKT 1977N-0066 2011-2828 - REQUEST LTR 2011-2814 - REQUEST LTR 2011-2811 - REQUEST LTR 2011-2762 - REQUEST LTR Subject 2011-2684 - REQUEST LTR
Page 203 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/22/2011 2011-3822 2011-3823 2011-3824 2011-3825 2011-3826 2011-3827 2011-3828 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/24/2011 06/22/2011 05/25/2011 06/23/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-3829 2011-3830 2011-3831 2011-3832 2011-3833 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 2011-3834 05/25/2011 06/23/2011 2011-3835 05/25/2011 CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ REBECCA MOCK HOSPIRA PTY AUSTRALIA LTD, AUSTRALIA - EIR 3/9-18/11 DANCER, KATHY ANDREW C BRISCOE III SUGAR ASSOCIATION INC FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ELIZABETH A MUSHILL HUSCH BLACKWELL LLP ANNA DEMKOVIC ABBOTT LABORATORIES, INC. MATT CANHAM SALT LAKE TRIBUNE ELENA HOWELL HOGAN LOVELLS LLP PHILIP MORRIS - GERANIUM OIL AS A FLAVORING IN US SMOKELESS TOBACCO, SKOAL MINT, WINFERGREEN OR APPLE LONG CUT SMOKELESS TOBACCO CORN REFINERS ASSN - HIGH FRUCTOSE CORN SYRUP CORR, MTGS, RPTS, ETC 1/11 TO PRESENT H2O PLUS LLC, CHICAGO, IL - H2O+ AQUAFIRM RETEXTURINZING CLEANSER RECALL RECS 10/06 TO 2/07 ABBOTT DIAGNOSTICS DIVISION, LAKE COUNTY - EIRS, FINAL DECISIONS, INSP CONCLUSIONS 10/27/08-12/11/08 DIETARY SUPPLEMENT COMPANIES IN UTAH - 483S 1/11 TO PRESENT FIBREK INC - RECYCLED FIBERS OR PULP FCN, CORR MERCK & CO., INC. JOHN M. SZABOCSIK, Ph.D. SZABOCSIK & ASSOCS GABRIELA GARZA Griffith Laboratories JALAPENO SAUCE ENTRY U93-0061757-5 - LAB RESULTS OPHTHALMIC DEVICE PANEL MEETING 6/10/08 MERCK & CO., INC. 2011-3215 MERCK & CO., INC. 2011-3161 MERCK & CO., INC. 2011-3147 MERCK & CO., INC. 2011-3083 Signature/ Requester MERCK & CO., INC. 2011-3081 Subject
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Total Records: 12455 Control # Recd Date / Due Date 06/23/2011 2011-3836 2011-3837 2011-3838 2011-3839 2011-3840 2011-3841 2011-3842 2011-3843 2011-3844 2011-3845 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 2011-3846 05/25/2011 06/23/2011 2011-3847 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3848 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3849 05/25/2011 FDA/OMPT/CDRH/OCER/DFOI/ NICOLE DEL VECCHIO THIRD AVE OPEN MRI INC (THIRD AVE RADIOLOGY & SAMUEL GEISLER AYLSTOCK WITKIN KREIS ET AL ULORIC - WARNING LTRS, LBLG, AER FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ MATT CANHAM SALT LAKE TRIBUNE ELIZABETH BARBEHENN, Ph.D. PUBLIC CITIZEN FOOD FIELD RPT 2/17/11; PROGRAM SUMMARY FOR IMPORTED & DOMESTIC DIETARY SUPPLEMENTS; DIETARY SUPPLEMENT BUDGET INFORMATION PAPER 2/11 SAVELLA NDA 22-256 - RVWS FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ DAWSON, WIN FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CHRISTINE DE VOS CORDIS CORP DR RONALD FAIRMAN, HOSPTIAL OF THE UNIV OF PENNSYLVANIA, PHILADELPHIA, PA - 483 2008 TEIKOKU PHARMA USA INC - ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) K072560 3M CO (3M HEALTH CARE) - 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR K103277 FOOD ADDITIVE SAFETY PROFILES OF TETRASODIUM EDTA, DISODIUM EDTA, CALCIUM DISODIUM EDTA, ETC VITAL IMAGES - VITREA2 & VERSION3.4 MEDICAL IMAGE PROCDESSING SOFTWARE K032748 VIATRONIX - VIATRONIX VISUALIZATION SHYS K002780 ORA/CE-FO/MIN-DO/MCB/ WHITE, JEFF S FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC AMERICAN PRECLINICAL SERVICES, COONRAPIDS, MN 483 MOST RECENT COVIDIEN - LIGASURE CURVED K102470 FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester GILEAD SCIENCES JOHN GILLINGS COLLINS STEWART LLC MEDTRONIC - AMPLIFY NON-APPROVABLE LTR CORR 2/11 TO PRESENT INFLUENCE INC - SLEEP IN BONE SCREW SYS K972023 Subject
Page 205 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/23/2011 2011-3850 05/25/2011 06/23/2011 2011-3851 2011-3852 2011-3853 2011-3854 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ 2011-3855 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3856 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-3857 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3858 2011-3859 2011-3860 05/25/2011 06/23/2011 05/25/2011 06/23/2011 05/25/2011 06/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ JOAN YAMADA MYOTRONICS KAREN BANNICK BANNICK CONSULTING LLC MICHEAL T. MULLEN LAW OFFICES PAUL B EPISCOPE MYOTRONICS-NOROMED INC - CORR, CMPLNTS, EIRS, ETC 1/10 TO PRESENT NEUROMED INC, FT. LAUDERDALE, FL - OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC K930536 TERBUTALINE (BRETHINE) - AER KAREN SCHULTZ DOMINION GROUP INC PADDOCK LABS - CLOBETASOL PROPIONATE SPRAY ANDA 90-898; TARO - CLOBETASOL PROPIONATE LOTION ANDA 74-249 APRVL LTR JOSEPH A. FUSELIER FUSELIER ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH K080228 DANIEL J. SMITH SMITH & SMITH DILAUDID (HYDROMORPHONE) - AER FOI SERVICES INC KRISTEN NICHOLE BALL JAMES MADISON UNIVERSITY FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ S ALBERT EDWARDS, PHARM D DR JOHN HAINSWORTH, NASHVILLE, TN - EIRS, 483S 1/00 TO PRESENT SARAH CANNON RESEARCH INSTITUTE, NASHVILLE, TN EIRS, 483S 1/00 TO PRESENT SPLENDA (SUCRALOSE) - CAERS, APRVL RECS CBER/OCTMA/DDOM/ALFB/ Action Office Signature/ Requester MARKS O'NEILL O'BRIEN ET AL RONI MINTZ OMRIX BIOPHARMCEUTICALS Subject IMAGING PC), BRONX, NY - CERTIFICATION & ACCREDITATION RECS 10/09; 483S RISK MITIGATION STRATEGIES TO ADDRESS POTENTIAL PROCOAGULANT ACTIVITY IN IMMUNE GLOBULIN PRODUCTS - WORKSHOP PRESENTATIONS 5/17-18/11 UTECH - PAIN PUMP PMA
Page 206 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3861 05/26/2011 06/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3862 05/26/2011 06/29/2011 2011-3863 05/26/2011 06/24/2011 2011-3864 05/26/2011 06/24/2011 2011-3865 05/26/2011 06/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3866 05/26/2011 06/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3867 05/26/2011 06/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3868 2011-3869 2011-3870 05/26/2011 06/24/2011 05/26/2011 06/24/2011 05/26/2011 06/24/2011 ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/LOS-DO/LACB/ KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS BRENNTAG GREAT LAKES, MEMOMONEE FALLS, WI; SUNOPTA ASEPTIC, ALEXANDRIA, MN; MERZ AESTHETICS, FRANKSVILLE, WI ETC - 483S 4/1-30/11 AVID BIOSERVICES, TUSTIN, CA; COSMEDX SCIENCE, CORONA, CA; COSWAY, CARSON, CA ETC - 483S 4/1-30/11 BBC BIOCHEMICAL, MT VERNON, WA - 483S 4/1-30/11 PATTI SMITH B BRAUN MEDICAL INC ASTRAZENECA/MERREM - MEROPENEM NDA 050706 APRVL PKG UNREDACTED PATTI SMITH B BRAUN MEDICAL INC CEREXA/TEFLARO - NDA 020327 APRVL PKG BRAUN MEDICAL INC - CEFEPIME INJ, DEXTROSE INJ NDA 50-821 APRVL RECS PATTI SMITH B BRAUN MEDICAL INC B BRAUN MEDICAL INC - CEFEPIME INJ, DEXTROSE INJ NDA 50-821 APRVL RECS REISING, BRIAN ORA METRIX INC, DALLAS, TX - SURESMILE SYS, K002620 REISING, BRIAN CBER/OCTMA/DDOM/ALFB/ DARBY, ANDREA HOLLISTER-STIER LABS - BACTERIAL VACCINES MIXED RESPIRATORY VAERS, DATE OF LICENCE REVOCATION, PROD CLASSIFICATION, ETC ALIGN TECHNOLOGY, SAN DIEGO, CA - ALIGN SYS K981095 RYAN BOUCHARD ORA INC PAREMYD (HYDROXYAMPHETAMINE HYDROBROMIDETROPICAMIDE - NDA 019261 SBA Signature/ Requester LLC Subject
Page 207 of 1132

Total Records: 12455 Control # 2011-3871 Recd Date / Due Date 05/26/2011 06/24/2011 2011-3872 05/26/2011 06/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/CE-FO/PHI-DO/PCB/ Signature/ Requester KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS Subject ACCUPAC, LANSDALE, PA; MEDICAL PRODUCTS LABS, PHILADELPHIA, PA; UNITED METAL FABRICATORS, JOHNSTOWN, PA ETC - 483S 4/1-30/11 LIDCO, LONDON, UK; PROCON MEDIZINTECHNIK GMBH, KLEINOSTHEIM, GERMANY; ADVANCED MEDICAL TECHNOLOGIES, NONNWEILER, GERMANY ETC - 483S 4/130/11 KREBS BIOCHEMICALS, ANDHRA PRADESH, INDIA; PHARMAZELL, VISHAKHAPATNAM, INDIA; SHASUN PHARMMACEUTICALS, CUDDALORE, INDIA ETC - 483S 4/130/11 PHARMACEUTICAL ASSOCS, GREENVILLE, SC; CURAE'LASE, LORIS, SC; ULTRALITE ENTERPRISES, LAWRENCEVILLE, GA ETC - 483S 4/1-30/11 MERCK & CO, ARECIBO, PR; EX-LAX, HUMACAO, PR; LILLY DEL CARIBE, CAROLINA, PR ETC - 483S 4/1130/11 NEUROWAVE SYSTEMS, CLEVELAND HTS, OH; COOPERSURGICAL, NEWBURY, OH; STERIS, MENTOR, OH ETC - 483S 4/1-30/11 VOT LLC, WARSAW, IN; SIGNAL MEDICAL CORP, MARYSVILLE, MI; SYMBIOS MEDICAL PRODUCTS, INDIANAPOLIS, IN ETC - 483S 4/11-30/11 CLOSED FOI REQUESTS 5/16020/11 FOI SERVICES INC CLOSED FOI REQUESTS 5/23-27/11 FOI SERVICES INC KEVIN O'ROURKE FDA NEWS VINTAGE PHARMACEUTICALS LLC DBA QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL; INTERNATIONAL BUSINESS SOLUTIONS, COLLIERVILLE, TN; TEAM TECHNOLOGIES, MORRISTOWN, TN - 483 4/1/11 TO 4/30/11 BAXTER HEALTHCARE, CHERRY HILL, NJ; AP DEAUVILLE, NEW BRUNSWICK, NJ; CETYLITE INDUSTRIES, PENNSAUKEN, NJ, ETC - 483 4/1/11 TO 4/30/11 CONCEPT LABS, CHICAGO, IL; DENTAL TECHNOLOGIES, LINCOLNWOOD, IL; MORTON GROVE PHARMACEUTICALS, MORTON GROVE, IL - 483 4/1/11 TO 4/30/11 RECEPTOPHARM, PLANTATION, FL; TROPICHEM RESEARCH LABS, JUPITER, FL; WATSON LABS, FORT LAUDERDALE, FL - 483 4/1/11 TO 4/30/11
2011-3873
05/26/2011 06/24/2011
2011-3874
05/26/2011 06/24/2011
ORA/SE-FO/ATL-DO/ACB/
2011-3875 2011-3876
05/26/2011 06/24/2011 05/26/2011 06/24/2011
ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/CIN-DO/CCB/
KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS
2011-3877
05/26/2011 06/24/2011
2011-3878 2011-3879 2011-3880
05/26/2011 06/24/2011 05/26/2011 06/24/2011 05/26/2011 06/24/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/
2011-3881
05/26/2011 06/24/2011
ORA/CE-FO/NJ-DO/NJCB/
2011-3882
05/26/2011 06/24/2011
ORA/CE-FO/CHI-DO/CCB/
MICHAEL O'ROURKE FDA NEWS
2011-3883
05/26/2011 06/24/2011
ORA/SE-FO/FLA-DO/FCB/
Page 208 of 1132

Total Records: 12455 Control # 2011-3884 Recd Date / Due Date 05/26/2011 06/24/2011 2011-3885 2011-3886 05/26/2011 06/24/2011 05/26/2011 06/24/2011 2011-3887 2011-3888 2011-3889 05/26/2011 06/24/2011 05/26/2011 06/24/2011 05/26/2011 06/24/2011 2011-3890 05/26/2011 06/24/2011 2011-3891 05/26/2011 06/24/2011 2011-3892 2011-3893 05/26/2011 06/24/2011 05/26/2011 06/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3894 2011-3895 05/27/2011 06/27/2011 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3896 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHARLES CELESTE EAS Consulting Group, LLC THEOPHYLLINE ER TABS ANDA 89-763 - APRVL LTR LBLG, CHEMISTRY RVW, ETC ORA/P-FO/LOS-DO/LACB/ Doe J CHARLES CELESTE EAS Consulting Group, LLC THEOPHYLLINE ER TABS ANDA 81-236 - APRVL LTR, LBLG, CHEMISTRY RVW, ETC INDIVIDUAL RECS FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/BLT-DO/CB/ CBER/OCTMA/DDOM/ALFB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS KEVIN O'ROURKE FDA NEWS SUE ANN McAVOY SENSIENT COLORS LLC ANDI POULSON LEXIS NEXIS COURTLINK INC 2010-6641 Subject SCARGUARD LABS, STAMFORD, CT; ASTRA ZENECA, WESTBOROUGH, MA; TECHMAN INTERNATIONAL, CHARLTON, MA - 483 4/1/11 TO 4/30/11 ID BIOMEDICAL CORP, ST FOY, CANADA - 483 4/1/11 TO 4/30/11 HAWKNAD MANUFACTURING, ALEXANDRIA, VA; EASTERN CRANIAL AFFILIATES, ARLINGTON, VA - 483 4/1/11 TO 4/30/11 HOSPIRA, AUSTIN, TX; CUT HEAL ANIMAL CARE PRODUCTS, CEDAR HILL, TX - 483 4/1/11 TO 4/30/11 SPARTON MEDICAL SYSTEMS, FREDERICK, CO - 483 4/1/11 TO 4/30/11 MARIANNA INDUSTIRES, OMAHA, NE; CENTRAL SOLUTIONS, KANSAS CITY, KS; EMERALD 3 ENTERPRISES, CMDENTON, MO - 483 4/1/11 TO 4/30/11 INVAGEN PHARMS, HAUPPAGE, NY; PROFESSIONAL DISPOSABLES INTERNATIONAL, ORANGEBURG, NY; AMES GOLDSMITH, GLEN FALLS, NY - 483 4/1/11 TO 4/30/11 JM HUBER MICROPOWDERS, MODESTO, CA; ABBOTT LABS, SANTA CLARA, CA; OPTOVUE, FREMONT, CA - 483 4/1/11 TO 4/30/11 LYCOPENE AS A COLOR ADDITIVE - REGULATORY RECS
Page 209 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3897 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3898 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3899 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3900 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3901 2011-3902 2011-3903 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3904 2011-3905 05/27/2011 06/27/2011 05/27/2011 06/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MARIA TERESA GUMA KENZ NATASHA MINSKER AMERICAN CIVIL LIBERTIES UNION OF NORTHERN CALIFORNIA AMIODORONE - AERS Doe J 2011-319 - MINOR DELETIONS EDAN SE 1010 PC ECG - K102854 ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ OMRI HAYET SYNERON BEAUTY LTD NIKKI M MONTANO MADISON HARBOUR & MROZ PA NATHAN A BEAVER FOLEY & LARDNER LLP LAS CRUCES BIOLOGICALS LLC - INVESTIGATOR NOTES 2000 TO PRESENT NOSTRUM PHARMS - CARBAMAZEPINE ER CAPS ANDA 76697 SBA HOME SKINOVATIONS - FLASH N GO K082298 MARINA FALAKHOVA TARO PHARMACEUTICALS U.S.A., INC LEO PHARM INC - TACLONEX NDA 21-852 SBA, LBLG, MOR, ETC MARINA FATAKHOVA TARO PHARMACEUTICALS U.S.A., INC HI-TECH PHARMACAL CO INC - SULFAMETHOXAZOLE & TRIMETHOPRIM ORAL SUSPENSION NDA 74-650 SBA,, LBLG, MOR, ETC CHARLES CELESTE EAS Consulting Group, LLC THEOPHYLLINE ER TABS ANDA 89-807 - APRVL LTR, LBLG, CHEMISTRY RVW, ETC CHARLES CELESTE EAS Consulting Group, LLC THEOPHYLLINE ER TABS ANDA 89-808 - APRVL LTR, LBLG, CHEMISTRY RVW, ETC Signature/ Requester Subject
2011-3906
05/27/2011 06/27/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
Page 210 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-3907 2011-3908 2011-3909 2011-3910 2011-3911 2011-3912 2011-3913 2011-3914 2011-3915 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3916 2011-3917 2011-3918 2011-3919 2011-3920 2011-3921 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INFORMATION ACCESS INFORMATION ACCESS 2011-1799 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INFORMATION ACCESS JAMES JOHNSON IMAGEWORKS AFP IMAGING CORP, ELMSFORD, NY - AFP 17X4 AUTOMATIC FILM PROCESSOR K925885 2011-1720 INFORMATION ACCESS 2011-1728 INFORMATION ACCESS 2011-2188 201-2218 INFORMATION ACCESS INFORMATION ACCESS 2011-2288 INFORMATION ACCESS 2011-2333 INFORMATION ACCESS 2011-2378 INFORMATION ACCESS 2011-2468 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-2549 2010-3425 2010-3387 2010-1848 2009-768 Signature/ Requester Subject
Page 211 of 1132

Total Records: 12455 Control # 2011-3922 2011-3923 2011-3924 2011-3925 2011-3926 2011-3927 2011-3928 2011-3929 2011-3930 Recd Date / Due Date 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 2011-3931 2011-3932 2011-3933 2011-3934 2011-3935 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 05/27/2011 06/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ FOI SERVICES INC ROBERT P. FITZSIMMONS FITZSIMMONS LAW OFFICES MYLAN PHARMACEUTICALS INC - LIMS SYS RPTS, TRANS, CORR, ETC FOI SERVICES INC PBM - INFANT FORMULA EIRS 1/10 TO PRESENT JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. NESTLE - INFANT FORMULA EIR 1/1/10 TO PRESENT 2011-635 2011-457 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INFORMATION ACCESS JOSEPH M DUNN WIGINGTON RUMLEY DUNN LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOSEPH M DUNN WIGINGTON RUMLEY DUNN LLP AIRSEP CORP - WARNING LTR 9/15/08 CORR, RESP LTRS, INVESTIGATIONS 10/30/10 TO PRESENT 2011-311 2011-297 2010-8204 2010-8152 2010-7841 AIRSEP CORP - OXYGEN CONCENTRATOR (NEWLIFE ELITE) MDRS 10/30/10 TO PRESENT (CERTIFIED) 2010-5889 Signature/ Requester Subject 2011-2105
Page 212 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/SJN-DO/SJCB/ 2011-3936 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3937 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3938 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3939 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3940 05/27/2011 06/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3941 2011-3942 05/27/2011 06/27/2011 05/27/2011 06/27/2011 2011-3943 05/27/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CIN-DO/CCB/ CAROLYN J DONALEK JOHNSON & BELL ASHBY PATE LIGHTFOOT FRANKLIN & WHITE LLC KIMBERLY R LAMBERT PROZAC (FLUOXETINE) - AERS, STUDIES, CORR, ETC AFFINITY BEDS - RECALLS 4083, 5398, 45444 WARNING LTR CIN-03-16736 8/7/03 (CERTIFIED) SUBHASH PANDYA GUARDIAN DRUG CO BRAINTREE LABS - MIRALAX POWDER NDA 22-015 APRVL PKG, CHEMISTRY RVW PAGES 1-27 KAREN SCHULTZ DOMINION GROUP INC PADDOCK LABS - CLOBETASOL PROPIONATE SPRAY ANDA 90-898;TARO - CLOBETASOL PROPIONATE LOTION ANDA 74-249 APRVL LTRS 6/10, 4/28/11 BLESSY JOHNS AUROLIFE PHARMA LLC ELMIRON (PENTOSAN POLYSULFATE SODIUM) CAPS NDA 20-193 - APRVL PKG MUJIB U QIDWAI GRIFOLS BIOLOGICALS INC OCTAPHAMA AB, STOCKHOLM, SWEDEN - EIRS, 483S 1/1020/11 JOHN P. JUDGE MONTGOMERY MCCRACKEN ET AL JOHNSON & JOHNSON; ORTHO MCNEIL NEUROLOGICS; PFIZER INC - HALOGENATED ANISOLE COMPOUNDS TOXICOLOGY Signature/ Requester Subject
Page 213 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/22/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ 2011-3944 05/27/2011 06/27/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ 2011-3945 05/27/2011 06/27/2011 ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-3946 2011-3947 05/31/2011 06/28/2011 05/31/2011 06/28/2011 2011-3948 05/31/2011 06/28/2011 2011-3949 05/31/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN CLOSED FOIA REQUESTS 5/2-6/11 CLOSED FOIA REQUESTS 4/25-29/11 REYNOLD, NANCY A FDA/OMPT/CDRH/OCER/DFOI/ REYNOLD, NANCY A ALIGN TECHNOLOGY INC - INVISALIGN SYS ORTHODONTIC PLASTIC BRACKET K081960 ALIGN SYSTEMS, ALIGN TECHNOLOGY INCORPORATED, INVISIALIGIN SYSTEMS - ORTHODONTIC PLASTIC BRACKET K981095 MICHELLE RYBAK ROANOKE TRADE SERVICES INC SUNNYLAKE TRADING INC - ENTRY J3400605823, J3400597004 NOTICES OF REFUSAL EUGENE SCALIA GIBSON DUNN & CRUTCHER LLP INTERAGENCY WORKING GROUP ON FOOD MARKETED TO CHILDREN - PARTICIPANTS, TRANS, MINS, ETC 5/5/09 Signature/ Requester LEVIN PAPANTONIO THOMAS ET AL Subject
Page 214 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/28/2011 2011-3950 05/31/2011 06/28/2011 2011-3951 05/31/2011 06/28/2011 2011-3952 05/31/2011 06/28/2011 2011-3953 05/31/2011 06/28/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-3954 2011-3955 05/31/2011 06/28/2011 05/31/2011 06/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3956 05/31/2011 06/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3957 05/31/2011 06/28/2011 2011-3958 2011-3959 2011-3960 05/31/2011 06/28/2011 05/31/2011 06/28/2011 05/31/2011 06/28/2011 2011-3961 05/31/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/FLA-DO/FCB/ KAY FLANAGAN STIEFEL GSK CO AVESHA HAMILTON HAMILTON LAW FIRM PC KENNETH WITTENBERG ABBOTT LABORATORIES, INC. BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN BODE MATZ KAREN SELTZER DR MARTIN ZAIAC, GREATER MIAMI SKIN & LASER CENTER, MIAMI BEACH, FL - EIRS 4/22/10 TO 7/14/10, RESP TO WARNING LTR 3/21/11 MEDICAL PRODUCTS LABORATORIES INC - EIRS, 482S, 483S, ETC 1/00 TO PRESENT CELLAY INC - GEN110528, GEN1100561, UNTITLED LTRS, WARNING LTRS, ETC NESTLE NUTRITION (NESTLE INFANT NUTRITION, GERBER PRODS CO) - INFANT FORMULA ATTACHMENTS, ENCLOSURES, EXHIBITS LISTERINE MOUTHWASH - CMPLNTS, INVESTIGATORY & MATTHEW S KNOOP ASHE RAFUSE & HILL LLP PHOSENAMINE - REGISTRATION FORMS 2656, 2657, 2658, ETC FDA/OF/CFSAN/OCD/EOS/ TODD D JACOBS SENSIENT COLORS LLC CYNTHIA SUNG DUKE NATIONAL UNIV OF SINGAPORE Signature/ Requester WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS lOIS ZIEBOL PURSUIT VASCULAR 3M - TEGADERM CHG DRESSING K080620, K063458; INTEGRA LIFESCIENCES CO - BIO PATCH ANTIMICROBIAL DRSSING K003229; VITAPHORE CO - VITA PATCH PIN PROTECTION DVC K895920 CERTIFIED COLOR ADDITIVE SAMPLING ASSIGNMENT #2 2005, 2006 MDL 28,574A IND 44,158 - PHARMACOLOGY & TOXICOLOGY RVW CLOSED FOIA REQUESTS 5/23-27/11 CLOSED FOIA REQUESTS 5/16-20/11 CLOSED FOIA REQUESTS 5/9-13/11 Subject
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Total Records: 12455 Control # Recd Date / Due Date 06/28/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ OC/COS/OL/ OC/OCC/ 2011-3962 05/31/2011 06/28/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OPPL/OP/ CTP/OD/ CTP/OD/ OC/OCC/ 2011-3963 2011-3964 05/31/2011 06/28/2011 05/31/2011 06/28/2011 2011-3965 2011-3966 2011-3967 2011-3968 05/31/2011 06/28/2011 05/31/2011 06/28/2011 05/31/2011 06/28/2011 05/31/2011 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ DIANNE L CHAMBERS HOGAN LOVELLS LLP DAVID P SHELDON LAW OFC OF DAVID P SHELDON PLLC JOSH HART SIDLEY AUSTIN LLP MARILYNN WHITNEY COVINGTON & BURLING LLP ANN LEBAR GE HALTHCARE MERLE ZIMMERMANN DKT FDA-1995-S-0039 GMP A./C TRANS 9/13-14/95, DKT 1990N-0172 DKT FDA-2010-P-0491 DKT 1975N-0066 iNDIVIDUAL RECS KELLOGG CO - MEMO OF MTG 5/2/11 CONLEY, GREGORY ELECTRONIC CIGARETTES (E-CIGARETTES, ELECTRONIC NICOTINE DELIVERY SYS) - INCOMING & OUT COMING EMAILS, ATTACHMENTS 6/30/08 TO 1/1/09 Signature/ Requester MARIAN S ROSEN & ASSOCIATES Subject ADMINISTRATIVE RECS
Page 216 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/28/2011 2011-3969 2011-3970 2011-3971 06/01/2011 06/29/2011 06/01/2011 06/29/2011 06/01/2011 06/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/OE/ ORA/OE/ 2011-3972 06/01/2011 06/29/2011 2011-3973 06/01/2011 06/29/2011 ORA/ ORA/ ORA/OE/ ORA/OE/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3974 2011-3975 2011-3976 06/01/2011 06/29/2011 06/01/2011 06/29/2011 06/01/2011 06/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ Doe J MARIA TERESA GUMA HILL-MED INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. PHOTOCURE ASA - CYSVIEW KIT (HEXAMINOLEVULINATE HCL) NDA 22-555 RECS EDAN SE-1010 PC ECG - K102854 CMPLNT 118772 FDA/OMPT/CDRH/OCER/DFOI/ NEIL R EULIANO PHD CONVERGENT ENGINEERING SMY EICHNER PHD UNITED STATES ANTI-DOPING AGENCY BRAVO PH MONITORING SYS - K102543; ACCUTEMP MONITORING SYS - K880639; VITALSENSE MONITOR K033534, ETC DIEATARY SUPPLEMENTS RECALLS 2000 TO PRESENT MEISEL, LEE B WILLIAM LAHEY OCEANA SEAFOOD FRAUD - IMPORT ALERTS, WARNING LTRS, ENFORCEMENT ACTIONS, ETC OC/OM/OMP/DDM/ Action Office Signature/ Requester AMERICAN HERBAL PRODUCTS ASSOCIATION KAVANAUGH LIVINGSTON GOODWIN PROCTOR 2011-2379, 2011-3366, 2011-2382, 2011-3367 DKT FDA-2010-P-0176 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3977 06/01/2011 06/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3978 2011-3979 06/01/2011 06/29/2011 06/01/2011 06/29/2011 2011-3980 2011-3981 06/01/2011 06/29/2011 06/01/2011 06/29/2011 2011-3982 2011-3983 2011-3984 06/01/2011 06/29/2011 06/01/2011 06/29/2011 06/01/2011 06/29/2011 ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-3985 2011-3986 06/01/2011 06/29/2011 06/01/2011 06/29/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ AUGUSTINE, TRACY E FDA/OF/CFSAN/OCD/EOS/ MEGAN B HAEBLER BEVERIDGE & DIAMOND PC ALLOSOURCE, CENTENNIAL, CO - ALLOWRAP 510K, 483S, WARNING LTRS, ETC 2005 TO 2011 STINE SEED FARM INC - HCEM485 RECS ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO LANCASTER LABS, LANCASTER, PA - EIR 10/09 FDA/OO/OFBA/OAGS/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JOHN HUBACHER PANTHEON RESEARCH INC JAMES D MASCHHOFF HERZOG CREBS LLP ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP LISA ALLEN ROTHWELL, FIGG, ERNST & MANBECK, P.C. LEGITSCRIPT FDA-SOL-10-1068201-02 - CORR, STATUS RPTS, ANALYSIS, ETC INDEPENDENCE TECHNOLOGY - IBOT 4000 WHEELCHAIR CMPLNTS EVONIK DEGUSSA CORP, LAFAYETTE, IN - EIR 3/12/10 WHITTLESTONE INC - BREAST PUMP K051112, K070435, K002696 CMPLNTS, PERFORMANCE STANDARDS, DEFECTS, ETC 2010-968 - EXHIBITS & ATTACHMENTS ES-130 - K081943 ANIL SACHDEVA STRIDES INC BIVALURIDIN INJ ANDA 91-468 - MOLECULAR WEIGHT AND STRUCTURE FOR DIMER AND TRIMER IMPURITIES Signature/ Requester Subject
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Total Records: 12455 Control # 2011-3987 Recd Date / Due Date 06/01/2011 06/29/2011 Action Office CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ 2011-3988 06/01/2011 06/29/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ 2011-3989 06/01/2011 07/15/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DEN-DO/COMP/ 2011-3990 06/01/2011 06/29/2011 2011-3991 2011-3992 06/01/2011 06/29/2011 06/01/2011 06/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-3993 2011-3994 2011-3995 2011-3996 2011-3997 2011-3998 06/01/2011 06/29/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BEVERIDGE & DIAMOND PC JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF NU VASIVE INC - INS-1 INTRAOPERATIVE NERVE SURVELLIANCE SYS K002677 NU VASIVE INC - GUIDED SPINAL ARTHROSCOPY SYS K990324 NU VASIVE INC - MODIFICATION TO NEUROVISON JB K062765 NU VASIVE INC - HEMI-ARC SURGICAL NAVIGATOR K013247 NUVASIVE INC - NEUROVISION JJB SYS K032083 CFSAN FOI REQUESTS 4/12/11-5/31/11 CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ NATHAN A BEAVER FOLEY & LARDNER LLP WHITNEY REMILY KENYON & KENYON LLP LUO HAN GUO FRUIT EXTRACT (SIRAITIA GROSVENORII) GRN 359 - RECS SALIX PHARMS, ALFA WASSERMANN SPA - RIFAXIMIN COMPASSIONATE USE OR OPEN-LABEL TRIALS PRIOR TO 2004 RECS, TRANS AUGUSTINE, TRACY E NUTECH MEDICAL, BIRMINGHAM, AL - NUGEL, BIOARTHRO 510K, 483S, WARNING LTRS, ETC 2005 TO 2001 AUGUSTINE, TRACY E AUGUSTINE, TRACY E MIMEDX GROUP INC, MARIETTA, GA; SURGICAL BIOLOGICS LLC, KENNESAW, GA - AMINOSHIELD, AMINOFIX, AMBIODRT2, ETC 510, 483S, WARNING LTRS, ETC 2005 TO 2011 AMEDICA CORP, AMEDICA/US SPINE, SALT LAKE CITY, UT; BIODLOGICS, BIOD LLC, MEMPHIS, TN - BIODEFENSE, BIODFACTOR 510K, 483S, WARNING LTRS, ETC 2005 TO 2011 AUGUSTINE, TRACY E Signature/ Requester Subject ALPHATEC HOLDINGS, ALPHATEC SPINE INC, CARLSBAD, CA; AFCELL, PARSIPPANY, NJ - AMINOCLEAR, AMINOCLEAR TN, AMINOSHIELD 510K, 483S, WARNING LTRS, ETC 2005 TO 2011
Page 219 of 1132

Total Records: 12455 Control # 2011-3999 2011-4000 2011-4001 2011-4002 2011-4003 2011-4004 Recd Date / Due Date 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4005 06/02/2011 06/30/2011 2011-4006 06/02/2011 06/30/2011 2011-4007 2011-4008 2011-4009 2011-4010 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 07/19/2011 06/02/2011 06/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4011 06/02/2011 07/13/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ MCCANN, JOE IMPAX LABS - 483S LAST 2 YRS WARD, JEANIE FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MANOJ ZACHARIAS LIBERTY MANAGEMENT GROUP LTD PERRI WALSH BUSINESS & DESIGN CONSULTANTS JEFF E SCHWARTZ DEWEY & LEBOEUF TIMOTHY WOENKER CHEMATICS INC NABILL MUHANNA THE LONGSTREET CLINIC PC POLYETHYLENE GLYCOL PRODS - AER ACON LABORATORIES INC, SAN DIEGO, CA - MISSION SALIVA ALCOHOLTEST STRIP K093879 MEDITECH - K021788 GE MEDICAL SYSTEMS CHINA CO LTD - ACHILLES BONE SONOMETER K103633 ALIGN TECHNOLOGY INC - INIVISALIGN SYS ORTHODONTIC PLASTIC BRACKET K081960 NU VASIVE INC - NEUROVISION JJB SYS K040543 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF JEFF E SCHWARTZ DEWEY & LEBOEUF MANISH AHUJA BIO TEX INC KATHRYN COSTELLO MARTIN MAGNUSON ET AL MORCHER ENDOSCASPULAR TENSION RING P0059 APRVL LTRS , RPTS 10/23/03; OCULAID/STABEYES CAPSULAR TENSION RING P030023 APRVL LTR, RPTS 4/27/04 (CERTIFIED) NU VASIVE INC - MODIFICATION TO NU VASIVE NEUROVISION J K051384 NU VASIVE INC - MODIFIED INS-1 INTRAOPERTIVE NERVE SURVEILLANCE SYS K013215 K000195 NU VASIVE INC - NEUROVISION JJB SYS K051718 Subject NU VASIVE INC - NEUROVISION JJB SYS K072343
Page 220 of 1132

Total Records: 12455 Control # 2011-4012 Recd Date / Due Date 06/02/2011 06/30/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-4013 2011-4014 06/02/2011 06/30/2011 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4015 2011-4016 2011-4017 2011-4018 2011-4019 2011-4020 2011-4021 2011-4022 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4023 2011-4024 06/02/2011 06/30/2011 06/02/2011 06/30/2011 CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/KAN-DO/COMP/ ANDRE E. TOWNSEL TOWNSEL LAW FIRM OFRA AXELROD ISRAELI MINISTRY OF HEALTH OHLSEN PHARMACAL CO, ST. LOUIS, MO - CMPLNTS, INVESTIGATIONS 1/10 TO 1/11 PROCOAGULANT ACTIVITY IN IMMUNE GLOBULIN PRODS RISK MITIGATION STRATEGIES WORKSHOP PRESENTATION & NOTES, RKVL, MD 5/17-18/11 Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ HEATHER GUERIN SYNTHES SPINE HEATHER GUERIN SYNTHES SPINE HEATHER GUERIN SYNTHES SPINE HEATHER GUERIN SYNTHES SPINE MICHAEL SHOEMAKER, PhD. ROFF RESOURCES HEATHER GUERIN SYNTHES SPINE HEATHER GUERIN SYNTHES SPINE ACCUTANE - AERS GLOBUS - SPFIX K102195 OSTEOMED SPINE - PRIMALOK K100354 ALIGN TECHNOLOGY INC - INVISALIGN SYS K081960 SPINE FRONTIER - VEGA SPAN SPINOUS PROCESS PLATE SYS K102020 X-SPINE - AXLE INSTERSPINOUS FUSION SYS K101471 LIFE SPINE - INTERSPINOUS FIXATION SYS K100407 PARADIGM - INTERSPINOUS FUSION PLATE K093438 FDA/OMPT/CDRH/OCER/DFOI/ HEATHER GUERIN SYNTHES SPINE PATRICK H. HIGGINS, Esq. ECKERT SEAMANS VELCADE (BORTEZOMIB) - ORANGE BOOK LISTING FOR 6713446, 6958319 MEDTRONIC - SPIRE K032037 Signature/ Requester HEATHER GUERIN SYNTHES SPINE Subject NUVASIVE - SPINOUS PROCESS PLATE SYS K073278
Page 221 of 1132

Total Records: 12455 Control # 2011-4025 2011-4026 2011-4027 Recd Date / Due Date 06/02/2011 06/30/2011 06/02/2011 06/30/2011 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4028 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4029 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4030 2011-4031 06/02/2011 06/30/2011 06/02/2011 06/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4032 06/02/2011 06/30/2011 2011-4033 06/02/2011 06/30/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALBRADLEY S. CLANTON BAKER DONELSON ET AL COVANCE INC, PRINCETON, NJ - 483S, WARNING LTRS, INSP 2006 TO 2011 ROBERT J. LEO MEEKS SHEPPARD LEO ET AL NATALIA IMPORTS LLC - ENTRY N77-0170971-9, N770170942-0 DOUGLAS, LAUREN V OC/OM/OMP/DDM/ JAMES B. STEELE VANITY FAIR AMERIDOSE; PHARMEDIIUM - REGISTRATION RECS DKT 1995N-0227 MARY BETH WIGLEY SHIRE DEVELOPMENT INC LIALDA (MESALAMINE) DELAYED RELEASE TABS NDA 22000 - ISRS 5309397, 5793274, 5827783, ETC TRACHELLE JOHNSON MORGAN CONSULTANTS INC COVANCE LABS LTD, NORTH YORKSHIRE UK - 483, EIR, CORR 5/26/06 TO 5/26/11 Doe J ORA/CE-FO/BLT-DO/CB/ Action Office OC/OM/OMP/DDM/ Signature/ Requester GLORIA GASKINS KLEINFELD KAPLAN & BECKER TRACHELLE JOHNSON MORGAN CONSULTANTS INC GENE LOGIC INC, GAITHERSBURG, MD - 483, EIR, WARNING LTR 10/17/03 TO 5/26/11 CELEXA (CITALOPRAM) - AERS 2005 TO PRESENT Subject DKTS 1993P-0421, 1996P-0459
Page 222 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office DO/COMPLIANCE/ 2011-4034 06/02/2011 06/30/2011 2011-4035 06/02/2011 06/30/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ 2011-4036 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4037 2011-4038 2011-4039 2011-4040 2011-4041 2011-4042 2011-4043 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 2011-4044 06/03/2011 07/01/2011 2011-4045 06/03/2011 07/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ CAHILL, PATRICK D FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP ROBIN L ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY (IMT) ROBIN L ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY (IMT) FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BECTON DICKINSON DIAGNOSTIC INSTRUMENT SYSTEM BACTEC 9050 SYSTEM K962210 TEEL PLASTICS INC, BARABOO, WI - EIRS, 483S, RECALLS 5/08 TO PRESENT FRUTAROM USA INC, NORTH BERGEN, NJ - EIRS, 483S, RECALLS 2/09 TO PRESENT NATUREX, SOUTH HACKENSACK, NJ - EIRS, 483S, RECALLS 5/09 TO PRESENT AVANTOR PERFORMANCE MATERIALS, PHILLIPSBURG, NJ - EIRS, 483S, RECALLS 7/07 TO PRESENT DEPUY ORTHOPOAEDICS INC, WARSAW, IN - GCK FEMORAL & TIBIAL COMPONENTS K070849 DEPUY ORTHOPAEDICS INC, WARSAW, IN - SIGMA HIGH PERFORMANCE UNITY KNEE RESURFACING SYS K070267 FORMS 2579 TREK DIAGNOSTIC SYSTEMS - VERSATREK K032306 FOI SERVICES INC HORIZON PHARMA - DUEXIS NDA 22-519 APRVL RECS 4/23/11 ALEXANDER R. WHEELER R REX PARRIS LAW FIRM INTRACAVERNOUS PHARMACOTHERAPY - MINS, TRANS, RECS, ETC Doe J SPL INV657709 Signature/ Requester Subject
Page 223 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ 2011-4046 2011-4047 06/03/2011 07/01/2011 06/03/2011 07/01/2011 2011-4048 2011-4049 06/03/2011 07/01/2011 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ 2011-4050 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4051 06/03/2011 07/01/2011 2011-4052 06/03/2011 07/01/2011 2011-4053 06/03/2011 07/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4054 06/03/2011 07/01/2011 2011-4055 06/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ KENNETH REID WASHINGTON INFORMATION SOURCE STEPHANIE NIELSEN VI-JON LABS, VI-JON INC, VI-JON, ETC - LTRS, PHONE FOI DAILY LOG 5/9-13/11 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS LOUISE GALANOS EVERETT LABORATORIES INC GLYNAZOL-1 NDA 19-881 - RVW SUMMARY FOI DAILY LOG 5/9-13/11 FOI DAILY LOG 5/2-6/11 ELIZABETH BARBEHENN PUBLIC CITIZEN ESAI, PFIZER - ARCEPT 23 (DONEPEZIL) NDA 22-568 MEMOS, TELEPHONE CONVERSATIONS, CORR 7/23/10 SUH, DON FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ MANISH AHUJA BIO TEX INC MANOJ ZACHRIAS LIBERTY MANAGEMENT GROUP LTD BRENDA M GARTZ ELI LILLY & CO LIST OF REGISTERED DRUG FIRMS IN MISSOURI 2006 TO 2011 GE MEDICAL SYSTEMS CHINA CO LTD - BONE SONOMETER K103633 K962913 Signature/ Requester Subject
VIRBAC, BRIDGETON, MO - EIR 9/23/09
Page 224 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/01/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ 2011-4056 06/03/2011 07/01/2011 2011-4057 06/03/2011 07/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4058 2011-4059 2011-4060 2011-4061 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 10/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/ORO/DFS/ ORA/ORO/DFS/ 2011-4062 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JULIE BRIAN FEDERAL PUBLIC DEFENDER SODIUM THIOPENTAL SHIPMENT - FORM 236, EIRS, VIDEOTAPES, AUDIO TAPES, ETC 4/1/11 FDA/OF/CFSAN/OCD/EOS/ ELLIZABETH SWELS INTERTEK EXPERT SERVICES GLADYS B TONKIN Center for Regulatory Services, Inc. WILLIAM A OLSON Center for Regulatory Services, Inc. JAY L T BREAKSTONE PARKER & WAICHMAN ATTYS MISLABELING, MISIDENTIFICATION OF DOMESTIC OR IMPORTED SEAFOOD - CAERS, INVESTIGATION, REGULATORY ACTIONS, ETC FOI DAILY LOG 5/2-6/11 FOI DAILY LOG 5/9-13/11 BASF SE - FCN 853 KENNETH REID WASHINGTON INFORMATION SOURCE MICHAEL A CAROME PUBLIC CITIZEN NEW DRUG APPLICATIONS - APPROVABLE, NON APPROVABLE & RESP LTRS 1/00 TO PRESENT FOI DAILY LOG 5/2-6/11 Signature/ Requester DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE Subject LOGS, E-MAILS, ETC
Page 225 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ CVM/OCD/ OC/OCC/ 2011-4063 2011-4064 2011-4065 2011-4066 2011-4067 2011-4068 2011-4069 2011-4070 2011-4071 2011-4072 2011-4073 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4074 06/03/2011 07/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CECELIA FRENCH CanReg, Inc. FOI DAILY LOG 5/9-13//11 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. FOI DAILY LOG 5/2-6//11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BIOMERIEUX - VITEK 2 COMPACT K050002 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BARBARA JONES DOMINION GROUP INC DADE BEHRING - MICROSCAN SYNERGIES PLUS K020142 FOI SERVICES INC BARBARA JONES DOMINION GROUP INC ORGANON TEKNIKA - BACT/ALERT 3D MICROBIAL DETECTION SYS K981736 FOI DAILY LOG 5/2-6/11 FOI DAILY LOG 5/9-13/11 FOI SERVICES INC FOI DAILY LOG 5/9-13/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 5/2-6/11 FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 5/2-6/11 FOI DAILY LOG 5/9-13/11 FOI DAILY LOG 5/2-6/11 Signature/ Requester Subject
Page 226 of 1132

Total Records: 12455 Control # 2011-4075 2011-4076 Recd Date / Due Date 06/03/2011 07/01/2011 06/03/2011 07/01/2011 2011-4077 2011-4078 2011-4079 2011-4080 2011-4081 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 2011-4082 2011-4083 2011-4084 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ 2011-4085 2011-4086 06/03/2011 07/01/2011 06/03/2011 07/01/2011 2011-4087 2011-4088 06/03/2011 07/01/2011 06/03/2011 07/01/2011 ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ RACINO, BRAD GODFREY BAKER QUALITEST PHARMACEUTICALS HYDROCODONE/ACETAMINOPHEN SPL 650012 - TEST METHODOLOGY, INVESTIGATION, CHROMATOLOGY, ETC FDA IMPORT REFUSAL DATABASE 2001 TO PRESENT OM/OMP/DODM/ KRISTIN DAVENPORT GOODWIN PROCTOR MARIA F. MUNOZ SEADCO USA CORP FROZEN PASTEURIZED EXTRA JUMBO U-130 ENTRY 5940216008-5 - LAB RESULTS DKT 2009N-0664-0037 NEMETH, FRED FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ETHEX CORP - MORPHINE SULFATE ER TABS RECALL FACTSHEET ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BIO-RAD - MRSA SELECT K070361 OM/OMP/DODM/ FOI SERVICES INC MICHELLE LESCKIEWICZ SEGAL MCCAMBRIDGE SINGER ET AL GOLDEN PEANUT CO, BLAKELY, GA - PEANUT FLOUR AERS, INVESTIGATION 10/17/09 HARDY DIAGNOSTICS - HARDYCHROM MRSA K102922 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ROCHE MOLECULAR SYSTEMS - LIGHTCYCLER MRSA ADVANCED TEST MODEL 5205727 DIAGNOSTICS (GENEOHM SCIENCES) - BD GENEOHM MRSA ACP ASSAY K093346 DKT 1996P-0460 - CLOTRIMAZOLE COMMENT #CP1 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KENDLE REGULATORY AFFAIRS HANDYLAB - GBS ASSAY; JAGUAR INSTRUMENT; DNA EXTRACTION STRIP; E3 EXTRACTION REAGENT; BD MAX GBS ASSAY K090191 CEPHEID - XPERT MRSA/SA NASAL ASSAY K100822 Signature/ Requester Subject FOI DAILY LOG 5/9-13//11
Page 227 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-4089 06/03/2011 07/01/2011 2011-4090 06/03/2011 07/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4091 2011-4092 2011-4093 2011-4094 2011-4095 2011-4096 2011-4097 2011-4098 2011-4099 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/03/2011 07/01/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4100 06/06/2011 07/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BARBAR A KOCHANOWSKI CONSUMER HEALTHCARE PRODUCTS ASSOCIATION FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ CROWELL & MORING CHRISTINE FORGUES MORGAN LEWIS CHRISTINE FORGUES MORGAN LEWIS WILLIAM GREENROSE QSERVE AMERICA MICHAEL E PENDERSON WEITZ & LUXEMBERG PC FOSAMAX TABS (ALENDRONATE SODIUM) NDA 20-560; FOXAMAX ORAL SOL (ALENDRONATE 70 MG WEEKLY) nDA 21-1575; FOSAMAX PLUS D TABS (ALENDRONATE SODIUM CHOLECALCIFEROL) NDA 21-762 - APPLICATIONS, MODIFICATIONS OF LABELS, AERS, ETC BENZOCAINE GEL OR LIQUID PRODS - AERS 3/16/11 TO 8/7/11 HOME SKINOVATIONS LTD - SILK'N FLASH N GO K103184 UNILEVER - WARNING LTR CORR 8/23/10 DR PEPPER SNAPPLE CO - WARNING LTR CORR 8/30/10 ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ALICIA B. RICHARDS AQUASOL CORP WHITNEY PHILLIPS NEWS 21 WHITNEY PHILLIPS NEWS 21 WHITNEY PHILLIPS NEWS 21 MYSTICAL ONE JUICES LLC - HACCP VIOLATIONS, INSPS, INJUNCTION RECS 1/11 FOI DAILY LOGS - VETERINARY MEDICINE 5/11 CATALINA OFFSHORE PRODUCTS INC - WARNING LTR 6/4/10 CORR, CLOSEO-UT LTR 3/3/11, INSP RECS WITMER FOODS INC - STATUS OF WARNING LTR 9/9/09 FCN 512, 540, 595, 794, 964 - TOXICOLOGY, TESTING DATA ORA/P-FO/SEA-DO/SCB/ ED McMANUS COMPREHENSIVE CLINICAL DEVELOPMENT SHARON FORNSHELL HUTTON & HUTTON LLC NORTHWEST KINETICS LLC, TACOMA, WA 8/4-7/00, 8/2131/06, 9/5-27/06; CHARLES RIVER CLINICAL SERVICES, TACOMA, WA 8/7-9/08 UNIMED PHARMACEUTICALS LLC - ANDROGEL (TESTOSTERONE GEL) AERS Signature/ Requester INC Subject
Page 228 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4101 06/06/2011 07/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4102 06/06/2011 07/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4103 2011-4104 2011-4105 2011-4106 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/05/2011 2011-4107 06/06/2011 07/05/2011 2011-4108 2011-4109 06/06/2011 07/05/2011 06/06/2011 07/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4110 06/06/2011 07/05/2011 ORA/SW-FO/DALDO/COMPLIANCE/ RON SIMON SIMON & LUKE LLP CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ JAMES F ROGERS NELSON MULLINS RILEY & SCARBOROUG PATRICK J WIGLE TURLEY LAW FIRM MICHAEL E PEDERSON WEITZ & LUXEMBERG PC FOSAMAX TABS (ALENDRONATE SODIUM) NDA 20-560; FOSOMAX ORAL SOL (ALENDRONATE 70 MG CHOLECALCIFEROL) NDA 21-575; FOSOMAX PLUS D TABS (ALENDRONATE SODIUM/CHOLECALCIFEROL) NDA 21-762 - MODIFICATION OF LABEL SAN GAR FRESH CUT PRODUCE CO, SAN ANTONIO, TX 2010 LISTERIA OUTBREAK FROM CELERY INVESTIGATIONS INVESTIGATION OF CONTAMINATED SYRINGES JOSEPH F DYRO - CONTRACT RECS (CERTIFIED) BRANDT, GEERT E ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ Doe J RISK MITIGATION STRATEGIES TO ADDRESS POTENTIAL PRO COAGULANT ACTIVITY IN IMMUNE GLOBULIN PRODS - WORKSHOP TRANS PRESETATIONS 5/17-18/11 ORA/NE-FO/NWE-DO/NWECB/ JOHN CHAPPELL CERICON LLC JOHN CHAPPELL CERICON LLC ZYNO MEDICAL LLC, ME - EIRS, 483S, CO RESP 1/06 TO PRESENT B BRAUN MEDICAL INC, TX - EIRS, 483S CO RESP 1/10 TO PRESENT DOLE - SALAD BLEND FIELD GREENS RECS BRIAN SMITH LEXIS NEXIS COURTLINK INC DIVI'S LABORATORIES LTD, ANDDHRI PRESDESH, INDIA EIRS 1/08 TO PRESENT Doe J CARACO PHARMS OF MICHIGAN/SUN PHARMS OXYCODONE 30MG TABS AERS Signature/ Requester Subject
Page 229 of 1132

Total Records: 12455 Control # 2011-4111 2011-4112 Recd Date / Due Date 06/06/2011 07/05/2011 06/06/2011 07/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4113 2011-4114 06/06/2011 07/05/2011 06/06/2011 07/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ 2011-4115 06/06/2011 07/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4116 06/06/2011 07/05/2011 2011-4117 06/06/2011 07/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4118 2011-4119 2011-4120 06/06/2011 07/05/2011 06/06/2011 07/05/2011 06/06/2011 07/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ ELENA HOWELL HOGAN LOVELLS LLP PAUL W. TRIPP LINCARE INC DR. GEORGE GAGNEJA BIOTRON DIAGNOSTICS INC OPTIGEN INC, FL - EIR, 483, WARNING LTR 1/1/04 TO PRESENT STERLING BIOCHEMICALS, TROY, MI; NUCLEAR DIAGNOSTICS, CA - TRIGLYCERIDES K823341, TOTAL CLOLESTROL REAGENT SET K820950, UREA NITROGEN SOAPTRONIC, LAKE FOREST, CA - 483, EIR 2006 TO 2011 ORA/SW-FO/KAN-DO/COMP/ DR. MICHAEL C. THORP BURLINGTON VETERINARY CENTER FRANCES DUFFY-WARREN, PhD ACTELION CLINICAL RESEARCH INC NASONEX (MOMETASONE FUROATE MONOHYDRATE) NDA 20-762/S023 - APRVL RECS INVESTIGATION MARGARET NAPPI LACHMAN CONSULTANT SERVICES, INC. LIST OF ALL DOMESTIC & FOREIGN INSP FOR DRUG COMPANIES BIORESEARCH MONITORING AND GOOD LABORATORY PRACTICES 5/2011 FDA/OMPT/CDRH/OCER/DFOI/ COREY JASEPH ULTRADENT PRODUCTS INC MARGARET NAPPI LACHMAN CONSULTANT SERVICES, INC. DOMESTIC & FOREIGN INSPS FOR DRUG COMPANIES, BIORESEARCH MONITORING (BIMO) AND GOOD LABORATORY PRACTICES 5/1-31/11 ULTRADENT - CONSEPSIS K924982 Action Office ORA/NE-FO/NYK-DO/NYDCB/ Doe J MARGARET NAPPI LACHMAN CONSULTANT SERVICES, INC. NONCLNCL LABORATORIES FOR GOOD LABORATORY PRACTICES IN 2010 Signature/ Requester Subject CMPLNT #120485
Page 230 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject SET K822237 2011-4121 2011-4122 06/06/2011 07/05/2011 06/07/2011 07/06/2011 2011-4123 2011-4124 06/07/2011 07/06/2011 06/07/2011 07/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4125 06/07/2011 07/06/2011 2011-4126 06/07/2011 07/06/2011 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ ORA/OCI/ ORA/OCI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4127 06/07/2011 07/06/2011 2011-4128 06/07/2011 07/06/2011 2011-4129 06/07/2011 07/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J OC/COS/OES/ OC/COS/OES/ OC/OCC/ ORA/SW-FO/DEN-DO/COMP/ J. ROBERT YEOMAN B&R COMPLIANCE ASSOCIATES LLC MAJOR MEDICAL SUPPLY INC, LONGMONT, CO - EIR 6/07 TO 6/11 LEVAQUIN (LEVOFLOX) - AER HERRMANN, PATRICK SINUNASAL LAVAGE APPEAL MTG - TRANS 3/1/11 FDA/OMPT/CDRH/OCER/DFOI/ MANOJ ZACHARIAS LIBERTY MANAGEMENT GROUP LTD DAVID A. DJRIKIAN KENNEDY & ASSOCIATES PC GRANTON MEDICAL LTD, NORTH ATTLEBORO, MA - C SELF SEAL STERILIZATION POUCHES K052665 FDA INCIDENT RPT #010594617A EHRENPREIS, ELI D FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL GRABELL PROPUBLICA MICHAEL D. LORTON NORTH COAST BIOTECHNOLOGY, INC. L. MARK BONNER NORMAN & EDEM PLLC NUVASIVE - NEUROVISION JJB NEUROLOGICAL MONITORING DEVICE - LBLG 2006 TO PRESENT ACCUTANE, IBD - ISRS 6024349, 6018181, 6010200 ETC DKT & DKT LOG OF FDA-2010-N-0477 OSI SYSTEMS - RAPISCAN SECURE 1000 MDRS
Page 231 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4130 06/07/2011 07/06/2011 2011-4131 2011-4132 06/07/2011 09/01/2011 06/07/2011 07/06/2011 2011-4133 06/07/2011 07/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OF/CFSAN/OCD/EOS/ DEBORAH FERNANDEZ VANDEGRIFT FORWARDING CO INC KRISTI O. SMEDLEY Center for Regulatory Services, Inc. RAQUEL RUTLEDGE MILWAUKEE JOURNAL SENTINEL NANCY W. MATHEWSON OLSSON FRANK & WEEDA NESTLE HEALTH CARE NUTRITION - COMPAT DUALFLO ENTERAL DELIVERY PUMP SET W/SPIKE RIGHT PIERCING SPIKE & 1000 WATER BAG; COMPAT Y SET PUMP SET W/IN LINE Y ADAPTER W/SPIKE RIGHT PIERCING SPIKE RECS DEIBEL LABORATORIES OF ILLINOIS, LINCOLNWOOD, IL 483 2/23/11-4/21/11 SPL NOS 676891 & 676892 TRIAD; H&P RECALL SINCE 1/1/11 FRESH PASTEURIZED CRABMEAT ENTRY NOS 3161912157-2, 316-1911707-5, 316-1911452-8 ETC Signature/ Requester Subject
CANTHAXANTHIN CAP 1C0101 - RECS
2011-4134 2011-4135
06/08/2011 07/07/2011 06/08/2011 07/07/2011
ORA/CE-FO/CHI-DO/CCB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/
RICHARD YOUNGSTROM NYCOMED US INC DWAYNE BOGGS MARTINDALE FEED MILL
2011-4136
06/08/2011 07/07/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CUTSHALL, JAN
LOTRONEX TABS - AER
2011-4137 2011-4138 2011-4139 2011-4140 2011-4141 2011-4142
06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011
ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS
GOLDEN STATE MEDICAL SUPPLY, INC, CAMARILLO, CA EIR, 483, CO RESP 1/19/11-2/2/11 LIFECELL CORP, BRANCHBURG, NJ - EIR, 483 , CO RESP 11/2-12/10 MILLIPORE DRUG DISCOVERY SBU, SAINT CHARLES, MO EIR, 483, CO RESP 11/08 FOI DAILY LOG 5/2-6/11 OHM LABORATORIES USA - EIR, 483, CO RESP 11/10/10 OCTAPHARM AB, STOCKHOLM, SWEDEN - EIR, 483, CO RESP 1/10-20/11
Page 232 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4143 2011-4144 2011-4145 2011-4146 2011-4147 2011-4148 2011-4149 2011-4150 2011-4151 2011-4152 2011-4153 2011-4154 2011-4155 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/27/2011 06/08/2011 07/07/2011 06/08/2011 07/27/2011 06/08/2011 08/30/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/NJ-DO/NJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-26) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS FRANCISCO J CANDAL, MD (NORTHSHORE RESEARCH ASSN), SLIDELL, LOS ANGELES, CA - EIR, 483, CO RESP 10/27/08-11/14/08 TERUMO CARDIOVASCULAR SYSTEMS CORP, ANN ARBOR, MI - EIR, 483, CO RESP 1/10 TO 3/10 ALLURE LABORATORIES INC, HAYWARD, CA - EIR, 483, CO RESP 10/18/10-11/22/10 FOI CLOSED REQUESTS 5/1-31/11 TERUMO CARDIOVASCULAR SYSTEMS CORP, ANN ARBOR, MI - EIR, 483, CO RESP 6/08 TO 8/08 FOI DAILY LOG 5/30/2011 TO 6/3/11 FOI DAILY LOG 5/23-27/11 REGIONAL MEDICAL CENTER OF HOPKINS COUNTY, MADISONVILLE, KY - EIR, 483, CO RESP 1/11/11-2/2/11 RUGER, USA - EIR, 483, CO RESP 4/8/10 POLYCARBON INDUSTRIES INC (DBA PCI SYNTHESIS), NEWBURYPORT, MA - EIR, 483, CO RESP 5/11/10-6/11/10 DR R JUDITH RATZAN, MIAMI, FL - EIR, 483, CO RESP 7/19/10-9/13/10 FOI DAILY LOG 5/16-20/11 FOI DAILY LOG 5/9-13/11 Signature/ Requester Subject
Page 233 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-4156 2011-4157 2011-4158 2011-4159 2011-4160 2011-4161 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/CHI-DO/CCB/ 2011-4162 2011-4163 2011-4164 2011-4165 2011-4166 2011-4167 2011-4168 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 2011-4169 06/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ VAPOTHERM INC - FLOWREST K103316 INTERNAL FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC VAPOTHERM INC - PRECISION FLOW K072845 INTERNAL REVIEWER MEMOS DRAEGER MEDICAL AG & CO KG - VENTSTAR HEATED, INFINITY ID BREATHING CIRCUT HEATED K102618 INTERSURGICAL INC - IINTERSURGICAL HEATED WIRE BREATHING SYS & HUMIDIFICATION CHAMBERS INTERNAL REVIEWER MEMOS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DRAEGER MEDICAL AG & CO KG - VENSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED K102618 VAPOTHERM INC - FLOWREST K103316 CBER/OCTMA/DDOM/ALFB/ ERICA SABLAN ROCHE MOLECULAR SYSTEMS VAPOTHERM INC - PRECISION FLOW K072845 OLERUP SSP AB - OLERUP SSP TYPING KITS BK090042 PEVNY, LORA CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DALDO/COMPLIANCE/ CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. WALTER E CHALKLEY THOMSON REUTERS JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. CEPHAZONE PHARMA, POMONA, CA - EIR, 483, CO RESP 7/12/10-8/26/10 MERCK & CO, GARDASOL - HPV VACCINE VAERS 5/1/11 TO PRESENT CHRISTUS SPOHN HOSPITAL (IRB), MEMORIAL CAMPUS, CORPUS CHRISTI, TX - EIR, 483, CO RESP 1/28/11-2/4/11 MERCK & CO INC, ROTATEQ - ROTAVIRUS VACCINE, LIVE ORAL PENTAVALENT VAERS 5/1-31/11 MERCK & CO INC, PROQUAD - VARICELLA VIRUS VACCINE LIVE, ENCEPHALITIS VAERS 5/1-31/11 SPLS 665246 & 665327 - TEST RESULTS Signature/ Requester Subject
Page 234 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/07/2011 2011-4170 2011-4171 06/08/2011 07/07/2011 06/08/2011 08/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4172 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4173 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4174 06/08/2011 07/07/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ KIERAN D O'DONNELL NY/NJ BAYKEEPER NJ DEPT OF ENVIRONMENTAL PROTECTION (NJDEP); NEW JERSEY DEPT OF HEALTH & SENIOR SERVICES (NJDHSS) STATE OF NJ SHELLFISH PROGRAM COMPLIANCE RPTS, COMM PAST 3 YRS RENOVIS SURGICAL TECHNOLOGIES LLC - RENOVIS T710 EXTERNAL FIXATION SYS K110965 SIMPLY THICK - INVESTIGATION RECS; INDIVIDUAL RECS WALTER E CHALKLEY THOMSON REUTERS MOEHS CANTABRA, RUBI, SPAIN - EIRS, 483S, CO RESP 12/13-17/10 WALTER E CHALKLEY THOMSON REUTERS MILLIPORE BIOPHARMA SERVICES, ABINGDON, UK - EIRS, 483S, CO RESP 9/10 FOI SERVICES INC WALTER E CHALKLEY THOMSON REUTERS MILLIPORE (UK) LTD, LIVINGSTON, UK - EIRS, 483S, CO RESP 9/09 Action Office Signature/ Requester FOI SERVICES INC Subject REVIEWER MEMOS CLOSED FOI REQUESTS 5/30/11-6/3/11
2011-4175 2011-4176
06/08/2011 07/07/2011 06/08/2011 07/07/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
TIFFANY M SISLER DEROYAL ERICHAGERMAN PRITZKER OLSEN ANDRENE HERON ROCHE DIAGNOSTICS CORP
2011-4177
06/08/2011 07/07/2011
LIFESCAN INC - ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYS K093745; ABBOTT DIABETES CARE INC FREESTYLE LIFE BLOOD GLUCOSE MONITORING K092602; INFOPIA CO LTD - ENVISION BLOOD GLUCOSE TEST SYS K082020, ETC CYNOSURE INC - K062321
2011-4178
06/08/2011 07/07/2011
FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
ANITA JOHNSON GARY C JOHNSON ATTYS
Page 235 of 1132

Total Records: 12455 Control # 2011-4179 Recd Date / Due Date 06/08/2011 07/07/2011 2011-4180 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4181 2011-4182 2011-4183 2011-4184 2011-4185 2011-4186 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 2011-4187 2011-4188 2011-4189 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4190 2011-4191 06/08/2011 07/07/2011 06/08/2011 ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/NOL-DO/NOCB/ Doe J CHERIE SMTIH INGREIDENTS CORPORATION OF AMERICA, MEMPHIS, TN EIR 6/09, 3/10, 11/10 CONSTELLATION WINES US - CMPLNT MERCK & CO., INC. ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN . MERCK & CO - ISENTRESS (RALTEGRAVIR) ISR 6522179-8 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ GERHARDT, NATHAN REEDS INC - 483, EIR 10/27/10-11/12/10 SOLUBLE PRODUCTS CO - 483, EIR 8/4-12/10 GERHARDT, NATHAN GERHARDT, NATHAN . OMEGA NUTRITION USA INC - 483, EIR 12/6-7,21/10 ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN NATURAL PATH - 483, EIR 8/3-5/10 ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN . GOD'S GARDEN PHARMACY - 483, EIR 1/14,18,20/11 ORA/CE-FO/NJ-DO/NJCB/ GERHARDT, NATHAN . NUVONYX INC - 483, EIR 10/18-21/10 ORA/CE-FO/NJ-DO/NJCB/ GERHARDT, NATHAN GASPARI NUTRITION INC - 483, EIR 9/2710-11/1/10 RASI LABS INC - 483, EIR 8/17/10- 9/3/10 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ROSINA ROBINSON RN MEDICAL DEVICE CONSULTANTS INC DEIRDRE R KOLE DRINKER BIDDLE & REATH LLP Subject MAQUET CADIOPULMONARY AG - CARDIOHELP SYS K102726 SCHERING CORP - TRIALFON (PERPHENAZINE) TABS NDA 10-775, NDA 11-213, NDA 11-557, ETC RECS
Page 236 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/07/2011 2011-4192 06/08/2011 07/07/2011 2011-4193 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4194 06/08/2011 07/07/2011 2011-4195 2011-4196 2011-4197 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4198 06/08/2011 07/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4199 2011-4200 2011-4201 2011-4202 2011-4203 2011-4204 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/08/2011 07/07/2011 06/09/2011 07/08/2011 06/09/2011 07/08/2011 06/09/2011 ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP MARILYNN WHITNEY COVINGTON & BURLING LLP JOSH HART SIDLEY AUSTIN LLP EILEEN BOYLE HOLOGIC ENGINEERING EILEEN BOYLE HOLOGIC ENGINEERING BARRY SHLACHTER LIST OF FOOD MFRS IN TARRANT, WISE, HOOD, PARKER, SPINEANALYER MODEL SAPOC - K103475 GE LUNAR - VISCERAL FAT SOFTWARE K103730 DKT FDA-2010-P-0614 DKTS 1987P-0024, 1998P-0221 DKTS 1987P-0210, 2001P-0574, 1987P-0024 BRIAN SMITH LEXISNEXIS COURTLINK INC DIVIS LABORATORIES, HYDERABAD, INDIA - DOCS 1/1/00 TO 12/31/03 ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ E MARK BONNER NORMAN & EDEM PLLC L MARK BONNER NORMAN & EDEM PLLC MATTHEW S. KNOOP,Esq. ASHE RAFUSE & HILL LLP BRIAN SMITH LEXISNEXIS COURTLINK INC MEDTRONIC INC, MEDTRONIC SOFAMORE DANEK USA INC, WARSAW ORTHOPEDIC INC - CD HORIZONS SPINAL SYS CLNCL STUDIES, 510K, PI, ETC NU VASIVE - NEUROVISION JJB NEUROLOGICAL MONITORING DVC 510K (CERTIFIED) RIVERS EDGE PHARMACEUTICALS LLC, SUWANEE, GA 11/2/09, 12/18/09, 2/11/10, 5/21/10 LETTERS DIVIS LABORATORIES LTD, HYDERABAD, INDIA - INSP RECS 1/04 TO 12/07 Doe J Action Office ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester SCHNUCK MARKETS, INC CHRISTOPHER SHAKIB, Esq. TERRELL HOGAN ELLIS YEGELWEL PA MEDTRONIC - IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MDRS VIOXX; CELEBEX - AER Subject
Page 237 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/08/2011 2011-4205 2011-4206 2011-4207 2011-4208 2011-4209 06/09/2011 07/08/2011 06/09/2011 07/08/2011 06/09/2011 07/08/2011 06/09/2011 07/08/2011 06/09/2011 07/08/2011 2011-4210 2011-4211 2011-4212 06/09/2011 07/08/2011 06/09/2011 07/08/2011 06/09/2011 07/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4213 06/09/2011 07/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4214 06/09/2011 07/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4215 2011-4216 06/09/2011 07/08/2011 06/09/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ TIMOTHY J TALCOTT SMITHS MEDICAL ASD INC METTE AABY ANDERSEN LUNDBECK - SERDOLECT APRVL, CLNCL TRIAL RECS SMITHS MEDICAL ASD INC, SOUTHINGTON, CT - EIR 8/25/04 NICHOLAS M WARNER SEGAR SCIORTINO DEPUY - ASR XL ACETABULAR SYS APRVL, CMPLNTS, MDRS ETC 1/07 TO PRESENT ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ACTIVIS MID ATLANTIC - INFANTS' FEVERALL NDA 18337/S013 APRVL LTR, RVWS, RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ SHER S KUNG PERKINS COIE COLEEN KLASMEIER SIDLEY AUSTIN LLP ALIA HUSAIN WEITZ & LUXEMBERG PC RADSCAN MEDICAL EQUIPMENT INC, PHOENIX, AZ RADSCAN EQUIPMENT SLICKER K101350 BIOMET INC - M2A-38 METAL ARTICULATION, M2AMAGNUM LARGE METAL ARTICULATION, M2A-MAGNUM SPIKE LARGE METAL ARTICULATION CLNCL TRIALS, MDRS, MEMOS, ETC CHATTANOOGA GROUP INC - BALANCE SYS K884926 FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ CATON, CATHRYN HAMID R DJALILLAN MD UNIV OF CALIFORNIA - IRVINE HAMID R DJALILLAN MD UNIV OF CALIFORNIA - IRVINE JORDAN L LURIE WEISS & LURIE TINNITUS OTOSOUND PRODUCTS LLC - CUSTOMIZED SOUND THERAPY K070599 NEUROMONICS PTY LTD - NEUROMONICS TINNITUS TREATMENT K043274 SYBARITIC INC - LASERPEEL, ERBIUM LASER PRODS 510K, IDE, CORR, ETC Action Office ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester FORT WORTH STAR-TELEGRAM HAMID R DJALILIAN UNIV OF CALIFORNIA - IRVINE HERBOLOGICS (LUMEN FOODS) - RECS Subject JOHNSON COUNTIES, TX WIDEX HEARING AID CO - MIND 440 HEARING AID K080955
Page 238 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/08/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4217 06/09/2011 10/14/2011 2011-4218 06/09/2011 07/08/2011 2011-4219 06/09/2011 07/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4220 06/09/2011 07/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4221 06/09/2011 07/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4222 06/09/2011 07/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4223 06/09/2011 07/08/2011 2011-4224 06/09/2011 07/08/2011 2011-4225 06/09/2011 07/08/2011 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JACK AURORA HISUN PHARMACEUTICAL (HANGZHOU) CO LTD MERCK - COZAR TABS NDA 20-386 APRVL RECS Gumpert, David ROBERT ROWLAND TANTUS TOBACCO CIGARETTE FILTER TUBES - APRVLS ISSUED IN ACCORDANCE WITH SECTIONS 905, 910 OF THE TOBACCO CONTROL ACT ALVIN SCHLANGEN, SCHLANGEN FAMILY FARM - CORR, RPTS 2009 TO 2011 Doe J LEVOFLOX - INDIVIDUAL RECS JING XIA ESQ BUDD LARNER ET AL KUVAN (BH4, SAPROPTERIN, PHENOPTIN, BIOPTEN) EMERGENCY, INDIVIDUAL PATIENT INDS MICHAEL R COHEN RPH MS SCD INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 5/1/11 TO 6/1/11 CBER/OCTMA/DDOM/ALFB/ DIANE M HARPER UNIV OF MIISSOURI KANSAS CITY SCHOOL OF MEDICINE RICHARD A ABRAMS GREEN HAINES SGAMBATI CO LPA J MARK POHL PPA LLC EXOGENOUS SEX HORMONES - ANALYSIS SIEMENS - AXIOMARTIS DBC RPTS MERCK - GARDASIL BLA SBLA 125126/773 Signature/ Requester DANISH BROADCASTING CORP Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4226 2011-4227 2011-4228 2011-4229 2011-4230 2011-4231 2011-4232 2011-4233 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 08/30/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4234 2011-4235 2011-4236 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ 2011-4237 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J LEVAQUIN - CAUSES OF DEATH OUTCOMES FDA/OMPT/CDRH/OCER/DFOI/ DEXTER, PHYLLIS BRENDA M GARTZ ELI LILLY & CO LONZA, PORTSMOUTH, NH - EIR 3/29/10, 7/19/10 FDA/OO/OFBA/OAGS/ WOLF, LOU SILICONE BREAST IMPLANT RUPTURE - MDRS HEITECH SERVICES INC - SERVICE CONTRACTS CREMER, KARL ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC FOI SERVICES INC PFIZER, NY - 483 6/29/09-8/10/09; WARNING LTR 5/26/10, CO RESP SEVOFLURANE - TOXICOLOGY STUDIES FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC IMPAX LABS, HAYWARD, CA - 483S, CORR 12/13/10-1/21/11 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC INTEL CORP - INTEL HEALTH GUIDE MODEL PHS6000 K0080798 DALLEN MEDICLA - COMPRESSYN BAND K101484 OC/OSHC/OPD/ FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC SHIRE HUMAN GENETICS THERAPIES INC, CAMBRIDGE, MA - VPRIV (VELAGLUCERASE-ALFA) ORPHAN DESIGNATION CIVATECH ONOCOLOGY - CIVASTRING PD-103 K082159 BRENDA PINKNEY - COMM 1/04 TO PRESENT Signature/ Requester Subject
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Total Records: 12455 Control # 2011-4238 2011-4239 2011-4240 2011-4241 Recd Date / Due Date 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 06/10/2011 07/11/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4242 06/10/2011 07/11/2011 2011-4243 2011-4244 06/10/2011 07/14/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4245 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ 2011-4246 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ 2011-4247 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP LIFETECH RESOURCES LLC - NEUVEAUBROW ACTIVE EYEBROW TECHNOLOGY WARNING LTR RESP, CMPLNTS, ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP LIFETECH RESOURCES LLC - RAPIDLASH EYELASH RENEWAL SERUM WARNING LTR RESP, CMPLNTS, CORR, ETC ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP ROCASUBA INC - RAPIDLASH EYELASH RENEWAL SERUM WARNING LTR RESP, CMPLNTS, CORR, ETC FDA/OF/CFSAN/OCD/EOS/ Doe J CHRISTOPHER CAPONETTI Morgan Stanley SANDOZ - ENOXAPARIN SODIUM INJ CORR, NOT APPROVABLE LTR 11/7/07 FDA/OMPT/CDRH/OCER/DFOI/ SCHMIDT, DAVID A METHODOLOGY TO USE MEDICARE CLAIMS DATABASE TO EVALUATION DEVICE SAFETY: EVALUATION OF UROGYNECOLOGIC SURGICAL MESH - STUDY FINDINGS FCN 889 CREMER, KARL THOMPSON, RAY ORA/CE-FO/NJ-DO/NJCB/ Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester RICARDO RONQUILLO NEUROGESX INC LINDA BOWEN SANOFI AVENTIS HUMAN DRUG, HUMAN MEDICAL DVC FIRMS - GMP, GLP, GCP INSPS 1/11 TO 5/11 INSOFLURANE - TOXICOLOGY STUDIES Subject CLINDATA SERVICES, BLOOMINGTON, IN - EIRS, 483S, WARNING LTRS ETC 1/10 TO PRESENT BASF CORP, WASHINGTON, NJ - EIR, 483 3/11
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ 2011-4248 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ 2011-4249 06/10/2011 07/11/2011 2011-4250 2011-4251 06/10/2011 07/11/2011 06/10/2011 07/11/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4252 2011-4253 06/10/2011 08/30/2011 06/10/2011 07/11/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4254 2011-4255 06/10/2011 07/11/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NYK-DO/NYDCB/ DONALD N BLUE ZETETIC ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP ROCASUBA INC - NEUVEAUBROW ACTIVE EYEBROW TECHNOLOGY WARNING LTR. CORR, CMPLNTS ENTRY # EB515069376 - RECS ANNEMIEKE M TENNIS KANNER & WHITELEY LLC JOSEPH S ROSS MD MHS YALE SCHOOL OF MEDICINE IMPAX LABS INC, HAYWARD, CA - WARNING LTR, CO RESP 12/13/10 TO 1/21/11 TEVA - FENOFIBRATE ANDA 75-753, ANDA 76-433; IMPAX LABS - FENOFIBRATE ANDA 75-868, ETC PROMOTIONAL LBLG FDA/OF/CFSAN/OCD/EOS/ DAWSON, WIN JOSEPH S ROSS MD MHS YALE SCHOOL OF MEDICINE ORA/SE-FO/ATL-DO/ACB/ MARGARET M GROVES DUKE UNIV/SCHOOL OF MEDICINE BEARELLY, SRILAXMI , MD. (DUKE UNIV EYE CTR), DURHAM, NC - EIR, 483 11/11/10-12/10/10 DOW CHEMICAL CO - PENTASODIUM EDTA & TRISODIUM EDTA FAP 7B4023 ABSTRAL (FENTANYL) SUBLINGUAL TABS NDA 22-510; ACTEMRA (TOCILIZUMAB) INJ BLA 125276/22,23; ACTONEL (RISEDRONATE SODIUM) NDA 20-835/S042,S043, ETC RISK EVALUATION & MITIGATION STRATEGY (REMS) NOTIFICATIONS ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP LIFETECH RESOURCES LLC - NEULASH ACTIVE EYELASH TECHNOLOGY WARNING LTR RESP, CMPLNTS, CORR, ETC Signature/ Requester Subject CORR, ETC
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NWE-DO/NWECB/ 2011-4256 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ 2011-4257 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4258 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4259 06/10/2011 FDA/OMPT/CDER/ORP/DIDP/ ANNE Y. BRODY SKIN RESEARCH LABS - NEUVEAU BROW ACTIVE ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP SKIN RESEARCH LABS - RAPID LASH EYELASH RENEWAL SERUM WARNING LTR, CORR, CMPLNTS ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP SKIN RESEARCH LABS - NEULASH ACTIVE EYELASH TECHNOLOGY WARNING LTR, CORR, CMPLNTS ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP ROCASUBA INC - NEULASH ACTIVE EYELASH TECHNOLOGY WARNING LTR, CORR, CMPLNTS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 07/11/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ 2011-4260 2011-4261 2011-4262 2011-4263 06/10/2011 07/29/2011 06/10/2011 10/13/2011 06/10/2011 10/13/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4264 2011-4265 06/10/2011 07/11/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4266 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4267 2011-4268 06/10/2011 07/11/2011 06/10/2011 07/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4269 06/13/2011 07/12/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ WALTER E CHALKLEY THOMSON REUTERS CATALENT PHARMA SOLUTIONS, WOODSTOCK, MI - EIRS, 483S, CO RESP 8/10 TO 1/11 FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE M. BURNS DISCOVERY LABORATORIES INC LINDA BOWEN Sanofi Aventis Corporation MONAGHAN MEDICAL CORP - AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER K012939 SANOFI CHIMIE; SANOFI-AVENTIS RECHERCHE & DEVELOPMENT, PARIS, FRANCE - EIRS 4/26-30/10 JACK AURORA, PhD. HISUN PHARMACEUTICAL (HANGZHOU) CO LTD MERCK - COZAAR NDA 20-386 APRVL 4/95 FDA/OMPT/CDRH/OCER/DFOI/ HANKUK LEE DAEWOONG AMERICA INC DR. AMY GIOVINO SARASOTA MEMORIAL HEALTH CARE SYSTEM MEDTRONIC SOFAMOR DANEK - INFUSE BONE GRAFT NON CLNCL LABORATORY STUDY CEPHALEXIN - AER Willis, Jerome CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ELIZABETH DOCHERTY B BRAUN MEDICAL INC ELIZABETH DOCHERTY B BRAUN MEDICAL INC ELIZABETH DOCHERTY B BRAUN MEDICAL INC TEVA PARENTERAL MEDICINES INC - HETASTARCH PLASTIC BAGS BA 740592 APRVL RECS HOSPIRA - HETASTARCH GLASS BOTTLES BA 720746 APRVL RECS REGLAN - AER, CMPLNTS HOSPIRA - HETASTARCH BA 740193 APRVL RECS Signature/ Requester GIBSON DUNN & CRUTCHER LLP Subject EYEBROW TECHNOLOGY WARNING LTR, CORR, CMPLNTS
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Total Records: 12455 Control # 2011-4270 2011-4271 2011-4272 2011-4273 2011-4274 2011-4275 2011-4276 2011-4277 2011-4278 2011-4279 2011-4280 Recd Date / Due Date 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/29/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4281 06/13/2011 07/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4282 06/13/2011 07/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4283 06/13/2011 FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY TARO PHARMACEUTICAL LTD, HAIFA BAY, ISREAL - EIRS, WALTER E CHALKLEY THOMSON REUTERS PAREXEL INTL, BERLIN, GERMANY - EIRS, 483S, CO RESP 9/10 WALTER E CHALKLEY THOMSON REUTERS CIPAN, LISBOON, PORTUGAL - EIRS, 483S, CO RESP 9/28/10 TO 10/1/10 ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ Action Office ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/NJ-DO/NJCB/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS WALTERE CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKELY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKELY THOMSON REUTERS PATHEON, CINCINNATI, OH - EIRS, 483S, CO RESP 8/10 TO 1/11 LUPIN LTD, INDIA - EIRS, 483S, CO RESP 2009 Subject AMGEN, THOUSAND OAKS, CA - EIRS. 483S, CO RESP 12/10 TO 2/11 NOVARTIS PHARMACEUTICAL, EAST HANOVER, NJ - EIRS, 483S, CO RESP 3/22/10-4/20/10 OMJ PHARMACEUTICAL, SAN GERMAN, PR - EIRS, 483S, CO RESP 6/8-11/09 WYETH PHARMS, SANFORD, NC - EIRS, 483S, CO RESP 8/3-7/09 INVAGEN PHARMS, HAUPPAUGE, NY - EIRS, 483S, CO RESP 8/4-10/10 PHARMACAL CORP, HAUPPAUGE, NY - EIRS, 483S, CO RESP 1/08 PHARMACAL CORP, HAUPPAUGE, NY - EIRS, 483S, CO RESP 4/10 SANOFI AVENTIS US, BRIDGEWATER, NJ - EIRS, 483S, CO RESP 4/16/10-5/13/10 PF LABS, TOTOWA, NJ - EIRS, 483S, CO RESP 5/10
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Total Records: 12455 Control # Recd Date / Due Date 07/12/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4284 2011-4285 06/13/2011 08/09/2011 06/13/2011 07/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4286 2011-4287 06/13/2011 07/12/2011 06/13/2011 07/12/2011 2011-4288 06/13/2011 07/12/2011 2011-4289 2011-4290 06/13/2011 07/12/2011 06/13/2011 07/12/2011 2011-4291 2011-4292 06/13/2011 07/29/2011 06/13/2011 07/12/2011 2011-4293 2011-4294 2011-4295 2011-4296 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY PRIMAPHARMA, SAN DIEGO, CA - EIR, 483, CO RESP LEHIGH VALLEY TECHNOLOGIES, ALLENTOWN, PA - EIR, 483, CO RESP 7/1-7/09 MDS PHARMA SERVICES, LINCOLN, NE - EIR, 483, CO RESP 8/27/09-9/4/09 PFIZER, NEW LONDON, CT - EIR, 483, CO RESP 5/4/09-6/3/09 ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS KFORCE CLINICAL RESEARCH, TAMPA,FL - EIR, 483, CO RESP 5/21/09-6/11/09 ELI LILLY, INDIANAPOLIS, IN - EIR, 483, CO RESP 7/19-28/10 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ DANIEL M SILVER MCCARTER & ENGLISH LLP JENNIFER ALLGAIR CENTURION RESEARCH SOLUTIONS JOHN PRUET SERVICES EMPLOYEES INTERNATIONAL UNION CHRISTOPHER A SUMMERS GORDON & REES LLP ADAM KANTER ORGANICS MANAGEMENT LLC LIST OF FOOD & BEVERAGE MFRS IN PUERTO RICO PUBLIC HEALTH SERVICES, INDIAN HEALTH SERVICES, FOOD & DRUG ADMINISTRATION - CONTRACT CODES, OPERATIONS MANUALS, GUIDANCE INSTRUCTIONS, ETC HYDROXYCUT - CAERS 2002 TO PRESENT DYNANET CORP - GS06F0067Z CERAMOPTEC INC - K955665 CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY THOMSON REUTERS JUBI SINGH INNOPHARMA LLC CANGENE CORP, WINNIPEG, CANADA - EIRS, 483S, CO RESP 4/12-22/10 ALCON PHARMS - TRIFLURIDINE OPHTHALMIC SOL ANDA 74-311 SBA; MONARCH PHARMA - INNOVATOR'S NDA 18299 SBA Signature/ Requester THOMSON REUTERS Subject 483, CO RESP 9/09 TO 5/10
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Total Records: 12455 Control # Recd Date / Due Date 07/12/2011 2011-4297 2011-4298 2011-4299 2011-4300 2011-4301 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/13/2011 07/12/2011 2011-4302 2011-4303 2011-4304 2011-4305 06/13/2011 07/12/2011 06/13/2011 07/12/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4306 06/14/2011 07/13/2011 CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ OC/OCC/ 2011-4307 06/14/2011 07/13/2011 2011-4308 2011-4309 06/14/2011 07/13/2011 06/14/2011 CVM/OCD/ ORA/ ORA/ OC/OER/OPA/ CVM/OCD/ RAQUEL RUTLEDGE MILWAUKEE JOURNAL SENTINEL ARLENE MORALES BURDOCK GROUP WILLIAM R LANCE DVM PHD ETORPHINE HCL NADA 047-870 - RECS DRUG MFRS - NUMBER OF WARNING LTRS, SEIZURES OF PRODS, CITATIONS, ETC 1/00 TO 4/11 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS DUFF WILSON NEW YORK TIMES VANESSA CARR UNIVERSITY OF CALIFORNIA AT BERKELEY JENNIFER SORENSON NATURAL RESOURCES DEFENSE COUNCIL/NRDC GENTRAC INC, MIDDLETON, WI - EIR, 483, CO RESP 1/2028/10 MARLIN COMPANY INC, LENOIR, NC - EIR, 483, CO RESP 6/3-11/09 STRYKER COMMUNICATIONS,FLOWER MOUND, TX - EIR 10/11/09 ROSE ACRE FARMS, REMBRANDT ENTERPRISES, IOWA INSPS 2008 TO PRESENT ANTIBIOTICS IN ANIMAL FEEDS - GUIDELINES, CRITERIA, CORR; SURVEILLANCE OF THE FLOW OF SALMONELLA & CAMPYLOBACTER IN A COMMUNITY - RPT 1984, ETC ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/SJN-DO/SJCB/ Action Office ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS Subject 1/10/11-2/2/11 SANOFI-AVENTIS US, KANSAS CITY, MO - EIR, 483, CO RESP 8/9-18/10 TEVA PARENTERAL MEDICINES, IRVINE, CA - EIR, 483, CO RESP 7/13-24/09 APP PHARMS, BARCELONA, PR - EIR, 483, CO RESP 5/1928/09 3M DRUG DELIVERY SYTEMS, NORTHRIDGE, CA - EIR, 483, CO RESP 8/10 TO 1/11 CHRISTOPHER CHAPPEL MD, KISSIMMEE, FL - EIR, 483, CO RESP 10/22/07-11/21/07
Y-TEX CORP - POLYSORBATE 80 CORR 3/3/08, 4/4/08
Page 247 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/13/2011 2011-4310 2011-4311 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4312 06/14/2011 07/13/2011 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ 2011-4313 06/14/2011 07/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-4314 2011-4315 2011-4316 2011-4317 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4318 2011-4319 06/14/2011 07/13/2011 06/14/2011 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SEA-DO/SCB/ EDDIE ANDERSON D4D TECHNOLOGIES AMY ERICKSON HAGEN EUROPEAN SPERM BANK USA, SEATTLE, WA -EIRS, 483S, D4D TECHNOLOGIES, RICHARDSON, TX - EIR 5/15-22/06 READE, SEAN ALAN FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ GERI L HAIGHT MINTZ LEVIN ET AL WHITNEY PHILLIPS NEWS21 PAUL HARDIMAN IRIDEX CORP BAYER HEALTHCARE - LAMPIT (NIFURTIMOX) AERS SYNTHES USA PRODUCTS LLC - HEMOSTATIC BONE PUTTY (HBP) K103822 LIST OF COMPANIES WITH HACCP VIOLATIONS 9/09 TO PRESENT MDRS MW5015543, MW5017084, MW5017755, ETC PATTI WALLER MARLER CLARK ATTYS DEL MONTE FRESH PRODUCE, COSTCO WHOLESALE CANTALOUPE SALMONELLA PANAMA OUTBREAK TEST RESULTS,CORR, HARVEST RECS, ETC FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester WILDLIFE PHARMACEUTICALS TERISA PRICE INASSIST JASON SNYDER PADUANO & WEINTRAUB LLP MICHAEL B MCCOLLUM FOLEY & LARDNER LLP FINAL RPT IN THE LONG TERM STUDY OF PRODISC-L 9/20/10 FACTOR HEALTH MANAGEMENT LLC, FCS PHARMACY LLC, FELDMAN'S MEDICAL CENTER PHARMACY INC, T ZENON PHARMACEUTICALS LLC - CORR, CMPLNTS, RPTS, ETC SYNTHES - PRODISC-L TOTAL DISC REPLACEMENT INVESTIGATION RECS Subject
Page 248 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/13/2011 2011-4320 2011-4321 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4322 2011-4323 2011-4324 2011-4325 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4326 06/14/2011 07/13/2011 2011-4327 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4328 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4329 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4330 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DENISE L. KWIATKOWSKI SCIENTIFIC PROTEIN LABORATORIES NANJING MAOHAI - 483, EIR, WARNING LTR LAST 2 INSPS DENISE L. KWIATKOWSKI SCIENTIFIC PROTEIN LABORATORIES YANTAI DONGCHENG BIOCHEMICAL - EIR, 483, WARNING LTR FOI SERVICES INC ASTRA ZENECA - SYMBICORT NDA 21-929/S012 APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ CVM/OCD/ ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ CVM/OCD/ KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. GABRIEL J MURACA JR HARVEST TECHNOLOGIES CORP GABRIEL J MURACA JR HARVEST TECHNOLOGIES CORP DENISE L. KWIATKOWSKI SCIENTIFIC PROTEIN LABORATORIES HILLS PET NUTRITION - ALPHA-LIPOIC ACID ANIMAL GRAS 3 LALLEMAND SPECIALTIES - VIRGINIAMYCIN ANIMAIL GRAS 4 EMERALD CAROLINA CHEMICALS - POLYETHYLENE GLYCOL (400) DIOLEATE ANIMAL GRAS 6 LIPOSE CORP - LIPOSE FAT TRANSFER SYS K081848, K093067 BIOMET BIOLOGICS INC - VORTECH ADIPOSE TRANSFER SYS K100114 NANJING KING BIOCHEMICAL PHARMACEUTICAL - EIR, 483, WARNING LTR ORA/P-FO/SAN-DO/SFCB/ O'BRIEN, MARY JOE CARMOSINO MANILDRA MILLING CORP VITAL WHEAT GLUTEN ENTRY #WV7-7007950-0 - LAB RPT Action Office Signature/ Requester CRYOGENIC LABORATORIES INC Subject CO RESP 5/05 TO PRESENT JAZZ PHARMS - XYREM 483 5/11
Page 249 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4331 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4332 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4333 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4334 2011-4335 06/14/2011 07/13/2011 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4336 2011-4337 06/14/2011 07/13/2011 06/14/2011 07/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4338 2011-4339 06/14/2011 07/13/2011 06/14/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP ANNE Y BRODY LA CANADA VENTURES INC, SAN MATEO, CA - MD LASH FACTOR CMPLNTS, CORR JAN MARINI SKIN RESEARCH INC, SAN JOSE, CA - AGE ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP ATHENA COSMETICS INC - REVITABROW EYEBROW CONDITIONER CMPLNTS, CORR ATHENA COSMETICS INC - REVITALASH EYELASH CONDITIONER CMPLNTS, CORR OM/OMP/DODM/ FOI SERVICES INC BENJAMIN L. ENGLAND, Esq. BENJAMIN L ENGLAND & ASSOCIATES LLC FDA GUIDANCE OF INDUSTRY, ELECTRONIC SOURCE DOCUMENTATION IN CLININCAL INVESTIGATIONS 12/10 NOVARTIS - LAMISIL AT NDA 21-958, 21-124 CLNCL TESTS, RPTS, CORR FOI SERVICES INC YUNG ZIP CHEMICAL INDUSTRIES CO, TAICHIA, TAICHUNG, TAIWAN - EIR, 483, WARNING LTR, ETC 8/6-9/07 DENISE L. KWIATKOWSKI SCIENTIFIC PROTEIN LABORATORIES ZHEJIANG NATIVE PRODUCT & ANIMAL BY PRODUCT - EIR, 483, WARNING LTR MOST RECENT DENISE L. KWIATKOWSKI SCIENTIFIC PROTEIN LABORATORIES CHANGZHOU QUINHONG BIOCHEMICAL PHARMACEUTICAL - EIR, 483, WARNING LTR Signature/ Requester Subject
Page 250 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/13/2011 Action Office ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4340 2011-4341 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4342 06/14/2011 07/13/2011 2011-4343 06/14/2011 07/13/2011 2011-4344 06/14/2011 07/13/2011 2011-4345 06/14/2011 07/13/2011 2011-4346 06/14/2011 07/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4347 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4348 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J CYBALTA - STEVENS JOHNSON SYNDROME SUSAN TODD WEST-WARD PHARMACEUTICAL CORP ABBOTT - ZEMPLAR (PARICALCITOL) RVWS, BIOEQV, SUMMARY MARTIN JAMES MARTINEZ MPH MARTINEZ LAW OFFICE BACTRIM DS - AERS, RECS FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OCC/ MATTHEW GEORGE WHEELER TRIGG & KENNEDY PC VALARIE N KLOECKER HINSHAW & CULBERTSON LLP ADVANCED BIONICS - COCHLEAR IMPLANT RECALL DISMISSAL ORDER ARTELON STT SPECER - K061956 MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION VALAIERIE N KLOECKER HINSHAW & CULBERTSON LLP ARTELON SPACER CMC-1 - K040070 DIETARY SUPPLEMENT MFRS - GMP INSP 1/10 TO 5/11 ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP VALERIE N KLOECKER HINSHAW & CULBERTSON LLP ATHENA COSMETICS INC - HAIR BY REVITALASH CMPLNTS, CORR ARTELON CMC SPACER - K061954 Signature/ Requester GIBSON DUNN & CRUTCHER LLP Subject INTERVENTION EYELASH CMPLNTS, CORR
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4349 06/14/2011 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4350 2011-4351 2011-4352 2011-4353 2011-4354 2011-4355 2011-4356 2011-4357 2011-4358 2011-4359 2011-4360 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 06/14/2011 07/13/2011 2011-4361 06/14/2011 07/13/2011 2011-4362 06/14/2011 07/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ HOGAN LOVELLS LLP WASHINGTON INFORMATION SOURCE 2011-3393 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 6/6-10/11 Center for Regulatory Services, Inc. FOI DAILY LOG 6/16-20/11 Center for Regulatory Services, Inc. FOI DAILY LOG 5/16-20/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 5/23-27/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 5/23-27/11 DOMINION GROUP INC FOI DAILY LOG 5/16-20/11 DOMINION GROUP INC FOI DAILY LOG 5/23-27/11 FOI SERVICES INC FOI DAILY LOG 5/16-20/11 FOI SERVICES INC FOI DAILY LOG 5/23-27/11 INFORMATION ACCESS FOI DAILY LOG 5/16-20/11 INFORMATION ACCESS FOI DAILY LOG 5/16-20/11 FOI DAILY LOG 5/23-27/11 DALY, KYLE H OTSUKA - SATIVEX CLNCL TRIAL CORR 3/17/11 TO PRESENT Signature/ Requester Subject
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Total Records: 12455 Control # 2011-4363 2011-4364 Recd Date / Due Date 06/14/2011 07/13/2011 06/15/2011 07/14/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4365 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4366 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4367 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4368 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4369 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4370 2011-4371 2011-4372 2011-4373 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LISA CHARTER THERMO FISHER SCIENTIFIC BRIAN BELL BOSTON SCIENTIFIC CORP NICK PALMER KEYSTONE INDUSTRIES MEDICAL PRODUCTS LABORATORIES INC VARNISHAMERICA K040098 RYMED - IN VISION PLUS CS WITH NEUTRAL ADVANTAGE DIAZYME LABS, POWAY, CA - 25-OH VITAMIN D ASSAY KIT, CALIBRATOR SET, CONTROL KIT K102432 PATIENT PROBLEM CODE (F10) - MDRS 1/06 TO PRESENT KUMARA SEKAR DR REDDY'S LABORATORIES INC APP - DIPRIVAN NDA-19-627 SBA KIM ERNST DR REDDY'S LABORATORIES INC ACTAVIS -CLOBETASOL PROPIONATE SHAMPOO ANDA 78-854 SBA CYNTHIA A IPATCH COMPLIANCE INSIGHT INC YANTIAI DONGCHENG BIOCHEMICAL - QINGDAO SHANDONG, CHINA - EIRS, CONTRACTS, DRAFTS, ETC CYNTHIA A IPACH COMPLIANCE INSIGHT INC NANJING KING FRIEND BIOCHEMICAL PHARMS, JIANZSU, CHINA - EIRS, CONTRACTS, DRAFTS, ETC CYNTHIA A IPACH COMPLIANCE INSIGHT INC CHANGZHOU QIAHONG BIOCHEMICAL PHARMS, WEJIING CITY, CHINA - EIRS, CONTRACTS, DRAFTS, ETC HOGAN LOVELLS LLP CYNTHIA A IPCH COMPLIANCE INSIGHT INC ZHEIJANG NATIVE PRODUCE & ANIMAL BY- PRODUCTS, ZHEJIONG, CHINA - EIR, CONTRACTS, DRAFTS, ETC Signature/ Requester Subject 2011-3472
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Total Records: 12455 Control # Recd Date / Due Date 07/14/2011 2011-4374 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4375 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4376 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4377 06/15/2011 07/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4378 06/15/2011 07/14/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ 2011-4379 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DAVID A RAY FIRST LAW GROUP GUIDANCE FOR INDUSTRY AND FDA: ADVISORY LEVELS FOR DEOXYNIVALENOL (DON) IN FINISHED WHEAT PRODUCTS FOR HUMAN CONSUMPTION AND FRAINS AND GRAIN BY-PRODUCTS USED FOR ANIMAL FEED (CERTIFIED) PERRIGO, ALLEGAN, MI - EIR 1/11 TO 5/11 WATSON LABORATORIES INC, WATSON PHARMA INC, ANDRX PHARMACEUTICALS INC - TAZTIA, TIAZAC, CARDIZEM, ETC CORR, TESTING, INSPS, ETC; CMPLNT 72995 KHUSHI K DESAI Earthjustice AQUABOUNTY TECHNOLOGIES - GENETICALLY ENGINEERED AQUADVANTAGE SALMON LAB STUDIES, MFG PROCESS, LBLG, ETC JONATHAN L GOULD LAW OFC JONATHAN L GOULD SIMVASTATIN ANDA 19-766/S077 - RECS CHARLES CELESTE EAS Consulting Group, LLC CLOBETASOL PROPIONATE TOPICAL LOTION ANDA 78-223 - APRVL LTR, LBLG, CHEMISTRY RVW, ETC REBECCA COLEMAN THERAVANCE INC NDA 21-929/S012 - RVWS ASKEROVA, ZENA Action Office Signature/ Requester ARSENYEV, ALEZX Subject K093489 PANTARAZOLE, GLIPIZIDE, AMOXICILLIN ETC - AERS 4/1/10 TO 6/30/10
2011-4380 2011-4381
06/15/2011 07/14/2011 06/15/2011 07/14/2011
ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/
MARLA PHILLIPS XAVIER UNIV JOHN T BOUNDAS WILLIAMS KHERKHER HART BOUNDAS, LLP
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Total Records: 12455 Control # 2011-4382 2011-4383 2011-4384 2011-4385 2011-4386 2011-4387 2011-4388 2011-4389 2011-4390 2011-4391 2011-4392 2011-4393 Recd Date / Due Date 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4394 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4395 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT MERCK & CO., INC. 2010-7808 JOAN STITT MERCK & CO., INC. 2009-9391 ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/CIN-DO/CCB/ GERHARDT, NATHAN JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOAN STITT MERCK & CO., INC. WL RESEARCH LABS, ASHLAND, OH - EIR, 483, CO RESP 10/26-30/10 HILL DERMACEUTICALS, SANFORD, FL - EIR, 483, CO RESP 2/1-19/10 ATL (AD, TAPE, LABEL), MENOMONEE, WI - EIR, 483, RECALL RECS 6/09 TO PRESENT GERRESHEIMER GLASS INC, VINELAND, NJ - EIR, 483S, RECALL RECS 5/09 TO PRESENT 2008-4274 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ HOOPER, EMILY CASEY B HARRIS Young Living Essential Oils ERIC LIPTON NEW YORK TIMES ERIC LIPTON NEW YORK TIMES NATURAL PATH/SILVER WINGS LLC - EIR, 483S 8/3-5/10 DANIEL FABRICANT, NUTRITIONAL SUPPLEMENT INDUSTRY OFFICIALS - MTG NOTES, CORR 1/1/11TO 6/13/11 DANIEL FABRICANT MTG SCHEDULE 1/1/11 TO 6/13/11 ORA/NE-FO/NYK-DO/NYDCB/ Doe J EGG SAFETY RULE - PHASE 1 STUDIES,CORR, RPTS, ETC 9/10 SACHA INCHI - GRAS NOTIFICATION Action Office ORA/P-FO/LOS-DO/LACB/ ZAFARI, ARDESHIR INDIVIDUAL RECS Signature/ Requester Subject AMDL DIAGNOSTICS INC, TUSTIN, CA - EIR MOST RECENT
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Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-4396 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4397 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4398 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4399 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4400 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4401 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4402 06/15/2011 07/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4403 06/15/2011 07/14/2011 2011-4404 06/15/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ JOAN STITT FOIA CLOSED REQUESTS 1/1/10-12/31/10 NORMA JEFFRIES AFI (CALIFORNIA) ENTRY #N16-4096904-7 - ANALYST W/S, COLLECTION RPTS, ANALYTICAL FINDINGS, ETC JOAN STITT MERCK & CO., INC. 2011-491 JOAN STITT MERCK & CO., INC. 2011-488 JOAN STITT MERCK & CO., INC. 2010-9484 JOAN STITT MERCK & CO., INC. 2010-7560 JOAN STITT MERCK & CO., INC. 2010-5893 JOAN STITT MERCK & CO., INC. 2009-8365 JOAN STITT MERCK & CO., INC. 2010-8615, 2010-8616 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 07/14/2011 2011-4405 2011-4406 06/15/2011 07/14/2011 06/15/2011 07/14/2011 2011-4407 2011-4408 2011-4409 2011-4410 2011-4411 2011-4412 2011-4413 2011-4414 2011-4415 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/15/2011 07/14/2011 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 07/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4416 2011-4417 2011-4418 2011-4419 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ RODNEY W SCARPELLI BIODATA CORP WILLIAM A OLSON PHD Center for Regulatory Services, Inc. WILLIAM A OLSON PHD Center for Regulatory Services, Inc. FATIMA ASLAM MULTISTATE SALMONELLA TYPHIMURIUM OUTBREAK KHS PLASMAX GMBH - FCN 904 ALCAN PACKAGING, ALCOA INC - FCN 772 BIO/DATA CORP, HORSHAM, PA - EIR 4/3-9/08 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHO, ALEX GENARO GARCIA GARCIA DEVELOPMENTS INC KERT SHUSTER PHARM D RAINBOW PHARMACY LLC OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ CVM/OCD/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DOBECK, MICHAEL MV LORENA PETETTA MEDICA VETERINARA MARILYNN WHITNEY COVINGTON & BURLING LLP ANDRICK LEWIS CRD ASSOCIATES LLC ALLEGIANCE HEALTHCARE CORP - POWDER-FREE BLUE NITRILE EXAMINATION GLOVES K022765 CRT 2000 THERMOGRAPHIC SYS K971956 - MARKETING AUTHORIZATION LTR NDA 19-766/S077 - RECS DKT 1977N-0356 MOXIDECTIN TOXICITY STUDY - INVESTIGATION METHODS RECS DKT FDA-2010-P-0491 FOI SERVICES INC AARON STOERMANN INNOVATION CENTER US DAIRY DATABASE FOR MILK PROCESSING PLANTS & TRUCKING CO - OPERATION NAME, ADDRESS, CITY, ETC MEP 90 HAIR GROWTH STIMULATION SYS K091496 ALL CLOSED REQUESTS 6/13-17/11 FOI SERVICES INC NORMA JEFFRIES AFI (CALIFORNIA) ENTRY #N16-4096904-7, REFUSAL #N16-4096904-7/1/1 ANALYST W/S, COLLECTION RPTS, ANALYTICAL FINDINGS, ETC Signature/ Requester MERCK & CO., INC. ALL CLOSED REQUESTS 6/6-10/11 Subject
Page 257 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/15/2011 Action Office ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4420 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4421 2011-4422 2011-4423 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4424 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4425 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4426 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4427 06/16/2011 07/15/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4428 06/16/2011 07/15/2011 ORA/ ORA/ MELO, JOSEPH DE HOT BODY SPL 628675 - LAB RESULTS MELO, JOSEPH DE BLACK MAMBA HYPERRUSH SPL 668610 - LAB RESULTS MELO, JOSEPH DE PHENTERDRENE P57 SPL 668611 - LAB RESULTS MELO, JOSEPH DE HYPERLEAN MEGA THEROGENICS FX7 DIETARY SUPPLEMENTS SPL 628671 - LAB REULTS MELO, JOSEPH DE DIABLOS ECA FIRE CAPS DS FAT INCINERATION COMPLEX 50 MG EPHEDRA SPL 628672 - LAB RESULTS MELO, JOSEPH DE ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ NICOLE LANDREVILLE GE HALTHCARE TIMOTHY P MALARCHICK MALARCHICK LAW OFC ASSEMBLER'S GUIDE TO DIAGNOSTICS X-RAY EQUIPMENT 11/80 RICHARD DIANA, PRO TRAINERS CHOICE CO, SILVERDALE, WA - EIRS, 483S, CORR DIABLOS ECA FIRE CAPS (FAT INCINCERATION COMPLEX EPHEDRA) SPL 628673 - LAB REUSLTS MELO, JOSEPH DE DIABLOS HYPERBURN 6.0 FAT INCINERATION SPL 628674 LAB RESULTS Signature/ Requester Keller and Heckman LLP Subject TECHNICAL RVW MEMOS, TELEPHONE CONFERENCES, RPTS 9/09
Page 258 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4429 06/16/2011 07/15/2011 2011-4430 06/16/2011 07/15/2011 2011-4431 2011-4432 06/16/2011 07/15/2011 06/16/2011 07/15/2011 2011-4433 2011-4434 2011-4435 2011-4436 2011-4437 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 11/25/2011 06/16/2011 07/15/2011 ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ OC/OCC/ ORA/OCI/ ORA/OCI/ 2011-4438 2011-4439 2011-4440 06/16/2011 07/15/2011 06/16/2011 07/15/2011 06/16/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ CONOR M KELLY ESQ WALKUP MELODIA ET AL ANTHONY J GALATI UINV OF TOLEDO KARL STORZ ENDOSCOPY INC - ENDOSCOPIC COLD KNIFE BLADES K934730 DR KAHALCH, MEDICAL COLLEGE OF OH - CLNCL INVESTIGATOR INSP RESULTS LTR 8/5/91 LUNDBECK - SERDOLECT APRVL ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JAMES LUCKY ATRICURE INC RICHARD CARFAGNA PRIVATELINE MEDICAL CORP JAMES LUCKY ATRICURE INC DIANA L GESEKING SEDGWICK LLP DIANA L GESEKING SEDGWICK LLP DIANA L GESEKING SEDGWICK LLP DAVID L DEEHL DEEHL & CARLSON PA NESTLE USA, EAU CLAIRE, WI - EIRS, 483S, WARNING LTRS 1/00 TO PRESENT WYETH, PBM PRODUCTS, PERRIGO, GEORGIA, VT - EIRS, 483S, WARNING LTRS 1/00 TO PRESENT ABBOTT LABS, STURGIS, MI; CASA GRANDE, AZ - EIRS, 483S, WARNING LTRS 1/00 TO PRESENT GLAXOSMITHKLINE - PAXIL CORR, TESTS, STUDIES, ETC EVERSINCERE (AW MEDICAL, KX MEDICAL), FORT LAUDERDALE, MIAMI, FL - SAFETY SYRINGES K050999, K042102 LAWSUITS, CMPLNTS, APRVL, ETC CRYOMEDICAL INSTRUMENTS - CRYOSTAR K031482 MYOSCIENCE - CRYO-TOUCH K100447 INNA ZUMERIS NANO VIBRONIX LTD DERMASTREAM - K0600464 SCHMIDT, DAVID MFR RPT #1213643-2009-00126, 1213643-2009-00127 DATES 2009-00127 Signature/ Requester Subject
Page 259 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/15/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4441 06/16/2011 07/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4442 2011-4443 06/16/2011 07/15/2011 06/16/2011 07/15/2011 2011-4444 06/16/2011 07/15/2011 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/OCI/ ORA/OCI/ ORA/ORO/DFS/ ORA/ORO/DFS/ 2011-4445 06/16/2011 07/15/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4446 06/16/2011 07/15/2011 2011-4447 2011-4448 2011-4449 06/17/2011 07/18/2011 06/17/2011 07/18/2011 06/17/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES FDA/OMPT/CDRH/OCER/DFOI/ JAE-SEONG HAN IRC KLOREA PHILIPS - ESSENTA DR K070528; CARESTREAM CARESTREAM DRX-1 SYS K0900318; DRGEM - DIAMOND K102408 AMERICAN RED CROSS GREATER OZARKS REGION, SPRINGFIELD, MO - 483 2011 AMERICAN RED CROSS GREATER OZARKS REGION, SPRINGFIELD, MO - 483 2009 AMERICAN RED CROSS GREATER CAROLINAS REGION, ST ANURAG AGRAWAL THE BOSTON CONSULTING GROUP PHARMACEUTICAL MFG PLANTS (API AND FORMULATION PLANTS) REGISTERED WITH FDA CBER/OCTMA/DDOM/ALFB/ ALEXANDRIA SEIFNER AGES PHARMED W KYLE DILLARD OGLETREE DEAKINS NASH SMOAK CLAY E TITAN LEGAL SERVICES TRIMAX GROUP, OXNARD, CA; PROFESSIONAL INDEMINITY AGENCY INC, MOUNT KISCO, NY; LLOYD'S OF LONDON, ETC - IMPORT ALERT 9931 10/10/08, IMPORT ALERT 9930 11/12/08, INTERIM SAFETY & RISK ASSESSMENTS, ETC INDIVIDUAL RECS IMMUNE GLOBUIN PRODS WORKSHOP - TRANS 5-17-18/11 LESLIE PAUL PERRIGO PLANT 5 DR REDDY'S INDUSTRIAS QUIMICAS FALEON DE MEXICO SA DE CV (AFGIER AKA) - EIRS, 483S 11-8-11/10 Signature/ Requester ANDERSEN, METTE AABY Subject
Page 260 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/18/2011 2011-4450 2011-4451 2011-4452 2011-4453 2011-4454 2011-4455 06/17/2011 07/18/2011 06/17/2011 07/18/2011 06/17/2011 07/18/2011 06/17/2011 07/18/2011 06/17/2011 07/18/2011 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ 2011-4456 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ 2011-4457 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ 2011-4458 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP DIMENSIONAL MERCHANDISING INC, WHARTON, NJ - HAIR BY REVITALASH CORR ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP DIMENSIONAL MERCHANDISING INC, WHARTON, NJ REVITABROW EYEBROW CONDITIONER CORR ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP NORTHWEST COSMETIC LABS, IDAHO FALLS, ID - REVITA BROW EYEBROW CONDITIONER CORR ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES ORA/SW-FO/KAN-DO/COMP/ MOONEY, CHARLES Action Office Signature/ Requester MOONEY, CHARLES Subject LOUIS, MO - 483 2011 AMERICAN RED CROSS GREATER CAROLINAS REGION, ST LOUIS, MO - 483 2010 AMERICAN RED CROSS GREATER CAROLINAS REGION, ST LOUIS, MO - 483 2009 AMERICAN RED CROSS GREATER OZARKS REGION, SPRINGFIELD, MO - 483 2011 AMERICAN RED CROSS GREATER OZARKS REGION, SPRINGFIELD, MO - 483 2010 AMERICAN RED CROSS GREATER OZARKS REGION, SPRINGFIELD, MO - 483 2009 DIMENSIONAL MERCHANDISING INC, WHARTON, NJ REVITALASH EYELASH CONDITIONER EIRS, CORR
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ 2011-4459 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ 2011-4460 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ 2011-4461 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ 2011-4462 06/17/2011 07/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4463 06/17/2011 07/18/2011 2011-4464 06/17/2011 07/18/2011 2011-4465 06/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ CVM/OCD/ EDIE LAU LIST OF CASES OF SECONDARY EXPOSURE IN VETERINARY PATIENTS TO TOPICAL FEMALE & MALE Doe J PATRICK LYNCH SIEMENS MEDICAL SOLUTIONS USA INC CMPLNT 119883 PHILIPS MEDICAL SYS INC, CLEVELAND, OH - EIR JEREMY HODGES NOVANT HEALTH MITOMYCIN - AERS ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP PHARMA TECH INTERNATIONAL INC, FAIRFIELD, NJ - EIRS, CORR ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP NORTHWEST COSMETIC LABS LLC, IDAHO FALLS, ID HAIR BY REVITALASH CORR ANNE Y. BRODY GIBSON DUNN & CRUTCHER LLP NORTHWEST COSMETIC LABS LLC, IDAHO FALLS, ID REVITALASH EYELASH CONDITIONER EIRS, CORR Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 07/18/2011 2011-4466 2011-4467 06/17/2011 07/18/2011 06/17/2011 07/18/2011 2011-4468 06/17/2011 07/18/2011 2011-4469 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4470 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4471 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4472 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4473 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4474 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3677- REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3694 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3746 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3759 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3875 - REQUEST LTR FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ Action Office Signature/ Requester VETERINARY INFORMATION NETWORK NEWS SERVICES YOUNG W. RYU LAW OFFICE OF YOUNG W RYU ARLENE MORALES BURDOCK GROUP GREGORY KAUFFMAN PENNSYLVANIA DEMOCRATIC PARTY JOAN STITT (UG2CD-16) MERCK & CO., INC. Subject HORMONE THERAPIES SINCE 4/12/10 TO PRESENT OH SO CLEAN INC - MRSA, STAPHYLOCOCUS AUREUS, KLEBSIELLA PNEUMONIAE, ETC LAB RESULTS DIETARY SUPPLEMENTS, FOOD ADDITIVES - CHROMIUM, DINICOCYSTEINATE COMPLEX REGULATORY STATUS, USES, SAFETY RECS, ETC INFORMATION REQUESTED BY SENATOR JACOB CORMAN 11/3/98 TO 6/15/11 2011-3964 - REQUEST LTR
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Total Records: 12455 Control # 2011-4475 2011-4476 2011-4477 Recd Date / Due Date 06/20/2011 07/19/2011 06/20/2011 07/19/2011 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4478 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4479 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4480 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4481 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4482 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4483 2011-4484 06/20/2011 07/19/2011 06/20/2011 CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ CAHO XIONG STAR TRIBUNE GEORGE SADLER PHD IONIZING RADIATION FOR TREATMENT OF POULTRY FEED CHATTANOOGA GROUP - PROD RECALLS, MDRS BRYAN #254638, T TERELL COGETIN, TEGRATOL, SEROQUEL, ETC - AERS JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3346 - REQUEST LTR JOAN STIT (UG2CD-16) MERCK & CO., INC. 2011-3478, 20111-3479 - REQUEST LTR JOAN STITT *+(UG2CD-16) MERCK & CO., INC. 2011-3580 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3524 - REQUEST LTR FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ANGELIA D SLAYTON KENDLE INTERNATIONAL INC MATT CLAUSEN MEDLINE INDUSTRIES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. 20111-3662 - REQUEST LTR K090921, K091141, K101224, K101906 Subject K052643
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Total Records: 12455 Control # Recd Date / Due Date 07/19/2011 2011-4485 2011-4486 06/20/2011 07/19/2011 06/20/2011 07/19/2011 2011-4487 2011-4488 2011-4489 06/20/2011 07/19/2011 06/20/2011 07/19/2011 06/20/2011 07/19/2011 2011-4490 2011-4491 06/20/2011 07/19/2011 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4492 2011-4493 06/20/2011 07/19/2011 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4494 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4495 06/20/2011 07/19/2011 2011-4496 06/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ PAULA THOMAS SARAH CANNON RESEARCH INSTITUTE TARRYN MENTO AGROPECUARIA MONTELIBANO, HONDURAS SALMONELLA OUTBREAK RESULTS, RECS, PROCEDURES JOHN HAINSWORTH - EIR 8/24/09 SANJAY KUMAR FLAMINGO PHARMACEUTICALS LTD FELDENE (PIROXICAM) CAPS 20 MG - SBA ORA/P-FO/SEA-DO/SCB/ CAROLYN VERDUYN BIOANALYTICAL SYSTEMS INC LLINDA A KOZAK SUMMIT RESEARCH LABS INC BIOANALYTICAL SYSTEMS INC, MCMINNVILLE, OR - EIRS, 9/24-27/07, 2/28/11-3/4/11 BK GUULINI CHEMIE GMBH & CO OHG, LADENBURG, GERMANY - EIR 2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ LINDA A KOZAK SUMMIT RESEARCH LABS INC LINDA A KOZZAK SUMMIT RESEARCH LABS INC GULBRANDSEN TECHNOLOGIES INC, ORANGEBURG, SC EIR 2011 GULBRANDSEN TECHNOLOGIES INDIA PRIVATE LTD, GUIJARAT, INDIA - EIR 2011 FDA/OMPT/CDRH/OCER/DFOI/ SYRING, GARY J ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS K041342 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC VASORING VRC VASCULAR RING CONNECTOR - K061626 K90337 FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester PROVE IT LLC KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS K964240 Subject - RECS OCEAN NUTRITION CANADA LTD - TUNA OIL GRAS 379
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Total Records: 12455 Control # Recd Date / Due Date 07/19/2011 Action Office ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SWFO/SWID/COMPLIANCE/ 2011-4497 2011-4498 2011-4499 06/20/2011 07/19/2011 06/20/2011 07/19/2011 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4500 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4501 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3750 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3771 - REQUEST LTR ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ BRIAN E FARRELL QUARLES & BRADY LLP TRACY WENTWORTH REMINGTON MEDICAL INC JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3894 - REQUEST LTR WALMART GREAT VALUE OATMEAL COOKIES, SUGAR COOKIE DOUGH, VANILLA WAFERS, ETC - MFR DATABASE DRAINAGE BAG - K990428 Signature/ Requester NEWS 21 Subject USED STARTING 1/08
Page 266 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4502 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4503 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4504 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4505 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4506 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4507 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4508 2011-4509 06/20/2011 07/19/2011 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4510 06/20/2011 FDA/OMPT/CDER/ORP/DIDP/ ELIZABETH DUDLEY, Esq. LEVLEN - PHARMACOKINETIC RECS JOAN STITT (UG2CD-16) MERCK & CO., INC. ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW KARIVA - PHARMACOKINETIC RECS 2011-3366, 2011-3367 - REQUEST LTRS JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3505 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3605 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3630 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3667 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3680 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3717- REQUEST LTR Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 07/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4511 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4512 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4513 2011-4514 06/20/2011 07/19/2011 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4515 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4516 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4517 2011-4518 06/20/2011 07/19/2011 06/20/2011 07/19/2011 ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MENTO, TARRYN ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW MIRCETTE - PHARMACOKINETIC RECS CANTALOUPE MELONS - IMPORT BULLETINS 1/01 TO 5/11 ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW LOESTRIN FE - PHARMACOKINETIC RECS JOAN STITT (UG2CD-16) SUMMIT RESEARCH LABS INC BK GIULINI GMBH, LUDWIGSHAFEN, GERMANY - EIR MOST RECENT ORA/CE-FO/NJ-DO/NJCB/ LINDA A KOZAK SUMMIT RESEARCH LABS INC LINDA A KOZAK SUMMIT RESEARCH LABS INC GULBRANDSEN TECHNOLOGIES INC, PHILLIPSBURG, NJ EIR MOST RECENT BK GIULINI PERSONAL CARE JIANGYIN CO LTD, JIANGSU PROVICE, CHINA - EIR MOST RECENT ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW LOESTRIN 24 - PHARMACOKINETIC RECS ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW LO LOESTRIN 24 - PHARMACOKINETIC RECS Signature/ Requester DOUGLAS LONDON PC ATTY AT LAW Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4519 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4520 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4521 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4522 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4523 06/20/2011 07/19/2011 2011-4524 06/20/2011 07/19/2011 2011-4525 2011-4526 06/20/2011 07/19/2011 06/20/2011 07/19/2011 2011-4527 06/20/2011 07/19/2011 2011-4528 06/20/2011 07/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP JOSEPH AVIZAD JOSEPH AVIZAD REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP REED TECKENBROCK LAW OFFICES WINCKLER & HARVEY LLP INDIVIDUAL RECS PEDICLE SCREW SPINAL SYS K092128 - SS&E PEDICLE SCREW SPINAL SYS K071438 - SS&E DKT FDA-1995-S-0039 PEDICLE SCREW SPINAL SYS K090033 - SUMMARY PEDICLE SCREW SPINAL SYS K073240 - SS&E ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW LEVLITE - PHARMACOKINETIC RECS ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW ORTHO TRI CYCLEN - PHARMACOKINETIC RECS ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW ORTHO TRI CYCLEN LO - PHARMACOKINETIC RECS ELIZABETH DUDLEY, Esq, DOUGLAS LONDON PC ATTY AT LAW OVCON 35 - PHARMACOKINETIC RECS Signature/ Requester Subject
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Total Records: 12455 Control # 2011-4529 2011-4530 Recd Date / Due Date 06/20/2011 07/19/2011 06/20/2011 07/19/2011 2011-4531 06/20/2011 07/19/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4532 06/20/2011 07/19/2011 2011-4533 2011-4534 2011-4535 06/20/2011 07/19/2011 06/20/2011 07/19/2011 06/20/2011 07/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4536 06/21/2011 07/20/2011 2011-4537 2011-4538 06/21/2011 07/20/2011 06/21/2011 07/20/2011 2011-4539 2011-4540 06/21/2011 07/20/2011 06/21/2011 07/20/2011 2011-4541 06/21/2011 07/20/2011 OC/COS/OL/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JOY FRESTEDT FREESTEDT JOY FRESTEDT FREESTEDT JOY FRESTEDT FREESTEDT MATT CLAUSEN MEDLINE INDUSTRIES INC CHRISTOPHER SHAKIB TERRELL HOGAN ELLIS YEGELWEL PA EZRA ROSS UNIV OF CALIFORNIA LOS MEDTRONIC - CONCERTO IMPLANTABLE CARDIO DEFIBRILLATOR SUMMARY MEMO, EMAILS, INVESTIGATION US CONGRESS, ADMINISTRATION OF THE PRESIDENT COLLECTION OF FINES, PENALTIES, RESTITUTIONARY BAXTER , DEEFIELD, IL- V-LINK ANTIMICROBIAL LUER ACTIVATED DVC & EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DVC K081289 CAREFUSION 2200 INC, SAN DIEGO, CA - CHLORASHIELD ANTIMICROBIAL DRESSING K103106 3/10 TO 3/11 ARROW INTERNATIONAL INC (TELEFLEX INC ), READING, PA - PRESSURE INJECTABLE PERIPHERALLY INSERTED CENTRAL CATHETER K100635 K090921, K091141, K101224, ETC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TONY SAAVEDRA ORANGE COUNTY REGISTER TONY SAAVEDRA ORANGE COUNTY REGISTER ELIZABETH DUDLEY, Esq. DOUGLAS LONDON PC ATTY AT LAW AXXENT ELECTRONIC BRANCH THERAPY SYS, XOFT FLEXISHIELD MINI - RVWS, MDRS, LTRS, ETC BALZIVA - PHARMACOKINETIC DATA LIST OF RECALLED DVCS, MDRS LAST TEN YRS BURKE RAFEL, JESSE MASIMO CORP, IRVINE CA - RAINBOW SET RAD 57 PULSE CO KO42536 Dr. LEE W. EVANS JOHNSON & JOHNSON PERRIGO ISRAEL - MINOXIDIL TOPICAL AEROSOL FOAM ANDA 91-344 SBA, SCIENTIFIC RVWS, CORR GIEGERICH, JULIE Action Office ORA/CE-FO/NJ-DO/NJCB/ SCHONHOFT, BRAD LIFECELL/KINETIC CONCEPTS; STRATTICE LTM SURGICAL MESH K070560 WARNING LTR, EIRS, CORR 11/2/10-11/12/10 Signature/ Requester Subject SIEGFRIED INC, PENNSVILLE, NJ - 483 10/1/09 TO 6/17/11
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Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester ANGELES 2011-4542 2011-4543 06/21/2011 07/20/2011 06/21/2011 09/08/2011 2011-4544 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4545 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-4546 06/21/2011 07/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ TERRENCE SMITH DAVIS SAPERSTEIN & SALOMON PC FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4548 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4549 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4550 06/21/2011 07/20/2011 2011-4551 06/21/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ BRAD SCHONHOFT BALYASNY ASSET MANAGEMENT JODY L GREEN AKORN INC, DECATUR, IL; SOMERSET, NJ - 483S 9/1/01 TO 6/20/11 ISRS 7098569-4, 7103583-6, 7103652-0, ETC AELISH M BAIG ROBBINS GELLER ET AL ALLERGAN INC - OFF LABEL MARKETING & UNLAWFUL PROD PROMOTION CORR, CMPLNTS, RPTS, ETC EMILY RAISOR COOK PHARMICA LIST OF DRUGS DECLARED SUITABLE FOR AN ANDA ANIL SACHDEVA STRIDES INC STRYKER HOWMEDICAL - TRIDENT ACETABULAR CUP SYS, TRIDENT ALUMINA CERMICA BEARING P000013 TECHNICAL ASSESSMENT & MEDICAL ASSESSMENT, REGULATORY SUMMARY, 510K, 3/1/06, 3/9/06, E/16/06, ETC SANDOZ - PARICALCITOL ANDA 91-108 SBA Doe J CELEXA, KLONOPIN, GEODON, ETC - AERS, STUDIES HOWELL, DAVID FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ BRIAN BELL BOSTON SCIENTIFIC MARLA CALER ALERE RESPONSE BIOMEDICAL CORP, BURNABY, BRITISH COLUMBIA - RAMP NT-PROBNP ASSAY K063662 CLIA WAIVER APPL PROZAC - AERS, WARNINGS, STUDIES, ETC Subject AWARDS CORR 2002 TO PRESENT TABLE OF ALL MDRS - PATIENT PROBLEM CODES
2011-4547
06/21/2011 07/20/2011
Page 271 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4552 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4553 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4554 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4555 2011-4556 06/21/2011 07/20/2011 06/21/2011 07/20/2011 2011-4557 06/21/2011 08/04/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-4558 2011-4559 2011-4560 2011-4561 2011-4562 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ ELENA HOWEL HOGAN LOVELLS LLP ELENA HOWELL HOGAN LOVELLS LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2009-5295 KRAFT FOODS - BOCA BURGERS HEXANE TESTING RESULTS GENERAL MILLS - CHEERIOS HEALTH CLAIMS CORR 3/15/11-4/3/11 ROXANE LABS, COLUMBUS, OH - EIRS, 483S, CO RESP 1/09 TO PRESENT 2010-2133 ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ MONTY, NATHAN P MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC STEPHANIE L GREENFIELD LITCHFIELD CAVO LLP ENTRY HG8-01273258 - NOTICE OF FDA ACTION, NOTICE TO MARK AND/OR REDELIVER WRIGHT MEDICAL TECHNOLOGY INC - TRANSCEND HIP PO3OO27, LINER CERAMIC TRANS, SHELL ACETABULAR LINEAGE, STEM FEMORAL CEMENTLESS 510K, WARNING LTRS, EIRS, ETC 1/93 TO PRESENT K031140, K071363, K090181, ETC ANNE MUTASHI HOGAN LOVELLS US LLP APOTEX INC, ONTARIO, CANADA - EIRS MOST RECENT WALKER HG4588, WILLIAM EFFEXOR, PAXIL - AERS JODY L GREEN ROCKY MOUNTAIN POISON DRUG CTR ISRS 7025484-4, 7026237-3, 7026651-6, ETC Signature/ Requester ROCKY MOUNTAIN POISON DRUG CTR Subject
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Total Records: 12455 Control # Recd Date / Due Date 07/20/2011 2011-4563 06/21/2011 07/20/2011 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4564 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4565 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/OCI/ 2011-4566 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ 2011-4567 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ 2011-4568 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP METICS PROFESSIONAL, PHOENIX, AZ - RENEWLASH EYELASH STIMULATOR CMPLNTS, CORR, RPTS, ETC ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP COSMETIC ALCHEMY, SCOTTSDALE, AZ - LIBROW CMPLNTS, CORR, RPTS, ETC ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP METICS PROFESSIONAL, PHOENIX, AZ - RENEWBROW CMPLNTS, CORR, RPTS, ETC KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES DR BRUCE PATSNER - CMPLNTS, DISCIPLINARY ACTIONS 2003 TO 2006 KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES DR BRUCE PATSNER, THE FUTURE OF DUG SAFETY AND PROTECTING THE HEALTH OF THE PUBLIC, DRUG SAFETY: IMPROVEMENT NEEDED IN FDA'S POST-MARKET DEICSION-MAKING AND OVERSIGHT PROCESS Signature/ Requester MERCK & CO., INC. KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES DR BRUCE PATSNER, PREMARIN, PREMPRO, PROVERA RECS Subject
Page 273 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ 2011-4569 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ 2011-4570 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-4571 06/21/2011 07/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-4572 2011-4573 2011-4574 2011-4575 2011-4576 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/21/2011 07/20/2011 06/22/2011 08/02/2011 2011-4577 06/22/2011 07/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC FOI SERVICES INC FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS GENETECH, SOUTH SAN FRANCISCO, VACAVILLE, CA, RESEARCH TRIANGLE PARK, NC - EIRS, 483S, CO RESP, ETC 2009 BIOGEN IDEC, SOUTH SAN FRANCISCO, VACAVILLE, CA, TRIANGLE PARK, NC - EIRS, 483S CO RESP, ETC 2009 2011-3123 2011-3173 2011-3189 2011-3217 ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP PETER THOMAS ROTH INC, NEW YORK, NY - BROWS TO DIE FOR CMPLNTS, CORR, RPTS, ETC ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP PETER THOMAS ROTH INC, NEW YORK, NY - LASHES TO DIE FOR CMPLNTS, CORR, RPTS, ETC ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP COSMETIC ALCHEMY, SCOTTSDALE, AZ - LILASH CMPLNTS, CORR, RPTS, ETC Signature/ Requester Subject
Page 274 of 1132

Total Records: 12455 Control # 2011-4578 2011-4579 Recd Date / Due Date 06/22/2011 07/21/2011 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4580 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4581 06/22/2011 07/21/2011 2011-4582 06/22/2011 07/21/2011 2011-4583 06/22/2011 07/21/2011 2011-4584 06/22/2011 07/21/2011 2011-4585 2011-4586 06/22/2011 07/21/2011 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4587 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ SCHONHOFT, BRAD ALLERGAN INC, WESTPORT IRLEAND, WACO, TX, SAN JOSE COSTA RICA - 483S, WARNINGS 9/1/10 TO 6/20/11 SCHONHOFT, BRAD FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ SCHONHOFT, BRAD FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD REVABCE THERAPEUTICS, NEWARK, CA, - 483S, WARNINGS 9/1/10 TO 6/20/11 BIO-TECHNOLOGY GENERAL (FERRING PHARMS), BE'ER TUVIA, ISRAEL - 483S, WARININGS 9/1/10 TO 6/20/11 ARKRAY FACTORY USA INC - ARK CARE DIABETES MANAGEMENT SYS K110709 M2 GROUP HOLDING INC - PEARL DIABETES MANAGEMENT SYS K100567 INTERNATIONAL REMOTE IMAGING -WHITE IRIS INSTRUMENT K953116 CHEMPAQ A/S - XBC ANALYZER K050758 FOI SERVICES INC GENENTECH - LUCENTIS BLA 125156/S053 APRVL RECS FOI SERVICES INC Action Office FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC B BRAUN - CEFAZOLIN & DEXTROSE NDA 50-779 LBLG Signature/ Requester Subject MEDPAC - SFC K951303
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Total Records: 12455 Control # 2011-4588 2011-4589 2011-4590 Recd Date / Due Date 06/22/2011 07/21/2011 06/22/2011 07/21/2011 06/22/2011 07/21/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/P-FO/SAN-DO/SFCB/ SCHONHOFT, BRAD ROBERT Z PHILLIPS TELEFLEX LALURA MOEN-FTACEK AMERICAN MEDICAL SYSTEMS INC MAQUET DATASCOPE CORP, MAHWAH, NJ - INRA-AORTIC BALLOON CLASS I RECALL HEALTH HAZARD EVALUATION AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYS WITH INTEGRO LITE K082677; AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYS, AMS ELVATE WITH INTEXEN LP PROLAPSE SYS K080185; AMS ELVATE APICAL & POSTERIOR PROLAPSE REPAIR SYSW ITH INTEPRO LITE K082730, ETC FOTONA DD - LIGHTWALKER LASER SYS FAMILY K101817 QUILLARD, JON FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4593 2011-4594 06/22/2011 07/21/2011 06/22/2011 07/21/2011 CVM/OCD/ ORA/ORO/DFS/ ORA/ORO/DFS/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ 2011-4595 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ASKEROVA, ZENA DETROL, VIAGRA, FOSAMAX, ETC - AERS 4/1/10 TO 6/30/10 FDA/OMPT/CDRH/OCER/DFOI/ QUILLARD, JON MARK STEIL MINNESOTA PUBLIC RADIO NEWS BIOLASE TECHNOLOGY INC - WATERLASE MD TURBO PLUS K101658 FY 2010 NATIONWIDE SURVEY OF DISTILLERS GRAINS FOR ANTIBOTIC RESIDUES - RESULTS MARY T NOVACHECK BOWMAN AND BROOKE LLP 1-FLOW CORP - ELASTOMERIC PUMP K040337 Signature/ Requester Subject BIOMARIN, NAVATO, CA - 483S, WARNINGS 9/1/10 TO 6/20/11
2011-4591 2011-4592
06/22/2011 07/21/2011 06/22/2011 07/21/2011
Page 276 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4596 06/22/2011 07/21/2011 2011-4597 2011-4598 2011-4599 2011-4600 06/22/2011 07/21/2011 06/22/2011 07/21/2011 06/22/2011 07/21/2011 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4601 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4602 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2011-4603 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2011-4604 06/22/2011 07/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MAX SCHWARTZ SCOTT & SCOTT LLP ELAN CORP - BAPINEUZUMAB CORR MAX SCHWARTZ SCOTT & SCOTT LLP PFIZER INC - BAPINEUZUMAB CORR MAX SCHWARTZ SCOTT & SCOTT LLP JOHNSON & JOHNSON - BAPINEUZUMAB NEW DRUG APPLICATIONS 9/09, CORR KRISTIN GEISS PEPPER HAMILTON LLP LAST TEN NEW DRUG APPLICATIONS WHICH CONTAIN CLAIMS FOR CATEGORICAL EXCLUSIONS FROM ENVIRONMENTAL ASSESSMENTS ORA/CE-FO/NJ-DO/NJCB/ GERHARDT, NATHAN. BILL PARTHUN MEDLINE INDUSTRIES INC SAGE PRODUCTS - CHLORHEXIDINE GLUCONATE TOPICAL CLOTH IND 64-413 ORA/CE-FO/BLT-DO/CB/ SCHONHOFT, BRAD CEREBRAL HEALTH LLC - 483 2/8-18/11 ORA/SE-FO/ATL-DO/ACB/ MOONEY, CHARLES CBER/OCTMA/DDOM/ALFB/ KEITH R STACHOWEIAK MURPHY & PRACHTHAUSER ATTY BAXTER LABS - INTRAVENOUS IMMUNOGLOBULIN (IVIG) VAERS PAST 20 YRS AMERICAN RED CROSS GREATER CAROLINAS REGION, CHARLOTTE, NC - 483S 2011 MYLAN INC, MORGANTOWN, WV - 483 9/1/10-6/20/11 Signature/ Requester Subject
Page 277 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2011-4605 2011-4606 2011-4607 06/22/2011 07/21/2011 06/22/2011 07/21/2011 06/22/2011 07/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ GERI L. HAIGHT MINTZ LEVIN ET AL SARAH GEISCRT GENERAL MILLS BRIAN E. FARRELL QUARLES & BRADY LLP WALMART - GREAT VALUE OATMEAL COOKIES, GREAT VALUE SUGAR COOKIES, GREAT VALUE SUGAR COOKIE DOUGH; TRADER JOES- DRUID CIRCLES OATMEAL RAISIN COOKIES CORR LOVASTIN, LISINOPRIL, METFORMIN - AERS ASHLEY, AARON SYNTHES USA PRODUCTS LLC - HEMOSTATIC BONE PUTTY K103822 GENERAL MILLS, WELLSTON, OH - EIR, 483 9/10 Signature/ Requester Subject
2011-4608
06/22/2011 07/21/2011
2011-4609
06/22/2011 07/21/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
MARK MANSOUR AKIN GUMP ET AL
QUIGDAO JIULONG BIOPHARMACEUTICAL CO LTD, QUIGDAO CHINA - EIR 3/14-18/11
2011-4610 2011-4611
06/22/2011 07/21/2011 06/22/2011 07/21/2011
OM/OMP/DODM/ FOI SERVICES INC FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC
DENTAL DEVICE CLASSIFICATION PANEL MTG - TRANS 4/5/77 RANBAXY - CARBILEV NDA 76-643
2011-4612
06/22/2011 07/21/2011
OC/OSHC/OPD/ WOOD, GERARD FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ TOOR, SAQUIB
DUSA PHARMACEUTICALS - LEVULAN (AMINOLEVULINIC ACID) PHOTODYNAMIC THERAPY ORPHAN DRUG DESIGNATION DELALUTIN NDA 10-347, 16-911
2011-4613
06/22/2011 07/21/2011
2011-4614
06/22/2011
ADAMED LTD, CZOSNOW, POLAND - KOLPEXIN SPHERE
Page 278 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/21/2011 2011-4615 2011-4616 06/22/2011 07/21/2011 06/22/2011 07/21/2011 ORA/CE-FO/MIN-DO/MCB/ ORA/ORO/ ORA/ORO/ ORA/ ORA/ 2011-4617 2011-4618 06/22/2011 07/21/2011 06/23/2011 07/22/2011 CVM/OCD/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4619 2011-4620 2011-4621 06/23/2011 07/22/2011 06/23/2011 07/22/2011 06/23/2011 07/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4622 06/23/2011 07/22/2011 2011-4623 06/23/2011 07/22/2011 2011-4624 06/23/2011 07/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4625 06/23/2011 07/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ TYSON Q BELLAMY FEFA LLC GUIDENT TECHNOLOGIES INC - CONTRACT #HHSF223200950034P CBER/OCTMA/DDOM/ALFB/ KIMBERLY A GRABBE MAGLIO CHRISTOPHER & TOALE LAW FIRM CLARKE W DUBOSE HAYNSWORTH SINKLER BOYD PA ERIKA MORKEVICH Cerner Galt CR BARD/DAVOL, RAM MEDICAL INC - COUNTERFEIT POLYPROPYLENE SURGICAL MESH PRODS INVESTIGATION RECS 6/10/10 ISR US-004119 INDIVIDUAL RECS SHAPIRO, RYAN NOAH H LEE THOMPSON THOMPSON LAW FIRM FDA/OF/CFSAN/OCD/EOS/ KERRY DAVIS UNIV OF MARYLAND ANIMAL RIGHTS AND ANTI-VIVISECTION ACTIVITY 1985 TO 1995 J MARTIN CARROLL, BOEHRINGER-INGELHEIM - LTR 9/29/08 FOOD FIRMS IN CHINA - EIRS 1/1/01 TO 6/1/11 JENNIFER FIALA VIN NEWS SERVICE ELIZABETH DUDLEY ESQ DOUGLAS LONDON PC ATTY AT LAW MERIAL LLC - HEARTGARD PLUS CORR, AERS, LBLG CHANGE, ETC JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT LLC - ORTHO-EVRA CONTRACEPTIVE PATCH (ETHINYL ESTRADIOL/NORELGESTROMIN) RECS FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester SCHNEIDEMAN, RALPH BOB STEURER SPACELABS HEALTHCARE JONEL ALECCIA MSNBC.COM Subject K032644 PHILIPS MEDICAL - INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE MODEL M3290A K050742 TRIAD GROUP & H&P INDUSTRIES INC, HARTLAND, WI COMPLIANCE RVW 6/9/11
Page 279 of 1132

Total Records: 12455 Control # 2011-4626 Recd Date / Due Date 06/23/2011 07/22/2011 2011-4627 06/23/2011 07/22/2011 2011-4628 06/23/2011 07/22/2011 2011-4629 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4630 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4631 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ 2011-4632 2011-4633 06/23/2011 07/22/2011 06/23/2011 07/22/2011 2011-4634 2011-4635 2011-4636 06/23/2011 07/22/2011 06/23/2011 07/22/2011 06/23/2011 07/22/2011 ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ WRIGHT, DAVID PAUL EICHHOLZ LEGACY PHARMACEUTICAL PACKAGING LLC JASON M KERR PRICE PARKINSON & KERR PLLC ERIC F GREENBURG ERIC F GREENBERG PC DENISE RIEKER SANOFI PASTEUR MERCK, WEST POINT, PA - 483 2011 FCN 865 LIFETECH - WARNING LTR RESP TRIGEN LABORATORIES INC - EIRS, 483S INDIVIDUAL RECS CHRISTOPHER NORRIS DELUCA & NEMEROFF ABBOTT - LUPRON (LEUPROLIDE) AERS, APRVL RECS, STUDIES, ETC TOOR, SAQUIB DELALUTIN NDA 10-347, NDA 16-911 - RECS POLLACK, DORIS FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ CLARKE W DUBOSE HAYNSWORTH SINKLER BOYD PA BARD, BAVOL - GENUINE OR COUNTERFEIT FLAT SURGICAL MESH MDRS, CMPLNTS MONARSEN - APRVL RECS Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DEBORAH N KLOOS MEDICAL ACTION INDUSTRIES INC JAMES F SCHERR SCHERR & LEGATE ATTY Subject INTERNAL X-RAY DETECTABLE GAUZE OR SPONGE K810184 AMERICAN MEDICAL SYSTEMS - HPS GREENLIGHT LASER SYS CMPLNTS
Page 280 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office CBER/OCTMA/DDOM/ALFB/ ORA/OE/ ORA/OE/ 2011-4637 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-4638 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-4639 06/23/2011 07/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-4640 06/23/2011 07/22/2011 2011-4641 06/23/2011 07/22/2011 2011-4642 2011-4643 06/23/2011 07/22/2011 06/24/2011 07/25/2011 2011-4644 06/24/2011 07/25/2011 2011-4645 06/24/2011 07/25/2011 OM/OMP/DODM/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JOHNSON & JOHNSON STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WAGNER CITIZENS COMMISSION ON NEUROLOGICAL DVCS PANEL - RECLASSIFICATION OF DVCS USED IN ELECTROCONVULSIVE THERAPY CORR, BRIEFINGS DKT 2009- M-0101, DKT 2010-N-0585 - POTENTIAL RECLASSIFICATION OF ELECTROCONVULSIVE THERAPY DVC STUDIES, SUMMARIES, BRIEFINGS, ETC DKT 2009-M-0101, 2010-N-0585 - MEDICAL DVC ORDER FOR CERTAN CLASS III DVC SUBMISSION OF SAFETY & EFFECTIVENESS RECS LTRS, CORR, COMMENTS, ETC FDA/OMPT/CDRH/OCER/DFOI/ YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD EIRS, 483S, WARNING LTRS 1/03 TO PRESENT INTERNATIONAL REMOTE IMGAGING - WHITE IRIS INSTRUMENT K953116 CHEMPAQ A/S - DIFFERENTIAL CELL COUNTER K050758 DENISE RIEKER SANOFI PASTEUR GLAXOSMTIHKLINE, DRESDEN, GERMANY - 483 2011 DENISE RIEKER SANOFI PASTEUR MEDIMMUNE, SPEKE, LIVERPOOL, UK - 483 2011 DENISE RIEKER SANOFI PASTEUR NOVARTIS, SPEKE, LIVERPOOL,UK - 483 2011 Signature/ Requester Subject
Page 281 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject
HUMAN RIGHTS INTERNATIONAL 4/2/09 2011-4646 2011-4647 2011-4648 06/24/2011 07/25/2011 06/24/2011 07/25/2011 06/24/2011 07/25/2011 2011-4649 06/24/2011 07/25/2011 2011-4650 06/24/2011 07/25/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4651 06/24/2011 07/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4652 06/24/2011 07/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4653 06/24/2011 07/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ 2011-4654 2011-4655 06/24/2011 07/25/2011 06/24/2011 07/25/2011 2011-4656 06/24/2011 ORA/ CBER/OCTMA/DDOM/ALFB/ SIEGEL, JAMIE LUCAS M WATSON ORA/NE-FO/NYK-DO/NYDCB/ DOUGLAS N BLUE II ZETETIC RISK MITIGATION STRATEGIES TO ADDRESS PROCOAGULANT ACTIVITY IN IMMUNE GLOBULIN PRODUCT MTG - TRANS, SLIDES 5/17-18/11 DUNKIN DONUTS - CMPLNTS OF BEING BURNED BY COFFEE 6/20/11 NOVARTIS - HEALTH CARE PRODS ENTRY 823-0144182-8 CHRISTOPHER NORRIS DELUCA & NEMEROFF ABBOTT LABS, TAKEDA ABBOTT PHARMACUTICALS PRODUCTS INC, TAP HOLDLINGS INC - LUPRON (LEUPROLIDE) NDA 20-011, NDA 20-517, NDA 20-708 AERS, STUDIES, APRVL, ETC ELIZABETH DUDDLEY DOUGLAS LONDON PC ATTY AT LAW JOHNSON & JOHNSON PHARMACEUTICAL RESEARCH & DEVELOPMENT LLC - NED-1 STUDY FOR ORTHO-EVRA CONTRACEPTIVE PATCH 3/10/03 CHRISTOPHER HENDEL CONSUMER REPORTS NANOPARTICLES USED IN SUNSCREENS - TESTING RECS LAUREL GERVAIS THOMSON REUTERS PREDICT MASHUP LIST OF DRUGS SCREENED 1/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MARK, SPIER E L LMARK BONNER NORMAN & EDEM PLLC DOUGLAS E CHABOT DECOF & DECOF PC JOIMAX GMBH - THESSYS SPINAL SURGERY ENDOSCOPY EQUIPMENT & DISPOSABLES APPLICATIONS, USER MANUALS, LBLG, ETC (CERTIFIED) 1-FLOW CORP - ON-Q PAINBUSTER & OR PAINBUSTER INFUSION SYS K980558 FDA/OMPT/CDRH/OCER/DFOI/ SALLY FOUST ARTHREX INC NMB MEDICAL APPLICATIONS LTD - PICCOLO COMPOSITE PLATE SYS K102597 GEN 1000157
Page 282 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/25/2011 Action Office ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4657 2011-4658 06/24/2011 07/25/2011 06/24/2011 07/25/2011 2011-4659 06/24/2011 07/25/2011 OC/COS/OL/ ORA/ ORA/ ORA/ORO/ ORA/ORO/ 2011-4660 06/24/2011 07/25/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-4661 06/24/2011 07/25/2011 2011-4662 06/24/2011 07/25/2011 2011-4663 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4664 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4665 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JESSICA TRENARY MORRISON & FOERSTER LLP ARSENIC TRIOXIDE - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP ARTANE - AERS, APRVL, LBLG OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ AMY L.FULTON BUCHANAN INGERSOLL & ROONEY PC MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION JESSICA TRENARY MORRISON & FOERSTER LLP LIDOCAINE - AERS, APRVL, LBLG DKT & DKT LOG OF FDA-1995-S-0039 DKT 1976N-0057 WILLILAM M SLAUGHTER II TEJAS INDUSTRIES SPLS 680701, 670702, 641833, ETC - ANALYTICAL RESULTS FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ DALE A BAUER KEMIRA JENNIFER ALLGAIER CENTURION RESEARCH SOLUTIONS JIM M PERDUEJR PERDUE & KIDD LLP H&P INDUSTRIES INC (TRIAD GROUP) - INTERNAL RETROSPECTIVE RVW LTR 6/9/11 CANE-SUGAR & BEET-SUGAR MILLS - SODIUM DIMETHYLDITHIOCARBAMATE OPINION LTR DYNANET CORP - GS06F0067Z Signature/ Requester LAW OFC OF LUCAS M WATSON LLC Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4666 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4667 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4668 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4669 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4670 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4671 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4672 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4673 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JESSICA TRENARY MORRISON & FOERSTER LLP THORAZINE - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP ATROPINE - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP ESERINE - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP 2-PAM CL (PRALIDOXIME CHORLIDE) - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP MYLAXEN - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP RITALIN - AERS, APRVL, LBLG jESICA TRENARY MORRISON & FOERSTER LLP PROLIXIN - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP TRILAFON - AERS, APRVL, LBLG Signature/ Requester Subject
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Total Records: 12455 Control # 2011-4674 Recd Date / Due Date 06/27/2011 07/26/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4675 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4676 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4677 06/27/2011 07/26/2011 2011-4678 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4679 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4680 2011-4681 06/27/2011 07/26/2011 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ 2011-4682 06/27/2011 ORA/CE-FO/CIN-DO/CCB/ MARK VAN METER COLTENE WHALEDENT INC, CUYAHOGA FALLS, OH - EIR 3/5-24/09 FDA/OO/OFBA/OAGS/ MAYNARD, SHARON NEAL A DUPREE CAPITAL COLLATERAL REGIONAL COUSNEL - SOUTH INTERACTIVE TECHNOLOGY SOLUTIONS LLC - CONTRACT #HHSF22320045500C-18 FLORIDA DEPT OF CORRECTIONS SUPPLY OF PENTOBARBITAL - IMPORTATION, TEST RESULTS, CHAIN OF CUSTODY, ETC 1/10 TO PRESENT CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC PADDOCK LABS - CLOBETSAOL PROPRIONATE TOPICAL SPRAY ANDA 90-898 SBA BARTZ, SCOTT ORA/CE-FO/NJ-DO/NJCB/ NICK SCHWELLEBACH PROJECT ON GOVERNMENT OVERSIGHT TYLENOL CAPS, TABS, POWDER, ETC - MONOGRAPH, STABILITY STUDIES, PI, ETC 1982 SANOFI-AVENTIS US LLC, BRIDGEWATER, NJ - EIR 5/13/10 JESSICA TRENARY MORRISON & FOERSTER LLP COGENTIN - AERS, APRVL, LBLG JESSICA TRENARY MORRISON & FOERSTER LLP SCOPOLAMINE - AERS, APRVL, LBLG Signature/ Requester JESSICA TRENARY MORRISON & FOERSTER LLP Subject SECONAL - AERS, APRVL, LBLG
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Total Records: 12455 Control # Recd Date / Due Date 07/26/2011 2011-4683 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ 2011-4684 06/27/2011 07/26/2011 2011-4685 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4686 06/27/2011 07/26/2011 ORA/ ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ 2011-4687 06/27/2011 07/26/2011 ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ 2011-4688 06/27/2011 07/26/2011 ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/OCI/ 2011-4689 06/27/2011 07/26/2011 2011-4690 06/27/2011 07/26/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DORSEY V-90313, PHILLIP L BPA, PHALATES - CLNCL STUDIES, RPTS SARAH OUDEMOLEN MAZZA HEALTHCARE ENTRY #416-0117099-0 - LAB RESULTS MARSH, CLAYTON S HANK ASHER, TLO LLC - RECS Doe J CMPLNT 120945 Doe J CMPLNT 120193 ORA/SE-FO/FLA-DO/FCB/ MARLENA HARBSAZEWSKA AVALON RISK MANAGEMENT INC SHARI CLAIRE LEWIS RIVKIN RADLER ATTY ENTRY #AM000470360 - NOTICE OF FDA ACTION, NOTICE TO MARK AND/OR REDELIVER NORTHSTAR RX LLC - METOCLOPRAMIDE HCL ANDA 78374 WARNINGS, LBLG, CORR, ETC Action Office Signature/ Requester COLTENE WHALEDENT OWEN FONOROW VITAMIN C FOUNDATION MATRIXX INITIATIVES INC - VITAMIN C CORR, RECS Subject
Page 286 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ 2011-4691 2011-4692 2011-4693 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 2011-4694 2011-4695 2011-4696 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 2011-4697 2011-4698 2011-4699 2011-4700 2011-4701 2011-4702 2011-4703 2011-4704 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC ANDI POULSON LEXISNEXIS COURTLINK INC ANDI POULSON LEXIS NEXIS COURTLINK INC 2011-2421 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC RANDY BYRD BIONOSTICS FIBREK INC - RECYCLED BLEACH KRAFT (RBK) PULP APRVL RECS 2009-8015 EUROTROL - GAS ISE CONTROL K955340 FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC OC/OSHC/OPD/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC NATHAN WHITE COLLIE FIRM PLLC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC NATHAN WHITE COLLIE FIRM PLLC FDA/OF/CFSAN/OCD/EOS/ DAVID L HASSIG Cancer Action NY PERSISTENT ORGANIC POLLUTANTS - FDA MONITORING PROGRAM ACTIVITIES 1/00 TO PRESENT TISSUE TECHNOLOGIES - SOFT FORM FACIAL IMPLANT K973462 THERMO PAC LLC, STONE MOUNTAIN, GA - SIMPLY THICK EIR 5/23/11-6/3/11, PROCESSING PROCEDURE, FINDINGS, ETC TISSUE TECHNOLOGIES - SOFT TISSUE AUGMENTATION TUBE K962496 COOK BIOTECH - SIS DERMAL AUGMENTATION STRAND K050246 THERMO PAC LLC, STONE MOUNTAIN, GA - SIMPLY THICK MFG PROCESS 1/11 TO PRESENT, WARNING LTR 5/20/11, INVESTIGATIONS, ETC COOK BIOTECH - SIS FACIAL CYLINDER; SIS FACIAL IMPLANT K070738 KV PHARMS - MAKENA NDA 21-945 ORPHAN DRUG DESIGNATION NATIONAL ASSN OF RARE DISORDERS MTG - RECS, CORR 6/3/11 UNITIKA LTD - FATTY ACIDS COCO FCN 1068 Signature/ Requester Subject
Page 287 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4705 2011-4706 2011-4707 2011-4708 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 06/27/2011 07/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4709 06/27/2011 07/26/2011 2011-4710 06/27/2011 07/26/2011 2011-4711 06/27/2011 07/26/2011 2011-4712 06/27/2011 07/26/2011 2011-4713 2011-4714 06/27/2011 07/26/2011 06/27/2011 07/26/2011 2011-4715 06/27/2011 07/26/2011 2011-4716 06/27/2011 07/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WOLTERS KLUWER LAW & BUSINESS WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/16-20/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/23-27/11 FOI SERVICES INC FOI DAILY LOG 6/6-10/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 6/20-24/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 6/20-24/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 6/13-17/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 6/6-10/11 FOI DAILY LOG 5/31-6/3/11 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ APTSIAURI, K CHAO XIONG STAR TRIBUNE ROBERT W. MANN YOUNG HASKINS ET AL LIZ OTTINGER, Ph.D. THERAPEUTICS FOR RARE AND NEGLECTED DISEASES PROGRAM ANGIOSEAL - VASCULAR CLOSURE AERS 2001 TO PRESENT LIORESAL INTRATHECAL NDA 20-275 - CHEMISTRY, STATISTICAL,CLNCL PHARMACOLOGY RVWS, ETC CHATTANOOGA GROUP - AERS, RECALLS PRIZM MEDICAL INC - K033122 Signature/ Requester Subject
Page 288 of 1132

Total Records: 12455 Control # 2011-4717 Recd Date / Due Date 06/27/2011 07/26/2011 2011-4718 06/27/2011 07/26/2011 2011-4719 06/27/2011 07/26/2011 2011-4720 06/27/2011 07/26/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4721 06/27/2011 07/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4722 2011-4723 2011-4724 2011-4725 2011-4726 06/28/2011 07/27/2011 06/28/2011 07/27/2011 06/28/2011 07/27/2011 06/28/2011 07/27/2011 06/28/2011 07/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4727 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4728 06/28/2011 FDA/OMPT/CDER/ORP/DIDP/ ANGELLIA D SLAYTON SANOFI AVENTIS US - TAXOTERE NDA 20-449/S035 APRVL ANGELLIA D SLAYTON KENDLE REGULATORY AFFAIRS GILEAD - DAUNOXOME NDA 50-704 APRVL LTR, RVWS, ETC 4/8/96 CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ANGELIA D SLAYTON KENDLE INTERNATIONAL INC SCHERING PLOUGH, MERCK, JOHNSON & JOHNSON, ETC OTC SUNSCREEN PRODS AERS 6/20/06 TO PRESENT FOI DAILY LOG 6/6-10/11 FOI DAILY LOG 6/13-17/11 MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 420284-1 FOI DAILY LOG 6/20-24/11 CanReg, Inc. FOI DAILY LOG 5/16-20/11 CanReg, Inc. WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/23-27/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/16-20/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/23-27/11 Signature/ Requester Subject FOI DAILY LOG 5/30-6/3/11
Page 289 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/27/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4729 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4730 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4731 2011-4732 2011-4733 06/28/2011 07/27/2011 06/28/2011 07/27/2011 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4734 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4735 06/28/2011 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ 2011-4736 2011-4737 2011-4738 06/28/2011 07/27/2011 06/28/2011 07/27/2011 06/28/2011 CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ MITCHELL S FUERST FUERST ITTLEMAN PL DEBRA L DOTSON ANNIE CHUNS INC INDIVIDUAL RECS LLORENS PHARNMACEUTICAL INTERNATIONAL - EIRS 8/6/10-9/3/10 SESAME SEAWEED SNACKS - CMPLNTS GRETCHEN VAN LIERE SPOHRER & DODD SANDOZ INC - METHOTREXATE INJ USP 250 MG, 50 MG AERS, RECALL, SAFETY ALERTS, PRESS RELEASES, ETC JAMES M PARKER STRATEGIC BIOSCIENCE CORP SANFOFI AVENTIS US - RILUTEK NDA 20-599 RVWS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ VICTOR C ARELLLANO SECHRIST INDUSTRIES INC VICTOR C ARELLANO SECHRIST INDUSTRIES INC SAMIT DEB PHARMACEUTICS INTERNATIONAL INC SECHRIST INDUSTRIES INC, ANAHEIM, CA - OHC VENTILATOR K760852 SECHRIST INDUSTRIES INC, ANAHEIM, CA - OHC VENTILATOR K770010 PHARMACEUTICS INTERNATIONAL INC - BRETYLIUM TOSYLATE INJ 50 MG - LBLG, PI ANGELIA S SLAYTON KENDLE INTERNATIONAL INC CHIRHOCLIN INC - CHIRHOSTIM (HUMAN SECRETIN FOR INJ) NDA 21-256 CORR, TELEPHONE CONVERSATIONS, EMAILS, ETC ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS SANOFI AVENTIS US - TAXOTERE NDA 20-449/S039 APRVL LTR, RVWS 10/17/06 Signature/ Requester KENDLE INTERNATIONAL INC Subject LTR, RVWS, ETC 3/22/06
Page 290 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/28/2011 2011-4739 06/28/2011 07/27/2011 2011-4740 06/28/2011 07/27/2011 2011-4741 2011-4742 2011-4743 06/28/2011 07/27/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 2011-4744 06/29/2011 07/28/2011 2011-4745 06/29/2011 07/28/2011 2011-4746 06/29/2011 07/28/2011 2011-4747 06/29/2011 07/28/2011 2011-4748 06/29/2011 07/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4749 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4750 06/29/2011 FDA/OMPT/CDER/ORP/DIDP/ CHARLES CELESTE DESOXIMETASONE CREAM ANDA 73-193 - APRVL LTR, CHARLES CELESTE EAS Consulting Group, LLC NOLVADEX (TAMOXIFEN CITRATE) NDA 17-970 - APRVL LTR LBLG, CHEMISTRY RVWS, ETC FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OMP/DODM/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/DEN-DO/COMP/ OC/OM/OMP/DDM/ ORA/ ORA/ CTP/OD/ CTP/OD/ FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ ANDREW C BRISCOE III SUGAR ASSOCIATION INC MARILYNN WHITNEY COVINGTON & BURLING LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL CHARLES CELESTE EAS Consulting Group, LLC DCI BIOLOGICALS LLC, GALLUP, NM - EIRS, 483S CO RESP LAST FIVE YRS DCI BIOLOGICLS LLC, QUEENS VLLAGE, NY - EIRS, 483S, CO RESP LAST FIVE YRS MEDICAL DVCS ORDER FOR CERTAIN CLASS III DVCS SUBMISSIONOF SAFETY & EFFECTIVENESS; DKT 2009-M0101, 2010-N-0585 - LTRS COMMENTS, COMM, ETC POTENTIAL RECLASSIFICATION OF ELECTONVULSIVE THERAPY DVCS; DKT 2009-M-0101, 2010-N-0585 STUDIES, SUMMARIES, BRIEFINGS, ETC RECLASSIFICATION OF DVCS USED IN ELECTROCONVULISIVE THERAPY - LTRS, MEMOS, BRIEFINGS, ETC 4/2/09 EULEXIN (FLUTAMIDE) NDA 18-554 - APRVL LTR LBLG, BIOEQV RVWS, ETC CORN REFINERS ASSN - CORN SUGAR CORR, MINS, NOTES, ETC DKT FDA-2010-P-0491 WILLIAM, MIESMER Action Office Signature/ Requester Doe J CYNTHIA S WINGERT OPPENHEIMER WOLFF & DONNELLY TOBACCO CO -CIGARETTE PACKAGING DESIGN RECS ORA INFORMATION DISCLOSURE MANUAL Subject
Page 291 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/28/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4751 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4752 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4753 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4754 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4755 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4756 06/29/2011 07/28/2011 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-4757 2011-4758 06/29/2011 07/28/2011 06/29/2011 07/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ TSAI, MICHELLE MONEE A TAKLA TUCKER ELLIS & WEST LLP CARGILL HEALTH AND FOOD TECHNOLOGIES - PLANT STEROL/STANOL ESTERS LTR 2/14/03 (CERTIFIED) ACUTE SYSTEM TOXICITY TEST PROCEDURES FOR FOODS AND DRUGS 2010 TO PRESENT LAURA KENNELLY FSI CMPLNT 120371 CHARLES CELESTE EAS Consulting Group, LLC LETARIS (AMBRISENTAN) TABS NDA 22-081 - CO RESP, CORR, ETC 2/27/09 CHARLES CELESTE EAS Consulting Group, LLC LETAIRIS NDA 22-081 - FORM 2253, PROMOTIONAL MATERIAL, CORR, ETC 1/08 TO PRESENT CHARLES CELESTE EAS Consulting Group, LLC AMBRISENTAN (LETAIRIS) - AERS CHARLES CELESTE EAS Consulting Group, LLC LETAIRIS (AMBRISENTAN) TABS NDA 22-081/S017 - APRVL LTR, LBLG, MOR RVWS, ETC 3/3/11 CHARLES CELESTE EAS Consulting Group, LLC DESOXIMETASONE CREAM ANDA 73-210 - APRVL LTR, LBLG, CHEMISTRY RVWS, ETC Signature/ Requester EAS Consulting Group, LLC Subject LBLG, CHEMISTRY RVWS, ETC
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ 2011-4759 2011-4760 2011-4761 2011-4762 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 2011-4763 06/29/2011 07/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4764 06/29/2011 07/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4765 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4766 06/29/2011 07/28/2011 2011-4767 06/29/2011 07/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4768 2011-4769 06/29/2011 07/28/2011 06/29/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ PAUL E LINSKEY RHODIA INC WALTER E CHALKLEY MARK KIRSCHBAUM MD, DURATE,CA - EIRS, 483S, CO RHODIA INC, SPARTANBURG, SC - EIR 12/09 MARGARET DAI BIEDERMANN HOENIG & RUFF ACCUTANE - APRVL RECS 1982, LBLG 1982-2001; CLARAVIS - LBLG 2002 TO PRESENT WALTER E CHALKLEY THOMSON REUTERS COVANCE, MADISON, WI - EIRS, 483S, CO RESP 8/10 WALTER E CHALKLEY THOMSON REUTERS CIPLA, MAHARASHA, INDIA - EIRS, 483S, CO RESP 3/09 DERBES, PETER D DEPUY ORTHOPAEDICS INC - K073413 WALTER E CHALKLEY THOMSON REUTERS REDDY'S LABORATORIES LTD, ANDRA PRADESH, INDIA EIRS, 483S, CO RESP 11/8-11/10 DERBES, PETER D FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J KENNETH R JONES BRASSELER USA KENNETH R JONES BRASSELER USA DEPUY ORTHOPAEDICS INC - K040627 BRASSELER USA (TAVA SURGICAL) - MICRO SURGICAL INSTRUMENTS SYS K885273 BRASSELER USA - RACE ENDODONTIC FILE K002709 INDIVIDUAL RECS Signature/ Requester Subject
Page 293 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/28/2011 2011-4770 06/29/2011 07/28/2011 Action Office ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4771 06/29/2011 07/28/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4772 06/29/2011 07/28/2011 2011-4773 2011-4774 2011-4775 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 2011-4776 2011-4777 2011-4778 2011-4779 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4780 06/29/2011 07/28/2011 ORA/SW-FO/KAN-DO/COMP/ WALTER E CHALKLEY THOMSON REUTERS BAYER HEALTH CARE, SHAWNEE, KS - EIRS, 483S, CO RESP 6/10 Doe J ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ CANDACE H SHIRLEY GURNEE & DANIELS LLP GENARO GARCIA GARCIA DEVELOPMENTS INC WALTER E CHALKLEY THOMSON REUTERS ZOLOFT - AERS ALLERGAN, IRVINE, CA - EIRS, 483S, CO RESP 7/10 INVACARE INC - ELECTRICALLY POWERED HOSPITAL BEDS RPTS, CMPLNTS, WARNING LTR 12/15/10, ETC WERNER EIDAM MEDIZIN-TECHNOLOGIE GMBH - K071956 ORA/SW-FO/KAN-DO/COMP/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ PEGGY BINZER EDWARDS ANGELL PALMER & DODGE LLP WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS LUITPOLD PHARMACEUTICALS, SHIRLEY, NY - EIRS, 483S, CO RESP 10/10 NOVARTIS CONSUMER HEALTH, LINCOLN, NE - EIRS, 483S, CO RESP 4/10 PHARMACIA & UPJOHN (DIV OF PFIZER), KALAMAZOO, MI EIRS, 483S, CO RESP 9/9-28/10 LALLEMARD INC - FAP 9A4779 SAMPLE #33949-037, BRANDON NICOTINE WATER, LIP BALM, LOLLIPOPS - CMPLNTS, APRVLS, SALES, ETC Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS Subject RESP 4/09 DANILO HODOBA MD (VRAPCE PSYCHIIATRIC HOSP), ZAGREB, CROATIA - EIRS, 483S, CO RESP 10/09
Page 294 of 1132

Total Records: 12455 Control # 2011-4781 2011-4782 Recd Date / Due Date 06/29/2011 09/06/2011 06/29/2011 07/28/2011 ORA/CE-FO/BLT-DO/CB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4783 2011-4784 2011-4785 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/CIN-DO/CCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS PHILIPS MEDICAL SYS, CLEVELAND, OH - EIRS, 483S, CO RESP 8/25/10 TO 12/3/10 CSL BIOTHERAPIES, PARKVILLE, VICTORIA, AUSTRALIA EIRS, 483S, CO RESP 3/21-31/11 RECTIVE - PI Action Office ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS MERLE SIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION Subject IMPAX LABORATORIES, HAYWARD, CA - EIRS, 483S, CO RESP 12/12/10 TO 1/21/11 DIETARY SUPPLEMENT FACILITIES - EIRS, 483S 8/10 TO 12/10
Page 295 of 1132

Total Records: 12455 Control # 2011-4786 2011-4787 Recd Date / Due Date 06/29/2011 07/28/2011 06/29/2011 07/28/2011 2011-4788 06/29/2011 07/28/2011 2011-4789 2011-4790 2011-4791 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4792 2011-4793 2011-4794 2011-4795 2011-4796 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/29/2011 07/28/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ANDERSON, JONATHAN YC LEI EPS BIO TECHNOLOGY CORP FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHEN BENJAMIN OLSEN MEDICAL CHERYL B. CLEVELAND Dow AgroSciences LLC DONALD L. HASSIG Cancer Action NY COCONUT FATTY ACID (DIMETHYLAMIDOPROPYLAMIDE) RECS PERSISTANT ORGANIC POLLUTANTS (POPS) - FDA MONITORING ACTIVITY RECS 1/00 TO PRESENT MILWAUKEE JOURNAL SENTINEL - TRIAD GROUP & H&P INDUSTRIES INVESTIGATION, APPEALS, RESP GRT SOLUTIONS INC, LOS ANGELES, CA - LiTE MODEL PRO-8A LIGHT THERAPY SYS K050668 LASERSAFE EYE SHIELDS - APRVL, SUMMARY K852404 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANDREA N. WALLEN DELPHINUS MEDICAL TECHNOLOGIES INC ANDREA N. WALLEN DELPHINUS MEDICAL TECHNOLOGIES INC MICHAEL T. TUSA, Jr. SUTTON & ALKER LLC ZACHARY H. GREENE MILLER & MARTIN PLLC C. GLORIA WANG SCIENTIFICTHERAPEUTICS INFORMATION INC ANAZAO HEALTH CORP, TAMPA, FL - HYALURONIDASE AERS SUPERSONIC IMAGINE - AIXPLORER K102041, AIXPLORER ULTRASOUND SYS K091970 GE LUNAR CORP, MADISON, WI - LUNAR ACHILLES EXPRESS ULTRASONOMETER P970040 ALMA LASERS - ACCENT XL LASER SYS K072699 CMPLNTS, EFFICACY METAFOLIN, EXTRAFOLATE, PRENATE ELITE - GRAS Signature/ Requester Subject 2009-5817
Page 296 of 1132

Total Records: 12455 Control # 2011-4797 Recd Date / Due Date 06/30/2011 07/29/2011 2011-4798 2011-4799 06/30/2011 07/29/2011 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-4800 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-4801 2011-4802 06/30/2011 07/29/2011 06/30/2011 07/29/2011 FDA/OF/CFSAN/OCD/EOS/ LEWIS, BRUCE S ORA/P-FO/SEA-DO/SCB/ CLARK, MAGGIE EVALUATION OF THE HEALTH ASPECTS OF SODIUM HYDROXIDE & POTASSIUM HYDROXIDE AS FOOD INGREDIENTS - 30 SCIENTIFIC & STATISTICAL SOURCES & COMPENDIA RPTS ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS INC, JANSSENORTHO LLC, ORTHO-MCNEIL NEUROLOGIES TOPAMAX (TOPIRAMATE) APRVL RECS, RVWS, WARNING LTRS, ETC WILLIE GREENS ORGANIC FARM, MONROE, WA - 483 PETETTA, MV LORENA MOXIDECTIN NADA 141-051 - AERS Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TRINA THOMPSON MCGUIREWOODS LLP VOLKMAR KOCH WEBER & WEBER GMBH & CO KG ABIOMED INC - IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYS UNTITLED LTR 1/28/10 ACUTE ORAL LD50 ASSAY IN RATS OTC VOL 2100303; FOUR-WEEK EXPLORATORY DIETARY TOXICITY STUDY IN RATS OCT VOL 210304 - UNPUBLISHED STUDY, ETC Signature/ Requester YC LEI EPS BIO TECHNOLOGY CORP Subject LIGHT BIOSCIENCE LLC, VIRGINIA BEACH, VA - GENTLE WAVES CONSUMER LED PHOTOMODULATLION DVC K062991
2011-4803
06/30/2011 07/29/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OL/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/OCI/ ORA/OCI/ ORA/SE-FO/SJN-DO/SJCB/
B KRISTIAN W RASMUSSEN CORY WATSON ET AL
2011-4804
06/30/2011
FDA/OF/CFSAN/OCD/EOS/
ELEENA HOWELL
INFANT FORMULAS - CAERS 1/10 TO PRESENT
Page 297 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/29/2011 2011-4805 2011-4806 06/30/2011 07/29/2011 06/30/2011 07/29/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4807 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4808 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4809 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4810 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4811 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4812 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4813 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC MYLAN - DIVALPROEX SODIUM ANDA 90-407 APRVL LTR FOI SERVICES INC MYLAN - ACARBOSE ANDA 91-053 APRVL LTR FOI SERVICES INC MYLAN - ERLOTINIB HCL ANDA 91-002 APRVL LTR FOI SERVICES INC MYLAN - ESZOPICLONE ANDA 91-151 APRVL LTR FOI SERVICES INC MYLAN - BUDESONIDE ANDA 90-410 APRVL LTR FOI SERVICES INC MYLAN - ROSUVASTATIN CALCIUM ANDA 79-161 APRVL LTR FOI SERVICES INC MYLAN - PEG3350 & ELECTROLYTES ANDA 90-928 APRVL LTR FOI SERVICES INC ROBLES, 88A8275, RAFAEL MYLLAN - GALANTAMINE HYDROBROMIDE ANDA 90-900 APRVL LTR Action Office Signature/ Requester HOGAN LOVELLS LLP CIGARETTE WARNING LABEL Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4814 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4815 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4816 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4817 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4818 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4819 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4820 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4821 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC MYLAN - MEMANTINE HCL ANDA 79-225 APRVL LTR FOI SERVICES INC EVA - OXYMORPHONE HCL ANDA 91-443 APRVL LTR FOI SERVICES INC MYLAN - PAROXETINE HCL ANDA 91-427 APRVL LTR FOI SERVICES INC MYLAN - CYCLOBENZAPRINE HCL ANDA 90-738 APRVL LTR FOI SERVICES INC MYLAN - LATANOPROST ANDA 20-1786 APRVL LTR FOI SERVICES INC MYLAN - FAMCICLOVIR ANDA 20-1333 APRVL LTR FOI SERVICES INC MYLAN - RISPERIDONE ANDA 91-537 APRVL LTR FOI SERVICES INC MYLAN - PIOGLITAZONE HCL, METFORMIN HCL ANDA 90406 APRVL LTR Signature/ Requester Subject
Page 299 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-4822 2011-4823 2011-4824 2011-4825 06/30/2011 07/29/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/SJN-DO/SJCB/ 2011-4826 06/30/2011 07/29/2011 2011-4827 06/30/2011 07/29/2011 2011-4828 2011-4829 06/30/2011 07/29/2011 06/30/2011 07/29/2011 2011-4830 06/30/2011 07/29/2011 2011-4831 2011-4832 2011-4833 06/30/2011 07/29/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DOMINION GROUP INC KANGERE, SAMUEL J BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 5/30/11-6/3/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KENNETH REID WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE BARBARA RICH STERIS CORP DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS COMPANIES THAT MAKE AND SUPPLY OLANZAPINE, BENZTROPINE, LORAZEPAM, ETC FOI DAILY LOG 6/6-10/11 FOI DAILY LOG 6/6/-10/11 ADVANCED STERILIZATION PRODUCTS - STERRAD 100NX STERILIZER K071385 FOI DAILY LOG 5/30/11-6/3/11 FOI DAILY LOG 6/6-10/11 FOI DAILY LOG 5/30/11-6/3/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ CHU, CAROLINE GLADYS B TONKIN Center for Regulatory Services, Inc. JEFFREY RIECK LYNCH DASKAL EMERY LLP MERCK & CO - PROPECIA AERS, CORR, INSP, WARNING LTRS FOI DAILY LOG 6/6-10/11 GLADYS B TONKIN Center for Regulatory Services, Inc. IMPAX LABS - WARNING LTR CORR 5/31/11 FOI DAILY LOG 5/30/11 TO 6/3/11 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-4834 Recd Date / Due Date 06/30/2011 07/29/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4835 2011-4836 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4837 2011-4838 2011-4839 06/30/2011 07/29/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4840 2011-4841 2011-4842 06/30/2011 07/29/2011 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4843 2011-4844 06/30/2011 07/29/2011 06/30/2011 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ KENDLE REGULATORY AFFAIRS MARY FALLON AUSTRALIAN BROADCASTING CORPORATION; RADIO NATIONAL CSL BIOTHERAPIES - WARNING LTR RESP, UNTITLED LTR RESP, EIR MOST RECENT, ETC FOI DAILY LOG 6/6-10/11 KENDLE REGULATORY AFFAIRS ANDREA N. WALLEN DELPHINUS MEDICAL TECHNOLOGIES INC ORISON CORP, JOHNSON CITY, TN - EMBRACE SYS K070477 FOI SERVICES INC FOI DAILY LOG 5/30/11-6/3/11 FOI DAILY LOG 5/30/11-6/3/11 FOI SERVICES INC KAREN BENSON VIVUS INC SUPRENZA NDA 20-2088 SBA JUDWAY, JEFFREY FOI DAILY LOG 6/6-10/11 DRIVING RECORD FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL T. TUSA, Jr. SUTTON & ALKER LLC CECELIA FRENCH CanReg, Inc. ALMA LASERS ACCENT XL LASER SYS K072699 CMPLNTS, STUDIES FOI DAILY LOG 6/6-10/11 Signature/ Requester CECELIA FRENCH CanReg, Inc. Subject FOI DAILY LOG 5/30/11-6/3/11
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Total Records: 12455 Control # 2011-4845 Recd Date / Due Date 06/30/2011 08/19/2011 2011-4846 2011-4847 06/30/2011 07/29/2011 06/30/2011 07/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4848 2011-4849 06/30/2011 07/29/2011 06/30/2011 07/29/2011 2011-4850 06/30/2011 07/29/2011 2011-4851 2011-4852 2011-4853 2011-4854 2011-4855 2011-4856 2011-4857 2011-4858 2011-4859 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/MIN-DO/MCB/ GUMPERT, DAVID . GARY DYKSTRA UNIVERSITY OF GEORGIA COLLEGE OF PHARMACY LINDA S. RECKLEIN NESTLE PURINA PETCARE STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL OLSEN MEDICAL - PRO-CLEAN K862367 OLSEN MEDICAL - SURGI-WIPES K863278 OLSEN MEDICAL - AMERICAN BIOSURGICAL ELECTROSURGICAL BIPOLOR CABLE/CORD K953889 OLSEN MEDICAL - DISPOSABLE BIPOLOR CORD & BIPOLAR FORCEP K884656 OLSEN MEDICAL - SURGITET BIOPOSABLE BIPOLAR CORD K871910 OLSEN MEDICAL - DERMACARE TIE HOLD K893995 DATA RESLULTING FROM 2008 REPORT NATIONWIDE ASSIGNMENT TO COLLECT & ANALYZE SAMPLES OF DIRECT HUMAN CONTACT FEEDS FOR SALMONELLA OLSEN MEDICAL - OLSEN 756 ROCKER SWITCHPEN K834329 OLSEN MEDICAL - OLSEN 770 DISPOSABLE HOLSTER K820158 OLSEN MEDICAL - BICORD BY QMED K863091 MICHAEL HARTMANN, HARTMANN FARM, GIBBON, MN RPTS, COMM 2009 TO 2011 LIST OF PHARMACEUTICAL MFRS IN PUERTO RICO ORA/SE-FO/FLA-DO/FCB/ Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester DENISE M. POWERS FULBRIGHT & JAWORSKI LLP DENISE M. POWERS FULBRIGHT & JAWORSKI LLP MICHAEL THEODORAKIS NTEU CHAPTER 282 Subject PROVIDENT PHARMACEUTICALS LLC, COLORADO SPRINGS, CO - EIR, WARNING LTRS, CORR 1/1/09 TO PRESENT DERMAZONE SOLUTIONS INC, SHERIDAN, WY - WARNING LTR, EIRS, CORR 1/1/09 TO PRESENT STAFF FELLOW GUIDANCE 200-4-1
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Total Records: 12455 Control # 2011-4860 2011-4861 2011-4862 2011-4863 2011-4864 2011-4865 2011-4866 2011-4867 2011-4868 2011-4869 Recd Date / Due Date 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 2011-4870 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4871 07/01/2011 08/01/2011 2011-4872 2011-4873 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ SCOTT FRIEDMAN KXAS NEWS MICHAEL GRABELL PRO PUBLICA WILLIAM A GARVIN ESQ BUCHANAN INGERSOLL & ROONEY PC DONNATAL - EVALUATIONS, SAFETY RECS AIRCRAFT WATERING POINTS, DFW AIRPORT, DALLAS LOVE FIELD EIRS 1/08 TO PRESENT; AMERICAN AIRLINES, SOUTHWEST AIRLINES - EIRS 6/09 TO PRESENT DANIEL KASSIDAY LTR 4/10/99 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL WILLER GHELFI NEXTRON MEDICAL TECHNOLOGIES INC NIGEL DUARA ASSOCIATED PRESS COMPASSIONATE INVESTIGATIONAL NEW DRUG PROGRAM - FDA MONITORING ACTIVITY RECS OLSEN MEDICAL - 500 SERIES FORCEPS W/CUT/COGULATE SWITCHES K885199 BIOPSYBELL SRL - K011104 OLSEN MEDICAL - MODIFIED OLSEN 755/756 SWITCHPENS K884174 OLSEN MEDICAL - 820/821 BIPOLAR ORCEPTS K884175 OLSEN MEDICAL - OLSEN 770 DISPOSABLE HOISTER K884172 OLSEN MEDICAL - 920 DISPOSABLE TUR CABLE K884173 Subject OLSEN MEDICAL - STERILE LASER RESISTANT SURGICAL FIELD DRAPE K854266 OLSEN MEDICAL - LASESRSAFE PERSONNEL & PATIENT SHIELDS EYE SHIELDS K852405 OLSEN MEDICAL - DOUBLE-COAGULATION SWITCHPENN 757 K834410 OLSEN MEDICAL - DISPOSABLE BIPOLAR CABLE K884171
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Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OMP/DODM/ OM/OMP/DODM/ 2011-4874 2011-4875 07/01/2011 08/01/2011 07/01/2011 08/01/2011 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ 2011-4876 2011-4877 2011-4878 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4879 2011-4880 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4881 07/01/2011 08/01/2011 2011-4882 07/01/2011 08/01/2011 2011-4883 2011-4884 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/LOS-DO/LACB/ CHRIS CLONTS NEUROMECHANICAL INNOVATIONS NATHANIEL ENOS CONWAY HOMER & CHINCAPLAN PC AUDREY VITALE LIFESCIENCE PLUS INC CYNDY BURINDA PHOENIX REGULATORY ASHLAND INC - FCN 979 DOCUMENT #GEN1100055 ACTIVATOR METHODS INC, PHOENIX, AZ - EIR, 483S, WARNING LTRS INDIVIDUAL RECS GIEGERICH, JULIE WALTER E CHALKLEY THOMSON REUTERS LIFECELL/KINETIC CONCEPTS - 483 11/2-12/10, WEBSITE PRINTOUTS SCHERING - INTRON A (INTERFERON ALPHA-2B) BLA 103132 OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ MORROW, LEN W JAN O FRIEDRICH MD ST MICHAELS HOSPITAL FINN HESSELBJERG COWI A/S DEPUY - DEPUY ULTIMA METAL-ON-METAL TOAL HIP REPLACEMENT SYS K001523 VACCINES AND RELATED BIOLOGICAL PRODUCTS A/C TRANS 9/4/91 FERTIN PHARMA A/S,VEJLE, DENMARK - EIR 5/26/-04-6/3/04 OM/OMP/DODM/ FATIMA ASLAM Keller and Heckman LLP MICHELLE RYBAK ROANOKE TRADE SERVICES INC ENTRY #J34 00610294 - NOTICES OF REFUSAL, NOTICE OF MARK/REDELIVER DKT 1998C-0790, DKT 1998C-0045 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester ASSOCIATES LTD 2011-4885 07/01/2011 08/01/2011 2011-4886 2011-4887 2011-4888 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4889 2011-4890 2011-4891 2011-4892 2011-4893 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4894 2011-4895 07/01/2011 08/01/2011 07/01/2011 08/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-4896 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SEAN HIGGINS ANDREWS & THORNTON PRODUCTS SUBJECT TO THE DRUG EFFICACY STUDY IMPLEMENTATION PROGRAM, PRESCRIPTION WRAP UP LIST, QUININE NDA FDA/OMPT/CDRH/OCER/DFOI/ WALLACH, STEVEN LAWRENCE M. SHAW NORMED YONGKANG BANGLI MEDICAL PRODUCTS CO LTD IMPORT ALERT 79-01 SPINAL GUIDES PACS - K092427 OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID J GERAGHTY SPACELABS MEDICAL, INC. DEBORAH C. ATTWOOD Keller and Heckman LLP DEBORAH C. ATTWOOD Keller and Heckman LLP BRUCE SILVERGLADE OFW LAW JUNE K. GHEZZI JONES DAY ATTYS ISR 7236473 DKT 1982G-0148 TELLES LLC - FCN 943 FCN 943 - CHEMISTRY RVW, TOXICOLOGY RVW BLEASE 6200 ANESTHESIA VENTILATOR - K982123 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CYNDY BURINDA PHOENIX REGULATORY ASSOCIATES LTD IRINA MOLOCHKO UNOMEDICAL LTD KYLE O'CONNOR CONVATEC INC BESS O'BRIEN KLOK LAW FIRM LLC ACTOS (PIOGLITAZONE) - AERS CONVATEC INC - DISARP ORIGINAL K802248 CONVATEC INC - DISARP ORIGINAL K802248 BUCKMAN LABORATORIES INTERNATIONAL INC - FCN 871 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4897 2011-4898 07/01/2011 08/01/2011 07/01/2011 08/01/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ 2011-4899 07/01/2011 08/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4900 2011-4901 2011-4902 07/01/2011 08/01/2011 07/01/2011 08/01/2011 07/05/2011 08/02/2011 2011-4903 2011-4904 2011-4905 07/05/2011 08/02/2011 07/05/2011 08/02/2011 07/05/2011 08/02/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4906 2011-4907 07/05/2011 08/02/2011 07/05/2011 CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ SALLY FOUST ARTHREX INC ALEX VEIZIS TOBACCO A/C METGS 2009 TO PRESENT CONMED LINVATEC - SOFT TISSUE TO BONE SYS K091549 ALLEN, PEGGY PERRY, SCOTT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ INFORMATION ACCESS MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC WILLIAM A OLSON Center for Regulatory Services, Inc. DRUG COS, GOOD LAB PRACTICES - DOMESTIC & FOREIGN INSPS, 483S, DATES, INVESTIGATORS 6/1-30/11 AKZO NOBEL SURFACE CHEMISTRY LLC - 2-PROPENOIC ACID, HOMOPOLYMER, SODIUM SALT FCN 751 FOOD MFG FACILITIES, DALLAS, TARRANT, DENTON & COLLIN COUNTIES, TX - INSPS 2010 TO PRESENT AVASTIN - AERS INFORMATION ACCESS FOI DAILY LOG 5/30-6/3/11 FOI DAILY LOG 6/6-10/11 VAN TRAN, DAVID ROCHE - OSELTAMIVIR (TAMIFLU) IND PAUL W. TRIPP LINCARE INC ANNEMIEKE M. TENNIS KANNER & WHITELEY LLC I CARE OF ARKANSAS INC - 483, EIRS, WARNING LTR 1/1/04 TO PRESENT TEVA PHARMS - LANSOPRAZOLE DELAYED RELEASE RECALL RECS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 08/02/2011 2011-4908 07/05/2011 08/02/2011 2011-4909 07/05/2011 08/02/2011 Action Office CTP/OD/ FDA/OO/OFBA/OAGS/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4910 2011-4911 2011-4912 07/05/2011 08/02/2011 07/05/2011 08/02/2011 07/05/2011 08/30/2011 2011-4913 07/05/2011 08/02/2011 2011-4914 2011-4915 2011-4916 2011-4917 2011-4918 2011-4919 07/05/2011 08/02/2011 07/05/2011 08/02/2011 07/05/2011 11/09/2011 07/05/2011 08/02/2011 07/06/2011 08/03/2011 07/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OF/CFSAN/OCD/EOS/ ANITA RASMUSSEN MCCORMICK CO INC PAUL CARDARELLI MEDICA CORPORATION JULIE EWEND GEN-PROBE GTI DIAGNOSTICS INC JULIE EWEND GEN-PROBE GTI DIAGNOSTICS INC MICHAEL N SEVIGNY BIOTEK INSTRUMENTS INC ELENA HOWELL HOGAN LOVELLS LLP J TODD KENNARD JONES DAY AMY JOHNSON SIDLEY AUSTIN LLP STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENAMIN SOAPTRONIC, LAKE FOREST, CA - EIR EXHIBITS 5,6,& 26 12/7-16/10 TTK LIG LTD, TT JAGANNATHAN - DUREX CONDOMS RECS, COMM DKT FDA-2005-P-0319, FDA-2004-P-0494, FDA-2011-P0087 OLSEN MEDICAL -TEFLON COATED ELECTRODE/ELECTRODES HANDLES K913108 OLSEN MEDICAL - SMOKE/ODOR EVACUATOR #757 BIOTEK INSTRUMENTS INC - EIR 4/13-14/09 ONE LAMBDA INC - LABSCREEN BK030069 ONE LAMBDA INC - LABSCREEN MULTI BK080071 MEDICA CORP, BEDFORD, MA - 482 3/2-9/11 KOHINOOR FOODS LTD, SONEPAT, INDIA - EIR 9/7/10 JEFFREY D DECARLO ATTY AT LAW BASAV SEN UFCW INTERNATIONAL UNION, CLC 2 SISTERS FOOD GROUP INC, CA - EIRS, WARNING LTRS, SEIZURES, ETC SALIX PHARMACEUTICALS INC - OSMOPREP TABS LBLG NEGOTIATIONS TELEPHONE CONFERENCE CONTACT MEMO & MINS 3/9/06 Signature/ Requester FDALIVE.COM Subject
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Total Records: 12455 Control # Recd Date / Due Date 08/03/2011 2011-4920 2011-4921 2011-4922 2011-4923 2011-4924 2011-4925 2011-4926 2011-4927 2011-4928 2011-4929 2011-4930 2011-4931 2011-4932 2011-4933 2011-4934 2011-4935 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ RENCHER, JEFF FRAN KOCH INFORMATION ACCESS #17478 FDA/OMPT/CDRH/OCER/DFOI/ RENCHER, JEFF LIGASURE CURVED SMALL JAW OPEN SEALER/VIVIDER K102470 2011-3471 FDA/OMPT/CDRH/OCER/DFOI/ RENCHER, JEFF FDA/OMPT/CDRH/OCER/DFOI/ RENCHER, JEFF CONMED - ALTRUS THERMAL TISSUE FUSION SYS K101534 SURGITRON 120 TEC (SURGITRON 4.0 DUAL RF) - K013255 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL LINA - POWER BLADE K063025 OLSEN MEDICAL - CIMMARRON 1000 OR 1000-2 K790293 OLSEN MEDICAL - DISPOSABLE SKIN RETRACTOR K801151 OLSEN MEDICAL - DUAL-TROL K802972 OLSEN MEDICAL - PAO BIPOLAR COAGULATOR K840545 OLSEN MEDICAL - QMED SLEF ADHERING ELECTRODE K862377 OLSEN MEDICAL - CORRECT-A-COUNT K853374 OLSEN MEDICAL - ASPEN RETURN MONITOR K873591 OLSEN MEDICAL - INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE K882421 OLSEN MEDICAL - QMED KLEENIT K843559 Subject K912612 OLSEN MEDICAL - LAPAROSCOPIC INSTR DISPOSABLE SINGLE USE K912611 OLSEN MEDICAL - DERMAMARKER K863280
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Total Records: 12455 Control # 2011-4936 2011-4937 2011-4938 2011-4939 2011-4940 2011-4941 Recd Date / Due Date 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4942 2011-4943 07/06/2011 08/03/2011 07/06/2011 08/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4944 07/06/2011 08/03/2011 2011-4945 07/06/2011 08/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ OC/OCM/EMOPS/ OC/OM/OEO/ 2011-4946 2011-4947 07/06/2011 08/03/2011 07/06/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ MARC J SCHEINESON ALSTON & BIRD LLP NEVADA HEART & VASCULAR CENTER, LAS VEGAS, NV EIRS, CORR RAWESOME FOODS, VENICE, CA - INVESTIGATION RECS MELVIN N KRAMER PHD MPH EHA CONSULTING GROUP INC DEL MONTE FRESH PRODUCE NA INC - CANTALOPES SALMONELLA PANAMA OUTBREAK RECS 2011 JONEL ALECCIA MSNBC.COM TRIAD GROUP (H&P INDUSTRIES), HARTLAND, WI - 483S 4/28/00, 8/29/02, 2/13/03, 1/19/06 ORA/P-FO/SAN-DO/SFCB/ CHRISTINE S RICHARD THE INDAGO GROUP WILLIAM F CASH III LEVIN PAPANTONIO ET AL CENTOCOR - REMICADE AERS INTUITIVE SURGICAL INC, SUNNYVALE, CA - EIR, 483 7/10 Signature/ Requester FRAN KOCH INFORMATION ACCESS #17478 FRAN KOCH INFORMATION ACCESS #17478 FRAN KOCH INFORMATION ACCESS #17478 FRAN KOCH INFORMATION ACCESS #17478 FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS 2011-3407 2011-3361 2011-3576 2011-3546 2011-3547 Subject 2011-3548
Page 309 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/03/2011 2011-4948 07/06/2011 08/03/2011 Action Office ORA/P-FO/LOS-DO/LACB/ OC/OCC/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ 2011-4949 2011-4950 2011-4951 2011-4952 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 2011-4953 07/06/2011 08/03/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4954 07/06/2011 08/03/2011 2011-4955 07/06/2011 08/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CTP/OD/ CTP/OD/ 2011-4956 07/06/2011 08/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SCOTT A HARFORD LYNCH DASKAL EMERY LLP MERCK & CO INC - PROPECIA AERS, CORR, SAFETY ALERTS, ETC 1996 TO PRESENT STARR M KINCAID LIPSON NEILSON COLE SELTZER GARIN PC RONALD S MILSTEIN LORILLARD INC ABBOTT VASCULAR DEVICES - STARCLOSE VASCULAR CLOSURE SYS APRVL RECS, WARNINGS, PROD PROTOCOLS, ETC 2011-3007 XIM TAO Keller and Heckman LLP ISR 3872540 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ REBECCA MOCK GILEAD SCIENCES INC LINDA BOWEN SANOFI AVENTIS JEFFREY K SHAPIRO Hyman Phelps and McNamara PC ALEX VEIZIS FDALIVE.COM HOSPIRA PTY AUSTRALIA LTD, MULGRAVE, AUSTRALIA EIR MOST RECENT VERTELLUS PERFORMANCE MATERIALS INC, BAYONNE, NJ - EIR MOST RECENT CUTERA - GENESISPLUS LASER SYS K103626; DOCUMENT CPT1100060 RECS TSE AND BLOOD PRODS A/C 8/1-3/11 - WEBCAST COST TO TAXPAYERS DANIEL J SMITH SMITH & SMITH ROXANE LABORATORIES INC - HYDROMORPHONE HCL MFG, DISTRIBUTION RECS 5/29/09 Signature/ Requester GUMPERT, DAVID . Subject 6/30/10
Page 310 of 1132

Total Records: 12455 Control # 2011-4957 Recd Date / Due Date 07/06/2011 08/03/2011 2011-4958 07/06/2011 08/03/2011 Action Office ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4959 07/06/2011 08/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4960 2011-4961 2011-4962 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4963 2011-4964 07/06/2011 08/03/2011 07/06/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-4965 2011-4966 2011-4967 2011-4968 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC CECELIA FRENCH CLOSED FOI REQUESTS 5/2-6/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ JARED MACCLEARY CROWELL & MORING ANGELIA SLAYTON KENDLE INTERNATIONAL INC CLOSED FOI REQUESTS 6/27/11 TO 7/1/11 DKT 1975N-0183 CVM FOI DAILY LOG 6/11 FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC CSL BIOTHERAPIES, VICTORIA, AUSTRALIA - EIR, 483, CO RESP 4/18/11-5/13/11 BAXTER SA, LESSINES, BELGIUM - EIR, 483, CO RESP 11/6/09-12/3/09 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ JOHNSON, JEFFREY FDA/OMPT/CDRH/OCER/DFOI/ JOHNSON, JEFFREY BOSTON SCIENTIFIC CORP - PRECISION SPINAL CORD STIMULATION SYS P030017 ADVANCED NEUROMODULATION SYSTEMS INC - GENESIS NEUROSTIMULATION SYS P010032 SANOFI AVENTIS US - CHILDREN'S ALLEGRA NDA 20-1373 APRVL RECS BETH M SALKIND LOWENTHAL & ABRAMS PC CLOMID NDA 16-131 - LBLG, PKG CHANGES Signature/ Requester DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC VASSILIOS CHRISTODOULOPOULOS SANDOZ CANADA INC. Subject HUMAN CELL AND TISSUE ESTABLISHMENTS - 483S 1/11 TO 6/11 NDA 22-434 - RECS
Page 311 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/03/2011 2011-4969 2011-4970 2011-4971 2011-4972 2011-4973 2011-4974 2011-4975 2011-4976 2011-4977 2011-4978 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/06/2011 08/03/2011 07/07/2011 08/04/2011 2011-4979 07/07/2011 08/04/2011 2011-4980 07/07/2011 08/04/2011 2011-4981 07/07/2011 08/04/2011 2011-4982 07/07/2011 08/04/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DOUGLAS CHABOT DECOF & DECOF PC I-FLOW CORP - SGARLATTO PUMP K982946 FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP DOUGLAS CHABOT DECOF & DECOF PC SIGMA INTL - SPECTRUM & SPECTRUM WITH MASTER DRUG LIBRARY K042121 CARDINAL HEALTH 303 INC - ALARIS PC UNIT MODELS 8000 & 8015 K091308 ABBOTT LABS - HOSPIRA PHOENIX INFUSION SYS WITH HOSPIRA MEDNET SOFTWARE K041550 CLOSED FOI REQUESTS 4/25-29/11 CLOSED FOI REQUESTS 6/27/11 TO 7/1/11 CLOSED FOI REQUESTS 6/20-24/11 CLOSED FOI REQUESTS 6/13-17/11 CLOSED FOI REQUESTS 6/6-10/11 CLOSED FOI REQUESTS 5/31/11 TO 6/3/11 CLOSED FOI REQUESTS 5/23-27/11 CLOSED FOI REQUESTS 5/16-20/11 CLOSED FOI REQUESTS 5/9-13/11 Subject
I-FLOW CORP - CLASS II MEDICAL DVC K984502
Page 312 of 1132

Total Records: 12455 Control # 2011-4983 Recd Date / Due Date 07/07/2011 08/04/2011 2011-4984 2011-4985 2011-4986 2011-4987 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 2011-4988 2011-4989 2011-4990 2011-4991 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4992 2011-4993 07/07/2011 08/04/2011 07/07/2011 08/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-4994 2011-4995 2011-4996 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J BETH GIESEKE GENERAL MILLS BONGARDS CREAMERIES, MN - EIRS, 483S LAST 18 MONTHS DEPUY - ASR HIP SURFACE REPLACEMENT SYS - PMA 2007 IV PREP WIPES LOT OK1390G256 - MDRS FDA/OMPT/CDRH/OCER/DFOI/ GEORGE E GLADY EUCLID SYSTEMS CORP FRANK FAUNCE ABBOTT LABORATORIES, INC. EUCLID SYSTEM CORP - 2891 FACILITY REGISTRATION 2001 TO 2004; 2892 PROD REGISTRATION 2004 PDL BIOPHARMA - IND 12,120 OC/COS/OES/ OC/COS/OES/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BROWN, GEORGANE SANDRA B BERRY ALLIANCE IMAGING INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. KEVIN EFFERING SOUTHWEST FOOD SAFETY SYSTEMS SUSANE YESNICK DRINKER BIDDLE & REATH LLP ALEXANDRIA FAIZ STUDLEY NEIL EULIANO CONVERGENT ENGINEERING MARK P BAYER REED TECHNOLOGY AND INFORMATION SERVICES INC VACCINE, VETERINARY PRODS, MEDICAL DVCS FACILITIES, ETC, NJ - EIRS 2009 TO PRESENT SURECALL EMG LABOR MONITOR - K090145, MONICA AN24 - K101801 SPL DRUG LISTING & LBLG RECS LIST OF SHELL EGG PRODUCER FARMS REGISTERED WITH FDA CLAUDE ALLEN MEMO 11/29/01 R & K INTERNATIONAL COSMETICS - EROZONE GLIDE FLUID K040428 MQSA NATIONAL STATISTICAL RECS - CERTIFIED FACILITIES 6/1/11 SIDEL SA (ACTIS TECHNOLOGY) - FCN 62 Signature/ Requester GOUGLAS CHABOT DECOF & DECOF PC Subject SGARLATO - CLASS II MEDICAL DVC K896422
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Total Records: 12455 Control # Recd Date / Due Date 08/04/2011 2011-4997 2011-4998 07/07/2011 08/04/2011 07/07/2011 08/04/2011 ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-4999 07/07/2011 08/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5000 07/07/2011 08/04/2011 2011-5001 2011-5002 07/07/2011 08/04/2011 07/07/2011 08/04/2011 2011-5003 07/07/2011 08/04/2011 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5004 2011-5005 2011-5006 2011-5007 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 2011-5008 07/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. QUYNH C SPERRAZZA FAEGRE & BENSON LLP SCOTT PODOLSKY MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 6/130/11 MERCK & CO INC - ROTATEQ (ROTAVIRUS VACCINE) VAERS 6/1=30/11 MERCK & CO INC - PROQUAD (MEASLES, MUMPS, RUBELLA, VARICELLA VIRUS VACCINE) VAERS 6/1-30/11 PLAINVIEW MILK PRODUCTS COOPERATIVE, PLAINVIEW, MN - DAIRY SHAKE POWDER SALMONELLA E COLI TEST RESULTS 8/11/09 NOVOBIOCIN-TETRACYCLINE COBINATION DRUGSMTG TRANS 8/13/69 CBER/OCTMA/DDOM/ALFB/ TIMOTHY MASON CONWAY HOMER & CHINCAPLAN PC NEIL MURPHY RAINBOW SEAFOOD INC DANIEL GELFOND MD UNIV OF BUFFALO SCHOOL OF MEDICINE JOE MCCANN SAC CAPITAL MANAGEMENT LLC CONFIRMATION THAT PROTEINS DERIVED FROM WHEAT (GLUTEN, GLIADIN, GLUTEN POLYMER) HAVE BEEN ADDED TO METHYLMETHACRYLATE INCIVEK (TELAPREVIR) - AERS YELLOWFIN SOLE ENTRY 036-0108164-3 - TEST RESULTS INDIVIDUAL RECS - VAERS Doe J ZOLOFT, CELEXA, FLEXERIL, ETC - AERS Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ NYROBIA FREEMAN CONMED LINVATEC CORP SYDIE ROBINSON COVENANT HEALTHCARE CUDA PRODUCTS CO, JACKSONVILLE, FL - FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE K901035 ROBERT PROVENZANO MD - INVESTIGATION RECS Signature/ Requester MORROW, LEN W Subject
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Total Records: 12455 Control # Recd Date / Due Date 08/04/2011 2011-5009 07/07/2011 08/04/2011 2011-5010 07/07/2011 08/04/2011 2011-5011 07/07/2011 08/04/2011 2011-5012 07/07/2011 08/04/2011 2011-5013 07/07/2011 08/04/2011 2011-5014 2011-5015 07/07/2011 08/04/2011 07/07/2011 08/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5016 2011-5017 2011-5018 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5019 2011-5020 2011-5021 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2010-8544 2010-8365 2010-3977 JOAN STITT (UGXCD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2010-3585 2010-3575 2010-3571 Action Office Signature/ Requester SCOTT PODOLSKY DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS JOAN STITT (UG2D-16) MERCK & CO., INC. JOAN STITT (UG2D-16) MERCK & CO., INC. 2010-3340 2010-2232 CLOSED FOI REQUESTS 6/27/11-7/1/11 CLOSED FOI REQUESTS 6/20-24/11 CLOSED FOI REQUESTS 6/13-17/11 CLOSED FOI REQUESTS 6/6-10/11 CLOSED FOI REQUESTS 5/31/11-6/3/11 Subject
Page 315 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/04/2011 2011-5022 2011-5023 2011-5024 2011-5025 2011-5026 2011-5027 2011-5028 2011-5029 2011-5030 2011-5031 2011-5032 2011-5033 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/07/2011 08/04/2011 07/08/2011 08/08/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ 2011-5034 07/08/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ WINSTON R BROWN BAXTER HEALTHCARE CORP ABBOTT, AMGEN, ASTRAZENCA, ETC - EIRS, 483S 1/1/116/30/11 Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-26) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. WINSTON R BROWN BAXTER HEALTHCARE CORP SIGMA-ALDRICH, TALECRIS BIOTHERAPEUTICS - EIRS, 483S 1/1/11-6/30/11 CLOSED FOI REQUESTS 6/1-30/11 FOI DAILY LOG 6/25/11 - 7/1/11 2011-2428 2011-2243 2011-2134 2011-2131 2011-2023 2011-2002 2011-1469 2011-1036 2011-965 Subject
Page 316 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5035 07/08/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ 2011-5036 07/08/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ WINSTON R BROWN BAXTER HEALTHCARE CORP CARDINAL HEALTH, CAREFUSION, COVIDIEN, ETC - EIRS, 483S 1/1/11-6/30/11 WINSTON R BROWN BAXTER HEALTHCARE CORP GE HEALTHCARE, HOSPIRA, JOHNSON & JOHNSON FAMILY OF COMPANIES, ETC - EIRS, 483S 1/11/11-6/30/11 Signature/ Requester Subject
Page 317 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5037 07/08/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5038 2011-5039 2011-5040 2011-5041 07/08/2011 08/05/2011 07/08/2011 08/05/2011 07/08/2011 08/05/2011 07/08/2011 08/05/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ESPN BETH JOHNSON READY SET LAUNCH THOMAS J QUINN Medical Resources Alliance ANDREA WEISS VETTER PHARMA-FERTIGUNG GMBH & CO BIOGEN IDEC, CAMBRIDGE, MA USA - EIR 9/10 MEDICAL SAFETY SOLUTIONS, MANSFIELD, OH - SHARPS TERMINATOR NEEDLE DESTRUCTION DVC 510K, PMA PICKER - 1200SX CT SCANNERS FORMS 2579 1980 TO 1983 FOIA REQUESTS 1/1/10-6/1/11 WINSTON R BROWN BAXTER HEALTHCARE CORP NOVARTIS, NXSTAGE, PFIZER, ETC - EIRS, 483S 1/1/116/30/11 Signature/ Requester Subject
Page 318 of 1132

Total Records: 12455 Control # 2011-5042 Recd Date / Due Date 07/08/2011 08/05/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ 2011-5043 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5044 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5045 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5046 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5047 2011-5048 07/08/2011 08/05/2011 07/08/2011 08/05/2011 2011-5049 2011-5050 07/08/2011 08/18/2011 07/08/2011 08/05/2011 FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ OC/OM/OEO/ ORA/ORO/DIOP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ ARAUZO, GODOFREDO MAGGIE CLARK NEWS21 FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL A CAROME PUBLIC CITIZEN ASHLEY FISHBURN HEALTH INDUSTRY DISTRIBUTORS ASSOCIATION ANESTHESIOLOGY & RESPIRATORY THERAPY DVC PANEL - POWER POINT PRESENTATIONS 10/28/09 SEASONAL INFLUENZA VACCINE - LOT NUMEBRS 20102011 ELENA HOWELL HOGAN LOVELLS US LLP SUN PHARMS - SUMATRIPTAN SUCCINATE ANDA 90-358 APRVL RECS, RVWS ANGELIA D SLAYTON KENDLE INTERNATIONAL INC SANOFI AVENTIS US - TAXOTERE NDA 20-449/S043 APRVL LTR, RVWS, ETC ULF R HIERLWIMMER ASTHMA ALLERGY CENTERS OF SOUTH WEST MICHIGAN CRESTOR (ROSUVASTIN), VYTORIN (SIMVASTATIN/EZETIMIBE) - AERS DONALD F GRABARZ INTERNATIONAL REGULATORY CONSULTA LABORATOIRE ICARE, SAINT-BEAUZIRE, FRANCE - EIR 3/25-26/10 Signature/ Requester FLORENCE GEORGE GRAVES BRANDEIS UNIV Subject DRUG INSPS IN CHINA 10/108-7/5/11 - RECS
MERCK - GARDASIL VACCINE LICENSE FOR COMMERCIALIZATION DEL MONTE FRESH PRODUCE NA INC, GUATEMALA CANTALOUPES SALMONELLA OUTBREAK INVESTIGATION RECS 3/22/11
Page 319 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5051 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/OCI/ ORA/OCI/ 2011-5052 2011-5053 2011-5054 07/08/2011 08/05/2011 07/08/2011 08/05/2011 07/08/2011 08/05/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5055 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J GENZYME - FABRAZYME COMPASSIONATE USE EXCEPTION, MONITORING, SHIPPING, SHORTAGE, ETC WILLIAMS #05723-000, CRAIG ALLAN ORA/SE-FO/SJN-DO/SJCB/ PAOLI, GRACE D MIKE NORTON NORTH ATLANTIC INC UPS/SCS HEALTHCARE, SAN JUAN, PR - INSP PHOTOGRAPHS 5/13/11 FROZEN TUNA STEAKS ENTRY 316-1912793-4 ANALYTICAL RESULTS VICTRELIS (BOCEPREVIR), INCIVEK (TELAPREVIR) - RECS PATRICK M LAVETTE DAVENPORT LAVETTE & CLECKER PC MEDS IV LLC - TOTAL PARENTERAL NUTRITION (TPN) SERRATIA MARCESCENS BACTERIA INVESTIGATION, LICENSING, REGISTRATION, ETC Signature/ Requester Subject
Page 320 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5056 2011-5057 2011-5058 07/08/2011 08/05/2011 07/08/2011 08/05/2011 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5059 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5060 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5061 07/08/2011 08/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5062 07/08/2011 08/05/2011 2011-5063 07/11/2011 08/08/2011 2011-5064 2011-5065 07/11/2011 08/08/2011 07/11/2011 08/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ TONY AMENSON COLUMBUS CHEMICAL INDUSTRIES INC CATHERINE M CORNELL PHILIPS MEDICAL SYSTEMS (CLEVELAND) INC CHRISTINE S RICHARD THE INGAGO GROUP ANDREA WEISS VETTER PHARMA-FERTIGUNG GMBH & CO GLAND PHARMA LTD, AMEERPET, HYDERABAD, INDIA - EIR 2010 METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS SIEMENS MEDICAL SOLUTIONS USA INC - BIOGRAPH MMR K103429 INTUITIVE SURGICAL - MDR #2955841-2010-00254 NESTOR SOSA MONTALVAN MD PAN-AMERICAN MEDICAL RESEARCH INSTITUTE SA DR NESTOR SOSA MONTALVAN, PAN-AMERICAN MEDICAL RESEARCH INSTITUTE, PANAMA - 483, CORR 3/29/04 DR EDWARD F DOMINO UNIV OF MICHIGAN DEPT OF PHARMACOLOGY MK-801 DIZOCILPINE - PHASE 1 STUDIES DR EDWARD F DOMINO UNIV OF MICHIGAN DEPT OF PHARMACOLOGY KETAMINE - PHASE 1 STUDIES ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ CARRIE KAHN CHEMRISK LLC W PATRICK NOONAN W PATRICK NOONAN DR EDWARD F DOMINO UNIV OF MICHIGAN DEPT OF PHARMACOLOGY COMPLIANCE PROGRAM EVALUATION FY 1974 TOTAL DIET STUDIES GAR LABORATORIES INC, RIVERSIDE,CA - EIR, 483, CO RESP,ETC LAST 5 YRS PHENCYCLIDINE CI-395 - PHASE 1 STUDIES Signature/ Requester Subject
Page 321 of 1132

Total Records: 12455 Control # 2011-5066 Recd Date / Due Date 07/11/2011 08/08/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5067 07/11/2011 08/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5068 07/11/2011 08/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5069 2011-5070 2011-5071 2011-5072 2011-5073 2011-5074 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/26/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 2011-5075 07/11/2011 08/08/2011 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/OE/ ORA/OE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC SHERRY YANG APPLEBY & CO INC JASON MILLIKEN KOBO INC ANEET PANESAR BURDOCK GROUP JOSHUA D DETRE LSU AGCENTER & LOUISANA STATE UNIV THEANINE & 1-THEANINE - REGULATORY STATUS, CONSUMPTION, SAFETY RECS RECALLS & FIELD CORRECTIONS FOR FOODS 1/1/80 TO 12/31/10 FOI DAILY LOG 6/13-17/11 LIST OF PET FOOD MFRS IN THE US ORA/CE-FO/CHI-DO/CCB/ FRED NICKI EDWARD W WILLLIAMS LTD TED S THALMANN, MEDICINE SHOPPE, EDWARDSVILLE, ILRECS 9/07 H LEE MOFFITT CANCER CTR & RESEARCH INSTITUTIONAL HOSPITAL INC, TAMPA, FL - EIRS, 483S, CO RESP, ETC 6/11 ABBOTT LABS - RECS FARQUHAR, RHEA ORLISTAT/ALLI - AERS LEDUC, EDWARD J SPRYCEL - AERS 2010, 2011 Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. Subject MERCK & CO INC - ISENTRESS (RALTEGRAVIR) IRS
Page 322 of 1132

Total Records: 12455 Control # 2011-5076 2011-5077 2011-5078 Recd Date / Due Date 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5079 07/11/2011 08/08/2011 2011-5080 07/11/2011 08/08/2011 2011-5081 2011-5082 2011-5083 2011-5084 2011-5085 2011-5086 2011-5087 2011-5088 2011-5089 2011-5090 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DOMINION GROUP INC GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. FOI DAILY LOG 6/27/11 TO 7/1/11 FOI DAILY LOG 6/20-24/11 FOI DAILY LOG 6/13-17/11 KENDLE INTERNATIONAL INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 6/27/11 TO 7/1/11 FOI DAILY LOG 6/20-24/11 FOI DAILY LOG 6/13-17/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 6/27/11 TO 7/1/11 KENDLE REGULATORY AFFAIRS FOI DAILY LOG 6/20-24/11 KENNETH REID WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 6/13-17/11 FOI DAILY LOG 6/13-17/11; 6/20-24/11; 6/27/11 TO 7/1/11 FOI DAILY LOG 6/27/11 TO 7/1/11 FOI DAILY LOG 6/20-24/11 FOI SERVICES INC KENNETH REID WASHINGTON INFORMATION SOURCE FOI DAILY LOG 6/13-17/11 FOI SERVICES INC FOI DAILY LOG 6/27/11 TO 7/1/11 Signature/ Requester Subject FOI DAILY LOG 6/20-24/11
Page 323 of 1132

Total Records: 12455 Control # 2011-5091 2011-5092 2011-5093 2011-5094 2011-5095 2011-5096 2011-5097 Recd Date / Due Date 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/11/2011 08/08/2011 07/12/2011 08/09/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SWFO/SWID/COMPLIANCE/ CVM/OCD/ OC/OCC/ 2011-5098 2011-5099 07/12/2011 08/09/2011 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5100 07/12/2011 08/09/2011 OC/OCM/EMOPS/ ORA/SW-FO/DEN-DO/COMP/ PATTI WALLER MARLER CLARK ATTYS WILD BASIN LODGE, ESTES PARK, CO - CLOSTRIDIUM PERFRINGENS OUTBREAK INVESTIGATION RECS 2010 FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL A CAROME MD PUBLIC CITIZEN JONATHAN T GILBERT FELDMAN FOX MORGADO PA ASTHMATX INC - ALAIR BRONCHIAL THERMOPLASTY SYS P080032 FLOMAX; INTERACTIONS BTWN FLOMAX, LEXAPRO, LEVITRA, ETC - AERS Signature/ Requester CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN CanReg, Inc. DEBI COHEN CanReg, Inc. DEBI COHEN CanReg, Inc. JOSEPH W LUBY DEATH PENALTY LITIGATION CLINIC MISSIOURI DEPT OF CORRECTIONS - SODIUM THIOPENTAL, NEMBUTAL (PENTOBARIAL), PAVULON (PANCURONIUM BROMIDE) FOR THE PURPOSE OF LETHAL INJECTION CORR 5/15/09 TO 7/7/11 FOI DAILY LOG 6/27/11 T0 7/1/11 FOI DAILY LOG 6/20-24/11 FOI DAILY LOG 6/13-17/11 FOI DAILY LOG 6/27/11 TO 7/1/11 FOI DAILY LOG 6/20-24/11 Subject FOI DAILY LOG 6/13-17/11
Page 324 of 1132

Total Records: 12455 Control # 2011-5101 2011-5102 Recd Date / Due Date 07/12/2011 08/09/2011 07/12/2011 08/09/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5103 07/12/2011 08/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-5104 2011-5105 2011-5106 07/12/2011 08/09/2011 07/12/2011 08/09/2011 07/12/2011 08/09/2011 2011-5107 2011-5108 2011-5109 07/12/2011 08/09/2011 07/12/2011 08/09/2011 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5110 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5111 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Fowler JQ9217, Mark TRUVADA, REYATAZ, NORVIA, ETC - AERS DeLorenzo, Helen AMGEN - DENOSUMAB; FORTEO, PROLIA - AERS OM/OMP/DODM/ ANDERSON, REBECCA NARONGSAK (TEK) THONGPAPANI PHD BROCK UNIV FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHERIE PARKER AMUSA CHERIE PARKER AMUSA CHERIE PARKER AMUSA CHERIE PARKER AMUSA NURSE ASSIST INC - WOUND FLUSH, STERILE WATER & NORMAL SALINE K083042 PACKAGING TECHNOLOGIES INC - CENTRAL VEIN CATHETERIZATION TRAY CC-20 K934073 CONTUR FABRICATION OF FLORIDA INC - REDI NURSE PREFILLED 60CC IRRIGATION SYRINGE WITH STERIAL WATER & SODIUM CHLORIDE SOL K952406 WAZ INDUSTRIES INC - 60CC IRRIGATING SYRINGE K791998 ANTIVIRAL DRUG A/C - VIRAMUNE (NEVIRAPINE) TRANS, SLIDES 6/7/1996 ANDA 76-274 - SBA DAVID M DEUTSCH DAVID M. DEUTSCH CO., L.P.A. MEDTRONIC - MEDTRONIC LEGACY RODS MDRS, RISK ANALYSIS, MINS, CORR, ETC Signature/ Requester ANDI POULSON LEXISNEXIS COURTLINK INC RENEE CAREY HARRIS FRC CORP ISSUES IN THE DESIGN OF CLINICAL TRIALS OF ANTIMYCOBACTERIAL DRUGS FOR TREATMENT OF TUBERCULOSIS WORKSHOP - SLIDES 7/30/09 Subject 2011-4677
Page 325 of 1132

Total Records: 12455 Control # 2011-5112 2011-5113 2011-5114 Recd Date / Due Date 07/12/2011 08/09/2011 07/12/2011 08/09/2011 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5115 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5116 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5117 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5118 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5119 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5120 2011-5121 2011-5122 07/12/2011 08/09/2011 07/12/2011 08/09/2011 07/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ GIL MOATS DRAPER VALLLEY FARMS JAMIE WOLSZON Hyman Phelps and McNamara PC CHARLES CELESTE DRAPER VALLEY FEED MILL, CHEHALIS, WA - MOST RECENT MEDICATED FEED LICENSE 501-489 POLY MEDICURE LTD, BALLABHGARH, FARIDABAD, INDIA EIR 7/10 SUMATRIPTAN SUCCINATE INJ ANDA 90-358 - APRVL LTR, HAWKINS, JOSEPH NEOSPORIN OPHTALMIC OINTMENT NDA 50-417 - SBA HAWKINS, JOSEPH CORTISPORIN OPHTHALMIC OINTMENT NDA 50-416 - SBA HAWKINS, JOSEPH ILOTYCIN OPHTHALMIC OINTMENT NDA 50-368 SBA HAWKINS, JOSEPH CORTIPORIN OPHTHALMIC SUSPENSION NDA 50-169 SBA HAWKINS, JOSEPH MAXITROL OPHTHALMIC OINTMENT NDA 50-065 - SBA HAWKINS, JOSEPH FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MAXITROL OPHTHALMIC SUSPENSION NDA 50-023 - SBA Action Office FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Signature/ Requester Subject MEDPAC - SMALL FRAGMENT PLATES AND SCREWS K951302 TRIMED - TBW K010545
Page 326 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/09/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5123 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5124 07/12/2011 08/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5125 2011-5126 07/12/2011 08/09/2011 07/13/2011 08/10/2011 2011-5127 2011-5128 07/13/2011 08/10/2011 07/13/2011 08/10/2011 2011-5129 07/13/2011 08/10/2011 2011-5130 07/13/2011 08/10/2011 2011-5131 07/13/2011 08/10/2011 2011-5132 07/13/2011 08/10/2011 2011-5133 07/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/OM/OMP/DDM/ ANDREWS S. FIX, DVM, PhD. PROCTER & GAMBLE AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC ANGELIA SLAYTON KENDLE INTERNATIONAL INC LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP lIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LA ROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LA ROCHELLE BAXTER HEALTHCARE - EXELTRA PLUS HIGH FLUX DIALYZER MODEL 210 K030975 BAXTER HEALTHCARE - EXELTRA HIGH FLUX DIALYZER MODEL 150 & 170 K030974 ALARIS MEDICAL SYSTEMS - SIGNATURE EDITION INFUSION PUMP K032147 MEDTRONIC MINIMED - PARAGIGM INSULIN PUMP K031390 ANIMUS CORP - INFUSION PUMP MODEL IR 1200 K032257 DKT 1978N-0038 DKT 1976N-0056 DKT 1997F-0522 EHRENPREIS MD, ELI D ISRS 5772581, 5752485, 5741584, ETC DAVID M. MAZZARELL LAB EXPRESS INTERNATIONAL CFR CODES OF REGULATIONS REQUIRING COMPANIES ENGAGED IN PHARMACEUTICAL IMPORTATION OF API TO REQUIRE FDA END USER LTRS Signature/ Requester EAS Consulting Group, LLC Subject LBLG, CHEMISTY RVW, ETC
EKOS CORP - PERIPHERAL INFUSION SYS K030637
Page 327 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/10/2011 2011-5134 2011-5135 07/13/2011 08/10/2011 07/13/2011 08/10/2011 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5136 07/13/2011 08/10/2011 2011-5137 07/13/2011 08/10/2011 2011-5138 07/13/2011 08/10/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5139 07/13/2011 08/10/2011 2011-5140 07/13/2011 08/10/2011 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OCC/ 2011-5141 07/13/2011 FDA/OMPT/CDER/ORP/DIDP/ LOVENOX - INIDIVIDUAL RECS CHRISTINA M PAUL K&L GATES DEL MONTE FRESH PRODUCE NA INC - CANTALOUPES SALMONELLA PANAMA OUTBREAK INVESTIGATION RECS 2011 COURTNEY M CALABRESE LAYSER & FREIWALD PC MUSCULOSKELETAL TRANSPLANT FOUNDATION CONTAMINATED ALLOGRAFTS RECALLS, INVESTIGATIONS, LTRS, ETC 2007 TO 2009 Doe J FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ PAUL EICHHOLZ LEGACY PHARMACEUTICAL PACKAGING LLC CATHERINE ADAMS HUTT RDR SOLUTIONS CONSULTING LLC XSTO SOLUTIONS CO - ZINC L-CARNOSINE 75-DAY PREMARKET NOTIFICATION, NO OBJECTION LTR CONSUMER CMPLNT - LAB RESULTS VERTICAL PHARMACEUTICALS INC, SAYREVILLE, NJ - 483 Action Office Signature/ Requester DEKA RESEARCH & DEVELOPMENT CORP JULIAN PECQUET HILL NEWSPAPER RICHARD FOSTER NEW YORK PUBLIC LIBRARY JEFF NOVITZKY - SALARY RECS, OVERTIME CHARGES, TRAVEL COSTS 4/08 TO PRESENT BRIEF DESCRIPTION OF THE AERS REPORTING SYS 1988 Subject
Page 328 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/10/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5142 2011-5143 07/13/2011 08/10/2011 07/13/2011 08/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5144 07/13/2011 08/10/2011 2011-5145 07/13/2011 10/28/2011 2011-5146 07/13/2011 08/10/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5147 07/13/2011 08/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5148 2011-5149 07/13/2011 08/10/2011 07/13/2011 08/10/2011 2011-5150 2011-5151 07/13/2011 08/10/2011 07/13/2011 08/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ PONCE, KEITH DAVID C STEINBERG STEINBERG & ASSOCIATES INC FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ANTHIONY DIMONTE VERICHEM LABORATORIES INC PATRICK COCHRAN PHD DEL MONACO SPECIALTY FOODS DE MONACO SPECIALTY FOODS, MORGAN HILL, CA - FEI AND CFN NUMBERS TRIS PHARMA, MONMOUTH, NJ - EIRS 1/5/09-10/17/07, 10/1910-11/3/09, 4/20-30/10, 5/6/11 BK GIULINI GMBH, JIANGYIN, CHINA; GULBRANDSEN TECHNOLOGIES INDIA PRIVATE LTD, GUJARAT, INDIA LABELER CODES, 483S, REGISTERED ACTIVE PHARMACEUTICAL INGREDIENTS VERICHEM LABS - ETHYL ALCOHOL STANDARD K882117 LEDUC, EDWARD J GLEEVAC - AERS KLASK MEDEIROS, AIMEE SERONO - ASELLACRIN 2, ASELLACRIN 10 NDA 17-726; GENENTECH - CRESCORMON NDA 17-992, PROTROPIN NDA 19-107, ETC RECS PALMER, JAMES ORA/P-FO/SEA-DO/SCB/ MARC D GIANNESCHI BENNETT RAINEY MORAN & GIANNESCHI INC INVACARE CORP, ELYRIA, OH - ELECTRICAL BEDS CMPLNTS, MEMOS, LTRS, ETC SUSHI KO - INVESTIGATION RECS, RPTS, FINDINGS, ETC FDA/OF/CFSAN/OCD/EOS/ Doe J EVAN T MAROWITZ MCHAUD MITTELMARK MAROWITX & ASRANI PA OPTIRAY 300 - WARNINGS, CLNCL PHARMACOLOGY, AERS, ETC GENETICALLY MODIFIED SOY - RECS Signature/ Requester Doe J Subject
Page 329 of 1132

Total Records: 12455 Control # 2011-5152 2011-5153 2011-5154 Recd Date / Due Date 07/13/2011 08/10/2011 07/13/2011 08/10/2011 07/13/2011 08/10/2011 ORA/CE-FO/NJ-DO/NJCB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/NJ-DO/NJCB/ 2011-5155 07/13/2011 08/10/2011 2011-5156 07/13/2011 08/10/2011 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ROBERT P CHARROW GREENBERG TRAURIG LLP SYNTHES SPINE - PRODISC-C TOTAL DISC REPLACEMENT DVC P070001; KENNETH CHAIKEN, ROBERT CHAIKEN, CHAIKEN & CHAIKEN PC - FOI REQUESTS 1/08 TO PRESENT POLYCARBON INDUSTRIES - EIR, 483 5/10/10-6/11/10 MENTOR - MEMORY GEL SMOOTH ROUND BREAST IMPLANT CHEMICAL INTERMEDIARIES EGG-PRODUCING, EGG-PROCESSING FACILITIES IN IOWA -EIRS, PENALTIES, SANCTIONS 2011 THYMOGLOBULIN - RECS JEFF KENDALL UPS SUPPLY CHAIIN SOLUTIONS ENTRY #UPS-3159408-2 - INVENTORY RECS FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester SID J KOTHARI TISHCON CORP KATSUMI USAMI OMRON MATSUSAKA CO LTD KATHLEEN S PICHA DENDREON CORP Subject CAPSULEWORKS, RONKONKOMA, NY - EIR, 483 MOST RECENT OMRON MATSUSAKA CO LTD, JAPAN - EIRS 12/6-9/04, 2/58/07 DENDREON CORP, MORRIS PLAINS, NJ - EIR 1/11-26/11
2011-5157 2011-5158 2011-5159 2011-5160
07/13/2011 08/10/2011 07/13/2011 08/10/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011
ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/
ROD SHIMA JOHNSON MATTHEY RUDEK, ROBERT W
ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/
CLARK KAUFFMAN DES MOINES REGISTER CHRISTINA DEARY GENZYME PHARMACOVIGILANCE SEANG MING CHU PT REX CANNING TARA RYAN PRESTIGE BRANDS INC GABRIEL B SHERMAN Hyman Phelps and McNamara PC DAN DAHLMAN ECOLAB INC JULIA M GICZEWSKI MCGUIRE WOODS LLP
2011-5161 2011-5162 2011-5163 2011-5164 2011-5165
07/14/2011 08/11/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011
PT REX CANNING, TIMUR, INDONESIA - EIR 6/9-10/11 WART FREEZE - K101049 ACON LABORATORIES INC - MISSION SALIVA ALCOHOL TEST STRIP K093879 INTRALYTIX INC - FCN 1016; GRN 218 RECS ABIOMED INC - IMEPLLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYS WARNING LTR RESP, CORR 1/28/10
Page 330 of 1132

Total Records: 12455 Control # 2011-5166 2011-5167 Recd Date / Due Date 07/14/2011 08/11/2011 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ 2011-5168 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ 2011-5169 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ 2011-5170 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ LAURA E STEWART WALSH MCKEAN FURCOLO LLP HEALTH ADVANCES - RECS LAURA E STEWART WALSH MCKEAN FURCOLO LLP FORTODOL - RECS LAURA E STEWART WALSH MCKEAN FURCOLO LLP KURT DONSBACH - RECS Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester RICK HENEGHAN BCATV LAURA E STEWART WALSH MCKEAN FURCOLO LLP LET'S TALK HEALTH INC - RECS Subject TACTICAL LIGHT & LASER TECHNOLOGY - RECS
Page 331 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/LOS-DO/LACB/ 2011-5171 07/14/2011 08/11/2011 2011-5172 07/14/2011 08/11/2011 2011-5173 07/14/2011 08/11/2011 2011-5174 2011-5175 2011-5176 2011-5177 07/14/2011 08/11/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011 07/14/2011 08/11/2011 2011-5178 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5179 2011-5180 07/14/2011 08/11/2011 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5181 07/14/2011 08/11/2011 2011-5182 07/14/2011 08/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ C.K. GUND, Ph.D. PHOENIX REGULATORY ASSOCIATES LTD FRANK WOODSON BEASLEY ALLEN ET AL DERMATOLO RESEARCH CTR, DAVID M. STOLL MD, SANTA MONICA, CA - 483 PAST 12 MONTHS ASTRA ZENECA - CRESTOR (ROSUVASTATIN CALCIUM) MOR, LBLG, SBA, ETC ORA/SW-FO/DEN-DO/COMP/ DAN HARTKEMEYER EL ENCANTO INC JUNE K. GHEZZI JONES DAY ATTYS ISR 7236473 EL ENCANTO INC, ALBUQUERQUE, NM - INSP 4/14/10 FDA/OF/CFSAN/OCD/EOS/ KLIPA, SCOTT VANESSA VERNI MEDISCA INC FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OMP/DODM/ STEVEN WAGNER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WAGNER NEUROLOGICAL DVCS PANEL - RECLASSIFICATION OF DVCS USED IN ELECTROCONVULSIVE THERAPY CORR, CITIZENS COMMISSION ON BRIEFINGS, MEMOS, ETC HUMAN RIGHTS INTERNATIONAL STEVE WAGNER RECLASSIFICATION OF ELECTROCONVULSIVE THERAPY DEVICES - STUDIES, SUMMARIES, MEMOS, ETC CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL SARAH HENDON VENABLE LLP DONALD M. FRY AMERICAN BIRD CONSERVANCY SERRAH NAMINI BIOLASE TECHNOLOGY INC CIBA SPECIALTY CHEMICAL CORP, MOUNTAIN VALLEY RECYCLING - PRE-NOTIFICATION CONSULTATION 890, RECYLCLED PLASTICS #135 NO OBJECTION LTR ROPIVACAINE - ADDITION OF PATENTS TO THE ORANGE BOOK BIOLASE TECHNOLOGY INC, IRVINE, CA - LASER RPT DKT 1982P-0371 DKT FDA-2010-P-0491 DKT 2009M-0101, DKT 2010N-0585 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-5183 2011-5184 07/14/2011 08/11/2011 07/15/2011 08/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5185 2011-5186 07/15/2011 08/12/2011 07/15/2011 08/12/2011 2011-5187 2011-5188 2011-5189 07/15/2011 08/12/2011 07/15/2011 09/13/2011 07/15/2011 08/12/2011 ORA/P-FO/LOS-DO/LACB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5190 07/15/2011 10/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5191 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5192 07/15/2011 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2010-8888 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2010-7413 BRIAN S FRANCISKATO NASH & FRANCISKATO LAW FIRM LARIAM (MEFLOQUINE HCL) - ISRS 3005648-7, 3003874-4, 3006775-0, ETC MCCANN, JOE ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/BLT-DO/CB/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC ALAN C SKLAR SKLAR WILLILAMS LLP KATHLEEN S PICKA DENDREON CORP LEHIGH VALLEY TECHNOLOGIES, ALLENTOWN, PA - EIRS 1/11 TO 2/11 NEVADA HEART & VASCULAR CENTER, LAS VEGAS, NV INVESTIGATION RECS 6/6/11 DENDREON CORP, SEAL BEACH, CA - PROVENGE BLA STN 12-5197 EIRS 4/4-8/11 INCIVEK (TELAPREVIR) - AERS BELL-MORE LABS, HAMPTON, MD - 483S 4/9/10 ORA/CE-FO/MIN-DO/MCB/ WESLEY K. JONES, Esq. WEEKLEY SCHULTE ET AL RUBY MALDONADO SMITH & NEPHEW INC 3M CO (3M HEALTH CARE), ST PAUL, MN - TEGADERM CHG IV DRESSING K080620 TRIAD GROUP INC - CMPLNTS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 08/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5193 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5194 07/15/2011 08/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5195 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5196 07/15/2011 08/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5197 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5198 07/15/2011 08/12/2011 2011-5199 07/15/2011 08/12/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5200 07/15/2011 FDA/OF/CFSAN/OCD/EOS/ ELIOT HARRISON FCN 178 ALISA D WILKKES SEXTON & WYKOFF PLLC METHOTREXATE MEDICATIONS - CONTAMINATION OF GLASS VIALS AERS, RPTS, LTRS, ETC 1/1/10 TO 7/13/11 LAUREN K PODESTA HERRICK FEINSTEIN LLP FLAVOR EXTRACT MANUFACTUERS ASSOCIATION (FEMA) - MERCURY IN VANILLA BEANS NOTES, EMAILS, SUMMARIES OF COMM, ETC JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-638 JOSHUA B SILVERMAN POMERANTZ HAUDEK BLOCK & GROSSMAN MANNKIND CORP - AFRESA (AFREZZA) INHALED INSULIN POWDER RESP LTR, MINS 6/9/10, 1/11, 5/4/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-138 Doe J ABBOTT, NORTH CHICAGO, IL - LUPRON 3.75 MG INJ MEDWATCH RPTS 1/18/11, 5/30/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2010-9332 Signature/ Requester MERCK & CO., INC. Subject
Page 334 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/12/2011 2011-5201 2011-5202 07/15/2011 08/12/2011 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5203 2011-5204 2011-5205 2011-5206 2011-5207 2011-5208 2011-5209 2011-5210 2011-5211 2011-5212 2011-5213 2011-5214 2011-5215 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. KATE O'HARA HUNTER MEDICAL RESEARCH REMIFENTANIL - PHARMACOKINETICS, PHARMACODYNAMICS , METABOLISM RECS 2011-2992 2011-2627 2011-2523 2011-2359 2011-2129 2011-2128 2011-2127 2011-2095 2011-1620 2011-1577 2011-1473 2011-1471 FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester LEWIS & HARRISON JUDY MA HARRIS SPICE COMPANY INC JOAN STITT (UG2CD-16) MERCK & CO., INC. OLAM VIETNAM LTD, GIA NGHIA TOWN, VIETNAM - EIRS, 483S 2011-902 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5216 2011-5217 07/15/2011 08/12/2011 07/15/2011 08/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5218 2011-5219 2011-5220 2011-5221 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 07/15/2011 08/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5222 07/18/2011 08/15/2011 2011-5223 07/18/2011 08/15/2011 2011-5224 07/18/2011 08/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/MIN-DO/MCB/ Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD YAARA BEN YOSEF PIXCELL MEDICAL TECVHNOLOGIES LTD HEPARIN, LOVENOX - RECALL RECS, POLICIES, PROCEDURES, ETC 2008 INTERNATIONAL REMOTE IMAGING - WHITE IRIS INSTRUMENT K953116 CHEMPAQ A/S - XBC ANALYZER K050758 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ CBER/OCTMA/DDOM/ALFB/ KIM HENDERSON SANOFI PASTEUR LUKE J. KELLER GOLDBERG WEISMAN ET AL JODY RHODES ALSTON & BIRD LLP CHRISTY TREUBIG PETWAY TUCKER & BARGANIER LLC CSL BIOTHERAPIES, PARKVILLE, VICTORIA, AUSTRALIA 483 2011 SMITH & NEPHEW DONJOY INC - DONJOY ICEMAN MODEL 1100 CMPLNTS, CLNCL STUDIES, MEMOS, ETC YE YA PRODUCTS CORP, MIAMI, FL - CMPLNTS, INVESTIGATIONS, ENFORCEMENT ACTIONS, ETC WATSON PHARMS - DURAGESIC (FENTANYL TRANSDERMAL PATCH) AERS OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP ROBERT RISSMANN, PHARMD, PhD CENTER FOR HUMAN DRUG RESEARCH INVERSINE (MECAMYLAMINE HCL)) NDA 10-251 - RECS DKT FDA-2010-P-0491 Signature/ Requester INSTITUTE Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OE/ ORA/OE/ 2011-5225 2011-5226 07/18/2011 08/15/2011 07/18/2011 08/15/2011 2011-5227 07/18/2011 08/15/2011 2011-5228 07/18/2011 08/15/2011 2011-5229 07/18/2011 08/15/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ 2011-5230 07/18/2011 08/15/2011 2011-5231 2011-5232 2011-5233 2011-5234 2011-5235 2011-5236 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ELENA HOWELL HOGAN LOVELLS US LLP ELENA HOWELL HOGAN LOVELLS US LLP ELENA HOWELL HOGAN LOVELLS US LLP ELENA HOWELL HOGAN LOVELLS US LLP ELTENA HOWELL HOGAN LOVELLS US LLP CATHERINE T HEACOX ESQ LANIER LAW FIRM BAFFNA SPICES, ERNAKULAM, KERALA STATE, INDIA EIRS, 483S LAST 12 MONTHS PLANT LIPIDS, ERNAKULAM, KERELE STATE, INDIA - EIRS, 483S LAST 12 MONTHS SYNTHITE INDUSTRIES, EMAKULAM, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS KISHORE SPICES, ALUVA, KERALE STATE, INDIA - EIRS, 483S LAST 12 MONTHS CCHIN SPICES, ERNAKULAM, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS MULTAQ (DRONEDARONE) - AERS CARLOS SANCHEZ BEAVER STEET FISHERIES INC FROZEN SNAPPER FILLETS ENTRY #002-8135694-9 ANALYTICAL RESULTS MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC DUF MACKAY ND COUNCIL FOR RESPONSIBLE NUTRITION ENTRY #63000801926 - NOTICE TO MARK AND/OR RDLIVERR, NOTICE OF FDA ACTION #1 FDA/OMPT/CDRH/OCER/DFOI/ MELISSA M PURPURA VTS MEDICAL SYSTEMS ROBERT E BROWNE NEAL GERBER & EISENBERG STORZ MEDICAL AG - D-ACTOR 50 & D-ACTOR 200 VIBRATION MASSAGE SYS INVESTIGATION RECS SMITH & NEPHEW - CONDOR CONTROL SYS K050209 Signature/ Requester Subject
ENTRY # 406-04515417 - NOTICE TO MARK AND/OR REDELIVER, NOTICE OF FDA ACTION #1
BIOSAN LABORATORIES INC, DERRY, NH 23/7/10 TO 1/25/11; COLUMBINE SPECIALTY PRODUCTS INC, DENVER CO 12/112/10; REEDS INC, LOS ANGELES, CA 10/27/10 TO 1/12/10 EIRS, 483S
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-5237 2011-5238 2011-5239 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5240 07/18/2011 08/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ 2011-5241 07/18/2011 08/15/2011 2011-5242 07/18/2011 08/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5243 07/18/2011 08/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5244 2011-5245 2011-5246 07/18/2011 08/15/2011 07/18/2011 08/15/2011 07/18/2011 08/15/2011 2011-5247 07/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC MELISSA M PURPURA VTS MEDICAL SYSTEMS MELISSA M PURPURA INDOCHINA TEA & COFFEE CO LTD, HOCHIMINH CITY, VIETNAM - EIR, 483 NGO GIA TRADING AND SERVICES CO, BINH DUONG PROVINCE, VIETNAM - EIR, 483 STRYKER - SINDE ENDOSCOPY VOICE ACTIVATION SYS CONSOLE K022393; SWITCH POINT INFINITY 3 CONTROL SYS K100852 COMPUTER MOTION - HERMES OR CONTROL CENTER VANESSA VERNI MEDISCA INC NORTHEAST GENERAL PHARMACEUTICAL FACTORY PIRACETAM NDC 54937-539 ORA/NE-FO/NYK-DO/NYDCB/ RAQUEL RUTLEDGE MILWAUKEE JOURNAL SENTINEL PRANANV SHAH APP PHARMACEUTICALS PROFESSIONAL DISPOSABLES INTERNATIONAL INC, ORANGEBURG, NY - EIRS, WARNING LTRS 2000 TO PRESENT ZHEJIANG HONGBO CHEMICAL CO LTD, ZHEJIANG, CHINA - EIR, 483 10/25-27/10 HILLARY PARROTT MICHAELS & MICHAELS EZVILLE INC - SOLO SLIM, SOLO SLIM EXTRA STRENGTH LAB RESULTS, TESTING, RPTS, ETC ELENA HOWELL HOGAN LOVELLS US LLP ELENA HOWELL HOGAN LOVELLS LLP BARBARA A BINZAK BUCHANAN INGERSOLL & ROONEY PC VKL (VALLABHDAS KANJI LTD), ALEPPEY, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS HARMONY SPICE LTD, KOCHI, KERALA STATE, INDIA EIRS, 483S LAST 12 MONTHS LANSOPRAZOLE ANDA 91-269, ANDA 90-763, ANDA 90-331, ETC - SBA Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 08/15/2011 2011-5248 2011-5249 2011-5250 2011-5251 2011-5252 2011-5253 2011-5254 2011-5255 2011-5256 2011-5257 2011-5258 2011-5259 2011-5260 2011-5261 2011-5262 2011-5263 07/18/2011 08/15/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester VTS MEDICAL SYSTEMS MELISSA M PURPURA VTS MEDICAL SYSTEMS CHRIS CELESTE EAS Consulting Group, LLC STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL JENNIFER N STEPHENS SIFFORD ANDERSON & CO PC JENNIFER N STEPHENS SIFFORD ANDERSON & CO PC JENNIFER N STEPHENS SIFFORD ANDERSON & CO PC JENNIFER N STEPHENS SIFFORD ANDERSON & CO PC JENNIFER N STEPHENS SIFFORD ANDERSON & CO PC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC TYSONQ BELLAMY FEFA LLC PERFECT NUTRITION INC - EIRS, 483S, CO RESP 1/05 TO PRESENT POWER SHACK INC - EIRS, 483S, CO RESP 1/05 TO PRESENT SON HA SPICE & FLAVORING CO LTD, DINH BANG VILLAGE, VIETNAM - EIRS, 483S TRUONG LOC COMPANY LTD, HOCHINIMINH CITY, VIETNAM - EIRS, 483S INTIMEX HOCHIMINH, HOCHINMINH CITY, VIETNAM - EIRS, 483S BOOZ ALLEN HAMILTON INC - HHSF223200750422W EUROPA SPORTS PRODUCTS INC - EIRS, 483S, CO RESP 1/05 TO PRESENT SNI USA INC - EIRS, 483S, CO RESP 1/05 TO PRESENT OLSELN MEDICAL, LOUISVILLE, KY - ELAN-E DISPOSABLE DRAPE K882494 OLSEN MEDICAL, LOUISVILLE, KY - INSULATED SPECULIUM W/SMOKE EVACUATOR OPTION K922154 OSLEN MEDICAL, LOUISVILLE, KY - ELECTROSURGICAL PENCIL K936304 OLSEN MEDICAL, LOUISVILLE, KY - 600 & 900 SERIES ELCTRODES,755 & 756 HANDLE ELECTRODES K885200 OLSEN MEDICAL, LOUISVILLE, KY - SURGI-TEK TUBE POSITIONER K863279 USA SPORTS LLC - EIRS, 483S, CO RESP 1/05 TO PRESENT Subject K031720 OLYMPUS - ENDOALPHA INTEGRATED ENDO SURGERY SYS SOFTWARE K051613 DKT LOG FDA-1995-S-0039
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Total Records: 12455 Control # 2011-5264 2011-5265 2011-5266 2011-5267 2011-5268 2011-5269 Recd Date / Due Date 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 2011-5270 07/19/2011 08/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5271 2011-5272 2011-5273 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5274 2011-5275 07/19/2011 08/16/2011 07/19/2011 08/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ GAPAC, ADELINA ORA/NE-FO/NYK-DO/NYDCB/ LISA ROSICK ANGIODYNAMICS INC ANGIODYAMICS, QUEENSBURY, NY - EIRS 5/28/03-6/5/03, 11/30/09 MIRA INC - MIRAGEL SCLERAL BUCKLE IMPLANT RECALL RECS, MDRS ROSENTHAL, AMIR FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ WYATT A LISON STEMBER FEINSTEIN ET AL WYATT A LISON STEMBER FEINSTEIN ET AL CACAO PRODS TREATED WITH ALKALI INGREDIENT RECS POTASSIUM CARBONATE PERMITTED TO BE USED FOR HUMAN CONSUMPTION - RECS TARO PHARMS - LORATADINE SYRUP ANDA 76-805 APRVL LTR 8/20/04 ANTHONY J CORRADO HOFFMANN-LA ROCHE INC OSE REVIEW OF ORISTAT AND GI BLEEDING 2/11 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ Action Office FDA/OO/OFBA/OAGS/ Signature/ Requester TYSON Q BELLAMHY FEFA LLC TYSON Q BELLAMY FEFA LLC TYSON Q BELAMMY FEFA LLC KIMBERLY BAXTER AFFYMAX INC KIMBERLY BAXTER AFFYMAX INC KATHY A LEE CLINE FARRELL ET AL ORACLE CORP, REDWOOD SHORES, CA - EIRS 2004 TO 2011 INDIVIDUAL RECS PIRA TESTING LLC, SUNNYVALE, CA - EIRS 2004 TO 2011 IBM - HHSF223201010492G IBM - HHSF223200910192G Subject BOOZ ALLEN HAMILTON INC - HHSF223200810029I
Page 340 of 1132

Total Records: 12455 Control # 2011-5276 Recd Date / Due Date 07/19/2011 08/16/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/CE-FO/NJ-DO/NJCB/ NCTR/OD/ 2011-5277 2011-5278 2011-5279 2011-5280 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5281 07/19/2011 08/16/2011 2011-5282 07/19/2011 08/16/2011 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5283 2011-5284 2011-5285 2011-5286 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FUJINO, YUKIO FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ JEFFREY T BARON ESQ BARON LAW FIRM PLLC JOHN P ROMFH PENDAR MEDICAL JOHN P ROMFH PENDAR MEDICAL KITASATO UNIV EAST HOSPITAL, KANAGAWA, JAPAN - EIR, 483 7/30/10 SPECTROS CORP - T-STAT TISSUE OXIMETER K040684 COPPOLA KERATIN EXPRESS BRAZILIAN SMOOTHING TREATMENT - CMPLNTS, WARNINGS, ALERTS, ETC INSPECTRA ST02 SPOT CHECK SYS - K103613 MARK ODYNOCKI PFIZER INC SANTE ADULTE GH ENFANT (SAGHE) STUDY - RECS HORNER, JOSEPH B CMPLNT 121417 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OC/COS/OL/ ROSENTHAL, JOSH DAVID P ANGUEIRA SWARTZ & SWARTZ NOVARTIS PHARMS - AREDIA INVESTIGATION RECS SPRAGUE, ANDREW D CONGRESSMAN STEVEN ARNOLD KING - CORR ORA/CE-FO/NJ-DO/NJCB/ JENNIFER RICHARDS SALIX PHARMACEUTICALS INC CMPLNT 117904 NOVEL LABORATORIES INC - 483 6/29/11 Signature/ Requester SCOT A HARFORD LYNCH DASKAL EMERY LLP Subject ET BROWNE DRUG CO INC - PALMER'S SKIN SUCCESS EVENTONE FADE CREAM EIRS, AERS, 14-DAY ALERT RPTS, ETC 12/00 TO PRESENT
Page 341 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-5287 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5288 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5289 07/19/2011 08/16/2011 2011-5290 07/19/2011 08/16/2011 2011-5291 07/19/2011 08/16/2011 2011-5292 07/19/2011 08/16/2011 2011-5293 07/19/2011 08/16/2011 2011-5294 07/19/2011 08/16/2011 2011-5295 2011-5296 2011-5297 2011-5298 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 08/16/2011 07/19/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP SALLY FOUST ARTHREX INC ANDRESSA BELOSO-VINHAS Ziyad Brothers Importing KRISTINE BLUM OMNILYTICS CORINNE COHEN K020257 FCN 1018 ENTRY# J89-0115161-5 6/17/11 DISETRONIC MEDICAL SYS - H TRON PLUS INSULIN INFUSION PUMP K023471 DELTEC INC - INSULIN INFUSION PUMP & ACCESSORIES K020655 MINIMED INC - PARADIGM INSULIN PUMP MODEL 511 K001829 DISETRONIC - DTRON INSULIN PUMP K001629 FUJINO, YUKIO LINICAL CORP,OSAKA, JAPAN - EIR, 483 7/24/09 YUKIO FUJINO FUJINO, YUKIO SHIONOGI & CO LTD, OSAKA, JAPAN - EIR, 483 7/31/09 Signature/ Requester Subject
SOOIL DEVELOPMENT COMPANY LTD - DANA DIABECARE II INSULIN PUMP & SUPERLINE EASY RELEASE K022317
MEDTRONIC - MINIMED COMLINK HARDWARE & SOFTWARE K021974
CON MED - LINVATEC SOFT TISSUE TO BONE SYS K091549
Page 342 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/16/2011 2011-5299 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5300 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5301 07/19/2011 08/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5302 2011-5303 07/20/2011 08/17/2011 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5304 2011-5305 2011-5306 2011-5307 2011-5308 2011-5309 2011-5310 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC ANH BO TRADING COMPANY LTD, HOCHIMINH CITY, VIETNAM - EIRS, 483S DONG NAI IMP/EXP PROCESS AGRI PRODUCTS CO, HOCHIMINH, VIETNAM - EIRS, 483S HOANG CONG TAN PRODUCTION - TRADING CO LTD, HOCHIMINH, VIETNAM - EIRS, 483S NAM PHONG TRADING CO, HO CHI MINH CITY, VIETNAM EIRS, 483S KIEN LONG CO, RACH GIA, VIETNAM - EIRS, 483S SPD DEVELOPMENT - CLEARBLUE EASY PREGNANCY TEST K110433 MY LE COMPANY LTD, BINH PHUOC, VIETNAM - EIRS, 483S FOI SERVICES INC ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC GREER LABS, LENOIR, NC - EIRS, 483S, CO RESP, ETC 9/97, 3/00, 6/05 PANCREASE- ISRS 0033361, 01425802, 01444791, ETC ROBERT BENINCASA NPR ISRS 6302479, 5715887, 6470110, ETC LOWES, ROBERT NOVO NORDISK - VICTOZA NDA 22-341/S004 REMS ASSESSMENT, CORR, AMDENDMENTS, ETC Action Office Signature/ Requester ABIOMED INC TYRAH L. MILES DJA Global Pharmaceuticals SUBOXONE FILM - SBA Subject
Page 343 of 1132

Total Records: 12455 Control # 2011-5311 Recd Date / Due Date 07/20/2011 08/17/2011 2011-5312 07/20/2011 08/17/2011 2011-5313 07/20/2011 08/17/2011 ORA/P-FO/LOS-DO/LACB/ Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/SW-FO/DEN-DO/COMP/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/CE-FO/PHI-DO/PCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC FDA/OMPT/CDRH/OCER/DFOI/ RON JEFFREY CASMED MEDICAL SYSTEMS INC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5320 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5321 2011-5322 07/20/2011 08/17/2011 07/20/2011 08/17/2011 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/DET-DO/DCB/ PARKIN, WILLILAM J FDA/OF/CFSAN/OCD/EOS/ DAHLIA SATTAR NY/NJ BAYKEEPER DEPT OF ENVIRONMENTAL PROTECTION - SHELLFISH HARVESTING RECS MICHIGAN BIOLOGIC PRODUCTS INSTITUTE/BIOPORT CORP - ANTHRAX VAERS, EIRS, SAFETY INSP, CONTAMINATED LOTS, ETC JODY GREEN DENVER HEALTH ROCKY MOUNTAIN POISON & DRUG CENTER ISR 7107380-7 GWYNNE, DAVID I ROSEMARY E MCGEADY LEVINSON AXELROD PA ALAN MINSK ARNALL GOLDEN GREGORY LLP STRYKER - INTERVENTIONAL SPINE RF MULTIGEN REF 0406-900-000 APRVL, CMPLNTS, RECALLS VALLEYLAB INC - FORCE ARGON II ENHANCED ELECTOSURGICAL SYS K964636 XALATAN (LATANOPROST) NDA 20-597 - APRVL HISTORY, LTRS, RVWS, ETC 6/5/96 Subject SPINAL USA LLC, PEARL MS 2/1/11; LIFESOURCE CRYOBANK LLC, COVINGTON, LA 3/31/11; NU TECH SPINE, BIRMINGHAM, AL 4/7/11, ETC - 483S NORTHERN CALIFORNIA TRANSPLANT BANK, SAN RAFAEL, CA - 483 6/13/11 HUNTINGTON REPRODUCTIVE CENTER, LOS ANGELES, CA 2/25/11; SOUTHERN CALIFORNIA REPRODUCTIVE CENTER, BEVERLY HILLS, CA 5/17/11; HEALTHBANKS BIOTECH USA INC, IRVINE, CA 5/17/11 - 483S PEROSE-ST FRANC HEALTH SERVICES BLOOD BANK, COLORADO SPRINGS, CO 3/3/11; PRESBYTERIAN APHERESIS/DONOR SERVICES, ALBLUQUERQUE, NM 4/25/11 - 483S CENTR FOR ORGAN RECOVERY & EDUCATION, PITTSBURGH, PA 5/12/11; REPRODUCTIVE HEALTH SPECIALISTS INC, PITTSBURGH, PA 2/23/11 - 483S NONIN MEDICAL INC - K102715
2011-5314
07/20/2011 08/17/2011
2011-5315
07/20/2011 08/17/2011
2011-5316
07/20/2011 08/17/2011
2011-5317 2011-5318 2011-5319
07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011
Page 344 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5323 2011-5324 07/20/2011 08/17/2011 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5325 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5326 07/20/2011 08/17/2011 ORA/CE-FO/CHI-DO/CCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/SW-FO/KAN-DO/COMP/ DENISE HAMMBURG BIOPHARMA COMPLIANCE SERVICES LLC ORA/NE-FO/NWE-DO/NWECB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/NE-FO/NYK-DO/NYDCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SEA-DO/SCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J ADVANCED SURGICAL INNOVATIONS, COUNTRYSIDE, IL 4/6/11; FRIBERG MEDICAL ASSOC, CHICAGO, IL 6/8/11; MIDWEST SPERM BANK LLC, DOWNERS GROVE, IL 3/1/11 483S MIDWEST REPRODUCTIVE CENTER PA, OLATHE, KS; ISTO TECHNOLOGIES INC, ST LOUIS, MO - 483 UNIVERSITY OF MASS MEMORIAL MEDICAL CTR BLOOD BANK, WORCESTER, MA - 483 4/20/11 EYE BANK FOR SIGHT RESTORATION, NEW YORK, NY; BATZOFIN FERTILITY SERVICES, NEW YORK, NY - 483 BEAMONE LLC, LIMA, OH; PLASTIC SURGERY, OKLAHOMA CITY, OK - 483 COMMUNITY BLOOD CTR, PORTLAND, OR 5/5/11; UNIVERSITY FERTILITY CONSULTANTS LLC, PORTLAND, OR 5/27/11; SEATTLE SPERM BANK LLC, SEATTLE, WA 5/24/11 - 483S ELI LILLY & CO - ZYPREXA AER CURTIS A. THURSTON, Jr. THURSTON LAW OFFICES SEPTODONT INC - SEPTOCAINE NDA 22-010 APRVL RECS ORA/CE-FO/BLT-DO/CB/ JEFFREY W SHERMAN HORIZON PHARMA INC CURTIS A. THURSTON, Jr. THURSTON LAW OFFICES PHARMACEUTICS INTERNATIONAL INC, HUNT VALLEY, MD - EIRS 11/29/10-12/16/10 SETPODONT INC - SEPTOCAINE NDA 20-971 APRVL RECS Signature/ Requester Subject
2011-5327
07/20/2011 08/17/2011
2011-5328
07/20/2011 08/17/2011
2011-5329
07/20/2011 08/17/2011
2011-5330
07/20/2011 08/17/2011
2011-5331
07/20/2011 08/17/2011
2011-5332
07/20/2011 08/17/2011
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Total Records: 12455 Control # 2011-5333 Recd Date / Due Date 07/20/2011 08/17/2011 Action Office ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5334 2011-5335 2011-5336 07/20/2011 08/17/2011 07/20/2011 08/17/2011 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5337 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5338 07/20/2011 08/17/2011 2011-5339 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5340 07/20/2011 08/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5341 2011-5342 07/20/2011 08/17/2011 07/20/2011 08/17/2011 2011-5343 07/20/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD MASTROLEO TRA & ACCESSOREIES DESHA J. MELTON, RN TEXAS BOARD OF NURSING AUNDREA-JASMINE ADAMS, INTERNATIONAL INSTITUTE OF HOLISTIC HEALING INC - 483. CORR, WARNING LTR 4/28/11 ETC ANTI-DEPRESSANTS - CLNCL STUDIES, CORR, AERS, ETC (CERTIFIED) TONO-PEN TIP COVER - K033146 SIDNEY M. WOLFE, M.D. PUBLIC CITIZEN CANAKINUMAB - SAMPLE INFORMED-CONSENT RECS FOR ONGOING STUDIES OC/OM/OMP/DDM/ AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC DAGMAR JUNG BULK MEDICINES & PHARMACEUTICALS GMBH ZHEJANG HUSHAI - LISINOPRIL NDC 064220-0020 DKT 1978N-0070 DON J. MIZERK HUSCH BLACKWELL LLP TORRENT PHARMS - KEPPRA XR ANDA 91-338 APRVL LTR 11/17/10, ANDA 91-399 APRVL LTR 5/1/11, ANDA 91-093 APRVL LTR 7/14/11 ORA/ORM/ ORA/ORM/ OC/OM/OMP/DDM/ TONY CHEN FDAZILLA JAMES D. KNOWLES ZUCKERMAN SPAEDER LLP AMY BYROM NYCOMED US INC KAON CL-10 (POTASSIUM CHLORIDE) ANDA 17-046 APRVL, SAFETY RPTS DKT 2002P-0435 LIST OF 483S 1/1/09 TO 7/17/11 Signature/ Requester RAQUEL RUTLEDGE MILWAUKEE JOURNAL SENTINEL Subject ROCKLINE INDUSTRIES, SHEBOYGAN, WI - WARNING LTRS. EIRS 2000 TO PRESENT
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Total Records: 12455 Control # Recd Date / Due Date 08/17/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5344 2011-5345 07/21/2011 08/18/2011 07/21/2011 08/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5346 07/21/2011 08/18/2011 2011-5347 07/21/2011 08/18/2011 2011-5348 07/21/2011 08/18/2011 2011-5349 07/21/2011 08/18/2011 2011-5350 2011-5351 07/21/2011 08/18/2011 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5352 2011-5353 07/21/2011 08/18/2011 07/21/2011 08/18/2011 ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ ELLIN M DROUIN DESIGN MENTOR INC CHRISTINE DEVILLERS DDN MEDICAL AFFAIRS AVCO MEDICAL PRODUCTS - PHYSIOLOGIC HEART SIMULATOR K770937 ALAVEN PHARMACEUTICAL LLC, SOMERSET, NJ - EIR 3/2429/11 Doe J FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ MELANIE LARY NEW ENGLAND ANTIVIVISECTION SOCIETY MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC SHIKO BEN-MENAHEM MSC MPHIL ERASMUS UNIV ROTTERDAM REBECCA MODIN RN BSN ISOPRODUCTS LLC THALIDOMIDE - RECS K962288 ESTABLISHMENT REGISTRATION AND MEDICAL DVC LISTING 1976 TO 2010 IIT RESEARCH INSTITUTE, CHICAGO, IL - 483 10/10 DIAGNOSTIC PATHOLOGY RPTS ON GOVERNMENTOWNED CHIMPANZEES 2001 TO PRESENT BIORELIANCE CORP, ROCKVILLE, MD - 483 9/10 Doe J ROBERT P CHARROW GREENBERG TRAURIG LLP MEDI-SIS SYRINGE INFUSION SYS - K972173, PAINBUSTER INFUSION SYS - K980558, PARAGON INFUSION KIT K984146, ETC INDIVIDUAL RECS Signature/ Requester Doe J Subject
Page 347 of 1132

Total Records: 12455 Control # 2011-5354 2011-5355 Recd Date / Due Date 07/21/2011 08/18/2011 07/21/2011 08/18/2011 2011-5356 07/21/2011 08/18/2011 2011-5357 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ OC/COS/OL/ 2011-5358 2011-5359 2011-5360 07/21/2011 09/22/2011 07/21/2011 08/18/2011 07/21/2011 09/23/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/SW-FO/KAN-DO/COMP/ CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2011-5361 2011-5362 2011-5363 2011-5364 2011-5365 2011-5366 07/21/2011 08/18/2011 07/21/2011 08/18/2011 07/21/2011 08/18/2011 07/21/2011 08/18/2011 07/21/2011 08/18/2011 07/21/2011 ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANDREW C. RITTS NANOVA INC ANDREW C. RITTS NANOVA INC ANDREW C. RITTS NANOVA INC ANDREW C. RITTS NANOVA INC ANDREW C. RITTS NANOVA INC MARGARET R. GROEL CHERI HILL KENNEL & SUPPLY INC, STANWOOD, MI - 483 KURARAY AMERICA - K ETCHANT GEL K062409 3M - FILTEK SUPREME ULTRA K083610 MEDICAL PRODUCTS LABS INC - VARNISH AMERICA K040098 3M ESPE - ADPER SINGLE BOND PLUS K962785 PULPDENT CORP - PULPDENT SEAL RITE UDMA K963921 MICHAEL J MONGIOVI MONGIOVI & MONGIOVI LLC MAURA MA NORDEN SIDLEY AUSTIN LLP MAURA M NORDEN SIDLEY AUSTIN LLP PETAG - ESBILAC PUPPY MILK REPLACER INVESTIGATION RPT TOBACCO RETAILERS - WARNING AND NOTICE OF VIOLATION LTRS ENFORCEMENT OR IMPLEMENTATION OF THE STATUTORY PROVISIONS RELATING TO TOBACCO PRODS CORR 1/21/11-7/19/11 OM/OMP/DODM/ ORA/P-FO/LOS-DO/LACB/ Action Office ORA/SE-FO/SJN-DO/SJCB/ Signature/ Requester ELIZABETH GARRARD DRUG SAFETY ALLIANCE ANNE Y BRODY GIBSON DUNN & CRUTCHER LLP KRISTIN GLOVER UNIV OF VIRGINIA SCHOOL OF LAW JULIE J BUNCE GRAY RITTER & GRAHAM ATTYS MERCK - TELECOM MINS 1/30/02, 3/7/02, 2/8/02; US HOUSE GOVERNMENT REFORM COMMITTEE - BRIEFING TRANS 5/3/05. ETC Subject SCHERING-PLOUGH, LAS PIEDRAS, PR - 483 11/15/0112/15/01 LIFETECH RESOURCES, CHATSWORTH, CA - WARNING LTR RESP 5/20/11, SAFETY & EFFICACY TESTS, EIR 8/1820/08. ETC DKT 2000N-0989
Page 348 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/18/2011 2011-5367 07/21/2011 08/18/2011 2011-5368 07/21/2011 08/18/2011 2011-5369 07/21/2011 08/18/2011 2011-5370 07/21/2011 08/18/2011 2011-5371 07/21/2011 08/18/2011 2011-5372 07/21/2011 08/18/2011 2011-5373 07/21/2011 08/18/2011 2011-5374 07/21/2011 08/18/2011 2011-5375 2011-5376 07/21/2011 08/18/2011 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5377 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOAN STITT MERCK & CO., INC. ASTRAZENECA PHARMS LP - SEROQUEL XR (QUETIAPINE FUMARATE) NDA 22-047 APRVL LTR, RVWS, PI ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/SW-FO/KAN-DO/COMP/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION JANIS D. KOUMOU ENDO PHARMACEUTICALS INC YUKI SAKURAGI PFIZER JAPAN DOMESTIC & FOREIGN FOOD MFRS - GMP INSPS 6/25076/25/11 DOMESTIC & FOREIGN DIETARY SUPPLEMENT MFRS GMP INSP 6/25/07-6/25/11 NOVARTIS CONSUMER HEALTH INC, LINCOLN, NE - EIR 6/13/11-7/8/11 ATIVAN (LORAZEPAM) NDA 18-140 - RECS Doe J ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ Signature/ Requester LACHMAN CONSULTANT SERVICES INC MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC CMPLNT 121169 MERCK & CO INC, UNION, NJ - 483 7/10 GENENTECH INC - SOUTH SAN FRANCISCO, CA - 483 8/10 CORNELL UNIVERSITY, DEPT OF ANIMAL SCIENCE, ITHACA, NY - 483 CHARLES RIVER LABS, SHREWSBURY, MA - 483 3/10 Subject 5/10 CHANTEST INC, CLEVELAND, OH - 483 7/10
Page 349 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-5378 07/21/2011 08/18/2011 2011-5379 2011-5380 07/21/2011 08/18/2011 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5381 07/21/2011 08/18/2011 ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5382 07/21/2011 08/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5383 2011-5384 2011-5385 2011-5386 2011-5387 2011-5388 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 2011-5389 07/22/2011 08/19/2011 ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ GAGLIO, JUANITA CHERYL A FORREST FISH & RICHARDSON PC CHERYL A FORREST FISH & RICHARDSON PC CHERYL A FORREST FISH & RICHARDSON PC CHERYL A FORREST FISH & RICHARDSON PC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLELNA HARBASZEWSKA AVALON RISK MANAGEMENT INC ST JUDE MEDICAL - ENSITE FUSION DYNAMIC REGISTRATION TOOL K0082467 BIOSENSE WEBSTER INC, DIAMOND BAR, CA - CARTO 3 EP NAVIGATION SYS VERSION 2 K103746 ST JUDE MEDICAL, ST PAUL, MN -ENSITE VELOCITY SYS WITH PRT K110549 MEDIGUIDE LTD, HAIFA, ISRAEL - GUIDED MEDICAL POSITIONING SYS K091781 RADHA'S FRESH PRODUCE ENTRY E84-00714109 NOTICE OF ACTION #1 MIAVANA & FAMILY INC - ENTRY 047-00506498 NOTICE OF ACTION #1 FRESH FRUIT PORTAL - SAFETY LAWS, COMMENTS REGAN, MARY E CHANTIX (VARENICLINE) - AERS 2006 TO PRESENT JIM DAVIS SNOKIST GROWERS SNOKIST GROWERS, YAKIMA, WA - INVESTIGATIONS, CORR, RPTS, ETC DAMAUER, STARR OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ STACEY N. IRIZARRY, Ph.D. GTC LAW GROUP LLP & AFFILIATES CHRISTINA KUHN COVINGTON & BURLING LLP AKIRMAX PHARMS - TIROSINT AER INSTITUT BIOCHEMIQUE SA - AVIVO MOBILE PATIENT MGMT SYS K083287, K091971 DKT FDA-2010-N-0621 Signature/ Requester Subject
Page 350 of 1132

Total Records: 12455 Control # 2011-5390 Recd Date / Due Date 07/22/2011 08/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5391 07/22/2011 08/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5392 07/22/2011 08/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5393 07/22/2011 08/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5394 2011-5395 2011-5396 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-5397 2011-5398 2011-5399 07/22/2011 08/19/2011 07/22/2011 08/19/2011 07/22/2011 08/19/2011 OC/OM/OMP/DDM/ CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ THOMAS H KING GLOBEIMMUNE INC ANEET PANSEAR BURDOCK GROUP MARCY SUSSMAN GlaxoSmithKline OTC VOL 160297, 160352 ENGERIX-B (HEPATITIS B VACCINE RECOMBINANT) RECS SODIUM HEXAMETAPHOSPHATE - RPTS ORA/CE-FO/DET-DO/DCB/ COLWELL, JESSICA MARIA WILLINGHAM ALVIS & WILLINGHAM LLP SHEA N SHAVER REILLY POZNER LLP UNITED BRANDS COMPANY INC - JOOSE INVESTIGATION RECS ZOLOFT (SERTRALINE HCL) NDA 19-839, NDA 20-990 AERS, APRVL LTRS, LBLG , ETC 8/30/01 FDA, DETROIT, MI - PERSONNEL LIST BURKE, CHARLES W RU 486 (MIFEPRISTONE) - AERS ROBERT M WEBER HERMANN CAHN & SCHNEIDER LLP CERVIDIL NDA 20-411/S027 - AERS, WARNINGS, LBLG CHANGES 5/10 TODD JUNEAU JUNEAU PARTNERS ABBOTT LABS - NORVIR (RITONAVIR) NDA 20-680/S011 CHEMISTRY MFG & CONTROLS SECTION, WITHDRAWAL RECS, COMM, ETC 3/1/96 Signature/ Requester TODD JUNEAU JUNEAU PARTNERS Subject ABBOTT LABS - NORVIR (RITONAVIR CAPS) SOFT GELATIN NDA 20-945 CLNCL PHARMACOLOGY, BIOPHARMACEUTICS RVW, BIOEQV STUDY, ETC 11/21/97, 3/1/99
Page 351 of 1132

Total Records: 12455 Control # 2011-5400 Recd Date / Due Date 07/22/2011 08/19/2011 2011-5401 07/25/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5402 07/25/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5403 07/25/2011 08/22/2011 2011-5404 2011-5405 07/25/2011 08/22/2011 07/25/2011 08/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-5406 07/25/2011 08/22/2011 2011-5407 07/25/2011 08/22/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5408 2011-5409 07/25/2011 08/22/2011 07/25/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ KOMAL K JAIN Keller and Heckman LLP JAMES N CAMPBELL MD VALLINEX INC ALGORX PHARMACEUTICALS INC - CAPSAICIN INJ IND 69,908 RECS ALGAL OIL - GRAS 384 ANDI POULSON LEXISNEXIS COURTLINK INC ISRS C00160619M C00182648, C00347390 DIANA L GESEKING SEDGWICK LLP INDIVIDUAL RECS FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ CARA WELCH PHD NATURAL PRODUCTS ASSOCIATION GABRIEL B SHERMAN Hyman Phelps and McNamara PC EMILY STEVENSON ALLIANCE FOR NATURAL HEALTH USA ACON LABORATORIES INC - MISSION SALIVA ALCOHOL TEST STRIP K093879 DIETARY SUPPLEMENTS - CAERS, AERS 1/10 TO PRESENT PROSTAR INC - EIRS, 483S, CORR, ETC 10/10 TO PRESENT CHRIS LIPPINCORR MD UNIV OF NORTH CAROLINA HOSPITALS SOLIRIS (ECULIZUMAB) - AERS Action Office OC/OM/OMP/DDM/ Signature/ Requester BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN BODE MATZ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC KING PHARMS R & D - OXECTA NDA 20-2080 APRVL LTR, RVWS Subject DKT & DKT LOG OF FDA-2011-D-0287
Page 352 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5410 07/25/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5411 2011-5412 07/25/2011 08/22/2011 07/25/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5413 07/25/2011 08/22/2011 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ ORA/OCI/ ORA/OCI/ 2011-5414 07/25/2011 08/22/2011 2011-5415 07/25/2011 08/22/2011 2011-5416 2011-5417 2011-5418 2011-5419 07/25/2011 08/22/2011 07/25/2011 08/22/2011 07/25/2011 08/22/2011 07/26/2011 08/23/2011 2011-5420 07/26/2011 08/23/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ LAURA J CONYERS FINDLING PARK AND ASSOCIATES PC A SMYTH IOVATE HEALTH SCIENCES RESEARCH INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC JUDY MA HARRIS SPICE COMPANY INC SANDY FRIEDMAN W0LTERS KLUWER LAW & BUSINESS DEBRA COHEN W0LTERS KLUWER LAW & CLOSED FOIA REQUESRS 7/11-15/11 LUCKY SHING ENTERPRISE CO LTD, HO CHI MINH CITY, VIETNAM - EIR, 483 TU HUNG TRADING CO, HO CHI MINH CITY, VIETNAM - EIR, 483 CLOSED FOIA REQUESTS 7/4-8/11 VIETMAN TH & D CO LTD, HANOI, VIETNAM - EIR, 483 CAERS 135342 K950419, K032147, K012383, ETC (CERTIFIED) FINCH, LINDA CMPLNT 120720 ORA/NE-FO/NYK-DO/NYDCB/ SHARLENE EDMONDS PPD BARBARA MORRISON BIOMARIN PHARMACEUTICAL INC JAMES P AYMER, UPSTATE NEUROLOGY CONSULTANTS, ALBANY, NY - EIRS, 483S, CORR, ETC RISPERDAL NDA 20-272/S036, NDA 20-588/S024, NDA 21444/S008 - MEDICAL RVWS ALAN W SHINDEL MD UNIV OF CALIFORNIA DAVIS SILDENAFIL, VARDENAFIL, TADALAFIL - APRVL RECS Signature/ Requester Subject
Page 353 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester BUSINESS 2011-5421 07/26/2011 08/23/2011 2011-5422 2011-5423 2011-5424 2011-5425 2011-5426 2011-5427 2011-5428 2011-5429 2011-5430 2011-5431 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5432 2011-5433 2011-5434 2011-5435 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2011-4759 - REQUEST LTR 2011-4748 - REQUEST LTR 2011-4738 - REQUEST LTR 2011-4666 - REQUEST LTR FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC FOI SERVICES INC BRISTOL-MYERS SQUIBB HOLDINGS PHARMA, MANATI, PR - 483S 7/31/06-8/7/06 GENERAL MILLS - REVISED LABELS FOR CHEERIOS, RESP LTR, CORR 7/14/09, 11/3/09 SUN PHARMACEUTICAL INDUSTRIES - SUMATRIPTAN SUCCINATE ANDA 90-358 APRVL RECS FOI SERVICES INC FEDERAL REGISTER VOL 44 NO 9 PG 2932-2953 1/12/79 FOI SERVICES INC CLOSED FOIA REQUEST 7/18-22/11 FOI SERVICES INC CLOSED FOIA REQUESTS 7/11-15/11 DEBRA COHEN W0LTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOIA REQUESTS 7/4-8/11 CLOSED FOIA REQUESTS 7/18-22/11 CLOSED FOIA REQUEST 7/11-15/11 CLOSED FOIA REQUESTS 7/4-8/11 CLOSED FOIA REQUESTS 7/18-22/11 Subject
Page 354 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/23/2011 2011-5436 2011-5437 2011-5438 2011-5439 2011-5440 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 07/26/2011 08/23/2011 2011-5441 2011-5442 07/26/2011 08/23/2011 07/26/2011 08/23/2011 2011-5443 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5444 2011-5445 07/27/2011 08/24/2011 07/27/2011 08/24/2011 2011-5446 07/27/2011 08/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5447 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5448 07/27/2011 FDA/OMPT/CDER/ORP/DIDP/ CHANDRAN TIRUVATTAR CAROLINA MEDCL - ABROBASE (TRIANCINOLONE SHERRIE FERDINAND LEVENTHAL BROWN ET AL LAMICTAL - AERS SERBY, VICTOR M JOHN A HUGHES DLA PIPER LLP US ELEN HOWELL HOGAN LOVELLS LLP LAXMI ENTERPRISES, MUMBAI, INDIA - EIRS, 483S LAST 12 MONTHS ALL-BOROUGH-IMAGING- PC - MAMMOGRAPHY QUALITY STANDARDS REAUTHORIZATION ACT CERTIFICATE 6/6/05 (CERTIFIED) 15 PRE-IND MTGS - ATTENDEES, BIOSIMILAR PRODS, FDA REPRESENTATIVES, ETC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GARY SYRING QUALITY & REGULATORY ASSOCS LLC ERIN BADALI VASCULAR SOLUTIONS INC PAMALA V CORPORA HISCOCK BARCLAY BARBARA MORRISON BIOMARIN PHARMACEUTICAL INC CIBA SPECIALTY CHEMICALS CORP, NEWPORT, DE - FAP 8B4566 NIRVANA INC, FORESTPORT, NY - NIRVANA SPRING WATER, SAM'S CHOICE PURIFIED WATER APRVLS, CERTIFICATIONS, PERMITS RISPERDAL NDA 20-272/S036, NDA20-588/S024, NDA 21444/S008 - MEDICAL RVWS PMT SUBDURAL CORTICAL ELECTRODES - K082472 2011-4893 - REQUEST LTR 2011-4882 - REQUEST LTR 2011-4880 - REQUEST LTR 2011-4825 - REQUEST LTR Subject
Page 355 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/24/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5449 2011-5450 2011-5451 2011-5452 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5453 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5454 2011-5455 07/27/2011 08/24/2011 07/27/2011 08/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5456 07/27/2011 08/24/2011 ORA/P-FO/LOS-DO/LACB/ PATRICIA L REGENYE Celgene Corporation DONALD TASHKIN (UNIV CALIFORNIA LOS ANGELES MEDICAL CTR), LOS ANGELES, CA - 483 10/01 TO PRESENT KEN L PILGRIM RESPONSE BIOMEDICAL CORP FERENA SALEK PHARM D NORTHWEST MEDICAL CENTER PROMETHAZINE - BLACK BOX WARNING RECS SIEMENS - STRATUS CS ACUTE CARE D-DIMER K110303 Doe J GEODON (ZIPRAZIDONE) - RECS THURMAN, WANDA ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ DOUGLAS N BLUE II ZETETIC DOUGLAS N BLUE II ZETETIC INC DOUGLAS N BLUE II ZETETIC COUMADIN, WARFARIN - AERS NOVARTIS - ENTRY #AV3-0023267-3 NOVARTIS - ENTRY #AV3-0023385-3 NOVARTIS - ENTRY #AV3-0023268-1 Signature/ Requester DR REDDY'S LABORATORIES INC Subject ACETONIDE) ANDA 89-595 SBA
Page 356 of 1132

Total Records: 12455 Control # 2011-5457 2011-5458 Recd Date / Due Date 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5459 2011-5460 2011-5461 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 2011-5462 07/27/2011 08/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation ANDREW C RITTS UNIV OF MISSOURI ANDREW C RITTS UNIV OF MISSOURI NANCY OLSEN (VANDERBILT UNIV MED CTR), NASHVILLE, TN - 483 8/10 TO PRESENT IVOCLAR NORTH AMERICA INC - HELIOSEAL F K932078; PULPDENT CORP - PULPDENT SEAL-RITE UDMA K963921; 3M CO - CLINPRO SEALANT K992326, ETC ULTRADENT PRODUCTS INC - PERMAFLO K974413; DENTSPLY INTERNATIONAL - QUIXX POSTERIOR RESTORATIVE K040144; IVOCLAR VIVADENT INC - TETRIC EVOCERAM K042819, ETC PASCAL CO INC - FLUORILAQ K030488; MEDICAL PRODUCTS LABORATORIES INC - VARNISHAMERICA K040098; DENTSPLY INTL - FLUORIDE VARNISH K031932, ETC UNICEP - MICRODOSE TOTAL ETCHANT K924822; KURARAY MEDICAL INC - K-ETCHANT GEL K062409; DEGUSSA AG - DEGUFILL ETCHANT GEL K901872, ETC CHINA - INSPS, TESTINGS, IMPORT REFUSALS, ETC 2005 TO PRESENT JEFFREY MILLER, TAMPA, FL - 483 9/02 TO PRESENT Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation Subject RICHARD MARTIN, GRAND RAPIDS, MI - 483 11/30/99 TO PRESENT JOACHIM SIEPER (CHARITE-UNIVERSITATSMEDIZIN BERLIN), BERLIN, GERMANY - 483 9/04 TO PRESENT
2011-5463
07/27/2011 08/24/2011
ANDREW C RITTS UNIV OF MISSOURI
2011-5464
07/27/2011 08/24/2011
ANDREW C RITTS UNIV OF MISSOURI
2011-5465
07/27/2011 08/24/2011
ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/OIASI/OIP/IAS/ ORA/ORO/ ORA/ORO/ ORA/ORO/DFS/ ORA/ORO/DFS/
JASON J CZARNEZKI VERMONT LAW SCHOOL
2011-5466
07/27/2011 08/24/2011
FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ ORA/
HEIDI A BARCUS LONDON & AMBURN PC
ALLERGAN - GASTRIC BALLOON SUCTION CATHETER INSPS, RECALLS, TESTING, ETC
Page 357 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5467 2011-5468 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5469 2011-5470 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5471 07/27/2011 08/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ ELISA TOSTADO STRYKER SUSTAINABILTY SOLUTIONS ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-5473 2011-5474 2011-5475 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ OC/COS/OES/ OC/COS/OES/ 2011-5476 07/27/2011 CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UGXCD-16) GARDASIL (HPV VACCINE) - VAERS #277326-1 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ KRISTA WHALEY VIJON LABORATORIES INC ANJALI KUMAR FLEXION THERAPEUTICS LEE BUDNER LACKEY HERSHMAN LLP COYLE V HORNELL BREWING CO; RIES V HORNELL BREWING CO INC - FDA DECISION REGARDING THE USE OF TERM NATURAL IN FOOD LBLG ETHICON INC - VICRYL (POLYGLACTIN) SUTURE PMA VI-JON INC, ST LOUIS, MO - EIR 9/15/09 SHIRLEY ROSS AGILIS NXT STEERABLE INTRODUCER MODEL G4O8324 K081645, AGILIS NXT STEERABLE INTRODUCER - K083083, AGILIS NXT STEERABLE INTRODUCER MODEL G4O8322 K083402, AGILIS STEERABLE INTRODUCER - K103083 ORA/SE-FO/FLA-DO/FCB/ DOUGLAS N. BLUE, II ZETETIC JOAN STITT (UG2CD-16) MERCK & CO., INC. SCHERING CORP - ZETIA (EZETIMIBE) ISRS 4935018-3, 4935106-1, 4941216-5, ETC NOVARTIS, PARSIPPANY, NJ - ENTRY #AV3-0023384-6 ORA/SE-FO/FLA-DO/FCB/ DOUGLAS N. BLUE, II ZETETIC JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK & CO INC - SINGULAIR (MONTELUKAST SODIUM) ISRS 5699186-0, 5699233-6, 5699248-8, ETC NOVARTIS, PARSIPPANY, NJ - ENTRY #AV3-0023293-9 Signature/ Requester Subject
2011-5472
07/27/2011 08/24/2011
ENTRY # BJG-00119882, #BJG-00120385, #BGJ 00120559, ROANOKE TRADE SERVICES INC ETC - REDELIVERY NOTICES, NOTICES OF REFUSAL, ETC
Page 358 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/24/2011 2011-5477 2011-5478 07/27/2011 08/24/2011 07/27/2011 08/24/2011 2011-5479 07/27/2011 08/24/2011 2011-5480 2011-5481 07/27/2011 08/24/2011 07/27/2011 08/24/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/DET-DO/DCB/ 2011-5482 07/27/2011 08/24/2011 2011-5483 07/27/2011 08/24/2011 2011-5484 07/27/2011 08/24/2011 2011-5485 07/27/2011 08/24/2011 2011-5486 07/27/2011 08/24/2011 2011-5487 2011-5488 07/27/2011 08/24/2011 07/27/2011 08/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/COS/OL/ SANDERS, SHANNON OC/COS/OL/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ OC/OM/OMP/DDM/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN BODE MATZ CASEY NESSELHAUF DEMOCRATIC CONGRESSIONAL CAMPAIGN COMM DOMINIQUE ALLEN PRICE ICE MILLER CONGRESSMAN RAYMOND "CHIP" CRAVAACK - CORR 1/11 TO PRESENT ELI LILLY & CO - DARVON, DARVOCET REQUESTS LAST THREE YRS CONGRESSMAN CHRISTOPHER S MURPHY - FOIA REQUESTS RECS 1/11 TO PRESENT DKT 1993N-0195 FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC ANDREW C. RITTS NANOVA INC DANUELLE MCINTOSH JENERIC INC - BOND I C&B K013543; SYBRON DENTAL SPECIALTIES INC - OPTIBOND SOLO PLUS 4 K014027; CAO GROUP INC - ASCENT UNIVERSAL ADHESIVE K070413 ETC DKT 1978N-0070 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANNMARIE BEATTIE HARMONIZED CUSTOMS BROKERS INC ENTRY #G76-0125663-7 - LAB RESULTS K061979 JOANNE DIGGETT KELSEN INC ENTRY #G7600963985 - LAB RESULTS Action Office Signature/ Requester MERCK & CO., INC. KEVIN O'ROURKE FDA NEWS SHERI L. MUSGNUNG OLYMPUS AMERICA INC PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG FACILITIES IN & OUTSIDE THE US - 483S 5/1/11-6/30/11 APERIO TECHNOLOGIES INC, VISTA, CA - SCANSCOPE XT SYS K071128, K080254; BIOIMAGENE INC, CUPERTINO, CA PATHIAM IMAGE ANALYSIS SOFTWARE FOR HER 2 K062756 Subject
ENTRY #AR820047561 - ENTRY SUMMARY, NOTICE OF ROANOKE TRADE SERVICES INC REFUSAL, REDELIVERY NOTICE, ETC
Page 359 of 1132

Total Records: 12455 Control # 2011-5489 2011-5490 Recd Date / Due Date 07/27/2011 08/24/2011 07/27/2011 08/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SAN-DO/SFCB/ 2011-5491 2011-5492 2011-5493 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/OE/ ORA/OE/ 2011-5494 2011-5495 2011-5496 2011-5497 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 07/27/2011 08/24/2011 2011-5498 07/28/2011 08/25/2011 ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5499 2011-5500 07/28/2011 08/25/2011 07/28/2011 08/25/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ KARL M NOBERT K&L GATES LAUREN SIROIS WEITZ & LUXEMBERG PC MEDSTEM LLC, RENOVOCYTE LLC - INAD 012-009, 012010, 012-011 RECS TAKEDA - ACTOS TABS (PIOGLITAZONE HCL) NDA 21-073 AERS, LBLG MODIFICATIONS, WARNING LTRS, ETC FDA/OMPT/CDRH/OCER/DFOI/ POPOWIESKI, STEVEN MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC C VERED JONA JONES DAY FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ GERHARDT., NATHAN SYDNEY GORDON SEAL SHIELD ELCAM MEDICAL, MEROM HAGALIL, ISRAEL - DOUBLE SAFE STOPCOCK, TRIPLE SAFE STOPCOCK K082106 PRODISC L TOTAL DISC REPLACEMENT - SAFETY, ANALYSIS, MDRS, ETC 2009 TO PRESENT ENTRY #H67-13415031,# H67-13384468 - NOTICE OF FDA ACTION #1 CEREBRAL HEALTH LLC, JUPITER, FL - 483 2/8-18/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GERALD DE FRANCO DE FRANCO & SONS HAZELNUTS RECALL #F-0988-89-2011 2 - 0988-89-2011 2 - LAB DATA, E-MAILS, ANALYSIS, ETC FOI DAILY LOG 7/11-15/11 FOI DAILY LOG 7/4-8/11 SCHARBERG, DAVID L Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester KEVIN TUCKER EXPONENT, INC. Subject BAYER CROPSCIENCE - FG72 SOYBEAN BIOTECHNOLOGY CONSULTATION RECS US ARMY MEDICAL RESEARCH INSTITUTE; GENESIS MIDWEST LABS; AMERICAN PRECLINICAL SERVICES; ISIS SERVICES LLC - NON CLNCL, BIOANALYTICAL TESTING, 483S
2011-2703 (CERTIFIED)
Page 360 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ 2011-5501 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5502 07/28/2011 08/25/2011 FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ ORA/CE-FO/PHI-DO/PCB/ ORA/OCI/ ORA/OCI/ 2011-5503 2011-5504 2011-5505 2011-5506 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-5507 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ 2011-5508 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ HANKUK LEE DAEWOONG AMERICA INC WATSON PHARMS - ACTIGALI NDA 19-594 CLNCL TRIAL RECS WESLEY D FEW ELLIS LAWHORNE & SIMS PA ANDREW M MARTIN CO (AMMCO) - BENSAL HP AFFADAVITS, CERTIFICATIONS, RPTS, ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ GILES, CRAIG LISA HESSABI SYBRON DENTALSPECIALTIES LISA HESSABI SYBRON DENTAL SPECIALTIES ASHLI WEBB PROVINCE WEBB & ASSOCIATES AASTROM BIOSCIENCES INC - IXMYELOCEL-T PHASE 3 CLNCL TRIAL RECS KERR CORP - PROP CONQUEST C&B VLC GLAZER/SEALANT K953381 KERR CORP - RM BOND (BOND-1) K072830 CHEMICAL ABSTRACT NUMBER CAS 9003-11-6 - RECS Gumpert, David DANIEL L ALLGYER, RAINBOW ACRES FARM, KINZERS, PA - INVESTIGATION RECS 2/4/10, 4/20/10 JENNIFER LOSCHER AMDIPHARM PLC SUMITOMO CHEMICAL COMPANY LTD, GIFU PREFECTURE, JAPAN - EIR 6/14-18/10 Signature/ Requester Subject
Page 361 of 1132

Total Records: 12455 Control # 2011-5509 Recd Date / Due Date 07/28/2011 08/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ 2011-5510 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5511 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-5512 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ 2011-5513 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-5514 07/28/2011 08/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2011-5515 07/28/2011 08/25/2011 FDA/OMPT/CDRH/OCER/DFOI/ KIM WILLIAMS EPSTEIN ASSOCIATES LLC EPSTEIN ASSOCIATES LL, ANNAPOLIS, MD - ENDO GRASTRIC SOLUTIONS, ESOPHYX2 DVC WITH SEROSA FUSE FASTENER & ACCESSORIES K092400 WESLEY D FEW ELLIS LAWHORNE & SIMS PA RICHARD A SHERIFF, JAMES DAVIS, SHERTECH PHARMACEUTICALS, SERTECH PHARMACY SERVICES INC, SHERTECH LABORATORIES LLC, ETC - OATHS, AFFIDAVITS, RPTS ETC WESLEY D FEW ELLIS LAWHORNE & SIMS PA RAYMOND E FAULK, DIHOMA CHEMICAL & MANUFACTURING INC - OATHS, AFFIDAVITS, RPTS ETC WESLEY D FEW ELLIS LAWHORNE & SIMS PA WARNER GRAHAM CO - OATHS, AFFIDAVITS, RPTS ETC WESLEY D FEW ELLIS LAWHORNE & SIMS PA R THOMAS STANLET SR, DAVID E STANLEY, 7 OAKS PHARMACEUTICAL CORP; 7 OAKS MANUFACTURING CORP, ETC - OATHS, AFFIDAVITS, RPTS ETC Doe J MYLAN - DURAGESIC (FENTANYL PATCH) AERS Signature/ Requester WESLEY D FEW ELLIS LAWHORNE & SIMS PA Subject MARK SZCZAWINKSI, JESTOR TECHNOLOGY PARTNERS INC - BENSAL HP AFFADAVITS, CERTIFICATIONS, RPTS, ETC
Page 362 of 1132

Total Records: 12455 Control # 2011-5516 Recd Date / Due Date 07/28/2011 08/25/2011 2011-5517 07/28/2011 08/25/2011 2011-5518 2011-5519 2011-5520 2011-5521 2011-5522 2011-5523 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5524 07/28/2011 08/25/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ OC/OM/OEO/ 2011-5525 07/28/2011 08/25/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5526 07/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ BRIAN K ANDREA NELLCOR N-200 PULSE OXIMETER - K863784 Doe J YELLOW FEVER & TYPHOID FEVER VACCINES - VAERS STEPHANIE A MONLANO DONGELL LAWRENCE FINNEY LLP HEPATITIS A OUTBREAK, TN, PA - RPTS 6/03 TO 12/03 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/NJ-DO/NJCB/ SHARLENE EDMONDS PPD JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP R. BRAD MILLER DURBIN LARIMORE & BIALICK LAURIE C STEELE REED SMITH LLP LESLIE SHOJI INTEREX INDUSTRIES LTD JOHN D HAINSWORTH, SARAH CANNON CANCER CTR/RESEARCH INST, NASHVILLE, TN - EIR, 483, CORR ETC 3/11 POLAROME, JERSEY CITY, NJ - EIRS, 483S, RECALL RECS 9/07 TO PRESENT RUGER CHEMICAL COMPANY INC, LINDEN, NJ - EIRS, 483S, RECALL RECS 9/07 TO PRESENT RICCA CHEMICAL CO, ARLINGTON, TX - EIRS, 483S, RECALL RECS 9/07 TO PRESENT ACTAVIS TOTOWA LLC, LITTLE FALLS, NJ - EIRS, 483S 2004 - 2008 RESTORATIVE HEALTHSERVICES INC - EIRS, 483S 1/1/02 12/31/03 UNITED 1 INTERNATIONAL LABS, FARMERS BRANCH, TX EIR, 483 8/10 Signature/ Requester KIM WILLIAMS EPSTEIN ASSOCIATES LLC Subject NDO SURGICAL ENDOSCOPIC PLICATION SYS K023234
Page 363 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/25/2011 2011-5527 2011-5528 2011-5529 2011-5530 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/28/2011 08/25/2011 07/29/2011 08/26/2011 2011-5531 07/29/2011 08/26/2011 2011-5532 07/29/2011 08/26/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-5533 07/29/2011 08/26/2011 2011-5534 07/29/2011 08/26/2011 2011-5535 07/29/2011 08/26/2011 2011-5536 07/29/2011 08/26/2011 2011-5537 07/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ ELENA HOWELL BAFFNA SPICES, ERNAKULAM, KERALA STATE, INDIA ELENA HOWELL HOGAN LOVELLS LLP PLANT LIPIDS, ERNAKULAM, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS ELENA HOWELL HOGAN LOVELLS LLP KISHORE SPICES, ALUVA, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS ELENA HOWELL HOGAN LOVELLS LLP COCHIN SPICES, ERNAKULAM, KERALE STATE, INDIA EIRS, 483S LAST 12 MONTHS ELENA HOWELL HOGAN LOVELLS LLP SYNTHITE INDUSTRIES, ERNAKULAM, KERALA STATE, INDIA - EIRS, 483S LAST 12 MONTHS ELENA HOWELL HOGAN LOVELLS LLP LAXMI ENTERPRISES, MUMBAI, INDIA - EIRS, 483S LAST 12 MONTHS ELENA HOWELL HOGAN LOVELLS LLP HARMONY SPICE LTD, KOCHI, KERALA STATE, INDIA EIRS, 483S LAST 12 MONTHS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ BYAS, TAMMY ELENA HOWELL HOGAN LOVELLS LLP VALLABHDAS KANJI LTD, KERELE STATE, INDIA - EIRS, 483S LAST 12 MONTHS FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester Mayer Brown LLP RACHEL A BOND Keller and Heckman LLP PETER D LOFTUS DOWJONES & CO CMPLNT 121354 MITSUI CHEMICALS INC, PRIME POLYMER CO LTD - FCN 978 MERCK & CO, WEST POINT, PA - 483S 4/28/08 TO PRESENT Subject
Page 364 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/26/2011 2011-5538 07/29/2011 08/26/2011 Action Office OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5539 07/29/2011 08/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5540 07/29/2011 08/26/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5541 07/29/2011 08/26/2011 2011-5542 07/29/2011 08/26/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5543 2011-5544 07/29/2011 08/26/2011 07/29/2011 08/26/2011 ORA/CE-FO/DET-DO/DCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CTP/OD/ CTP/OD/ 2011-5545 2011-5546 07/29/2011 08/26/2011 07/29/2011 ORA/ CVM/OCD/ LARRY J THOMPSON DVM PHD NESTLE PURINA PETCARE SALT PELLET - RESTRICTIONS ON SALE TO THE PUBLIC SPECTROSCOPY ARTICLE RVWS BOBBY SCHOCHET OLSSON FRANK & WEEDA WESLEY D FEW ELLIS LAWHORNE & SIMS PA MEAD JOHNSON NUTRITION CO, GLENVIEW, IL - CORR, RESPS, MINS, ETC 10/18/10 TOBACCO TECHNOLOGY INC - BENSAL HP RPTS, AFFIDAVITS, LICENSING, ETC ELAINE H TSENG KING & SPALDING ST JUDE MEDICAL, PLANO, TX - EIRS 8/9-25/10 LEN COLLETT MARBLE MEDICAL INC K973507, K940694, K971918 ANDI POULSON LEXIS NEXIS ISRS M00151180, M00160626 (CERTIFIED) COLLIN E LEE EMORY HEALTHCARE TORADOL (KETOROLAC) - BLACK BOX WARNINGS JAYA LAKSHMI DR REDDY'S LABORATORIES INC SUN PHARM INDS INC - SUMATRIPTAN SUCCINATE ANDA 90-358 SBA Signature/ Requester HOGAN LOVELLS LLP Subject EIRS, 483S LAST 12 MONTHS
Page 365 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/26/2011 Action Office ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-5547 07/29/2011 08/26/2011 2011-5548 07/29/2011 08/26/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ CHERIE PARKER AMUSA GREGORY N CONNOLLY DMD MPH HARVARD SCHOOL OF PUBLICH HEALTH 2011-5549 07/29/2011 08/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5550 2011-5551 2011-5552 07/29/2011 08/26/2011 07/29/2011 08/26/2011 07/29/2011 08/26/2011 CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5553 07/29/2011 08/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ 2011-5554 2011-5555 07/29/2011 08/26/2011 07/29/2011 08/26/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LISA SUTTNER NPS PHARMACEUTICALS MATTHEW WHITAKER WESTLAW COURTEXPRESS CETERO RESEARCH, SAN ANTONIO, TX - EIR, 483 MOST RECENT NOROXIN, CIPRO, FLOXIN, ETC - BOXED WARNINGS LBLG SUPPLEMENTS, RVWS Doe J INDIVIDUAL RECS FOI SERVICES INC FOI SERVICES INC IVAX SUB TEVA PHARMS - NICOTINE POLACRILEX BUCCAL CHEWING GUM ANDA 76-880 APRVL RECS FOI SERVICES INC TOBACCO ESTABLISHMENT REGISTRATIONS 12/31/09 TO PRESENT TOBACCO PROD LISTINGS 12/31/09 TO PRESENT FOI SERVICES INC CONTOUR FABRICATORS OF FLORIDA INC - REDI NURSE SYS (RNS) PRE-FILLED 10CC, 30CC, 60CC SYRINGE WITH STERILE WATER K952407 MODIFIED RISK TOBACCO PRODS - NUMBER OF APPLICATIONS FOR RVW BY MFR NAME, NUMBER OF RPTS OF PRODS INTRODUCED INTO INTER-STATE COMMERCE, ETC 7/1/11 IVAX SUB TEVA PHARMS - NICOTINE POLACRILEX BUCCAL CHEWING GUM ANDA 77-850 APRVL RECS Signature/ Requester VILLAREAL, GONZALO Subject
Page 366 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5556 2011-5557 2011-5558 07/29/2011 08/26/2011 07/29/2011 08/26/2011 07/29/2011 08/26/2011 2011-5559 2011-5560 07/29/2011 08/26/2011 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5561 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5562 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5563 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SAN-DO/SFCB/ 2011-5564 08/01/2011 08/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ ROY ROWLEY UTAH CENTER FOR ADVANCED MACHNET CAROTIDS COIL ARRAY ASSEMBLY - K012491 KEVIN BRODWICK THINKOPERATIONS LLC THINKOPERATIONS LLC, AUSTRIALIA - EIR 5/3-4/10 JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK & CO INC - ISENTRESS (RALTEGRAVIR) ISRS 59228101, 59277845, 59365531, ETC BACCALI, LENCA COMBIGAN - AERS OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ GABRIEL B SHERMAN Hyman Phelps and McNamara PC GABRIEL B SHERMAN Hyman Phelps and McNamara PC MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION GLORIA GASKINS KLEINFELD KAPLAN & BECKER SUSANNA GREENBERG BALLARD SPAHR LLP ANDA 77-415, ANDA 77-825 - APRVL RECS DKT 1994P-0208 HIDALGO LTD - EQUIVITAL VITAL SIGNS PHYSIOLOGICAL MONITOR K061993 ZEPHYR TECHNOLOGY CORP - AMBULATORY PATIENT MONITOR K100040 DKT FDA-1997-S-0039 Signature/ Requester Subject
Page 367 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester IMAGING RESEARCH 2011-5565 2011-5566 2011-5567 2011-5568 2011-5569 2011-5570 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/01/2011 08/29/2011 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5571 08/01/2011 08/29/2011 2011-5572 2011-5573 08/01/2011 08/29/2011 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5574 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5575 08/01/2011 08/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TATSUHIRO SAIDO SAYA WAVETECH INC SALTON INC - REJUVENIQUE MODEL #RJV10 K011935 Doe J BRISTOL-MYERS SQUIBB - AVAPRO (IRBESARTAN) AERS FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ MOTEN, LAVEETA MICHAEL T MULLEN PAUL A EPISCOPE LLC BRETHINE (TERBUTALLINE) - ISRS 3002741-X, 3066452-7, 3143920-0, ETC CFSAN - SUPERVISORY TEAM LEADER RESUME PKG IAN S ILLUMINATO FRIENDS OF THE EARTH TESTING OF FOODS CONTAINING NANOPARTICLES 1/06 TO PRESENT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ OM/OMP/DODM/ FREIBERG, RICHARD A KATHLEEN ROSS MPI RESEARCH CETERO RESEARCH, HOUSTON, TX - WARNING LTR 5/10, 12/10; ISIS SERVICES LLC, SAN CARLOS, CA - 483 3/21/114/7/11; MPI RESEARCH INC, MATTAWAN, MI - EIR 6/28/107/7/10, ETC QUINN, THOMAS J GENE PARKS HEALTHCARE IMAGING LC CBER/OCTMA/DDOM/ALFB/ OTSU, MOTOTA VIK BAJNATH ARTHREX INC PHILIPS - SD1200, 1200SX MDRS, INVESTIGATIONS, CORR, ETC PHILIPS - SD1200, 12SX MDRS, INVESTIGATIONS, CORR, ETC 2010- TO PRESENT DKT 1994-0443J PPD (TUBERCULIN PURIFIED PROTEIN DERIVATIVE) - MFR NAME MDR MW#5021050 Subject
Page 368 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5576 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5577 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5578 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5579 08/01/2011 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5580 2011-5581 2011-5582 2011-5583 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/01/2011 08/29/2011 08/02/2011 08/30/2011 2011-5584 2011-5585 08/02/2011 08/30/2011 08/02/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/SJN-DO/SJCB/ OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ LORI COHEN AMERISYS INC SUSANNA GREENBERG BALLARD SPAHR LLP TARRA FULLER Hyman Phelps and McNamara PC AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY LILLY DEL CARIBE, CAROLINA, PR - EIR, 483, CO RESP 7/31/09 JOSEPH B MICHELSON MD, ARTESIA, CA - EIR, 483, CO RESP 7/26/10-8/24/10 DKT 1978N-0070 DKT 1986P-0360 ANDA 77-284, ANDA 77-715, ANDA 77-415 - APRVL RECS CREDIT CARD HOLDER LIST REENA ZADE DR REDDY'S LABORATORIES INC TEVA PARENTERAL - PROPOFOL ANDA 75-102 SBA REENA ZADE DR REDDY'S LABORATORIES INC HOSPIRA - PROPOFOL ANDA 77-908 SBA REENA ZADE DR REDDY'S LABORATORIES INC BEDFORD - PROPOFOL AND 74-848 SBA ANNE L WEISMANN CITIZENS FOR RESPONSIBILITY & ETHICS IN WASHINGTON MARTIN SHKRELI, MSMB CAPITAL MANAGEMENT - CORR 1/10 TO PRESENT Signature/ Requester Subject
Page 369 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/30/2011 2011-5586 2011-5587 2011-5588 2011-5589 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5590 2011-5591 2011-5592 2011-5593 2011-5594 2011-5595 2011-5596 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 2011-5597 08/02/2011 08/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5598 08/02/2011 08/30/2011 2011-5599 08/02/2011 OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC KENNETH BRASLOW ENTRY WUG-01485837, WUG-01474963, WUG 01491090 NOTICE OF FDA ACTION #1, NOTICE TO MARK AND/OR REDELIVER CARDINAL HEALTH 414 LLC, ORLANDO, FL, SOSUTH FOI SERVICES INC KITTY DAWSON WOLTERS KLUWER LAW & BUSINESS MUHAMMED SHERID MD ELI D EHRENPREIS MD ISRS 5831270, 5830569, 5827979, ETC CLOSED FOIA REQUEST 7/25-30/11 FDA/OMPT/CDRH/OCER/DFOI/ MARK E GARDNER Duval & Associates CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOIA REQUESTS 7/25-29/11 CLOSED FOIA REQUESTS 7/25/30/11 CLOSED FOIA REQUESTS 7/11-15/11 CLOSED FOIA REQUESTS 7/18-22/11 CLOSED FOIA REQUESTS 7/4-8/11 GEN 1100329 ORA/SW-FO/KAN-DO/COMP/ Action Office ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS MOTHER FRANCES HOSPITAL (IRB), TYLER, TX - EIR, 483, CO RESP 2/28/11-3/4/11 NOSTRUM LABS, KANSAS CITY, MO - EIR, 483, CO RESP 12/1/09 DR SPENCER WAYNE, LENEXA, KS - EIR, 483, CO RESP 11/16-18/10 ZYDUS GROUP (ZYFINE DIVSION OF CADLILA HEALTHCARE LTD), AHMEDABAD, GUJARAT, INDIA - EIR, 483, CO RESP 1/17/11-2/3/11 Subject
Page 370 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/30/2011 2011-5600 08/02/2011 09/19/2011 2011-5601 2011-5602 08/02/2011 08/30/2011 08/02/2011 08/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-5603 2011-5604 2011-5605 2011-5606 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 09/16/2011 08/02/2011 08/30/2011 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5607 2011-5608 2011-5609 2011-5610 2011-5611 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 09/22/2011 08/02/2011 08/30/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5612 08/02/2011 CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY BAXTER BIOSCINECES, LESSINES, BELGIUM - EIRS, 483S, ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/BLT-DO/CB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS CENTRAL HEALTH (IRB), LYNCHBURG, VA - EIRS, 483S, CO RESP 2/3-15/11 GENZYME CORP, ALLSTON, MA - EIRS, 483S, CO RESP 11/13/09 JAMES A HOLLAND, THOMASVILLE, GA - EIRS, 483S, CO RESP 11/14/02 TO 1/3/03 CETERO RESEARCH, HOUSTON, TX - EIRS, 483S, CO RESP 5/3-7/10; 12/6-10/10 ALPHA LABS, TORONTO, CANADA - EIRS, 483S, CO RESP 10/25-27/10 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/BLT-DO/CB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS LINDA D BOSSERMAN, MD (WILSHIRE ONCOLOGY MEDICAL GROUP INC), LAVERNE CA - EIR, 483, CO RESP 12/8-22/10 JACQUES R CALDWELL, TIMONIUM, MD - EIR, 483, CO RESP 2/19/02 - 4/3/02 ISIS SERVICES LLC, SAN CARLOS, CA - EIRS, 483S, CO RESP 3/22/11- 3/22/11-4/7/11 LEDESMA GILBERT MD, ARLINGTON, TX - EIRS, 483S, CO RESP 9/28/09 ORA/P-FO/LOS-DO/LACB/ Doe J ANGELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC IOVATE, HYDROXYCUT, MAX OR MAX AQUA SHED, ETC AERS, CAERS Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ Signature/ Requester PETNET SOLUTIONS INC KENNETH A BERKOWITZ GOLDFADEN BERKOWITZ NELLY FRIED ET AL APIDEXIN - RECS Subject SEATTLE, WA, SAINT LOUIS, MO, ETC - 483S RAW SHELFISH, AVALON, NJ - RECS
Page 371 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/30/2011 2011-5613 2011-5614 2011-5615 2011-5616 2011-5617 2011-5618 2011-5619 2011-5620 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/02/2011 08/30/2011 08/03/2011 08/31/2011 08/03/2011 08/31/2011 08/03/2011 08/31/2011 2011-5621 08/03/2011 08/31/2011 2011-5622 2011-5623 08/03/2011 08/31/2011 08/03/2011 08/31/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5624 08/03/2011 08/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5625 08/03/2011 08/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ THOMAS ZETTERBERG DUECOM AB CELL LINES (IN VITRO) - PRE-CLNCL TRIALS , DOSAGE, PATIENT SPLS INFO THOMAS ZETTERBERG DUECOM AB DOCETAXEL - CELL LINES USED IN PRE-CLNCL TRIALS (IN-VITRO), RESISTANT, DOSAGE, PATIENT SPLS ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/CHI-DO/CCB/ Action Office Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS BARBARA JONES DOMINION GROUP INC GLADYS B TONKIN Center for Regulatory Services, Inc. KENNETH REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. THOMAS ZETTERBERG DUECOM AB TORISEL - PRE-CLNCL TRIAL CELL LINES USED IN (INVITRO) - DOSAGE, PATIENT SPLS INFO FOI DAILY LOG 7/5-8/11 FOI DAILY LOG 7/5-8/11 FOI DAILY LOG 7/5-8/11 FOI DAILY LOG 7/5-8/11 FOI DAILY LOG 7/5-8/11 HOSPIRA INC, CLAYTON, NC - EIRS, 483S, CO RESP 2/23/10 Subject CO RESP 10/19/09 BAXTER HEALTHCARE, DEERFIELD, IL - EIRS, 483S, CO RESP 4/22/09 BAXTER HEALTHCARE, GUAYAMA, PR - EIRS, 483S, CO RESP 9/30/10 HOSPIRA INC, ROCKY MOUNT, NC - EIRS, 483S, CO RESP 1/19/10 HOSPIRA INC, CLAYTON, NC - EIRS, 483S, CO RESP 4/29/09
Page 372 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-5626 08/03/2011 08/31/2011 2011-5627 08/03/2011 08/31/2011 2011-5628 08/03/2011 08/31/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5629 08/03/2011 08/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5630 08/03/2011 08/31/2011 2011-5631 08/03/2011 08/31/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ 2011-5632 2011-5633 2011-5634 08/03/2011 08/31/2011 08/03/2011 08/31/2011 08/03/2011 08/31/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5635 08/03/2011 08/31/2011 CVM/OCD/ SUE MADRID DRUG PROCESS LICENSING LIST OF VETERINARY MASTER FILE HOLDERS ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ LESLIE PAUL PERRIGO CO SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP SUE MADRID DRUG PROCESS LICENSING ASSOCIATES LLC VINTAGE PHARMS, HUNTSVILLE, AL - EIR, 483 MOST RECENT MEDAVIR MEDICAL ADVANCES, INC - RESP TO WARNING LTR 4/28/11 LIST OF ALL DRUG MASTER FILE HOLDERS CLAIRE PERKINS Texas Department State Health Services RACHEL CORNETT NORTH FLORIDA/SOUTH GEORGIA VETRANS HEALTH SYSTEM PHIL'S CAKE BOX BAKERIES (ALESSI BAKERIES) - EIR, 483 3/24/11 DR THOMAS WIEGMANN, KANSAS CITY VA MEDICAL CTR ENGAGE TRIAL INVESTIGATION RECS BRENDA M GARTZ ELI LILLY & CO WORWAG PHARMA GMBH & CO, BOBLINGEN, GERMANY; SOLUPHARM PHARMAZEUTISCHE, MESLUNGER, GERMANY; RATIOPHRM GMBH, BLAUBEUREN, GERNMANY, ETC - EIRS STEVEN WANGER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL STEVEN WANGER NEUROLOGICAL DEVICES PANEL - DKTS 2009M-0101, 2010N-0585 CONFLICT OF INTEREST RECS Signature/ Requester Subject
DR SARAH LISANBY, DR HAROLD SACKEIM, AMERICAN PSYCHIATRIC ASSN - CLASSIFICATION OF ECT DVCS CITIZENS COMMISSION ON LTRS, EMAILS HUMAN RIGHTS INTERNATIONAL FLORIAN STROHMAIER ACINO PHARMA AG BUTRANS NDA 021-306 - APRVL LTR, LBLG, RVWS, ETC
Page 373 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester ASSOCIATES LLC 2011-5636 08/03/2011 08/31/2011 2011-5637 08/03/2011 08/31/2011 2011-5638 08/03/2011 08/31/2011 2011-5639 08/03/2011 08/31/2011 2011-5640 2011-5641 08/03/2011 08/31/2011 08/03/2011 08/31/2011 2011-5642 2011-5643 2011-5644 08/03/2011 08/31/2011 08/03/2011 08/31/2011 08/03/2011 08/31/2011 2011-5645 08/03/2011 08/31/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5646 08/03/2011 08/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5647 08/03/2011 FDA/OF/CFSAN/OCD/EOS/ KEVIN S. FRIES NYLON-6 CAS NO 25038-54-5; NYLON-11 CAS NO 25035COLLIN E LEE EMORY HEALTHCARE KETOROLAC (TORADOL) - BLACK BOX WARNINGS & DATE CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ ORA/SE-FO/ATL-DO/ACB/ CAYEA, GREG COLLEEN GRACE DONOFRIO BABST CALLAD CLEMENTS ET AL SUE MADRID DRUG PROCESS LICENSING ASSOCIATES LLC CAYEA, GREG CTP/OD/ CTP/OD/ ORA/SE-FO/FLA-DO/FCB/ CAYEA, GREG MARLENA HABASZEWSKA AVALON RISK MANAGEMENT INC ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ CVM/OCD/ SUE MADRID DRUG PROCESS LICENSING ASSOCIATES LLC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC PRODUCTOS NICARAGUENSES CORP - ENTRY T9400479737 NOTICE OF FDA ACTION #1 LA CANDELABRIA MARKET & GROCERY - ENTRY # AWB00086367 NOTICE OF FDA ACTION #1 ENVIROMENTAL IMPACT RPTS FOR ROLLING PAPERS, TOBACCO PRODS CAFETERIA ADELITA - ENTRY # AWB-00075584V NOTICE OF FDA ACTION #1 SUBMISSIONS FOR SUBSTANTIAL EQUIVALENCE REQUIREMENTS FOR TOBACCO PRODUCTS IN 2011 SUBSTANTIAL EQUIVALENCE RPTS FOR TOBACCO PRODUCTS IN 2011 GILES CHEMICAL, WAYNESVILLE, NC - EIRS, 483S, CO RESP ETC 1/09 TO PRESENT LIST OF APPLICANTS FOR APPROVED DRUGS LIST OF ALL APPROVED ANIMAL DRUG SPONSORS ANDREAS IMPORT & EXPORT - ENTRY BYV00042560, ROANOKE TRADE SERVICES INC BYV00043048, BYV00043147 NOTICES OF REFUSAL, NOTICE OF REDELIVERY, CF28 AND/OR CF29 CLAUDIA HORNBACK Subject
Page 374 of 1132

Total Records: 12455 Control # Recd Date / Due Date 08/31/2011 2011-5648 2011-5649 2011-5650 08/03/2011 08/31/2011 08/03/2011 08/31/2011 08/03/2011 08/31/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester COSMETIC INGREDIENT REVIEW KEVIN S. FRIES COSMETIC INGREDIENT REVIEW TATYANA BOGDAN CARDINAL HEALTH KEVIN S. FRIES COSMETIC INGREDIENT REVIEW MEDLOGIC GLOBAL LTD - LIQUIBAND DUAL MODEL LBD001 K102076 SODIUM LAURIMINODLPROPIONATE (CAS NO 26256-79-1); DISODIUM LAURIMINODIPROPIONATE (CAS NO 3655-00-3); LAURIMINODIPROPIONIC ACID (CAS NO 17066-08-9) TOXICOLOGY STUDY, SBA CPM CONTRACT PHARMA, FELDKIRCHEN-WESTERHAM, GERMANY; ALPS PHARMACEUTICAL IND CO LTD, GIFU, JAPAN - QUALITY ASSURANCE PROFILE (QAP) Subject 04-5; NYLON-12 CAS NO 25038-74-8 - TOXICOLOGY STUDY, SBA GLUTARAL (CAS NO 111-30-8) - TOXICOLOGY STUDY, SBA
2011-5651
08/03/2011 08/31/2011
PAM LARSON MEDIGENE, INC
2011-5652
08/03/2011 08/31/2011
MARIA C DREW REMEDY REPACK
LIST OF FDA REGISTERED DRUG REPACKERS IN US
2011-5653
08/03/2011 08/31/2011
ORA/ORM/ ORA/ORM/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
MARGARET R. GROEL LACHMAN CONSULTANT SERVICES INC Doe J
DOSMESTIC & FOREIGN INSPS OF DRUG COMPANIES, BIORESEARCH MONITORING (BIMO), GOOD LABORATORY PRACTICES (GLP) 7/1/11-7/29/11 CMPLNT 121649
2011-5654
08/03/2011 08/31/2011
2011-5655
08/03/2011 08/31/2011
JEROME M PARSONS, MD., P.C.
TORSEMIDE, IRBESARTAN, HYDCORCHLOROTHIAZIDE, ETC - AER
2011-5656
08/03/2011 08/31/2011
ORA/SW-FO/DALDO/COMPLIANCE/
JIM EDWARDS BNET.COM
CETERO RESEARCH - INTERNAL INVESTIGATION FOR DATA INTEGRITY CONCERNS RECEIVED 4/22/09; JULY 27 2009 INTERNAL INVESTIGATION UPDATE FOR DATA INTEGRITY CONCERNS RECEIVED 4/22/09, ETC CMPLNT 121174
2011-5657 2011-5658
08/03/2011 08/31/2011 08/03/2011 08/31/2011
ORA/P-FO/LOS-DO/LACB/ Doe J OM/OMP/DODM/ FOI SERVICES INC
DOCKET 76N-052T
Page 375 of 1132

Total Records: 12455 Control # 2011-5659 Recd Date / Due Date 08/03/2011 08/31/2011 2011-5660 08/04/2011 09/01/2011 2011-5661 08/04/2011 09/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5662 2011-5663 08/04/2011 09/26/2011 08/04/2011 09/01/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ 2011-5664 2011-5665 08/04/2011 09/01/2011 08/04/2011 09/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5666 2011-5667 2011-5668 2011-5669 2011-5670 2011-5671 08/04/2011 09/15/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ DR PHILIP JACOBY MAYZO CORP ROSEMARY HARRY Orthocon MUHAMMED MALIK SYNTHO PHARMACEUTICAL INC FRANK G BOTTONE, JR CONTRACT MEDICAL WRITER JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH CONTRACT COATING INC, HACKENSACK, NJ - EIRS, 483S 2007 TO PRESENT SEATTLE SPERM BANK, LLC - CO RESP TO WARNING LTR 7/15/11 SCHOTT, ELMSFORD, NY - EIRS, 483S, RECALLS ETC 10/09 TO PRESENT ACCU-GLASS LLC, ST LOUIS, MO - EIRS, 483S, RECALLS KRYPTONITE BONE CEMENT - K091382 BOREALIS POLYLEFINE GMBH - FCN 793 EDWARDS, S ALBERT FDA/OMPT/CDRH/OCER/DFOI/ ROBERTO KHATCHADOURIAN SYNTHES SPINE MEDTRONIC SOFAMOR DANEK USA - CD HORIZON SPINAL SYS K091445, K091974 RONDEC DM DROPS - APRVL LTR FDA/OF/CFSAN/OCD/EOS/ BOBBY SCHOCHET OLSSON FRANK & WEEDA WENDY R FLEISHMAN LIEFF, CABRASER, HEIMANN & BERNSTEIN, LLP THERMO PAC LLC, STONE MOUNTAIN - EIRS 5/23/11-6/3/11; SIMPLYTHICK LLC -THICKENING GEL PRODS CORR, RECALL RECS, ETC INFANT FORMULA NOTIFICATIONS (IFN) 1/1/11-7/1/11 ORA/SE-FO/FLA-DO/FCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ MELKUMYAN, ARTEM MARLENA HARBASZEWSKI AVALON RISK MANAGEMENT INC RACHEL NGO CEDARS SINAI MEDICAL CENTER Signature/ Requester Subject DEFIBRILLATOR EXPLANTED FROM ONE PATIENT IMPLANTED TO REQUESTER - CLINIC ACG, MEDTRONIC, & OTHER DOCS AVAILABLE ENTRY #D79-00161416 - CONTINUOUS BOND, NOTICE OF FDA ACTION #1 METHYLENE BLUE - AERS
Page 376 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/01/2011 2011-5672 2011-5673 08/04/2011 10/05/2011 08/04/2011 09/01/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5674 2011-5675 08/04/2011 09/01/2011 08/04/2011 09/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5676 2011-5677 2011-5678 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5679 2011-5680 2011-5681 2011-5682 2011-5683 2011-5684 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SAMJIV KUMAR MYCO MEDICAL SANJIV KUMAR MYCO MEDICAL JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4225 - REQUEST LTR 2011-4217 - REQUEST LTR DR JAPAN FACIL POINT SPINAL NEEDLE - K020934 DISPOSABLE SYRINGE, DISPOSABLE NEEDLE - K945225 2011-4193 - REQUEST LTR 2011-4180 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SUSAN SULLIVAN OMEROS CORP ALLERGAN - PREFRIN-A NDA 07-953 SUMMARY RVS, MEDICAL RVW, INTEGRATED SUMMARY OF SAFETY 2011-4117 - REQUEST LTR 2011-4109 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. SUSAN SULLIVAN OMEROS CORP ACTOS NDA 21-073, ACTOPLUS MET NDA 21-842, DUETACT NDA 21-925, ETC - AERS 2011-4099 - REQUEST LTR Action Office Signature/ Requester JAMES ALEXANDER CORP JONI KOENIG MSPH SETON FAMILY OF HOSPITALS SUSAN SULLIVAN OMEROS CORP ALCON - CYCLOMYDRIL ANDA 84-300 SUMMARY RVW, MEDICAL RVW, INTEGRATED SUMMARY OF SAFETY Subject ETC 10/09 TO PRESENT SETON IRB - EIR 1/12/09
Page 377 of 1132

Total Records: 12455 Control # 2011-5685 2011-5686 2011-5687 2011-5688 Recd Date / Due Date 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5689 2011-5690 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5691 2011-5692 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5693 2011-5694 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5695 2011-5696 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5697 2011-5698 2011-5699 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. FRITZ KOLLE SIRONA DENTAL SYSTEMS GMBH JOAN STITT (UG2CD-16) MERCK & CO., INC. FRITZ KOLLE SIRONA DENTAL SYSTEMS GMBH JOAN STITT 9UG2CD-16) MERCK & CO., INC. FRITZ KOLLE SIRONA DENTAL SYSTEMS GMBH JOAN STITT (UG2CD-16) MERCK & CO., INC. FRITZ KOLLE SIRONA DENTAL SYSTEMS GMBH JOAN STITT (UG2CD-16) MERCK & CO., INC. FRITZ KOLLE SIRONA DENTAL SYSTEMS GMBH JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4617 2011-4608 - REQUEST LTR 2011-4595 - REQUEST LTR K091756 2011-4528 - REQUEST LTR K081005 2011-4443 - REQUEST LTR K072642 2011-4415 - REQUEST LTR K060880 2011-4383 - REQUEST LTR K032158 2011-4377 - REQUEST LTR 2011-4266 - REQUEST LTR Subject 2011-4251 - REQUEST LTR
Page 378 of 1132

Total Records: 12455 Control # 2011-5700 2011-5701 2011-5702 Recd Date / Due Date 08/04/2011 09/01/2011 08/04/2011 09/01/2011 08/04/2011 09/01/2011 2011-5703 2011-5704 08/05/2011 09/02/2011 08/05/2011 09/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5705 08/05/2011 09/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5706 08/05/2011 09/02/2011 2011-5707 08/05/2011 09/02/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OL/ ORA/CE-FO/MIN-DO/MCB/ 2011-5708 08/05/2011 09/02/2011 2011-5709 08/05/2011 09/02/2011 2011-5710 2011-5711 08/05/2011 09/02/2011 08/05/2011 ORA/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ CLEMENS, RANDY STEBEN L MCALEER Formatech Inc. KAREEM KHAIRAT RAWESOME FOODS/RIGHT TO CHOOSE HEALTH FOOD, VENICE, CA; HEALTH FAMILY FARMS, PAULA, CA CMPLNTS, LAB RESULTS, CORR, ETC FORMATECH INC, ANDOVER, MA - FIELD INVESTIGATORS RPT 8/25/10-10/15/10 ENTRY #605-1576021-7 JONATHON A RABIN HALL RENDER KILLIAN ET AL GENESYS HEALTH SYSTEM, GENESYS REGIONAL MEDICAL CENTER, GRAND BLANC,MI - CMPLNTS, INVESTIGATIONS JEREMY HERB MINNEAPOLIS STAR TRIBUNE MINNESOTA CONGRESSIONAL DELEGATION - MEDICAL DVC APRVL PROCESS MINS, MEMOS, LTRS, ETC 1/10 TO PRESENT LOIS ZIEBOL PURSUIT VASCULAR K950118, K021557, K000251, ETC BURKE #BN-4840, SEAN CARLOS GLAXOSMITHKLINE - RELATEN (NABUMETONE), VENTOLIN HFA ALBUTEROL AERS, WARNINGS FDA/OO/OFBA/OAGS/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC TYSON O BELLAMY FEFA LLC SARAH BLISS TUFTS MEDICL CENTER RESEARCH TRIANGLE INSTITUTE - CONTRACT #HHSF223200510008I PURDUE PHARMA LP - OXYCONTIN TABS WARNING LTR 1/03 DKT 1978N-0070 2011-4636 - REQUEST LTR Subject 2011-4622 - REQUEST LTR
Page 379 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/07/2011 Action Office ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ 2011-5712 08/05/2011 10/07/2011 2011-5713 08/05/2011 09/02/2011 2011-5714 2011-5715 2011-5716 2011-5717 2011-5718 08/05/2011 09/02/2011 08/08/2011 09/06/2011 08/08/2011 09/06/2011 08/08/2011 09/06/2011 08/08/2011 09/06/2011 2011-5719 2011-5720 2011-5721 2011-5722 08/08/2011 09/06/2011 08/08/2011 09/06/2011 08/08/2011 09/06/2011 08/08/2011 09/06/2011 2011-5723 2011-5724 2011-5725 08/08/2011 09/06/2011 08/08/2011 09/06/2011 08/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CHARLES CELESTE FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ COATES, DAVID M WALTER PETERS REX MEDICAL ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET - K924607 ORGAN RECOVERY SYSTEMS INC - SPS-1 STATIC PRESERVATION SOL, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L K091656 ORGAN RECOVERY SYSTEMS INC - KIDNEY PREFUSION SOL K013575 ORGAN RECOVERY SYSTEMS INC - MODIFICATION TO KPS-1 KIDNEY PERFUSION SOL K022391 GRALISE TABS NDA 22-544 - LBLG, APRVL, CHEMISTRY FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ COATES, DAVID M MEDRAD - INTEGO PET INFUSION SYS K080297 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ OC/OM/OMP/DDM/ KAREEM KHAIRAT EMCCO FOR OILS AND FOOD INDUSTRIES SAE KAREEM KHAIRAT EMCCO FOR OILS AND FOOD INDUSTRIES SAE CARRIE COREY CORETHERAPEUTICS JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. STEVEN WANGER CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL MERCK & CO INC - GARDASIL (HPV VACCINE ) VAERS 7/131/11 MERCK & CO INC - ROTATEQ, (ROTAVIRIS VACCINE LIVE ORAL PENTAVALENT) VAERS 7/1-31/11 MERCK & CO INC - PROQUAD (VARICEOOA VIRUS VACCINE LIVE ) VAERS 7/1-31/11 ECT RESEARCH - MEMOS & ANALYSIS OF GOVERMENT GRANTS MEDRAD - INTEGO PET INFUSION SYS K100798 DKT 1994P-0443 ENTRY #605-1575670-2 ENTRY #605-1576542-2 Signature/ Requester EMCCO FOR OILS AND FOOD INDUSTRIES SAE Subject
Page 380 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/06/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5726 2011-5727 08/08/2011 09/06/2011 08/08/2011 09/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5728 2011-5729 08/08/2011 09/06/2011 08/08/2011 09/06/2011 2011-5730 08/08/2011 09/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5731 2011-5732 08/08/2011 09/06/2011 08/08/2011 09/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5733 2011-5734 08/08/2011 09/06/2011 08/08/2011 09/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5735 2011-5736 08/08/2011 09/06/2011 08/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) CLOSED FOI REQUESTS 7/1-31/11 FOI DAILY LOG 7/25-29/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. MICHAEL R. COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 6/1/11-8/1/11 FOI DAILY LOG 7/18-22/11 FOI SERVICES INC FOI SERVICES INC PAR PHARMACEUTICAL - PROPAFENONE HCL ANDA 78540 APRVL RECS CLOSED FOI REQUETS 8/1-31/11 CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS SUSAN SULLIVAN OMEROS CORP ALLERGAN - ACULAR NDA 19-700 SBA, MEDICAL RVW, PHARMACOLOGY RVW CLOSED FOI REQUESTS 8/1-5/11 CLOSED FOI REQUESTS 8/1-5/11 FOI SERVICES INC CHARLES CELESTE EAS Consulting Group, LLC DUEXIS TABS NDA 22-519 - LBLG, APRVL, CHEMISTRY RVW, ETC 2010-8254 Signature/ Requester EAS Consulting Group, LLC Subject RVW, ETC
Page 381 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/06/2011 2011-5737 2011-5738 08/08/2011 09/06/2011 08/08/2011 09/06/2011 2011-5739 08/08/2011 09/06/2011 2011-5740 08/08/2011 09/06/2011 2011-5741 08/08/2011 09/06/2011 CTP/OD/ CTP/OD/ ORA/SE-FO/ATL-DO/ACB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-5742 08/08/2011 09/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5743 08/08/2011 09/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5744 08/08/2011 09/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5745 08/08/2011 09/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MARY CLAUSEN MEDLINE INDUSTRIES INC KO61615, K092926, K060888 ETC SUSAN SULLIVAN OMEROS CORP ANGELINI REV EYES NDA 19-849 INTEGRATED SAFETY OF SUMMARY Doe J AMBIEN CR - AERS BLACKBURN, SIMON PHARMALUCENCE - SULFUR COLLOID LABEL EXTENSION PAULINE MARALIT MEDLINE INDUSTRIES INC ENTRY # BDF-0015823-2 - LAB RESULTS FOI SERVICES INC OC/OM/OMP/DDM/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MERCK & CO., INC. JARED MACCLEARY CROWELL & MORING DR G L GAGNEJA BIOTRN DIAGNOSTICS INC AMY LATALLADI - FULTON BUCHANAN INGERSOLL & ROONEY PC NEWPORT NON-MENTHOL CIG 80'S - 1-O-29-750&1-O30-750; NEWPORT NON-MENTHOL BOX 100'S - 1-O-29440 & 1-30-440 - RECALL 7/19/11 STERLING BIOCHEMICALS INC, TROY, MI - AMYLASE, K833864; SICKLE CELL K781250; HDL CHOLESTEROL, K781249 9-06-78 DKT FDA-1975-N-0336 FOI REQUESTS, CVM -7/1-29/11 Subject
Page 382 of 1132

Total Records: 12455 Control # 2011-5746 Recd Date / Due Date 08/08/2011 09/06/2011 Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ 2011-5747 08/08/2011 09/06/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ 2011-5748 2011-5749 08/09/2011 09/07/2011 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5750 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5751 08/09/2011 09/07/2011 2011-5752 08/09/2011 09/07/2011 ORA/ ORA/ ORA/SE-FO/SJN-DO/SJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-5753 2011-5754 08/09/2011 09/07/2011 08/09/2011 09/07/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ KEVIN S FRIES Cosmetic Group USA KEVIN S FRIES Cosmetic Group USA NYLON-6, NYLON-11, NYLON-12, ETC - TOXICOLOGY STUDIES GLUTARAL (GLUTARALDEHYDE) - TOXICOLOGY STUDIES HEMBREE, DIANA PURDUE PHARMA - OXYCONTIN MARKETING, REFORMULATION, APRVL RECS, ETC Doe J INDIVIDUAL RECS ERIC WALTER CAMIL SR CAMIL CONSULTING CORP ACTHAR - SBA Doe J FDA/OMPT/CDRH/OCER/DFOI/ Doe J WATSON PHARMS - RAPAFLO (SILODOSIN) NDA 22-206 PHASE 3 TRIAL RESULTS CORDIS - HEPACOAT STENT RPT CARPENTER, MURRAY . DR PEPPER SNAPPLE GROUP - RECALLS F-1248-2011, F0217-2010 CORR Signature/ Requester STACY K. HAUER JOHNSON BECKER PLLC Subject MEDTRONIC - CONCERTO CRT D; VIRTUOSO ICD APRVL, RVWS, CMPLNTS
Page 383 of 1132

Total Records: 12455 Control # 2011-5755 Recd Date / Due Date 08/09/2011 09/07/2011 2011-5756 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2011-5757 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ 2011-5758 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ 2011-5759 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ 2011-5760 2011-5761 08/09/2011 09/07/2011 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ MAREN KROENKE SPEED TO MARKET INC STEVEN WAGNER CITIZENS COMMISSION ON CARTICEPT MEDICAL INC - NAVIGATOR DELIVERY SYS K101194 THOMAS LAUGHREN, MITCHELL MATHIS, RUSSELL KATZ CONFLICT OF INTEREST RECS DUANE STUMPF SEARCHLIGHT COMPLIANCE ADVISORS GENZYME - HECTOROL INJ FDA ACTION LTRS, WARNING LTRS, NOTICE OF VIOLATION LTRS, ETC DUANE STUMPF SEARCHLIGHT COMPLIANCE ADVISORS GENZYME - HECTOROL CAPS FDA ACTION LTRS, WARNING LTRS, NOTICE OF VIOLATION LTRS, ETC DUANE STUMPF SEARCHLIGHT COMPLIANCE ADVISORS AMGEN CORP - ROCALTROL CAPS, ORAL SOL FDA ACTION LTRS, WARNING LTRS, NOTICE OF VIOLATION LTRS, ETC Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester KEVIN S FRIES Cosmetic Group USA DUANE STUMPF SEARCHLIGHT COMPLIANCE ADVISORS Subject SODIUM LAURIMINODIPROPIONATE, DISODIUM LAURIMINODIPROPIONATE, LAURIMINODIPROPIONIC ACID - TOXICOLOGY STUDIES AMGEN INC - SENSIPAR TABS FDA ACTION LTRS, NOTICE OF VIOLATION LTRS, WARNINNG LTRS, ETC
Page 384 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5762 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5763 08/09/2011 09/07/2011 2011-5764 2011-5765 08/09/2011 09/07/2011 08/09/2011 09/07/2011 ORA/ORM/ ORA/ORM/ ORA/ ORA/ 2011-5766 08/09/2011 09/07/2011 2011-5767 08/09/2011 09/07/2011 ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5768 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5769 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5770 08/09/2011 ORA/CE-FO/MIN-DO/MCB/ ED PATT CETERO RESEARCH, FARGO, ND - 483 3/09 JOHN WALSH JAMES ALEXANDER CORP CHANZHOU WUJIN FEIDA CHEMICAL CO, CHANGZHOU, CHINA - EIRS, 483S, RECALLS 7/07 TO PRESENT TOPA, YOLANDA ZYPREXA, PROZAC, FLUOXETINE - AERS RAUL MAGANA AGROMOD PRODUCE INC AGROMOD PRODUCE INC, MCALLEN, TX - SPLS INV 682159, INV 682160 ANALYTICAL RESULTS SUNNIE GUO PERGASUS SHIPPING INC FROZEN COOKED SHRIMP ENTRY 906-1087545-3 - LAB ANALYSIS RPT OC/COS/OES/ OC/COS/OES/ FDA/OF/CFSAN/OCD/EOS/ ERIK HOUSER DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE BARBARA BLAKISTONE PHD National Fisheries Institute AFSAN KHAN BIOPHARM INSIGHT SOUTHERN SHRIMP ALLIANCE - INCREASE IN SHRIMP SHIPMENTS FROM AN INDIAN EXPORTER LTR 6/15/11 BIOTECH, GENERICS, PHARMACEUTICAL COMPANIES, ETC - CLNCL INVESTIGATION, MFG FACILITIES INSPS LAST 12 MONTHS SCOTT STANZEL - LTRS, MEMOS, RPTS, ETC Doe J P&G - ASACOL LTR 1/10 Signature/ Requester HUMAN RIGHTS INTERNATIONAL Subject
Page 385 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/07/2011 2011-5771 08/09/2011 09/07/2011 2011-5772 08/09/2011 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5773 08/09/2011 09/07/2011 2011-5774 08/09/2011 09/07/2011 2011-5775 2011-5776 2011-5777 2011-5778 2011-5779 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5780 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5781 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ SUSAN D FOSTER LLOYD INC VINTAGE PHARMS - PREDNISONE TAB 5 MG, ANADA 040256BA OR BE TESTING APRVL OR WAIVER GRANTED SUSAN D FOSTER LLOYD INC WEST WAARD - PREDNISONE TAB, ANADA 080292, BA OR BE TESTING APRVL OR WAIVER GRANTED WENDY LEES NORTWEST COSMETIC LABS LLC WENDY LEES NORTWEST COSMETIC LABS LLC BRODY MULLINS WALL STREET JOURNAL BRODY MULLINS WALL STREET JOURNAL BRODY MULLINS WALL STREET JOURNAL BRODY MULLINS WALL STREET JOURNAL SUSAN D FOSTER LLOYD INC 2010-1394 - DEUTSCHE BANK SECURITIES RE STRYKER ORTHOPEDICS MUTUAL PHARM - PREDNISONE TAB 5 MG, ANADA 089245, BA OR BE TESTING APRVAL OR WAIVER GRANTED 2010-1186 2009-1423 - JANUS CAPITAL RE LUPIN INTL 2009-1420 - JANUS CAPITAL RE SUNS PHARMS INTL CMPLNT 117639 CMPLNT 59846 FERGUSON, SHANNON M FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester GREER LABORATORIES INC ROBERT Z PHILLIPS TELEFLEX ARROW INTERNATIONAL INC - NEXTSTEP ANTEGRADE CHRONIC HEMOSIALYSIS CATHETER CLASS 1 RECALL HEALTH HAZARD EVALUATION (HHE) ELIDEL - AERS Subject
Page 386 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5782 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5783 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5784 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5785 08/10/2011 09/08/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5786 2011-5787 2011-5788 2011-5789 2011-5790 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-5048 - REQUEST LTR 2011-5044 - REQUEST LTR 2011-5000 - REQUEST LTR 2011-4999 - REQUEST LTR 2011-4956 - REQUEST LTR SUSAN D FOSTER LLOYD INC JUBILANT CADISTA - PREDNISONE TAB 5 MG, ANADA 080352, BA OR BE TESTING APRVL OR WAIVER GRANTED SUSAN D FOSTER LLOYD INC WATSON LABS - PREDNISONE TAB 5 MG, ANADA 080356, BA OR BE TESTING APRVL OR WAIVER GRANTED SUSAN D FOSTER LLOYD INC CONTRACT PHARMACAL - PREDNISONE TAB 5 MG, ANADA 080209, BA OR BE TESTING APRVAL OR WAIVER GRANTED SUSAN D FOSTER LLOYD INC JUBILANT CADISTA - PREDNISONE TAB 5 MG, ANADA 080362, BA OR BE TESTING APRVL OR WAIVER GRANTED Signature/ Requester Subject
Page 387 of 1132

Total Records: 12455 Control # 2011-5791 2011-5792 2011-5793 2011-5794 2011-5795 2011-5796 2011-5797 2011-5798 2011-5799 2011-5800 2011-5801 2011-5802 2011-5803 2011-5804 2011-5805 Recd Date / Due Date 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5806 08/10/2011 FDA/OMPT/CDER/ORP/DIDP/ NANCY ZHANG, Ph.D. COPAXONE - MEDICAL RVW, STATISTICAL RVW Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT 9UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. NANCY ZHANG, Ph.D. QUANTITATIVE SOLUTIONS INC AVONEX BLA 103628 - MEDICAL, STATISTICAL RVWS 2011-4279 2011-4271 2011-4270 2011-4139 2011-2171 2011-2009 2011-716 2011-302 2010-3598 2011-5180 - REQUEST LTR 2011-5099 - REQUEST LTR 2011-5097 - REQUEST LTR 2011-5054 - REQUEST LTR Subject 2011-5049 - REQUEST LTR
Page 388 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/08/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5807 2011-5808 2011-5809 2011-5810 2011-5811 2011-5812 2011-5813 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5814 2011-5815 2011-5816 2011-5817 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 08/10/2011 09/08/2011 2011-5818 2011-5819 2011-5820 08/10/2011 09/08/2011 08/10/2011 10/05/2011 08/11/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/FDAHO/ OC/OER/OSHI/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ ROBINSON 454518, CHARLES . JONATHAN A. PARRISH WAYNE GRANT PC JAMES H. LIDE HISTORY ASSOCIATES INC AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC SOLOMON S. NEUHARDT NEUHARDT LAW FIRM PC ANTHONY W. HAFNER PITZER SNODGRASS PC JULIA M GICZEWSKI UNITED BLOOD SYSTEMS INC, BILLINGS, MT - LAST 5 INSPS K-V PHARMACEUTICAL CO - RECS, MEMOS, EMAILS, ETC 6/1/09 PREMIER RESEARCH INTERNATIONAL LLC, PHILADELPHIA, PA; PREMIER RESEARCH BOSTON LLC, QUINCY, MA; MEDTRONIC - ARTCTIC FRONT CARDIAC CRYO ABLATION CATHETER SYS INVESTIGATION THALIDOMIDE INVESTIGATIONS - AF 1-542, AF 12-575, NDA 12-611 DKT 1978N-0070 THERAPEUTIC DIETS, DIETARY SERVICES MANUAL DUBECK B00004, ROBERT ORA/SW-FO/KAN-DO/COMP/ Doe J SLEEP DRIVING CONDITION FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ TYSON Q. BELLAMY FEFA LLC TYSON Q. BELLAMY FEFA LLC EUGENE L. MATAN MATAN WRIGHT AND NOBLE MARILYNN WHITNEY COVINGTON & BURLING LLP KEVIN S. FRIES COSMETIC INGREDIENT REVIEW BIS-DIGLYCERYL PLOYACYLAPIPATE 1; BIS-DISLYCERYL POLYACYLADIPATE 2 - TOXICOLOGY STUDIES CMPLNT 115161 BOSTON SCIENTIFIC CORP - ACCUSTICK II INTRODUCER SYS WITH RADIOPAQUE MARKER CMPLNTS, RECALLS GRN 385 CONTRACT HHSF22301000090C CONTRACT HHSF2232008500241 Signature/ Requester QUANTITATIVE SOLUTIONS INC Subject
Page 389 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/09/2011 Action Office ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5821 08/11/2011 09/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ 2011-5822 08/11/2011 09/09/2011 2011-5823 2011-5824 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5825 08/11/2011 09/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5826 2011-5827 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5828 2011-5829 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5830 2011-5831 08/11/2011 09/09/2011 08/11/2011 ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ GRIECO, CAROLE APRIL HOLLIS ORA/CE-FO/CIN-DO/CCB/ CVM/OCD/ ORA/SW-FO/DEN-DO/COMP/ ORA/SE-FO/FLA-DO/FCB/ WILLIAM A DEAN FORD & DEAN PA GIOVANNI PARINELLO PHD MACLEOD PHARMACEUTICALS INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. APRIL HOLLIS FDA NEWS AVON PRODUCTS, SPRINGDALE, OH; NATURAL ESSENTIALS, STREETSBORO, OH; BEN VENUE LABS, BEDFORD, OH, ETC - 483S 5/1/11-6/30/11 OCULUS - PURACYN SKIN AND WOUND CLEANSER WITH PRESERVATIVES K090206 SAGE PHARMS, SHREVEPORT, LA; KEYSTON LABS, MACLEOD PAHRMACEUTICALS INC, FORT COLLINS, CO EIR 3/15-18/11 LANXESS CORP - CALCIUM FORMATE FAP 2261 INDIVIDUAL RECS ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OC/OSHC/OPD/ ORA/CE-FO/DET-DO/DCB/ FOI SERVICES INC MARISOL CARPENTER AMERICAN RED CROSS GREAT LAKES REGION TRUEMAN TUCK TUCK'S PROFESSIONAL SERVICES NATIONAL ASSN FOR RARE DISORDERS - COMM 6/3/11 TO PRESENT AMERICAN RED CROSS GREAT LAKES REGION, LANSING, MI - EIR 3/3-21/08 BIE HEALTH PRODUCTS, BURLINGTON, ONTARIO, CANADA - CORR, MINS, INVESTIGATION RECS, ETC 1997 TO PRESENT GABRIEL E ESTADELLA GABRIEL E ESTADELLA PLLC LUKAS FOODS INC, BIDDEFORD, ME - ERIS, 483S, WARNING LTRS, ETC LAST 10 YRS DAVID P MCCORMACK SUGARMAN AND SUGARMAN PC SCHERING CORP/SCHERIG-PLOUGH CO - INTRON A RECALL #D-343-2010 RPTS, INVESTIGATIONS, TEST RESULTS, ETC Signature/ Requester MCGUIRE WOODS LLP Subject PREMIER RESEARCH ATLANTA INC, MARIETTA, GA, ETC EIRS, 483S, WARNING LTRS, ETC 2009-2011
Page 390 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/09/2011 2011-5832 08/11/2011 09/09/2011 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ Signature/ Requester FDA NEWS APRIL HOLLIS FDA NEWS Subject MEMPHIS, TN; TECHNOLOGY DELIVERY SYSTEMS, NEW ORLEANS, AL, ETC - 483S 5/1/11-6/30/11 FUTURE PAK, WIXOM, MI; SCHWARZ PHARMA MANUFACTURING, SEYMOUR, IN, SIGMA-TAU PHARMASOURCE, INDIANPOLIS, IN, ETC - 483S 5/1/116/30/11 DEPAKOTE - LBLG 1999. 2000 GALEAS, PEDRO F
2011-5833
08/11/2011 09/09/2011
2011-5834 2011-5835
08/11/2011 09/09/2011 08/11/2011 09/09/2011
FDA/OMPT/CDRH/OCER/DFOI/ BENENFELD, DANNY FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC
MERIDIAN CO LTD - LAPEX BCS K081962 ANDA 91-108 - PARAGRAPH IV CERTIFICATION
2011-5836
08/11/2011 09/09/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC
PHARMACIA AND UPJOHN - XALATAN (LATANOPROST) NDA 20-597 APRVL RECS
2011-5837
08/11/2011 09/09/2011
ORA/SE-FO/SJN-DO/SJCB/
APRIL HOLLIS FDA NEWS
JANSSEN ORTHO, GURABO, PR; PATHEON PUERTO RICO, MANATI, PR; MEDTRONIC PUERTO RICO OPERATIONS, JUNCOS, PR; ETC - 483S 5/1/11-6/30/11 YICHANG CHANGJIANG PHARMS, YIDU CITY, CHINA; ZHEJANG CHEMPACIFIC, JIAXINGSHI, CHINA; SAVIOR LIFETEC, MIAO LI, TAIWAN, ETC - 483S 5/1/11-6/30/11
2011-5838
08/11/2011 09/09/2011
2011-5839
08/11/2011 09/09/2011
ORA/CE-FO/BLT-DO/CB/
APRILL HOLLIS FDA NEWS
SANOFI PASTEUR BIOLOGICS, ROCKVILLE, MD; MERCK SHARP & DOHME CORP, ELKTON, VA; PHARMACEUTICALS INTERNATIONAL, HUNT VALLEY, MD, ETC - 5/1/11-6/30/11 NATIONAL CANCER INSTITUTE (NCI) - RANDOMIZED TRIAL OF PATIENT-SPECIFIC VACCINATION WITH CONJUGATED FOLLICULAR LYMPOHOMA-DERIVED IDIOTYPE COMM 1/1/00 TO 6/1/09
2011-5840
08/11/2011 09/28/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/
DAVID MOSER BIOVEST INTERNATIONAL
2011-5841
08/11/2011
APRIL HOLLIS
MEGO AFEK AC, AFEQ, ISRAEL; IN'TECH MEDICAL, RANG
Page 391 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/09/2011 2011-5842 08/11/2011 09/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-5843 08/11/2011 09/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-5844 08/11/2011 09/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-5845 2011-5846 2011-5847 08/11/2011 09/09/2011 08/11/2011 09/09/2011 08/11/2011 09/09/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5848 08/11/2011 09/09/2011 OC/OIASI/OIP/IAS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-5849 08/11/2011 09/09/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KEN REID WASHINGTON INFORMATION SOURCE FOI DAILY LOG 7/11-15/11 APRIL HOLLIS FDA NEWS GLAXOSMITHKLINE BIOLOGICALS, DRESDEN, GERMANY; CAF-DAF SCRL, NEDER-OVER-HEEMBEEK, BELGIUM; CATALENT PHARMA SOLUTIONS, BRUXELLES, BELGIUM, ETC - 483S 5/1/11-6/30/11 BARBARA JONES DOMINION GROUP INC CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 7/11-15/11 FOI DAILY LOG 7/11-15/11 FOI DAILY LOG 7/11-15/11 MARIA E TOUCHET GADDY JARAMILLO LAW FIRM CENTER FOR INTERNATIONAL BONE AND MARROW TRANSPLANT RESEARCH - FILGRASTIM-MOBILIZATION STEM CELLS FOR TRANSLANTATION USING UNRELATED DONORS MARIA E TOUCHET GADDY JARAMILLO LAW FIRM NATIONAL MARROW DONOR PROGRAM RESEARCH COLLECTION OF PERIPHERAL BLOOD STEM CELLS FOLLOWING STIMULATION WITH FILGRASTIM AERS Action Office Signature/ Requester FDA NEWS DAVID MOSER BIOVEST INTERNATIONAL Subject DU FLIERES, FRANCE; VARAIN MEDICAL SYSTEMS, HELSINKI, FINLAND, ETC - 5/1/11-6/30/11 BIOVEST - RANDOMIZED TRIAL OF PATIENT-SPECIFIC VACCINATION WITH CONJUGATED FOLLICULAR LYMPHOMA-DERIVED IDIOTYPE COMM 1/1/00 TO 6/1/09
Page 392 of 1132

Total Records: 12455 Control # 2011-5850 Recd Date / Due Date 08/11/2011 09/09/2011 2011-5851 2011-5852 2011-5853 2011-5854 08/11/2011 09/09/2011 08/11/2011 09/09/2011 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5855 08/11/2011 09/09/2011 2011-5856 2011-5857 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5858 08/11/2011 09/09/2011 2011-5859 08/11/2011 09/09/2011 2011-5860 08/11/2011 09/09/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/OE/ ORA/OE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ FOI SERVICES INC APRILL HOLLIS FDA NEWS APRILL HOLLIS FDA NEWS LEE ROSEBUSH MORGAN LEWIS & BOCKIUS LLP APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS AAA PHARMS, PAULSBORO, NJ; TRIS PHARMA, MONMOUTH JUNCTION, NJ; NATUREX, S HACKENSACK, NJ, ETC - 483S 5/1/11-6/30/11 KENDALL, ORISKANY FALLS, NY; ABBE LABS, FARMINGDALE, NY; A&Z PHARM, DEER PARK, NY, ETC 483S 5/1/11-6/30/11 CEDARBURG PHARMS, GRAFTON, WI; WISCONSIN PHAMACAL, JACKSON, WI; NEMSCHOFF CHAIRS, SHEBOYGAN, WI, ETC - 483S 5/1/11-6/30/11 MUTUAL PHARMACEUTICAL CO, PHILADELPHIA, PA; GLOBAL PHARMACEUTICAL SUPPLY GROUP, MALVERN, PA; SIGMAPHARM LABS, BENSALEM, PA, ETC - 483S 5/1/116/30/11 MEDIMMUNE VACCINES, SANTA CLARA, CA; NOVARTIS PHARMACEUTICALS, VACAVILLE, CA; NUSI TECHNOLOGY, BAKERSFIELD, CA, ETC - 483S 5/1/11-6/30/11 ORGANON TEKNIKA, DURHAM, NC; UNIQUE LABS, CHATSWORTH, GA; HOSPIRA, ROCKY MOUNT, NC, ETC 483S 5/1/11-6/30/11 NEOS THERAPEUTICS, GRAND PRAIRIE, TX; CAREFUSION 213, EL PASO, TX; ALOE LABS, HARLINGEN, TX, ETC - 483S 5/1/11-6/30/11 SEATTLE GENETICS, BOTHELL, WA; MICROSURGICAL TECHNOLOGY, REDMOND, WA; PRO TRAINERS CHOICE, KINGSTON, WA, ETC - 5/1/11-6/30/11 LINUS GMBH, MECKENHEIM, GERMANY; SAVIOR LIFETECH CORP, TAINAN, TAIWAN; AUROBINDO PHARMA, MEDAK, INDIA, ETC - 483S 5/1/11-6/30/11 ELI LILLY - EVISTA ORPHAN DRUG DESIGNATION KENDLE INTERNATIONAL INC FOI DAILY LOG 7/11-15/11 Action Office ORA/CE-FO/CHI-DO/CCB/ Signature/ Requester APRIL HOLLIS FDA NEWS WILLIAM A OLSON PHD Center for Regulatory Services, Inc. FOI DAILY LOG 7/11-15/11 Subject ALVA-AMCO PHARMACAL, NILES, IL; BLISTEX, OAK BROOK, IL; MERICON INDUSTRIES, PEORIA, IL, ETC 483S 5/1/116/30/11 FOI DAILY LOG 7/11-15/11
2011-5861
08/11/2011 09/09/2011
2011-5862
08/11/2011 09/09/2011
2011-5863
08/11/2011 09/09/2011
Page 393 of 1132

Total Records: 12455 Control # 2011-5864 Recd Date / Due Date 08/11/2011 09/09/2011 2011-5865 08/11/2011 09/09/2011 2011-5866 08/11/2011 09/09/2011 2011-5867 08/11/2011 09/09/2011 ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/FLA-DO/FCB/ Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester APRILL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS APRIL HOLLIS FDA NEWS Subject ORTHO DEVELOPMENT CORP, DRAPER, UT; SANDOZ INC, BROOMFIELD, CO; SOMBRA COSMETICS, ALBUQUERQUE, NM, ETC - 483S 5/1/11-6/30/11 SCC SOFT COMPUTER, CLEARWATER, FL; SPF CONSULTING LABS, POMPANO BEACH, FL; TERMAC PRODUCTS, HIALEAH, FL, ETC - 483S 5/1/11-6/30/11 CARDINAL HEALTH 414, SAINT LOUIS, MO; MALLINCKRODT, MARYLAND HEIGHTS, MO; Q A LABS, KANSAS CITY, KS, ETC - 483S 5/1/11-6/30/11 AMPHASTAR PHARMS, RANCHO CUCAMONGA, CA; CARDINAL HEALTH 414, VAN NUYS, CA; PRESTIGE COSMETICS, HUNTINGTON BEACH, CA, ETC - 483S 5/1/16/30/11 LONZA BIOLOGICS, HOPKINTON, MA; SHIRE HUMAN GENTIC THERAPIES, CAMBRIDGE, MA; JOHNSON MATTHEY PHARMACEUTICAL MATERIALS, NORTH ANDOVER, MA, ETC - 483S 5/1/11-6/30/11 FOI DAILY LOG 7/11-15/11 AMERICAN RED CROSS, WINCHESTER, VA - EIR 8/11/09 & 4/5/11 PHARMACEUTICAL, BIOLOGICS , MEDICAL DVC MFG, ETC IN AND OUTSIDE THE US - 483S 7/1-31/11 T & S SALES COMPANY LLC - SEIZURE OF CANNED COCONUT MILK DELETED RECS ENTRY NO 002-8135746-7 HYALURONIDASE - AERS
2011-5868
08/11/2011 09/09/2011
2011-5869 2011-5870
08/11/2011 09/09/2011 08/11/2011 09/09/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/
FRAN KOCH INFORMATION ACCESS AMY KLAUM AMERICAN RED CROSS BLOOD SERVICES
2011-5871 2011-5872
08/11/2011 09/09/2011 08/11/2011 09/09/2011
ORA/ORM/ ORA/ORM/ ORA/SE-FO/FLA-DO/FCB/
AMY HOLLIS FDA NEWS PETER S KERRICK PA ATTY AT LAW
2011-5873 2011-5874
08/11/2011 09/09/2011 08/11/2011 09/09/2011
ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
PAIGE SAVITZ BEAVER STEET FISHERIES INC C. GLORIA WANG SCIENTIFICTHERAPEUTICS INFORMATION INC
2011-5875
08/11/2011 09/09/2011
OM/OMP/DODM/
WENDY WAGNER UNIVERSITY OF TEXAS SCHOOL OF LAW
DKTS 1993N-0195, 1994P-0036
2011-5876
08/11/2011 09/09/2011
CYNTHIA S. NG GOODWIN PROCTOR
DRUG & BIOLOGICAL ESTABLISHMENTS - FEE WAIVERS OR REDUCTIONS FY2010
Page 394 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5877 2011-5878 08/11/2011 09/09/2011 08/11/2011 09/09/2011 2011-5879 2011-5880 08/12/2011 09/12/2011 08/12/2011 09/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5881 2011-5882 2011-5883 2011-5884 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5885 2011-5886 2011-5887 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5888 08/12/2011 09/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4277 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. AMY POULSON LEXIS NEXIS SAFYRAL NDA 22-574 - CLNCL RVW 2011-4274 2011-4273 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ANDI POULSON LEXIS NEXIS YASMIN NDA 21-098 - MEDICAL RVW 2011-4171 2011-1286 2011-717 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ RUSSELL C-90473 D7 2, MICHAEL DAVID SHARLENE EDMONDS PPD JOAN STITT (UG2CD-16) MERCK & CO., INC. PPD (BIOANALYTICAL LAB), RICHMOND, VA - EIRS, 483S, CORR, ETC 5/15-17/06, 9/27-29/10, 12/6-9/10 2010-3601 FDA/OMPT/CDRH/OCER/DFOI/ PROFESSOR RALPH F. HALL University of Minnesota Law School INDIVIDUAL RECS RECALL RECS FOR CLASS I, II, III DVCS Signature/ Requester Subject
Page 395 of 1132

Total Records: 12455 Control # 2011-5889 2011-5890 2011-5891 Recd Date / Due Date 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5892 2011-5893 2011-5894 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5895 08/12/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5896 2011-5897 2011-5898 2011-5899 2011-5900 2011-5901 2011-5902 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MARY MEJAES BAM CORPORATION LTD MARY MEJAES BAM CORPORATION LTD MARY MEJAES BAM CORPORATION LTD NEE YIN CHOU, Ph.D. CW OPTICS INC MARY MEJAES BAM CORPORATION LTD NEE-YIN CHOU, Ph.D. CW OPTICS INC NEE-YIN CHOU, Ph.D. MEDLINE - STERILE DISPOSABLE SURGICAL GOWNS/DRAPES K032666 KIMBERLY-CLARK - SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM K102666 MEDLINE - DISPOSABLE SURGICAL DRAPES & GOWNS K964142 MOORFLPI FULL FILED LASER PERFUSION IMAGER K063586 KIMBERLYL-CLARK - SURGICAL DRAPES MODEL KC100 (SURGICAL EQUIPMENT COVERS MODEL KC100) K083234 MOORVMS-LDF1 & MOORVMS-LDF2 LASER DOPPLER PERFUSION AND TEMPERATURE MONITORS K083082 MOORLDLS LASER DOPPLER LINE SCANNER K063561 ANDI POULSON LEXIS NEXIS BEYAZ NDA 22-532 - MEDICAL RVW, CLNCL RWV JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ANDI POULSON LEXIS NEXIS YAZ NDA 21-873 - MEDICAL RVW 2011-5186 2011-4914 Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ANDI POULSON LEXIS NEXIS YAZ NDA 21-676 - MEDICAL RVW, CLNCL RVW 2011-4823 Subject 2011-4291
Page 396 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/12/2011 2011-5903 2011-5904 2011-5905 08/12/2011 09/12/2011 08/12/2011 09/12/2011 08/12/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5906 08/12/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5907 2011-5908 08/12/2011 09/12/2011 08/12/2011 09/12/2011 2011-5909 2011-5910 08/12/2011 09/19/2011 08/12/2011 09/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OC/OM/OMP/DDM/ ORA/SE-FO/ATL-DO/ACB/ PARIS, THANO M AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC ROBERT H MILLER MRRRAY MURPHY MOUL ET AL NED FEDER, M.D. PROJECT ON GOVERNMENT OVERSIGHT FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ASHLEY A PIGGOTT MORRIS POLICH & PURDY LLP NED FEDER, M.D. PROJECT ON GOVERNMENT OVERSIGHT FDA/OMPT/CDRH/OCER/DFOI/ NED FEDER, M.D. PROJECT ON GOVERNMENT OVERSIGHT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ ANDI POULSON LEXIS NEXIS YAZ NDA 21-873 - CLNCL RVWS 9/28/06, 1/20/06, 1/19/06, ETC ICAD INC - P010038/S012 LTR 9/7/07 STRYKER INSTRUMENTS - EIR 5/4-14/09; ACE MEDICAL US LLC - AUTOFLUSER EIRS, CORR KELLY ANDERSON & ASSOCIATES INC - CDRH ENVIRONMENTAL SCAN, RECOMMENDATIONS DEVELOPMENT, AND ALLEGATIONS MANAGEMENT FUNCTION ESTABLISHMENT NUVASIVE INC, SAN DIEGO, CA - NUVASIVE XLP LATERAL PLATE EIRS, 483S, MDRS ETC ICAD - SECOND LOOK P010038/S012 MEMO 4/13/08 GRADY HOSPITAL, ATLANTA, GA - DEPO-PROVERA STUDY, AUDIT RESULTS 1978 DKT 1978N-0070 MCCANN, JOE ACTHAR GEL (ADRENOCORTICOTROPIC HORMONE) AERS MCCANN, JOE ORA/NE-FO/NYK-DO/NYDCB/ YOUUNGSTROM, RICHARD VICTOZA (LIRAGLUTIDE RDNA INJ) - AERS FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester CW OPTICS INC NEE-YIN CHOU, Ph.D. CW OPTICS INC MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR NYCOMED US INC, MELVILLE, NY - 483 11/10 TO 12/10 Subject
2011-5911 2011-5912
08/12/2011 09/12/2011 08/12/2011 09/12/2011
2011-5913
08/12/2011 09/12/2011
2011-5914
08/12/2011 09/12/2011
Page 397 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5915 08/12/2011 09/12/2011 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5916 08/12/2011 09/12/2011 2011-5917 08/12/2011 09/12/2011 2011-5918 2011-5919 08/12/2011 09/12/2011 08/12/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5920 08/12/2011 09/12/2011 ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ANITA RASMUSSEN MCCORMICK & COMPANY INC SAFFRON ENRTY #UPS-2765756-4 - ANALYTICAL RESULTS FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ WORLEY, TERRY W WILLIAM G GAINER TOLIVER & GAINER MCNEIL-PPC INC - TYLENOL LABEL CHANGES, APRVL LTRS,CORR ETC VISTAKON, JACKSONVILLE, FL - EIR, 483 5/11, 6/11 FDA/OF/CFSAN/OCD/EOS/ KEVIN S FRIES Cosmetic Ingredent Review KATHY PERLMAN Philips Healthcare BIS-DIGLYCERYL POLYACYLADIPATE-1; BIS-DIGLYCERYL POLYACYLADIPATE-2 (82249-33-0) - TOXICOLOGY STUDIES, SBA, AERS ETC ZOLL - AEDPRO W/SEE THRU CPR K071025; E SERIES W/SEE THRU CPR K070455 MOLLY SHEARER UNITEHERE! LSG SKY CHEFS, PHOENIX, AZ; CHICAGO, IL 1/1/08; BOSTON, MA 3/1/11 - EIRS Signature/ Requester Subject
Page 398 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/CIN-DO/CCB/ 2011-5921 08/12/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5922 2011-5923 2011-5924 2011-5925 08/15/2011 09/13/2011 08/15/2011 09/13/2011 08/15/2011 09/13/2011 08/15/2011 09/19/2011 2011-5926 2011-5927 08/15/2011 09/13/2011 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5928 2011-5929 08/15/2011 09/13/2011 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5930 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5931 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J RADIATION THERAPY - INDIVIDUAL RECS AFSAN KHAN BIOPHARM INSIGHT STUDY TITLE & IDENTIFIER OF MAJOR DEPRESIVE DISORDER (MDD) SUBMISSIONS TO FDA LAST 5 YRS, NUMBER OF APRVLS & REJECTIONS, ETC JI, FAN FDA/OMPT/CDRH/OCER/DFOI/ GENA DUNIVAN UNIV OF NEW MEXICO LIST OF GYNECOLOGIC RECALLED MEDICAL DVCS 1/90 TO PRESENT ORANGE BOOK - DRUG PATENTS EXPIRED DURING 1980 TO 2010 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANN M DAUL LEIB & KATT LLC ANN M DAUL LEIB & KATT LLC ANN M DAUL LEIB & KATT LLC STANLEY R GOODMAN GOODMAN & SAPERSTEIN KENNON DANIELS BERAUFORT LLC ANDI POULSON LEXIS NEXIS YAZ NDA 22-045 - CLNCL RVWS, SUMMARY MEMO (CERTIFIED) JOHNSON & JOHNSON, LIFE SCAN INC - SURESTEP 50S & 100S ON TOUCH ULTRA 50S & 100S BLOOD GLUCOSE TEST STRIPS MDRS 1/1/04 TO 4/30/08 EPT CERTAINTY 1-STEP TEST - K083716 RPT NO - MW5017897 RPT NO - 1223688-2007-00009 RPT NO - 1223688-2007-00011 UMBERGER, CHRIS BUPROPION, NALTREXONE, SERTRALINE - AERS, CMPLNT FORMS Signature/ Requester Subject
Page 399 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-5932 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5933 2011-5934 08/15/2011 09/13/2011 08/15/2011 09/13/2011 2011-5935 2011-5936 2011-5937 08/15/2011 09/13/2011 08/15/2011 09/13/2011 08/15/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5938 2011-5939 08/15/2011 09/13/2011 08/15/2011 09/13/2011 2011-5940 2011-5941 2011-5942 08/15/2011 09/13/2011 08/15/2011 09/13/2011 08/15/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ BUDNER, MICHAEL FDA/OMPT/CDRH/OCER/DFOI/ OTOHARMONICS SRL 1997-27579, 1997-26629, 1997-2688, ETC FDA/OMPT/CDRH/OCER/DFOI/ OTOHARMONICS SRL MIM SOFTWARE - K103785 CVM/OCD/ COFFEY, DEBBIE FDA/OF/CFSAN/OCD/EOS/ RICHARD YU RICHYU CHEMICAL CO LTD TRIDECANOL PHOSPHITE CONDENSATION WITH BUTYLIDENEBIS - FCN 13003-12-8 GONACON, SPRAYVAC, FIELD SPAYING IN CONNECTION WITH STRAY, FERAL & WILD HORSES - LTRS OF INVESTIGATION EXEMPTIONS 1/00 TO PRESENT NEUROMONICS PTY LTD - K043274 ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NWE-DO/NWECB/ TONJA NICHOLS GRESHAM PC ATTY AT LAW ANGELA ALEXANDER AMERICAN RED CROSS BLOOD SERVICES JOAN STITT (UG2CD-16) MERCK & CO., INC. FRAN KOCH INFORMATION ACCESS CAESAR CURRIN WINSTON & STRAWN STATISTICAL PROCEDURES FOR BIOEQV STUDIES USING A STANDARD TWO-TREATMENT CROSSOVER DESIGN 7/92 2011-2188 NEW ENGLAND CRYOGENIC CENTER INC - REGISTRATION #3002733251, 305374514 RECS AMERICAN RED CROSS-SOUTHEASTERN MICHIGAN EIRS 2008 2011-4893 FLORENCE GRAVES BRANDEIS UNIV CSPC OUYI PHARMACETICALCO LTD, CHINA; JIANGSU HENGRUI MEDICINE CO LTD, CHINA; SUZHOU NO 4 PHARMACEUTICAL FACTORY, CHINA, ETC - EIRS 10/1/08 TO PRESENT Signature/ Requester Subject
Page 400 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5943 08/15/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5944 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-5945 08/15/2011 09/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5946 2011-5947 08/15/2011 09/13/2011 08/15/2011 09/15/2011 2011-5948 08/15/2011 09/13/2011 2011-5949 08/15/2011 09/13/2011 FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5950 2011-5951 08/15/2011 09/13/2011 08/15/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ WILLIAM A OLSON Center for Regulatory Services, Inc. RAYMOND M PANAS PHD VITAMIN DERIVATIVES INC - 1-ALPHAHYDROXYCHOLECALCIFEROL AGRN 9 BRAINTREE LABORATORIES INC - MIRALLAX MICHAEL BUDNER SALTZ MONGELUZZI ET AL DAVID L ROSEN FOLEY & LARDNER LLP AIRSEP CORP - LIFESTYLE OXYGEN CONCENTRATOR, NEW LIFE ELITE, REMBRANDT SYS, ETC CLAIMS, CMPLNTS, MDRS, ETC IND 63,997 - CORR, IND APPL, AMENDMENTS , ETC FDA/OF/CFSAN/OCD/EOS/ ERIC F GREENBERG ERIC F GREENBERG PC JEFF STACHEWICZ FOIA GROUP INC JSR CORP, ASAHI KASEI CORP, GOI CHEMICAL COMPANY LTD - ALPHA-METHYLSTYRENE DIMER FCN 324 CONTRACT #HHSF223200710013C CATHERINE W ANGLIN PAINE TARWATER & BICKERS LLP ANNUAL ADVERSE DRUG EXPERIENCE RPTS 10/30/97; ADVERSE EVENT REPORTING SYSTEM (AERS) BRIEF DESCRIPTION WITH CAVEATS OF SYSTEM 7/18/05 ANNA EDNEY BLOOMBERG NEWS CETERO RESEARCH, HOUSTON, TX - LIST OF COMPANIES THAT USED CETERO TO CONDUCT BIOANALYTICAL STUDIES; LIST OF STUDIES CETERO CONDUCTED FOR EACH COMPANY 4/05 TO 6/10 BUDNER, MICHAEL 2011-3930, 2011-3923, 2010-9021, ETC Signature/ Requester Subject
Page 401 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/13/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5952 2011-5953 08/15/2011 09/13/2011 08/15/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5954 08/15/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5955 2011-5956 08/16/2011 09/14/2011 08/16/2011 09/14/2011 2011-5957 2011-5958 2011-5959 08/16/2011 09/14/2011 08/16/2011 09/14/2011 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5960 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5961 08/16/2011 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2011-563 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2010-8852 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ DAVID GULLIVER BRADENTON HERALD CARL BEAURLINE CMB REGULATORY SPECIALTIES DAVID LEE KIMBERLY-CLARK CORP DAVID LEE KIMBERLY-CLARK CORP JOAN STITT (UG2CD-16) MERCK & CO., INC. 2009-6089 AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYS K083097 BIOLIFE LLC - RESP TO WARNING LTR, FDA RESP JULIA M GICZEWSKI MCGUIRE WOODS LLP ABIOMED - IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYS RESP TO LTR 1/28/10 SALTZ MONGELUZZI ET AL C GLORIA WANG SCIENTIFIC THERAPEUTICS INFORMATION INC HYALURONIDASE - AERS PRIOR TO 1998 2010-9015, 2011-2546 Signature/ Requester SUCAMPO PHARMACEUTICALS INC Subject (POLYETHYLENE GLYCOL 3350) NDA 220-015, NDA 20-698 PROTOCOLS, CLNCL STUDY RPTS, SAFETY RPTS, ETC
FARRELL VALVE WITH CORFLO ANTI-IV CONNECTORS K100365 ENTRACARE GASTROSTOMY FEEDING TUBE K092419
Page 402 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/14/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5962 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5963 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5964 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5965 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5966 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5967 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5968 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5969 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3984 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3883 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3869 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3471 SPL JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3347 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-3282 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-2908 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-2093 Signature/ Requester MERCK & CO., INC. Subject
Page 403 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5970 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5971 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5972 2011-5973 2011-5974 2011-5975 08/16/2011 09/14/2011 08/16/2011 09/14/2011 08/16/2011 09/14/2011 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5976 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5977 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5978 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5979 08/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ FRANCIS WILKIE ORGAN RECOVERY SYSTEMS INC - KIDNEY PERFUSION JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-5218 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4736 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4638 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ TYSON Q. BELLAMY FEFA LLC TYSON Q. BELLAMY FEFA LLC JOHN J. MALLOY MALLOY & ASSOCIATES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. VENTANA MEDICAL SYSTEMS INC, TUCSON, AZ - INFORM HER2 DUAL ISH DNA PROBE COCKTAIL P100027 2011-4637 CONTRACT NO HHSF223201011888P CONTRACT NO HHSF223201010144A - UNIV OF MARYLAND JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4587 JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-4297 Signature/ Requester Subject
Page 404 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/14/2011 2011-5980 2011-5981 08/16/2011 09/14/2011 08/16/2011 09/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5982 08/16/2011 09/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5983 08/16/2011 09/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5984 08/16/2011 09/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5985 08/16/2011 09/14/2011 CBER/OCTMA/DDOM/ALFB/ CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-5986 08/16/2011 09/14/2011 2011-5987 2011-5988 2011-5989 08/16/2011 09/14/2011 08/16/2011 09/14/2011 08/16/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ MILES HARTFELD DEN-MAT HOLDINGS LLC THOMAS MACK DOLE FRESH VEGETABLES ALICIA B. RICHARDS FCN 12, FCN 284 - FORM 3480, MIGRATION TESTING DATA, FRESH EXPRESS - 483 2010 TO PRESENT INOVATIV LLC - ACETAL K022032 CHANG, WUNGKOU SAMPLE 5777765 MELANIE LARY NEAVS CORR BETWEEN FDA & INSTITUTE OF MEDICINE RE THE IOM COMMITTEE ON THE USE OF CHIMPANZEES IN BIOMEDICAL & BEHAVIORAL RESEARCH DONNA FISHER SENNIGER POWERS ARLACEL (DIPOLYHYDROXYSTEARATE) INACTIVE INGREDIENTS 2002 CHARLES CELESTE EAS Consulting Group, LLC EDECRIN NDA 16-092 - CHEMISTRY RVW, MEDICAL RVW, LBLG, ETC MILIONE, RALPH . BENZALKODIUM CHORIDE ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester COLEMAN LAWFIRM REBECCA MACIEL FOOD SCIENCE CORP JOAN STITT (UG2CD-16) MERCK & CO., INC. Subject SOLUTION K013575, K022391, K091656 ALL AMERICAN PHARMACEUTICAL & NATURAL FOODS CORP, BILLINGS, MT - EIR 8/5-6/10 2011-1007
Page 405 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/14/2011 2011-5990 08/16/2011 09/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5991 2011-5992 08/17/2011 09/15/2011 08/17/2011 09/15/2011 2011-5993 2011-5994 08/17/2011 09/15/2011 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5995 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5996 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5997 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-5998 2011-5999 2011-6000 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ DEBORAH C ATTWOOD Keller and Heckman LLP FATIMA ASLAM Keller and Heckman LLP LINDA TOWLER SYNAPSE BIOMEDICAL INC - NEURX DIAPHRAGM PACING SYS MDRS EID PARRY LTD - SPIRULINA GRN 391 ENVIRO TECH CHEMICAL SERVICES - FCN 699, FCN 908 MORRISSEY, JOHN GRACEWAY PHARMACEUTICALS LLC - ZYCLARA AERS SHAWN FOX TRACEY LAW FIRM RW JOHNSON PHARMACEUTICAL RESEARCH LLC, ORTHOMCNEIL-JANSSEN PHARMACEUTICAL RESEARCH & DEVELOPMENT, ETC - TOPAMAX CORR, 15-DAY ALERTS, SS&E, ETC Doe J INDIVIDUAL RECS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ TZIMENT, MOSHE MARK HEROUX BAKER TILLY VIRCHOW KRAUSE LLP KATHY LEE GENERAL MILLS INC OLIVIER HUYGHE PRESCRIRE LYSTEDA (TRANEXAMIC ACID) - AERS, MEDICAL, STATISTICAL RVWS DKT 1995P-0197 CASE # 06-0388-CV-W-FJG, # 05-00315-09-CR-W-ODS MAZOR ROBOTICS LTD - K101446, K110911 Action Office Signature/ Requester AQUASOL CORP DAVID E. KENNEY, Esq. KENNEY & KROPFF Subject FOOD SAFETY DATA, ETC GENENTECH INC - AVASTIN FORM 1571, FORM 1572
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Total Records: 12455 Control # Recd Date / Due Date 09/15/2011 2011-6001 2011-6002 2011-6003 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6004 2011-6005 2011-6006 2011-6007 2011-6008 2011-6009 2011-6010 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 08/17/2011 09/15/2011 2011-6011 2011-6012 08/17/2011 09/15/2011 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6013 08/17/2011 09/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC GB-RANBAXY - ISR 5530887; SANDOZ - ISR 7018899; HOSPIRA - ISR 7022310, ETC FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC SCHERING PLOUGH - CLARITIN-D NDA 19-670/S020 APRVL RECS MIRAMAR LABS INC - MIRADRY SYS K103014 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP ANDREA PIGNI REGENLAB ANDREAS PIGNI REGENLAB MELKER EMERGENCY CRICITHYROTOMY CATHETER SET K013916 THERMOGENESIS CORP - CRYOSEAL FS APPLICATOR SYS K071126 ORTHOVITA INC - VITAGEL HEMOSTAT SPRAY SET K052173 AGRO FARMA, NEW BERLIN, NY - EIRS, 483S, WARNING LTRS, ETC 7/1/08 TO PRESENT ACCESS PHARMACEUTICALS - MUGARD MUCOADHESIVE ORAL WOUND RINSE K062795 INPHARMA AS - CAPHOSOL K030802 COSMAN - G4 RADIOFREQUENCY GENERATOR K082051 Doe J OM/OMP/DODM/ ORA/P-FO/LOS-DO/LACB/ Action Office Signature/ Requester AVERY BIOMEDICAL DEVICES DR PAUL BEVAN WILEX AG WENDY WAGNER UNIV OF TEXAS DEPO-PROVERA - LBLG, PI DKT 1984N-0103 AVID BIOSERVICES INC, TUSTIN, CA - EIR 3/22/11-4/3/11 Subject
Page 407 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6014 2011-6015 08/17/2011 09/15/2011 08/17/2011 09/15/2011 FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ BOBBY SCHOCHET OLSSON FRANK & WEEDA DAVID A. SANCHEZ DISTRIBUIDORA Y CONVERTIDORA INDUSTRIAL SA DE CV OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6022 08/18/2011 09/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OM/OMP/DODM/ 2011-6023 08/18/2011 09/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-6024 08/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ KEVIN BUCHANAN MEDTRONIC INC - SYNCHROMED EL & PAIN PUIMPS CHLOE BIRD PCCA MEDISCA INC, IRVING, TX; GALLIPOT INC, ST PAUL, MN; SPECTRUM PHARMACEUTICALS INC, IRVINE, CA, ETC ESTRIOL RECS, CORR YAHIRO, MARTIN SPINAL PEDICLE SCREW DVCS, RECLASSIFICATION/CLASSIFICATION OF PEDICLE SCREWS, ABC 20/20 INTERVIEWS WITH DAVID KESSLER MD, ETC - MINS, NOTES COMM, ETC BEVERIDGE & DIAMOND PC DAVID P JORDAN THOMSON REUTERS DOUGLAS E CHABOT DECOF & DECOF PC LIST OF FOREIGN & DOMESTIC DRUG INSPS 4/1/11 TO PRESENT MCKINLEY INC - OUTBOUND SYRINGE INFUSER K982256 INFORMATION ACCESS ALL CFSAN REQUESTS FILED FROM 6/1/11 TO 7/25/11 FOI SERVICES INC DAILY LOG 7/5-8/11 KENDLE REGULATORY AFFAIRS DAILY LOG 7/4-8/11 FOI DAILY LOG 7/5-8/11 FCN 15, 180, 636, 685, 837, 889 - TECHNICAL RVW MEMO DKT FDA-1994-P-0127 Signature/ Requester Subject
2011-6016 2011-6017 2011-6018 2011-6019 2011-6020 2011-6021
08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011
Page 408 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/16/2011 2011-6025 08/18/2011 09/16/2011 Action Office ORA/SE-FO/SJN-DO/SJCB/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ 2011-6026 08/18/2011 09/16/2011 ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ 2011-6027 2011-6028 2011-6029 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 2011-6030 08/18/2011 09/16/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6031 2011-6032 08/18/2011 10/27/2011 08/18/2011 09/16/2011 2011-6033 2011-6034 2011-6035 2011-6036 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ LESLIE PAUL PERRIGO PLANT 5 KYUNG-AH KIM PHD PRINCETON BIOMEDITECH CORP DAVID LEE KIMBERLY-CLARK CORP DAVID LEE KIMBERLY-CLARK CORP DAVID LEE KIMBERLY-CLARK CORP DAVID LEE ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE - K083685 FOTTPRINT MEDICAL POLYURETANE FEEDING TUBE K102458 MEDISOURCE ENDOTRACHEAL TUBE - K080339 PORTEX TRACHEAL TUBE - K083119 ABBOTT DIABETES CARE, ALAMEDA, CA - EIR,483 MOST RECENT CHRUCH & DWIGHT CO INC - K083716 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ PAUL W TRIPP LINCARE INC MARK L FOOTE PACKAGING PARTNERS LTD STANLEY R GOODMAN GOODMAN & SAPERSTEIN DARLENE ASLAM PHARMATRUST JOHNSON & JOHNSON, LIFE SCAN INC - COUNTERFEIT LIFESCAN SURESTEP 50S, 100S, ONETOUCH ULTRA 50S, 100S BLOOD GLUCOSE TEST STRIPS MDRS LIST OF REPACKERS/RELABELERS REGISTERED WITH FDA VALLEY MEDICAL CORP, OH - EIRS, 483S, WARNING LTRS 1/1/04 TO PRESENT JEN-COAT INC, WESTFIELD, MA - INSP 2011 LEETHEA LENTZ GLYNN & FINLEY LLP CYTOSPORT INC - INVESTIGATIONS, RVWS, RPTS, ETC Signature/ Requester BUCHANAN & BELLAN LLP QUYNH C SPERRAZZA FAEGRE & BENSON LLP Subject MDRS, RECALLS Z-1147-2008, Z-0589-2009, WARNING LTRS, ETC MULTISTATE OUTBREAK OF SALMONELLA HEIDELBERG LINKED TO GROUND TURKEY - INVESTIGATION RECS 2011
Page 409 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/16/2011 2011-6037 2011-6038 2011-6039 2011-6040 2011-6041 2011-6042 2011-6043 2011-6044 2011-6045 2011-6046 2011-6047 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 2011-6048 08/18/2011 09/16/2011 2011-6049 08/18/2011 09/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6050 08/18/2011 10/24/2011 CBER/OCTMA/DDOM/ALFB/ SHEKAR, YB NOVARTIS - TRIAL NCT00464672 CLNCL DATA ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ PHILIP J. GREGORY THERAPEUTIC RESEARCH FACULTY ANGIE CANCINO ISICOFF RAGATZ & KOENIGSBERG AMBIEN CR - MEDICATION GUIDE (CERTIFIED) GERANIUM OIL - CAERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester KIMBERLY-CLARK CORP DAVID LEE KIMBERLY-CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP DAVID LEE KIMBERLY-CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP DAVID LEE KIMBERLY-CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP CHRISTINE L. MACAULEY KIMBERLY CLARK CORP SUNNIE GUO PEGASUS SHIPPING INC TELEFLEX ISIS HVT TRACHEAL TUBE CUFFED W/SUBGLOTTIC SECRETION SUCTION PORT K091761 FROZEN COOKED IQF SHRIMP - ENTRY NO 906-1087545-3 LAB ANALYSIS PARKER FLEX-TIP ORAL/NASAL INTUBATION TUBE K100546 PONSKY NON BALLOON REPLACEMENT GASTROSTOMY TUBE K103109 BIVONA ADJUSTABLE & FIXED NECKFLANGE HYPER FLEX TRACHEOSTOMY TUBE - K081440 STRYKER - RF MULTI LESION GENERATOR MODEL 0406900-000 K071482 SHILEY TRACHEOSOFT XLT EXTENDED LENTH TRACHEOSTOMY TUBE & INNER CANNULA K051416 VERSATUBE TAPERED TRACHEOSTOMY TUBE W/DISPOSABLE INNER CANNULA K100283 CUFFALERT INFLATABLE CUFF TRACHEAL TUBE K081805 PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT - K041348 PYTON INFLATABLE CUFF TRACHEAL TUBE K092733 Subject
Page 410 of 1132

Total Records: 12455 Control # 2011-6051 2011-6052 2011-6053 2011-6054 Recd Date / Due Date 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/26/2011 08/18/2011 09/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6055 08/18/2011 11/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/COS/OL/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6056 2011-6057 2011-6058 2011-6059 2011-6060 08/18/2011 09/16/2011 08/18/2011 09/16/2011 08/18/2011 09/22/2011 08/18/2011 09/16/2011 08/18/2011 09/16/2011 2011-6061 08/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BRADLEY SOUTHWORTH B FLEX ANTI SNORING DVC K073004 OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ DEBORAH C. ATTWOOD Keller and Heckman LLP DAN KERAVICH GlaxoSmithKline PHILIP Z. GLORIEUX MARTIN CLEARWATER & BELL ANGELIA SLAYTON KENDLE INTERNATIONAL INC DOUGLAS E. CHABOT DECOF & DECOF PC CLASS II MEDICAL DEVICE K944692 DKTS 1978N-0018 CARPENTIER EDWARDS VALVE - MDRS OTC VOLS 210009, 210173, 210174, ETC. ENVIRO TECH CHEMICAL SERVICES FCN 699, 908 NANDINI GOPINADH ALLIANCE FOR NATURAL HEALTH USA DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATONS AND RELATED ISSUES 7/11 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/DET-DO/DCB/ Action Office ORA/SW-FO/KAN-DO/COMP/ Signature/ Requester PAUL W. TRIPP LINCARE INC KEVIN BUCHANAN BUCHANAN & BELLAN LLP STEPHEN S. KRELLER KRELLER LAW FIRM PETER SAXON SAXON INTERNATIONAL ASSOCIATES Subject SLEEPCAIR INC, SPECTRUM MEDICAL EQUIPMENT INC, KS, MO - EIRS, 483, WARNING LTR 1/04 TO PRESENT MEDTRONIC, PR - SYNCHROMED II PAIN PUMP RECALL, WARNING LTRS, MDERS 483S, ETC ABBOTT LABS INC - SIMILAC CMPLNTS, RPTS 1/1/07 TO 5/15/10 NOVARTIS - GLEEVEC (IMATINIB MESYLATE) NDA 21-335 CHEMICAL NAME, STRUCTURE
Page 411 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/16/2011 2011-6062 2011-6063 08/19/2011 09/19/2011 08/19/2011 09/19/2011 2011-6064 08/19/2011 09/19/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OL/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6065 08/19/2011 09/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6066 08/19/2011 09/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6067 2011-6068 08/19/2011 09/19/2011 08/19/2011 09/19/2011 2011-6069 08/19/2011 09/19/2011 2011-6070 08/19/2011 09/19/2011 2011-6071 2011-6072 08/19/2011 09/19/2011 08/19/2011 09/19/2011 ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ CITIGROUP ELIZABETH WOENKNER CITIZENS FOR RESPONSIBLE CARE & RESEARCH ROBERT L DUCKELS GREENSFELDER HEMKER & GALE PC BARBARA SIMON DR OZ SHOW (ZO CO PRODUCTIONS) KIYOSHI SAITAKA NIPPON DIXIE CO LTD TREVOR LUTZ MCFLEEG INC ESSEX INSTITUTIONAL REVIEW BORARD INC - EIRS, 483S 3/14-21/11 THUMB OILSEED PRODUCERS COOPERATIVE, UBLY, MI EIRS, 483S, RESP LTRS 2/23/10, 3/2/10, 3/24/10, ETC ARSENIC IN PEAR JUICE PRODS - HEALTH HAZARD ASSESSMENT MEMO AASHI GLASS CO LTD - FCN 599 TOXICOLOGICAL RECS, HAZARD IDENTIFICATION, ETC O2EX-CELL - CMPLNT HOSPIRA, ROCKY MOUNT, NC - 483 5/11 SEIBERT, SUSAN NOVARTIS - RECLAST AERS JACK S NYBERG DEY PHARMA LP SYMBIOCORT - MEDICAL, STATISTICAL RVWS FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester SOMNOMED INC DEBORA DEMERS ACTUATED MEDICAL INC PETER MATZ OLSSON FRANK WEEDA TERMAN BODE MATZ ELIZABETH BAREHENN PUBLIC CITIZEN NOVA DESIGN TECHNOLOGIES LTD - TUBE DECLOGGER K905164 ORIGINAL EQUIPMENT MFRS - LTR, CORR, MINS, ETC 3/23/06 ISR 6626979, 6645751, 6660632, ETC Subject
Page 412 of 1132

Total Records: 12455 Control # 2011-6073 Recd Date / Due Date 08/19/2011 09/19/2011 Action Office ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ 2011-6074 2011-6075 08/22/2011 09/20/2011 08/22/2011 09/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ 2011-6076 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6077 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6078 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6079 2011-6080 08/22/2011 04/26/2012 08/22/2011 09/20/2011 FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ HEATHER MURRAY DEFENDERS OF WILDLIFE KIT DOUGLASS PUBLIC EMPLOYEES FOR ENVIRONMENTAL RESPONSIBILITY FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ IAN R WALSWORTH SHERIDAN ROSS PC PERMITTING OF BIOMEDICAL FACILITIES ENGAGED IN BLEEDING HORSEHOE CRABS - RECS CULTIVATION OF GENETICALLY ENGINEERED CROPS ON NATIONAL WILDLIFE REFUGES - COMM 1/09 TO PRESENT HEATHER KOHN RJ KOHN FAMILY MEDICINE PC BUSPAR, LORAZEPAM - MEDWATCH RPT ANGELIA D SLAYTON KENDLE REGULATORY AFFAIRS REMICADE (INFLIXIMAB) - ISRS 6963779, 6959186, 6524338, ETC ANN MCGEE DUKE UNIVERSITY HOSPITAL HOSPIRA WORLDWIDE INC - TOPOTECAN HCL NDA 200582 STABILITY RECS GLAZE, M ROBERT P CHARROW GREENBERG TRAURIG LLP LIST OF CHINESE MEDICAL DVC, PHARMACEUTICAL, BIOTECH COMPANIES REGISTERED WITH FDA ELI LILLY & CO - CYMBALTA FOIA REQUESTS, CORR Doe J Signature/ Requester Subject INDIVIDUAL RECS
2011-6081
08/22/2011 09/20/2011
MEDTRONIC SOFAMOR DANEK INC - CAPSTONE SPINAL SYS, BOOMERANG SPINAL SYS, CRESCENT SPINAL SYS, ETC RPTS, INVESTIGATIONS, CORR, ETC
Page 413 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-6082 2011-6083 2011-6084 2011-6085 2011-6086 2011-6087 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6088 08/22/2011 09/20/2011 2011-6089 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-6090 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6091 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6092 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ W E CHALKLEY PFIZER - DIABINESE (CHLORPROPAMIDE) NDA 11-641/S065 RECS CHRISTINE A RINGLER RN ESDAILE BARRETT JACOBS & MONE LABETALOL - AERS JUDY M ATKINS PHARM D COMPLIANCE RESOURCSES LLC ASTRAZENECA - BRILINTA (TICAGRELOR) NDA 22-433 SBA LUTIN, MATTHEW FDA/OMPT/CDRH/OCER/DFOI/ ANGELIKA SCHERP BUSINESS SUPPORT INTERNATIONAL CHURCH & DWIGHT CO INC (ARM & HAMMER) - SIMPLY SALINE STERILE SALINE NASAL MIST ALLERGY & SINUS RELIEF APRVL RECS TRACOE MEDICAL GMBH - K781729 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ NEWMAN J50399, GEOFF STEVE BONIN MEDTOX LABORATORIES INC LOIS ZIEBOL PURSUIT VASCULAR AARON L HARRAH HILL PETERSON CARPER, ET AL MATT CLAUSEN MEDLINE INDUSTRIES INC FREDERICK A STEARNS Keller and Heckman LLP SHANGHAI MISAWA MEDICAL INDUSTRY CO LTD - EIR, 483 3/30/11-4/4/11 DOW CORNING CORP - DRUG PROD LISTING MEDTOX LABORATORIES INC, ST PAUL, MN - EIR, 483 3/711/11 ARROW+ARD BLUE CATHETER FOR HIGH VOLUME INFUSIONS - K993933 INDIVIDUAL RECS ASPARTAME - RECS Signature/ Requester Subject
Page 414 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6093 08/22/2011 09/20/2011 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-6094 08/22/2011 09/20/2011 2011-6095 08/22/2011 09/20/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OIASI/OCP/ 2011-6096 2011-6097 2011-6098 2011-6099 2011-6100 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 2011-6101 08/22/2011 09/20/2011 2011-6102 2011-6103 08/22/2011 09/20/2011 08/22/2011 FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS KRISTI SMEDLY Center for Regulatory Services, Inc. FLEXERIL NDA 17-821 - MEDICAL RVW NADA 135-468 CLOSED FOI REQUESTS 8/8-12/11 CLOSED FOI REQUESTS 8/15-19/11 CLOSED FOI REQUESTS 8/15-19/11 CLOSED FOI REQUESTS 8/5-12/11 FOI SERVICES INC CLOSED FOI REQUESTS 8/8-12/11 CLOSED FOI REQUESTS 8/15-19/11 KRISTIN M ZIELINSKI HOGAN LOVELLS US LLP LACLEDE INC - LUVENA PRE-BIOTIC VAGINAL LUBRICANT AND MOISTURIZER MARKETING RECS, CORR DONALD W SINGLETON SINGLETON LAW FIRM LLC LIFE MAX INC - CHIA SEED (SALVIA HISPANICA L) CMPLNTS Doe J INDIVIDUAL RECS Signature/ Requester THOMSON REUTERS Subject
Page 415 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6104 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6105 2011-6106 2011-6107 2011-6108 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6109 08/22/2011 09/20/2011 2011-6110 08/22/2011 09/20/2011 2011-6111 08/22/2011 09/20/2011 2011-6112 2011-6113 2011-6114 2011-6115 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC Center for Regulatory Services, Inc. GLADYS B. TONKIN Center for Regulatory Services, Inc. DAILY LOG 7/18-22/11 DAILY LOG 8/1-5/11 Center for Regulatory Services, Inc. DAILY LOG 7/25-29/11 WASHINGTON INFORMATION SOURCE DAILY LOG 7/18-22/11 WASHINGTON INFORMATION SOURCE DAILY LOG 8/1-5/11 WASHINGTON INFORMATION SOURCE DAILY LOG 7/25-29/11 DAILY LOG 7/18-22/11 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHEN BENJAMIN OLSEN MEDICAL STEPHEN BENJAMIN OLSEN MEDICAL MARTINE D SCHNEIDER COOPERVISION NARINE DEMIRCHIAN ODAN LABORATORIES LTD DOAK DERMATOLOGICS - CAMOL-40 (UREA 40% CREAM) CLNCL RECS OLSEN MEDICAL, LOUISVILLE, KY - CIMMARRON 1000 OR 1000-2 K790293 OLSEN MEDICAL, LOUISVILLE, KY - PAO BIPOLAR COAGULATOR K840545 REACTIVE BLUE 246 - CAP 1C0242 MICHAEL E GATTO VEEN FIRM PC ATTYS ABBOTT LABS - MERIDIA AERS, APRVL RECS, CORR, ETC, 2001 TO PRESENT Signature/ Requester HALL, ERIC C Subject
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Total Records: 12455 Control # 2011-6116 2011-6117 2011-6118 2011-6119 2011-6120 2011-6121 Recd Date / Due Date 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6122 08/22/2011 09/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6123 08/22/2011 09/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6124 2011-6125 2011-6126 2011-6127 2011-6128 2011-6129 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KENDLE INTERNATIONAL INC DAILY LOG 8/1-5/11 KENDLE REGULATORY AFFAIRS DAILY LOG 7/18-22/11 KENDLE REGULATORY AFFAIRS DAILY LOG 7/25-29/11 INFORMATION ACCESS DAILY LOG 8/1-5/11 INFORMATION ACCESS DAILY LOG 7/18-22/11 DAILY LOG 7/25-29/11 WOLTERS KLUWER LAW & BUSINESS DAILY LOG 8/1-5/11 WOLTERS KLUWER LAW & BUSINESS DAILY LOG 7/18-22/11 FOI SERVICES INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DAILY LOG 7/25-29/11 DAILY LOG 7/18-22/11 DAILY LOG 7/25-29/11 DAILY LOG 8/1-5/11 FOI SERVICES INC DAILY LOG 8/1-5/11 Signature/ Requester Subject DAILY LOG 7/25-29/11
Page 417 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/20/2011 2011-6130 2011-6131 2011-6132 2011-6133 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/22/2011 09/20/2011 08/23/2011 09/21/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6134 08/23/2011 09/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6135 2011-6136 2011-6137 2011-6138 2011-6139 2011-6140 2011-6141 2011-6142 2011-6143 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-5406 REQUEST LETTER 2011-5397 REQUEST LETTER 2011-5371 REQUEST LETTER 2011-5357 REQUEST LETTER 2011-5354 REQUEST LETTER 2011-5344 REQUEST LETTER 2011-5339 REQUEST LETTER 2011-5273 REQUEST LETTER 2011-5269 REQUEST LETTER ABALLA A SAAD UNIV OF WISCONSIN-MADISON WYETH - ZOSYN (PIPERACILLIN/TAZOBACTAM FOR INJ) IND CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. ABALLA A SAAD UNIV OF WISCONSIN-MADISON SAMYANG - GENXOL-PM (PACLITAXEL LOADED POLYMERIC MICELLE) IND DAILY LOG 7/18-22/11 DAILY LOG 7/25-29/11 Signature/ Requester INFORMATION ACCESS DAILY LOG 8/1-5/11 Subject
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Total Records: 12455 Control # 2011-6144 2011-6145 2011-6146 2011-6147 2011-6148 2011-6149 2011-6150 2011-6151 Recd Date / Due Date 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 08/23/2011 09/21/2011 2011-6152 2011-6153 08/23/2011 09/21/2011 08/23/2011 09/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6154 2011-6155 08/23/2011 09/21/2011 08/23/2011 09/21/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ORM/ ORA/ORM/ 2011-6156 08/23/2011 09/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOHNA HOEY OPEN SOCIETY INSTITUTE VIVITROL - AERS MICHAEL RAVNITZKY DAVID GROB Chattem Inc CHATTEM INC, CHATTANOOGA, TN - MEMO OF INVESTIGATION 5/4-5/11 IPADS, BLACKBERRY PLAYBOOK, GALAXY TAB FOR EMPLOYEE USE, ETC - INTERNAL AGENCY MEMOS, CORR, DISADVANTAGES, ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (8G2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GREG MOREAU CENTRIX INC ANDREA N WALLEN DELPHINUS MEDICAL TECHNOLOGIES INC MARA CALER ALERE DAN DIEGO INC ANASTACIA CHETTY ASPEN PHARMACARE ULTRASONIX MEDICAL CORP, RICHMOND, BRITISH COLUMBIA, CANADA - SONIX ULTRASOUND SCANNER K0093462 MITISUBISHI CHEMICAL MEDICINE CORP - PATHFAST C TNI-II TEST K100130 ATRIPLA - AERS CENTRIX INC - D/SENSE 1-STEP (CERTIFIED, NOTARIZED) FOI DAILY LOG 8/1-5/11 FOI DAILY LOG 8/8-12/11 2011-5555 REQUEST LETTER 2011-5553 REQUEST LETTER 2011-5528 Subject 2011-5410 REQUEST LETTER
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6157 08/23/2011 09/21/2011 2011-6158 2011-6159 2011-6160 08/23/2011 09/21/2011 08/24/2011 09/22/2011 08/24/2011 09/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6161 08/24/2011 09/22/2011 2011-6162 2011-6163 2011-6164 08/24/2011 09/22/2011 08/24/2011 09/22/2011 08/24/2011 09/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6165 2011-6166 2011-6167 2011-6168 2011-6169 08/24/2011 09/22/2011 08/24/2011 09/22/2011 08/24/2011 09/22/2011 08/24/2011 09/22/2011 08/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ WALKER, ELIJAH KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. GERALD J. HADDOCK IRIS DIAGNOSTICS CALLIE BUYS K090820 K070910 WHEAT GLUTEN - NON-OBJECTION LTR 12/11/09 WHEAT GLUTEN - NON-OBJECTION LTR 12/11/09 K953293, K922818, K880956 JOHNSON, JAMES FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CALLIE BUYS PRINCE YEATES & GELDZAHLER CALLIE BUYS PRINCE YEATES & GELDZAHLER ALLOPURINOL, ASPIRIN, ATENOLOL - AER K973324 K013028 CALLIE BUYS PRINCE YEATES & GELDZAHLER K080521 FDA/OMPT/CDRH/OCER/DFOI/ MORROW, LEN W CHRISTOPHER A SUMMERS GORDON & REES LLP OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP DEPUY ORTHOPAEDICS INC - PINNACLE METAL-ONMETAL ACETABULAR CUP LINER K023786 HYDROXYCUT MARKETING & SALES PRACTICES LITIGATION DKT FDA-2010-P-0491 DANIEL RIGSJO WWW.SAGERTI PASTE.ORG USE OF THE FDA LOGO APRVL, SANCTIONS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 09/22/2011 2011-6170 08/24/2011 09/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6171 2011-6172 08/24/2011 09/22/2011 08/24/2011 09/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6173 2011-6174 08/24/2011 09/22/2011 08/24/2011 09/22/2011 2011-6175 08/24/2011 09/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6176 2011-6177 08/24/2011 09/22/2011 08/24/2011 09/22/2011 2011-6178 2011-6179 08/24/2011 09/22/2011 08/24/2011 09/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6180 2011-6181 08/24/2011 09/22/2011 08/24/2011 ORA/ FDA/OMPT/CDRH/OCER/DFOI/ MONIKA BHATT HODGSON RUSS LLP CMPLNT 121701 HOLOGIC INC - SELENIA DIMENSIONS 3D SYS PMA ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ ORA/P-FO/SEA-DO/SCB/ CBER/OCTMA/DDOM/ALFB/ LIPPMANN, MATT ANDREAS PIGNI REGENLAB R IAN KLUGE Hyman Phelps and McNamara PC MARK HEROUX BAKER TILLY VIRCHOW KRAUSE LLP CASCADE MEDICAL ENTERPRISES LLC, WAYNE, NJ MEDICAL FIBRINET, AUTOLOGOUS PLATELET SYS BK020051 NATIONAL GENETICS INSTITUTE, LOS ANGELES, CA EIRS, 483S, CO RESPS, ETC 1/08 TO PRESENT CASE NO 05-00315-09-CR-W-ODS; CASE NO 06-0388CV-W-FJ - COMPLAINT FOR FORFEITURE IN REM & THE STIPULATION SEATTLE GENETICS, BOTHELL, WA - EIR, 5/17-19/11 KAREN COLLINS HARDISON COCHRAN ACTOS - AERS, RPTS, STUDIES FDA/OMPT/CDRH/OCER/DFOI/ ANDREAS PIGNI REGENLAB ANDREAS PIGNI REGENLAB BIOMET MANUFACTURING CORP - MARROWSTIM CONCENTRATION KIT & MINI KIT K071934 MICROMEDICS INC - FIBRIJET AEROSOL APPLICATOR K012868 LECATES, JOSEPH FDA/OMPT/CDRH/OCER/DFOI/ ANDREAS PIGNI REGENLAB HARVEST TECHNOLOGIES CORP - SMARTPREP 2 BMAC SYS, PLATELET CONCENTRATION SYS K103340 LEUCOVORIN CALCIUM - NDA 008107 & 018459LABLS, LTRS ETC LECATES, JOSEPH Action Office Signature/ Requester PRINCE YEATES & GELDZAHLER JANSSEN PHARMACEUTICALS - ERGAMISOL, LTRS, LBLS, ETC NDA 020035 Subject
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Total Records: 12455 Control # Recd Date / Due Date 09/22/2011 2011-6182 08/24/2011 09/22/2011 2011-6183 08/24/2011 09/22/2011 Action Office ORA/ ORA/SE-FO/ATL-DO/ACB/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6184 08/24/2011 09/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OC/OIASI/OCP/ 2011-6185 2011-6186 2011-6187 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6188 08/25/2011 09/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6189 08/25/2011 09/23/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OM/OSS/OPILS/DFI/ WILLIAM N G BARRON IV BOWMAN AND BROOKE LLP TRIAD GROUP INC, H&P INDUSTRIES INC - ALCOHOL PREP TESTING, INSPS LAST 10 YRS; INDIVIDUAL RECS, ETC LAWRENCE R CAGNEY WESTRUP KLICK LLP CHATTEM INC - BULLFROG; JOHNSON & JOHN INC NEUTROGENA; PLAYTEX PRODUCTS INC - BANANA BOAT, ETC LBLG 1/00 TO PRESENT ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J DAVID DION CARDINAL HEALTH STEPHEN E RAYNES ESQ RAYNES MCCARTY LOVENOX (ENOXAPARIN SODIUM) - APRVL RECS, CLNCL TRIALS, AERS, ETC MEDTRONIC - IN SYNC MAXIMO CARDIOVERTER DEFIBRILLATOR RECS AMERICAN CONTRACT SYSTEMS - RESP TO WARNING LTR LAURA CATHELYN KEMIN INDUSTRIES INC DUTCH OPHTHALMIC - VISION BLUE (TRYPAN BLUE SOL) NDA 21-670 REQUEST FOR DESIGNATION (RFD) SUSAN D. FOSTER LLOYD INC CONTRACT PHARMACAL - ANDA 80-209; MUTUAL PHARM ANDA 89-245; WINTAGE PHARMS - ANDA 40-256, ETC PREDNISONE TABS BIOAVAIL RECS MEGAN B. HAEBLER BEVERIDGE & DIAMOND PC ALLL FILED CFSAN REQUESTS 7/25/11 TO 8/22/11 Signature/ Requester Doe J Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OER/OPA/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ 2011-6190 08/25/2011 09/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6191 2011-6192 2011-6193 2011-6194 2011-6195 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6196 08/25/2011 09/23/2011 2011-6197 2011-6198 08/25/2011 09/23/2011 08/25/2011 10/19/2011 CBER/OCTMA/DDOM/ALFB/ ORA/OE/ O'GRADY, RITA FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JAY PRUSKI SURGILOGIX STACEY ELLUL NEUROPACE INC INTERBODY FUSION SYS - K090064; FANG PLATE SYS K090415; KING COBRA CERVICAL PLATE SYS - K103068, ETC WIDEX HEARING AID CO - CLEAR 440 PASSION HEARING AID 510K LEDERLE LABS - OPV LOT #0693A CONTAMINANTS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ PETER C BOWMAN ESTY & BUCKMIR LLC PETER C BOWMAN ESTY & BUCKMIR LLC AARON L HARRAH HILL PETERSON CARPER, ET AL SAMUEL ESAN MCGUIRE WOODS LLP GARY D HINDMAN PHD BECKLOFF ASSOCIATES INC INFUSIVE TECHNOLOGIES LLC - PRE-FILLED DUAL CHAMBER SYRINGE K082713 ASTRAZENECA - SEROQUEL XR NDA 22-047 SBA SMITH & NEPHEW - ECHELON BOWED POROUS FEMORAL COMPONENT RECS INDIVIDUAL RECS INDIVIDUAL RECS UMBERGER, CHRIS NALTREXONE, SERTRALINE, OPANA, ETC - AERS, INIDCATIONS, PRESCRIBING RECS, ETC Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OE/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/BLT-DO/CB/ 2011-6199 08/25/2011 10/19/2011 CBER/OCTMA/DDOM/ALFB/ ORA/OE/ ORA/OE/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/BLT-DO/CB/ 2011-6200 08/25/2011 09/23/2011 2011-6201 2011-6202 08/25/2011 09/23/2011 08/25/2011 09/23/2011 2011-6203 2011-6204 2011-6205 2011-6206 2011-6207 2011-6208 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/25/2011 09/23/2011 2011-6209 08/25/2011 09/23/2011 ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ SCOTT S LIEBMAN PORZIO PHARMACEUTICAL SERVICES LLC CHARLES CELESTE EAS Consulting Group, LLC AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC CHARLES CELESTE EAS Consulting Group, LLC CHARLES CELESTE EAS Consulting Group, LLC LESLIE HONDA ZENO CORP MARILYNN WHITNEY COVINGTON & BURLING LLP LESLIE HONDA ZENO CORP NICK SCHWELLENBACH PROJECT ON GOVERNMENT OVERSIGHT NICK SCHWELLENBACH PROJECT ON GOVERNMENT OVERSIGHT PHAROS LIFE CORP - TANDA RESTORE THERAPEUTIC HEATING LAMP K090008 NEO IMAGERY TECHNOLOGIES INC, HACIENDA HEIGHTS, CA 5/1/09; EAGLE HEALTH SUPPLIES INC, ORANGE, CA 7/26/10; MONARCH LABS LLC, IRVINE, CA 6/14/10, ETC - EIRS TOBY'S NOSE FILTERS INC, MERRITT ISLAND, FL 9/23/10 ; ARJ MEDICAL INC, OLDSMAR, FL 3/9/10; AMERICAN CATHETER CORP, OCALA, FL 6/17/09, ETC - EIRS DKT & DKT LOG OF 2003N-0361 PHAROS LIFE CORP - TANDA SKINCARE SYS K080591 FCN 535 FCN 697 DKT 1975N-0184 PRESCRIPTION DRUG MARKETING ACT (PDMA) - LIST OF INSPS 2000 TO PRESENT FCN 614 O'GRADY, RITA LEDERLE LABS - DTAP LOT #372920 CONTAMINANTS Signature/ Requester Subject
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Total Records: 12455 Control # 2011-6210 Recd Date / Due Date 08/25/2011 09/23/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6211 2011-6212 2011-6213 08/25/2011 09/23/2011 08/25/2011 09/23/2011 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6214 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6215 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6216 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6217 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6218 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6219 08/26/2011 FDA/OMPT/CDER/ORP/DIDP/ HOLLIE J WELLIS MONOPRIL ( NDA 19-915 - PI, MEDICATION GUIDE, ETC HOLLIE J WELLIS SANDOZ INC MACROBID NDA 20-064 - PI, MEDICATION GUIDE, HOLLIE J WELLS SANDOZ INC DAYRO NDA 18-841 - PI, MEDICATION GUIDE, ETCANDA 75-845 LBLG HOLLIE J WELLS SANDOZ INC BETAPACE) NDA 19-865 - PI MEDICATION GUIDE, ETCTABS ANDA 75HOLLIE J WELLS SANDOZ INC VANCOCIN HCL (RLD) NDA 50-606 - PI, MEDICATION GUIDE HOLLIE J WELLS SANDOZ INC MEVACOR (RLD)NDA 19-643 - PI, MEDICATION GUIDE, ETC GATES, DONALD ORA/P-FO/LOS-DO/LACB/ DeARMOND, ROBERT L PHENTERMINE HCL - PHARMACODYNAMIC, PHARMACOKINETIC STUDIES CVM/OCD/ Doe J BIOFILM INC, VISTA, CA - AUDIT 5/31/11 PFIZER - RIMADYL AERS Signature/ Requester JOSE M. BIAGGI JUNQUERA BIAGGI & BIAGGI PSC ATTY AT LAW Subject TYLENOL EXTRA STREGTH - AERS 3/31/11 TO PRESENT
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Total Records: 12455 Control # Recd Date / Due Date 09/26/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6220 2011-6221 2011-6222 2011-6223 08/26/2011 09/26/2011 08/26/2011 09/26/2011 08/26/2011 09/26/2011 08/26/2011 09/26/2011 2011-6224 08/26/2011 09/26/2011 2011-6225 08/26/2011 09/26/2011 2011-6226 08/26/2011 09/26/2011 2011-6227 08/26/2011 09/26/2011 2011-6228 08/26/2011 09/26/2011 2011-6229 08/26/2011 09/26/2011 2011-6230 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6231 08/26/2011 FDA/OMPT/CDER/ORP/DIDP/ DAVID KAO HISTORICAL RECS - AERS SYS 1969 TO 2003 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CHEE YEN LIM MICROPOINT TECHNOLOGIES PTE LTD STEVE SCOTT BIOMEASURE INC SOLSTICE NEUROSCIENCES LLC - MYOBLOC (RIMABOTULINUMTOXIN B) NDA 10-3846 POST MARKETING COMMITMENTS, SPONSOR COMM, RESPONDING STATUS, ETC 12/8/00 K981827, K932725 MELKUMYAN, ARTEM MEDTRONIC -CLINIC ACG EXPLANTED DEFIBILIATORS RECS Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ GLAXZE, M JOSEPH G GALARDI BEASLEY HAUSER KRAMER ET AL CINDI SARTAIN MEDICAL TECHNOLOGIES GEORGIA INC FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/NJ-DO/NJCB/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO JURI SCHULE ORTHOMETRIX INC WILLY LIOU ADVANCED STERILIZATION PRODS INTERTEK USA INC, WHITEHOUSE, NJ - EIR, CO RESP 8/09 TO PRESENT METRICS INC, GREENVILLE, NC - EIR, CO RESP 11/09 TO PRESENT UNIV OF GEORGIA, ATHENS, GA - FORM 2579 5/04, 6/04, 7/04 STERIS CORP - AMSCO V-PRO LOW TEMPERATURE STERILIZATION SYS K102330; STERILIZATION MATS K103226 LIST OF MEDICAL DVC MFRS WHO HAVE INSPS CONDUCTED & 510KS REVIEWED BY ACCREDITED PERSONS MEDTRONIC SOFAMOR DANEK'S - CD HORIZON SOLERA SPINAL SYS APPL APRVL 9/2/09 MEDICAL TECHNOLOGIES OF GEORGIA INC, COVINGTON, GA - INSTANTCATH (READYCATH) CATHETER K973120 BIOMET - RECAP FEMORAL & MAGNUM ACETABULAR SYS MDRS Signature/ Requester SANDOZ INC Subject
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Total Records: 12455 Control # Recd Date / Due Date 09/26/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6232 08/26/2011 09/26/2011 ORA/SW-FO/DALDO/COMPLIANCE/ SCOTT FRIEDMAN NBC 5 KXAS-TV 20011-4817 - AMERICAN AIRLINES DFW AIRPORT, TX EXHIBITS 5,6,7 9/3/10; AMERICAN EAGLE AIRLINES, AMARILLO, TX - EXHIBITS 1, 2 9/24/10; AMERICAN EAGLE, BENTONVILLE, AR, EXHIBITS 1,2,5 11/10/10, ETC MEAD JOHNSON & CO LLC - ENFAMIL, PROSOBEE, LIPIL SPL 356733 RPTS, RESULTS, ANALYTICAL W/S, ETC Signature/ Requester UNIV OF COLORADO SCHOOL OF MEDICINE Subject
2011-6233
08/26/2011 09/26/2011
ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/SEA-DO/SCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/
DAVID GRYCZ SEDGWICK LLP ELENA HOWELL HOGAN LOVELLS LLP ELENA HOWELL HOGAN LOVELLS LLP DREMONAS, GEORGE
2011-6234 2011-6235 2011-6236 2011-6237
08/26/2011 09/26/2011 08/26/2011 09/26/2011 08/26/2011 09/26/2011 08/26/2011 09/26/2011
SPIRULINA (ANTHROSPIRA PLATENSIS) - GRAS 394 SPIRULINA (ANTHROSPIRA PLATENSIS) - GRAS 391 SWIFT & CO, CHICAGO, IL - SIZZLEAN BRAND OF BACON NLEA FILINGS LATE 1970S TO MID 1980S KAMER - FDA FORM 2541A FOR GREEN & BLACK OLIVES
FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ BAYAT, LOUAY KRISTEN L FLAHERTY MORRISON MAHONEY LLP SAN SABA PECAN SAN SABA PECAN LP
2011-6238
08/26/2011 09/26/2011
BAY STATE MEDICAL CENTER, SPRINGFIELD, MA - BOTOX RPTS, NOTES, ETC 5/9/07
2011-6239
08/26/2011 09/26/2011
SPL 696166 - ANALYTICAL RESULTS
2011-6240
08/26/2011 09/26/2011
HANS EIBL BIO-PRODUCTS & BIOENGINEERING A G
EVIDENCE THAT DR HANS EIBL SERVED AS RESPONSIBLE OPERATIOR/RESPONSIBLE HEAD OF OSTERREICHISCHES INSTIUT FUR HAEMODERIVATE, VIENNA, AUSTRIA 1966 TO 1997 KEITH LOISELLE, LON WILSON, HERB CLAUHS, ETC CORR, COMM, LTRS, ETC 1/1/94 TO 8/23/11
2011-6241
08/26/2011 10/07/2011
FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/
GREGORY KAUFFMAN PENNSYLVANIA DEMOCRATIC PARTY
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Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ 2011-6242 08/26/2011 09/26/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCM/EMOPS/ OC/OER/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NWE-DO/NWECB/ 2011-6243 08/26/2011 09/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ OC/OIASI/OCP/ OC/OPPL/OP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ 2011-6244 2011-6245 08/26/2011 09/26/2011 08/26/2011 09/26/2011 ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6246 08/29/2011 CBER/OCTMA/DDOM/ALFB/ ERIN OXFORD QVD USA LLC PAUL PENTEL, MD UNIVERSITY OF MINNESOTA DIVISION OF CLINICAL PHARMACOLOGY & TOXICOLOGY JENNIFER BURKE GARDASIL - SUMMARY BASIS FOR REGULATORY ACTION FROZEN SWAI FILLETS ENTRY # 231-2449364-8 - LAB ANALYSIS LILLY - FORTEO (TERIPARATIDE) AERS FLINT, JUDITH DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMMENTS - COMM, SAFETY ISSUES, COST BENEFIT ANAYLSIS, ETC HAMZA CHAUDARY ADLER POLLOCK & SHEEHAN PC WM E MARTIN & SONS CO OR WILLIAM E MARTIN & SONS INC - SALMONELLA OUTBREAK REGARDING PEPPER EMAILS, RPTS 2009-2010 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 10/07/2011 2011-6247 2011-6248 08/29/2011 09/27/2011 08/29/2011 09/28/2011 2011-6249 2011-6250 08/29/2011 09/27/2011 08/29/2011 09/27/2011 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-6251 2011-6252 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6253 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/MIN-DO/MCB/ 2011-6254 2011-6255 2011-6256 2011-6257 2011-6258 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MANISH AHUJA BIO TEX INC MANISH AHUJA BIO TEX INC MANISH AHUJA BIO TEX INC MANISH AHUJA BIO TEX INC MANISH AHUJA BIO TEX INC K943541 K102743 K030172 K022986 K060260 OC/COS/OL/ MINNESOTA PUBLIC RADIO NEWS JONEL ALECCIACDER MSNBC INTERACTIVE NEWS LLC FDA/OF/CFSAN/OCD/EOS/ BUSHONG, JAMES SEN AL FRANKEN, SEN AMY KLOBUCHAR, REP ERIK PAULSEN - CORR H&P INDUSTRIES; TRIAD GROUP OF HARTLAND, WI RECONDITIONING PLAN DIMETHYLDIALKYLAMONIUM CHLORIDE - FDA PETITION FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ OC/OM/OMP/EIS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ Doe J RUSSEL GOMES TRANSWORLD LOGISTICS SHIPPING SERVICES (TLSSI) LITTLE BEE IMPEX, DORAHA, INDIA - ENTRY #NF72110609-6 LAB ANALYSIS SNOKIST GROWERS, YAKIMA, WA - RPT Action Office Signature/ Requester AGENUS CHARLES LIM EDGEPRO TRADING INC JOE EATON Subject 6/06 MAXIMUM NUTRITION LLC, CULPEPPER, VA; MANASSAS, VA - GMP RECS
FDA EMPLOYEE CONFLICT-OF-INTEREST WAIVERS 2008CENTER FOR PUBLIC INTEGRITY 2010
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Total Records: 12455 Control # 2011-6259 2011-6260 Recd Date / Due Date 08/29/2011 09/27/2011 08/29/2011 09/27/2011 Action Office CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6261 2011-6262 2011-6263 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6264 2011-6265 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6266 2011-6267 2011-6268 2011-6269 2011-6270 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ 2011-6271 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JASON P JOHNSTON ZIMMERMAN REED PLLP MERCK - PROPECIA LABEL CHANGES, MARKETING, ADVERTISING RPTS, MEMOS CORR ETC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DAVID W PLUNKETT Center for Science in the Public Interest FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JONATHAN REEVES MAKO SURGICAL CORP MAKO SURGICAL CORP - PATELLOFEMORAL KNEE IMPLANT SYS II K082088 MAKO SURGICAL CORP - PATELLOFEMORIAL KNEE IMPLANT SYS K080029 ARTHROSURFACE INC - HEMICAP PATELLO-FEMORAL RESURFACING SYS K071413 STAKEHOLDER LISTENING SESSIONS ON A PROGRAM TO SAMPLE MILK FOR DRUG RESIDUES - RPTS, MEMOS, CORR, ETC 3/1/11-8/1/11 BIOPRO INC - TOWNLEY TOTAL KNEE K904448 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ DeARMOND, ROBERT L BRIAN CALLACI CHANGE TO WIN WILLIAM A OLSON PHD Center for Regulatory Services, Inc. JONATHAN REEVES MAKO SURGICAL CORP ZIMMER INC - BRIGIT SURGICAL DVC K060556 2 SISTERS FOOD GROUP INC, WILD ROCKET FOODS LLC, FRESH & EASY NEIGHBORBOOD MARKET INC, RIVERSIDE, CA - EIRS, WARNING LTRS, INJUNCTIONS, ETC ASAHI GLASS CO LTD - FCN 599 ALLEN, IRA R ASSOCIATE COMMISSIONER BETH MARTINO - CORR 3/1/10-10/15/10 BIOFILM INC, VISTA, CA - EIR 5/31/11 Doe J Signature/ Requester ELENA HOWELL HOGAN LOVELLS LLP Subject STAR SCIENTIFIC - STONEWALL MOIST-BDL SNUFF APRVL APPL, RECS MEDWATCH RPT - INDIVIDUAL RECS
Page 430 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6272 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6273 2011-6274 2011-6275 2011-6276 2011-6277 2011-6278 2011-6279 2011-6280 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC WALTER E. CHALKLEY THOMSON REUTERS MARK PIFKO BARON BUDD PC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ADVANCE SUTURE INC - ABSORBABLE GUT SUTURE K903174 TCA CELLULAR THERAPY LLC, COVINGTON , LA - EIR, 483, CO RESP 2/22-3/31/11 CYTOSPORT INC - CHOCOLATE MUSCLE MILK PROTEIN NUTRITON SHAKE, VANILLA CREAM MUSCLE MILK LIGHT NUTRITION SHAKE MEMOS, NOTES, LAB DATA, INVESTIGATION RECS, ETC YALE COHEN MD, HOLLYWOOD, CA - EIR, 483, CO RESP 2/7-11/11 SALIX PHARMS - XIFAXAN (RIFAXIMIN) NDA 21-361 APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC GARY DORROUGH ARTHREX INC GARY DORROUGH ARTHREX INC PHOTO THERAPEUTICS LTD - OMNILUX RED K030426 MVV 5021428 - MAUDE RVW FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ARTHROSURFACE INC - HEMICAP PATELLO-FEMORAL RESURFACING PROSTHESIS K060127 AGELESS BEAUTY CORP - EVIS MD PLATINUM RED LIGHT THERAPY K082247 MVV 5-51240 - MAUDE RVW JASON P JOHNSTON ZIMMERMAN REED PLLP MERCK - PROSCAR LABEL CHANGES, ADVERTISING, MARKETING RPTS, MEMOS, CORR ETC Signature/ Requester Subject
2011-6281 2011-6282
08/29/2011 09/27/2011 08/29/2011 09/27/2011
WALTER E. CHALKLEY THOMSON REUTERS FOI SERVICES INC
2011-6283
08/29/2011 09/27/2011
WALTER E. CHALKLEY THOMSON REUTERS
CHEM AGIS, BER SHEVA, ISRAEL - EIR, 483, CO RESP 4/10
Page 431 of 1132

Total Records: 12455 Control # 2011-6284 Recd Date / Due Date 08/29/2011 09/27/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6285 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6286 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6287 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ 2011-6288 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ 2011-6289 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6290 2011-6291 08/29/2011 09/27/2011 08/29/2011 09/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6292 08/29/2011 FDA/OMPT/CDER/ORP/DIDP/ SANOFI AVENTIS - DRISDOL NDA 03-444 APRVL RECS FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ LESLIE HONDA ZENO CORP PHAROS LIFE CORP, CAMBRIDGE, ONTARIO - TANDA MAX SYS K103415 ICON CLINICAL RESEARCH - WARNING LTR 10-HFD-4511-04 CORR FOI SERVICES INC HUMIRA - ISRS 7134330, 7091003, 7090163, ETC HENRY F. BAYARD COLE, SCOTT & KISSANE PHARMACY INFUPHARMA LLC, HOLLYWOOD, FL CMPLNTS, RPTS HENRY F. BAYARD COLE SCOTT AND KISSANE AVASTIN - APPLICATION FOR EYE TREATMENTS DONE IN MAIMI, FL 2011 RPTS, INVESTIGATION WALTER E. CHALKLEY THOMSON REUTERS AUROBINDO PHARMA LTD, UNIT VI, HYDERABAD, INDIA EIR, 483, CO RESP 12/7-10/10 FOI SERVICES INC SALIX PHARMS - XIFAXAN (RIFAXIMIN) NDA 22-554 APRVL RECS Signature/ Requester WALTER E. CHALKLEY THOMSON REUTERS Subject CHEM AGIS, RAMA HEVAV, ISRAEL - EIR, 483, CO RESP 10/07
Page 432 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/27/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6293 2011-6294 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6295 08/29/2011 09/27/2011 ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6296 2011-6297 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6298 08/29/2011 09/27/2011 2011-6299 08/29/2011 09/27/2011 2011-6300 2011-6301 2011-6302 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6303 08/29/2011 09/28/2011 2011-6304 08/29/2011 09/27/2011 ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/PHI-DO/PCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ ROBERT STONE TOWER LABORATORIES LTD LAURA J. CONYERS FINDLING PARK AND ASSOCIATES PC GLENN A MURPHY LITIGATION & ADVOCACY GROUJP GLENN A MURPHY LITIGATION & ADVOCACY GROUJP JP DEATON SERVICE CENTER LLC VAIJEAN TR0TMAN ARROW OTC INC FRANK MAFRICE FRANK MAFRICE & ASSOCIATES PLLC SETH CROMPTON HOLLAND GROVES SCHNELLER STOLZE JOHN D CARSON JR DUFFY & FEEMSTER LLC CORR BETWEEN JOHN DAVID BLAHA MD & FDA 1/1/00 TO PRESENT DIAL CORP - USE OF TRICLOSAN IN DIALCOMPLETE INVESTIGATION RECS LIKEN ENTERPRISES INC (DBA ACTIVE NUTRITION CORP) RAGE RV5 (RADICAL ANABOLIC GROWTH EVOLUTION) RECS AMERILAB TECHNOLOGIES INC, PLYMOUTH, MN - EIR 10/30/09, 11/3/09 ALARIS SYS INC - K950419, K032147, K012383, K993524 (CERTIFIED) DEPUY - ASR XL ACETABULAR SYS MDRS LAST 12 MONTHS ZIMMER - DUROM ACETABULAR COMPONENT (DUROM CUP) MDRS LAST 24 MOS ALERT MEDICAL INC, SOUTHFIELD. MI - MEDICAL OXYGEN CYLINDER CMPLNT RESULTS LNK INTERNATIONAL INC, HAUPPAGE, NY - EIR 1/19-26/11 FDA/OMPT/CDRH/OCER/DFOI/ KENT L. KLAUDT, Esq. LIEFF CABRASER ET AL QUYNH C SPERRAZZA FAEGRE & BENSON LLP BILLIE B RELYEA YOUNG CONAWAY STARGATT & TAYLOR MEDTRONIC INC - INFUSE BONE GRAFT MDRS, INVESTIGATIONS, APRVL HILLANDALE FARMS - SHELL EGGS SALMONELLA ENTERITIDIS OUTBERAK INVESTIGATION, TRACEBACK RECS, CORR, ETC 2010 IV CLINDAMYCIN - AERS Signature/ Requester FOI SERVICES INC Subject
Page 433 of 1132

Total Records: 12455 Control # 2011-6305 2011-6306 2011-6307 Recd Date / Due Date 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 Action Office ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/BLT-DO/CB/ 2011-6308 2011-6309 2011-6310 2011-6311 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6312 2011-6313 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6314 2011-6315 2011-6316 08/29/2011 09/27/2011 08/29/2011 09/27/2011 08/29/2011 09/27/2011 2011-6317 08/30/2011 09/28/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INFORMATION ACCESS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ANDREW ZELTWANGER RESPIRONICS INC TAMMY ADKINS COATS ALOE INTERNATIONAL HAMZA CHAUDARY ADLER POLLOCK & SHEEHAN PC WM E MARTIN & SONS CO INC - SALMONELLA OUTBREAK 2009-2010 FOI DAILY LOGS 8/8-12/11 COATS ALOE INTL, DALLAS, TX - EIR 1/10 NOX T3, NOXTURNAL - K082113 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TRENT OSTLER NOVARAD CORP SUSAN B. MILLS WEINBERG WHEELER ET AL SHELL EGGS - SALMONELLA ENTERITIDIS MULTISTATE OUTBREAK INVESTIGATION 5/10 TO 12/10 MIM SOFTWARE INC - MOBILE MIM K103785 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ELENA HOWELL HOGAN LOVELLS LLP BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO LESLIE HONDA ZENO CORP WEST COAST ANALYTICAL SERVICES INC, SANTA FE SPRINGS, CA - EIRS 8/09 TO PRESENT PHAROS LIFE CORP, CAMBRIDGE, ONTARIO - TANDA SKINCARE SYS K070185 GENERAL MILLS - CHEERIOS CEREAL CORR 5/1/11 TO 8/26/11 EXIVA INC, SATA FE SPRINGS, CA - EIR 6/09 TO PRESENT BOWMAN, BENJAMIN Signature/ Requester THAD SITTERSON CH GUENTHER & SON INC DARLENE A. SKINNER, Esq. LIFEBRIDGE HEALTH AMERICAN RED CROSS & ALL BLOOD BANKS - WARNING LTRS, FINES, ENFORCEMENT ACTIONS 1/1/2000 TO PRESENT Subject CH GUENTHER & SON INC - SPL # 696165 ANALYSIS RESULTS TRIAD SURGICAL LUBRICANT JELLY - RECALL 2010, 2011
Page 434 of 1132

Total Records: 12455 Control # 2011-6318 2011-6319 2011-6320 2011-6321 2011-6322 Recd Date / Due Date 08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011 09/28/2011 2011-6323 08/30/2011 09/28/2011 2011-6324 2011-6325 2011-6326 2011-6327 08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011 09/28/2011 2011-6328 08/30/2011 09/28/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC SANDY FRIEDMAN WOLTERS KLUWER LAW & BUSINESS ROBERT P CHARROW GREENBERG TRAURIG LLP TEVA, LEMMON CO - PROPACET PROPOXPHENE NAPSYLATE & ACETAMINOPHEN TABS ANDA 70-107, ANDA 70-146, ANDA 70-732; PROPOXYPHENE HCL ASPRIN & CAFFEINE CAPS ANDA 80-044, ANDA 80-269, ETC COOK UROLOGICAL INC - LINDER/GOLOMB SP INTRODUCING SOUND - K953024 PROCON 2 - K042431 INVACARE CORP, SANFORD, FL - EIRS 8/2-18/10; RESP TO EIRS 9/8/10, CMPLNTS, ETC MEDIWARE INC - 483 7/11 CLOSED FOIA REQUESTS 8/22-25/11 CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOIA REQUESTS 8/22-26/11 CLOSED FOIA REQUESTS 8/16/22/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY 8/8-12/11 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 8/8-12/11 Center for Regulatory Services, Inc. FOI DAILY LOG 8/8-12/11 DOMINION GROUP INC FOI DAILY LOG 8/8-12/11 FOI SERVICES INC FOI DAILY LOG 8/8-12/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 8/8-12/11 Signature/ Requester Subject FOI DAILY LOG 8/8-12/11
2011-6329
08/30/2011 09/28/2011
NORMAN F ESTRIN ESTRIN CONSULTING GROUP INC
2011-6330 2011-6331 2011-6332
08/30/2011 09/28/2011 08/30/2011 09/28/2011 08/30/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CHI-DO/CCB/
ZVI SHALVI FORCONTI MEDICAL GLORIA KUI MELWANI MILBERG LLP JON ZENKER
Page 435 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/28/2011 2011-6333 2011-6334 08/30/2011 09/28/2011 08/30/2011 09/28/2011 2011-6335 08/30/2011 09/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6336 08/30/2011 09/28/2011 2011-6337 08/30/2011 09/28/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6338 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6339 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6340 08/31/2011 09/29/2011 2011-6341 08/31/2011 09/29/2011 2011-6342 08/31/2011 09/29/2011 ORA/SW-FO/DEN-DO/COMP/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J ORA/P-FO/SEA-DO/SCB/ WENDY LEES NORTHWEST COSMETIC LABS LLC WENDY LEES NORTHWEST COSMETIC LABS LLC MELANOTAN II INJ - MEDWATCH RPT CMPLNT 117639 CMPLNT 59846 L ANDREW HOLLIS HOLLIS WRIGHT & COUCH PC ROCHE INC - TORADO AERS (CERTIFIED) L ANDREW HOLLIS HOLLIS WRIGHT & COUCH PC SHIRE US INC - ADDERALL AERS (CERTIFIED) ROBERT H BRETZ ROBERT H BRETZ ATTY AT LAW CRISTINA N RUBKE SHARTSIS FRIESE LLP NATURALS INC, THRESHOLD ENTERPRISES LLC, MRS GOOCH'S NATURAL FOODS MARKETS, ETC - CHLORELLA CAERS, WARNINGS, TESTING, ETC PINE NUTS (PINE MOUTH) - CMPLNTS, CAERS, SPL ANALYSIS, ETC ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/DET-DO/DCB/ Action Office Signature/ Requester NORTH SHORE UNIV HOSPITAL TAMMY ADKINS COATS ALOE INTERNATIONAL ANDREA L NORDLUND AMERICAN RED CROSS GREAT LAKES REGION BENJAMIN MAJORS MIGHTY OAK MEDICAL COATS ALOES INTERNATONAL INC, DALLAS, TX - EIR 1/1115/10 AMERICAN RED CROSS-GREAT LAKES, MUSKEGON, FLINT, PETOSKEY, MI - EIRS 2/3-24/04, 4/26/04, 6/8-10/04 TRIATHLON CUSTOM KNEE - K051146 Subject
Page 436 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6343 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6344 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6345 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6346 2011-6347 2011-6348 08/31/2011 09/29/2011 08/31/2011 09/29/2011 08/31/2011 09/29/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6349 2011-6350 08/31/2011 09/29/2011 08/31/2011 09/29/2011 2011-6351 08/31/2011 09/29/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NYK-DO/NYDCB/ CRAIG ROUSH ROCHLINE INDUSTRIES VICKI L HART JAMES DARK & BRILL ATTY AT LAW DUFF MACKAY COUNCIL FOR RESPONSIBLE NUTRITION ABH NATURES PRODUCTS INC, FARMINGDALE, NY 8/20/10; ALOE FARMS INC, HARLINGEN, TX 3/17/10; ALOE VERA OF AMERICA INC, DALLAS, TX 9/28/10, ETC - EIRS, 483S PROFESSIONAL DISPOSABLES INTERNATIONAL (PDI) INC, ORANGEBURG, NY - EIR, 483, ETC 8/1/10 TO 8/25/11 BIOFLEX INC - ELECTRICAL STIMULATION DVC RECS ORA/P-FO/LOS-DO/LACB/ RON LAPRE OBAGI MEDICAL PRODUCTS MONICA ENGEBRESTON BORN FREE USA PATRICIA L REGENYE Celgene Corporation JUNGLE GEORGE AMUSEMENTS INC, FREEMONT, CA - EIR 1/10 TO PRESENT MICHAEL WEISMAN, THORNTON HOSPITAL, LA JOLLA, CA 483 5/99 OT 8/11 OBAGI MEDICAL PRODUCTS INC, CARSON, CA - EIR 8/19/08 PAUL SOS OPTIMA VEIN CARE BIONICHE PHARMA USA - SOTRADECOL SODUIM TETRADECYL SULFATE AERS 2009 TO PRESENT ROSS S LADERMAN KOWA RESEARCH INSTITUTE INC HERITAGE PHARMS INDOMETHACIN NDA - 18-851 APRVL, RVWS, HISTORY, ETC KAHLENBERG, SUSAN FORTEO - AERS 1/02 TO PRESENT Signature/ Requester Subject
Page 437 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-6352 08/31/2011 09/29/2011 2011-6353 08/31/2011 09/29/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6354 08/31/2011 09/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6355 08/31/2011 09/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6356 2011-6357 2011-6358 2011-6359 2011-6360 08/31/2011 09/29/2011 08/31/2011 09/29/2011 08/31/2011 09/29/2011 08/31/2011 09/29/2011 08/31/2011 09/29/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ MORROW, LEN W BOBBY SCHOCHET OFW LAW SUMMARY OF INFANT FORMULA NOTIFICATION 1/1/118/1/11 OM/OMP/DODM/ PORTER, ANN DEPUY INTL LTD, LEEDS, UK - EIR 2003 TO 2010 OC/OM/OMP/DDM/ ORA/SE-FO/ATL-DO/ACB/ Doe J KATHERINE PORTNOY THE PEW CHARITABLE TRUSTS ADVISORY COMMITTEE MTG ON LOVASTATIN 2/19/87 DKT 1999P-5332, 1986G-0289 CMPLNT 119014 WHITTINGTON, RICHARD CHINESE COMPANIES REGISTERED AS FOREIGN DRUG ESTABLISHMENTS GARY J. SYRING QUALITY & REGULATORY ASSOCS LLC SYMMETRY AORTIC CLIP SYS - K003446; CORLINK AAD K011589; COALESCENT SURGICAL U-CLIP - K013664 W E CHALKLEY THOMSON REUTERS NOVARTIS - LESCOL XL (FLUVASTATIN SODIUM) NDA 21192/S002 APRVL LTR ERIC HAGEMAN PRITZKER OLSEN SIMPLY THICK - INDIVIDUAL RECS Signature/ Requester Subject
Page 438 of 1132

Total Records: 12455 Control # 2011-6361 Recd Date / Due Date 08/31/2011 09/29/2011 2011-6362 2011-6363 08/31/2011 09/29/2011 08/31/2011 09/29/2011 2011-6364 2011-6365 09/01/2011 09/30/2011 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6366 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6367 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6368 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6369 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6370 2011-6371 09/01/2011 09/30/2011 09/01/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ANGELIA D SLAYTON PPD LABS, MIDDLETON, WI - EIRS, 483S, CO RESP 2/1/118/1/11 PBM MILK-BASED INFANT FORMULA SUPPLEMENTED WITH DHA & ARA - CORR, CLNCL DATA 2005, 2006 ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PATHEON INC, WHITBY, ONTARIO, CANADA - EIRS, 483S, CO RESP 2/1/11-8/1/11 CHARLES EATON MD HAND CENTER XIAFLEX (COLLAGENASE CLOSTRIDIUM HISTOLYTICUM) AERS ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PATHEON INC, BOURGOIN-JALLIEU, CEDEX, FRANCE EIRS, 483S, CO RESP 2/1/11-8/1/11 ANGELIA D SLYTON KENDLE INTERNATIONAL INC PATHEON INC, BURLINGTON, ONTARIO, CANADA - EIRS, 483S, CO RESP 2/1/11-8/1/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ ORA/SE-FO/FLA-DO/FCB/ LIA OBATA DOWD DOWD & DOWD PC FANNIE BURTON-SHELBY CHERRY PETERSEN LANDRY ET AL ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PATHEON, CINCINNATI, OH - EIRS, 483S, CO RESP 2/1/118/1/11 PATHEON, MISSISAUGA, ONTARIO, CANADA - EIRS, 483S, CO RESP 2/1/11-8/1/11 INVACARE CORP, ELYRIA, OH - WARNING LTR, CO RESP 12/15/10 2010-8206 - DELETED RECS Signature/ Requester JEFF STACHEWICZ, Esq. FOIA GROUP INC Subject HHSF223201000014I - CONTRACT, INVOICES, RPTS
Page 439 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/30/2011 2011-6372 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6373 2011-6374 2011-6375 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6376 2011-6377 2011-6378 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 2011-6379 09/01/2011 09/30/2011 2011-6380 09/01/2011 09/30/2011 2011-6381 09/01/2011 09/30/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ SIMMONS, MARK DRAFT GUIDANCE FOR INDUSTRY: DIETARY SIPPLEMENTS - CONGRESSIONAL CORR, SAFETY ISSUES, FINANCIAL ESTIMATES, ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/PHI-DO/PCB/ ANGELLIA D SLAYTON KENDLE INTERNATIONAL INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ZUHAL TOMPKINS TECHNOLOGY SCIENCES GROUP INC CARYN CAPONE EMINENT SPINE LLC LORI PFOHL TELEFLEX MEDICAL INTERBODY FUSION SYS - K090064, FANG PLATE SYS K090415, DIAMONDBACK PEDICLE SCREW SYS - K100377, ETC COVIDIAN - TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES K090352 ALMAC CLINICAL SERVICES, AUDUBON, PA - EIRS, 483S, CO RESP 2/1/11-8/1/11 CELSIS LABORATORY GROUP, ST LOUIS, MO - EIRS, 483S, CO RESP 2/1/11-8/1/11 K051342, K080631, K000996 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC JUSTIN LOVELACE C R BARD INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PATHEON (NOVA PHARMACEUTICAL CORP), MANATI, PR EIRS, 483S, CO RESP 2/1/11-8/1/11 CIANNA S1 SINGLE LUMEN BALLOON APPLICATOR K103215 NYCOMED GMBH, SINGEN, GERMANY - EIRS, 483S, CO RESP 2/1/11-8/1/11 Action Office Signature/ Requester KENDLE INTERNATIONAL INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC SHASUN PHARMA SOLUTIONS (FORMERLY RHODIA PHARMA SOLUTIONS), NORTHUMBERLAND, ENGLAND EIRS, 483S, CO RESP 2/1/11-8/1/11 Subject
Page 440 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6382 09/01/2011 09/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ 2011-6383 09/01/2011 09/30/2011 FDA/OMPT/CDRH/OCER/DFOI/ WALKER, STEPHEN LEVITRONIX LLC - PEDIMAG BLOOD PUMP K090051; MAQUET CADIOPULMONARY AG - ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING K090515; MEDTRONIC PERFUSION SYSTEMS - TRILLIUM BIOPUMP PLUS K050109, ETC REGLAN, METOZOLV ODT (METOCLOPRAMIDE) - RPTS, CMPLNTS, STUDIES, ETC DAMON ELDER ARNOLD & PORTER NASTOS CONSTRUCTION INC, WASHINGTON, DC; NASTOS GROUP INC, CLINTON, MD; MTR LLC, WASHINGTON, DC, ETC - CONTRACTS COSTS, WAGE RECS, RECEIPTS, ETC Signature/ Requester Subject
2011-6384
09/01/2011 09/30/2011
ELIZABETH S LAWTON ESQ SHUMAN MCCUSKEY & SLICER ATTYS
2011-6385
09/01/2011 09/30/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/
JEFF STACHEWICZ FOIA GROUP INC
K984114
2011-6386
09/01/2011 09/30/2011
K979497 FOIA GROUP INC JAN MILLER VANTAGE CONSULTING INTERNATIONAL LTD ETHICON - SURGIFLOW P990004/S008
2011-6387
09/01/2011 09/30/2011
2011-6388
09/01/2011 09/30/2011
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ RATLIGFF, SARAH
TOPOMAX (TOPIRAMATE) - AERS
2011-6389
09/01/2011
LARRY G MCGIRR
PROCTER & GAMBLE CO - STEARYL FAP 8B2200
Page 441 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/30/2011 2011-6390 2011-6391 09/01/2011 09/30/2011 09/01/2011 09/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6392 2011-6393 2011-6394 2011-6395 2011-6396 2011-6397 2011-6398 2011-6399 2011-6400 2011-6401 2011-6402 2011-6403 2011-6404 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ SMITH, JOSHUA D ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KNIPPER & CO INC, LAKEWOOD, NJ - EIR, 483, CO RESP 2/1/11-8/1/11 LANCASTER LABORATORIES, LANCASTER, PA - EIR, 482, CO RESP 2/1/11-8/1/11 MEDCOMM SOLUTIONS, EMERYVILLE, CA - EIR, 483, CO RESP 2/1/11-8/1/11 NEXT BREATH LLC, BALTIMORE, MD - EIR, 483CO RESP 2/1/11-8/1/11 NORWICH PHARMACEUTICALS INC, NORWICH, NY - EIR, 483, CO RESP 2/1/11-8/1/11 PACE ANALYTICAL LIFE SCIENCES LLC, OAKDALE, MN EIR, 483, CO RESP 2/1/11-8/1/11 PFIZER INC, KALAMAZOO, MI - 483, INSP, CO RESP 2/18/1/11 PHARMACETUICS INTERNATIONAL INC, HUNT VALLEY, MD - 483, INSP, CO RESP 2/1-8/1/11 ORA/SE-FO/SJN-DO/SJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ANEET PANSAR BURDOCK GROUP KENNON DANIELS PHD BEAUFORT LLC ANDREW MCNICOLL PATHEON INC ANDI POULSON LEXIS NEXIS FDA FOI REQUESTS 8/22-26/11 2011-5447 PYCNOGENOL - REGULATORY STATUS, CONSUMPTION, SAFETY RECS, ETC 1/03 TO PRESENT MASIMO - RAINBOX SET PRONTO PULSE CO-OXIMETER & ACCESSORIES K082052 MERCK, ARECIBO, PR - INSPS 2010, 2011 FRATTI, JOHN Action Office Signature/ Requester CANTOX Health Sciences International ALEX TRAHEY ANALYSIS GROUP FDA A/C PANEL - NICOTINE PATCH TRANS, MINS 1992; NICOTROL, NICODERM OTC SALE TRANS, MINS 1996 LEVAQUIN, CIPRO, AVELOX (FLUOROQUINOLONES) - AERS LAST 10 YRS Subject
Page 442 of 1132

Total Records: 12455 Control # Recd Date / Due Date 09/30/2011 2011-6405 2011-6406 09/01/2011 09/30/2011 09/01/2011 09/30/2011 2011-6407 2011-6408 2011-6409 2011-6410 2011-6411 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6412 2011-6413 2011-6414 2011-6415 2011-6416 2011-6417 2011-6418 2011-6419 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 09/01/2011 09/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC DYNAMIT NOBEL GMBH, KALKSTRASSE, LEVERKUSEN, GERMANY - INSP, 483, CO RESP 2/1/11-8/1/11 3M HEALTH CARE, LT LOUGBOROUGH, LEICESTERSHIRE, UK - INSP, 483, CO RESP 2/1-8/1/11 BESPAK EUROPE LTD, NORFOLK, ENGLAND - 483, INSP, CO RESP 2/1-8/1/11 AEROCAN FRANCE SAS, BELLEGARDE, FRANCE - INSP, 483, CO RESP 2/1-8/1/11 MICRONISIERUNGS KONTOR OBERROT GMBH, OBERROT, GERMANY - INSP, 483, CO RESP 2/1-8/1/11 DOW CHEMICAL CO, MIDLAND, MI - INSP, 483, CO RESP 2/1-8/1/11 HOLOPACK, COLUMBIA, SC - INSP, 483, CO RESP 2/1-8/1/11 ABC LABS, COLUMBIA, MO - 483, INSP, CO RESP 2/1-8/1/11 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/NJ-DO/NJCB/ Action Office Signature/ Requester KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC PHARMAGISTICS LLC, SOMERSET, NJ - 483, INSP, CO RESP 2/1-8/1/11 UNIVERSITY OF IOWA, PHARMACEUTICAL SERVICES DIVISION, COLLEGE OF PHARMACY, IOWA CITY, IA - 483, INSP, CO RESP - 2/1-8/1/11 UPS SUPPLY CHAIN SOLUTIONS, LOUISVILLE, KY - INSP, 483, CO RESP 2/1-8/1/11 UPS SUPPLY CHAIN SOLUTIONS, RENO, NV - INSP, 483, CO RESP 2/1-8/1/11 WEST ANALYTICAL SERVICES LLC, MAUMEE, OH - INSP, 483, CO RESP 2/1-8/1/11 LAKESHORE DRIVE, WOODSTOCK, IL - 483, INSP, CO RESP 2/1-8/1/11 DAINIPPON SUMITOMO PHARMA, SUZUKA, MIE, JAPAN INSP, 483, CO RESP 2/1-8/1/11 Subject
Page 443 of 1132

Total Records: 12455 Control # 2011-6420 Recd Date / Due Date 09/01/2011 09/30/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6421 2011-6422 2011-6423 2011-6424 2011-6425 2011-6426 2011-6427 09/01/2011 09/30/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6428 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6429 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ KAMRAN MALIK MALIK, KAMRAN ORCHID CHEMCIALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - LEVETIRACETAM EIRS 2010, 2011 KAMRAN MALIK MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - TADALAFIL EIRS 2010, 2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC ROY J HARDMAN RIGHT TIME BUSINESS ROY J HARDMAN RIGHT TIME BUSINESS ROY J HARDMAN RIGHT TIME BUSINESS MARINA GUEVREKIAN BIOSENSE WEBSTER INC MARINA GUEVREKIAN BIOSENSE WEBSTER INC KAMRAN MALIK MALIK, KAMRAN VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS - K090976 ASCENT HEALTHCARE SOLUTIONS - REPROCESSES DIAGNOSTIC ULTRASOUND CATHETER K063076 ASCENT HEALTHCARE SOLUTIONS - REPROCESSES 3D DIAGNOSTIC ULTRASOUND CATHETERS K092425 ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - EIRS 2010, 2011 3M PHARMACEUTICALS, HORTHRIDGE, CA - INSP, 483, CO RESP 2/1-8/1/11 VERICORE ABUTMENT IN ZIRCONIA FOR IMPLANT SYSTEMS - K082299 VERICORE CUSTOM ABUTMENT IN TITANIUM - K092857 Signature/ Requester ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC Subject LABOR L&S AG BAD BOCKLET GROSSENBRACH, GERMANY - 483, INSP, CO RESP 2/1-8/1/11
Page 444 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-6430 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6431 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6432 09/02/2011 10/03/2011 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/OCC/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6433 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6434 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ JULIE PITT FEDERAL PUBLIC DEFENDER ARKANSAS COMMUNICATIONS REGARDING SOUTH DAKOTA IMPORTATION OF SODIUM THIOPENTONE/THIOPENTONE SODIUM/THIOSOL SODIUM ELAINE JANKE CANGENE CORP WINRHO SDF - AER PAIGE TOMASELLI CENTER FOR FOOD SAFETY POSILAC (RBST, RBGH) - RPTS, STUDIES, SS&E; MONSANTO - RBST, RBGH INTERNAL AGENCY COMM, CONTAMINATION ISSUES, HEALTH ISSUES, ETC KAMRAN MALIK MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - DIPYRIDAMOLE EIRS 2010, 2011 KAMRAN MALIK MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - TERBINAFINE HCL EIRS 2010, 2011 Signature/ Requester Subject
Page 445 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office CVM/OCD/ 2011-6435 09/02/2011 10/03/2011 2011-6436 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6437 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6438 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6439 2011-6440 2011-6441 09/02/2011 10/03/2011 09/02/2011 10/03/2011 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6442 09/02/2011 10/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6443 09/02/2011 10/03/2011 2011-6444 09/06/2011 10/04/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MERCK & CO., INC. FOI DAIL LOG 8/15-19/11 LISE TERKELSEN TONICA ELEKTRONIK AS MARIANO, JOSEPHINE LEE M. POLLACK, A. MOSHOLDER, SUICIDALITY: VARENICLINE, BUPROPION NICOTINE TRANSDERMAL PATCH FDA DOC 2008; M. POLLACK, J. JU, A. MOSHOLDER: PSYCHIATRIC EVENTS (EXCLUDING SUICIDES) VARENICLINE & BUPROPION 2008 NEURONETICS INC - NEUROSTAR TMS THERAPY SYS K083538 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER SUTTMOELLER CERVANTES & ASSOCIATES CEMIL GOKSU THERENVA SAS HOLLIE J. WELLS SANDOZ INC 3 MENSIO MEDICAL IMAGING BV - 3 VISEON SURGERY K072653 MONOPRIL NDA 19-915; MACROBID NDA 20-064; DAYPRO NDA 18-841, ETC - LBLG VASCULAR SOLUTIONS - DUETT CLOSURE DVC RECS TREVOR M. POLISCHUK, PhD., MBA ORBIMED HEALTHCARE FUND MANAGEMENT NOVARTIS - GILENYA (FINGOLIMOD) AER 10/10 TO PRESENT SEAN BRYNJELSEN AKORN INC ATON PHARMA - TIMOPTIC IN OCUDOSE NDA 19-463 Farmer, Linda OC/OM/OMP/DDM/ AMY L. FULTON BUCHANAN INGERSOLL & ROONEY PC AZRITHROMYCIN - AER DKT 1975N-0223 Signature/ Requester Subject
Page 446 of 1132

Total Records: 12455 Control # 2011-6445 2011-6446 2011-6447 2011-6448 2011-6449 2011-6450 Recd Date / Due Date 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 2011-6451 09/06/2011 10/04/2011 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ CBER/OCTMA/DDOM/ALFB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ MERCK & CO., INC. JON STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS MERCK & CO INC - ROTATEQ ROTAVIRUS VACCINE VAERS 8/1-31/11 MERCK & CO INC - GARDASIL HPV VACCINE VAERS 8/131/11 APPLIED DIABETES RESEARCH INC, CARROLTON, TX; COATS INTERNATIONAL HOLDINGS INC, DALLAS, TX; ERCHONIA CORP, MCKINNEY, TX - 483S 7/1-31/11 KBD INC, CRESCENT SPRINGS, KY; MEAS US LLC/MEASUREMENT SPECIALITIES INC, DAYTON, OH; SUN PHARMACEUTICAL INDUSTRIES, INC, BRYAN, OH - 483S 7/1-31/11 ABBOTT LABS, ABBOTT PARK, IL; AMERICAN BLENDING & FILING COMPANY INC, WAUKEGAN, IL; CORPARK MEDSYSTEMS, WHEELING, IL, ETC - 483S 7/1-31/11 ADVANCED BIO-HEALING INC, LA JOLLA, CA; AMPRONIX, IRVINE, CA; COSMOCEUTICAL RESEARCH CENTER INC, VAN NUYS,CA, ETC - 483S 7/1-31/11 SALBA SMART NATURAL PRODUCTS LLC - CMPLNTS MERCK & CO., INC. CLOSED FOIA REQUESTS 8/1-31/11 MERCK & CO., INC. FOI DAILY LOG 8/22-26/11 Signature/ Requester Subject FOI DAILY LOG 8/29/11-9/2/11
2011-6452
09/06/2011 10/04/2011
JOHNATHAN RICKMAN FDA NEWS
2011-6453
09/06/2011 10/04/2011
ORA/P-FO/LOS-DO/LACB/
2011-6454
09/06/2011 10/04/2011
ORA/SW-FO/DEN-DO/COMP/
WILLIAM A RALSTON SALBA SMART NATURAL PRODUCTS LLC
2011-6455 2011-6456
09/06/2011 10/04/2011 09/06/2011 10/04/2011
ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/NJ-DO/NJCB/
JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDA NEWS
NOVARTIS CONSUMER HEALTH, LINCOLN, NE; CLASSIC LADY PACKAGING INC, WENTZVILLE, MO - 483S 7/1-31/11 ARTHRON INC, FRANKLIN, TN; KLINGER EYE SHIELDS INC, SELMA, AL; RESTORATIVE HEALTH SERVICES INC, MURFREESBORO, TN - 483S 7/1-31/11 API INC, FAIRFIELD, NJ; MILESTON SCIENTIFIC INC, LIVINGSTON, NJ; NOVUS FINE CHEMICALS, CARLSTADT, NJ, ETC - 483S 7/1-31/11 JOHNSON & JOHNSON - EIRS ALLERGAN INC - BOTOX (ONABOTULINUMTOXINA) AERS
2011-6457
09/06/2011 10/04/2011
2011-6458 2011-6459
09/06/2011 10/04/2011 09/06/2011
ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/
DORCIE MCKNIFF JASPERSE RALAND TECHNOLOGIES LLC MICHELLE FAY CORTEZ
Page 447 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/04/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6460 2011-6461 09/06/2011 10/04/2011 09/06/2011 10/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6462 09/06/2011 10/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6463 2011-6464 09/06/2011 10/04/2011 09/06/2011 10/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6465 2011-6466 09/06/2011 10/04/2011 09/06/2011 10/04/2011 2011-6467 2011-6468 2011-6469 2011-6470 2011-6471 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011 ORA/P-FO/SAN-DO/SFCB/ ORA/ORM/ ORA/ORM/ CBER/OCTMA/DDOM/ALFB/ FDA/OO/OFBA/OAGS/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ CLOSE, BRANDON JOHNATHAN RICKMAN FDA NEWS JAMES PELUSO AVID RADIOPHARMACEUTICALS ROSE SANTOS FOIA GROUP INC JOHNATHAN RICKMAN FDA NEWS FELLENZ L MORGAN LOGISTICS HEALTH INC JOHNATHAN RICKMAN FDA NEWS PHARMACEUTICAL, BIOLOGICS , MEDICAL DVC MFG, ETC IN AND OUTSIDE THE US - 483S 8/1-31/11 GSK, SANOFI, JHP, ETC - ACTIVE US APRVD VACCINES 2011 BIO-RAD LABORATORIES INC, HERCULES, CA; IVY SPORTS MEDICINE LLC, REDWOOD CITY, CA; PHILIPS HEALTHCARE CONTRACT #FDA09223SOL00042 POSEY CO, ELK GROVE VILLAGE, IL - POSEY CUFFLATOR K912723 PERFECTO PRODUCTS MFG INC, ATLANTA, GA; ALWELL MEDICAL CORP, RALEIGH, NC; MERZ PHARMACEUTICALS, LLC, GREENSSBORO, NC - 483S 7/1-31/11 BIOMED IRB - EIRS PAST 12 MONTHS FDA/OMPT/CDRH/OCER/DFOI/ CLOSE, BRANDON GARY D HAINDMAN BECKLOFF ASSOCIATES INC WARE-MEDICS GLASS WORKS INC, PEARL RIVER, NY HYPODERMIC SYRINGE LUER LOX K901203 AZUR PHARMA - AVC CREAM NDA 06-530 APRVL LTR, SUPPL 1,2,3,5, LBLG, ETC KAY NOEL JK NOEL & ASSCOIATIES LUPRON DEPOT-PED NDA 20-263/S036 - MEDICAL RVWS 7/20/10 TO 8/15/11 ORA/NE-FO/NWE-DO/NWECB/ DORCIE MCKNIFF JASPERSE RALAND TECHNOLOGIES LLC MICHAEL R HAMRELL MORIAH CONSULTANTS DR YARI SHIVARTZ, SARATOV, RUSSIA - EIRS 11/16-19/09 PFIZER INC - EIRS 8/4/09, 6/3/09 Signature/ Requester BLOOMBERG NEWS Subject
Page 448 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject INFORMATICS INC, FOSTER CITY, CA ETC - 483S 7/1-31/11 2011-6472 09/06/2011 10/04/2011 ORA/P-FO/SEA-DO/SCB/ JOHNATHAN RICKMAN FDA NEWS 21ST CENTURY SCIENTIFIC INC, COEUR D'ALENE, ID; NORTHWEST COSMETIC LABORATORIE, IDAHO FALLS, ID; INTERNATIONAL ISOTOPES INC, IDAHO FALLS, ID ETC 483S 7/1-31/11 AGROPHARMA LABORATORIES INC, SALINAS, PR; KNOLL LLC/DBA ABBOTT LABORATORIES, JAYUYA, PR; RD MEDICAL MANUFACTURING INC, LAS PIEDRAS, PR ETC 483S 7/1-31/11 CANGENE BIOPHARMA INC, BALTIMORE, MD; MEDICAL SUPPLIES CORPORATION, BALTIMORE, MD; INDUSTRIAL MUNICIPAL EQUIPMENT, ELDERSBURG, MD - 483S 7/131/11 AIG TECHNOLOGIES INC, DEERFIELD BEACH, FL; DEMETECH CORP, MIAMI, FL; HEARTWARE, INC, MIAMI LAKES, FL ETC - 483S 7/1-31/11 ZIMMER INC, WARSAW, IN - 483S 7/1-31/11 SANDHILL SCIENTIFIC INC, LITTLETON, CO; WESCOR INC, LOGAN, UT - 483S 7/1-31/11 CHURCHILL MEDICAL SYSTEMS INC, DOVER, NH; COVIDIEN LLC, CHICOPEE, MA; DOREL JUVENILE GROUP, FOXBORO, MA - 483S 7/1-31/11 ARKRAY USA INC, EDINA, MN; CLARUS MEDICAL LLC, MINNEAPOLIS, MN; D&S DENTAL LABORATORY INC, WAUNAKEE, WI ETC - 483S 7/1-31/11 APP PHARMACEUTICALS LLC, GRAND ISLAND, NY; HARD MANUFACTURING CO INC, BUFFALO, NY; INNOTECH USA INC, TARRYTOWN, NY ETC - 483S 7/1-31/11 DELPHARM TOURS, CHAMBRAY LES TOURS, FRANCE 483S 7/1-31/11
2011-6473
09/06/2011 10/04/2011
ORA/SE-FO/SJN-DO/SJCB/
2011-6474
09/06/2011 10/04/2011
ORA/CE-FO/BLT-DO/CB/
2011-6475
09/06/2011 10/04/2011
2011-6476 2011-6477 2011-6478
09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/06/2011 10/04/2011
ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/NE-FO/NWE-DO/NWECB/
JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS
2011-6479
09/06/2011 10/04/2011
ORA/CE-FO/MIN-DO/MCB/
2011-6480
09/06/2011 10/04/2011
ORA/NE-FO/NYK-DO/NYDCB/
2011-6481
09/06/2011 10/04/2011
ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
2011-6482
09/06/2011 10/04/2011
APTER INDUSTRIES INC, MCKEESPORT, PA; TEVA PHARMACEUTICAL USA INC, SELLERSVILLE, PA, HERCON LABORATORIES CORP, EMIGSVILLE, PA - 7/1-31/11 AGFA-GEVAERT HEALTHCARE GMBH, MUNICH, GERMANY;
2011-6483
09/06/2011
JOHNATHAN RICKMAN
Page 449 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/04/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6484 09/06/2011 10/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6485 09/06/2011 10/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6486 2011-6487 2011-6488 2011-6489 09/06/2011 10/04/2011 09/06/2011 10/04/2011 09/07/2011 10/05/2011 09/07/2011 10/05/2011 2011-6490 09/07/2011 10/05/2011 2011-6491 09/07/2011 10/05/2011 2011-6492 09/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ SMITH, JOSHUA MARILYNN WHITNEY COVINGTON & BURLING LLP THOMAS SHRADER MEDICAL IMAGING RESOURCES INC THOMAS SHRADER MEDICAL IMAGING RESOURCES INC THOMAS SHRADER MEDICAL IMAGING RESOURCES INC KATHI RINESMITH X-RAY ASSEMBLER DATABASE - EQUIPMENT MAKE, MODEL, DATE TEVA CZECH INDUSTRIES SRO, CZECH REPUBLIC - EIRS, TRANSPARENCY/UCM2 06662.XLS - SPREADSHEETS MRI SCANNERS - FACILITY NAME, ADDRESS, MFG DKT & DKT LOG OF 1996N-0512 FDA/OMPT/CDRH/OCER/DFOI/ JULIA M GICZEWSKI MCGUIRE WOODS LLP ABIOMED INC - IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYS CO RESP FOI REQUESTS 8/26/11 JAESA MCLIN RIGUER SILVA LLC DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS ETC - USE OF TIME & MONEY FOR RESEARCH, COMM, RECS ETC 7/11 BERNADETTE ATTINGER SANDOZ INC BAXTER HEALTHCARE - CYCLOPHOSPHAMIDE, ANDA 40745, CMC, APRVL LTR, RECS Signature/ Requester FDA NEWS Subject AGFA-GEVAERT AG/WERK PEISSENBERG, PEISENBERG, GERMANY; CABLON MEDICAL BV, LEUSDEN, NETHERLANDS ETC - 483S 7/1-31/11
Page 450 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/05/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6493 09/07/2011 10/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6494 09/07/2011 10/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6495 09/07/2011 10/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6496 09/07/2011 10/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6497 2011-6498 2011-6499 09/07/2011 10/05/2011 09/07/2011 10/05/2011 09/07/2011 10/05/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6500 09/07/2011 10/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ REBECCA L DANDEKER K&L GATES SCHERING-PLOUGH HEALTHCARE - CLARITIN-D 12 HOUR, CLARITIN-D 24 HOUR (LORATADINE & PSEUDOPHEDRINE SULFATE) ER TABS NDAS 19-670/S019, 20-470/S022 SUPPL FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LORI COLVIN CYBERSONICS INC BOGDAN RENTEA RENTEA & ASSOCIATES ANNE SAVAS MAGSTIM COMPANY US LLC NEURONETICS - K061053, K083538 IMAGING 3 - 510K, AMENDMENTS, SUPPL, ETC CYBERWAND DUAL PROBE LITHOTRIPTER - K052135 ADDI SOLOMON HOSPITAL OF THE UNIV PENNSYLVANIA/DEPT OF PHARMACY TARCEVA (ERLOTINIB) - AERS ADDI SOLOMON HOSPITAL OF THE UNIV PENNSYLVANIA/DEPT OF PHARMACY CELEXA (CILALOPRAM) - AERS KATHI RINESMITH VALLEY PHARMACEUTICALS LLC BAYER SCHERING PHARMA AG, BERGKAMEN, GERMANY EIRS, COVER LTR 2/8-12/10 KATHI RINESMITH VALLEY PHARMACEUTICALS LLC BAYER SCHERING PHARMA AG, BERLIN, GERMANY - EIRS, COVER LTR 7/11-14/11 Signature/ Requester VALLEY PHARMACEUTICALS LLC Subject COVER LTR 9/2/10, 5/24/10-6/1/10
Page 451 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6501 09/07/2011 10/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6502 2011-6503 09/07/2011 10/05/2011 09/07/2011 10/05/2011 2011-6504 2011-6505 2011-6506 09/07/2011 10/05/2011 09/07/2011 10/05/2011 09/07/2011 10/05/2011 2011-6507 2011-6508 09/07/2011 10/05/2011 09/07/2011 10/05/2011 2011-6509 09/07/2011 10/05/2011 ORA/SE-FO/FLA-DO/FCB/ THOMPSON, RAY FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ CVM/OCD/ KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. MARILYNN WHITNEY COVINGTON & BURLING LLP RUBINUM SA ANIMAL HEALTH - BACILLUS CEREUS VARIANT TOYOI ANIMAL GRAS 8 6/10/11 ZEAXANTHIN TRADE ASSN, KEMIN HEALTH LC, ZEAVISION LLC - MESOZEAXANTHIN RECS, CORR 2/16/11 TO PRESENT ADVANCED CONCEPT INNOVATIONS LLC, LAKELAND, FL 483 4/11-13/11; AMERICAN CATHETER CORP, OCALA, FL 483 4/4-4/5/11; APHERESIS TECHNOLOGIES INC, PALM HARBOR, FL - 483 2/28/11-3/3/11 APOTHECA INC, WOODBINE, IA - 483 3/14/11-3/25/11; CENTRAL SOLUTIONS INC, KANSAS CITY, KS - 483 4/14/114/19/11; BUCKEYE INTL INC. MARYLAND HEIGHTS, MO - 483 1/24/11-2/4/11 BAXTER PHARMACEUTICALS SOLUTIONS LLC, CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ CASTIAUX, ERNIE DAVID B BOWER akzonobel MAHLON M WILKES HYGEIA ASSOCIATES M. MUNOZ SEADCO USA CORP KEDBUMIN (ALBUMIN HUMAN) - PRE-CLNCL, CLNCL STUDIES FOZEN PASTEURIZED EXTRA JUMBO U-130 SPLS ENTRY #E4P-0016713-0 - LAB RESULTS FDA/OF/CFSAN/OCD/EOS/ RICHARD C KRASKA GRAS ASSOCIATES LLC MOUNTAIN PINE INC, SAN LEANDRO, CA, SHING KEE FOOD INSUSTRIAL CO LTD, XIAMEN, CHINA - REGULATORY RECS, CORR FCN 1074 FCN 178, FCN 475 LOUIS H WEINSTEIN DUBB LARNER COUNSELORS AT LAW PFIZER - ATORVASTATIN CALCIUM NDA 20-702 MEDICAL & CLNCL PHARMACOLOGY RVWS, SUBMISSIONS 2/12,13/02, 6/18/02, 9/27/02, ETC Signature/ Requester Subject APRVL LTR, RVWS SUMMARY, PI, ETC
2011-6510
09/07/2011 10/05/2011
ORA/SW-FO/KAN-DO/COMP/ THOMPSON, RAY
2011-6511
09/07/2011
Page 452 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/05/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6512 09/07/2011 10/05/2011 ORA/SW-FO/DEN-DO/COMP/ THOMPSON, RAY AMEDICA CORP, SALT LAKE CITY, UT - 483 5/5-13/11; ABL MANUFACTURING LLC, AMERICAN FORK, UT - 483 3/2125/11; MEDTRONIC NAVIGATION INC, LOUISVILLE, CO - 483 3/10-24/11 DREW SCIENTIFIC INC, DALLAS, TX - 483 2/22-3/4/11; HOSPIRA INC, AUSTIN, TX - 483 4/4-27/11; ARGON MEDICAL DEVICES INC, ATHENS, TX - 483 5/9-18/11 Signature/ Requester THOMPSON, RAY Subject BLOOMINGTON, IN - 483 3/16-25/11; ORTHO PEDIATRICS CORP, WARSAW, IN - 483 3/7-11/11; ROCHE INSULIN DELIVERY SYS INC, FISHERS, IN - 483 2/23-28/11
2011-6513
09/07/2011 10/05/2011
ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
THOMPSON, RAY
2011-6514
09/07/2011 10/05/2011
ORA/CE-FO/CIN-DO/CCB/ THOMPSON, RAY
COSMED LABS INC, LOUISVILLE, KY - 483 2/8/11-3/22/11; HOSPITAL SPECIALITY CO, NICHOLASVILLE, KY - 483 12/27/10-1/26/11; 3M COMPANY CINCINNATI, OH - 483 3/2429/11 3M COMPANY, CORDOVA, IL - 483 4/5-13/11; ABBOTT LABS, NORTH CHICAGO, IL - 483 2/23/11-3/10/11; ABBOTT MOLECULAR, DES PLAINES, IL 5/16-24/11 3CPM CO INC, TOWSON, MD - 483 2/9-25/11; BELL-MORE LABS INC, HAMPSTEAD, MD 1/11-26/11; CAPRICORN PHARMA INC, FREDERICK, MD - 483 2/7-25/11 CELONOVA BIOSCIENCES INC, PEACHTREE CITY, GA - 483 1/24-28/11; MARIETTA VISION, MARIETTA, GA - 483 1/252/9/11; UNIQUE LABS INC, CHATSWORTH, GA - 483 4/215/4/11 FROZEN IQF WILD SEA SCALLOP MEAT ENTRY #0380627523-0 - INSP RESULTS, ANALYSIS DARVOCET-N 100 NDA 17-122; DARVON COMPOUND-65 NDA 10-996; DARVON NDA 10-997 - LBLG
2011-6515
09/07/2011 10/05/2011
ORA/CE-FO/CHI-DO/CCB/ THOMPSON, RAY ORA/CE-FO/BLT-DO/CB/ THOMPSON, RAY ORA/SE-FO/ATL-DO/ACB/ THOMPSON, RAY
2011-6516
09/07/2011 10/05/2011
2011-6517
09/07/2011 10/05/2011
2011-6518 2011-6519
09/07/2011 10/05/2011 09/07/2011 10/05/2011
ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
JOSEPH FURTADO EASTERN FISHERIES INC ROBERT P. CHARROW GREENBERG TRAURIG LLP
2011-6520
09/07/2011 10/05/2011
NATHANIEL ENOS CONWAY HOMER & CHINCAPLAN PC
INDIVIDUAL RECS
2011-6521
09/07/2011 10/05/2011
MARK D. LURIE LURIE LAW FIRM LLC
MANNKIND CORP, DR DASKALOVA, SOFIA, BULGARIA; DR YURI SHVARTS, SARTOV, RUSSIA - AFREZZA CLNCL STUDIES, CORR, DATA INTEGRITY ISSUES, ETC
Page 453 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ ORA/OCI/ ORA/OCI/ 2011-6522 09/08/2011 10/06/2011 ORA/ ORA/ ORA/ ORA/ OC/COS/OES/ OC/COS/OES/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/OE/ ORA/OE/ 2011-6523 09/08/2011 10/06/2011 ORA/CE-FO/PHI-DO/PCB/ AMY KLAUM AMERICAN RED CROSS GREATER ALLEGHENIES REGION FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-6525 09/08/2011 10/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ SF MAYS FLOYD MAYS INSURANCE AGENCY INC DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, CONSUMER ACCESS, RESEARCH RECS, ETC MICHAEL G SAWICKI SAWICKI & LAUTEN LLP AMERICAN RED CROSS BLOOD SERVICES, JOHNSTOWN,PA - EIR 9/7-24/10 JACKIE KUCINICH USA TODAY GOV RICK PERRY - CORR 12/21/00 TO PRESENT Signature/ Requester Subject
2011-6524
09/08/2011 10/06/2011
MD ANDERSON CANCER CENTER, HOUSTON, TX SERRATIA MARCESCENS OUTBREAK INVESTIGATION 2007-2008; AM2PAT - SALINE SYRINGE RECALL 2007-2008, ETC
Page 454 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6526 09/08/2011 10/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6527 09/08/2011 10/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6528 09/08/2011 10/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6529 2011-6530 09/08/2011 10/06/2011 09/08/2011 10/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KAREN B STUEBER CYBERONICS TATSUHIRO SAIDO SAYA WAVETECH INC PROTEUS BIOMEDICAL INC - RAISIN PERSONAL MONITOR K093976 CAROL COLE CO - NUFACE TRANSCUTANEOUS ELECTRICAL STIMULATOR K072260 MARY B SZALKOWSKI PRISMA CORP INDAPAMIDE, PERINDOPRIL - AERS 5/18/11 TO PRESENT SALLY COHEN NATURAL HEALING TOOLS DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, CONSUMER ACCESS, RESEARCH RECS, ETC COWIN, CARYN L DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, CONSUMER ACCESS, RESEARCH RECS, ETC Signature/ Requester Subject
Page 455 of 1132

Total Records: 12455 Control # 2011-6531 2011-6532 2011-6533 Recd Date / Due Date 09/08/2011 10/06/2011 09/08/2011 10/06/2011 09/08/2011 10/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6534 09/08/2011 10/06/2011 OC/OSHC/OPD/ MEGAN COLLEY MPH GENZYME CORP VELCADE MANTLE CELL LYMPHOMA - ORPHAN DRUG DESIGNATION APRVD 4/18/11; VELCADE FOLLICULAR LYMPHOMA - ORPHAN DRUG DESIGNATION APRVD 1/4/11, ETC AASHI GLASS CO LTD - FCN 604 MIC-KEY LOW PROFILE GASTRONOMY TUBE - K043114; MEDLINE SILVER TOUCH FOLEY CATHETER - K052168 ORA/P-FO/SAN-DO/SFCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ERIC MITCHELL LINKAGE BIOSCIENCES MATTHEW LOPER ORBIMED ADVISORS LLC RHETT D KLOK KLOK LAW FIRM LLC Subject ERAGEN BIOSCIENCES INC - MULTICODE RTX HERPES SIMPLEX VIRUS 1 & 2 KIT K100336 IMPAX LABS - EIRS 1/00 TO PRESENT; 483S 12/13/10-1/21/11, WARNING LTRS 5/11, ETC DIFLUCAN (FLUCONAZOLE) - AERS
2011-6535 2011-6536
09/08/2011 10/06/2011 09/08/2011 10/06/2011
FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/
KYOSHI SAITAKA NIPPON DIXIE CO LTD ZOYA LEE DEGANIA SILICONE LTD
2011-6537 2011-6538
09/08/2011 10/06/2011 09/08/2011 10/06/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
ANDREW FAY THALES COMPONENTS CORP MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC WALBO #HY6861, JOE
K112054 DRUG COMPANIES, BIORESEARCH MONITORING (BIMO), GOOD LABORATORY PRACTICES - FOREIGN & DOMESTIC INSPS, 483S 8/1-31/11 LAMICTAL - AERS, CLNCL TESTS, FACT SHEETS, ETC
2011-6539
09/08/2011 10/06/2011
2011-6540 2011-6541
09/08/2011 10/06/2011 09/08/2011 10/06/2011
CBER/OCTMA/DDOM/ALFB/ MERCK & CO., INC. FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ YI-KANG HU PHD JD SPECTRA LAW GROUP LLC YI-KANG HU PHD JD
MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 427517-1 HI-DOW INTERNATIONAL INC - HI-DOW MODEL JQ-5C TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR K102598 TENSCARE LTD - TENSCARE MODEL XL-Y3
2011-6542
09/08/2011
Page 456 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/06/2011 2011-6543 2011-6544 2011-6545 09/08/2011 10/06/2011 09/08/2011 10/06/2011 09/08/2011 10/06/2011 2011-6546 2011-6547 2011-6548 2011-6549 09/08/2011 10/06/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ 2011-6550 09/09/2011 10/07/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ 2011-6551 09/09/2011 10/07/2011 2011-6552 2011-6553 2011-6554 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ CLAYTON HUNTLEY MORRISON CLAYTON H MORRISON LLC JENNIFER SUTTMOELLER CERVANTES & ASSOCIATES MELISSA I KLESCH BAXTER HEALTHCARE CORP JOANNE S HAWANA ARENT FOX LLP FRESENIUS MEDICAL CARE HOLDINGS INC - LIBERTY LINE CYCLER SET WITH STAY SAFE CONNECTORS EIRS, 483, CO RESP, ETC 6/15/10-8/6/10 VASCULAR SOLUTIONS - DUETT CLOSURE DVC CLASS III MEDICAL DVC RECS ZHEJIANG MEDICINE CO LTD, XINCHANG PHARMACUTICAL FACTORY, ZHEIJIANG PR, CHINA - 483S 4/10 ISRS 7035118, 7045876, 7102717, ETC ADRIANA L KING KING MIDAS STRAWBERRY FLAVORED SALTED PLUM ENTRY 1751911707-5 - LAB RESULTS NANOVA INC ADRIANO L KING KING MIDAS HOLA SWEET & SOUR FLAVORED SALTED PLUM ENTRY 175-1911707-5 - LAB RESULTS OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/BLT-DO/CB/ Action Office Signature/ Requester SPECTRA LAW GROUP LLC ELENA HOWELL HOGAN LOVELLS LLP ELENA HOWELL HOGAN LOVELLS US LLP MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION MARILYNN WHITNEY COVINGTON & BURLING LLP JOSEPH W. CORMIER ARNOLD & PORTER K931096, K760417, K874556, ETC DKT 1978N-2285 DKT FDA-2010-P-0491 Subject TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR K011543 MCCORMCK & COMPANY INC, HUNT VALLEY, MD - EIR, 483 2/10 MCCORMICK & COMPANY INC, HUNT VALLEY, MD - EIR, 483 4/10 DKT FDA-1995-S-0039
Page 457 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6555 2011-6556 09/09/2011 04/02/2012 09/09/2011 10/07/2011 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC CONNIE BENDER AMERICAN RED CROSS GREATER CHESAPEAKE & POTOMAC REGION ORA/SE-FO/ATL-DO/ACB/ MILETTE MORRIS AMERICAN RED CROSS SOUTHERN REGION FDA/OF/CFSAN/OCD/EOS/ SUMMERS, CHRISTINA OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6562 09/09/2011 10/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ 2011-6563 2011-6564 2011-6565 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ CBER/OCTMA/DDOM/ALFB/ CHRISTINE STUBBS PHILIPS MEDICAL SYSTEMS PATRICK WILLHITE MED EL CORP USA ANGELIA D. SLAYTON KENDLE INTERNATIONAL INC FDA NIH WORKSHOP FOR PLURIPOTENT STEM CELLS IN TRANSLATION EARLY DECISIONS 3/11; NIH/JDRF/FDA WORKSHOP FOR THE NEXT GENERATION BETA CELL TRANSPLANTATION 11/9/09; FDA/NIST WORKSHOP FOR IN VITRO ANALYSES OF CELL SCAFFOLD PRODUCTS 12/67/07 - TRANS LUPIN BIORESEARCH CTR, MAHARASHTRA, INDIA - EIR HEWLETT PACKARD - NEONATAL STERILE DISPOSABLE NONINVASIVE BLOOD PRESSURE CUFFS K905101 12/20/90 ADVANCED BIONICS LLC - EIR, 483, RECALL 11/24/10 PATRICK WILLHITE MED EL CORP USA COCHLEAR AMERICAS - EIR, 483, RECALL WYATT A LISON STEMBER FEINSTEIN ET AL CRAIG ROUSH ROCKLINE INDUSTRIES BRENDA M. GARTZ ELI LILLY & CO US NONWOVENS CORP, BRENTWOOD, NY - EIR, 483 11/29/10 ALBERTO JOAO CAMPOS, PAX CLINICA PSIQUIATRICA, GOLANIA, GOLAS, BR - 483 8/23/10 CORELAB PARTNERS INC, PRINCETON, NJ - EIRS, 483S, CO RESP 8/31/10 AMERICAN RED CROSS GREATER CHESAPEAKE & POTOMAC REGION, BALTIMORE, MD - EIRS 7/15-31/09 Signature/ Requester Subject
2011-6557
09/09/2011 10/07/2011
AMERICAN RED CROSS , ALBANY DONOR CENTER, ALBANY, GA; ATHENS DONOR CENTER, ATHENS, GA; CAMP CREEK DONOR CENTER, EAST POINT, GA, ETC - EIRS 11/09 TO PRESENT CNCA-CERTIFIED CERAMICWARE FACTORIES TELEPHONE NUMBER, EMAIL ADDRESS 2010-4943 (CERTIFIED)
2011-6558 2011-6559 2011-6560 2011-6561
09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011
2011-6566
09/09/2011
LESLIE SANDS
Page 458 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/07/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6567 09/09/2011 10/07/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/OE/ ORA/OE/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6568 2011-6569 2011-6570 2011-6571 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 09/09/2011 10/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6572 09/12/2011 10/11/2011 ORA/CE-FO/CIN-DO/CCB/ JEFFREY MCCULLOUGH UNIV OF MINNESOTA COMMUNITY BLOOD CENTER, DAYTON, OH; HOXWORTH BLOOD CENTER UNIV OF CINCINNTI MEDICAL CENTER; KENTUCKY BLOOD CENTER INC, LEXINGTON, KY, ETC 483S 2009, 2010 BERGEN COMMUNITY REGIONAL BLOOD CENTER, PARAMUS, NJ; BLOOD CENTER OF NEW JERSEY INC, EAST ORANGE, NJ; CENTRAL JERSEY BLOOD CENTER, SHREWSBURY, NJ, ETC - 483S 2009, 2010 CENTRALL BLOOD BANK, PITTSBURGH, PA/;CENTRAL PLOCK, DIANNE OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ DEBBIE ANDERSON FLAVOR HOUSE INC JILLIAN GRAY BAIN & COMPANY INC DIANE McDERMAID PARSONS BEHLE & LATIMER DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSION CORR, CONSUMER ACCESS, SAFETY ISSUES, ETC CALIFORNIA DEPR OF PUBLIC HEALTH FOOD & DRUG BRANCH, ONTARIO, CA - INSP 8/10/11 TAS CDRH TO DEVELOP TOP DATA TO ASSESS BARRIERS WITH INDUSTY & FDA 1/28/11 HEALTHTEK INC - ADFUSE K881590 CHRISTOPHER T. LEE DICKIE MCCAMEY & CHILCOTE SIMPLY THICK LLC, STONE MOUNTAIN, GA - RECALL, SUMMARIES, STUDIES, RPTS, ETC 5/20/11 Signature/ Requester LUPIN PHARMACEUTICALS INC Subject 10/18-22/10
2011-6573
09/12/2011 10/11/2011
JEFFREY MCCULLOUGH UNIV OF MINNESOTA
2011-6574
09/12/2011
JEFFREY MCCULLOUGH
Page 459 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/11/2011 Action Office Signature/ Requester UNIV OF MINNESOTA Subject PENNSYLVANIA BLOD BANK, HUMMELSTOWN, PA; COMMUNITY BLOOD BANK OF ERIE COUNTY, ETC - 483S 2009-, 2010 CARTER BLOODCARE, BEDFORD, TX; CENTRAL TEXAS REGIONAL BLOOD & TISSUE CENTER, AUSTIN, COASTAL BEND BLOOD CENTER, CORPUS CHRISTI, TX, ETC - 483S 2009, 2010 ALTRU HEALTH SYSTEMS, GRAND FORKS, ND/; AVERA MCKENNAN HOSPITAL & UNIV HEALTH CENTER, SIOUX FALLS, SD; BLOOD CENTER OF NORTHCENTRAL WISCONSIN INC, WAUSAU, WI, ETC - 483S 2009, 2010 BELLE BONFILS MEMORAL BLOOD CENTER, DENVER, CO; OGDEN MEDICAL CENTER INC, OGDEN, UT; ST MARYS HOSPITAL & MEDICAL CENTER INC, GRAND JUNCTION, CO - 483S 2009, 2010 COMUNITY BLOOD CENTERS OF FLORIDA INC, LAUDERHILL, FL; CONTINENTAL SERVICES GROUP INC, MIAMI, FL; FLORIDA BLOOD SERVICES INC, ST PETERSBURG, FL, ETC - 483S 2009, 2010 LAS AMERICAS LABORATORY & BLOOD BANK INC, HATO REY, PR - 483S 2009, 2010 BLOOD BANK OF DELMARVA INC, NEWARK, DE: BLOOD BANK OF THE WASHINGTON HOSPITAL CENTER, WASINGTON, DC; DEPARTMENT OF THE AIR FORCE, FALLS CHURCH, VA, ETC - 483S 2009, 2010 AURORA AREA BLOOD BANK, AURORA, IL LIFESOURCE, GLENVIEW, IL; NOTHERN ILLINOIS BLOOD BANK INC, ROCKFORD, IL, ETC - 483S 2009, 2010 K780832, K801092, K830387, ETC NANOVA INC PHILIPS - INTEGRIS V5000 K9733482 (CERTIFIED) MINAYA, LLAUGER A FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6585 2011-6586 09/12/2011 10/11/2011 09/12/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ DETWILER, LINDA A DRAFT GUIDANCE FOR NEW DIETARY INGREDIENTS (NDI) KALUSTYAN CORP, UNION, NJ - EIR, CORR LAST 3 YRS JODY L GREEN ROCKY MOUNTAIN POISON DRUG CTR ISRS 6710469-5, 6710686-4, 6710688-8, ETC
2011-6575
09/12/2011 10/11/2011
2011-6576
09/12/2011 10/11/2011
2011-6577
09/12/2011 10/11/2011
2011-6578
09/12/2011 10/11/2011
2011-6579 2011-6580
09/12/2011 10/11/2011 09/12/2011 10/11/2011
ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/BLT-DO/CB/
JEFFREY MCCULLOUGH UNIV OF MINNESOTA JEFFREY MCCULLOUGH UNIV OF MINNESOTA
2011-6581
09/12/2011 10/11/2011
2011-6582 2011-6583 2011-6584
09/12/2011 10/11/2011 09/12/2011 10/11/2011 09/12/2011 10/11/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/
Page 460 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/11/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ 2011-6587 2011-6588 09/12/2011 10/11/2011 09/12/2011 10/11/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ 2011-6589 09/12/2011 10/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-6590 09/12/2011 10/11/2011 ORA/P-FO/SEA-DO/SCB/ JEFFREY MCCULLOUGH MD UNIV OF MINNESOTA BLOOD BANK OF ALASKA INC, ANCHORAGE, AK; INLAND NORTWEST BLOOD CENTER, SPOKANE, WA; LANE MEMORIAL BLOOD BANK, EUGENE,OR, ETC - 483S 2009, 2010 CONTAMINATED AVASTIN - INDIVIDUAL RECS IBUPROFEN, ASPIRIN, MORPHINE, ETC - AERS, MIZE #276339, JASON E A LUKE SMITH FARUQI & FARUQI LLP NOVO NORDISK PHARMACEUTICALS INC - PRANDIN (REPAGLINIDE) LBLG, APRVL, MEDICAL RVWS, ETC ORA/NE-FO/NYK-DO/NYDCB/ DOUGLAS N BLUE ZETETIC INC GINGER HEYMAN PIGOTT REED SMITH LLP LIFESCAN INC - GLUCOSE BLOOD STRIPS ENTRY #F239042558-5/1/1 RECS MEDTRONIC MINIMED INC - FOI REQUESTS 9/08 TO PRESENT; PARADIGM INSULIN PUMP APRVL RECS, MDRS, ETC Signature/ Requester POLISKY, P SCOTT Subject 7/1/11
2011-6591 2011-6592
09/12/2011 10/11/2011 09/12/2011 10/11/2011
ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
GARY ALAN FRIEDMAN FRIEDMAN & FRIEDMAN
Page 461 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6593 2011-6594 09/12/2011 10/11/2011 09/12/2011 10/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6595 09/12/2011 10/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6596 2011-6597 2011-6598 09/12/2011 10/11/2011 09/12/2011 10/11/2011 09/12/2011 10/11/2011 ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ YI-KANG HU PHD JD SPECTRA LAW GROUP LLC YI-KANG HU PHD JD SPECTRA LAW GROUP LLC JEFFREY MCCULLOUGH UNIV OF MINNESOTA HI-DOW INTERNATIONAL INC - TRANSCUTANEOUS ELECTRIC NERVE STIMULATOR FOR PAIN RELIEF K102598 WELL-LIFE HEALTHCARE INC - TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR K052785 COMMUNITY BLOOD CENTERS OF FLORIDA, LAUDERHILL, FL; CONTINENTAL SERVICES GROUP INC, MIAMI, FL; FLORIDA BLOOD SERVICES INC, ST PETERSBURG, FL ETC BROWN, GREGG DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, SAFETY ISSUES, CONSUMER ACCESS, ETC BROWN, LIDA ORA/SE-FO/FLA-DO/FCB/ PAIGE SAVITZ BEAVER STREET FISHERIES INC FROZEN SNAPPER FILLETS - 28-DAY EXTENSION OF NOTICE #3 (TO 9/7/11) DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, SAFETY ISSUES, CONSUMER ACCESS, ETC Signature/ Requester Subject
Page 462 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject - 483S, 1/1/2009-12/31/2010 2011-6599 09/12/2011 10/11/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6600 09/12/2011 10/11/2011 2011-6601 09/12/2011 10/11/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6602 2011-6603 2011-6604 09/12/2011 10/11/2011 09/12/2011 10/11/2011 09/12/2011 10/11/2011 2011-6605 09/12/2011 10/11/2011 2011-6606 09/12/2011 10/11/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ WILLIAM A OLSON PHD Center for Regulatory Services, Inc. JARED MACCLEARY CROWELL & MORING JEFFREY MCCULLOUGH UNIV OF MINNESOTA JEFFREY MCCULLOUGH UNIV OF MINNESOTA JEFFREY MCCULLOUGH UNIV OF MINNESOTA BLOOD BANK OF HAWAII, HONOLULU, HI; BLOOD CENTERS OF THE PACIFIC, SAN FRANCISCO, CA; BLOODSOURCE INC, SACRAMENTO, CA ETC - 483S 2009, 2010 INDIANA BLOOD CENTER, INDIANAPOLIS, IN; MARQUETTE GENERAL HOSPITAL INC, MARQUETTE, MI; MICHIGAN BLOOD, GRAND RAPIDS, MI ETC - 483S 2009, 2010 BLOOD BANK OF SAN BERNARDINO & RIVERSIDE COUNTIES, SAN BERNARDINO, CA; BLOOD BANK OF THE REDWOODS, SANTA ROSA, CA; BLOOD SYSTEMS INC ETC - 483S 2009, 2010 NEW YORK BLOOD CENTER INC, NEW YORK, NY; NORTH COUNTY REGIONAL BLOOD CENTER, PLATTSBURGH, NY 483S 2009, 2010 CORAL BLOOD SERVICES, SCARBOROUGH, ME; GENERAL HOSPITAL CORP, BOSTON, MA; HOLYOKE MEDICAL CENTER INC, HOLYOKE, MA ETC - 483S 2009, 2010 ANMED HEALTH, ANDERSON, SC; BLOOD CONNECTION INC, GREENVILLE, SC; COMMUNITY BLOOD CENTER OF THE CAROLINAS, CHARLOTTE, NC ETC - 2009, 2010 MENTHOL, METHYL SALICYLATE, CAPSAICIN - AERS, 8/12/11, MEDWATCH FORMS 3500 CVM FOI REQUESTS 8/11 AGC CHEMCIALS AMERICAS INC - FCN 604 POLAND #145512, WAYNE FREDERICK VENLAFAXINE - AERS JEFFREY MCCULLOUGH UNIV OF MINNESOTA BLOOD ASSURANCE INC, CHATTANOOGA, TN; BLOOD CENTER, NEW ORLEANS, LA; INTERSTATE BLOOD BANK INC, MEMPHIS, TN ETC - 483S 2009, 2010 MICHAEL R COHEN RPH MS SCD INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 8/1/119/1/11
2011-6607
09/12/2011 10/11/2011
2011-6608
09/12/2011 10/11/2011
2011-6609
09/12/2011 10/11/2011
2011-6610
09/12/2011 10/11/2011
BARBARA A KOCHANOWSKI CONSUMER HEALTHCARE
Page 463 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6611 09/12/2011 10/11/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6612 2011-6613 2011-6614 2011-6615 2011-6616 2011-6617 2011-6618 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6619 09/13/2011 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2011-5597 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. AMGEN INC - KINERET (ANAKINRA) BLA 103950/5039 APRVL LTR, RVWS, PI, ETC 2011-5490 2011-5136 2011-4598 2011-4231 2011-4156 2010-8205 ANDRENE HERON ROACH DIAGNOSTICS CORPORATION K022774 Signature/ Requester PRODUCTS ASSOCIATION Subject
Page 464 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/12/2011 2011-6620 2011-6621 2011-6622 2011-6623 2011-6624 2011-6625 2011-6626 2011-6627 2011-6628 2011-6629 2011-6630 2011-6631 2011-6632 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 2011-6633 2011-6634 2011-6635 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GE - INNOVA CV + VERSION 2 K022322 2011-6085 - REQUEST LTR 2011-6073 - REQUEST LTR Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MOORE, MARCY JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. M ELIZABETH BIERMAN MORGAN LEWIS & BOCKIUS LLP PALOMAR MEDICAL PRODUCTS INC - LOI SYS K090525 2011-6064 - REQUEST LTR Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. PRIMAEVA MEDICAL, FREMONT, CA - FINESSE SYS K072261 2011-6012 - REQUEST LTR 2011-5995 - REQUEST LTR 2011-5951 - REQUEST LTR 2011-5878 - REQUEST LTR 2011-5839 - REQUEST LTR 2011-5826 - REQUEST LTR 2011-5821 - REQUEST LTR 2011-5751 - REQUEST LTR 2011-5705 - REQUEST LTR 2011-5655 - REQUEST LTR Subject
Page 465 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/12/2011 2011-6636 2011-6637 2011-6638 2011-6639 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6640 2011-6641 2011-6642 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6643 2011-6644 2011-6645 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6646 2011-6647 2011-6648 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LAUBJERG, KRISTIAN JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. NOVONORDISK - VICTOZA AERS 2011-6271 - REQUEST LTR 2011-6260 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SURANI FERNANDO BIOPHARM INSIGHT UNITED THERAPEUTICS - REMODULIN (TREPROSTINIL) CLNCL TRIAL RECS 2011-6246 - REQUEST LTR 2011-6214 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOSEPH B KADANE CARNEGIE MELLON UNIV FELBATOL - STUDIES 2011-6193 - REQUEST LTR 2011-6191 - REQUEST LTR OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester MINAYA, LLAUGER A JOAN STITT (UG2CD-16) MERCK & CO., INC. CEMIL GOKSU THERENVA SAS JOAN STITT (UG2CD-16) MERCK & CO., INC. LESLIE SANDS LUPIN PHARMACEUTICALS, INC LUPIN BIORESEARCH CENTER, MAHARASHTRA, INDIA EIRS 10-18-22/10 VITAL IMAGES INC - VITREA ENDOVASCULAR STENT PLANNING SOFTWARE K091498 2011-6093 - REQUEST LTR 2011-6091 - REQUEST LTR Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6649 2011-6650 2011-6651 2011-6652 2011-6653 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6654 2011-6655 09/13/2011 10/12/2011 09/13/2011 10/12/2011 2011-6656 2011-6657 2011-6658 2011-6659 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OL/ MIRAKIAN, ELIZABETH ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ JONEL ALECCIA NSNBC.COM MICHAEL R HAMRELL MORIAH CONSULTANTS EUGENE L MATAN MATAN WRIGHT AND NOBLE DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, CONSUMER ACCESS, FINANCIAL ESTIMATES, ETC 2011-5809 - DELETED RECS H&P INDUSTRIES INC, HARTLAND, WI - NOTIFICATION OF BUSINESS CHANGES DRUG SAFETY ALLIANCE, DURHAM, NC - EIRS 1/12-14/05 JOAN STITT (UG2CD-16) MERCK & CO., INC. MATT HOLLISTER FRUTAROM USA FRUT AROM USA, CORONA , CA - EIR 8/3/11 2011-6394 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. PER ULLMAN OREXO AB SUBOXONE/NALTREXONE - AERS 2006 TO 2011 2011-6391 - REQUEST LTR 2011-6384 - REQUEST LTR 2011-6358 - REQUEST LTR 2011-6272 - REQUEST LTR Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ OC/OM/OEO/ OC/OPPL/OP/ OM/OMP/DODM/ OC/COS/OES/ OC/COS/OES/ 2011-6660 2011-6661 09/13/2011 10/12/2011 09/13/2011 10/12/2011 2011-6662 2011-6663 2011-6664 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ORO/DFS/ ORA/ORO/DFS/ 2011-6665 09/13/2011 10/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6666 09/13/2011 10/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ TASKINEN, BEN DIETARY SUPPLEMENTS NEW DIETARY INGREDIENT NOTIFICATIONS & RELATED ISSUES - EXPENDITURE OF TIME & MONEY, COMM, FINANCIAL ESTIMATES, ETC 7/11 PRATT, CLINTON DIETARY SUPPLEMENTS NEW DIETARY INGREDIENT NOTIFICATION & RELATED ISSUES - EXPENDITURE OF TIME & MONEY, COMM, FAFETY ISSUES, ETC 7/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ RODRIQUEZ, EMMANUEL CDCH AB9928 SEAN PARNELL THE AUSTRALIAN STEPHEN H MEYER NICK STEIN LAW OFCS RON SIMON SIMON & LUKE LLP Doe J TRIAD GROUP - ALCOHOL PADS CLASSIFIED, APRVD, AERS, ETC FOOD VIOLATIONS LAWS PROHIBITED WHILE CONDUCTING A RESTAURANT COMMONWEALTH SERUM LABS, MELBOURNE, AUSTRALIA - EIRS, 483S, WARNING LTRS LAST 18 MONTHS ENTEROBACTER SAKAZAKII CRONOBACTER SAKAZAKI SPECIES - RPTS, MEMOS, E-MAILS, ETC 4/08, 5/08 MULTISTATE OUTBREAK OF SALMONELLA ENTERIDIS INFECTIONS ASSOCIATED WITH SHELL EGGS - LINE LIST JEGX01.004, DNA FINGERPRINT 5/1/10-12/31/10 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6667 09/13/2011 10/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6668 2011-6669 2011-6670 09/13/2011 10/12/2011 09/13/2011 10/12/2011 09/13/2011 10/12/2011 2011-6671 2011-6672 09/13/2011 10/12/2011 09/14/2011 10/13/2011 2011-6673 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6674 09/14/2011 OM/OSS/OPILS/DFI/ RON SIMON WHOLE BLACK PEPPER FROM VIETNAM - PULSENET FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ REGENLAB LAURA BAUGHMAN BARON & BUDD ATTYS GABRIELA TORO AVALON RISK MANAGEMENT INC BRIAN SMITH LEXIS NEXIS AMY E WARREN BURG SIMPSON ELDREDGE HERSH JARDINE PC W E CHALKLEY THOMSON REUTERS ORGANON USA INC - REMERON SOLTAB (MIRTAZAPINE) NDA 21-208/S001,002,003,004,005 APRVL LTR , LBLG 2/22/01, 3/23/01, 11/20/01, ETC PIONEER HI-BRED - CONOLA TOLERANT TO GLYPHOSATE PETITION 11-063-01P 2010-8718 (CERTIFIED) BIOMET BIOLOGICS INC, WARSAW, IN - CLOTALYST & GPS III PLATELET CONCENTRATE SEPARATION KIT BK080004 GIB LLC DBA BRAZILLIAN BLOWOUT - LAB, TEST RESULTS, MEMOS, LTRS, ETC 8/22/11 ENTRYS KB5-00467919, KB5-00466887, KB5-475482, ETC WALTERS, MARY C DIETARY SUPPLEMENTS NEW DIETARY INGREDIENT NOTIFICATIONS & RELATED ISSUES - EXPENDITURE OF TIME & MONEY, COMM, SAFETY RECS, ETC 7/11 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 10/13/2011 2011-6675 09/14/2011 10/13/2011 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6676 2011-6677 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-6678 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6679 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6680 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6681 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6682 2011-6683 09/14/2011 10/13/2011 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ JEFF KELLY LOWENSTEIN HOY CHICAGO W E CHLKLEY THOMSON REUTERS ASTRAZENECA - ZOMIG-ZMT (ZOLMITRIPTAN) NDA 21231/001,002 APRVL LTR, LBLG 12/4/01 WRIGHT COUNTY EGGS - RECS W E CHALKLEY THOMSON REUTERS PFIZER - GEODON (ZIPRASIDONE HCL) NDA 20825/S001,S002,S003,S004,S005 APRVL LTR, LBLG 6/25/02, 11/12/09 W E CHALKLEY THOMSON REUTERS GALDERMA LABS LP - PERIOSTATE (DOXYCYCLINE HYCLATE) NDA 50-783/S001 APRVL LTR, LBLG 7/19/01 KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES SUN PAHRMA - SUMATRIPTAN AUTOINJECTOR ANDA 90358 SBA W E CHALKLEY THOMSON REUTERS JOHNSON & JOHNSON - MONISTATE 3 COMBINATION PACK & PREFILLED (MICONAZOLE NITRATE) NDA 21261/S001,S002,S003 APRVL LTR, LBLG 11/28/01, 4/10/02, 10/28/02 MELINDA R ZAMORA BOWLES & CROW ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PUBLIC HEALTH ADVISORY: SUICIDALITY IN ADULTS BEING TREATED WITH ANTIDEPRESSANT MEDICATIONS 6/30/05 ABBOTT - CYCLINEX-1, GLUTAREX-1, HOMINEX-1, ETC RECS Signature/ Requester SIMON & LUKE LLP W E CHALKLEY THOMSON REUTERS Subject ISOLATE FCF 390620 RPTS, LAB RESULTS, NOTES, ETC MERCK - CANCIDAS (CASPOFUNGIN ACETATE) NDA 21227/S004,S006,S008,S009 APRVL LTR, LBLG 4/11/02, 6/12/02, 11/15.02, ETC
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6684 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6685 09/14/2011 10/13/2011 2011-6686 09/14/2011 10/13/2011 ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6687 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6688 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6689 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6690 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6691 09/14/2011 10/13/2011 2011-6692 09/14/2011 10/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ PAUL G CARTER POINT DEFIANCE CAPITAL MANAGEMENT LLC LOIS ZIEBOL PURSUIT VASCULAR HANSEN MEDICAL - MAGELLAN ROBOTIC SYS, NORTHSTAR ROBOTIC CATHETER ADDITIONAL INFORMATION (AI) LTR CATHEJELL - K935548 W E CHALKLEY THOMSON REUTERS JANSSEN PHARMS - RAZADYNE (GALANTAMINE HYDROBROMIDE) NDA 21-169/S001,S004 APRVL LTR, LBLG 8/15/01, 7/31/02 VAL SAWYER ZYMOGENETICS INC BOVINE THROMBIN, THROMBIN NOS, THROMBINI LOCAL SOL - ISRS 7282389, 7340966, 7360860, ETC W E CHALKLEY THOMSON REUTERS SANDOZ - INFUVITE PEDIATRIC (MULTIPLE VITAMINS) NDA 21-265/S002,SX003,S004 APRVL LTR, LBLG 6/26/01, 7/09/02, 7/10/02 W E CHALKLEY THOMSON REUTERS ASTRAZENCA - NEXIUM (ESOMPERAZOLE MAGNESIUM) NDA 21-153/S001,S002,S003,S006 APRVL LTR, LBLG 5/16/01, 3/14/02, 10/1/02 DANIEL D CASALE DANIEL D CASALE CUSTOMS BROKER INC W E CHALKLEY THOMSON REUTERS ORAPHARMA - ARESTIN (MINOCYCLINE HCL) NDA 50781/S001,S002,S004,S005,S006 APRVL LTR, LBLG 7/13/01, 8/14/01, 9/14/01, ETC ENTRY #EHR-0001245-9 - LAB ANALYSIS W E CHALKLEY THOMSON REUTERS NOVARTIS - FORADIL (FORMOTEROL FUMARATE) NDA 20831/001,003, 004 APRVL LTR, LBLG 4/25/01, 11/21/01, 5/17/02 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-6693 Recd Date / Due Date 09/14/2011 10/13/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6694 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6695 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6696 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6697 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6698 09/14/2011 10/13/2011 2011-6699 09/14/2011 10/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6700 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6701 09/14/2011 10/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ NICK RUDIKOFF CHANGE TO WIN SHANGJIANG GUOLIAN AQUATIC PRODUCTS CO, GUANGDONG, CHINA - REGISTRATIONI, FOREGIN INSPS, TESTING, ETC W E CHALKLEY THOMSON REUTERS UCB INC - METADATE CD (METHYLPHENIDATE HCL) NDA 21-259/S002,S003,S004 APRVL LTR, LBLG, 4/9/02, 11/6/02 W E CHALKLEY THOMSON REUTERS WYETH PHARMS INC - PROTONIX IV (PANTOPRAZOLE SODIUM) NDA 20-988/S001,S002,S004 APRVL LTR, LBLG 10/11/09, 9/27/01, 7/3/01, ETC NICK RUDIKOFF CHANGE TO WIN RUBICON RESOURCES - REGISTRATION, FOERIGN INSPS, TESTING, ETC W E CHALKLEY THOMSON REUTERS DEY - DUONEB (ALBUTEROL SULFATE; IPRATROPIUM BROMIDE) NDA 20-950/S001,S002,S003 APRVL LTR, LBLG 6/18/01, 8/31/01, 9/5/01, ETC W E CHALKLEY THOMSON REUTERS ALLERGAN - LUMIGAN (BIMATOPROST) NDA 21275/S002,S003,S005 APRVL LTR, LBLG 8/7/01, 4/12/02, 4/17/02 W E CHALKLEY THOMSON REUTERS ALLERGAN - ALPHAGAN P (BRIMONIDINE TARTATE) NDA 21-262/S001,S002,S003 ,APRVL LTR, LBLG 6/5/01, 10/15/01, 12/4/01, ETC W E CHALKLEY THOMSON REUTERS ALCON PHARMS LTD - TRAVATAN (TRAVOPROST) NDA 21257/S001,S002,S003,S005 APRVL LTR, LBLG 3/25/02, 2/15/02, 8/28/02, ETC Signature/ Requester W E CHALKLEY THOMSON REUTERS Subject NOVARTS - TAVIST (ACETAMINOPHEN, CLEMASTINE FUMARATE & PSEUDOEPHEDRINE HCL) NDA 21082/S001,S001 APRVL LTR, LBLG 12/3/01, 6/12/02
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ 2011-6702 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6703 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6704 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6705 09/14/2011 10/13/2011 2011-6706 09/14/2011 10/13/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6707 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6708 09/14/2011 10/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6709 09/14/2011 10/13/2011 ORA/SE-FO/ATL-DO/ACB/ VINCENT ABRUZZESE AMERICAN RED CROSS MIDATLANTIC BLOOD SERVICES REGION ORA/P-FO/LOS-DO/LACB/ GERI COX NATIONAL GENETICS INSTITUTE NATIONAL GENETICS INSTITUTE, LOS ANGELES, CA - EIR 2/9-20/09. 1/11-21/11 AMERICAN RED CROSS, GREENVILLE, NC - EIR 4/26-19/10 W E CHALKLEY THOMSON REUTERS 3M - AVAGARD (ALCOHOL; CHLORTHEXIDINE GLUCONATE) NDA 21-074/S001 APRVL LTR, LBLG 7/23/02 W E CHALKLEY THOMSON REUTERS KING PHARMS - LEVOXYL (LEVOTHYROXINE SODIUM) NDA 21-301/S001,S003 APRVL LTR, LBLG 4/3/02, 12/31/02 W E CHALKLEY THOMSON REUTERS NOVARTIS - TRILEPTAL (OXCARBAZEPINE) NDA 21285/S001/S002,S003 APRVL LTR, LBLG 1/18/02, 9/10/02 NICK RUDIKOFF CHANGE TO WIN THAI UNION GROUP - REGISTRATION, FOREIGN INSPS, TESTING, ETC W E CHALKLEY THOMSON REUTERS BAYER HEALTHCARE - YASMIN (DROSPIREONE; ETHINYL ESTRADIOL) NDA 21-098/S001,S002,S003 APRVL LTR, LBLG 11/26/01, 11/30/01, 112/12/01, ETC W E CHALKLEY THOMSON REUTERS TAKEDA PHARMS NA - PREVACID (LANOPRAZOLE) NDA 21-281/S001/S003/005 APRVL LTR, LBLG 12/07/01, 3/07/02, 12/03/02, ETC W E CHALKLEY THOMSON REUTERS GLAXOSMITHKLINE - VENTOLIN HFA (ALBUTEROL SULFATE) NDA 20-983/S001,S002,S003 APRVL LTR, LBLG 7/9/01, 10/25/01, 3/4/02, ETC Signature/ Requester Subject
2011-6710
09/14/2011 10/13/2011
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Total Records: 12455 Control # 2011-6711 Recd Date / Due Date 09/14/2011 10/13/2011 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-6712 2011-6713 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6714 2011-6715 09/14/2011 10/13/2011 09/14/2011 10/13/2011 2011-6716 09/14/2011 10/13/2011 2011-6717 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6718 09/14/2011 10/13/2011 2011-6719 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6720 2011-6721 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WILLIAM A OLSON Center for Regulatory Services, Inc. WILLIAM A OLSON Center for Regulatory Services, Inc. FOI DAILY LOG 8/22-26/11 FOI DAILY LOG 8/15-22/11 WALKER, STEPHEN KENNETH REID WASHINGTON INFORMATION SOURCE MEDTRONIC BIO-MEDICUS INC - BPX80 BIO-PUMP K973011; LEVITRONIX LLC - LEVITRONIX CENTRIMAG K020271; ABIOMED INC - IMPELLA RECOVER K063723 FOI DAILY LOG 8/22-26/11 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ SHULMAN, SHANA KENNETH REID WASHINGTON INFORMATION SOURCE PER ULLMAN OREXO AB SUBOXONE, SUBUTEX (BUPRENORPHINE/NALTREXONE) AERS DAVID LOY APHENA PHARMA SOLUTIONS COMMUNITY BLOOD CENTERS OF SOUTH FLORIDA INC, LAUDERHILL, FL - INSP, ENFORCEMENT ACTION MOST RECENT FOI DAILY LOG 8/15-22/11 PREPAK SYSTEMS INC, COOKEVILLE, TN - EIR 8/16-20/10 MASTEN, LAWRENCE W RAYMONS M PANAS PHD SUCAMPO PHARMACEUTICALS INC BRAINTREE LABORATORIES INC - MIRALAX (POLYETHYLENE GLYCOL 3350) NDA 20-698 PROTOCOLS, STUDY RPT, FINAL RPT FOR 851-4, ETC CHANTIX (VERENICLINE) - AERS 1/25/10 TO PRESENT Signature/ Requester SANDY KING AMERICAN RED CROSS GREAT OZARKS-ARKANSAS REGION Subject AMERICAN RED CROSS GREATER OZARKS-ARKANSAS REGION, RUSSELLVILLE, AR 2/4/10; SPRINGFIELD, MO 4/2022/10; LITTLE ROCK, AR 9/21-28/10 - EIRS
Page 474 of 1132

Total Records: 12455 Control # 2011-6722 2011-6723 2011-6724 Recd Date / Due Date 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 2011-6725 2011-6726 2011-6727 2011-6728 2011-6729 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6730 2011-6731 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6732 2011-6733 2011-6734 2011-6735 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/14/2011 10/13/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ BARBARA JONES DOMINION GROUP INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. LANXESS CORP - CALCIUM FORMATE ANIMAL FAP 2261 FOI DAILY LOG 8/22-26/11 GENERAL ELECTRIC CO - SILOXANES, SILICONES FCN 363 FOI DAILY LOG 8/15-22/11 FOI SERVICES INC HOWARD A SNYDER HOWARD A SNYDER LAW OFCS DEPAKOTE NDA 18-723 - LBLG, APRVL RECS, EXPIRATION DATE CHANGE, ETC FOI DAILY LOG 8/22-26/11 FOI SERVICES INC HOWARD A SNYDER HOWARD A SNYDER LAW OFCS DEPAKOTE NDA 19-680 - APRVL RECS, LBLG, MODIFICATION, ETC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS STEPHEN BENJAMIN OLSEN MEDICAL FOI DAILY LOG 8/15-22/11 OLSEN MEDICAL - PRO-CLEAN TIP CLEANER K862367 FOI DAILY LOG 8/22-26/11 FOI DAILY LOG 8/15-22/11 KENDLE INTERNATIONAL INC MARIA F MUNOZ SEADCO USA CORP EXTRA JUMBO U-130 SPLS ENTRY #E4P-0016713-0 - LAB RESULTS KENDLE INTERNATIONAL INC FOI DAILY LOG 8/22-26/11 Signature/ Requester Subject FOI DAILY LOG 8/15-22/11
Page 475 of 1132

Total Records: 12455 Control # 2011-6736 Recd Date / Due Date 09/14/2011 10/13/2011 2011-6737 09/14/2011 10/13/2011 2011-6738 2011-6739 2011-6740 2011-6741 2011-6742 2011-6743 2011-6744 2011-6745 09/14/2011 10/13/2011 09/14/2011 10/13/2011 09/15/2011 10/14/2011 09/15/2011 10/14/2011 09/15/2011 10/14/2011 09/15/2011 10/14/2011 09/15/2011 10/14/2011 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6746 2011-6747 09/15/2011 10/14/2011 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6748 2011-6749 09/15/2011 10/14/2011 09/15/2011 10/14/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CIN-DO/CCB/ ADAM WALSER WHAS-TV JOAN M. FRIEND AMERICAN RED CROSS CAUDILL SEED & WAREHOUSE INC, LOUISVILLE, KY - INSP 1/1/08 TO PRESENT; RECALLS 1/1/06 TO PRESENT AMERICAN RED CROSS, WICHITA, KS - EIR 3/17-31/10 OM/OMP/DODM/ Battersby, Luann ANIL SACHDEVA STRIDES INC EXELA - BRIMONIDINE TARTRATE OPHTHALMIC SOL ANDA 78-590 SBA FDA/OMPT/CDRH/OCER/DFOI/ FETTIG, JAMIE WHITNEY P. CARON UNIVERSITY OF NORTH CAROLINA PHARMACOTHERAPY & EXPERIMENTAL THERAPEUTICS ADRIAMYCIN RDF (DOXORUBICIN HYDROCHLORIDE) NDA 50-467 8/7/74 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. ANGELA BOUSE TELEFLEX MEDICAL ANGELA BOUSE TELEFLEX MEDICAL ANGELA BOUSE TELEFLEX MEDICAL ANGELA BOUSE TELEFLEX MEDICAL CARDINAL HEALTH INC - STERILE WATER FOR INHALATION FLEX BAG K090915 HOLOPACK INTL LP - SODIUM CHLORIDE INHALATION SOL K974056 HOLOPACK INTL LP - STERILE WATER FOR INHALATION K972467 AUTOMATIC LIQUID PACKAGING INC - PREFILLED FLEXIBLE RT CONTAINERS W/STER SODIUM K901762 YOLO MEDICAL INC - YOLO CURVE K110342 FOI DAILY LOG 8/22-26/11 FOI DAILY LOG 8/15-22/11 FOI DAILY LOG 8/22-26/11 Subject FOI DAILY LOG 8/15-22/11
ORAL CONTRACEPTIVE VOLUNTARY RECALLS 1988
Page 476 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester CENTRAL PLAINS BLOOD SERVICES REGION 2011-6750 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6751 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6752 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-6753 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6754 2011-6755 09/15/2011 10/14/2011 09/15/2011 10/14/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-6756 2011-6757 09/15/2011 10/14/2011 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JONES, CYNTHIA L OC/OSHC/OPD/ RICHARD BERENSON THERMALIN DIABETES LLC DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES 7/11 SOMATOKINE - ORPHAN PRODUCT DESIGNATION FDA/OMPT/CDRH/OCER/DFOI/ SHAKA, JUSTIN MEAGHAN MEYER MAPLEHURST RODENSTOCK - SCANNING LASER OPHTHALMOSCOPE K871268 PLUSH PIPPIN, KENT, WA; GRANNYS KITCHEN, FRANKFORT, NY; FREED'S BAKERY LLC, MANCHESTER, NH - 483, EIR DON J. MIZERK HUSCH BLACKWELL LLP LUPIN LTD - KEPPRA XR NDA 91-399 , WATSON LABS KEPPRA XR NDA 91-093 , APOTEX - KEPPRA XR NDA 91261 - APRVL LTRS 9/12/11 SEAN HIGGINS, Esq. ANDREWS THORNTON WATSON LABS, WATSON PHARMACEUTICALS INC, ROYCE LABORATORIES INC - QUININE, QUININE SULFATE CORR 1/1/95 TO 12/31/07 DAVID T. LIN, Ph.D. BIOLOGICS CONSULTING GROUP HOFFMANN LaROCHE - ACCUTANE CAP (ISOTRETINOIN) NDA 18-662 CLNCL RVW, MEDICAL RVW, CHEMISTRY RVW DAVID T. LIN, Ph.D. BIOLOGICS CONSULTING GROUP ORTHO JANSSEN - RENTIN-A (TRETINOIN) TOPICAL SOLUTION NDA 16-921 MEDICAL RVW, CHEMISTRY RVW, CLNCL RVW Subject
Page 477 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6758 09/15/2011 10/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6759 2011-6760 2011-6761 2011-6762 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6763 2011-6764 2011-6765 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ANA M SERNA CIBA VISION CORP IOANA RUSU CONSUMERS UNION MELISSA HUNG SIDLEY AUSTIN LLP COR THERAPEUTICS INC - INTEGRILIN (EPTIFIBRATIDE) NDA 20-718 CORR, LBLG, MEMOS 3/10/98-5/18/98 CIBA VISION - FOCUS DAILIES (NELFILCON A) ONE-DAY CONTACT LENS K050065 (CERTIFIED) ARSENIC CONCENTRATIONS IN FRUIT JUICE - RECS FOI SERVICES INC A PETER LOVELEY WISTOW & BARYLICK ATTYS FOI SERVICES INC FOI SERVICES INC TOBACCO PRODS - DISCLOSURE OF ADDITIVES 3/22/11 TO PRESENT TOBACCO PRODS - DISCLOSURE OF ADDITIVES TRANSMITTAL COMM 3/22/11 TO PRESENT TOBACCO PRODS - TOTAL NUMBER OF DISCLOSURE OF ADDITIVES 3/22/11 TO PRESENT CARACO PHARMACEUTICAL LABS - DIGOXIN TABS RECALL RECS, AERS, TESTING, ETC ASHTON, SUSAN R DRAFT GUIDANCE FOR INDUSTRY DIETARY SUPPLEMENTS NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES 7/11 Signature/ Requester Subject
Page 478 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6766 09/16/2011 10/17/2011 2011-6767 2011-6768 09/16/2011 10/17/2011 09/16/2011 10/17/2011 2011-6769 2011-6770 09/16/2011 10/17/2011 09/16/2011 10/17/2011 2011-6771 2011-6772 09/16/2011 12/21/2011 09/16/2011 10/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6773 2011-6774 2011-6775 2011-6776 2011-6777 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 2011-6778 09/16/2011 10/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SCHAFER, DEBORAH CALLEY HERZOG BIOLOGICS CONSULTING GROUP GOJEB L FREHYWOT GENZYME CORP ORANGE BOOK - PREVIOUS ANNUAL EDITIONS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ DAVIS, TIFFANY TIANA M ROSAMILIA EVONIK INDUSTRIES ANGELA BOUSE TELEFLEX MEDICAL TCOYF FERTILITY SOFTWARE - K002726; CONTRACEPTION CALCULATOR - K954183; LADY COMP - K050094 3DFIS MODEL IES-FL-101 - K013841 CARDINAL HEALTH - AIRLIFE NEBULIZER CAP K072119 SUDZUCKER - ISOMALTULOSE GRAS 6G0321 K002577 ORA/SE-FO/SJN-DO/SJCB/ ORA/SE-FO/FLA-DO/FCB/ CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ OTSU, MOTOTA JUAN PABLO OBREGON SUCESORES PEDRO CORTES INC ANDREW S FIX DVM PHD PROCTER & GAMBLE P EDWIN LETCHER DONGELL LAWRENCE FINNEY LLP KVK TECH INC - PHENTERMINE HCL ANDA 40-876, ANDA 40-886, ANDA 40-887 APRVL RECS, LBLG ANITOX CORP - FAP 2215 CMPLNT 120949 ORA/SE-FO/FLA-DO/FCB/ CBER/OCTMA/DDOM/ALFB/ CALDARRERA, AMY LENNY FELDMAN ESQ SANDLER TRAVIS & ROSENBERG PA MMR VACCINATIONS - MFR NAMES CBER/OCTMA/DDOM/ALFB/ TIFFANY K HANNUS LOMMEN ABDO COLE KING STAGEBERG PA SANOFI-AVENTIS -FLUZONE (INFLUENZA VACCINE) INGREDIENTS CLASSIC FRUIT CO - ENTRY #EPR-0003111-3 INDIVIDUAL RECS - VAERS RPT Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-6779 09/16/2011 10/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6780 2011-6781 09/16/2011 10/17/2011 09/16/2011 10/17/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-6782 2011-6783 2011-6784 2011-6785 2011-6786 2011-6787 2011-6788 2011-6789 2011-6790 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/NJ-DO/NJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BAUSCH & LOMB INC - STELLARIS MICROSURGICAL SYS K082473 FOI SERVICES INC MEDISURG LTD - FUGO BLADE K001498 FOI SERVICES INC FOI SERVICES INC BLACKSTONE MEDICAL, SPRINGFIELD, MA - 483 9/16-0810/7/08, RESP TO 483 10/31/08, 1/31/09 2009-2713 FOI SERVICES INC BLACKSTONE MEDICAL - WARNING LTR RESP 3/13/09 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LINDA KARIYA NIHON KOHDEN AMERICA LINDA KARIYA NIHON KOHDEN AMERICA LINDA KARIYA NIHON KOHDEN AMERICA EDWARDS LIFESCIENCE - EV1000 CLINICAL PLATFORM K110597 PULSION MEDICAL SYSTEMS INC - PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYS K001762 EDWARDS LIFESCIENCE - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR K043065 2010-7654 SZYMANSKI #105022, EUGENE SARA ARANDA GORDON FOOD SERVICE METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS GUIDE SOYBEAN DERIVATIVES, SODIUM IN FOOD IN PRISON; DRUGS PROVIDED TO MICHIGAN PRISONS ANIL SACHDEVA STRIDES INC PAR PHARMA - TRAVOPROST OPHTHALMIC SOL ANDA 91341 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-6791 2011-6792 2011-6793 2011-6794 2011-6795 2011-6796 Recd Date / Due Date 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 09/16/2011 10/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6797 2011-6798 09/19/2011 10/18/2011 09/19/2011 10/18/2011 2011-6799 09/19/2011 10/18/2011 2011-6800 09/19/2011 10/18/2011 2011-6801 09/19/2011 10/18/2011 2011-6802 09/19/2011 10/18/2011 2011-6803 2011-6804 09/19/2011 10/18/2011 09/19/2011 10/18/2011 FDA/OMPT/CDRH/OCER/DFOI/ SMUTKA, MARK FDA/OMPT/CDRH/OCER/DFOI/ SMUTKA, MARK FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC NANCY C MACDONALD HEALTH POLICY ASSOCIATES INC NANCY C MACDONALD HEALTH POLICY ASSOCIATES INC NANCY C MACDONALD HEALTH POLICY ASSOCIATES INC NANCY C MACDONALD HEALTH POLICY ASSOCIATES INC NANCY C MACDONALD HEALTH POLICY ASSOCIATES INC INTERMEDICS ORTHOPEDICS INC - MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) K960626 WRIGHT MEDICAL TECHNOLOGY INC - GUARDIAN LIMB SALVAGE SYS K013035 HOWMEDICA OSTEONICS CORP - GLOBAL MODULAR REPLACEMENT SYS K023087 PEREGRINE - SOFT TIP ASPIRATING LASE PROBE K0601024 20G SMA LASER FIBER - K050807 ZIMMER SPINE, AUSTIN,TX, MINNEAPOLIS, MN, MEMPHIS, TN - EIRS, 482S, 483S, ETC 1/08 TO PRESENT VALPO ORTHOPEDIC TECHNOLOGY INC UNICOMPARTMENTAL KNEE K072704 BIOMET INC - ONCOLOGY SALVAGE SYS K002757 DIEDRICH, JOHN OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ ABC NEWS, INC. JAMES KNOWLES ZUCKERMAN SPAEDER LLP ANGELIA SLAYTON KENDLE INTERNATIONAL INC NICK WINBUSH SIDLEY AUSTIN LLP TRIAD GROUP/H&P iNDUSTRIES - AERS ACTIVITY INVESTIGATED BY FDA DKT 1996N-0119 OTC VOL 060095 DKT 1999P-0792 Signature/ Requester MEGAN B HAEBLER BEVERIDGE & DIAMOND PC LEVEL 23 PPB FOR APPLE JUICE - HAZARD ASSESSMENT Subject CFSAN FOI REQUESTS 8/22/11-9/15/11
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Total Records: 12455 Control # 2011-6805 2011-6806 2011-6807 2011-6808 2011-6809 2011-6810 2011-6811 2011-6812 Recd Date / Due Date 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 2011-6813 2011-6814 09/19/2011 10/18/2011 09/19/2011 10/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-6815 09/19/2011 10/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6816 2011-6817 2011-6818 09/19/2011 10/18/2011 09/19/2011 10/18/2011 09/19/2011 10/18/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ CBER/OCTMA/DDOM/ALFB/ JOHN ALTHEN JUDICIAL WATCH VIVIAN A CABALLERO BRAINTREE LABORATORIES INC CARTER NAVARRO BOSTON SCIENTIFIC CORP BRAINTREE LABORATORIES INC, HOLBROOK, MA - EIRS 1/09 TO PRESENT ASTHMATX INC, SUNNYVALE, CA - EIR P080032/E007 3/222/11 HPV4 (HUMAN PAPILOMAVIRUS VACCINE) - VAERS JUN LIMLENGCO MCGUFF PHARMACEUTICALS INC BIONICHE PHARMA, CO GALWAY, IRELAND - EIR, 482 MOST RECENT FISHER, DON FDA/OMPT/CDRH/OCER/DFOI/ CORONADO, RICHARD FDA APRVD TESTS OF ALZHEIMERS, CT-SCANS & PET SCANS - APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ SMUTKA, MARK FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS ROBERT WICK TOSOH BIOSCIENCE INC DAVID BOREACOS BLOOMBERG NEWS IMMUNODIAGNOSTICS SYSTEMS LTD - GAMMA-B 25HYDROXY VITAMIN D RIA K991998 JOHNSON & JOHSNON - PROLIFT & PROLIFT M APPL & APRVL FORMAL OR INORMAL COMM, ETC; ETHICON APPL, APRVL ANALOG & DIGITAL MAMMOGRAPHY UNITS - RECS 2011-4677 2011-5045 2011-4617 2011-4277 2011-4734 Signature/ Requester Subject PEREGRINE - ILLUMINATING LASER PROBE K031023
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Total Records: 12455 Control # 2011-6819 Recd Date / Due Date 09/19/2011 10/18/2011 2011-6820 09/19/2011 10/18/2011 2011-6821 2011-6822 09/19/2011 10/18/2011 09/19/2011 10/18/2011 2011-6823 09/19/2011 10/18/2011 CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ OC/OSHC/OPD/ CBER/OCTMA/DDOM/ALFB/ Action Office ORA/SE-FO/FLA-DO/FCB/ Signature/ Requester WILLIAM S WINGO MORGAN & MORGAN ATTY AT LAW LETICIA GARCIA B T I BIOTECHNOLOGY INSTITUTE SL R IAN KLUGE Hyman Phelps and McNamara PC RUCHIKA RAVAL GLOBAL BIOPHARMACEUTICAL REGULATIONS INC BRUCE CARTER NOVARTIS ANIMAL HEALTH Subject WHITNEY LABS, ORMOND BEACH, FL - INVESTIGATION, RPTS, NOTES, ETC 3/12-14,17/08 HARVEST TECHNOLOGIES - PRP SEPARATION SYS BK100059 ORPHAN DRUG DESIGNATION & APRVL - POLICIES, MEMOS ORGANON TEKNIKA CORP - BCG LIVE VACCINE; MERCK VARICELLA VIRUS VACCINE; SANOFI PASTEUR - YELLOW FEVER LIVE ATTENUATED, ETC VAERS ANIMAL & PLANT HEALTH INSPECTION SERVICES (APHIS), DEPT OF AGRICULTURE (USDA), FOOD & DRUG ADMINISTRATION (FDA), ETC - PRODS REGULATED AS VETERINARY BIOLOGICAL PRODS MEMOS OF UNDERSTANDING 2011-80 - PERPHENAZINE ANDA 89-683 PI (CERTIFIED)
2011-6824
09/19/2011 10/18/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
DENNIS W MORROW DRINKER BIDDLE REATH LLP
2011-6825
09/19/2011 10/18/2011
ORA/OCI/ ORA/OCI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/
JOHN M STEELE RUNFT & STEELE LAW OFC
SMITH & NEPHEW PLC, SMITH & NEPHEW INC, ETC PROMOS MODULAR SHOULDER SYS K063578 EMAILS, VIDEOTAPES, RECALLS, ETC
2011-6826
09/19/2011 10/18/2011
KIT DOUGLASS GANNETT WASHINGTON BUREAU
CORN REFINERS ASSN - CORN SUGAR LTR 7/12/11
2011-6827
09/20/2011 10/19/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/
JENNIFER SORENSON NATURAL RESOURCES DEFENSE COUNCIL KATHERYN PATTERSON SHINN
2011-4306 - DELETED RECS
2011-6828
09/20/2011
CONSUMER ALERT: FDA PLANS REGULATION OF
Page 483 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ 2011-6829 09/20/2011 10/19/2011 OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ 2011-6830 2011-6831 09/20/2011 10/27/2011 09/20/2011 10/19/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6832 09/20/2011 10/19/2011 2011-6833 09/20/2011 10/19/2011 CBER/OCTMA/DDOM/ALFB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/OCI/ FDA/OO/OFBA/OAGS/ TOMAS MERCADO GOVERNMENT SECURITY GUARDS ASSN WILLIAM K GALLITTO ESQ GORDON MUIR AND FOLEY LLP CASA BLANCA SECURITY - CONTRACT #HHSF223201110044C INDIVIDUAL RECS MAURA MARTIN NORDEN SIDLEY AUSTIN LLP MARK A HOGARTH HYACINTHIAN GROUP INC TOBACCO PRODUCTS SCIENTIFIC A/C (TPSAC) MEMBERS, CONSULTANTS, NOMINATIONS, ETC DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC ROBERT J BECERRA ESQ FUERST ITTLEMAN PL ENTRY #BIP-0016803-1 CORR, SUMMARIES, ENFORCEMENT ACTIONS, ETC Signature/ Requester GORDON & REES LLP Subject PROHIBITING THE SALE OF EPHEDRA-CONTAIING DIETARY SUPPLEMENTS AND ADVISES CONSMUERS TO STOP USING THESE PRODUCTS 12/30/03
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OCI/ 2011-6834 09/20/2011 11/30/2011 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6835 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6836 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6837 2011-6838 2011-6839 2011-6840 2011-6841 2011-6842 2011-6843 09/20/2011 10/19/2011 09/20/2011 10/19/2011 09/20/2011 10/19/2011 09/20/2011 10/19/2011 09/20/2011 10/19/2011 09/20/2011 10/19/2011 09/20/2011 11/17/2011 2011-6844 09/20/2011 10/19/2011 ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JACKIE CHRISTENSEN AMERICAN RED CROSS AMERICAN RED CROSS ARIZONA REGION, TUSCON FOOTHILLS COLLECTION SITE, TUCSON MAIN CENTER, PHOENIX DISTRIBUTION SITE, 3/17-18/10, 9/7-10/10, 8/3031/11, ETC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA STELLA K HERRERA GRIFOLS BIOLOGICALS INC APP PHARMACEUTICAL LLC, GRAND ISLAND, NY - EIRS, 483S 1/1/08 TO 8/30/11 BETA-GLUCANS - CAERS 1/05, 9/11 5-HYDROXY TRYOTOPHAN - CAERS 1/05, 9/11 DIOSMIN - CAERS 1/05, 5/11 FDA/OF/CFSAN/OCD/EOS/ HELLEN A OKETCH USP PHARMACOPEIA ELENA HOWELL HOGAN LOVELLS US LLP HOLY BASIL OSCIMUM SANCTUM - CAERS 1/05, 9/11 2011-6070 GYMEMA SYLVESTRE - CAERS 1/05, 9/11 NICOLE LARUSSO DRINKER BIDDLE & REATH LLP ELI LILLY - PRESS RELEASE 10/6/03 JIM LEVENTHAL LEVENTHAL BROWN ET AL LAMICTAL (LAMOTRIGINE) - AERS JONATHAN W JOHNSON JONATHAN W JOHNSON LLC CMPLNTS 114580, 116203 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-6845 2011-6846 Recd Date / Due Date 09/20/2011 10/19/2011 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6847 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6848 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6849 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6850 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6851 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6852 2011-6853 09/20/2011 10/19/2011 09/20/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ KELLY A MAGURANY Nalco Company ANDREW S FIX ANITOX CORP, BUFORD, GA - FORMALDEHYDE FAP 2215 FCN 18, 31, 64 WILLIAMS, GRAIG ALLAN VICTRELIS NDA 20-2258, SNCIVEK NDA , 20-1917 - APRVL RECS GARDEN, ANDREW K TEVA, (F/K/A BARR) - DEXTROAMPHETAMINE SULFATE ANDA 76-137 APRVL LTR, LBLG, RVWS, ETC YULLA FREHKEL TRIS PHARMA INC CHATTEM INC - DOZYLAMINE SUCCINATE TABS NDA 18066 APRVL PKG SCOTT PODOSKY COUNTWAY LIBRARY OF MEDICINE PFIZER - SIGMAMYCIN APRVL & APPROVABILTY CORR 1956 SUSANE YESNICK DRINKER BIDDLE REATH LLP CLOZAPINE (CLOZARIL), RISPERDAL (RISPERIDONE), ZYREXA (OLANZAPINE), ETC - SUMMARY Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DAVE LAMB OMNI SURGICAL DBA SPINE360 JOANNE S HAWANA ARENT FOX LLP ISR 721693, 7267082, 7275281, ETC Subject ACME SPINE LLC - K001044
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Total Records: 12455 Control # Recd Date / Due Date 10/19/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ 2011-6854 09/20/2011 10/19/2011 2011-6855 2011-6856 09/20/2011 10/19/2011 09/20/2011 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6857 2011-6858 2011-6859 2011-6860 2011-6861 2011-6862 09/20/2011 10/19/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 2011-6863 09/21/2011 10/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6864 2011-6865 2011-6866 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ BEVERLY DARLING MDCI ROY KERNAGHAN OTODYNAMICS LTD ROY KERNAGHAN OTODYNAMICS LTD ROY KERNAGHAN OTODYNAMICS LTD ROY KERNAGHAN OTODYNAMICS LTD CARL BEAURLINE CMB REGULATORY SPECIALTIES CARL BEAURLILNE CMB REGULATORY SPECIALTIES CANDICE BETZ BD BIOSCIENCES GREGORY H LEVINE ROPES & GRAY NANITA CRANFORD OCERA THERAPEUTICS INC - SPHERICAL CARBON ADSORBENT AST-120 RECS BIORELIANCE CORP, ROCKVILLE, MD - EIRS, WARNING LTRS, ETC 8/10-2/11 ABBOTT LABS - STERILE PISTON SYRINGE K002717; ACACIA - PISTON SYRINGE K092986; B BRAUN MEDICAL INJEKT SYRINGE K063289 MEDLINE - ANGIOGRPHIC CONTROL SYRINGE K093830; SHANDONG WEIGAO GROUP MEDICAL POLYMER CO DISPOSABLE ANIOGRAPHIC SYRING K082439; ANT ANGIOGRAPHIC SYRINGES K072696, ETC TRADITIONAL 510K CLL FISH PROBE KIT - K100015 MAICO DIAGNOSTIC - MB 11 WITH BERAPHONE PROBE K082035 NATUS MEDICAL INC - ALGO 5 NEWBORN HEARING SCREENER K073665 VIVOSONIC INC - NEUSCREEN K080060 BIOANALOGICS INC, SAN DIEGO, CA - IMPEDANCE PLETHYSMOGRAPH K962783 INTERACOUSTIC A/S - ECLIPSE TEOAE EP15 K052562 SAINI, GURSEWAK FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ BRIAN ROCKWELL BAKER DONELSON MIRALAX- (POLYETHYLENE GLYCOL) 3350 AERS; ISR 6035677-0, 5878818-8, 5139380-0, ETC DKT 2003N-0539 ELENA HOWELL HOGAN LOVELLS US LLP CORN REFINERS ASSN - HIGH FRUCTOSE CORN SYRUP (CORN SUGAR) CORR 7/12/11 Signature/ Requester PROCTER & GAMBLE Subject 10/18/90
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Total Records: 12455 Control # Recd Date / Due Date 10/20/2011 2011-6867 09/21/2011 10/20/2011 2011-6868 09/21/2011 10/20/2011 2011-6869 2011-6870 2011-6871 2011-6872 2011-6873 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6874 2011-6875 09/21/2011 10/20/2011 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/CE-FO/MIN-DO/MCB/ 2011-6876 2011-6877 09/21/2011 10/20/2011 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ WINEGAR, BRIAN ORA/P-FO/SEA-DO/SCB/ KATIE KOSTY SAGEMAX BIOCERAMICS INC SAGEMAX BIOCERAMICS, AUBURN, WA - EIRS 7/29/10 TO 7/2/10 (CERTIFIED) H&P INDUSTRIES INC; TRIAD GROUP INC; TRIAD DISPOSABLE INC - CONSENT DECREE OF CONDEMNATION FORFEITURE & PERMANT INJUCTION - RECONDITIONG PROPOSAL, REVISED RECONDITION PROPSAL, WORK PLAN FOR CGMP 6/13/11 CVM/OCD/ ALAN YOUNG Reckitt Benckiser Pharmaceuticals DONALD H KIDD PERDUE KIDD & VICKERY RECKITT BENCKISER PHARMACEUTICALS INC VETERGESIC NADA ATTACHMENTS H&P INDUSTRIES INC; TRIAD GROUP INC; TRIAD DISPOSABLE INC, ETC - CONSENT DECREE OF CONDEMNATION FORFEITURE & PERMANT INUUNCTION RECONDITIONING PROPOSAL, REVISED RECONDITION PROPOSAL, WORK PLAN FOR CGMP, ETC 6/13/11 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester NEUROGESX INC VINCENT G LOBDELL HEALTHWAY HOME PRODUCTS, INC. NANITA CRANFORD NEUROGESX INC JAY H GELLER JAY H GELLER LAW OFFICES NANITA CRANFORD NEUROGESX INC NANITA CRANFORD NEUROGESX INC ELIZABETH M RICHARDS LATHAM & WATKINS LLP NANITA CRANFORD NEUROGESX INC PLASTICS ENGINEERING & DEVELOPMENT CO (PEDI), CARLSBAD, CA - EIRS, WARNING LTRS, ETC 1/1/06 TO PRESENT BIO SIL VCAPS ENTRY GEO-6210787-1, GEO-621C788-9 MEMO JAMES ALEXANDER CORP, BLAIRSTOWN, NJ - EIRS, WARNING LTRS ETC 1/1/06 TO PRESENT ACM PIVOTAL, ROCHESTER, NY - EIRS, WARNING LTRS, ETC 1/1/06 TO PRESENT REQUIRED WARNINGS FOR CIGARETTE PACKAGES & ADVERTISMENTS - RESEARCH PROTOCOL 6/22/11 CONTRACT PHARMACEUTICAL LTD, MISSISSAUGA, ONTARIO, CANADA - EIRS, WARNING LTRS, ETC 1/1/06 TO PRESENT ADVANCED AIR PURFICATION SYS - K012549 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/MIN-DO/MCB/ 2011-6878 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6879 09/21/2011 10/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6880 09/21/2011 10/20/2011 2011-6881 2011-6882 09/21/2011 10/20/2011 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6883 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ COUCHMAN, JERRY DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/11 DUSA, EDITH OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ JOHNSEN, PETER JAMES RUSSO OFFICE OF THE PUBLIC DEFENDER FDA REQUESTS LABEL CHANGE FOR ALL SLEEP DISORDER DRUG PRODUCTS - PRESS RELEASE 3/14/07 CAMELINA (CAMELINA SATIVA) AS ANIMAL FEED INGREDIENTS - APRVL RECS DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/11 Doe J LUPRON - AERS AUDRA FERGUSON-ALLEN ICEMILLER, LLP TAKEDA PHARMACEUTICALS NORTH AMERICA INC; TAKEDA GLOBAL RESEARCH & DEVELOPMENT CTR INC LANSOPRAZOLE PRODUCTS (PREVACID) & BONE TURNOVER, CLNCL TRIAL RECS LAST 6 YRS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6884 2011-6885 09/21/2011 10/20/2011 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6886 09/21/2011 10/20/2011 2011-6887 09/21/2011 10/20/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6888 09/21/2011 10/20/2011 ORA/SE-FO/FLA-DO/FCB/ KIM CHIN ALPHA RETAIL ALPHA RETAIL, ORLANDO, FL - LIST OF ENTRIES, HELD/REVIEWED FREUND, JAMES PAULA THOMAS SARAH CANNON RESEARCH INSTITUTE JOHN HAINSWORTH, MD (SARAH CANON RESEARCH INSTITUTE) - EIR 8/24/09, AMENDMENTS, ADDENDMS, DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/11 MOORE, LEON ORA/NE-FO/NYK-DO/NYDCB/ CRISTIAN SALAZAR ASSOCIATED PRESS MAZE CORD BLOOD LABORATORIES INC; AMERICORD REGISTRY LLC; ALPHA CORD INC ETC - EIRS LAST 5 YRS DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/10 Signature/ Requester Subject
Page 490 of 1132

Total Records: 12455 Control # 2011-6889 2011-6890 2011-6891 Recd Date / Due Date 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DEN-DO/COMP/ ORA/P-FO/SAN-DO/SFCB/ OC/OCC/ 2011-6892 2011-6893 2011-6894 2011-6895 2011-6896 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 2011-6897 09/21/2011 10/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS MICHAEL R KOCH CASSIDY TURLEY DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/11 CLOSED FOI REQUESTS 8/29/11-9/2/11 CLOSED FOI REQUESTS 9/12-16/11 CLOSED FOI REQUESTS 9/5-9/11 CLOSED FOI REQUESTS 8/29/11-9/2/11 CLOSED FOI REQUESTS 9/12-16/11 FOI SERVICES INC SARAH GEISERT GENERAL MILLS BLUE FIELD SICHUAN FOOD IND CO LTD; CALIFORNIA CEREAL PRODUCTS INC; CREST FOODS ETC - EIRS, CORR, RPTS ETC, 1/1/10 TO PRESENT FOI SERVICES INC CLOSED FOI REQUESTS 9/5-9/11 Signature/ Requester Subject CLOSED FOI REQUESTS 8/29/11-9/2/11
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Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6898 09/21/2011 10/20/2011 2011-6899 09/21/2011 10/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-6900 09/21/2011 10/20/2011 2011-6901 09/21/2011 10/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6902 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6903 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ NEWMAN, MICHAEL W DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES - CONGRESSIONAL CORR, FINANCIAL ESTIMATES, COST BENEFIT ANALYSIS, ETC 7/11 MUHAMMED SHERID, MD ELI D EHRENPREIS MD ISRS 6031839, 6014349, 6023920 ETC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS VINCENT LODATO SILLS CUMMIS ET AL PROPYLTHIOURACIL (PTU), METHIMAZOLE (MMZ) - AERS, WARNINGS. CORR, ETC CLOSED FOI REQUESTS 9/12-16/11 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DAVID KWIARTKOWSKI ASTRAZENECA PHARMACEUTICALS LP CEREXA INC, CHULA VISTA, CA 5/5-7/10, 5/10,13-14/10, ETC - CEFTAROLINE EIRS CLOSED FOI REQUESTS 9/5-9/11 Signature/ Requester Subject
Page 492 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6904 2011-6905 2011-6906 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 2011-6907 2011-6908 2011-6909 09/21/2011 10/20/2011 09/21/2011 10/20/2011 09/21/2011 10/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6910 09/22/2011 10/21/2011 2011-6911 09/22/2011 10/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6912 09/22/2011 10/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6913 09/22/2011 10/21/2011 2011-6914 09/22/2011 10/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ EMILIE R CAULFIELD SEGAL MCCAMBRIDGE SINGER ET AL SUSANE YESNICK DRINKER BIDDLE REATH LLP ASTRAZENCA - SEROQUEL (QUETIAPINE FUMARATE) LABEL CHANGE CORR 9/1/03 TO 1/30/04 #12485-97, 12594-97, 12609-97, ETC - AERS EXHIBITS ERIC WALTER CAMIL CAMIL CONSULTING CORP ACTHAR - AERS NATIONAL ASSOCIATION FOR BIOMEDICAL RESEARCH JOAN STITT (UG2CD-16) MERCK & CO., INC. VEROSCIENCE LLC -CYCLOSET NDA 20-866 APRVL LTR, PI, RVWS FOI REQUEST 1/11 TO PRESENT OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ Doe J DE SPRIT SMITH SIDLEY AUSTIN LLP CHRIS CELESTE EAS Consulting Group, LLC CORI ANNAPOLEN GOLDBERG FULLBRIGHT & JAWORSKI CERTIFICATION OF ATTACHED RECS DKT LOG FDA-1995-S-0039 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ DOUGLAS E CHABOT DECOF & DECOF PC HENRY SU BASF CORP NUTRITIONAL FOOD MANAGEMENT POLICY - MEDICAL NUTRITIONAL THERAPEUTIC DIETS FOR PRISIONERS IN NC DKT 1996N-0119 CELLCEPT - MFG APPLICATIONS, CLEARANCE &/OR REJECTIONS, CORR ETC VALSPAR CORP - FCN 1074 Signature/ Requester Subject
Page 493 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6915 09/22/2011 10/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6916 2011-6917 2011-6918 09/22/2011 10/21/2011 09/22/2011 10/21/2011 09/22/2011 10/21/2011 2011-6919 09/22/2011 10/21/2011 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ 2011-6920 09/22/2011 10/21/2011 2011-6921 2011-6922 2011-6923 09/22/2011 10/21/2011 09/22/2011 10/21/2011 09/22/2011 10/21/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ MAX BUSETTI THOMPSON PUBLISHING GROUP KELLY A MAGURANY Nalco Company MEDTRONIC VASCULAR - DUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYS, P840001/S042 VALERITAS INC - VALERITAS V-GO INSULIN DELIVERY DVC K103825 CORN REFINERS ASSOCIATION - BARBARA SCHNEEMAN LTR 7/12/11 ASHLAND INC - FCN 979 BENSON, MARK ORA/SW-FO/DEN-DO/COMP/ MARC STEWART KMGH-TV SHARLENE EDMONDS PPD LESLIE NICHOLSON AMERICAN RED CROSS MUSSER BLOOD CENTER MD ANDERSON CANCER CENTER, HOUSTON, TX - EIRS, 483S, CO RESP, ETC 6/10 TO 12/10 PHILADELPHIA DONOR & CLIENT SUPPORT CTR, PHILADELPHIA, PA - EIR 9/2/10-10/29/10 LISTERIA OUTBREAK COLORADO - RPTS, COMM 9/1-19/11 COOPER, JACK #328257 CEODON, WELLBUTRIN, REMEON, ETC - AERS Signature/ Requester Subject
DRAFT GUIDANCE FOR INDUSTRY NEW DIETARY INGREDIENT NOTIFICATIONS & RELATED ISSUES EXPENDITURE OF TIME & MONEY, COMM, SAFETY RECS, ETC 7/11
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Total Records: 12455 Control # 2011-6924 Recd Date / Due Date 09/22/2011 10/21/2011 2011-6925 2011-6926 2011-6927 2011-6928 2011-6929 2011-6930 09/22/2011 10/21/2011 09/22/2011 10/25/2011 09/22/2011 10/21/2011 09/22/2011 10/21/2011 09/22/2011 10/21/2011 09/22/2011 11/16/2011 2011-6931 2011-6932 2011-6933 09/22/2011 10/21/2011 09/22/2011 10/21/2011 09/22/2011 11/01/2011 2011-6934 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-6935 2011-6936 09/23/2011 10/24/2011 09/23/2011 10/24/2011 ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC ORA/CE-FO/MIN-DO/MCB/ DIEDRICH, JOHN GENENTECH/BIOGEN IDEC, RESEARCH TRAINGLE PARK, NC - EIRS, 483S, CO RESP, ETC 2009 TRIAD/H & P - PROD RECALL RECS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ FDA/OF/CFSAN/OCD/EOS/ AMIDON 08B1873, JONATHAN CLAIRE MITCHELL MARLER CLARK LLP, PS DOUGLAS N BLUE ZETETIC INC JOHN HARLOE FREESE & GOSS, PLLC LIFESCAN SCOTLAND LTD, INVERNESS, UK - ONETOUCH GLUCOSE TEST STRIPS ENTRY 322-0510670-5/1/1 PHOTOGRAPHS MEDTRONIC - INFUSE WARNING LTRS, ADVERTISING, MDRS, ETC 2009-4448 (CERTIFIED) CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ SHAKA, JUSTIN KELLY A MAGURANY Nalco Company JENNIFER D NEWBERGER Hyman Phelps and McNamara PC CYTOSOL LABS - BN010409; HAEMONETICS CORP BN980123; TERUMO MEDICAL CORP - BN781214 ETC SUBMISSIONS, CORR, RECS ETC ENERGY DRINKS CONTAINING ALCOHOL - RPTS, STUDIES FDA/OMPT/CDRH/OCER/DFOI/ SHAKA, JUSTIN FDA/OF/CFSAN/OCD/EOS/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester LAINE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP RACHEL A BOND Keller and Heckman LLP KELLY R STAROSTA Keller and Heckman LLP M&T CHEMICALS, RAHWAY, NJ - FAP 5B2801 RVWS, MEMOS, CORR ETC OPTOS PLC - SCANNING LASER OPTHALMOSCOPE K102492 OPTOS PLC - SCANNING LASER OPTHALMOSCOPE K983999 BUCKMAN LABORATORIES INTERNATIONAL INC - FCN 871 Subject VALERITAS INC - VALERITAS V-GO INSULIN DELIVERY DVC, K100504
CHEVRON PHILLIPS CHEMICAL CO LP - FCN 1083
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Total Records: 12455 Control # 2011-6937 2011-6938 2011-6939 2011-6940 2011-6941 2011-6942 Recd Date / Due Date 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 2011-6943 09/23/2011 10/24/2011 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6944 09/23/2011 10/24/2011 2011-6945 09/23/2011 10/24/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-6946 2011-6947 09/23/2011 10/24/2011 09/23/2011 10/24/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/COS/OES/ OC/COS/OES/ FOI SERVICES INC ORA/P-FO/SAN-DO/SFCB/ FOI SERVICES INC IMPAX LABORATORIES INC, HAYWARD, CA - EIR, 48312/13/10 TO 1/21/11 CAFFEINE & ALCOHOL - RPTS, STUDIES, EMAILS, ETC 1/01 TO PRESENT FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC ULTREPET LLC - POST-CONSUMER RECYCLED POLYETHYLENE TEREPHTHALATE NON OBJECTION LTR 9/12/07 UTHERA: SYS MODEL 8850-0001 - K072505, WARNING LTRS AERS, ETC FOI SERVICES INC NEOMYCIN - COMM, RESP, ELECTRONIC MAIL, ETC FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC ERIC K SCHWARTZ ESQ SULLIVAN PAPAIN BLOCK ET AL FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC KELLY A MAGURANY Nalco Company Action Office FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Signature/ Requester Subject ORTHOPEDIC SYSTEMS INC - CTI II STRAIGHT STEM K891539 ORTHOPEDIC SYSTEMS INC - CTI STRAIGHT STEM K873627 BUCKMAN LABORATORIES INTERNATIONAL INC MONOCHLORAMINE NO OBJECTION LTR 12/15/06, CORR DR HOWARD SCHWARTZ, MIAMI RESEARCH ASSOCIATES, MIAMI, FL - EIRS, 483S, CO RESP, ETC 4/20, 10/05, 1/07 ALLERGAN - LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYS WITH OMNIFORM DESIGN DR ERIC SHELDON, MIAMI RESEARCH ASSOCIATES, MIAMI, FL ERIC - EIRS, 483S, CO RESP, ETC 1/05
Page 496 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ 2011-6948 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6949 2011-6950 09/23/2011 10/24/2011 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6951 2011-6952 09/23/2011 10/24/2011 09/23/2011 10/24/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/PHI-DO/PCB/ BOUIS-TOWE, KARINE CINDY INGOLD AMERICAN RED CROSS MISSOURI-ILLINOIS BLOOD SERVICES REGION CBER/OCTMA/DDOM/ALFB/ NATHANIEL ENOS CONWAY HOMER & CHINCAPLAN PC ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-6956 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6957 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANTHONY SOCIA ATLANTIC PHARMACEUTICALS LEHIGH VALLEY - OXYCODONE HCL 5MG CAP NDA 200534 MAXIMUM THERAPEUTIC DAILY DOSE 200 MG/DAY RECS ANNE MUTASHI HOGAN LOVELLS US LLP APOTEX INC, ONTARIO, CANADA - EIR 2/11 DENISE WHITLOCK BARRON & STADFELD, P.C. ANNE MUTASHI HOGAN LOVELLS US LLP DAVOL - SALUTE FIXATION DVC 483S, VIOLATIONS, RECALLS, ETC APOTEX INC, ONTARIO,CANADA - DETENTION OF FINISHED DRUG PRODS 1/09 TO PRESENT RAINBOW ACRES FARM RAW MILK CO - INVESTIGATION RECS AMERICAN RED CROSS (COLUMBIA CENTER), ST LOUIS MO; - 4/28/0, AMERICAN RED CROSS (SOUTH COUNTY CENTER), ST LOUIS, MO - 9/8/10, AMERICAN RED CROSS (ST CHARLES CENTER), ST LOUIS, MO11/22/10 EIRS, ETC INDIVIDUAL RECS OC/COS/OL/ MAXWELL, KYLE NANCY YUEN GlaxoSmithKline QUETIAPINE - ISRS 3408953-5, 393557-4, 3943583-8, ETC CONGRESSMAN JASON CHAFFETZ - HHS CORR ANGELIA D SLAYTON KENDLE INTERNATIONAL INC MCNEIL CONS - TYLENOL (GELTAB) NDA 19-872/S006 APRVL LTR, LBLG, RVIWS, ETC 1/11/11 Signature/ Requester Subject
2011-6953
09/23/2011 10/24/2011
2011-6954 2011-6955
09/23/2011 10/24/2011 09/23/2011 10/24/2011
Page 497 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6958 2011-6959 09/23/2011 10/24/2011 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6960 2011-6961 2011-6962 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 2011-6963 09/23/2011 10/24/2011 ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ CARL BEAURLINE CMB REGULATORY SPECIALTIES FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JAE-SEONG HAN IRC KOREA KATHY BANKERT INTEGRA LIMIT UNCERTAINTY KATHY BANKERT INTEGRA LIMIT UNCERTAINTY FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ KATHY BANKERT INTEGRA LIMIT UNCERTAINTY ANITA JOHNSON GARY C JOHNSON PSC ANITA JOHNSON GARY C JOHNSON PSC TRACY PALMER BERNS COVIDIEN ANITA JOHNSON MALLINCKRODT INC, RALEIGH, NC - EIRS 3/1-5/10, 8/1620/10 CYNOSURE INC - K072484 APPLICATION, CORR, RECS ETC CYNOSURE INC - K083795 J JAMMER SURGICAL INSTRUMENTS INC ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES K931959 RUGGLES CORP - MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTS K902818 CYNOSURE INC - K091537 STERIS CORP VIS-U-ALL II SELF SEAL POUCH - K070765; STERIS CORP VIS-U-ALL HEAT SEAL POUCH & TUBING K071087; KIMBERLY-CLARK CORP KIMGUARD ONE-STEP STERILIZATION WRAP - K092167 ETC PHILIPS - ESENTA DR K070528; CARESTREAM - DRX-1 SYS K090318; DRGEM - DIAMOND 5A/6A/8A K102408 RUGGLES CORP - ZEPPELIN INSTRUMENTS K902850 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC GEORGE L DIMOTSIS DRIPPING WET WATER MICHELLE RYAAK ROANOKE TRADE SERVICES INC MARK/REDELIVER - NOTICES OF REFUSAL ENTRY TZ0105832-2 WILD FLAVORS INC - MTG MEMOS, LTRS, PETITIONS, ETC 1/07 TO PRESENT NATIONAL FOOD PROCESSORS ASSN - FAP 4A4415 ORA/SW-FO/KAN-DO/COMP/ OUTLAW, GARY FRANKLIN ANTHONY SOSCIA ATLANTIC PHARMACEUTICALS INC OXECTA (OXYCODONE HCL) TABS NDA 20-2080 - APRVL RECS CMPLNT 121856 Signature/ Requester INC Subject
2011-6964 2011-6965 2011-6966
09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011
2011-6967 2011-6968 2011-6969 2011-6970 2011-6971
09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011
Page 498 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/24/2011 2011-6972 09/23/2011 10/24/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ 2011-6973 2011-6974 2011-6975 2011-6976 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6977 09/23/2011 10/24/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6978 09/23/2011 10/24/2011 2011-6979 09/23/2011 10/24/2011 2011-6980 09/26/2011 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/SEA-DO/SCB/ OC/OM/OMP/DDM/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN BODE MATZ CHRIS HAWLEY ASSOCIATED PRESS PROPOSED RESCHEDULING OF HYDROCODONE COMBINATION MEDICATIONS TO SCHEDULE II - RECS, COMM 1999 TO PRESENT DKT 1994P-0286 RUDY TOTH GROSSMAN ROTH PA INDIVIDUAL RECS FOI SERVICES INC NANCY F OLIVIERI MD (HOSPITAL FOR SICK CHILDREN), TORONTO, ONTARIO, CANADA - EIR, 483, WARNING LTR, ETC 7/6/09 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANITA JOHNSON GARY C JOHNSON PSC ANITA JOHNSON GARY C JOHNSON PSC ANITA JOHNSON GARY C JOHNSON PSC THOMAS J SCHANK HUNTER & SCHANK CO LPA CENTOCOR ORTHO BIOTECH INC - REMICADE (INFLIXIMAB) AERS, STUDIES CYNOSURE INC - K083379 CYNOSURE INC - K08O121 CYNOSURE INC - K073394 JOHN HARLOE FREESE & GOSS, PLLC MEDTRONIC - INFUSE DOJ SETTLEMENT RECS 2004-2005 Signature/ Requester GARY C JOHNSON PSC Subject
Page 499 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ 2011-6981 09/26/2011 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ 2011-6982 09/26/2011 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6983 2011-6984 09/26/2011 10/25/2011 09/26/2011 10/25/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6985 2011-6986 2011-6987 2011-6988 2011-6989 09/26/2011 10/25/2011 09/26/2011 10/25/2011 09/26/2011 10/25/2011 09/26/2011 10/25/2011 09/26/2011 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6990 2011-6991 09/26/2011 01/11/2012 09/26/2011 10/25/2011 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ CRISTINA N RUBKE SHARTSIS FRIESE LLP ISABELLE S COATS PHD BAYER CROPSCIENCE GLYPHOSATE & GLUFOSINATE TOLERANT SOYBEAN EVENT DAS-44406-6 2 4-D - PRE-MARKET BIOTECHNOLOGY NOTIFICATION PINE NUTS - CMPLNTS RAPOPORT, GREGG A FDA/OMPT/CDRH/OCER/DFOI/ BELLISSIMO, JOSEPH S FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Shaunnessey, Jerome DELVIN KHONG SOURCELINK PHARMA PTE LTD RS MEDICAL - RS-FBG FULL BACK CONDUCTIVE GARMENT RECS MYLAN - LETROZOLE ANDA 78-190; TEVA PHARMS LETROZOLE ANDA 90-289; ACTIVIS TOTOWA - LETROZOLE ANDA 90-292, ETC RECS FDA/OMPT/CDRH/OCER/DFOI/ LEX PEARCE ICU MEDICAL INC ANDREW LEHREN NEW YORK TIMES LARA SAY DOUGLAS & LONDON BAYER HEALTHCARE PHARMACEUTICALS INC, BERLEX LABS - YASMIN (DROSPIRENONE/ETHINYL ESTRADIOL NDA 21-098 LTR 7/10/03; LEVITRA (VARDENAFIL HCL) NDA 21400, MIRENA (LEVONORGESTREL-RELEASING INTRAUTERINE SYS LTR 3/26/09, ETC CAREFUSION - POSTMARKET SURVEILLANCE (PS) STUDY ORDER PS100009, PS100010 LTR 7/10, ETC MONTERIS MEDICAL INC - INVESTIGATIONAL DVC EXEMPTION (IDE) APPL RECS K1008461 - LBLG INTERNATIONAL INSPS DATABASE LAST 5 YRS LARA SAY DOUGLAS & LONDON YASMIN, ALESSE, MIRETTE, ETC - CDER MEMO 1/16/03 CHRIS HAWLEY ASSOCIATED PRESS DEA PETITION PERTAINING TO THE RESCHEDULING OF SOMA (CARISOPRODOL) UNDER THE CONTROLLED SUBSTANCES ACT 1996 - RECS, CORR Signature/ Requester Subject
Page 500 of 1132

Total Records: 12455 Control # 2011-6992 Recd Date / Due Date 09/26/2011 10/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6993 2011-6994 09/26/2011 10/25/2011 09/26/2011 10/25/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-6995 09/26/2011 10/25/2011 2011-6996 2011-6997 2011-6998 09/26/2011 10/25/2011 09/26/2011 10/25/2011 09/26/2011 10/25/2011 2011-6999 2011-7000 09/26/2011 10/25/2011 09/26/2011 10/25/2011 2011-7001 09/26/2011 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7002 09/26/2011 10/25/2011 FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ CASEY, JANE DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS - CONGRESSIONAL CORR, SAFETY ISSUES, FINANCIAL ESTIMATES, ETC ARNOLD, NANCY J FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ DIEDRICH, JOHN JUDY F GORDON DVM CLINREG CONSULTING SERVICES INC ACCORD HEALTH CARE - GENERIC CLONAZEPAM AERS ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CHI-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ MARILYNN WHITNEY COVINGTON & BURLING LLP DEENA BLANCHETTE-MAJSZAK CSL BEHRING DANIEL KOZUH PFAFF & GILL, LTD. SHAWN H HUBER PROFESSIONAL HOSPITAL SUPPLY INC PROFESSIONAL HOSPITAL SUPPLY INC, TEMECULA, CA INSP 4/20-29/11 RECS PROFESSIONAL DISPOSABLES INTERNATIONAL/NICEPAK, ORANGEBURG, NY - EIRS 4/11 TO PRESENT OPTONOL LTD - K012852 BUBBA FOODS LLC - CMPLNTS PERSONAL CARE PRODUCTS COUNCIL - COSMETIC PRODS MICROBIAL CONTAMINATION RECS 2005 TO PRESENT CSL BEHRING, BRADLEY, IL - EIR, 483 2011 RUSS DUBA PERRIGO PLANT 5 MARY ANDERSON SHIRE INC DR REDDY'S, ANDHRA, PRADESH, INIDA - EIRS, 483S MOST RECENT SYMBYAX NDA 21-520/S012 - SBA Signature/ Requester JAYA LAKSHMI DR REDDY'S LABORATORIES INC Subject ADVANCE BIOFACTURES - SANTYL BLA 101995 SBA
Page 501 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-7003 2011-7004 2011-7005 2011-7006 2011-7007 2011-7008 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7009 2011-7010 09/27/2011 10/26/2011 09/27/2011 11/03/2011 2011-7011 09/27/2011 10/26/2011 2011-7012 2011-7013 09/27/2011 10/26/2011 09/27/2011 10/26/2011 2011-7014 2011-7015 2011-7016 2011-7017 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 OM/OSS/OPILS/DFI/ OM/OMP/DODM/ OM/OMP/DODM/ GARRISON, MARK VICTOR C ARELLANO SECHRIST INDUSTRIES INC DEANA BOUSHELL NIPPON SHERWOOD R&D CENTER - 2009-389 RESP DKT 77P-0308 - RECLASIFICATION PETITION, TRANS CBER/OCTMA/DDOM/ALFB/ SHAPIRO, ELIZABETH ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ Doe J BARBARA A BENTON ARTHUR CHAPMAN, KETTERING SMETAK ET AL EVER CAT FUELS, WILMAR, MN - EIRS 15 EXHIBITS, 3 ATTACHMENTS, ETC 2/22-23/11 NEUROMAS (FEET), DIPLOPIA, CRANIAL NERVE PALSY, ETC - E-23340 VAERS DKT 95N-0308 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/NJ-DO/NJCB/ WALTERE CHALKLEY THOMSON REUTERS A LUKE SMITH FARUGI & FARUGI LLP DENISE M POWERS FULBRIGHT & JAWORSKI LLP SOUTH TEXAS INNOVATIVE MEDICINE, CORPUS CHRISTI, TX - EIRS, 483S, CO RESP 4/5-8/11 SUN PHARMACEUTICAL INDUSTRIES LTD, CRANBURY, NJ CGMP CONCERNS REGULATORY COMPLIANCE ISSUES 8/07 TO PRESENT ULTMATE FORMULATIONS INC (BEST FORMULATIONS) , CITY OF INDUSTRY, CA - EIRS, 483S, 482S, ETC 5/1/10 TO PRESENT 100% PURE - CONSUMER CMPLNT ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/SAN-DO/SFCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS GENENTECH VACAVILLE, CA - EIRS, 483S, CO RESP 9/2128/09 ADVANCED TESTING LABORATORY, CINCINNATI, OH EIRS, 483S CO RESP 8/18/10-4/9/10 ABSOLUTE PACKAGING, MELBOURNE, FL - EIRS, 483S, CO RESP 3/24/10-4/9/10 FRESENIUS MEDICAL CARE HOLDINGS, WALTHAM, MA EIRS, 483S, CO RESP 6/15/10-8/6/10 JOSEPH B MICHELSON MD, ARTESIA, CA - EIRS, 483S CO RESP 7/10, 8/10 YAG MAG LABS PRIVATE LTD, ANDHRA PRADESH, INDIA EIRS, 483S, CO RESP 6/27/10-7/2/11 Signature/ Requester Subject
Page 502 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/26/2011 2011-7018 09/27/2011 02/10/2012 Action Office OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/ORO/ ORA/ORO/ ORA/ ORA/ FDA/OO/OFBA/OAGS/ 2011-7019 09/27/2011 10/26/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7020 2011-7021 2011-7022 2011-7023 2011-7024 2011-7025 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/DET-DO/DCB/ WALTER A CHALKLEY THOMSON REUTERS WALTER A CHALKLEY THOMSON REUTERS WALTER A CHALKLEY THOMSON REUTERS WALTER A CHALKLEY THOMSON REUTERS WALTER A CHALKLEY THOMSON REUTERS WALTER A CHALKLEY THOMSON REUTERS COVENANT HEALTHCARE INSTITUTIONAL REVIEW BOARD, SAGINAW, MI - EIRS, 483S, CO RESPS 4/4-20/11 DR JOHN CATON, SPRINGFIELD, OR - EIRS, 483S, CO RESPS 8/2-20/10 BIOLAB CO, BAYAMON, PR - EIRS, 483S, CO RESPS 2/2/11 3/1/11 NOVEN PHARMACEUTICALS, CARLSBAD, CA - EIRS, 483S, CO RESPS 1/31/11 - 2/14/11 MIRAMAR COSMETICS, DORAL, FL - EIRS, 483S, CO RESPS 2/4-14/11 LUITPOLD PHARMACEUTICALS, SHIRLEY, NY - EIRS, 483S, CO RESPS 2/9-15/11 PETTIGREW, DAVID DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS NEW DIETARY INGREDIENT NOTIFICATIONS & RELATED ISSUES - EXPENDITURE OF TIME & MONEY, COMM, SAFETY ISSUES, ETC 7/11 HERBISON, GEORGE Signature/ Requester SMITH & NEPHEW Subject 12/21/09 DIETARY SUPPLEMENTS - ENFORCEMENT INSP, RULES & REGULATIONS
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Total Records: 12455 Control # 2011-7026 2011-7027 2011-7028 2011-7029 Recd Date / Due Date 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 09/27/2011 10/26/2011 2011-7030 2011-7031 09/27/2011 10/26/2011 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7032 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7033 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7034 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7035 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DAVID S COOPER JOHNS HOPKINS UNIV ENDROCRINOLOGY & METABOLISM PROPYLTHIOURACIL & METHIMAZOLE - HEPATOTOXICITY AERS; AMERICAN THYROID ASSOC RECS BY JOSLYN SWANN, 4/18/09 JOAN STITT (UG2CD-16) MERCK & CO., INC. BIONICHE PHARMA - DOLOPHINE HYDROCHLORIDE (METHADONE HYDROCHLORIDE), NDA 21-624, APRVL LTR, PKG CIRCULAR, RVWS, ETC S ALBERT EDWARDS, PHARM D GLOBAL SUBMIT INC - SOFTWARE FILES, RECS, COMM ETC LYNCH, DESIREE EPINEPHRINE - SPECIFIC HEAT CAPACITY (MEASURED IN JOULES); 1/2 LIFE OF DRUG FILIPIAK, MARGARET OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ LAURA J BAUGHMAN BARON & BUDD ATTYS FORMALDEHYDE, METHYLENE GLYCOL - ANALYTICAL MEASURING METHODS, RPTS, RECS DIVIS LABORATORIES LTD - EIR 7/25-30/11 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester WALTER A CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS Subject LONZA BIOLOGICS INC, PORTSMOUTH, NH - EIRS, 483S, CO RESPS 4-4/11 - 5/6/11 LEHIGH VALLEY TECHNOLOGIES, ALLENTOWN, PA - EIRS, 483S, CO RESPS 1/10/11 - 2/3/11 DEIBEL LABORATORIES OF ILLINOIS, LINCOLNWOOD, IL EIRS, 483S, CO RESPS 2/23/11 - 4/21/11 SPENCER WAYNE MD, LENEXA, KANSAS - EIRS, 483S, CO RESPS 11/10
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7036 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7037 2011-7038 09/27/2011 10/26/2011 09/27/2011 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7039 2011-7040 09/28/2011 10/27/2011 09/28/2011 10/27/2011 2011-7041 2011-7042 2011-7043 2011-7044 2011-7045 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7046 2011-7047 2011-7048 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ SHARP PACKAGING, ALLENTOWN, PA - EIR 9/10 SHARP PACKAGING, ALLENTOWN, PA - EIR 4/11 SHARP PACKAGING, CONSHOHOCKEN, PA - EIR 5/08 FDA/OMPT/CDRH/OCER/DFOI/ JAEN, CYNTHIA BRENDA M GARTZ ELI LILLY & CO CATALENT PHARMA SOLUTIONS, CORBY UK - EIR 3/10 FDA/OMPT/CDRH/OCER/DFOI/ JAEN, CYNTHIA ARTHROTEK - MAXFIRE K061776 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ARDAUGH, BRENT BIOMET - JUGGERKNOT K110145 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. K951000, K955033, K004043, ETC - SUMMARY CLOSED FOIA REQUEST 9/19-23/11 CLOSED FOIA REQUESTS 9/19-23/11 CLOSED FOIA REQUESTS 9/19-23/11 FOI SERVICES INC OC/OM/OMP/DDM/ IAN KLUGE Hyman Phelps and McNamara PC ISRS 01496726, 3475646, 5701932 ETC DKT 1998C-0790 MARGARET R GROEL LACHMAN CONSULTANT SERVICES, INC. QINGDAO JIULONG BIOPHARMACEUTICALS CO LTD, QUINGDAO, PEOPLE'S REPUBLIC OF CHINA (PRC) - EIRS, 483S 3/11 Signature/ Requester Subject
Page 505 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/27/2011 2011-7049 2011-7050 2011-7051 2011-7052 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 2011-7053 09/28/2011 10/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7054 09/28/2011 10/27/2011 2011-7055 09/28/2011 10/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7056 2011-7057 09/28/2011 10/27/2011 09/28/2011 10/27/2011 2011-7058 2011-7059 09/28/2011 10/27/2011 09/28/2011 10/27/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/P-FO/LOS-DO/LACB/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7060 09/28/2011 10/27/2011 FDA/OMPT/CDRH/OCER/DFOI/ YUSU LIN INTERNATIONAL LEISURE SINOCHEM NINGBO LATEX GLOVES FACTORY - K980827 NANCY SWANSON AMERICAN CIGARETTE CO CRAIG TRAUTMAN INTAGRAS INC AMERICAN CIGARETTE COMPANY INC - PROD LISTINGS, INGREDIENTS, SUBSTANTIAL EQUIVALENT RPTS, ETC ESTABLISHMENT REGISTRATIONS DATA SET SAMANIEGO, JAMES MICHELLE RYBAK CASE #2011270420175801, #2011270420175201, ROANOKE TRADE SERVICES INC #2011270420121101 - NOTICE OF MARK/REDELIVER SMITHS MEDICAL LTD - EIRS, 483S, WARNING LTRS, ETC FDA/OF/CFSAN/OCD/EOS/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC RICHARD YOON Rakoczy Molino Mazzochi Siwik LLP SINEQUAN NDA 16-798 - RECS BOREALIS POLYOLEFINE GMBH - FCN 793 FDA/OMPT/CDRH/OCER/DFOI/ ARDAUGH, BRENT MARK E TRUESDELL BEVING SWANSON & FOREST PC WILLIAM A GARVIN BUCHANAN INGERSOLL & ROONEY PC ZUTRIPRO (CHLORPHENIRAMINE MALEATE, HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HCL), REZIRA (HYDROCODONE BITARTRATE, PSEUDOEPHEDRINE HCL) - SBA IOWA EGG PRODUCERS - EIRS 2011 OC/COS/OL/ ORA/CE-FO/PHI-DO/PCB/ Action Office Signature/ Requester ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO THEODORE A EMERY EMERY, THEODORE A K951000, K974728, K955033, ETC SEN AMY KLOBUCHAR, SEN SCOTT BROWN - LTRS SHARP PACKAGING, CONSHOHOCKEN, PA - EIR 8/11 Subject
Page 506 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester PRODUCTS INC 2011-7061 2011-7062 09/28/2011 10/27/2011 09/28/2011 10/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7063 09/28/2011 10/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ 2011-7064 09/28/2011 10/27/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ 2011-7065 09/28/2011 10/27/2011 2011-7066 09/28/2011 10/27/2011 ORA/ORM/ ORA/ORM/ ORA/NE-FO/NYK-DO/NYDCB/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION JONEL ALECCIA MSNBC.COM FOREIGN AND DOMESTIC DIETARY SUPPLEMENT, DRUG MFG, PACKING FACILITIES, ETC 6/25/07 TO 6/25/11 PROFESSIONAL DISPOSABLES INTERNATIONAL INC, ORANGEBURG, NJ 5/17/01, 3/3/05, 12/18/06, ETC; NICE-PAK INC, ORANGEBURG, NY 12/9/05, 1/30/08, 9/15/08, ETC - 483S MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION HI TEC PHARMS, NORCROSS; BALCHEM CORP, CHANNAHON; OPTIMUM NUTRITION INC, AURORA, ETC EIRS, 483S JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC SPRUNK JANSEN - WEIGH LEVEL, GLUCO LEVEL, CHO LEVEL AERS, RECS ORA/SE-FO/ATL-DO/ACB/ PATTY CRONAN OWEN MUMFORD INC ALLISON PAYNTER WILLIAM BEAUMONT ARMY MEDICAL CENTER CONCOMITANT USE OF ZYVOX (LINEZOLID) & DILAUDID (HYDROMORPHONE) OWEN MUMFORD USA INC, MARIETTA, GA - EIR 9/23-30/08 Subject
Page 507 of 1132

Total Records: 12455 Control # 2011-7067 Recd Date / Due Date 09/28/2011 10/27/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7068 09/28/2011 10/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7069 2011-7070 2011-7071 2011-7072 2011-7073 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 09/28/2011 10/27/2011 2011-7074 2011-7075 2011-7076 2011-7077 09/28/2011 10/27/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-7078 09/29/2011 10/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ALDIN, ROSAMARIE CRESTOR, METFORMIN, LISINOPRIL, ETC - AERS Doe J ROMAN E LONGORIA JR INTERNATIONAL CONSULTING ISRAEL, ELENA CLAIRE MITCHELL MARLER CLARK LLP, PS OB/GYN DVCS PANEL MTG - SURGICAL MESH RECS 9/89/11 CANNED JALAPENO PEPPERS - SPL COLLECTION RPT, LBLG, LAB RPT, ETC SERRATO QUIROGA, ANDRES ERNESTO FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TARO KANAI MIC INTERNATIONAL CORP TARO KANAI MIC INTERNATIONAL CORP TARO HANAI MIC INTERNATIONAL CORP TARO KANAI MIC INTERNATIONAL CORP MEDICAL EQUIPMENT REGISTERED WITH FDA 2008 TO 2011 NESTLE COOKIE DOUGH E-COLI OUTBREAK - RECS 5/09, 6/09 2010-980 (CERTIFIED) TOPCON MEDICAL SYSTEMS INC - TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYS K072971 OPTOVUE INC - RTVUE 100 K101505 CARL ZEISS MEDTEC INC - CIRRUS HD-OCT K063378 REICHERT INC - SOCT COPERNICUS K071839 JONEL ALECCIA MSNBC.COM TRIAD GROUP, H & P INDUSTRIES INC - AERS INVESTIGATIONS, RPTS Signature/ Requester JONEL ALECCIA MSNBC.COM Subject NOVEN PHARMS - FENTANYL TRANSDERMAL SYS AERS
Page 508 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7079 09/29/2011 10/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7080 2011-7081 09/29/2011 10/28/2011 09/29/2011 10/28/2011 2011-7082 09/29/2011 10/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7083 09/29/2011 10/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7084 09/29/2011 10/28/2011 2011-7085 09/29/2011 10/28/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-7086 2011-7087 2011-7088 2011-7089 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 ORA/ ORA/ ORA/SW-FO/DALORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ KARI WROBLEWSKI Ortho Molecular Products KARI WROBLEWSKI Ortho Molecular Products KARI WROBLEWSKI Ortho Molecular Products ANITA MARSIN MORRISON MILLING CO BIOBOTANICA, NATURAL PRODUCTS PACKAGING LTD, HAUPPAUGE, NY - EIR, 483 5/11 YELLOW CORN SPL 709010 - ANALYSIS RESULTS FOODPHARMA, SANTA FE SPRINGS, CA - EIR, 483 2008 TO PRESENT NUTRAMED INC, CHINO, CA - EIR, 483 2011 FDA/OO/OFBA/OAGS/ RAVNITZKY, MICHAEL CHRISTOPHER T LEE DICKIE MCCAMEY & CHILCOTE CARL BEAURLINE CMB REGULATORY SPECIALTIES ADVANCED STERILIZATION PRODUCTS - STERRAD STERILIZATION POUCH K951295; CASE MEDICAL STERITITE PERFORATED BASE REUSABLE STERILIZATION CONTAINER K991023, ETC EASTERN RESEARCH - CONTRACT #HHSF2232008100171:HHS0016; CONTRACT #HHFS2232008100171:HHSF22301004T SIMPLY THICK - CMPLNT 120919 TEST RESULTS, RPTS, SUMMARIES, ETC Doe J CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ Shaunnessey, Jerome KATHRYN W CHRISTMAS DVM BOEHRINGER INGELHEIM VETMEDICA INC TAMSULOSIN HCL - RECS MONTERIS MEDICAL INC - INVESTIGATIONAL PLAN SUBPART B SECTION 812.25 PRIMIDONE NADA 009-392, NADA 010-091 - RPT 1969 PATRICK L PERSONS LOMMEN ABDO COLE KING STAGEBERG PA ANDA 87-425/S000,015,020,021 - APRVL RECS Signature/ Requester Subject
Page 509 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office DO/COMPLIANCE/ 2011-7090 09/29/2011 10/28/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-7091 2011-7092 2011-7093 2011-7094 2011-7095 2011-7096 2011-7097 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 09/29/2011 10/28/2011 FDA/OO/OFBA/OAGS/ RAVNITZKY, MICHAEL FDA/OMPT/CDRH/OCER/DFOI/ GUIDO, DAWN FDA/OMPT/CDRH/OCER/DFOI/ GUIDO, DAWN FDA/OMPT/CDRH/OCER/DFOI/ GUIDO, DAWN MCKINLEY INC - PAIN PUMP 510K, WITHDRAWAL OF APRVL, ETC STRYKER CORP - PAIN PUMP 510K SUMMARY 1998, DENIAL EASTERN RESEARCH GROUP INC - SMOKING & TOBACCO ECONOMIC STUDIES CONTRACT #HHSF2232008100171:HHSF22301003T; TOBACCO PROD STANDARDS CONTRACT #HHSF2232008100171:HHS0016:1 FOI DAILY LOG 9/5-9/11 FOI DAILY LOG 9/12-16/11 FOI DAILY LOG 9/19-23/11 MERCK & CO INC - GARDASIL ISR 33797-1 VAERS EVALUATION OF METAL ON METAL ARTICULATION WITH THE ULTIMA MOM TOTAL HIP SYS - IDE G960262 SHANGHAI HUIHU MEDICAL APPLANCE CO LTD - LIGHT SURGICALACCESSORIES - 510K COOPER SURGICAL - 1007LP M-STYLE MUSHROOM CUP FDA/OMPT/CDRH/OCER/DFOI/ GUIDO, DAWN BERG INC - PAIN CARE 2000L K002321 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DOLLY MISTRY COVIDIEN DOLLY MISTRY COVIDIEN VERMONT MEDICAL INC - VERMED A10021 RESTING EKG TAB ELECTRODE K030073 VERMED INC -TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE K090180 BERG INC - PAIN CARE 2000 K983454 ANITA MARSIN MORRISON MILLING CO WHITE CORN SPL 709011 - ANALYSIS RESULTS Signature/ Requester Subject
2011-7098 2011-7099 2011-7100 2011-7101 2011-7102 2011-7103
09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/
JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MORROW, LEN W
DEBORAH N KLOOS MEDICAL ACTION INDUSTRIES INC
2011-7104
09/30/2011
RICHARD T WRIGHT
Page 510 of 1132

Total Records: 12455 Control # Recd Date / Due Date 10/31/2011 2011-7105 09/30/2011 10/31/2011 Action Office ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7106 09/30/2011 10/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7107 09/30/2011 10/31/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7108 09/30/2011 10/31/2011 2011-7109 2011-7110 2011-7111 2011-7112 09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011 09/30/2011 10/31/2011 2011-7113 09/30/2011 10/31/2011 2011-7114 09/30/2011 10/31/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ CHRISTINA M PAUL K&L GATES DEL MONTE FRESH PRODUCE NA INC - SALMONELLA PANAMA OUTBREAK ATTRIBUTED TO CANTALOUPES 2011 - QUESTIONAIRES, RPTS, STATISTICL TESTS, ETC MOTEN, LAVEETA RESUME PKG DETAIL ANNOUNCEMENT - RECS MOTEN, LAVEETA ORA/SW-FO/KAN-DO/COMP/ Doe J INDIVIDUAL RECS ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ TODD GRUBER NOVARTIS PHARMACEUTICAL CORP WILLIAM MESTRANDREA PFIZER INC WILLIAM MESTRANDREA PFIZER INC FAMVIR (FAMCICLOVIR) 1% CREAM NDA 20-363 - AERS 6/29/94 LUITPOLD PHARMACEUTICALS INC, SHIRLEY, NY - EIRS, 483S 2/9/11-3/15/11 WEST AGRO (AKA DELAVAL MFG), HAMILTON, NY - EIRS, 483S 5/25-31/11 CMPLNT RATLIFF, SARAH LAMICTAL (LAMOTRIGINE) - AERS LATESHA R BAKER HINSHAW & CULBERTSON LLP AVASTIN - AERS Signature/ Requester GEROGE F RESTOVICH ASSOCIATES MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC Subject VACCUM ASSIST DELIVERY SYS - PMA, WARNINGS , LBLG, ETC QINGDAO JIULONG BIOPHARMACEUTICALS CO LTD, JIAOSHOU CITY, PEOPLE'S REPUBLIC OF CHINA - EIR 3/11
Page 511 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/ 2011-7115 2011-7116 2011-7117 2011-7118 2011-7119 2011-7120 2011-7121 09/30/2011 10/31/2011 09/30/2011 10/31/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 2011-7122 10/03/2011 11/01/2011 2011-7123 10/03/2011 11/01/2011 2011-7124 10/03/2011 11/01/2011 2011-7125 10/03/2011 11/01/2011 2011-7126 2011-7127 2011-7128 10/03/2011 11/01/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OO/OFBA/OAGS/ CARPENTER, MURRAY . DAMON ELDER ARNOLD & PORTER ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC CYNDY BURINDA PHOENIX REGULATORY ASSOCIATES LTD CYNDY BURINDA PHOENIX REGULATORY ASSOCIATES LTD CYNDY BURINDA PHOENIX REGULATORY ASSOCIATES LTD MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLENA HARBASZEWKA AVALON RISK MANAGEMENT INC WINSTON R BROWN BAXTER HEALTHCARE CORP WINSTON R BROWN BAXTER HEALTHCARE CORP WINSTON R BROWN BAXTER HEALTHCARE CORP MAKUPSUMTING INC - ENTRY AZR-47095097 NOTICE OF FDA ACTION #1 SEVEN STAR TRADING IMPORT EXPORT - ENTRY AH300245877 NOTICE OF FDA ACTION # 1 CARDINAL HEALTH; CAREFUSION, COVIDIEN, ETC - EIR 6/1/11-9/30/11 SIGMA-ALDRICH; TALECRIS BIOTHERAPEUTICS - EIRS 6/1/11-9/30/11 NOVARTIS ; NXSTAGE; PFIZER, ETC - EIRS 6/1/11-9/30/11 FOOD ADDITIVE MASTER FILE #513 DOW CHEMICAL CO - FCN 846 LANXESS CORP - FCN 835 REPROCESSED COLD BIOPSY FORCEPS - K042648 NASTOS CONSTRUCTION INC, NE WASHINGTON, DC CONTRACTS VANGUARD - REPROCESSED ELECTRIC BIOPSY FORCEPTS K011800 VANGUARD - REPROCESSED NON-ELECTRIC BIOPSY FORCEPS K0425594 REPROCESSED HOT BIOPSY FORCEPTS - K050316 DISPUTED DELETIONS Signature/ Requester Subject
Page 512 of 1132

Total Records: 12455 Control # 2011-7129 2011-7130 2011-7131 Recd Date / Due Date 10/03/2011 11/01/2011 10/03/2011 11/01/2011 10/03/2011 11/01/2011 Action Office ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7132 10/03/2011 11/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7133 2011-7134 10/03/2011 11/01/2011 10/03/2011 11/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-7135 10/03/2011 11/01/2011 2011-7136 10/03/2011 11/01/2011 ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7137 10/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ AMBROSIA WALSH OSTEOHEALTH - GEM 21s (GROWTH-FACTOR ENHANCED TERRY J ENFIELD Kleinfeld, Kaplan and Becker, LLP NUTRITION LBLG REFORM - RECS, COMM, ETC SHIRLEY ROSS ROANOKE TRADE SERVICES INC ENTRY #AGT00056458 - ACTION REDELIVERY NOTICE, NOTICE OF REFUSAL KEEL D-12127, KENNETH G FDA/OF/CFSAN/OCD/EOS/ ARLENE MORALES BURDOCK GROUP HIGH FIBER DIET, LOW FIBER DIET, CALCIUM POLYCARBOPHIL, ETC - CAERS, AERS ALOE - REGULATORY STATUS, SAFETY RECS MICHAEL KIM PAREXEL INTERNATIONAL CORP JANSSEN PHARM - RISPERDAL CONSTA (RISPERIDONE) NDA 21-346/S025,S028 RVWS Signature/ Requester WINSTON R BROWN BAXTER HEALTHCARE CORP WINSTON R BROWN BAXTER HEALTHCARE CORP TIM KENDALL NATIONAL COLLABORATING CENTRE FOR MENTAL HEALTH GE HEALTHCARE; HOSPIRA; JOHNSON & JOHNSON FAMILOF CO, ETC - EIRS 6/1/11-9/30/11 QUETIAPINE, OLANZAPINE, RISPERDONE, ETC - CLNCL TRIALS Subject ABBOTT; AMGEN; ASTRAZENECA, ETC - EIR 6/1/11-9/30/11
Page 513 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/01/2011 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/NE-FO/NYK-DO/NYDCB/ 2011-7138 10/03/2011 11/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ 2011-7139 10/03/2011 11/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7140 2011-7141 10/03/2011 11/01/2011 10/03/2011 11/01/2011 2011-7142 10/03/2011 11/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7143 2011-7144 10/03/2011 11/01/2011 10/03/2011 11/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7145 2011-7146 10/03/2011 11/01/2011 10/03/2011 11/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ LAURA M SHAMP, LLC FDA/OMPT/CDRH/OCER/DFOI/ BRENT LEWIS MERGE HEALTHCARE MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS - P030053, CONDITIONS OF APRVL AMICAS PACS 6.0 - K082144 PMA STEPHEN W MULLINS LUCKEY & MULLINS PLC JAYSON PERSAUD STEVEN E NORTH LAW BAYER CORP - AVELOX, AERSRESEARCH/TESTS, CORR ETC MORPHINE SULFATE - AERS DOCS, RPTS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ KAY E MITCHEN Natural Immunogenics Corp. CATHERINE M CONNELL PHILLIPS MEDICAL SYSTEMS (CLEVELAND) INC POLLY HUTCHISON PHILLIPS ORAL HEALTHCARE COLLOIDAL SILVER PRODS FOR INGESTION - BRAND NAMES, CAERS 1/80 TO 12/95 GENERAL ELECTRIC CO - GE VEO RECONSTRUCTION OPTION, K103489 PERIO PIK - K905188; WATER PIK W/ADD'T CLAIMS TELEDYNE WATER PIK - K900547 - RECS CALVIN Y ZHOU SCHROER CAPITAL, L.P. XIFAXAN - AERS, 2011 Doe J INDIVIDUAL RECS Signature/ Requester STRAUMANN USA Subject MATRIX), DOC GEN 0901401 INVESTIGATION, RPTS, MTG RECS ETC
Page 514 of 1132

Total Records: 12455 Control # 2011-7147 Recd Date / Due Date 10/03/2011 11/01/2011 2011-7148 2011-7149 10/03/2011 11/01/2011 10/03/2011 11/01/2011 2011-7150 10/03/2011 11/01/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID M LEE, JD KIMBERLY-CLARK CORP KIMBERLY CLARK CORP, (PREVIOUSLY TACTYL TECHNOLOGIES INC) - TACTYLON(TM) CONDOM, K911431; LUBRICATED CONDOM , K953583 - MERGER DOCS UNREDACTED FOI DAILY LOG 8/29/11-9/2/11 FOI DAILY LOG 9/5-9/11 FOI DAILY LOG 9/5-9/11 FOI DAILY LOG 9/12-16/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 8/29/11-9/2/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 9/5-9/11 FOI SERVICES INC FOI SERVICES INC BOEHRINGER INGELHEIM - VIRAMUNE XR NDA 20-1152 APRVL RECS Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester YUSU LIN INTERNTIONAL LEISURE PRODUCTS INC CMPLNT 152400527 - RECS, CORR ETC HERBISON, GEORGE JONATHAN KNOLL, ESQ COHEN & MALAD LLP K991363, K002434, K033325, ETC (CERTIFIED) Subject SINOCHEM NINGBO LAGTEX GLOVES FACTORY - K980827
2011-7151 2011-7152 2011-7153 2011-7154 2011-7155 2011-7156 2011-7157
10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
FRAN KOCH INFORMATION ACCESS FRAN KOCH INFROMATION ACCESS BARBARA JONES DOMINION GROUP INC
2011-7158
10/04/2011 11/02/2011
FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC
GUIDANT CORP - EASY TRAK 3 CORONARY VENOUS STERIOD ELUTING BIPOLAR PACE/SENSE LEAD P010012/S25 APRVL RECS ST JUDE MEDICAL - RIATA STS OPTIM LEADS P950022/S040 APRVL RECS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT RIATA/RIATA I DEFIBRILLATION LEADS P950022/S025 APRVL RECS
2011-7159 2011-7160
10/04/2011 11/02/2011 10/04/2011 11/02/2011
Page 515 of 1132

Total Records: 12455 Control # 2011-7161 Recd Date / Due Date 10/04/2011 11/02/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7162 2011-7163 2011-7164 2011-7165 2011-7166 2011-7167 2011-7168 2011-7169 2011-7170 2011-7171 2011-7172 2011-7173 2011-7174 2011-7175 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ KENDLE INTERNATIONAL INC JULIE G DALE BIOFILM INC SUE CARLSON CARGILL ANIMAL NUTRITION ERIN O'BOYLE A P PHARMA CARGILL ANIMAL NUTRITION, MILTON, WI - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 4/11/11 PALONOSETRON VS MOXIFLAXACIN - E14 STUDY 9/08 PRE-VA VAGINAL LIBRICANT - K072741 FOI SERVICES INC FOI DAILY LOG 9/5-9/11 FOI SERVICES INC FOI DAILY LOG 8/29/11 - 9/2/11 ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 9/12-16/11 FOI DAILY LOG 9/12-16/11 FOI DAILY LOG 9/2/12-16/11 CARGILLL ANIMAL NUTRITION, KANSAS CITY, KS - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 1/19/11 CARGILL ANIMAL NUTRITION, MENTONE, IN - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 3 /8/11 CARGILL ANIMAL NUTRITION, NEW RICHLAND, MN - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 5/4/11 CARGILL ANIMAL NUTRITION, SIOUX CITY, IA - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 4/19/11 CARGILL ANMAL NUTRITION, MINEOLA, TX - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 4/8/11 FOI DAILY LOG 8/29/11-9/2/11 FOI SERVICES INC Signature/ Requester Subject GMT FINE CHEMICALS, COUVET, SWITZERLAND - EIRS, 483S, CO RESP, ETC 1998 TO 2011
Page 516 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7176 2011-7177 2011-7178 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7179 2011-7180 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7181 2011-7182 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7183 10/04/2011 11/02/2011 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7184 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7185 10/04/2011 11/02/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ INGRID DYOTT NEUBERGER BERMAN LLC HOSPIRA INC - 483S 1/1/10 TO 5//30/11 JOSEY HOBBS ALVEDA PHARMA ABBOTT LABS, HOSPIRA - PENTOTHAL, SODIUM THIOPENTAL INJ LBLG, CORR TYLER LAKIN EGON ZEHNDER INTERNATIONAL PHARMACEUTICAL MFG PLANTS IN USA - LOCATIONS ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL ANIMAL NUTRITION ELENA HOWELL HOGAN LOVELLS US LLP CARGILL ANIMAL NUTRITION, DUNCAN, NE - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 1/6/11 LAZANDA (FENTANYL CITRATE) NASAL SPRAY NDA 22-569 - LBLG, RVWS, SBA KANG, SEUNGHO ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL ANIMAL NUTRITION CARGILL ANIMAL NUTRITION, MCPHERSON, KS - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 3/2/11 GEMIFLOXCIN MESYLATE (FACTIVE) NDA 21-158 STATISTICAL STUDY 068 ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION JEAN-PAUL LE CLERCQ MARKAREN & ASSOCIATES APLC CARGILL ANIMAL NUTRITION, SIOUX CITY, IA - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 5/4/11 CARGILL ANIMAL NUTRITION, ELK RIVER, MN - EIR, FORM 2481, ENDORSEMENT PG, NARRATIVE RPT 4/26-28/11 ELI LILLY & CO - ZYEREXA OLANZAPINE WARNING LABEL 2003, 2007 Signature/ Requester Subject
Page 517 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7186 2011-7187 2011-7188 2011-7189 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-7190 2011-7191 2011-7192 10/04/2011 11/02/2011 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7193 10/04/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC GNOSIS SPA, DESIO (MB), ITALY - GMPS, EIRS, 483S ETC, 1998 - 2011 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ST JUDE MEDICAL - RIATA ST OPTIM LEADS MODELS 7020, 7021, 7022 ETC, P950022/S030 ST JUDE MEDICAL - RIATA ST OPTIM; RIATA STS OPTIM P950022/S042 CERBIOS PHARMA SA, BARBENGO, SWITZERLAND - GMPS, EIRS, 483S ETC, 1994-2011 ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ FOI SERVICES INC RON REGAN WEWS-TV MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC PREMIER SERVICES TRADE INC - ENTRY BOY00004223 NOTICE OF FDA ACTION #1 FDA/OF/CFSAN/OCD/EOS/ ANGELIA D SLAYTON KENDLE INTERNATIONAL INC GNOSIS SPA - QUATREFOLIC 75 DAY PREMARKET NOTIFICATION OF NEW DIETARY INGREDIENT RPT BAXTER HEALTHCARE CORP, DEERFIELD, IL - EIRS, 483S, CO RESPS, ETC, 1/1/09-9/1/11 BEN VENUE/BEDFORD LABS - 483 MOST RECENT Signature/ Requester Subject
Page 518 of 1132

Total Records: 12455 Control # 2011-7194 2011-7195 Recd Date / Due Date 10/04/2011 11/02/2011 10/04/2011 11/02/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ 2011-7196 10/04/2011 11/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-7197 2011-7198 10/04/2011 11/02/2011 10/04/2011 11/02/2011 2011-7199 10/05/2011 11/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7200 2011-7201 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7202 2011-7203 2011-7204 2011-7205 2011-7206 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JONATHAN KNOLL ESQ COHEN & MALAD LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2011-6584 - REQUEST LTR 2011-6554 - REQUEST LTR 2011-6520 - REQUEST LTR 2011-6500 - REQUEST LTR INFORMATION FOR HEALTHCARE PROFESSIONALSCHONDROLYSIS REPORTED WITH CONTINUOUSLY INFUSED LOCAL ANESTHETICS (CERTIFIED) 2011-6494 - REQUEST LTR 2011-6493 - REQUEST LTR ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ GALLI, CYNTHIA K ABC NEWS ANNE LEBLANC LIEFF, CABRASER, HEIMANN & BERNSTEIN, LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. SIMPLY THICK, GA - THICKENING GEL PRODS ANALYSIS. TESTING RESULTS, COMM, ETC MERCK & CO INC - ISENTRESS (RALTEGRAVIR) ISR 5557094-X, 5813666-6 EGG FARM INSPECTIONS - EIRS MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC ENTRY K51-00674156 - NOTICE OF FDA ACTION #1 Action Office ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC VICTOR WINDEYER CITIGROUP Signature/ Requester Subject THERMO PAC LLC, STONE MOUNTAIN, GA - SIMPLY THICK EIRS, 483S, CO RESPS ETC 1/10 TO PRESENT COCHLEAR - C1512 IMPLANT P970051 RECALL RECS, COMM, ETC
Page 519 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/03/2011 2011-7207 2011-7208 2011-7209 2011-7210 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7211 2011-7212 2011-7213 2011-7214 2011-7215 2011-7216 2011-7217 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7218 2011-7219 2011-7220 2011-7221 2011-7222 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MARIA ISABEL ROSALES LOPEZ CENTRO NACIONAL DE METROLOGIA JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. BRIAN CALLACI CHANGE TO WIN JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOHN C HAMMELL INTERNATIONAL ADVOCATES FOR HEALTH FREEDOM JOAN STITT (UG2CD-16) MERCK & CO., INC. LORI E ANDRUS ANDRUS ANDERSON LLP DIDER SAILHAN SUDIMPLANT DIDER SAILHAN SUDIMPLANT CORN REFINERS ASSN - USE OF THE TERM CORN SUGAR LTR 7/12/11 SUDIMPLANT SA, TOULOUSE, FRANCE - TBR ZIRCONNECT K070935 SUDIMPLANT SA, TOULOUSE, FRANCE - TBR IDE @ CONIC K050956 DRAFT GUIDANCE FOR INDUSTRY: DIETARY DANIEL FABRICANT PHD - CONFLICT OF INTEREST STATEMENT 2011-6816 - REQUEST LTR 2011-6769 - REQUEST LTR 2011-6766 - REQUEST LTR 2011-6765 - REQUEST LTR 2011-6263 - DELETED RECS 2011-6746 - REQUEST LTR HIGH PERFORMANCE LIQUID CHROMATOGRAPHY ANALYSIS OF SIX CONJUGATED AND UNCONJUGATED ESTROGENS IN SERUM 2011-6713 - REQUEST LTR 2011-6675 - REQUEST LTR 2011-6673 - REQUEST LTR 2011-6642 - REQUEST LTR Subject
Page 520 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/03/2011 Action Office OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7223 2011-7224 10/05/2011 11/03/2011 10/05/2011 11/03/2011 OC/OIASI/OCP/ CBER/OCTMA/DDOM/ALFB/ OC/OIASI/OCP/ 2011-7225 10/05/2011 11/03/2011 2011-7226 2011-7227 10/05/2011 02/17/2012 10/05/2011 11/03/2011 2011-7228 2011-7229 2011-7230 2011-7231 2011-7232 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7233 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS NANDAKUMARA D SARMA RPH PHD USP PHARMACOPEIA BETA-ALANINE - CAERS 1/00 TO 8/11 CLOSED FOI REQUESTS 10/3-7/11 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ CVM/OCD/ ORA/CE-FO/PHI-DO/PCB/ CHERYL VAN LEAR AMERICAN RED CROSS MUSSER BLOOD CENTER KATHLEEN M SANZO ESQ MORGAN LEWIS & BOCKIUS LLP CHERYL VAN LEER AMERICAN RED CROSS MUSSER BLOOD CENTER JULIE G DALE BIOFILM INC DON GUINAN GYNOVA LLC CECELIA FRENCH CanReg, Inc. CLOSED FOI REQUESTS 9/26-30/11 CLOSED FOI REQUESTS 10/3-7/11 GYNOVA LLC - K052420 CBER/OCTMA/DDOM/ALFB/ DR TOPAZ KIRLEW TISSUETECH INC DR TOPAZ KIRLEW TISSUETECH INC TISSUE REFERENCE GROUP - CARTILAGE ALLOGRAFT RECOMMENDATION ANNUAL RPT FY 2011 TISSUE REFERENCE GROUP - DECELLULARIZED PARTICULATE HUMAN PLACENTAL CONNECTIVE TISSUE MATRIX INTENDED TO REPLACE OR SUPPLEMENT DAMAGED OR INADEQUATE INTEGUMENTAL TISSUE AMERICAN RED CROSS PENN-JERSEY REGION , PHILADELPHIA, PA - EIRS 7/21-29/08 BIOENGINEERED PICHIA PASTORIS PHYTASE SUBMISSION RECS AMERICAN RED CROSS PENN-JERSEY REGION, PHILADELPHIA, PA - EIRS 5/24/10-6/4/10 PRE-VA VAGINAL LUBRICANT - K072741 Signature/ Requester KUHN, CAROL Subject SUPPLEMENTS - CONGRESSIONAL CORR, COST BENEFIT ANALYSIS, CONSUMER ACCESS, ETC 7/11
Page 521 of 1132

Total Records: 12455 Control # 2011-7234 Recd Date / Due Date 10/05/2011 11/03/2011 Action Office ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-7235 2011-7236 2011-7237 2011-7238 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7239 2011-7240 10/05/2011 11/03/2011 10/05/2011 11/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7241 2011-7242 2011-7243 10/05/2011 11/22/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7244 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ Doe J MAE HAFIZI RN WUESTHOFF MEDICAL CENTER ERIC KOLB DOCTORS RESEARCH GROUP INC JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-6833 - REQUEST LTR SYNTHES USA - K051879 FLU VACCINE - VAERS INDIVIDUAL RECS RONALD F DENARDIS DENARDIS & MILLER PC ANDREW FRIEDMAN FRIEDMAN KHAFIF & SANCHEZ LLP ETHICON ENDO-SURGERY INC - PROXIMATE RELOADABLE LINEAR STAPLER TL 60 RECS MERITS HEALTH PRODUCTS CO LTD - RECS ORA/ORO/DIOP/ ORA/ORO/DIOP/ CBER/OCTMA/DDOM/ALFB/ ALTMAN, KERRY PAUL MARIA KECLAN GAMBRO RENAL PRODUCTS B BRAUN - BICARBONATE DIALYSATE K052393 OM/OMP/DODM/ ANDERSON, REBECCA J SALLY KESTIN SUN-SENTINEL MERCK & CO INC - GARDASIL VAERS ANTIVIRAL DRUGS A/C - BRISTOL-MYERS SQUIBB DIDANOSINE (DDL) NDA SUBMISSION TRANS 7/18-19/91 IMPORT REFUSAL RPTS DATABASE 1/06 TO PRESENT Signature/ Requester MAHNAZ GOLSHAN AGAHAN AYANDEYE PARS INC Subject LIST OF INDIAN PHARMACEUTICAL, NUTRACEUTICAL, NUTRITIONAL COMPANIES REGISTERED WITH FDA
Page 522 of 1132

Total Records: 12455 Control # 2011-7245 Recd Date / Due Date 10/05/2011 11/09/2011 2011-7246 10/05/2011 11/03/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7247 2011-7248 10/05/2011 11/03/2011 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7249 2011-7250 10/05/2011 11/03/2011 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7251 2011-7252 10/05/2011 11/03/2011 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7253 2011-7254 2011-7255 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. KALINA PAGANO VITAL PHARMA INC WEST DULUTH DISTRIBUTION CO/CHK NUTRITION, DULUTH, MN - NEURORESEARCH CLINICS INC WARNING LTRS, RESP TO WARNING LTRS, CONSENT AGREEMENTS, ETC 2011-6915 - REQUEST LTR 2011-6856 - REQUEST LTR 2011-6846 - REQUEST LTR Doe J JOAN STITT (UG2CD-16) MERCK & CO., INC. PROPECIA 1 MG - AERS FOI DAILY LOG 9/26-30/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. JEFFREY A TRAVERS MILLER FIRM ACTOS (PIOGLITAZONE) - AERS, ADVERTISING MATERIALS, CLNCL TRIALS, ETC CLOSED FOI REQUESTS 9/1-30/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. JASON PERSAUD STEVEN E NORTH LAW MORPHINE SULFATE - AERS 2011-6822 - REQUEST LTR Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester HENRY HADRY LEGAL RESEARCH INSTITUTE HEATHER A JACKSON SHEFSKY AND FROELICH Subject HOME ACCESS HIV-1 TEST SYS, HOME ACCESS HIV-1 EXPRESS TEST SYS, VIAGUARD ACCU-HIV I & II SALIVA TEST - RECS FINASTERIDE - AERS
2011-7256
10/05/2011 11/03/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
JOAN STITT (UG2CD-16) MERCK & CO., INC.
Page 523 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7257 2011-7258 2011-7259 2011-7260 2011-7261 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7262 2011-7263 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7264 2011-7265 10/05/2011 11/03/2011 10/05/2011 11/03/2011 2011-7266 2011-7267 2011-7268 10/05/2011 11/03/2011 10/05/2011 11/03/2011 10/05/2011 03/08/2012 ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/OCI/ ORA/OCI/ CTP/OD/ CTP/OD/ CTP/OD/ CTP/OD/ FDA/OO/OFBA/OAGS/ CTP/OD/ CTP/OD/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC MATT MCLAUGHLIN MATT MCLAUGHLIN LAW OFCS GARY ALAN FRIEDMAN FRIEDMAN & FRIEDMAN CONCENTRATED FOODLINE CORP, SUN VALLEY, CA EIRS, COMM, CMPLNTS, ETC 2009 CONTAMINATED AVASTIN EYE INJURIES - RPTS, COMM, EMAILS, ETC 7/7-8/11 REPUBLIC OF PALAU - FDA REGULATIONS CORR, RECS FOI SERVICES INC FOI SERVICES INC LIST OF TOBACCO ESTABLISHMENT REGISTRATIONS, TOBACCO PRODUCT LISTINGS 6/11 TOBACCO - IN-VIVO TOXICOLOGY STUDIES REQUEST FOR PROPOSAL (RFP) 1/11 TO PRESENT ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. CHAD MAZUREK JM2 CONSULTING LLC MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 9/130/11 MIDWEST RESEARCH SWINE, GIBBON, MN - RPTS NOTES, INVESTIGATIONS 1/1/10 TO 7/1/11 MCNAIR, JAMES OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/PHI-DO/PCB/ CAROLYN ZIMMER GRUNENTHAL USA INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK & CO INC - ROTATEQ (ROTAVIRUS VACCINE) VAERS 9/1-30/11 INVACARE - WARNING LTR CORR, RPTS, RECALLS, ETC 12/15/10 2011-6978 - REQUEST LTR PHARMACEUTICAL MANUFACTURING RESEARCH SERVICES INC - EIR, NDA 20-1655 2011-6953 - REQUEST LTR Signature/ Requester Subject
Page 524 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-7269 10/05/2011 11/03/2011 CVM/OCD/ COFFEY, DEBBIE GONACON, SPRAYVAC, FIELD SPAYING IN CONNECTION WITH STRAY, FERAL & WILD HORSES - USDA, BUREAU OF LAND MANAGEMENT, DEPT OF THE INTERIOR , ETC LTRS OF INVESTIGATION EXEMPTIONS 1/00 TO PRESENT JENSEN FARMS - CANTALOUPE LISTRIA OUTBREAK INVESTIGATION RECS Signature/ Requester Subject
2011-7270
10/05/2011 11/03/2011
ORA/SW-FO/DEN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/
BRAN HARTMAN ABC NEWS, INC.
2011-7271
10/06/2011 11/04/2011
STEVEN R SCOTT BIOMEASURE INC
BOTOX - RVW SUMMARIES
2011-7272
10/06/2011 11/04/2011
PAUL A ANDREWS PHD EISAI INC
IND 4682 - CYNOMOLGUS MONKEY TOXICOLOGY RPT
2011-7273 2011-7274
10/06/2011 11/04/2011 10/06/2011 11/04/2011
CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
BETH GUSTIN AGNESIAN HEALTHCARE MARITZA SANCHEZ ENDO PHARMACEUTICALS INC
GLAXOSMITHKLINE - FLUARIX (FLU VACCINE) VAERS MEDICHEM SA, GIRONA, SPAIN - EIRS, 483S
2011-7275
10/06/2011 11/04/2011
SANDY WILLIAMS FRIDAY ELDREDGE & CLARK LLP
ZOLOFT (SERTRALINE HCL) - AERS 1/1/97-1/20/10
2011-7276
10/06/2011 11/04/2011
JOHN P LEADER ESQ LEADER LAW FIRM
SEROQUEL - AERS
2011-7277
10/06/2011 11/04/2011
ASHA LAMBATOS AVALON RISK MANAGEMENT
ENTRY #900-00580044 - NOTICE FDA ACTION #1
Page 525 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester INC 2011-7278 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7279 10/06/2011 11/04/2011 2011-7280 10/06/2011 11/04/2011 2011-7281 10/06/2011 11/04/2011 2011-7282 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7283 10/06/2011 11/04/2011 2011-7284 10/06/2011 11/04/2011 2011-7285 10/06/2011 11/04/2011 2011-7286 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7287 10/06/2011 11/04/2011 ORA/ ORA/ ORA/ORM/ ORA/ORM/ FOI SERVICES INC IMPORT OF COSMETIC PRODUCTS 9/2/2001 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ROBIN L. ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY ROBIN L. ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY ROBIN L. ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY (IMT) LAI MEI TANG FAGRON GROUP BV MAKO SURGICAL CORP - PATELLOFEMORAL KNEE IMPLANT SYS K080029 HARMAN FINOCHEM - EIR MOST RECENT, CORR MAKO SURGICAL CORP - PATELLOFEMORAL KNEE IMPLANT SYS K082088 SMITH & NEPHEW INC - JOURNEY KNEE SYS K093056 Doe J FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC ROBIN L. ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY MAKO SURGICAL CORP - RESTORIS MULTICOMPARTMENTAL KNEE SYS K090763 INDIVIDUAL RECS ENTRY #WUG-01474963 - NOTICE OF FDA ACTION #1 ENTRY #WUG-01491090 - NOTICE OF FDA ACTION #1 DANIEL A DANCZYK MD FAIRVIEW UNIV MEDICAL CENTER CELEXA (CITALOPRAM) - QT STUDY Subject
Page 526 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-7288 10/06/2011 11/04/2011 2011-7289 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7290 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7291 2011-7292 10/06/2011 11/04/2011 10/06/2011 11/04/2011 OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7293 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7294 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7295 10/06/2011 11/04/2011 2011-7296 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ YUSU LIN INTERNATIONAL LEISURE PRODUCTS INC ELIZABETH KRUTOHOLOW BIOPHARM INSIGHT OREXIGEN - CONTRAVE CORR 1/11 FINGER COT K052387 CHRISTINE LIVOTI BIOPHARM INSIGHT PHARMASSET - PSI-7977 PHASE III TRIAL RECS, GUIDANCE, CORR DONIEL JACKSON MD WORLDWIDE CLINICAL TRIALS DIHYDROERGOTAMINE (DHE) - AERS ANGELIA D. SLAYTON KENDLE REGULATORY AFFAIRS GUILLAUME HERRY EVERETT LABORATORIES INC COMISSIONER HAMBURG, J&J REPRESENTATIVES - MTG MEMO 9/14/11 PRE-NATAL VITAMINS - CLNCL DEVELOPMENTS, REGISTRATION PATHWAY, CORR, ETC ZOIA PLOSCARU NOSTRUM LABORATORIES INC TARO PHARMACEUTICALS INDUSTRIES LTD CARBAMAZEPINE XR TABS ANDA 78-115 BIOEQV STUDIES FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC HARWOOD C STILES JOHNSON MATTHEY TELCARE INC - BLOOD GLUCOSE MONITORING SYS; TEST STRIPS; CONTROL SOLUTIONS; TELSERVE HOME USE; TELESERVE PROFESSIONAL USE K110571 ADDERALL XR NDA 21-303 - CHEMICAL STRUCTURE OF AMPHETAMINE ASPARTAATE, TYPE OF ASPARTIC ACID, ETC Signature/ Requester Subject
Page 527 of 1132

Total Records: 12455 Control # 2011-7297 Recd Date / Due Date 10/06/2011 11/04/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7298 2011-7299 10/06/2011 11/04/2011 10/06/2011 11/04/2011 2011-7300 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7301 2011-7302 10/06/2011 11/04/2011 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7303 10/06/2011 11/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7304 10/06/2011 11/04/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7305 10/06/2011 11/04/2011 2011-7306 10/06/2011 11/04/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFDA/OO/OFBA/OAGS/ THOMAS MERCADO GOVERNMENT SECURITY GUARDS ASSN MICHELLE RYBAK ENTRY #26403098225 - NOTICES OF REFUSAL, FDA ROANOKE TRADE SERVICES INC ACTION, NOTICE MARK/REDELIVER CONTRACT HHSF223201110044C ANGELIA D SLAYTON KENDLE INTERNATIONAL INC BIOVAIL TECHNOLOGIES - MEPHYTON NDA 10-104 APRVL LTR, LBLG, RVWS, ETC ANDI POULSON LEXISNEXIS COURTLINK INC 2011-4677 OC/COS/OL/ FREDERIC J. FROMMER ASSOCIATED PRESS ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PERFORMANCE ENHANCING DRUGS AMONG ATHLETES CONGRESSIONAL COMM, INVESTIGATION RECS ASTRAZENECA - MERREM NDA 50-706/S016 LBLG ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ERIC D. BRUCE HEINTZ & BECKER GEORGE MARINO, R.Ph. LEGACY GOOD SAMARITIAN HOSPITAL & MEDICAL CTR ANGELIA D SLAYTON KENDLE INTERNATIONAL INC AIDAPAK SERVICES LLC, VANCOUVER, WA - EIRS, CORR 1/1/10 TO 9/30/11 WATSON LABS - CABERGOLINE ANDA 78-035 APRVL TLR, LBLG, RVWS, ETC INDIVIDUAL RECS Signature/ Requester AHANA NANAVATI BIOPHARM INSIGHT Subject CARDIOME PHARMA CORP - INTRAVENOUS & ORAL VERNAKALANT GUIDANCE, TRIALS, SAFETY RECS, ETC
Page 528 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FO/SWID/COMPLIANCE/ 2011-7307 2011-7308 10/06/2011 11/04/2011 10/06/2011 11/04/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-7309 2011-7310 10/07/2011 11/07/2011 10/07/2011 11/07/2011 2011-7311 10/07/2011 11/07/2011 2011-7312 2011-7313 2011-7314 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/07/2011 11/07/2011 2011-7315 10/07/2011 11/07/2011 2011-7316 2011-7317 2011-7318 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Center for Regulatory Services, Inc. FOI DAILY LOG 8/29/11-9/2/11 CanReg, Inc. FOI DAILY LOG 8/29/11-9/2/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 9/5-9/11 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 9/5-9/11 Center for Regulatory Services, Inc. FOI DAILY LOG 9/5-9/11 CanReg, Inc. FOI DAILY LOG 9/5-9/11 WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 9/12-16/11 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 9/12-16/11 Center for Regulatory Services, Inc. FOI DAILY LOG 9/12-16/11 FOI DAILY LOG 9/12-16/11 CINDY GALLI ABC NEWS SABRINA K. CUNNINGHAM HARE WYNN NEWELL & NEWTON LLP MEDS IV PHARMACY - IV COMPOUNDED PRODS SERRATIA MARCESCENS BACTEREMIA OUTBREAK, RECALL RECS 3/3/11 EGG FARM INSP RPTS 2010, 2011 Signature/ Requester Subject
Page 529 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/07/2011 2011-7319 10/07/2011 11/07/2011 2011-7320 2011-7321 10/07/2011 11/07/2011 10/07/2011 11/07/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7322 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7323 10/07/2011 12/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7324 10/07/2011 11/07/2011 2011-7325 10/07/2011 11/07/2011 2011-7326 10/07/2011 11/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7327 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ STEVEN R SCOTT BIOMEASURE INC DYSPORT (ABOBOTULINUMTOXIN A) - SBA SAPNA G LALMALANI ANDERSON RASOR & PARTNERS LLP BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & ASSOC LLC STEVEN R SCOTT BIOMEASURE INC BOTOX - RVW SUMMARY MEDTRONIC INC - SYNCHROMED II, SYNCHROMED EL IMPLANTABLE INFUSION PUMP & REFILL KITS RECALL RECS, DESIGN DEFECTS, RPTS, ETC K032968, K060176, K100910, ETC EARL GOEHRING DEGGE GROUP LTD ISRS 6164283, 6299251, 6419580, ETC Doe J CONCERTA - RECS CanReg, Inc. JONEL ALECCIA MSNBC.COM TRIAD GROUP & H&P INDUSTRIES INC, HARTLAND, WS ALCOHOL PREP WIPES AERS WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 8/29/11-9/2/11 Signature/ Requester WASHINGTON INFORMATION SOURCE FOI DAILY LOG 8/29/11-9/2/11 Subject
Page 530 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7328 10/07/2011 11/07/2011 2011-7329 10/07/2011 11/07/2011 2011-7330 2011-7331 10/07/2011 11/07/2011 10/07/2011 11/07/2011 2011-7332 10/07/2011 11/07/2011 2011-7333 2011-7334 10/07/2011 11/07/2011 10/07/2011 11/07/2011 2011-7335 2011-7336 10/07/2011 11/07/2011 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7337 2011-7338 2011-7339 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7340 10/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ DEBORAH ARTHUR XOMED INC - MODIFIED IMPLANT FOR XOMED AUDIANT Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DEBORAH ARTHUR COCHLEAR AMERICAS DEBORAH ARTHUR COCHLEAR AMERICAS SOPHONO INC - OTOMAG CONE CONDUCTION HEARING SYS K100193 XOMED INC - AUDIANT BONE CONDUCTOR WITH IMPROVED AA COIL K861971 DIPYRIDAMOLE, MELOXICAM, METAFORMIN ETC - AERS COOPER, PAMELA S ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC AMANDA ORLANDO AVALON RISK MANAGEMENT INC ED HORTON DEFIBTECH LLC JEN BJORK CHICKEN OF THE SEA INTERNATIONAL MARGARET R GROEL LACHMAN CONSULTANT SERVICES, INC. SHARLENE EDMONDS PPD MARGARET R GROEL LACHMAN CONSULTANT SERVICES, INC. DEBORAH ARTHUR COCHLEAR AMERICAS UNIV OF MISSOURI OFFICE OF GENERAL COUNSEL, COLUMBIA, MO; JEFFREY O PHILLIPS, ASHLAND MO; DEPT CHAIR, UNIV OF MISSOURI DEPT OF SURGERY, COLUMBIA, MO, ETC - ZEGERID COMM 2001 TO PRESENT MEDICAL DVC MFRS - DOMESTIC & FOREIGN INSPS, 483S, 9/1-30/11 XOMED INC - AUDIANT BONE CONDUCTOR K881382 HEARTSTART 1000 AUTOMATED EXTERNAL DEFIBRILLATOR - K883341 CHICKEN OF THE SEA INTERNATIONAL, SAN DIEGO, CA EIR 9/20/11 DRUG COS, BIORESEARCH MONITORING (BIM0S), GOOD LAB PRACTICES (GLPS) - DOMESTIC & FOREIGN INSPS, 483S 9/1-30/11 PPD (BIOANALYTICAL LAB) - EIRS, 483S, CO RESP ETC 2/11 ENTRY #AW600929133 - FDA ACTION #1 ENTRY #WUG-0145837 - NOTICE OF FDA ACTION #1 Signature/ Requester Subject
Page 531 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/07/2011 2011-7341 2011-7342 2011-7343 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7344 2011-7345 2011-7346 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/07/2011 11/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/OCI/ ORA/OCI/ 2011-7347 10/07/2011 11/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7348 10/07/2011 11/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7349 2011-7350 2011-7351 10/07/2011 11/07/2011 10/07/2011 11/07/2011 10/11/2011 11/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ GABRIEL SHERMAN Hyman Phelps and McNamara PC MARILYN WHITNEY COVINGTON & BURLING LLP SMITHS MEDICAL MD, INC - MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARDTOOLBOX 2 MEDICATION SAFETY SOFTWARE & SUPPORTED SYRINGES (PSS) K111386 DKT FDA-2010-P-0491 DKT 1985P-0299, 1985P-0235, ETC. AMY E WARREN BURGSIMPSON COMBINED HORMONAL CONTRACEPTIVES (CHC) DRUGS: THROMBOEMBOLKIC DISEASE & DEATH OUTCOMES PROTOCOL & FINAL RPT (CERTIFIED) CANDICE BRAVARD MCINTOSH LAW FIRM PC SUNOVION PHARMS INC - LUNESTA 2MG TABS N021476 PI (CERTIFIED) Doe J ORA/CE-FO/DET-DO/DCB/ BRIDGET BODMAR MICHIGAN RADIO ERIC J PARKER STOTIS & BAIRD CHARTERED LELA WARREN, DEARBORN HEIGHTS, MI GLITTERSNIFFER COSMETICS EIRS MEDTRONICS - SPRINT FIDELIS DEFIBRILLATION LEADS, MDRS, EIRS, 483S ETC INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester COCHLEAR AMERICAS PATRIZIA TRENTO TERARECON INC DEBORAH ARTHUR COCHLEAR AMERICAS MICHAEL R COHEN INSTITUTE FOR MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS, 9/1/11 TO 10/1/11 Subject BONE K884056 CALGARY SCIENTIFIC INC - RESOLUTIONMD MOBILE MODEL RMB-MOB-2X, K111346 XOMED INC - AUDIANT BONE CONDUCTOR (ABC) K855059
Page 532 of 1132

Total Records: 12455 Control # 2011-7352 2011-7353 Recd Date / Due Date 10/11/2011 11/08/2011 10/11/2011 11/08/2011 2011-7354 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7355 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7356 10/11/2011 11/08/2011 2011-7357 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7358 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-7359 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7360 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WILLIAM KONSTAND TAG HEALTHCARE MEDAVIR - EIRS, AERS, 483S ETC 2007 TO 2010 DANIEL A DANCZYK DANIEL A DANCZYK MD ABNORMAL HEART RHYTHMS ASSOCIATED WITH HIGH DOES OF CELEXA (CITALOPRAM HYDROBROMIDE) - QT STUDY 8/24/11 WILLIAM KONSTAND TAG HEALTHCARE VIRADERM - EIRS, AERS, 483S ETC 2000 TO 2005 FDA/OMPT/CDRH/OCER/DFOI/ MARC C SANCHEZ CANDICE BRAVARD MCINTOSH LAW FIRM PC OCU-EASE OPTICAL PROD - OCU-FLEX 53 CUSTOM PROSTHETIC (OCUFILCON B) SOFT CONTACT LENS, K020690 SUNOVION PHARMS INC - LUNESTA 2MG TABS NDA 21-476 PI, MEDICATION GUIDES, DEAR DOCTOR LTRS 2007, 2008 (CERTIFIED) JAMES J O'SHEA HANCOCK ESTABROOK LLP GENENTECH INC - RAPTIVA (EFALIZUMAB) AERS, WARNING BOX LABEL CHANGES, WITHDRAWAL RECS 10/16/08 ZHOU, CALVIN Y FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester PRISCILA A ZAWADSKI IKARIA INC PRISCILLA A ZAWADSKI IKARIA INC Subject AERONOX NITRIC OXIDE DELIVERY DVC - DAFETY RPTS, DATES, ETC INTERNATIAONAL BIOMEDICAL LTD, AUSTIN, TX AERONOX NITRIC OXIDE TITRATION & MONITORING SYS K093260 AVASTIN (BEVACIZUMAB), LUENTIS (RANIBIZUMAB INJ) AERS 1/11 TO PRESENT
Page 533 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-7361 2011-7362 2011-7363 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7364 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7365 2011-7366 2011-7367 2011-7368 2011-7369 2011-7370 2011-7371 2011-7372 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FOI SERVICES INC 2011-1546 MERCK & CO., INC. 2011-1039 FOI SERVICES INC 2010-8374 closed (duplicate of 2010-8135) FOI SERVICES INC 2010-8205 FOI SERVICES INC 2011-3778 FOI SERVICES INC 2010-7023 FOI SERVICES INC 2010-2951 2010-2061 CHRISTY MENG INNOPHARMA LLC ORTHO MENEIL PHARM - INJECTAPAP (ACETAMINOPHEN INJECTION), NDA 017785 RECS ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ MATHEW SWANSON INSTITUTIONAL CAPITAL LLC TODD S PAYNE ZEBERSKY & PAYNE LLP WILLIAM KONST TAG HEALTHCARE COSMETIC SOLUTIONS LLC, COSMETIC SOLUTIONS INC EIRS, FINES, SANCTIONS, ETC VIRADERM - NDA, APRVL RECS, 2000 TO 2004 HOSPIRA, ROCKY MOUNT, NC - 483 6/11 Signature/ Requester Subject
Page 534 of 1132

Total Records: 12455 Control # 2011-7373 2011-7374 2011-7375 2011-7376 2011-7377 2011-7378 Recd Date / Due Date 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7379 2011-7380 2011-7381 2011-7382 2011-7383 2011-7384 2011-7385 2011-7386 2011-7387 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 10/11/2011 11/08/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ FOI SERVICES INC VICTOR C ARELLANO SECHRIST INDUSTRIES INC FATIMA ASLAM Keller and Heckman LLP OHC CONTINUOUS VENTILATOR - DKT 77P-0398, DEVICE RECLASSIFICATION & TRANS VELVEETA SHELLS & CHEESE ORIG MICROWAVEABLE CUPS, 2.39; VELVEETA SHELLS & CHEESE ORIG 4 PACK MICROWAVEABLE CUPS, 4X2.39 OZ CUP; VELVEETA SHELLS & CHEESE MADE W/2% MILK MICROWAVEABLE FOI SERVICES INC 2011-6310 FOI SERVICES INC 2011-5904 FOI SERVICES INC 2011-5871 FOI SERVICES INC 2011-5860 FOI SERVICES INC 2011-5653 FOI SERVICES INC 2011-5632 2011-5494 FOI SERVICES INC ELLIOT FAVUS, MD FAVUS INSTITUTIONAL RESEARCH LLC TELAPREVIR (INCIVEK) - AERS 5/23/11 TO PRESENT FOI SERVICES INC 2011-4677 FOI SERVICES INC 2011-4231 FOI SERVICES INC 2011-4156 FOI SERVICES INC 2011-3884 Signature/ Requester Subject 2011-3578
Page 535 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject CUPS, 2.19 OZ CUP ETC - UPC 2100002322, 2100002339, 2100002323 ETC 2011-7388 2011-7389 10/11/2011 11/08/2011 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7390 10/11/2011 11/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ 2011-7391 10/11/2011 11/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7392 10/11/2011 11/08/2011 2011-7393 2011-7394 2011-7395 2011-7396 2011-7397 2011-7398 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 12/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC PATRICK WILLHITE MED-EL CORP MARY ALICE MOORE LEONHARDT MOORE LEONHARDT & ASSOC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANGIOSYSTEMS INC - STERILE DISPOSABLE SURGICAL DRAPE/C-SECTION DRAPE K905465 COCHLEAR LTD/COCHLEAR AMERICAS - RECALL Z00032012 RECS GARDASIL - AERS, RPTS, FILES, ETC ORA/CE-FO/CHI-DO/CCB/ FOI SERVICES INC OC/OSHC/OPD/ CBER/OCTMA/DDOM/ALFB/ OC/OSHC/OPD/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANGIOSYSTEMS INC - STERILE DISPOSABLE SURGICAL DRAPE/ABODOMINAL DRAPE K905466 RUSH-PRESBYTERIAN, ST LUKE'S MEDICAL CENTER, CHICAGO, IL - EIRS, 483S, CO RESP, ETC 1/01 TO PRESENT BIOMEDICAL LIFE SYSTEMS INC - PAIN BUDDY K102051 SARAH ADRIANO ADRIANO & ASSOC VAXON CORPORATION; IMMATICS CORPORATION WHOOPING CAUGH VACCINE ORPHAN DRUG APPL TIM KENDALL NATIONAL COLLABORATING CTRE FOR MENTAL HEALTH QUETIAPINE, OLANZAPINE, RISPERIDONE, ETC - CLINICAL TRIALS (18 YRS & YOUNGER) MICHELLE L GOMEZ LONG & PAGE LLP MEDTRONIC, INC, MEDTRONIS SOFAMOR DANEK INC, MEDTRONIC PS MECICAL INC ETC - LENOX BONE MILL, EIRS, RPTS, COMM ETC ORA/SE-FO/ATL-DO/ACB/ FYE, JESSICA ELENA HOWELL HOGAN LOVELLS US LLP AMPHASTAR PHARMACEUTICALS INC - ENOXAPARIN SODIUM (PRESERVATIVE FREE), APRVL PKG RECS ROCKY MOUNT HOSPIRA - 483S, 5-11 - 6/11; 8/11
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-7399 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7400 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7401 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7402 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7403 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-7404 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7405 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7406 10/12/2011 FDA/OMPT/CDER/ORP/DIDP/ KEALY C SEHIC JUBILANT LIFE - LAMOTRIGINE ANDA 20-0220 APRVL LTR KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES RANBAXY, INDIA - EIRS ZSOLT MACSKASI ANALYSIS-RESEARCHPLANNING WYETH; SCHWARZPHARMA; ALAVEN ETC; (GENERIC MFRS TEVA, BARR, PAR) - REGLAN (METOCLOPRAMIDE), AERS ZELECKHA AMIRZADA EPPSTEINER & FIORICA ATTORNEYS LLP ELECTRIC HEATING PADS - RPTS, STUDIES 12/12/95 GARLON G FROST HAMILTON DISTRIBUTION LLC LIST OF APRVD PHARMACEUTICAL PLANTS OUTSIDE OF THE USA - NAME, ADDRESS. PHONE OR EMAIL OF CO MCGARITY, GARY J BRISTOL MYERS SQUIBB - TEQUIN (GATIFLOXACIN) AERS ARRON M TEJANI FRASER HEALTH AUTHORITY META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS COMPARING ANGIOTENSIN RECEPTOR BLOCKERS - RECS 6/2/11 KUMAR, JAY DESI NOOH - DRUGS PENDING DESI RVWS Signature/ Requester LLC Subject
Page 537 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/09/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7407 2011-7408 10/12/2011 11/09/2011 10/12/2011 11/09/2011 2011-7409 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ 2011-7410 2011-7411 10/12/2011 11/09/2011 10/12/2011 11/09/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7412 2011-7413 2011-7414 2011-7415 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 11/09/2011 10/12/2011 11/09/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-7416 10/12/2011 FDA/OMPT/CDER/ORP/DIDP/ CHARLES "CHRIS" CELESTE FERMIC SA DE CV, IZTAPALAPA, MEXICO - EIR, 6/27-29/11 BINFORD, PAUL RASCH, HILARY CMPLNT 122249 - RESULTS ORA/P-FO/SEA-DO/SCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ CHRISTNA K LICHTY Proprietary Wellness, LLC CHRISTINA K LICHTY Proprietary Wellness, LLC FOI DAILY LOG 9/1-30/11 ERGOPHARM (PROVIANT) - RECS RESP TO WARNING LTR 7/7/06 ANDI POULSON LEXISNEXIS COURTLINK INC ANDI POULSON LEXISNEXIS COURTLINK INC MEDWATCH REPORT - ISR 4416925 (CERTIFIED) 2011-7107 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ WARREN REEVES CAMBRIDGE SENSORS LTD CHRISTINE L MACAULEY KIMBERLY-CLARK CORP GARY ALAN FRIEDMAN FRIEDMAN & FRIEDMAN NOVA BIOMEDIOCAL CORP - NOVA MAX BLOOD GLUCOSE & BETA-KETONE MONITORING SYS, K091547 SUBMITTED BY SENSICON CORP; ACQUIRED & OWNED BY KIMBERLY-CLARK CORP - LUBRICATED BAGGY TACTYLON, K974121; TACTYLON CONDOM, K971590 AVASTIN - AERS, RECS, COMM Signature/ Requester JOHNSON TRENT WEST EL AL Subject
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Total Records: 12455 Control # Recd Date / Due Date 11/09/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7417 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CTP/OD/ CTP/OD/ 2011-7418 2011-7419 10/12/2011 11/09/2011 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7420 10/12/2011 11/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7421 2011-7422 2011-7423 10/12/2011 11/09/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 2011-7424 10/13/2011 11/10/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7425 10/13/2011 11/10/2011 2011-7426 10/13/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KIRA DALE PFISERER HEPWORTH JANIS & KLUKSDAL LAW OFCS ROBERT E TROP DEPUY ORTHOPAEDICS INC - ENGAGE FEMORAL STEM MDRS, APRVL RECS INDIVIDUAL RECS ORA/SE-FO/SJN-DO/SJCB/ MENA, ELOY B BENJAMIN S CREEDY MURPHY TAYLOR ET AL SCOTT H SAHAM ROBBINS GELLER ET AL MATTHEW BLEDSOE PHARM D BRISTOL REGIONAL MEDICAL CENTER STRYKER IRELAND LTD, CORK COUNTY, IRELAND WARNING LTR 3/15/07, 483 10/31/06-11/3/06 MATRIXX INIATIVES INC - ZICAM COLD REMEMDY NASAL GEL, NASAL SWABS, KIDS SIZE INVESTIGATION RECS, CORR, CMPLNTS, ETC 1/99 TO PRESESENT ISOXSUPRINE - AERS SPL #'S 694095, 479617, 479618 ETC - RESULTS JAYA AYYAGARI DR REDDY'S LABORITORIES INC KINGS PHARMS - SKELAXIN, NDA 013217/S053, LATEST LBL APRVL (10/31//08) FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE LIVOTI BIOPHARM INSIGHT JULIENNE M KING MERCHANT & GOULD MELA SCIENCES - MELAFIND APRVL LTR 9/11; ADVISORY MTG CORR ORION CORP - ENTACAPONE 200 MG TABS (COMTAN) NDA 020796 POLITO, JOHN R ZYBAN, BUPROPION - MICHAEL C FIORE CORR, 1/1/96; 8/1/00 Signature/ Requester EAS Consulting Group, LLC Subject
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Total Records: 12455 Control # Recd Date / Due Date 11/10/2011 2011-7427 10/13/2011 11/10/2011 2011-7428 2011-7429 10/13/2011 11/10/2011 10/13/2011 11/10/2011 ORA/P-FO/SAN-DO/SFCB/ Action Office ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ LEWIS WARD LW WARD AND ASSOCIATES FRANCO A CORRADO MORGAN LEWIS & BOCKIUS LLP PLASTIC TYPE PRODS - REAL TIME AGING DECISION REQUIREMENT RECS COMMONWEALTH OF THE NORTHERN MARIANA ISALNDS COMMONWEALTH HEALTH CENTER, SAIPAN, NORTHERN MARIANA ISLANDS - REVERSE OSMOSIS WATER TREATMENT INVESTIGATIONS, CMPLNTS, CORR, ETC BARTOR PHARMACAL, RYE, NY - EIRS, 483S, CO RESPS ETC, 1/1/02 TO PRESENT STI571 D6 - CHEMICAL NAME, STRUCTURE Signature/ Requester ROBERT EVAN TROP LAW OFC MICHELLE RYBAK PAN OCEAN USA LLC - ENTRY D9705036017NOTICE OF ROANOKE TRADE SERVICES INC REFUSAL, MARK/REDELIVER, FDA ACTIONS Subject
2011-7430 2011-7431
10/13/2011 11/10/2011 10/13/2011 11/10/2011
ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ PETER SAXON SAXON INTERNATIONAL ASSOCIATES
2011-7432 2011-7433
10/13/2011 11/10/2011 10/13/2011 11/10/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP LISA GRAVES CENTER FOR MEDIA AND DEMOCRACY MARIANO, JOSEPHINE
SURGICAL PROCEDURE PACKS - K110724 PRO GEAR N95 PARTICULATE FILTER RESPIRATOR K102092
2011-7434 2011-7435
10/13/2011 11/10/2011 10/13/2011 11/10/2011
NEXT GENERATION DRAPE INFUSED OR TOWEL - K094016 TUCKER ADKINS DAIRY, YORK COUNTY, SC UNPASTEURIZED MILK CAMPYLOBACTER JEJUNI INVESTIGATION RECS VARENICLINE - AERS (NON-SPONTANEOUS) RECS
2011-7436
10/13/2011 11/10/2011
2011-7437 2011-7438
10/13/2011 11/23/2011 10/13/2011 11/10/2011
CBER/OCTMA/DDOM/ALFB/ Doe J FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MARIANO, JOSEPHINE
GARDASIL VAERS - INDIVIDUAL RECS VARENICLINE/BUPROPION - SUICIDAL IDEATION AERS, NEUROPSYCHIATRIC EVENTS STUDY DATA, ETC
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7439 2011-7440 2011-7441 2011-7442 2011-7443 2011-7444 10/13/2011 11/10/2011 10/13/2011 11/17/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 2011-7445 2011-7446 10/13/2011 11/10/2011 10/13/2011 11/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7447 10/13/2011 11/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7448 10/13/2011 11/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7449 2011-7450 10/13/2011 11/10/2011 10/13/2011 11/10/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP MICROTEK - EQUIPMENT DRAPES K050322 3M - BASIC DISPOSABLE SURGICAL GOWN K101468 JODY L GREEN ROCKY MOUNTAIN POISON & DRUG CTR COUGH/COLD PREPARATIONS - ISRS 7210274-X, 72176365, 7226493-0 ETC Doe J DILANTIN, TRAZADONE, DEPAKOTE, ETC - AERS LOPEZ FJ-1029, RAYMOND FDA/OMPT/CDRH/OCER/DFOI/ BARNHART, DARRELL HEPATITIS C - DIAGNOSIS, TREATMENT, RX AERS, ETC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC FRESH DAY CORP - ENTRY # JF7-00669092, NOTICE OF FDA ACTION #1 K073656 ORA/CE-FO/DET-DO/DCB/ KENYON, TYLER 2009-2679 FDA/OMPT/CDRH/OCER/DFOI/ FIELDS, ERIN FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ GLEN, JEFFREY D JEFF STACHEWICZ FOIA GROUP INC HOLOGIC INC - SELENIA DIMENSIONS 3D SYS READER STUDY TRIALS LTR 2008 ZIMMER HOLDINGS - 483 MOST RECENT CONTRACT #HHSF2232007101104C Q-MIX 2 IN 1 ENDODONTIC IRRIGATING SOL - K103244 Signature/ Requester Subject
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Total Records: 12455 Control # 2011-7451 2011-7452 2011-7453 2011-7454 Recd Date / Due Date 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 2011-7455 10/13/2011 11/10/2011 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/ORM/ ORA/ORM/ ORA/OE/ ORA/OE/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-7456 10/13/2011 11/10/2011 2011-7457 2011-7458 10/13/2011 11/10/2011 10/13/2011 11/10/2011 OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7459 2011-7460 10/13/2011 11/10/2011 10/13/2011 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ WASIK, JOHN F COSMETIC - AER 1/00 TO 1/31/10 COSMETIC FACILITY INSP 1/00 TO 12/31/10 MC CLURE, CHRISTINE FDA/OF/CFSAN/OCD/EOS/ WASIK, JOHN F FDA/OF/CFSAN/OCD/EOS/ WASIK, JOHN F MEMBERS OF COSMETIC INGREDIENT REVIEW, ANNUAL BUDGET SINCE 2001, ACTIONS TAKEN BY THE PANEL 1/1/00 TO 12/31/10 PRODUCT INGREDIENTS UNDER VOLUTARY COSMETIC REGISTRATION PROGRAM "DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS & RELATED ISSUES", (7/11) - FDA PERSONNEL/TIME/MONEY EXPENSE, COMMS, SAFETY EVALUATIONS ETC WASIK, JOHN F COURT ORDERS, SEIZURES, REFUSED ENTRY, CO RECALL 1/00 TO 12/31/11 WASIK, JOHN F FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP PURCHASED PRODUCTS & TESTED BY FDA 1/1/00 TO 12/31/10 MEDICAL SURGICAL MASK, RESPIRATORY MASK - K093179 INTERNATIONAL MEDSURG CONNECTION - MASK K100856 Subject CROSSTEX - SURGICAL EARLOOP MASK K103303
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Total Records: 12455 Control # Recd Date / Due Date 11/10/2011 2011-7461 2011-7462 2011-7463 2011-7464 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 2011-7465 10/13/2011 11/10/2011 ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7466 2011-7467 2011-7468 2011-7469 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 10/13/2011 11/10/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7470 10/13/2011 11/10/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7471 10/13/2011 11/10/2011 FDA/OMPT/CDRH/OCER/DFOI/ ELISA TOSTADO STRYKER SUSTAINABILTY SOLUTIONS CVM/OCD/ ELENA HOWELL HOGAN LOVELLS LLP DIAMONDBACK - 360 ORBITAL ATHERECTOMY SYS, STEALTH 360 ORBITAL PAD SYS K111388; DIAMONDBACK 360 DBX 090521; DIAMONDBACK - 360 DEGREE ORBITAL ATHERECTOMY SYS W/VIPERSLIDE LUBRICANT K081944 CVMS RVW TIME FOR SUBMISSIONS TO INVESTIGATIONAL FOOD ADDITIVE FILE SHAUNAK DEEPAK JEFFERIES & CO BRENTUXIMABVEDOTIN - EAP FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ROBBI PERRY NORTH AMERICAN RESCUE LLC ROBBI PERRY NORTH AMERICAN RESCUE LLC KAREN DANIELS T MARSHALL CONSULTANT JEAN PAUL LeCLERCQ, Esq. MAKAREM & ASSOCIATES PLC SANGER FRESH CUT PRODUCT, SAN ANTONIO, TX - EIR; NINO'S PRODUCE, SAN ANTONIO, TX - EIR ELI LILLY - ZYPREXA (OLANZAPINE) CORR 2000 TO 2009 BELMONT BUDDY LITE FLUID WARMER K090508 PORTEX EMERGENCY CRICOTHYROIDIOTOMY KIT K050166 BRANDON L. CLARK LAW OFFICES OF PETER A MILLER LEVOFLOXACIN - LBLG, PACKAGE INSERT, MEDICATION GUIDE 2008, 2009 CERTIFIED CHAZA, ALLEN TATAWY, SARAH FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester WASIK, JOHN F AARON DeMENT STERIGENICS INTERNATIONAL AARON DeMENT STERIGENICS INTERNATIONAL CORD BLOOD REGISTRY, TUCSON, AZ; VIACORD, CINCINNATI, OH - EIR, 483 MOST RECENT ABBOTT LABS - 483 2011 STERIGENICS SOMERCOTES, UK - EIR 12/3-6/07 STERIGENICS SOMERCOTES, UK - EIR 9/22-24/08 Subject
2011-7472
10/13/2011 11/10/2011
Page 543 of 1132

Total Records: 12455 Control # 2011-7473 Recd Date / Due Date 10/13/2011 11/10/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7474 2011-7475 10/13/2011 11/10/2011 10/13/2011 11/10/2011 2011-7476 10/14/2011 11/14/2011 2011-7477 2011-7478 2011-7479 2011-7480 10/14/2011 11/14/2011 10/14/2011 11/14/2011 10/14/2011 11/14/2011 10/14/2011 11/14/2011 2011-7481 10/14/2011 11/14/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ LEBEAU, CONRAD DIETARY SUPPLEMENT MFRS - FIRST AMENDMENT LBLG RIGHTS MEMOS; HELATH CLAIMS FOR NON-PATENTABLE FOOD, HERB, DIETARY SUPPLEMENT RECS, SOURCES OF EXPERT OPINION ON ALTERNATIVE MEDICINE, ETC UNIMED II INC, KS, MO - EIRS, 483, WARNING LTRS, ETC 1/04 TO PRESENT TEXTURED VEGETABLE PROTEIN - CAERS HARRIS V13733, ERIC D CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ IWASHIMA, FUMIYOSHI FDA/OMPT/CDER/ORP/DIDP/ IAN S SHAINBROWN APOSTOLOU, ALEXANDER MEDICAL DEVICES AND NANOTECHNOLOGY, MANUFACTURING, CHARACTERIZATION, AND BIOCOMPATIBILITY - PUBLIC WORKSHOP TRANS 9/23/10 CATALENT PHARMA SOLUTIONS LLC, RESEARCH TRIANGLE, NC - EIRS TWO MOST RECENT MDS PHARMA SERVICES (CANADA) INC; MDS PHARMA ORA/ORM/ ORA/ORM/ ORA/CE-FO/CHI-DO/CCB/ DIEDRICH, JOHN ELLEN GABLER CHICAGO TRIBUNE ANGELIA D SLAYTON KENDLE INTERNATIONAL INC EVANGER'S DOG AND CAT FOOD CO, WHEELING, IL - EIRS, CMPLNTS 2005 TO PRESENT PAM AMERICAN LABS (PAMLAB), COVINGTON, LA WARNING LTR 11/20/09, CORR CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ KATHYRN E BALMFORD ESQ OLSSON FRANK WEEDA TERMAN MATZ PC KERRY CRAMER TROUW NUTRITION STEVE HUTSON, PHOTO THERAPEUTICS LTD - LUMIERE LTR 9/29/04 BETAINE (BETAINE ANHYDROUS, BETAINE HCL) - AAFCO INGREDIENTS DEFINITION LTR INSPS AND RESULT DATA 10/10 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ ANN W. FEREBEE BRYAN CAVE LLP PETER D. LOFTUS DOW JONES & CO INC BEN VENUE LABS, BEDFORD, OH - CO RESP SINCE 1/10 HTTP HYPOTHERMIA THERAPY LTD K040440 Signature/ Requester JODY L. GREEN, PhD ROCKY MOUNTAIN POISON DRUG CTR Subject 7293881-8, 7295103-0, 7295260-6 - AER
2011-7482 2011-7483 2011-7484
10/14/2011 11/14/2011 10/14/2011 11/14/2011 10/14/2011 11/14/2011
ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/
PAUL W TRIPP LINCARE INC
2011-7485 2011-7486
10/14/2011 11/14/2011 10/14/2011
Page 544 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/14/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7487 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7488 10/14/2011 11/14/2011 CTP/OD/ CTP/OD/ GEORGE N CONNOLLY DMD MPH HARVARD SCHOOL OF PUBLIC HEALTH 2011-7489 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7490 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7491 10/14/2011 11/14/2011 2011-7492 2011-7493 10/14/2011 11/14/2011 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7494 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7495 10/14/2011 11/14/2011 FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE L MACAULEY KIMBERLY-CLARK CORP 84E SERIES SINCLE PLY WRAPPER STERILIZATION WRAP K102864 STEVEN R SCOTT BIOMEASURE INC BOTOX - CMC RVW SUMMARY FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ NATHANIEL ENOS CONWAY HOMER & CHINCAPLAN PC DANIEL A KRACOV ARNOLD & PORTER STEVEN R SCOTT BIOMEASURE INC BOTOX - MEDICAL RVW SUMMARY LUITPOLD PHARMACEUTICALS INC - EQUIMATRIX K111816 INDIVIDUAL RECS ELAINE RIZZO B&H CONSULTING SERVICES INC APOKYN NDA 21-264 - SBA MANDY KIM MCDERMOTT WILL & EMERY MODIFIED RISK TOBACCO PRODS - NUMBER OF APPLS 7/1/11; NUMBER OF RPTS OF EQUIVALENT PRODS INTO INTER-STATE COMMERCE, ETC CEPHALON - NDA 21-947 DATE SUMBITTED TO THE ORANGE BOOK AMY M BYROM FOUGERA PHARMACEUTICALS INC SAVAGE LABS - KAON CI10 (POTASSIUM CHLORIDE XR TABS) NDA 17-046 APPL, AMENDMENTS, ANNUAL RPTS, ETC Signature/ Requester GREENBERG TRAURIG LLP Subject SERVICES (US) INC; MDS INC, ST LAURENT & BLAINVILLE, QUEBEC, CANADA - RECS 2000 TO 2006 (CERTIFIED)
Page 545 of 1132

Total Records: 12455 Control # 2011-7496 2011-7497 Recd Date / Due Date 10/14/2011 11/14/2011 10/14/2011 11/14/2011 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7498 10/14/2011 11/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7499 2011-7500 2011-7501 2011-7502 2011-7503 2011-7504 2011-7505 2011-7506 2011-7507 2011-7508 2011-7509 10/14/2011 11/14/2011 10/14/2011 11/14/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ Doe J SUSAN HAMANN PERKINELMER INC ROGER DONALDSON Doe J OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ BUTLER, ELSIE HOGAN LOVELLS US LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GENETICALLY MODIFIED/ENGINEERED FOODS - LBLG, ADVERTISING RECS 1/10 TOPRESENT KRAFT - NABISCO PRODS CONTAMINATED W/DRUGS, INFO/RECS GENERAL MILLS INC - CHEREOS/HONEY CHEREOS CONTAMINATED W/DRUGS, RECS/INFO ID-BIOLOGICS (PERKINELMER HEALTH SCIENCES, INC),GREENVILLE, SC - EIR, 8/3/09 RS MEDICAL - POLICIES, INSPS, DEBARMENT LISTS, ETC 2011---7112 2011-7078 2011-7053 2011-6984 ELENA HOWELL HOGAN LOVELLS US LLP 2011-6764 2011-6792 CIHAK, BRIAN SHELF LIFE EXTENSION PROGRAM - PRESCRIPTION & NON-PRESCRIPTION DRUGS EXPIRATION DATES SKAINS, JARRED Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CMPLNT 122598 Subject BARRIER N95 PARTICULATE RESPIRATOR - K102923
Page 546 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/15/2011 2011-7510 10/17/2011 11/15/2011 2011-7511 2011-7512 10/17/2011 11/15/2011 10/17/2011 11/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7513 10/17/2011 11/15/2011 2011-7514 10/17/2011 11/15/2011 ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7515 10/17/2011 11/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7516 10/17/2011 11/15/2011 2011-7517 2011-7518 2011-7519 10/17/2011 11/15/2011 10/17/2011 11/15/2011 10/17/2011 11/15/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MANOJ ZACHARIAS LIBERTY MANAGEMENT GROUP LTD FOI SERVICES INC ANNE SAVAS MAGSTIM COMPANY US LLC ANNE SAVAS MAGSTIM COMPANY US LLC SPECTRA MEDICAL DEVICES INC, WILLIAMSBURG, VA SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, AND L/L K081524 DR. BETH ANN HELLERSTEDT MD, AUSTIN, TX - CORR, WARNING LTR, CO RESP, EIR, 483 9/19/11 MAGPRO - DANTEC MAGNETIC STIMULATOR K926516; DANTEC KEYPOINT K944547 DIGITIMER - DS7A K051357; DIGITMER D185 K020400 REYES, JOYCE EFALIZUMAB (RAPTIVA) - RVWS. SBA CHARLES W. VAUGHN BENJAMIN L ENGLAND, ESQ BENJAMIN L ENGLAND & ASSOC LLC SEA DELIGHT LLC - ENTRY # D97-060229-0 RECS, RPTS, ANALYSIS RESULTS ETC Action Office OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID LEE KIMBERLY-CLARK CORP PAUL GAVAZA APPALACHIAN COLLEGE OF PHARMACY MEDWATCH RPTS SUBMITTED BY HEALTHCARE PROFESSIONALS, PHARMACISTS, PATIENTS LAST 10 YRS COOK VERSA TUBE - K100283 SHIRLEY ROSS ENTRY #J2300268500 - NOTICE OF FDA ACTION, ROANOKE TRADE SERVICES INC REDELIVERY NOTICE, NOTICE OF REFUSAL Signature/ Requester ALLSTATE INSURANCE CO Subject
WHITEHALL LABS - SALOXIUM (SALSALATE) - MTG MINS
Page 547 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-7520 2011-7521 10/17/2011 11/15/2011 10/17/2011 11/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ 2011-7522 10/17/2011 11/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7523 10/17/2011 11/15/2011 FDA/OO/OFBA/OAGS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7524 10/17/2011 11/15/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ 2011-7525 10/17/2011 11/15/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ LAURA E. STEWART WALSH MCKEAN FURCOLO LLP LETS TALK HEALTH - ENFORCEMENT ACTION FOR PRODS CONTAINING NIMESULIDE LAURA E. STEWART WALSH MCKEAN FURCOLO LLP HEALTH ADVANCES USA INC - ENFORCEMENT ACTION FOR PRODS CONTAINING NIMESULIDE RAVNITZKY, MICHAEL. EASTERN RESEARCH GROUP - CONTRACT #HHSF2232008100171 FINAL RPT FOI SERVICES INC WOCKHARDT - METOPROLOL SUCCINATE NDA 90-615 BIO RWV FDA/OMPT/CDRH/OCER/DFOI/ ANNE SAVAS MAGSTIM COMPANY US LLC BRIAN P SULLIVAN SEARCY DENNEY ET AL MAGPRO - MAGOPTION, MODEL R30 X100 K091940, K061645 TEVA PHARMS - PROPOFOL LOT #31308278B AERS, INDIVIDUAL RECS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OCI/ ORA/OCI/ 2011-7526 10/17/2011 11/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7527 2011-7528 2011-7529 2011-7530 2011-7531 10/17/2011 11/15/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 2011-7532 2011-7533 10/18/2011 11/16/2011 10/18/2011 11/16/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7534 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7535 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ERIC WALTER CAMIL CAMIL CONSULTING CORP ACTHAR GEL - STUDIES RYAN SCARBOROUGH WILLIAMS & CONNOLLY LLP INDIVIDUAL RECS MCCANN, JOE Doe J R&D WAREHOUSING , WV; WAREHOUSING, TX; WAREHOUSING , PR, ETC - APRVD PRODS 1/1/11 TO PRESENT ALLERGAN - SILICONE BREAST IMPLANTS RPT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ MERCK & CO., INC. CRAIG ROUSH ROCKLINE INDUSTRIES CRAIG ROUSH ROCKLINE INDUSTRIES JEFFREY GLEN JEFREY D GLEN DDS US NONWOVENS CORP, BRENTWOOD, NY - EIR RESP 111/8-29/10 PREMIER CARE INDUSTRIES, HAUPPAUGE, NY, INDUSTRY, CA - EIRS, 483S 10/14/09 TO 10/14/11 PULPENT CALCIUM HYDROXIDE PREPARATION - K022734 OC/OM/OMP/DDM/ AMY JOHNSON SIDLEY AUSTIN LLP FOI DAILY LOG 10/3-7/11 DKT 1999D-0972 JULIE A. HAGER LAW OFFICES OF JULIE A HAGER LLC OPTIRAY 300 - AERS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7536 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7537 10/18/2011 11/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/NOL-DO/NOCB/ KIRSTY RAMES BIOPHARM INSIGHT MEDTRONIC INC - INVESTIGATIONS, WARNING LTRS, GMP VIOLATIONS, ETC LAST 5 YRS ABIGAIL MOSS BIOPHARM INSIGHT NCT000464269, NCT00490035, NCT101364597, ETC Signature/ Requester Subject
Page 550 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SE-FO/NOL-DO/NOCB/ 2011-7538 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7539 2011-7540 2011-7541 2011-7542 2011-7543 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 2011-7544 10/18/2011 11/16/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-7545 2011-7546 2011-7547 2011-7548 2011-7549 2011-7550 2011-7551 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 11/16/2011 10/18/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ ALBA 89560-012, DENNIS HUY NGOC TRINH, SAN JOSE GASTOENTEROLOGY, SAN JOSE, CA - EIRS, 483S, CO RESP, ETC MOST RECENT SAMUEL S LEE MD, HEALTH SCIENCES CENTRE, CALGARY AB, CANADA - EIRS, 483S CO RESP, ETC MOST RECENT ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ GLEN, JEFFREY D JOONSHICK HWANG B&D DENTAL TECHNOLOGIES RICHARD D. NEWMAN, Ph.D. RND SERVICES LLC SACCHARIN - CAERS PHARMEDIUM, EDISON, NJ - EIR 7/11 K110719 FDA/OMPT/CDRH/OCER/DFOI/ GLEN, JEFFREY PULPDENT CALCIUM HYDROXIDE PREPARATION K022734 VITAPEX PRE LOADED DENTAL SYRINGE K973667 GALUSHKO, SERGEY OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MURIELLE STEVEN WALSH POMERANTZ HAUDEK BLOCK & GROSSMAN BIOMIMETIC THERAPEUTICS INC - AUGMENT BONE GRAFT RECS KOMPAS, VLADIVOSTOK, RUSSIA - IMPORTATION OF CRAB IINTO THE US 2008-2011 CVM/OCD/ CVM/OCD/ CVM/OCD/ KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. 2008-7835 LALLEMAND - AGRN 12 GEVO - ARGN 13 GEVO - AGRN 10 JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL H&P (DBA TRIAD) - AERS 6/11 TO PRESENT Signature/ Requester Subject
Page 551 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/16/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7552 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7553 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7554 10/18/2011 11/16/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ OM/OMP/DODM/ NCTR/OD/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ CVM/OCD/ 2011-7555 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7556 10/18/2011 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ KUMARA S. SEKAR, Ph.D. MICRO LABS USA INC MICRO LABS USA INC - DIAMOX NDA 12-945 SBA JILLIAN M. CUNNINGHAM BECKER & ASSOCIATES CONSULTING INC TYLENOL CAPLETS NDA 19-872 - APRVL, LBLG NICK MORALES NATURAL RESOURCES DEFENSE COUNCIL BISPHENOL A - HEALTH EFFECTS, RISK ASSEMENT, REGULATION, ETC 1/1/10 TO PRESENT SUE HOLLY VA Sierra Nevada Health Care System METHYLENE BLUE - AERS FOI SERVICES INC ROBERT P MYERS MD, CALGARY, AB, CANADA - EIRS, 483S CO RESP, ETC MOST RECENT Signature/ Requester FOI SERVICES INC Subject
Page 552 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7557 2011-7558 10/18/2011 11/16/2011 10/18/2011 11/16/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INFORMATION ACCESS DWIGHT W. SCOTT, Jr. MUNSCH HARDT ET AL METHODIST HOSPITAL - POST-ARTHROSCOPY ORGAN/SPACE SITE INFECTIONS (SSI) INVESITGATION RECS 4/22/09-5/7/09; ARTHROSCOPIC SHAVERS - SAFETY RVWS FEDERAL REGISTER VOL 74 NO 81 REFERENCES 1-12 2011-6188 Signature/ Requester Subject
2011-7559
10/19/2011 11/17/2011
OM/OMP/DODM/
META M COOPER BUTLER, SNOW, O'MARA, STEVENS & CANNADA, PLLC ATTORNEYS AT LAW
2011-7560 2011-7561 2011-7562
10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/
JONEL ALECIA MSNBC.COM RICHARD CARFAGNA JR PRIVATELINE MEDICAL CORP DONALD WU PROMEDICAL PRODUCTS CO LTD
COOPERVISION INC - AVAIRA TORIC CONTACT LENSES RECALL CORR 6/1/11-10/17/11 JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP - YI XIN SAFETY SYRINGE K042102 K042111, K091097, K042131, K042137
2011-7563 2011-7564
10/19/2011 11/17/2011 10/19/2011 11/17/2011
FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
TOMAS FRIEND KIPA AB JAMINE SCHWERTER SNELL & WILMER LAW OFCS
AGA MEDICAL CORP - AMPLATER VASCULAR PLUG II VASCULAR EMBOLISM DVC K071125 MERZ PHARMACEUTICALS LLC - XEOMIN (INCOBOTULINUMTOXIN A); IPSON GROUP - DYSPORT (ABOTULINUMTOXIN A) LBLG, CORR, SAFETY RPTS, ETC
2011-7565
10/19/2011 11/17/2011
ANGELA BOUSE Teleflex Medical
TELEFLEX MEDICAL HUDSON RESPIRATORY CARE INC SIDE DRAFT NEB-U-MIST NEBULIZER MODEL 4189 K994352 TIVAMED INC (VIVEVE INC) - TIVAMED COOLED RF SYS 510K LUPIN PHARMS, GOA, INDIA - EIR MOST RECENT
2011-7566 2011-7567
10/19/2011 11/17/2011 10/19/2011 11/17/2011
FDA/OMPT/CDRH/OCER/DFOI/ PARMER, JONATHAN B FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J
Page 553 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7568 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7569 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7570 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/CIN-DO/CCB/ 2011-7571 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7572 2011-7573 10/19/2011 11/17/2011 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7574 10/19/2011 11/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-7575 10/19/2011 FDA/OMPT/CDER/ORP/DIDP/ SAMUEL S LEE MD, HEALTH SCIENCES CENTER, CALGARY, AB, CANADA - EIR, 483 CORR, ETC MOST RECENT CHERYL P VOLLWEILER TRAUB LIEBERMAN STRAUS ET AL CONVACTEC, UNOMEDICAL MEDTRONIC- PARADIGM QUICK SET INFUSION SETS CORR, WARNING LTRS, MINS, ETC FOI SERVICES INC ORA/P-FO/SEA-DO/SCB/ KURT R WEBER CARDIFF CONSULTANCY LLC NDA 21-130/S012, NDA 21-131/S012, NDA 21-132/S012 RVWS SIGHTLIFE, SEATTLE, WA - EIRS LAST TWO CAROLEL MITNICK HARVARD MEDICAL SCHOOL DEPT OF GLOBAL HEALTH & SOCIAL MEDICINE SANOFI AVENTIS - RIFADIN (RIFAMPIN) NDA 50-420 APRVL SUMMARIES Doe J DIPRIVAN (PROPOFOL) - AERS, RECALL RECS, LOT NUMBERS, ETC JIM FAUCETT NORTHWEST CLINICAL RESEARCH CTR CLOZARIL NDA 19-758 -SBA, SAFETY RECS DEERE, RAY ADVAIR - AERS, TRAILS, POLICES, SUBMISSIONS, ETC Signature/ Requester Subject
Page 554 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/17/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7576 10/19/2011 11/17/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7577 2011-7578 2011-7579 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7580 2011-7581 2011-7582 2011-7583 2011-7584 2011-7585 2011-7586 2011-7587 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/BLT-DO/CB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. SARAH HENSON RHODES PHARMACEUTICALS SARAH HENSON RHODES PHARMACEUTICALS JOAN STITT (UG2CD-16) MERCK & CO., INC. SARAH HENSON RHODES PHARMACEUTICALS SARAH HENSON RHODES PHARMACEUTICALS SARAH HENSON RHODES PHARMACEUTICALS MARYPAUL LABORATORIES INC, SPARTA, NJ - EIR MOST RECENT PAR PHARMACEUTICAL, SPRING VALLEY, NY - EIR MOST RECENT AAI PHARMA, WILMINGTON, NC - EIR MOST RECENT PARMACEUTICS INTL INC, HUNT VALLEY, MD - EIR 12/16/10, 5/16-25/11 2011-5188 PF LABS INC, TOTOWA, NJ - EIR MOST RECENT 2011-5034 2011-4252 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. CHARLES EAS Consulting Group, LLC SUPRENZA NDA 20-2088 - APRVL LTR, LBLG, RVWS, ETC 2011-2173 2010-8154 FOI SERVICES INC ROBERT P MYERS MD, MARK G SWAIN ,D. KELLY W BURAK MD, ETC, CALGARY, AB, CANADA - EIR, 483, WARNING LTR, ETC MOST RECENT Signature/ Requester FOI SERVICES INC Subject
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Total Records: 12455 Control # 2011-7588 2011-7589 2011-7590 2011-7591 2011-7592 Recd Date / Due Date 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7593 2011-7594 2011-7595 2011-7596 2011-7597 2011-7598 2011-7599 2011-7600 2011-7601 2011-7602 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OSHC/OPD/ ORA/CE-FO/NJ-DO/NJCB/ SARAH HENSON RHODES PHARMACEUTICALS FRAN KOCH INFORMATION ACCESS CAROL SCHMIDT SEATTLE GENETICS INC SARAH HENSON RHODES PHARMACEUTICALS JOAN STITT (UG2CD-16) MERCK & CO., INC. SARAH HENSON RHODES PHARMACEUTICALS JOAN STITT (UG2CD-16) MERCK & CO., INC. SARAH HENSON RHODES PHARMACEUTICALS JOAN STITT (UG2CD-16) MERCK & CO., INC. SONIA E VADLEZ ORRICK HERRINGTON & SUTCLIFFE LLP AERS - REQUEST FOR PROPOSAL (RFP), TECNICAL REQUIREMENTS RECS, USER MANUALS, DATES, ETC DSM PHARMACEUTICAL INC, GREENVILLE, NC - EIR MOST RECENT 2011-6375 WHITEHOUSE ANALYTICAL LABS, WHITEHOUSE, NJ - EIR MOST RECENT 2011-5862 CELGENE CORP - ISTODAX (ROMIDEPSIN) ORPHAN DRUG DESIGNATION QUALITY CHEMICAL LABS, WILMINGTON, NC - EIR MOST RECENT 2011-5861 CONSUMER PRODUCT TESTING COMPANY INC, FAIRFIELD, NJ - EIR MOST RECENT 2011-5839 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester SARAH HENSON RHODES PHARMACEUTICALS FRAN KOCH INFORMATION ACCESS JOAN STITT (UG2CD-16) MERCK & CO., INC. SARAH HENSON RHODES PHARMACEUTICALS SZYMAZTKI, EUGENE HALO PHARMACEUTICALS INC, WHIPPANY, NJ - EIR MOST RECENT PHARMACORR CORP (OKC), OKLAHOMA CITY, OK - RECS 2011-5857 Subject TEDOR PHARMA INC, CUMBERLAND, RI - EIR MOST RECENT 2011-5758
Page 556 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OO/OFBA/OAGS/ 2011-7603 2011-7604 10/19/2011 11/17/2011 10/19/2011 11/17/2011 2011-7605 2011-7606 10/19/2011 11/17/2011 10/19/2011 11/17/2011 2011-7607 10/19/2011 11/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7608 2011-7609 2011-7610 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 2011-7611 10/19/2011 11/17/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OO/OFBA/OAGS/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SEA-DO/SCB/ 2011-7612 2011-7613 2011-7614 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ROBERT TOWNSEND R H TOWNSEND & ASSOCIATES BODEE LLC - ZENCORE PLUS, ZENCORE TABS, ENCORE TABS, ETC CRIMINAL INVESTIGATION 2011-6480 2011-6421 SCHARBERG, DAVID L OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ JOAN STITT (UG2CD-16) MERCK & CO., INC. KRISTI O SMEDLEY Center for Regulatory Services, Inc. SONIA E VALDEZ ORRICK HERRINGTON & SUTCLIFFE LLP KEMIN INDUSTRIES INC - CHROMIUM PROPIONATE FOR USE IN DAIRT CATTLE DAF SUBMISSION VAERS - USER MANUALS TECHNICAL REQUIREMENTS, RECS, DATES, ETC COVANCE LABORATORIES INC, BALTIMORE, MD 9/2/11; AVANZA LABORATORIES LLC BALTIMORE, MD 7/27/11; BRISTOL MYERS PHARM RSCH INSTITUTE, DETROIT, MI 7/18/11 - 483S 2011-6420 SONIA E VALDEZ ORRICK HERRINGTON & SUTCLIFFE LLP AERS - REMOTE USER DATA, ANALYSIS, DATA STORAGE, ETC 5/1/00 TO 5/1/01 GOLDMAN, ROBERT OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. SONIA E VALDEZ ORRICK HERRINGTON & SUTCLIFFE LLP JOAN STITT (UG2CD-16) MERCK & CO., INC. HOSPIRA, ROCKY MOUNT - 483 5/16 - 6/17/11 VAERS - REMOTE USER DATA, ANALYSIS, DATA STORAGE, ETC 5/1/00 TO 5/1/01 2011-6409 2011-6402 Signature/ Requester Subject
Page 557 of 1132

Total Records: 12455 Control # 2011-7615 2011-7616 Recd Date / Due Date 10/19/2011 11/17/2011 10/19/2011 12/16/2011 2011-7617 2011-7618 10/19/2011 11/17/2011 10/19/2011 11/17/2011 2011-7619 10/19/2011 11/17/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7620 2011-7621 2011-7622 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ ORA/CE-FO/NJ-DO/NJCB/ OM/OSS/OPILS/FDAHO/ 2011-7623 10/19/2011 11/17/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ ORA/CE-FO/NJ-DO/NJCB/ 2011-7624 10/19/2011 11/17/2011 2011-7625 10/19/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ FDA/OMPT/CDRH/OCER/DFOI/ DIAGNOSTIC TEST KITS - LBLG REQUIREMENTS, TRANS, ROBINSON, JOAN HOME PREGNACY TESTS - CLASSIFICATION RECS, 1979 ROBINSON, JOAN FARADAY LABS, HILLSIDE, NJ - OVA ll RECALL RECS 1972 ROBINSON, JOAN FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ NEILL MCCORMACK GE Healthcare MELISSA BASNIGHT ZEST ANCHORS LLC PERMA PURE LLC, TOMS RIVER, NJ - EIRS, 482S, 483S, ETC 8/10/10 TO 10/18/11 ZEST ANCHORS LLC - LOCATOR BAR FEMALE, LOCATOR BAR CAST-TO-FEMALE, K033699 PRINCETON LABS, NJ - CONFIDELLE HOME PREGNACY TEST HEARINGS, RECALLS, CORR ETC 1971 SIMS, JUDITH A Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ ZOOK, JONAS A JOAN STITT (UG2CD-16) MERCK & CO., INC. LASALOCID NADA 096-293; BOVATEC FOR PASTURE CATTLE FEED NADA 96-298; MONENSIN NADA 095-735 FOI SUMMARY DRAFT GUIDANCE FOR INDUSTTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATION & RELATED ISSUES - EXPENDITURE OF TIME & MONEY, SAFTEY RECS, COMM 7/11 2011-6538 Doe J Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. INDIVIDUAL RECS Subject 2011-6482
Page 558 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/17/2011 2011-7626 10/19/2011 11/17/2011 2011-7627 10/19/2011 11/17/2011 2011-7628 2011-7629 2011-7630 2011-7631 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/CE-FO/MIN-DO/MCB/ ORA/OCI/ ORA/OCI/ 2011-7632 10/19/2011 11/17/2011 2011-7633 2011-7634 2011-7635 2011-7636 2011-7637 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/19/2011 11/17/2011 10/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ LEIGH DAY & CO STACEY ANDELMAN MARIETTA EYE CLINIC NILOUFAR SAMIMI ZEVEX INC FRAN KOCH INFORMATION ACCESS FREDERICK A. MOORE, 483, 3/4/09 MORABITO, MICHAEL MATTHEW LOESCH HOSPIRA INC, ROCKY MOUNT, NC - 483S, WARNING LTRS DEPUY - CORAIL AMT - PINNACLE ULTAMET COMPONENT MDRS, ANALYSIS, 510K, ETC 2004 TO PRESENT PAUL MITCHELL MD. MARIETTA EYE CLINIC - 483S, WARNING LTR, 12/13/99 VILTECHMEDA - PUMP INFUSION. SEP-10S PLUS; SP-125 PRO, K010937 2011-5759 FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ ORA/CE-FO/NJ-DO/NJCB/ AREHART, MELISSA A ARTHUR P LICYGIEWICZ MIM SOFTWARE INC JARED MACCLEARY CROWELL & MORING JASON W DOZARK CRIVELLO.CARLSON H & P INDUSTRIES INC (DBA TRIAD GROUP), HATLAND, WI INSPS, 7/15/09 TO 1/07/11 BUTTERFLY BAKERY, CLIFTON, NJ - CO RESP TO WARNING LTR GEN1001303 DOC ( SELLING DVCS W/O FDA CLEARANCE/APRVL) - INVESTIGATION RECS FOI LOG, CVM - 9/11 ROBINSON, JOAN MEDICAL DVCS AMENDMENTS W/SECTION 510K - HEARING RECS CORR 1976 ROBINSON, JOAN MEDICAL DEV AMENDMENTS - HEAROMG TRANS, CORR, 1976 Signature/ Requester ROBINSON, JOAN Subject CORR 1972
Page 559 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/18/2011 2011-7638 10/20/2011 11/18/2011 Action Office OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ 2011-7639 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7640 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7641 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7642 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7643 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7644 10/20/2011 11/18/2011 2011-7645 10/20/2011 11/18/2011 ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ Law Office of Alvin J. Lorman JOHNATHAN RICKMAN FDA NEWS FCN 1103 - BUTYL ACRYLATE-STYRENE-METHACRYLIC ACID-HYDROXYPROPYL METHACRYLATE-GLYCIDYL METHACRYLATE COPOLYMER PHARMACEUTICAL, BIOLOGICS, MED DVC MFRS, CLINICAL TRIAL FACILITIES IN & OUTSIDE THE US - 483S 9/1-31/11 MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA,INDIA - DIPYRIDAMOLE EIRS 2000 TO 2011 MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA,INDIA - TERBINAFINE HCL EIRS 2000 TO 2011 MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA,INDIA - LEVETIRACETAM EIRS 2000 TO 2011 MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA,INDIA - TADALAFIL EIRS 2000 TO 2011 MALIK, KAMRAN ORCHID CHEMICALS & PHARMACEUTICALS LTD, MAHARASHTRA, INDIA - EIRS, MOST RECENT Signature/ Requester TOCQUEVILLE ASSET MANAGEMENT LP E CLAY PARKER ESQ E CLAY PARKER LAW OFCS Subject 2011 THERMO PAC LLC, SIMPLY THICK LLC - SIMPLY THICK SAFETY RECS, EIRS, CORR, ETC 2009 TO PRESENT
Page 560 of 1132

Total Records: 12455 Control # 2011-7646 2011-7647 2011-7648 Recd Date / Due Date 10/20/2011 11/18/2011 10/20/2011 01/30/2012 10/20/2011 11/18/2011 2011-7649 2011-7650 2011-7651 2011-7652 2011-7653 2011-7654 2011-7655 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 CVM/OCD/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ENTELLUS MEDICAL GARRETT P AHLBORG ENTELLUS MEDICAL GARRETT P AHLBORG ENTELLUS MEDICAL KATHRYN DOUGLASS PUBLIC EMPLOYEES FOR ENVIRONMENTAL RESPONSIBILITY SONIA E VALDEZ ORRICK HERRINGTON & SUTCLIFFE LLP FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LAMBRECHT, BILL BARRY MEIER NEW YORK TIMES GARRETT P AHBORG ENTELLUS MEDICAL GARRETT P AHLBORG ENTELLUS MEDICAL Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester SONIA E VALDEZ ORRICK HERRINGTON ET AL GARY MALINOWKSI ATPAC MEDICAL LLC MONSANTO CO - GENETICALLY ENGINEERED CROPS ENFORCEMENT ACTIONS, EIRS 2000 TO PRESENT METAL-ON-METAL HIP REPLACEMENTS - STUDY PROPOSOALS, CO RESPS, ETC ACCLARENT INC - CYCLOPS MULTI-ANGLE ENDOSCOPE, K100577 ACCLARENT INC - RELIEVA SPIN SINUS DILATION SYS K111875 CORR, MINS, RVWS, ETC ACCLARENT INC - RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) K110687 CORR, MINS, RVWS, ETC ACCLARENT INC - RELIEVA SOLO ELITE BALLOON CATHETER K111254 CORR, MINS, RVWS, ETC ACCLARENT INC - CYCLOPS MULTI-ANGLE ENDOSCOPE, K110097, CORR, MINUTES, RVWS ETC FAMPHUR, FLORFENICOL, LINCOMYCIN, ETC - NATIONAL ENVIRONMENTAL POLICY ACT (NEPA) COMPLIANCE RECS Subject SPONTANEOUS REPORTING SYSTEM - DATA ANALYSIS, STORAGE, UPDATES, ETC 5/1/00 TO 5/1/01 K111018
2011-7656
10/20/2011 11/18/2011
SUBSTANCE REGISTRATION SYSTEM - REQUEST FOR PROPOSAL, USER MANUAL, TECHINCAL REQUIREMENT RECS, ETC 5/00, 5/01
2011-7657
10/20/2011 11/18/2011
SONIA E VALDEZ ORRICK HERRINGTON & SUTCLIFFE LLP
SUBSTANCE REGISTRATION SYSTEM - REMOTE USER ACCESS, DATA STORAGE, DATA ANALYSIS, ETC 5/00, 5/01
2011-7658 2011-7659
10/20/2011 11/18/2011 10/20/2011
FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/
D DOUGLAS GRUBBS MONSOUR LAW FIRM SHELLEY K SPOFFORD
HOWMEDICA OSTEONICS - ABC SYS, TRIDENT SYS P000013 CLNCL TRIAL RECS, PI, CORR, ETC H & P INDUSTRIES - BACILLUS CEREUS INSP 11/29/10-
Page 561 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/18/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/CE-FO/MIN-DO/MCB/ 2011-7660 2011-7661 2011-7662 2011-7663 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7664 2011-7665 10/20/2011 11/18/2011 10/20/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7666 2011-7667 10/20/2011 11/18/2011 10/20/2011 11/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7668 2011-7669 2011-7670 10/20/2011 11/18/2011 10/20/2011 11/18/2011 10/21/2011 11/21/2011 OC/OM/OMP/DDM/ ORA/SE-FO/ATL-DO/ACB/ OC/OM/OMP/DDM/ JENNIFER PELAIA COVINGTON & BURLING LLP PAUL STEPHANO SANFORD BERNSTEIN LLC ANGELIA SLAYTON KENDLE INTERNATIONAL INC DKT FDA-1977-N-0013 HOSPIRA INC, ROCKY MOUNT, NC - 483 8/11 DKT 1998P-0167 GORTLER, DAVID JOAN STITT (UG2CD-16) MERCK & CO., INC. SOLODYN (MINOCYCLINE) - ISRS 3035643, 3146295, 3151684, ETC FOI DAILY LOG 10/10-14/11 EHRENPREIS MD, ELI D ORA/CE-FO/MIN-DO/MCB/ BRUCE MCKEEMAN SUMMIT TO SEA LLC SUMMIT TO SEA, MOUND, MN - OFF-LABEL MARKETING CMPLNT, INVESTIGATION 7/13/11 ACCUTANE - ISRS 618722, 6172853,6167577, ETC ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/NE-FO/NYK-DO/NYDCB/ SHELLEY K SPOFFORD MCINTYRE & BARNS PLLC SHELLEY K SPOFFORD MCINTYRE & BARNS PLLC GREGORY HERTZ CITIGROUP ERIN O'BOYLE AP PHARMA INC ZOFRAN (ONDANSETRON IV), ANZEMET (DOLASETRON IV) , KYTRIL (GRANISETRON IV) - AERS HOSPIRA, ROCKY MOUNT, NC - 483 8/11, CO RESP PROFESSIONAL DISPOSABLES INTERNATIONAL INC - 483S 5/17/01. 5/3/03, 5/22/08 NICE-PAK PRODUCTS INC - 483S 12/9/05, 9/15/08,2/10/10 Signature/ Requester MCINTYRE & BARNS PLLC Subject 1/7/11, INVESTIGATION RECS
Page 562 of 1132

Total Records: 12455 Control # 2011-7671 Recd Date / Due Date 10/21/2011 11/21/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7672 10/21/2011 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ 2011-7673 10/21/2011 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/SW-FO/KAN-DO/COMP/ 2011-7674 2011-7675 10/21/2011 11/21/2011 10/21/2011 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7676 10/21/2011 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7677 10/21/2011 01/18/2012 FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OFM/ 2011-7678 10/21/2011 11/21/2011 2011-7679 10/21/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ CAROLINE CHU GOLDMAN SACHS ASSET MANAGEMENT PATTI CAIN CETERO RESEARCH, ST CHARLES, MO - EIRS 7/1/10, 11/22/10, 12/28/10, ETC HOSPIRA, ROCKY MOUNT, NC - 483S, WARNING LTRS SARAH CHACKO FEDERAL TIMES NUMBER OF PAYMENTS MADE TO CONTRACTORS, SMALL BUSINESSES FY 2010, FY 2011; AMOUNT PAID IN PENALTIES FOR LATE PAYMENTS FY 2010, FY 2011, ETC TOM MYERS AIDS HEALTHCARE FOUNDATION GILEAD SCIENCES INC - TRUVADA (TENOFOVIR/EMTRICITABINE) CORR, EVALUATIONS 1/1/10 TO 8/19/11 FDA/OMPT/CDRH/OCER/DFOI/ DAVID QUIGLEY THS INTERNATIONAL INC KENNETH FLAMM UNIV OF TEXAS LBJ SCHOOL OF PUBLIC AFFAIRS EPICOR MEDICAL ABLATION SYSTEMS, ULTRASOUND & ACCESSORIES - DVC APPL NMES - NDA APRVLS 1980 TO 2008 DIANA SCHILLING LITTLER MENDELSON INDIVIDUAL RECS ADAM T FUNK ESQ BRANCH LAW FIRM TAKEDA PHARMS NA - ACTOS (PIOGLITAZONE HCL) NDA 21-073 RECS Signature/ Requester YAIR TAYLOR DUKE UNIV DEPT OF ECONOMICS Subject PHARMACEUTICAL MFRS DATABASE 1990 TO PRESENT
Page 563 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/21/2011 2011-7680 10/21/2011 11/21/2011 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ 2011-7681 2011-7682 2011-7683 10/21/2011 11/21/2011 10/21/2011 11/21/2011 10/21/2011 01/06/2012 2011-7684 10/21/2011 11/21/2011 2011-7685 2011-7686 10/21/2011 11/21/2011 10/21/2011 11/21/2011 2011-7687 2011-7688 2011-7689 10/21/2011 11/21/2011 10/21/2011 11/21/2011 10/21/2011 11/21/2011 2011-7690 2011-7691 10/21/2011 11/21/2011 10/21/2011 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ACCESS BIOLOGICALS BARBARA DELADE CONVATEC GARY DORROUGH ARTHREX INC MARY KWON CHILDREN'S HOSPITAL OF WISCONSIN (MEDICAL COLLEGE OF WISCONSIN) PROPRANOLOL - AERS ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID QUIGLEY THS INTERNATIONAL INC INSIGHTEC LTD - EXABLATE ABLATION SYS, HIGH INTENSITY FOCUSED ULTRASOUND (HIFU) RECS PHYSICIAN'S PLASMA ALLIANCE LLC, GRAY, TN - EIR MOST RECENT UNOMEDICAL INC - MANUAL PULMONARY RESUSCITATOR RECALL Z-0039/0058-2010, Z-0070/0072-2010 HEALTH HAZARD EVALUATION (HHE) MW# 5021240 ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ Doe J SAPNA G LALMALANI ANDERSON RASOR & PARTNERS LLP WILLIAM J SKINNER MUSCATATUCK PUBLISHERS INC PATRICIA A MALONE COMMUNITY BLOOD CENTER SHIRLEY ROSS NEW LIFE GENERATION INC, INIDANAPOLIS, IN - EIR MOST RECENT PHILIPS HELATHCARE - AVALON FETAL MONITOR CMPLNTS, SAFETY ALERTS, RECALL RECS, ETC DKT 2011D-0376-0063 CBER/OCTMA/DDOM/ALFB/ BROWN, DENISE D LYE (NAOH) - PRODUCTION & CONSUMPTION RECS DTAP, HIB , MMR VACCINES - VAERS MOST RECENT Signature/ Requester CETERO RESEARCH INGRID DYOTT NEUBERGER BERMAN LLC BECKMAN COULTER INC, BREA, CA, MIAMI, FL, INDIANAPOLIS, IN, ETC - 483S 1/1/10 TO 10/19/11 Subject
ENTRY #96601934266, #96601931932, #96602169854 NOTICE OF FDA ACTION, REDELIVERY NOTICES, NOTICE ROANOKE TRADE SERVICES INC OF REFUSAL
Page 564 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-7692 2011-7693 2011-7694 2011-7695 10/21/2011 11/21/2011 10/21/2011 11/21/2011 10/21/2011 11/21/2011 10/21/2011 11/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/OCI/ ORA/OCI/ 2011-7696 2011-7697 2011-7698 2011-7699 2011-7700 2011-7701 2011-7702 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 2011-7703 10/24/2011 11/22/2011 2011-7704 10/24/2011 11/22/2011 2011-7705 10/24/2011 11/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS GARY DORROUGH ARTHREX INC MW#5021050 - RECS CLOSED FOIA REQUESTS 10-17-21/11 CLOSED FOI REQUESTS 10-11-14/11 CLOSED FOIA REQUESTS 10/3-7/11 CLOSED FOIA REQUESTS 10/3-7/11 CLOSED FOIA REQUESTS 10-11-14-11 CLOSED FOIA REQUESTS 10/17-21/11 FOI SERVICES INC CLOSED FOIA REQUESTS 10/10-14/11 FOI SERVICES INC CLOSED FOIA REQUESTS 10/3-7/11 CLOSED FOIA REQUESTS 10/17-21/11 Doe J ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID P QUIGLEY THS INTERNATIONAL INC DAVID QUIGLEY THS INTERNATIONAL INC MICHAEL DIAMOND ASBURY PARK PRESS INC INSIGHTEC LTD - EXABLATE ULTRASOUND HYPERTHERMIA CANCER TREATMENT APPL EPICOR MEDICAL - ABLATION SYSTEMS SURGICAL DVC FOR ABLATION OF CARIDAC TISSUE APPL MCNEIL CONSUMER HEALTHCARE, FORT WASHINGTON, PA - INVESTIGATION PHOTOGRAPHS 4/9-30/10 INDIVIDUAL RECS Signature/ Requester Subject
Page 565 of 1132

Total Records: 12455 Control # 2011-7706 2011-7707 2011-7708 2011-7709 2011-7710 2011-7711 Recd Date / Due Date 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7712 2011-7713 2011-7714 2011-7715 2011-7716 2011-7717 2011-7718 2011-7719 2011-7720 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 10/24/2011 11/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC GARY DORROUGH ARTHREX INC GARY DORROUGH ARTHREX INC MED WATCH 5021428 ALLIANCE FOR A HEALTHY TOMORROW - FOI REQUESTS 9/06 TO 9/11 ENVIRONMENTAL WORKING GROUP - FOI REQUESTS 9/06 TO 9/11 CAMPAIGN FOR SAFE COSMETICS - FOI REQUESTS 9/06 TO 9/11 SAFE COSMETICS ACTION NETWORK - FOI REQUESTS 9/06 TO 9/11 MW #2266280 BREAST CANCER FUND - FOI REQUESTS 9/06 TO 9/11 CLEAN WATER FUND - FOI REQUESTS 9/06 TO 9/11 COMMONWEAL - FOI REQUESTS 9/06 TO 9/11 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester GARY DORROUGH ARTHREX INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC RICHARD TELOFSKI KAHUNA INSTITUTE INC WOMEN'S VOICES OF THE EARTH - FOI REQUESTS, 9/06 T0 9/11 NATIONAL ENVIRONMENTAL TRUST - FOI REQUESTS 9/06 TO 9/11 NATIONAL BLACK ENVIRONMENTAL JUSTICE NETWORK FOI REQUESTS 9/06 TO 9/11 MASSACHUSETTS BREAST CANCER COALITION - FOI REQUESTS 9/06 TO 9/11 FRIENDS OF EARTH - FOI REQUESTS 9/006 TO 9/11 Subject MW#502379 - RECS
Page 566 of 1132

Total Records: 12455 Control # 2011-7721 Recd Date / Due Date 10/24/2011 11/22/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7722 2011-7723 10/24/2011 11/22/2011 10/24/2011 12/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7724 2011-7725 10/24/2011 11/22/2011 10/24/2011 11/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7726 10/24/2011 11/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7727 10/24/2011 11/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7728 2011-7729 10/24/2011 11/22/2011 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7730 10/25/2011 11/23/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ JOHN B HALLAGAN HALLAGAN, JOHN B US PATENT 2009/0246343AL - CORR 2010, 2011; COLOR ADDITIVES EXEMPT FROM CERTIFICATION - CORR 20092011 ORA/SE-FO/FLA-DO/FCB/ DAVIS, BRITTANY TOM LOPAC MICROMEDICS INC DMF #18074 - BIOCOMPATIBILITY TEST RESULTS SPINETRONICS - WARNING LTR, CMPLNTS HUNTER, CYNTHIA SANDOZ - BUPROPION STUDIES HUNTER, CYNTHIA SANDOZ - CHANTIX, ZYBAN, WELLBUTRIN (BUPROPION) AERS COFFEY BOMAR LLP FDA/OMPT/CDRH/OCER/DFOI/ SABINE BRAYETTE ANTHOGYR GLAXO SMITH KLINE - ARIXTRA RECS BEFORE 2007 BICON IMPLANT - K101849 TIMBLIN JS-0326, JEFF OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP SEROQUEL - AERS, CLNCL TESTS, APRVL RECS, ETC DKT FDA-2010-N-0637, FDA-2007-N-0475, ETC. Signature/ Requester MICHAEL T. DWYER AZAYA THERAPEUTICS INC Subject ORTHO BIOTECH - DOXORUBICIN HCL LIPOSOME NDA 50718
Page 567 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ 2011-7731 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7732 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-7733 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7734 10/25/2011 11/23/2011 2011-7735 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7736 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7737 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7738 10/25/2011 11/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7739 10/25/2011 FDA/OMPT/CDER/ORP/DIDP/ DREW BARLOW MPH HOVIONE LTD, CO CORK, IRELAND - QUALITY ASSURANCE BRIGGS Y40816, JAMES ROXANE LABORATORIES INC - ROXICODONE ADDITIONAL DOSAGE RECS CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC IDENTI PHARMS INC - FLUOCINOLONE ACETONIDE NDA 91-306 SBA CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC IDENTI PHARMS INC - FLUOCINOLONE ACETONIDE NDA 20-1759 SBA FDA/OMPT/CDRH/OCER/DFOI/ MIKE R TURNER NEAL GERBER & EISENBERG CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC MERGE HEALTHCARE INC - CEDARA WEBACCESS K092915; CEDARA SOFTWARE CORP - CEDARA ISOFTVIEW K022881 IDENTI PAHRMS INC - FLUOCINOLONE ACETONIDE NDA 20-1764 SBA MIHAELA MACNAIR VOISIN CONSULTING INDERAL (PROPRANOLOL HCL) NDA 16-418, NDA 19-536 APRVL RECS NANDAKUMARA D SARMA RPH PHD USP PHARMACOPEIA BETA-ALANINE - AERS 1/05 TO 9/11 FRANK GUTHART DERM/BURO INC ADAMIS PHARMS - EPINEPHRINE PREFILLED SINGLE DOSE SYRINGE CLOSE OUT LTR 2/15/11 Signature/ Requester Subject
Page 568 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/23/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7740 2011-7741 10/25/2011 11/23/2011 10/25/2011 11/23/2011 2011-7742 2011-7743 10/25/2011 11/23/2011 10/25/2011 11/23/2011 2011-7744 2011-7745 10/25/2011 11/23/2011 10/25/2011 11/23/2011 ORA/P-FO/LOS-DO/LACB/ ORA/ ORA/ ORA/SWFO/SWID/COMPLIANCE/ 2011-7746 2011-7747 2011-7748 2011-7749 10/25/2011 11/23/2011 10/25/2011 11/23/2011 10/25/2011 11/23/2011 10/25/2011 11/23/2011 2011-7750 2011-7751 10/25/2011 11/23/2011 10/25/2011 11/23/2011 ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/SJN-DO/SJCB/ OC/OM/OMP/DDM/ OM/OMP/DODM/ MACAPINLAC, MANUEL NANDAKUMARA SARMA U. S. PHARMACOPEIA SEAN PARK JOHNSON & JOHNSON McNEIL CONSUMER HEALTHCARE, LAS PIEDRAS, PR; FORT WASHINGTON, PA; JOHNSON & JOHNSON MERCK CONSUMER PHARMS, LANCASTER, PA - WARNING LTR, 483, EIR, CO RESP 1/09 TO PRESENT TEXTURED VEGETABLE PROTEIN - CAERS FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ PAPAZYAN, HELEN PROCEDURES FOR REINSTATING ELIGIBILITY OF DISQUALIFIED CLNCL INVESTIGATORS TO RECEIVE INVESTIGATIONAL ARTICLES DKT FDA-1995-S-0039 GLEN DDS, JEFFREY D ORA/CE-FO/DET-DO/DCB/ BRENDA M. GARTZ ELI LILLY & CO QMIX 2 IN 1 ENDODONTIC IRRIGATING SOLUTION K103244 STEMBANC INC, CHARDON, OH - 483 STERICYCLE, INDIANAPOLIS, IN - EIRS 1/07 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ JENNIFER POLLACK SAC CAPITAL ADVISORS LP JACQUELINE PRENDERGAST INSTITUTE FOR PEDIATRIC INNOVATION MEGAN B. HAEBLER BEVERIDGE & DIAMOND PC JONATHAN W. JOHNSON, LLC. JONATHAN W JOHNSON LLC MELISSA LIMA PERMA LABORATORIES LLC ADRIANA KING KING MIDAS HOLA - SWEET & SOUR FLAVORED SALTED PLUM ENTRY #175-1913267-8 LAB RESULTS HEALTH HAZARD EVALUATION BOARD HHE 7702 POWDER INFANT FORMULA DID NOT MEET ITS QUALITY STANDARDS (CERTIFIED) MAJEST DRUG INC - RELINE IT K101771 ALL CFSAN REQUESTS FROM 9/15/11 TO PRESENT MEDTRONIC - HEART LING MACHINE K070213 ZIMMER INC, WARSAW - 483 2011 Signature/ Requester VERTEX PHARMACEUTICALS INC Subject PROFILE (QAP)
2011-7752
10/25/2011
Page 569 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/23/2011 2011-7753 2011-7754 10/25/2011 11/23/2011 10/25/2011 11/23/2011 2011-7755 2011-7756 10/25/2011 11/23/2011 10/25/2011 11/23/2011 2011-7757 10/25/2011 11/23/2011 ORA/NE-FO/NWE-DO/NWECB/ ORA/OCI/ ORA/OCI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7758 2011-7759 2011-7760 2011-7761 2011-7762 10/25/2011 11/23/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7763 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ALLEN D NICKOL ACTELION CLINICAL RESEARCH INC REMICADE (INFLIXIMAB) BLA 103772/5032 - SUMMARY, ASSESSMENT FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ MOLIKEN, MURRAY ANDREW T TILLAPAUGH DICKIE MCCAMEY & CHILCOTE DONALD M KREKE DONALD M KREKE LAW OFCS HILLANDALE EGG - EGG RECALL, TRACEBACK INVESTIGATION TARO PHARMS - WARFARIN AERS 1/1/10-9/22/11 MITCHELL S. FUERST, Esq. FUERST ITTLEMAN PL JON M STEELE RUNFT & STEELE LAW OFC FLU VACCINE - VAERS 2011-6825 - DELETED RECS LLORENS PHARMS INT'L DIVISION - EIR FEI 3008468946 LUBERDA, DANIEL PURDUE PHARMA, HOWARD UDELL, MICHAEL FRIEDMAN, DR PAUL GOLDENHEIM - RECS; OXYCOTIN PROFITS 1995 TO 2010; OXYCOTIN DEATHS 1995 TO PRESENT, ETC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ABRAHAM PAYTON AMERICAN BRIDGE DAMON CORP - CMPLNTS, RPTS, INVESTIGATIONS 1990 TO 1994 ORA/CE-FO/BLT-DO/CB/ Action Office Signature/ Requester DuPREE 120528-L2111L, TONY ELENA HOWELL HOGAN LOVELLS US LLP MARK E. TRUESDELL BEVING SWANSON & FOREST PC NARRATIVE ANSWERS BY FDA TO THE DES MOINES REGISTER BEFORE 8/28/11 TISSUE REPAIR CO - EXCELLAGEN K110318 McCORMICK & CO INC, HUNT VALLEY, MD - 483, EIR 8/11 Subject
Page 570 of 1132

Total Records: 12455 Control # 2011-7764 Recd Date / Due Date 10/26/2011 11/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7765 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7766 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7767 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7768 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7769 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7770 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7771 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7772 10/26/2011 FDA/OMPT/CDER/ORP/DIDP/ PATRICK MORIARTY HUMAN GENOME SCIENCES - BENLYSTA AERS FOI SERVICES INC AMNEALL PHARMS - ACEBUTOLOL HCL CAPS ANDA 75047 SECTON VI CLNCL STUDIES JOHN A CLARK RISKBENEFITS LLC VANCOMYCIN - ISRS 4039208-6, 4378629-9, 437861-X JOHN A CLARK RISKBENEFITS LLC VANCOMYCIN - ISRS 3894531-0, 3894533-4, 3894600-5, ETC JOHN A CLARK RISKBENEFITS LLC METRONIDAZOLE - ISRS 3971290-4, 4224973-5, 4318039-3, ETC ALEN D NICKOL ACTELION CLINICAL RESEARCH INC REMICADE (INFLIXIMAB) BLA 103772/5301 - SUMMARY, ASSESSMENT ALLEN D NICKOL ACTELION CLINICAL RESEARCH INC REMICADE (INFLIXIMAB) BLA 103772/5145 - SUMMARY, ASSESSMENT ALLELN D NICKOL ACTELION CLINICAL RESEARCH INC REMICADE (INFLIXIMAB) BLA 103772/5016 - SUMMARY, ASSESSMENT Signature/ Requester ALLEN D NICKOL ACTELION CLINICAL RESEARCH INC Subject REMICADE (INFLIXMAB) BLA 103772/5113 - SUMMARY, ASSESSMENT
Page 571 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/25/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7773 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7774 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7775 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7776 10/26/2011 11/25/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7777 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7778 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ EMMANUEL GUTIERREZ SHIRE INC RISPERDAL (RISPERIDONE) NDA 20-272/S9036 - RECS RICHARD F LOWE VENTURE STRATEGIES INOVATIONS PIRAMAL HEALTHCARE UK LTD - MISOPROSTOL DISPERSION DMF #21188 RECS BILL OSMUNSON WASHINGTON ACTION FOR SAFE WATER FLUORIDATED WATER, PUBLIC WATER ADDITIVES INTENDED TO TREAT DISEASE - REGULATIONS, GMP, STANDARDS, ETC PATEL, MAHLAQA LYSODREN (MITOTANE) NDA 16-885 - SBA SHEA N SHAVER REILLY POZNER LLP ACTOS (PIOGLITAZONE) NDA 21-073 - RECS RICHTER, THEODORE J CIPRO XR (CIPROFLOXACIN) - NDA Signature/ Requester HEALTHCOR MANAGEMENT LP Subject
Page 572 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7779 10/26/2011 11/25/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ 2011-7780 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7781 2011-7782 2011-7783 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 2011-7784 2011-7785 2011-7786 2011-7787 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7788 2011-7789 10/26/2011 11/25/2011 10/26/2011 11/25/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BROOKS EGERTON DALLAS MORNING NEWS BROOKS EGERTON DALLAS MORNING NEWS DR PABLO S SANCHEZ, UT SOUTHWESTERN MEDICAL CENTER - INSP RECS 2008 DR KEVIN KLEIN, UT SOUTHWESTERN MEDICAL CENTER WARNING LTR RECS 2008; DR PAUL F WHITE, UT SOUTHWESTERN MEDICALCENTER - INSP RECS 2006 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J HILARY GRAY Reckitt Benckiser Pharmaceuticals ORLAAM (LEVOMETHADYL ACETATE HCL) , DKT 2007P0347, 2010P-0505 - WITHDRAWAL RECS, AERS FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/NJ-DO/NJCB/ SETH AUGENSTEIN STAR-LEDGER CYNTHIA LIPTON BIOZONE LABORATORIES INC CHRISTINE QUINTUS VETTER PHARMA-FERTIGUNG GMBH & CO JESSICA STENBERG PHILIPS ULTRASOUND INC ERIC K SCHWARTZ ESQ SULLIVAN PAPAIN BLOCK ET AL DERMARITE INDUSTRIES, PATERSON, NJ - MEDICAL DVCS ENFORCEMENT ACTION LTR LAST 2 MONTHS BIOZONE LABORATORIES INC, PITTSBURG, CA - EIR 4/2224,28/09 ABBOTT PHARMACEUTICALS (PR) LTD, DIAGNOSTICS INTL, BIOTECHNOLOGY LTD, VASCULAR INTERVENTION, BARCELONETA, PR - EIR 2011 SUPERSONIC IMAGINE - AIXPLORER ULTRASOUND SYS K091970 ALLERGAN - LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYS APRVL RECS (CERTIFIED) ORTHOFIX INC - MW5017722 KEALY S SEHIC JOHNSON TRENT WEST EL AL UNICHEM LABS LTD - LAMOTRIGINE ANDA 90-170 APRVL LTR, LBLG JED H HANSEN THORPE NORTH AND WESTERN SELECT MILK PRODUCERS INC - MOOTOPIA RECS Signature/ Requester Subject
Page 573 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DALDO/COMPLIANCE/ 2011-7790 2011-7791 2011-7792 2011-7793 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 10/26/2011 11/25/2011 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ 2011-7794 10/26/2011 11/25/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ 2011-7795 10/26/2011 11/25/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SWFO/SWID/COMPLIANCE/ 2011-7796 10/26/2011 11/25/2011 ORA/P-FO/LOS-DO/LACB/ WONDA SOMERVILLE AMERICAN RED CROSS SOUTHERN CALIFORNIA REGION OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KENDLE INTERNATIONAL INC DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS GLADYS B TONKIN FOI DAILY LOGS 9/26/30/11 FOI DAILY LOGS 9/26-30/11 BETTY BEHRENS REGAN ZAMBRI LONG FOI DAILY LOGS 9/19/23/11 AMERICAN RED CROSS, POMONA, CA 8/9/10-9/24/10; PASADENA, CA 2/9-15/11 - EIRS ADRIANNA KING KING MIDAS HOLA - SWEET & SOUR FLAVORED SALTED PLUM ENTRY #175-1913380-9 LAB RESULTS ADRIANNA KING KING MIDAS HOLA - PLUM WITH CHILI ENTRY #175-1913380-9 LAB RESULTS BROOKS EGERTON DALLAS MORNING NEWS BROOKS EGERTON DALLAS MORNING NEWS BROOKS EGERTON DALLAS MORNING NEWS ADRIANNA KING KING MIDAS DR PAUL F WHITE, UT SOUTHWESTERN MEDICAL CENTER - INSP RECS PRE-2006 DR KEVIN KLEIN, UT SOUTHWESTERN MEDICAL CENTER MEMO TO FILE DR PHILIP RASKIN, UT SOUTHWESTERN MEDICAL CENTER - INSP RECS 1984, 1998, 1999, 2010 HOLA - STRAWBERRY FLAVORED SALTED PLUM ENTRY #175-1913380-9 LAB RESULTS Signature/ Requester Subject
2011-7797 2011-7798 2011-7799
10/26/2011 11/25/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011
SIMPLYTHICK - RECALL INVESTIGATION RESULTS 5/11
2011-7800
10/27/2011
Page 574 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/28/2011 2011-7801 2011-7802 10/27/2011 11/28/2011 10/27/2011 11/28/2011 2011-7803 2011-7804 2011-7805 2011-7806 2011-7807 2011-7808 2011-7809 2011-7810 2011-7811 2011-7812 2011-7813 2011-7814 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 04/04/2012 10/27/2011 11/28/2011 2011-7815 10/27/2011 11/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORT, GLENNA KENNETH WITTENBERG ABBOTT MOLECULAR STEPHANIE MARTIN ST AUGUSTINE SURGERY CENTER NOEL SOUTHALL NATIONAL HUMAN GENOME RESEARCH INSTITUTE, BOSTWICK LABS - BLADDERUYSION, UROFISH APRVL 1/10 TO PRESENT MERIDIAN - AG MICRORUPTER V YAG LASER SERVICE, SUPPORT & TECHNICAL MANUALS HOFFMANN-LA ROCHE LTD - RO 24-7429 HIV INFECTION IND APPL FOI SERVICES INC FRAN KOCH INFORMATION ACCESS JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD0-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. K071786 - USER MANUAL 2011-6427 2011-5277 2011-2133 2011-2833 2011-5605 2011-7004 FOI DAILY LOGS 9/26-30/11 Signature/ Requester Center for Regulatory Services, Inc. CECELIA FRENCH CanReg, Inc. KEN RIED WASHINGTON INFORMATION SOURCE BARBARA JONES DOMINION GROUP INC FOI DAILY LOGS 9/19-23/11 FOI DAILY LOGS 9/19-23/11 FOI DAILY LOG 9/19-23/11 FOI DAILY LOG 9/26-30/11 Subject
Page 575 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7816 2011-7817 2011-7818 2011-7819 2011-7820 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 2011-7821 2011-7822 2011-7823 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ 2011-7824 10/27/2011 11/28/2011 2011-7825 10/27/2011 11/28/2011 2011-7826 10/27/2011 11/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7827 10/27/2011 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2010-8719 ERNESTO CRUZ III HIGHLINE CAPITAL MANAGEMENT VERTEX PHARMACEJUTICAL - INCIVEK (TELAPREVIR) AERS JOHN WALSH JAMES ALEXANDER CORP SUNOCO CHEMICAL, PHILADELPHIA, PA - EIRS, 483S, RECALL RECS, 10/08 TO PRESENT JOHN WALSH JAMES ALEXANDER CORP BRENNTAG NORTHEAST INC, READING, PA - EIRS, 483S, REALLL RECS 10/08 TO PRESENT KENDLE INTERNATIONAL INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS BARBARA JONES DOMINION GROUP INC JUAN RODRIQUEZ ROD INTERNATIONAL JOHN WALSH JAMES ALEXANDER CORP SOUTHWIND FOODS LLC (DBA GREAT AMERICAN SEAFOOD) - ENTRY #ROD-0014665-8 LAB RESULTS HONEYWELL CHEMICAL, PHILADELPHIA, PA - EIRS, 483S, RECALL RECS, 10/08 TO PRESENT FOI DAILY LOG 9/26-30/11 FOI DAILY LOG 9/19-23/11 FOI SERVICES INC FOI DAILY LOG 9/26-30/11 Signature/ Requester NATIONAL INSTITUTES OF HEALTH FRAN KOCH INFORMATION ACCESS GLADYS B TONKIN Center for Regulatory Services, Inc. FOI DAILY LOG 9/26-30/11 FOI DAILY LOG 9/19-23/11 FOI DAILY LOG 9/19-23/11 Subject
Page 576 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/28/2011 2011-7828 2011-7829 2011-7830 2011-7831 2011-7832 2011-7833 2011-7834 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 10/27/2011 11/28/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ 2011-7835 2011-7836 10/27/2011 11/28/2011 10/27/2011 11/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7837 10/27/2011 11/28/2011 2011-7838 10/27/2011 11/28/2011 2011-7839 10/27/2011 11/28/2011 2011-7840 10/27/2011 CTP/OD/ OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ KENNETH REID WASHINGTON INFORMATION SOURCE AMY FULTON BUCHANAN INGERSOLL & ROONEY PC AMY FULTON BUCHANAN INGERSOLL & ROONEY PC EGG A copy of any and all of the tobacco manufacturers and importers for which a user fee was ASSESSED during fiscal year starting DKT 1984N-0167 DKT & DKT LOGS OF 1984N-0167 FOI DAILY LOG 9/26-30/11 CECELIA FRENCH CanReg, Inc. COLEEN KLASMEIER SIDLEY AUSTIN LLP COR THERAPEUTICS INC, MILLENNIUM PHARMS, SCHERING-PLOUGH - INTEGRILIN NDA 20-718, PROMOTIONAL MATERIALS; CORR, CMPLNTS, ETC FOI DAILY LOG 10/19-23/11 Doe J Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. CMPLNT #119529 - BEFORE GRAIN 100% BUFFALO; CMPLNT #119530 - NATURE'S VARIETY INSTINCT LAMB INVESTIGATION RESULTS 2011-6372 2011-5848 2011-5770 2011-5033 2011-1544 2011-934 Subject
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Total Records: 12455 Control # Recd Date / Due Date 11/28/2011 2011-7841 10/27/2011 11/28/2011 2011-7842 10/28/2011 11/29/2011 2011-7843 2011-7844 2011-7845 2011-7846 2011-7847 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7848 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7849 2011-7850 10/28/2011 11/29/2011 10/28/2011 12/29/2011 2011-7851 2011-7852 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ TAYLOR, MATTHEW ENN-LING CHEN HEART IMAGING TECHNOLOGIES LLC ANDI POULSON LEXISNEXIS COURTLINK INC LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP ALR TECHNOLOGIES - HEALTH-E-CONNECT SYS K102063 MERGE OEM (MERGE HEALTHCARE), MISSISSAUGA, ONTARIO, CANADA - K092915 2011-6835 2011-483 ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC PEGASYS (PEGINTERFERON ALFA-2A) - AERS 5/23/10, 10/17/10 Doe J ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC VICTRLIS (BOCEPREVIR) - AERS 5/13/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office CTP/OD/ OC/OM/OFM/ CTP/OD/ CTP/OD/ OC/OM/OFM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MONICA KING KIMBERLY-CLARK HEALTHCARE MONICA KING KIMBERLY-CLARK HEALTHCARE MONICA KING KIMBERLY-CLARK HEALTHCARE BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST K012521 INDIVIDUAL RECS BD DIRECTIGEN FLUA+B - K001364 WELLCOGEN BACTERIAL ANTIGEN KIT - K854852 MINICA KING KIMBERLY-CLARK HEALTHCARE QUICKVIEW INFLUENZA A+B TEST - K031899 EGG FOI SERVICES INC A copy of any and all of the tobacco manufacturers and importers for which a user fee was RECEIVED during fiscal year starting October 1, 2010. Our control number is 5246088.; Signature/ Requester FOI SERVICES INC Subject October 1, 2010. Our control number is 5246087.;
Page 578 of 1132

Total Records: 12455 Control # 2011-7853 2011-7854 2011-7855 Recd Date / Due Date 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7856 2011-7857 2011-7858 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 2011-7859 10/28/2011 11/29/2011 2011-7860 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7861 10/28/2011 11/29/2011 2011-7862 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7863 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-7138 - REQUEST LTR FDA/OMPT/CDRH/OCER/DFOI/ ENN-LING CHEN HEART IMAGING TECHNOLOGIES LLC SHAUNAK DEEPAK JEFFERIES & CO SANQUIN (SANQUIN BLOOD SUPPLY FOUNDATION) CINRYZE (C1 ESTERASE) INHIBITOR HUMAN 483 CLIENT OUTLOOK INC - EUNITY K111164 CORR SHANNON 290938, DANIEL FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KUMAR, SWATI AUSTIN NELSON RBC CAPITAL MARKETS ENN-LING CHEN HEART IMAGING TECHNOLOGIES LLC ENN-LING CHEN HEART IMAGING TECHNOLOGIES LLC BELLADONNA, DONNATOL - LBLG WEBPAX - APPLICATIONS LISTING K051325 AS PREDICATE DEVICE, 5/9/05 TO PRESENT VITAL IMAGES INC, MINNETONKA, MN - K111892 CORR HOSPIRA, AUSTIN, TX - 483 4/4-27/11 HOSPIRA PHARMA, AUSTIN, TX - 483, 4/11 Signature/ Requester ANDI POULSON LEXISNEXIS COURTLINK INC ANDI POULSON LEXISNEXIS COURTLINK INC DEREK FRANSEEN BEELER WALSH & WALSH PLLC OCTAPHARMA - OCTAGAM RPTS 2011-6982 Subject 2011-6984
Page 579 of 1132

Total Records: 12455 Control # 2011-7864 2011-7865 2011-7866 2011-7867 2011-7868 2011-7869 Recd Date / Due Date 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7870 2011-7871 2011-7872 2011-7873 2011-7874 2011-7875 2011-7876 2011-7877 2011-7878 2011-7879 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ FDA/OF/CFSAN/OCD/EOS/ MAHANAZ GOLSHAN AGAHAN AYANDEYE PARS INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. BTENDA M GARTZ ELI LILLY & CO JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MAHANAZ GOLSHAN AGAHAN AYANDEYE PARS INC CATHERINE CHAPPUIS ARROW INTERNATIONAL INC JOAN STITT (UG2CD-16) MAQUET - CARDIOSAVE HYBRID INTRA-AORTIC BALLON PUMP K112372 2011-7252 - REQUEST LTR LIST OF GENERALLY REGARDED AS SAFE INGREDIENTS 2011-7246 - REQUEST LTR 2011-7242 - REQUEST LTR 2011-7241 - REQUEST LTR ASH STEVENS INC, DETROIT, MI - EIR, 1/9/09 2011-7237 - REQUEST LTR 2011-7175 - REQUEST LTR DIETARY SUPPLEMENT PRODS - GRAS LIST Doe J ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. REBECCA MACIEL FoodScience Corporation JENNIFER LANZ WIRB REBECCA MACIEL FoodScience Corporation JORGE A CASTANOS OHIO MEDICAL CORPORATION VENUS PHARMACEUTICALS INC, HAUPPAUGE, NY - EIR 9/6/11 OHIO MEIDCAL CORP, GURNEE, IL - EIRS 4/28/10 TO 6/14/10, 5/11/11 TO 6/9/11 LEVAQUIN - PSEUDOTUMOR CEREBRI RPTS, RESEARCH RESULTS, CORR FREDERICK A MOORE - EIR, 483, CORR, ETC 4/4/09 GEMINI PHARMACEUTICALS INC, COMMACK, NY - EIR 5/11 Subject 2011-7143 - REQUEST LTR
Page 580 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/29/2011 2011-7880 2011-7881 10/28/2011 11/29/2011 10/28/2011 11/29/2011 2011-7882 2011-7883 10/28/2011 11/29/2011 10/28/2011 03/15/2012 CVM/OCD/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ 2011-7884 2011-7885 2011-7886 10/28/2011 11/29/2011 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ 2011-7887 2011-7888 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7889 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-7398 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. DON J MIZERK HUSCH BLACKWELL LLP RLD:KEPPRA XR, - MUTUAL, NDA 09-1285; LUPIN LTD, NDA 09-1399; WATSON LABVS INC, NDA 09-1093 ETC 2011-7339 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. LYDIA A KRAUSE CRAIG GOLDENFARB PA ZOLL MEDICAL CORP, CHELMSFORD, MA - EIRS, MEMOS, WARNING LTRS, ETC 1/08 TO PRESENT 2011-7323 - REQUEST LTR 2011-7298 - REQUEST LTR FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. DAN LITVIN GARWIN GERSTEIN & FISHER LLP CATHERINE CHAPPUIS TELEFLEX MEDICAL JOHN H DONBOLI DEL MAR LAW GROUP LLP NUTRO CO - DOG FOOD PRODS CORR, COMM, ETC MAQUET - SENSATION PLUS K112327 DKT 2007D-0369 - BIOEQV RECS, COMMENTS 2011-7282 - REQUEST LTR Subject
Page 581 of 1132

Total Records: 12455 Control # 2011-7890 2011-7891 Recd Date / Due Date 10/28/2011 11/29/2011 10/28/2011 11/29/2011 2011-7892 10/28/2011 11/29/2011 2011-7893 10/28/2011 11/29/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7894 2011-7895 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7896 2011-7897 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7898 2011-7899 10/28/2011 11/29/2011 10/28/2011 11/29/2011 2011-7900 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ JOAN STITT (UG2CD-16) MERCK & CO., INC. DAN LITVIN GARWIN GERSTEIN & FISHER LLP DAN LITVIN GARWIN GERSTEIN & FISHER ASTELLAS PHARMA US INC - DKT FDA-2007-P-011, PROGRAF ANTITRUST LITIGATION, RECS SANDOZ INC - TACROLIMUS ANDA 65-461 RVW, APRVL RECS 2011-7491 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. DAN LITVIN GARWIN GERSTEIN & FISHER LLP ACCORD HEALTHCARE LTD - TACROLIMUS ANDA 91-195, RVW APRVL RECS 2011-7437 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. DAN LITVIN GARWIN GERSTEIN & FISHER LLP WATSON PHARMACEUTICALS INC - TACROLIMUS, ANDA 09-402 RVW, APRVL RECS 2011-7426 - REQUEST LTR Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC MARLENA HARBASZEWSKA AVALON RISK MANAGEMENT INC DAN LITVIN GARWIN GERSTEIN & FISHER LLP MYLAN INC - TACROLIMUS, ANDA 09-596 RVW, APRVL RECS ENTRY #316-20026240 - NOTICE OF FDA ACTION #1 ENTRY #84-00719835 - NOTICE OF FDA ACTION #1 RECS Subject 2011-7404 - REQUEST LTR
Page 582 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7901 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-7902 2011-7903 10/28/2011 11/29/2011 10/28/2011 11/29/2011 2011-7904 2011-7905 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7906 10/28/2011 11/29/2011 CTP/OD/ CTP/OD/ EGG FOI SERVICES INC List of all available Tobacco Establishment or Registrants notice of discontinuation for the commercial distribution of a tobacco product included in any registrants list filed under 905(i)(1) or 905(i)(3)(A) from 12/31/2009 to Current. Our control number is 5246089.; JOHNA D LUCAS - INSP RECS SEROPHENE (CLOMIPHENE CITRATE) NDA 18-361 - RECS JAYARAM, PRASHANTH FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC J. Hogan FOI SERVICES INC OM/OMP/DODM/ ALEX TRAHEY ANALYSIS GROUP 1992 ADVISORY COMMITTEE PANEL MTG REGARDING HEART PROBLEMS WITH THE NICOTENE PATCH ULTREPET LLC - POST CONSUMER RECYCLED POLYETHYLENE TEREPHTHALATE (PCT PET) NON OBJECTION LTR 48 6/6/97 Copy of the response to FOIA log #2011-911 (OXYCOTCIN NDA 18-261/S023 - PI); INCIVEK (TELAPREVIR) - AERS 5/23/11 TO PRESENT DAN LITVIN GARWIN GERSTEIN & FISHER LLP DR REDDY'S LABORATORIES LTD - TACROLIMUS ANDA 90-509 RVW, APRVL RECS Signature/ Requester LLP Subject
2011-7907 2011-7908
10/28/2011 11/29/2011 10/28/2011 11/29/2011
CARINA WALZ VERIFICATIONS INC SHEA N. SHAVER REILLY POZNER LLP
2011-7909
10/28/2011 11/29/2011
ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ ORA/ ORA/ Doe J ZIELEN, KAREN E
CMPLNT 121351
2011-7910
10/28/2011 11/29/2011
CONAGRA FOODS - KIDS CUISINE CHICKEN NUGGETS INVESTIGATION 9/12-10/15/11
Page 583 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/BLT-DO/CB/ 2011-7911 10/28/2011 11/29/2011 2011-7912 10/28/2011 11/29/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OC/COS/OL/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7913 10/28/2011 11/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ 2011-7914 10/28/2011 11/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7915 2011-7916 10/28/2011 11/29/2011 10/28/2011 11/29/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7917 10/28/2011 11/29/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ LORI E. ANDRUS ANDRUS ANDERSON LLP CORN REFINERS ASSN - CITIZENS PETITION CORR REGARDING THE USE OF THE TERM CORN SUGAR JON M. STEELE RUNFT & STEELE LAW OFC SHELDON T. BRADSHAW HUNTON & WILLIAMS LLP IDENTI PHARMS INC - FLUOCINOLONE ACETONIDE DROPS ANDA 91-306; FLUOCINOLONE ACETONIDE TOPICAL OIL ANDA 20-1759; ANDA 20-1764 APRVL LTR, LBLG 2011-6825 - DELETED RECS CANDICE BRAVARD MCINTOSH LAW FIRM PC SUNOVION PHARMS INC - LUNESTA DEAR DOCTOR LTRS 2007 TO 2008 CERTIFIED LINDA TURLEY TURLEY LAW FIRM ALIGN TECHNOLOGY INC - INVISALIGN SYS MDRS, CMPNTS, WARNING LTRS, CORR ORA/P-FO/LOS-DO/LACB/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC SARAH N. WESTCOT BURSOR & FISHER PA MARC ULLMAN ESQ, METAGENICS INC - RESP TO 8/17/04 LTR GLOBE ALL WELLNESS LLC, HOLLYWOOD, FL SLIMXTREME HERBAL SLIMMING CAPS CLAIMS, CORR, ANALYSIS Signature/ Requester Subject
Page 584 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OES/ OC/COS/OL/ OC/OCC/ 2011-7918 10/28/2011 11/29/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ 2011-7919 10/28/2011 11/29/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-7920 2011-7921 2011-7922 10/31/2011 02/10/2012 10/31/2011 11/30/2011 10/31/2011 01/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ 2011-7923 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-7924 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BRENDA M GANTZ ELI LILLY & CO ACS DOBFAR SPA, TRIBIANO, ITALY - EIR 5/10-13/10 BRENDA M GARTZ ELI LILLY & CO CATALENT PHARMA SOLUTIONS, BRUSSELS, BELGIUM 483 6/11 ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ BRENDA M GARTA ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO OSO BIOPHARMACEUTICALS, ALBUQUERQUE, NM - EIR 3/20/10 OSO BIOPHARMACEUTICALS, ALBUQUERQUE, NM - EIR 8/8-12/11, ETC CATALENT PHARMA SOLUTIONS, BRUSSELS, BELGIUM EIR 6/11 NAWAB QIZILBASH OXON EPIDEMIOLOGY LTD DRUGS - FIRST LABELS 2001 TO 2010 CROMBIE, KRISTY A INDIVIDUAL RECS Signature/ Requester Subject
Page 585 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7925 2011-7926 2011-7927 2011-7928 2011-7929 2011-7930 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 2011-7931 10/31/2011 11/30/2011 2011-7932 10/31/2011 11/30/2011 2011-7933 10/31/2011 11/30/2011 2011-7934 2011-7935 10/31/2011 11/30/2011 10/31/2011 11/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-7936 10/31/2011 11/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 10/10-14/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ SHSERRY LL SINGER SHERRY L SINGER ATTORNEY AT LAW VICENTE GARCIA GAMMA SEAFOOD CORP FRAN KOCH INFORMATION ACCESS MY IMPORT USA INC, EDISON, NJ - ENTRY 212-00334353 NOTICE OF DETENTION & NOTICE OF REFUSAL OF ADMISSION 4/24/10, 7/28/10 FROZEN YELLOW FIN TUNA LOIN - ENTRY RC9-0020345-1 LAB RESULTS FOI DAILY LOGS 10/3-7/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/BLT-DO/CB/ JOHN J GRIFFIN CARDIOVASCULAR ASSOCIATES LTD NANITA CRANFORD NEUROGESX INC JOHN J GRIFFIN MD, CARDOVASCULAR ASSOCIATES LTD, VIRGINA BEACH, VA - EIR 7/15/10 CHARLES RIVER, HORSHAM, PA - EIR, 483, WARNING LTRS, ETC 1/06 TO PRESENT ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO JEREMY S HYNDMAN K&L GATES HENTGES DAIRY, ADDY, WA - CORR, INSPS, LAB ANALYSIS, ETC COVANCE LABORATORIES INC (BIOANALYTICAL SERVICES), PORTSMOUTH, NH - EIR 4/12-16/10 COVANCE LABORATORIES INC (BIOANALYTICAL SERVICES), PORTSMOUTH, NH - EIR 8/2-6/10 ALKERMES, WILMINGTON, OH - 483 8/11 LONZA, PORTSMOUTH, NH - EIR 4/11 NYPRO, CLINTON, MA - EIR 7/11 Signature/ Requester Subject
Page 586 of 1132

Total Records: 12455 Control # 2011-7937 2011-7938 Recd Date / Due Date 10/31/2011 11/30/2011 10/31/2011 11/30/2011 2011-7939 10/31/2011 11/30/2011 2011-7940 2011-7941 2011-7942 2011-7943 2011-7944 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 12/29/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 2011-7945 10/31/2011 11/30/2011 2011-7946 2011-7947 2011-7948 2011-7949 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 2011-7950 10/31/2011 11/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MUSGROVE R7811, CARL CHERYL VAN LEER AMERICAN RED CROSS PENNJERSEY REGION JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ RIVA, CATHERINE CECELIA FRENCH CanReg, Inc. DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS KEN REID WASHINGTON INFORMATION SOURCE WILLIAM A OLSON PHD Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC ALCOHOL & TOBACCO PRODS - REGULATORY RECS, RESEARCH, STATISTICS, ETC AMERICAN RED CROSS PENN-JERSEY REGION, PHILADELPHIA, PA - EIRS 1/25-26/05, 2/15/05, 2/23/05 FOI DAILY LOG 10/10-14/11 FOI DAILY LOG 10/10-14/11 FOI DAILY LOG 10/10-14/11 FOI DAILY LOG 10./10-14/11 Signature/ Requester CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS KEN REID WASHINGTON INFORMATION SOURCE WILLIAM A OLSON PHD Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC MERCK - GARDASIL PHASE 2 MTG MINS, CORR, PROD DEVELOPMENT, ETC FOI DAILY LOG 10/10-14/11 FOI DAILY LOG 10/3-7/11 FOI DAILY LOG 10/3-7/11 FOI DAILY LOG 10/3-7/11 FOI DAILY LOG 10/3-7/11 Subject FOI DAILY LOG 10/3-7/11
LIST OF DRUG FIRM CURRENT REGISTRATION STATUS, FIRMS NOW OUT OF BUSINESS FY1999 TO PRESENT
Page 587 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7951 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7952 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7953 10/31/2011 02/23/2012 2011-7954 2011-7955 10/31/2011 11/30/2011 10/31/2011 11/30/2011 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7956 2011-7957 2011-7958 2011-7959 2011-7960 2011-7961 2011-7962 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ VOLKOVAITE, JUDITA BRENDA M. GARTZ ELI LILLY & CO ALEXANDRA STONE UNIV OF TEXAS LBJ SCHOOL OF PUBLIC AFFAIRS NDA 21-436, NDA 21-660, NDA 20-941, ETC PER ORANGE BOOK - VALID & EXPIRED PATENTS ALKERMES, WILMINGTON, OH - EIR 8/11 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO JOHN M KIRKWOOD MD , PITTSBURGH, PA - EIR 4/09 TO 5/10 BAXTER PHARMS SOLUTIONS LLC, BLOOMINGTON, IN EIR 3/10 LEAD IN COSMETIC PRODS - CAERS HOLLISTER STIER, SPOKANE, WA - EIR 5/09 HOLLISTER STIER, SPOKANE, WA - EIR 5/10 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ANNA T FLOOD Keller and Heckman LLP ANEET PANESAR BURDOCK GROUP DOUG HEIKEN Oregon Wild YEW TREES - EA 2006 TO 2011 LUBRIZOL CORP - FCN 148; MIZUSAWA INDUSTRIAL CHEMICALS LTD - FCN 177; ASAHI DENKA KOGYO KK FCN 204, ETC BENZALKONIUM CHLORIDE, METHYLPARABEN - GRAS MARILYN OPARAUGO Banner Pharmacaps Inc. OXASORALEN ULTRA CAPS NDA 19-600 - SBA, APRVL LTR, RVWS MICHAEL L RICH PORZIO BROMBERG & NEWMAN PC IDENTI PHARMACEUTICALS INC - FLUOCINOLONE ACETONIDE ANDA 91-306, ANDA 20-1759, ANDA 20-1764 Signature/ Requester Subject
Page 588 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-7963 10/31/2011 11/30/2011 2011-7964 2011-7965 10/31/2011 11/30/2011 10/31/2011 11/30/2011 FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7966 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7967 2011-7968 2011-7969 2011-7970 2011-7971 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7972 2011-7973 2011-7974 2011-7975 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ KENDLE INTERNATIONAL INC BRENDA M. GARTZ HOSPIRA, MCPHERSON, KS - EIR 5/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ KENDLE INTERNATIONAL INC BRENDA M. GARTZ ELI LILLY & CO FOI DAILY LOG 10/3-7/11 BEAM ONE, SAN DIEGO, CA - EIR 5/11 FOI DAILY LOG 10/10-14/11 FOI SERVICES INC BRENDA M. GARTZ ELI LILLY & CO ORION CORP, ESPOO, FINLAND - EIR 9/10 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ FOI SERVICES INC BRENDA M. GARTZ ELI LILLY & CO BAXTER PHARMACEUTICAL SOLUTIONS, BLOOMINGTON, IN - EIR 7/11 FOI DAILY LOG 10/3-7/11 ORA/CE-FO/DET-DO/DCB/ BRENDA M. GARTZ ELI LILLY & CO BAXTER PHARMACEUTICAL SOLUTIONS, BLOOMINGTON, IN - EIR 3/11 FOI DAILY LOG 10/10-14/11 JENNIFER SMITH BIOPHARM INSIGHT PROTALIX - CMC ANALYSIS, CORR, CO RESP, ETC CARPENTER, MURRAY ABAIGAIL MOSS BIOPHARM INSIGHT FDA/OF/CFSAN/OCD/EOS/ DAVID PAVLICH DEFOAMER INDUSTRY TRADE ASSN MAZER CHEMICAL CO - FAP BEFORE 1990; FOOD ADDITIVES CORR 1950 TO 1996 PEPSICO, COCA COLA CO, INTERNATIONAL LIFE SCIENCES INSTITUTE - CAFFEINE CORR 1/77 TO 12/81 UCB - BRIVARACETAM IND NUMBER Signature/ Requester Subject
Page 589 of 1132

Total Records: 12455 Control # Recd Date / Due Date 11/30/2011 2011-7976 2011-7977 10/31/2011 11/30/2011 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7978 2011-7979 10/31/2011 11/30/2011 10/31/2011 11/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7980 2011-7981 2011-7982 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7983 10/31/2011 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7984 2011-7985 2011-7986 2011-7987 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 10/31/2011 11/30/2011 ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO HOLLISTER STIER, SPOKANE, WA - EIR, 6/10 BOEHRINGER INGELHEIM PHARMACEUTICALS INC, DANBURY, CT - EIR 9/10 HOLLISTER STIER, SPOKANE, WA - EIR 10/10 WIL RESEARCH LABS, ASHLAND, OH - EIR 10/09 BRENDA M. GARTZ ELI LILLY & CO VETTER, RAVENSBURG, GERMANY - EIR 1/10 ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO VETTER, RAVENSBURG, GERMANY - EIR 9/08 PATHEON PHARMS, CINCINNATI, OH - EIR 3/10 PATHEON PHARMS, CINCINNATI, OH - EIR 2/22/11-3/24/11 LARRY BIEGLESEN WELLS FARGO SECURITIES BRENDA M. GARTZ ELI LILLY & CO PATHEON, MONZA, ITALY - EIR 6/11 ZIMMER HOLDINGS INC - 483 7/1/11-9/30/11 ORA/SW-FO/KAN-DO/COMP/ Action Office Signature/ Requester ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRENDA M. GARTZ ELI LILLY & CO BRECON PHARMS, HEREFORD, UK - EIR 2/11 HOPIRA, MCPHERSON, KS - EIR 5/11 Subject
Page 590 of 1132

Total Records: 12455 Control # 2011-7988 2011-7989 Recd Date / Due Date 10/31/2011 11/30/2011 10/31/2011 11/30/2011 2011-7990 2011-7991 2011-7992 2011-7993 11/01/2011 12/01/2011 11/01/2011 12/01/2011 11/01/2011 12/01/2011 11/01/2011 12/01/2011 2011-7994 2011-7995 11/01/2011 12/01/2011 11/01/2011 12/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7996 11/01/2011 12/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7997 11/01/2011 12/01/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-7998 11/01/2011 12/01/2011 2011-7999 2011-8000 11/01/2011 12/01/2011 11/01/2011 OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ GOLDMAN, ROBERT M ORA/CE-FO/CIN-DO/CCB/ MARLENE L CHURCH PALM BEACH RESEARCH CENTER RAPID MEDICAL RESEARCH INC, CLEVELAND, OH AUDITS, RESP 1/24/11, 5/4/10, 5/18/10 INTEGRA LIFESCIENCES, PLAINSBORO, NJ - 483 1/1/1110/31/11 INTERNATIONAL LIFE SCIENCES INSTITUTE - LISTING OF ANNE CROSSLEY RECKITT BENCKISER HEALTHCARE (UK) LTD ADVIL LIQUI-GEL CAPS - AERS LAST TEN YRS CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC IDENTI PHARMS INC - FLUOCINOLONE ACETONIDE ANDA 30-1759, ANDA 20-1764, ANDA 91-306 SBA PATEL, MAHLAQA FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ SALLY HERRICK RAC KIMBERY-CLARK HEALTH CARE LYSODREN (MITOTANE) NDA 16-885 - SBA DURA BLUE STERILIZATION WRAP - K1122II OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ SCHNEIDMAN, RALPH THOMAS D HAUETER ORTHO DEVELOPMENT CORP AESCULAP - MODIFICATION TO S4 K060152 SCHROER CAPITAL, L.P. WILIAM A OLSON PHD Center for Regulatory Services, Inc. JOHNSON & JOHNSON - K930618 2011-6774 REQUEST & RESP LTR Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ SMITH, KIMBERLY MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION ZIMMER HOLDINGS INC, WARRSAW, IN - 483 DKT FDA-1995-S-0039 Signature/ Requester Subject 2011-7378
Page 591 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/01/2011 2011-8001 11/01/2011 12/01/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8002 11/01/2011 12/01/2011 2011-8003 11/01/2011 12/01/2011 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OL/ OM/OMP/DODM/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8004 11/01/2011 12/01/2011 2011-8005 11/01/2011 12/01/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8006 2011-8007 2011-8008 11/02/2011 12/02/2011 11/02/2011 12/02/2011 11/02/2011 OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO INC - ROTATEQ (ROTAIVRUS VACCINE) VAERS 10/1-31/11 CLOSED FOIA REQUESTS 10/1-31/11 MERCK & CO INC - GARDASIL VAERS 10/1-31/11 MITCHELL S FUERST FUERST HUMPHREY ITTLEMAN PL JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL SUPREME MANUFACTURING COMPANY INC ADMINISTRATIVE & CIVIL ENFORCEMENT ACTIONS, 483S, 482S, ETC 7/14/11 PROFESSIONAL DISPOSABLE INTERNATIONAL PRODS AERS 1/09 TO PRESENT B KRISTIAN W RASMUSSEN CORY WATSON ET AL CHANTIX (VARENICLINE) - AERS, SAFETY ANNOUNCEMENT, EPIDEMIOLOGICAL STUDIES 10/24/11 DOWDON, RICHARD D TRADER JOE'S - DARWINS BRAND SOY PROTEIN POWDER CMPLNT Signature/ Requester KAPLAN, SHEILA LIAM J MONTGOMERY WILLIAMS & CONNOLLY LLP Subject TRAVEL, HOTEL ESPENSES 10/1/06 TO 10/1/11 RAPTIVA (EFALIZUMAB) - RPTS, TELEPHONE CALLS, VOICE RECORDINGS, ETC 1/9 TO PRESENT
Page 592 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/02/2011 2011-8009 2011-8010 11/02/2011 12/02/2011 11/02/2011 12/02/2011 2011-8011 11/02/2011 12/02/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8012 11/02/2011 12/02/2011 2011-8013 11/02/2011 12/02/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8014 11/02/2011 12/02/2011 2011-8015 2011-8016 2011-8017 11/02/2011 12/02/2011 11/02/2011 12/02/2011 11/02/2011 12/02/2011 2011-8018 11/02/2011 12/02/2011 2011-8019 2011-8020 2011-8021 11/02/2011 12/02/2011 11/02/2011 12/02/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER SHARKEY PRECISE LIGHT SURGICAL JENNIFER SHARKEY PRECISE LIGHT SURGICAL THOMAS SAMUELSON ISRS 5110839, 5155927, 5207867 ALLMED SYS INC - REVOLIX & REVOLIX JR LASER SYS K051167 ALLMED SYS INC - REVOLIX 120 LASER SYS, K070476 JENNIFER SHARKEY PRECISE LIGHT SURGICAL ALLMED SYSTEMS INC - REVOLIX LASER SHYS K033423 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER SHARKEY PRECISE LIGHT SURGICAL JENNIFER SHARKEY PRECISE LIGHT SURGICAL JENNIFER SHARKEY PRECISE LIGHT SURGICAL JENNIFER SHARKEY PRECISE LIGHT SURGICAL LUMENIS - VERSAPULSE POWER SUITE K011703 BIOLITEC - CERALAS 1950 DIODE (50W) K072682 RAND, ROGER FDA/OMPT/CDRH/OCER/DFOI/ GARY SYRING QUALITY & REGULATORY ASSOCS LLC K003017 & K010672 - CLEARANCE TO MARKET NOTIFICATIONS BAUERFEIND AG - VENOTRAIN CURAFLOW K111662; BSNJOBST INC - JOBST TRAVEL SOCKS K032325; JOBST A BEIERSDORF CO - MEDICAL SUPPORT STOCKINGS K951234 QUANTA - POLYSURG 1950 K083613 PERFORMANCE TESTING SECTIONS: BENCH, ANIMAL, CLNCL TO ALL THE REST OF THE PRECISE LIGHT SURGICAL REQUESTS TRIMEDYNE - OMNIPULSE/OMNIPULSE-MAX K962632 CHRISTINA GULDBERG BRIDGE BIORESEARCH BUPIVACAINE HCL NDA 16-964 - CLNCL RVWS, CLNCL PHARMACOLOGY RVWS, CMC, RVWS, ETC Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. TYLER KENYON NORTHCOAST RESEARCH ZIMMER HOLDINGS, WARSAW, IN - 483, CO RESP MOST RECENT FOI DAILY LOG 10/24-28/11 Subject
Page 593 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/02/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8022 11/02/2011 12/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8023 11/02/2011 12/02/2011 2011-8024 11/02/2011 12/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8025 11/02/2011 12/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8026 11/02/2011 12/02/2011 2011-8027 11/02/2011 12/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8028 2011-8029 11/02/2011 12/02/2011 11/02/2011 12/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8030 11/02/2011 OM/OSS/OPILS/DFI/ MICHAEL A TRUNK 2011-911 - OXYTOCIN NDA 18-261/S023 PI (CERTIFIED) CURRY, MARY L OM/OMP/DODM/ DOUGLAS FLINT RECKITT BENCKISER INC ADRIANI J ABSORPTION & SYSTEMIC TOXICITY OF ANESTHETICS GENERAL PRACTITIONER RISPERIDONE - AER ORA/CE-FO/BLT-DO/CB/ LEE A PEIFER SUTHERLAND ASBILL & BRENNAN SHIRLEY ROSS ROANOKE TRADE SERVICES INC BELL-MORE LABS, HAMPSTEAD, MD - EIRS, 483S, CO RESP, ETC 3/10, 4/10, 1/11 WASHINGTON INTERNATIONAL INSURANCE - NOTICES OF ACTION REDELIVERY NOTICES & NOTICES OF REFUSAL AMY WEST RAYNES MCCARTY LOVENOX - ISR 3176520, 3194053, 3389356, ETC FDA/OMPT/CDRH/OCER/DFOI/ TIMOTHY S ADKINS ALCON RESEARCH LTD A LUKE SMITH FARUQI & FARUQI LLP ADVANCED MEDICAL OPTICS INC - SENSAR SOFT ACRYLIC UV LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSE (IOL) P980040 HOSPIRA - TAXOTERE NDA 02-2234 SBA JOJENE E MILLS JOJENE MILLS PC CARONDELET ST JOSEPH'S HOSPITAL - METHOTREXATE AERS 3/09 TO PRESENT Signature/ Requester ANALYSIS GROUP Subject
Page 594 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/02/2011 2011-8031 11/02/2011 12/02/2011 Action Office OM/OSS/OPILS/DFI/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8032 2011-8033 11/02/2011 12/02/2011 11/02/2011 12/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8034 11/02/2011 12/02/2011 2011-8035 11/02/2011 12/02/2011 ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8036 11/02/2011 12/02/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8037 11/02/2011 12/20/2011 2011-8038 2011-8039 11/02/2011 12/02/2011 11/02/2011 03/22/2012 2011-8040 2011-8041 11/02/2011 12/02/2011 11/02/2011 FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ VICENTE GARCIA GAMMA SEAFOOD CORP PATTY ANN TRANTHAM FROZEN MAHI FILLET ENTRY #RC9-0020345-1 - LAB RESULTS MCNEIL CONSUMER HEALTHCARE - MOTRIN WARNING FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ ORA/SE-FO/FLA-DO/FCB/ OC/COS/OL/ TODD A. HARRISON VENABLE LLP RICHARD J. BENJAMIN, MD PhD AMERICAN RED CROSS FATALITIES REPORTED TO FDA FOLLOWING BLOOD COLLECTION AND TRANSFUSION ANNUAL FISCAL SUMMARY FOR FY 2010 SEN DICK DURBIN - CORR 1/08 TO PRESENT HONG K. JUNG, Esq. JUNG & ASSOCIATE ENDOTEC INC - RECS PATRICK MORIARTY, PhD HEALTHCOR MANAGEMENT LP MERCK - VICTRELIS (BOCEPREVIR) AERS PATRICK MORIARTY, PhD HEALTHCOR MANAGEMENT LP VERTEX - INCIVEK (TELAPREVIR) AERS PETER GALLAGHER ZIFF BROTHERS INVESTMENTS JAZZ PHARMS - CO RESP, 483 9/27/07 ASHLEY AA-3143, AARON ANNELIEKE ROEST UNIVERSITY MEDICAL CENTER GRONINGEN PROZAC (FLUOXETINE) NDA 18-936; 20-187 - MEDICAL RVWS, STATISTICAL RVW DIABETES EFFECTS - 2000 TO PRESENT WOODY, MD, JOE H Signature/ Requester KLINE & SPECTER TRANSCRIPT OF INTRAOCULAR LENS HEARING 1980 Subject
Page 595 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/02/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ 2011-8042 2011-8043 11/02/2011 12/02/2011 11/02/2011 12/02/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8044 2011-8045 2011-8046 2011-8047 11/02/2011 12/02/2011 11/02/2011 12/02/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8048 2011-8049 11/03/2011 12/05/2011 11/03/2011 12/05/2011 ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ 2011-8050 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ GREGORY TUMOLO DALEY ORTON INDIVIDUAL RECS MICHAEL RICH RAYMOND JAMES & ASSOCS JOHN P LEADER ESQ LEADER LAW FIRM LIFESCIENCES HOLDINGS CORP, PLAINSBORO, NJ - 483 6/30/11-9/30/11 ASTRAZENECA - SEROQUEL AERS, MEMOS, ANALYSES, ETC ORA/SE-FO/FLA-DO/FCB/ Doe J JEFFREY D DECARLO JEFFREY D DECARLO ATTY AT LAW OSMOPREP (SODIUM PHOSPHATE MONOBASIC MONOHYDRATE) TABS NDA 21-892 - AERS FDA/OMPT/CDRH/OCER/DFOI/ GAPAC, ADELE CMPLNT #121621 OC/OM/OMP/DDM/ JOYCE RIDLEY WOLTERS KLUWER MIRA IINC - MIRAGEL K760550 PMA, IDE DKT FDA-1995-S-0039 LIA OBATA DOWD DOWD & DOWD PC KIMBERLY J. ANNESSER ARNSTEIN & LEHR EVERGLADES LABORATORIES - AFEBRILE, VALODON, CONTAINERS OF GLYCERINE RECS 1995 TO PRESENT MINOR DELETION 2011-6362 Signature/ Requester LAW OFFICE OF ROBERT L SALIM Subject LTRS, LBLG CHANGES, 483S, ETC
Page 596 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8051 2011-8052 11/03/2011 12/05/2011 11/03/2011 12/05/2011 2011-8053 2011-8054 11/03/2011 01/09/2012 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8055 11/03/2011 12/05/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8056 2011-8057 2011-8058 11/03/2011 12/05/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8059 11/03/2011 12/06/2011 2011-8060 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8061 11/03/2011 12/05/2011 ORA/ ORA/ Doe J INDIVIDUAL RECS ORA/CE-FO/PHI-DO/PCB/ JOSE M BIAGGI JUNQUERA BIAGGI & BIAGGI PSC ATTY AT LAW SHU CHI HSU TLC BIOPHARMACEUTICALS INC MCNEIL CONSUMER HEALTHCARE, FT WASHINGTON, PA EIRS, LBLG, QUALITY CONTROL, ETC HOSPIRA, VIC, AUSTRALIA - EIRS 2007 TO 2011 ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ DIEDRICH, JOHN WILLIAM A OLSON PHD Center for Regulatory Services, Inc. PAUL PENTEL UNIV OF MINNESOTA ISRS 5025027-0, 5032587-2, 5053183-7, ETC DRUG COMPANIES, DVC MFRS - INSP DATABASE FY2000 TO PRESENT BASF CORP - FCN 1072 Matthews, Brian ORAL POTASSIUM IODIDE PREPARATIONS, CHELATION PRODS APRVD FOR USE IN PROPHYLAXIS ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER L FINGER PERMOBIL INC AMANDA ORLANDO AVALON RISK MANAGEMENT INC NELSON LAM INTUITY MEDICAL ABE THOMAS PHD PRIMEDICA LABORATORIES LLC TRAVATAN Z (TRAVAPROST) - ANALYTICAL METHODS, MFG PROCESS SECTIONS OF THE CMC K110637, K111371, K110571 ENTRY #D5209317960 - NOTICE OF FDA ACTION #1 PERMOBIL INC, LEBANON, TN - EIRS 2004, 2009 Signature/ Requester Subject
Page 597 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ 2011-8062 11/03/2011 12/05/2011 2011-8063 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8064 2011-8065 11/03/2011 12/05/2011 11/03/2011 12/05/2011 ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ 2011-8066 2011-8067 2011-8068 11/03/2011 12/05/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 2011-8069 2011-8070 11/03/2011 12/05/2011 11/03/2011 12/05/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8071 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8072 11/03/2011 CBER/OCTMA/DDOM/ALFB/ RALPH MAKAR FDA COMMUNICATION ON USE OF JET INJECTORS ABE THOMAS PHD PRIMEDICA LABORATORIES LLC PATANOL (OLOPATADINE HCL) - ANALYTICAL METHODS, MFG PROCESS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ HUBLE, THEODORE J MARK MCLEAN MEYERSON LAW FIRM PC LARA SAY DOUGLAS LONDON PC ATTY AT LAW ROSEMARY JACKSON KRAFT FOODS DAVID LIEBERMAN SOUTHPOINT CAPITAL ST JUDE MEDICAL, CDRH, WASHINGTON, DC - LIST OF MTG ATTENDEES 10/17/11 VERTICOR LTD, INTERBODY INNOVATIONS LP - ECLIPSE PEEK SPINAL SPHERE MDRS, CORR YAZ NDA 21-676, NDA 21-873, NDA 22-045; YASMIN NDA 21-098 - CORR KRAFT FOODS, ALLENTOWN, PA; TARA FOODS, ALBANY, GA - EIRS CINRYZE - AERS 10/10/08 TO PRESENT FDA/OO/OFBA/OAGS/ JOSEPH P KRAUSE KELLY & KRAUSE LP KATE B WILSON HUMAN CELL AND TISSUE ESTABLISHMENT CENTER FOR PUBLIC INTEGRITY REGISTRATION - 483S. WARNING LTRS LISTING INGENIX - CONTRACTS 1/1/11-9/1/11 ORA/CE-FO/PHI-DO/PCB/ ROGELIO SANTOS AMYLEX PHARMACEUTICALS INC BARBARA MINTZES UNIV OF BRITISH COLUMBIA FRONTAGE LABORATORIES INC, MALVERN, PA 4/4/-5/11; EXTON, PA 3/18-19/10 - EIRS GENENTECH - LUCENTIS (RANIBIZUMAB) MEDICAL & STATISTICAL RVWS Signature/ Requester Subject
Page 598 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/03/2012 Action Office OC/OER/OPA/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ OC/OIASI/OCP/ 2011-8073 11/03/2011 12/05/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8074 11/03/2011 12/05/2011 2011-8075 11/03/2011 12/05/2011 2011-8076 2011-8077 2011-8078 2011-8079 2011-8080 11/03/2011 12/05/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 11/03/2011 12/05/2011 2011-8081 11/03/2011 12/05/2011 2011-8082 11/03/2011 12/05/2011 2011-8083 11/03/2011 12/05/2011 2011-8084 11/03/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER ACORN STAIRLIFTS, INC, ORLANDO, FL - CORR, MOST RECENT STANNAH STAIRLIFTS INC, FRANKLIN, MA - CORR, MOST RECENT STERLING AIRLIFTS LTD, MOUNT POCONO, PA - CORR ACORN STAIRLIFTS INC, ORLANDO, FL - EIR, 483, NOTES, ETC MOST RECENT MEDITEK INC, APEX, NC - CORR MOST RECENT CLOSED FOIA REQUESTS 10/31/11-11/4//11 CLOSED FOIA REQUESTS 10/24-28/11 FOI SERVICES INC CLOSED FOIA REQUESTS 10/24-28/11 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOIA REQUESTS 10/31/11-11/4//11 CLOSED FOI REQUESTS 10/31/11-11/4/11 CLOSED FOIA REQUESTS 10/24-28/11 MARY KWON CHILDREN'S HOSPITAL OF WISCONSIN PROPRANOLOL - AERS 8/09 TO PRESENT Signature/ Requester BIOJECT INC Subject W/INFLUENZA VACCINES - CORR 1/11 TO 10/11
Page 599 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/05/2011 2011-8085 11/03/2011 12/05/2011 2011-8086 11/03/2011 12/05/2011 2011-8087 11/03/2011 12/05/2011 2011-8088 11/03/2011 12/05/2011 2011-8089 11/03/2011 12/05/2011 2011-8090 11/03/2011 12/05/2011 2011-8091 11/03/2011 12/05/2011 2011-8092 11/03/2011 12/05/2011 2011-8093 11/03/2011 12/05/2011 2011-8094 2011-8095 2011-8096 2011-8097 11/03/2011 12/05/2011 11/04/2011 12/06/2011 11/04/2011 12/06/2011 11/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/ATL-DO/ACB/ Signature/ Requester BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC PAUL STEPHANO SANFORD C BERNSTEIN & CO LLC AMANDA ORLANDO AVALON RISK MANAGEMENT INC SABRE MADDOCK-BRACY BOTTAR LEONNE, PLLC SCOTT C BYRD BYRD LAW FIRM SCOTT C BYRD BYRD LAW FIRM RICHARD KELLER GOOD FOOD LLC - ENTRY #D5209301022, NOTICE OF FDA ACTION #1 RECS POTE TIALLY FATAL ERRORS W/GDH-PQQ GLUCOSE MONITORING TECHNOLOGY 8/13/09 (CERTIFIED) JARROW FORMULAS INC, LOS ANGELES, CA - RECS LAST FIVE YRS TO PRESENT JARROW INDUSTRIES INC, SANTA FE SPRINGS, CA - RECS LAST 5 YRS TO PRESENT ACORN MOBILITY SERVICES LTD, WEST YORKSHIRE, UK STERLING STAIRLIFTS LTD, ALLENTOWN, PA - EIRS, 483S, RECS, MOST RECENT STERLING STAIRLIFTS LTD, MOUNT POCONO, PA - EIRS, 483, RECS, MOST RECENT STANNAH STAIRLIFTS INC, FRANKLIN, MA - EIR, 483S, RECS, MOST RECENT ACORN STAIRLIFTS INC, PLAINFIELD, NJ - EIRS, 483S, RECS, MOST RECENT ACORN STAIRLIFTS INC, EDISON, NJ - EIRS, 483S, RECS, MOST RECENT ACORN STAIRLIFTS INC, FULLERTON, CA - EIRS, 483S, RECS, MOST RECENT MYLAN INC - 483 LTRS 2010 TO 2011 Subject MOST RECENT MEDITEK INC, APEX, NC - EIR, 483S, RECS, MOST RECENT
Page 600 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/06/2011 2011-8098 11/04/2011 12/06/2011 2011-8099 11/04/2011 12/06/2011 2011-8100 11/04/2011 12/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8101 11/04/2011 12/06/2011 2011-8102 11/04/2011 12/06/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8103 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8104 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8105 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8106 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J ALLI (ORLISTAT) - AERS Doe J MENTAL HEALTH MEDICATIONS WITH BLACK BOX WARNINGS - MEDWATCH RPT GARY CONTE ANGELINI PHARMACEUTICALS INC BRISTOL MYERS SQUIBB - DESYREL (TRAZODONE) NDA 18-207 CMC SECTION & UPDATES FEINREICH, HANNAH HEPARIN - RECS; NOVARTIS AG - EXJADE, NOVARTIS MAALOX TOTAL RELIEF RECS CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC ORTHO MCNEIL JANSSEN - NUCYNTA ER (TAPENTADOL HCL) NDA 20-0533 SBA SIMONE CERETTI RAND SRL MAQUET CARDIOPULMONARY AG - CARDIOHELP SYS K102726 LIAT TSOREF SLENDER MEDICAL LTD 1 S MESA ULTHERA INC, MESSA, AZ - ULTHERA SYS & COAGULATION & ACCESSORIES K072505 FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC LIAT TSOREF SLENDER MEDICAL LTD Subject EIRS, 483S, INVESTIGATORS NOTES, ETC MOST RECENT ACORN MOBILITY SERVICES LTD, KEIGHLEY, UK - EIRS, 483S, INVESTIGATOR NOTES, ETC MOST RECENT MEDICS TECHNOLOGIES CORP, WAHSINGTON, DC LIPONSON SYS FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION K100874
Page 601 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8107 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8108 2011-8109 11/04/2011 12/06/2011 11/04/2011 12/06/2011 2011-8110 2011-8111 11/04/2011 12/27/2011 11/04/2011 12/06/2011 2011-8112 11/04/2011 12/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-8113 11/04/2011 12/06/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8114 11/04/2011 12/06/2011 2011-8115 11/04/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ DEANNA CRUZ LIST OF DRUGS COMING OFF PATENT PROTECTION MILLS #09-b-1746, JAMES G NAMES OF COMPANIES THAT DO NOT USE GENETIC ENGINEERING PRODUCE DISTRIBUTION MILLS #09-b-1746, JAMES G GLEEVAC - TRIALS, MFR ADDRESS, NAME OF ORGANIC SUBSTANCES MOST RECENT ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ PIERCE #982762, JASON BOB BARTON HARTVILLE CHOCOLATE KITCHEN/LCF INC TYLER KENYON NORTHCOAST RESEARCH TRVIS SCHAFTENAAR USB GLOBAL ASSET MANGEMENT KATE WILLSON ICIJ SUNSHINE PEANUT CO, TAMPA, FL - VIOLATIONS RPT 2009 HARTVILLE CHOCOLATE KITCHEN/LCF INC, HARTVILLE, OH - EIRS LAST 10 YRS INTEGRA LIFE SCIENCES, PLAINSBORO, NJ - 483, CO RESP MOST RECENT INTEGRA LIFESCIENCES, PLAINSBORO, NJ - RECS 8/11, 9/11 BIOMEDICAL TISSUE SERVICES LTD, FT LEE, NJ DESTINATION OF RECALLED PRODS, ETC SHAH, ALPA P TAMSULOSIN - AERS Signature/ Requester Subject
Page 602 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/06/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8116 2011-8117 11/04/2011 12/06/2011 11/04/2011 12/06/2011 2011-8118 2011-8119 11/04/2011 12/06/2011 11/07/2011 12/07/2011 CVM/OCD/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/DET-DO/DCB/ ORA/ORM/ ORA/ORM/ OC/OM/OMP/DDM/ MARILYN WHITNEY COVINGTON & BURLING LLP KATHYRN DOUGLAS PUBLIC EMPLOYEES FOR ENVIRONMENTAL RESPONSIBILITY FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ EILEEN ROSENBLOOM DAVID R BRIEN LAW OFCS JACQUELINE PRENDERGAST INSTITUTE FOR PEDIATRIC INNOVATION FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8123 11/07/2011 12/07/2011 2011-8124 2011-8125 2011-8126 11/07/2011 12/07/2011 11/07/2011 12/07/2011 11/07/2011 12/07/2011 2011-8127 11/07/2011 12/07/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WALTON K31994, RAYMOND TRAMADOL HCL 50 MG TABS - AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JACQUELINE PRENDERGAST INSTITUTE FOR PEDIATRIC INNOVATION JACQUELINE PRENDERGAST INSTITUTE FOR PEDIATRIC INNOVATION CHARLENE S FALLON LINNAN & FALLON LLP JOE EATON CENTER FOR PUBLIC INTEGRITY NELSON LAM INTUITY MEDICAL K093745, K093755, K100806, ETC BECTON DICKINSON CONSUMER HEALTCARE ULTRAFINE INSULIN SYRINGE K955235 BECTON DICKINSON CONSUMER HEALTHCARE ULTRAFINE INSULIN SYRINGE K024112 USE & APRVL OF ANIMAL DRUGS FOR SUB-THERAPEUTIC USES DKT FDA-2010-P-0491 TONEY CHEN FDAZILLA TYLER KENYON NORTHCOAST RESEARCH SYMMETRY MEDICAL, AVILLA, IN - 483S LAST THREE MONTHS; LIST OF INSP OF MEDICAL DVC COMPANIES LAST SIX MONTHS LIST OF 483S THROUGH 11/2/11 Signature/ Requester CLARKSTON CONSULTING Subject NEXT FIVE YRS
2011-8120 2011-8121
11/07/2011 12/07/2011 11/07/2011 12/07/2011
AMPLATZER VSD - PI, APRVL RECS
2011-8122
11/07/2011 12/07/2011
BECTON DICKINSON CONSUMER HEALTHCARE ULTRAFINE INSULIN SYRINGE K941657 BASSETT HEALTHCARE COOPERSTOWN - MQSA CERTIFIED ARTHROSCOPIC SHAVERS - CO RESP
Page 603 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8128 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8129 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8130 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8131 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8132 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8133 2011-8134 11/07/2011 12/07/2011 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8135 11/07/2011 12/07/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8136 11/07/2011 ORA/SE-FO/FLA-DO/FCB/ ANDREW POTTS LISTERIA MONOCYTOENES ENTRY ETN0000137-4 - LAB ELIZABETH J MAHONEY BAXTER HEALTHCARE CORP NATIONAL GENTICS IINSTITUTE, LOS ANGELES, CA - EIRS 1/11-21/11 ORA/P-FO/SAN-DO/SFCB/ MONICA ENGEBRETSON BORN FREE USA ANDREW HEDIN FIDELITY BIOSCIENCES SIERRA MEATS, RENO, NV, MONTEREY, CA, SANTA CLARA, CA - EIRS 1/1/09 TO PRESENT DURAMED - REVIA (NALTREXONE HCL) NDA 18-932 APRVL RECS ANDREW HEDIN FIDELITY BIOSCIENCES ENDO PHARMS - NUBAIN (NALBUPHINE HCL) NDA 18-024 APRVL RECS MARCUS PETOYAN GIANNI PETOYAN ATTY ZANTAC 150 NDA 18-703 - PHARMACOLOGY RVWS JUWTA HOFFRITZ DIE ZEIT BOEHRINGER INGELHEIM - PRADAXA (DABIGATRAN ETEXILATE MESYLATE) AERS JAMA WHITTAKER FLAHERTY SENSABAUGH & BONASSO HYCODAN - ISR 3267015; C-PHEN - ISR 5792539; TUSSIONEX - ISR 3171954, ETC MICHAEL R COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 10/1/11-11/1/11 Signature/ Requester Subject
Page 604 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/07/2011 2011-8137 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8138 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8139 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8140 11/07/2011 12/07/2011 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-8141 2011-8142 11/07/2011 12/07/2011 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8143 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8144 11/07/2011 12/07/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ HAL LIPTON GYMA LABORATORIES OF AMERICA INC CAMBREX KARLSKOGA, KARLSKOGA, SWEDEN - EIR 1/31/11-2/4/11 HAL LIPTON GYMA LABORATORIES OF AMERICA INC TRIFARMA SPA, ROZZANO, ITALY - EIR 1/25-28/10 FDA/OF/CFSAN/OCD/EOS/ FATIMA ASLAM Keller and Heckman LLP HAL LIPTON GYMA LABORATORIES OF AMERICA INC FIFIA FARMACEUTICI SPA, MULAZZANO, ITALY - EIR 4/1114/11 D-PSICOSE - GRN 400 JOHN E KING JR JOHN E KING LAW LLC PROPOXYPHENE - LABELS 1/1/00 TO 12/31/10 HAL LIPTON GYMA LABORATORIES OF AMERICA INC DIPHARMA FRANCIS SRL, MERETO DI TOMBA, ITALY - EIR 12/17-20/10 HAL LIPTON GYMA LABORATORIES OF AMERICA INC ERCROS SA, MADRID, SPAIN - EIR 7/11-15/11 Action Office Signature/ Requester ST JAMES SMOKEHOUSE INC HAL LIPTON GYMA LABORATORIES OF AMERICA INC Subject RESULTS ANTIBIOTICOS SA, LEON, SPAIN - EIR 7/21-24/11
Page 605 of 1132

Total Records: 12455 Control # 2011-8145 2011-8146 2011-8147 Recd Date / Due Date 11/08/2011 12/08/2011 11/08/2011 12/08/2011 11/08/2011 12/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8148 11/08/2011 12/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8149 2011-8150 2011-8151 11/08/2011 12/08/2011 11/08/2011 12/08/2011 11/08/2011 12/08/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8152 2011-8153 11/08/2011 12/08/2011 11/08/2011 12/08/2011 2011-8154 11/08/2011 12/08/2011 2011-8155 11/08/2011 12/08/2011 2011-8156 11/08/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OF/CFSAN/OCD/EOS/ MARILYNN WHITNEY COVINGTON & BURLING LLP BRANDY QUARLES GRADUATE MEDICAL EDUCATION LARA SAY DOUGLAS LONDON PC ATTY AT LAW LARA SAY DOUGLAS LONDON PC ATTY AT LAW JENNIFER SAYO DR MICHAEL H RIVNER - LAST CORR REGARDING 1994 AUDIT, RESP YAZ NDA 21-676, NDA 21-873, NDA 22-045; YASMIN NDA 21-098 - DDMAC CORR (CERTIFIED) YAZ NDA 21-676, NDA 21-873, NDA 22-045; YASMIN NDA 21-098 - APRVL RECS (CERITFIED) ANMAR INTERNATIONAL LTD, BRIDGEPORT, CT - EIR 6/08 GRN 385 FDA/OF/CFSAN/OCD/EOS/ GREENE, DANIEL KEVIN A KEELING WINSTON & STRAWN LLP FDA/OMPT/CDRH/OCER/DFOI/ KANDA IKEDA TSK LABORTORY JAPAN K-PACK II NEEDLE - K984576; NIPRO HYPODERMIC NEEDLE - K052474; DEPOTONE - K050505 TRIARCO INDUSTRIES - GARY NULL ULTIMATE POWER MEAL CAERS MEDICIS PHARMACEUTICAL CORP - LOPROX GEL NDA 20519 APRVL LTR, LBLG, RVWS ETC ROSS C OPSAHL AKZO-NOBEL CHEMICALS CAMBREX KARLSKOGA AB, KARLSKOGA, SWEDEN HYDROUS BENZOYL PEROXIDE (BPO) USP (BULK) EIRS, 483S CO RESP, ETC 4/19/02 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ADRIENNE HAMMOND VUCOMP INC ADRIENNE HAMMOND VUCOMP INC RISS C OPSHL AKZO-NOBEL CHEMICALS ICAD INC - SECOND LOOK P010038/S005,S007,S008, S009,S012, S013 FARCHEMIA SRL (TESSENDERLO CHEMIE) - HYDROUS BENZOYL PEROXIDE EIRS, 488S, CO RESP, ETC 4/19/02 TO PRESENT Subject RIVERAIN MEDICAL GROUP - SOFTVIEW K092363
Page 606 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/08/2011 2011-8157 2011-8158 11/08/2011 12/08/2011 11/08/2011 12/08/2011 2011-8159 2011-8160 11/08/2011 12/08/2011 11/08/2011 12/08/2011 2011-8161 2011-8162 11/08/2011 12/08/2011 11/08/2011 12/08/2011 2011-8163 11/08/2011 12/08/2011 2011-8164 2011-8165 2011-8166 11/08/2011 12/08/2011 11/08/2011 12/08/2011 11/08/2011 12/08/2011 2011-8167 11/09/2011 12/13/2011 2011-8168 11/09/2011 12/09/2011 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ 2011-8169 11/09/2011 ORA/SW-FO/KAN-DO/COMP/ JOHN WALSH GENERAL DRUG & CHEMICAL CORP, TONGANOXIE, KS EIRS, 483, RECALL RECS 10/07 TO PRESENT SHIRLEY ROSS ROANOKE TRADE SERVICES INC JOWDY INDUSTRIES INC - ENTRY #D9705599626 RECS ARMENTROUT, BRYAN OC/OM/OMP/DDM/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/CIN-DO/CCB/ ORA/OCI/ ORA/OCI/ CVM/OCD/ Doe J GENNA REED Food & Water Watch ROSS C OPSAHL AKZO-NOBEL CHEMICALS JOHN WALSH JAMES ALEXANDER CORP JOHN WALSH JAMES ALEXANDER CORP AMY FULTON BUCHANAN INGERSOLL & ROONEY PC WHITE WAVE FOODS CO, JACKSONVILLE, FL - EIR, MOST RECENT, COVER LTRS, RECS OXITEC, UNIV OF CALIFORNIA, IRVINE - GENETICALLY ENGINEERED MOSQUITO VARIETY AEDES AEDYPTI PERMITS, LICENSES, NOTIFICATIONS, ETC GLAXOSMITHKLINE, RESEARCH TRIANGLE PARK, NC; STIEFEL LABORATORIES INC, RESEARCH TRIANGLE PARK, NC, OAK HILL, NY - EIRS, 483S 1/06 TO PRESENT USB MOLECULAR BIOLOGY REAGENTS AND BIOCHEMICALS, CLEVELAND, OH - EIRS, 483S, RECALLS ACETO CORPORATE HEADQUARTERS, PORT WASHINGTON, NY - EIRS, 483S, RECALLS DKT 1975N-0184 ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNY YU GREAT LAKES DANIEL W ERNSBERGER BEHREND & ERNSBERGER PC MEDTRONIC INC - SYNCROMED II PUMP & CATHETER MODEL 8709S MDRS, 15-DAY ALERTS, CMPLNTS, ETC 11/10 TO 2/11 INDIVIDUAL RECS GLAXOSMITHKLINE - EIRS, 483S 2005 TO PRESENT ORA/NE-FO/NYK-DO/NYDCB/ Action Office Signature/ Requester AN MAR INTERNATIONAL LTD ROSS C OPSAHL AKZO-NOBEL CHEMICALS ROBERT LUZZO BRUNO SCHEIDT INC ARKEMA INC, NEW YORK, NY - HYDROUS BENZOYL PEROXIDE EIRS, 483S CO RESP, ETC 5/11/07 TO PRESENT CREAM OF COCONUT ENTRY 390-6198655-8 - LAB RESULTS Subject
Page 607 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/09/2011 2011-8170 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8171 11/09/2011 12/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ MARIA KEELAN GAMBRO RENAL PRODUCTS ADVANCED RENAL TECHNOLOGIES INC - CITRASATE DIALYSATE ACID CONCENTRATE LIQUID K000792; ROCKWELL MEDICAL TECHNOLOGIES INC -CITRPURE ACID CONCENTRATE K062399 MEDTRONIC INC - MEDTRONIC SYNCROMED II PUMP & CATHETER MODEL 8709SC RECS, MDRS, 15 DAY ALERT RPTS, PROD REACTIONS RPTS THERAPUTIC CMPLNT RPTS, 11/10 TO 2/11 ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS 1/1/10 TO PRESENT TARPLY, WANDA Action Office Signature/ Requester JAMES ALEXANDER CORP AMLODIPINE BESYLATE 5 MG - RECS Subject
2011-8172
11/09/2011 12/09/2011
DANIEL W ERNSBERGER BEHREND ERNSBEERGER, PC
2011-8173
11/09/2011 12/09/2011
ELLIOTT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC
2011-8174
11/09/2011 12/09/2011
GLORIA WOO CITI INVESTMENT RESEARCH, US EQUITY RESEARCH
INCIVEK - AERS, 5/22 TO PRESENT
2011-8175
11/09/2011 12/09/2011
GLORIA WOO CITI INVESTMENT RESEARCH, US EQUITY RESEARCH
VICTRELIS - AERS, 5/11 TO PRESENT
2011-8176
11/09/2011 12/09/2011
ROBERT VAN OSDEL Nexgen Pharma
WATSON LABS - PRECOSE (ACARBOSE) NDA 77-532; IMPAX - PRECOSE (ACARBOSE) NDA 78-441; ROXANE PRECOSE (ACARBOSE) NDA 78-470, ETC BIOEQV RVW
2011-8177
11/09/2011 12/09/2011
BOCEPREVIR - AERS 5/13/11 TO PRESENT
2011-8178
11/09/2011 12/09/2011
JOAN STITT (UG2CD-16) MERCK & CO., INC.
VICTRELIS (SCHERING - BOCEPREVIR) - AERS 5/13/11 TO PRESENT
Page 608 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8179 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8180 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8181 2011-8182 2011-8183 2011-8184 2011-8185 2011-8186 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8187 2011-8188 2011-8189 2011-8190 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC KILA B. BALDWIN KLINE & SPECTER KEVIN A. KEELING WINSTON & STRAWN LLP CONCENTRIC MEDICAL - MERCI RETRIEVAL SYS RPTS, CORR, PHOTOS LOPROX LOTION NDA 19-824 - APRVL, LBLG, MED RVW ORA/CE-FO/BLT-DO/CB/ FOI SERVICES INC ALBERTO R YATACHO MD, TOWSON, MD - EIR, 483 CO RESP, ETC 3/30/09 CAP 8C0257 - PAGES 78-79; 110-127; 1189-1351 FOI SERVICES INC ORA/CE-FO/BLT-DO/CB/ ARMENTROUT, BRYAN ORA/CE-FO/BLT-DO/CB/ ARMENTROUT, BRYAN ORA/NE-FO/NYK-DO/NYDCB/ ARMENTROUT, BRYAN ORA/CE-FO/NJ-DO/NJCB/ ARMENTROUT, BRYAN ORA/P-FO/LOS-DO/LACB/ ARMENTROUT, BRYAN WHITE WAVE FOODS CO, CITY OF INDUSTRY, CA - EIR, CO RESP, EXHIBITS MOST RECENT WHITE WAVE FOODS CO, BRIDGETON, NJ - EIR, CO RESP, EXHIBITS MOST RECENT HP HOOD LLC, ONEIDA, NY - EIR, CO RESP, EXHIBITS MOST RECENT HP HOOD LLC, WINCHESTER, VA - EIR CO RESP, EXHIBITS MOST RECENT WHITE WAVE FOODS CO, MOUNT CRAWFORD, VA - EIR, CO RESP, EXHIBITS MOST RECENT TELAPREVIR - AERS 5/23/11 TO PRESENT FOI SERVICES INC BIOGEN IDEC INC - NATALIZUMAB BB-IND 6895 LTR 11/18/05 (CERTIFIED) Haden, Steven T EFFEXOR (VENLAFAXINE), LAMICTAL (LAMOTRIGINE), TRAZODON (DESYREL) - AERS, RVWS, ETC Signature/ Requester Subject
Page 609 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8191 2011-8192 2011-8193 11/09/2011 12/13/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8194 2011-8195 2011-8196 11/09/2011 12/09/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 2011-8197 2011-8198 11/09/2011 12/09/2011 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8199 2011-8200 11/09/2011 12/09/2011 11/09/2011 12/09/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8201 2011-8202 2011-8203 11/09/2011 12/21/2011 11/09/2011 12/09/2011 11/09/2011 12/09/2011 OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CHI-DO/CCB/ GERHARDT, NATHAN MARILYNN WHITNEY COVINGTON & BURLING LLP DKT 1986P-0033, 1986P-0034, 1986P-0235 MELISSA PEDERSEN HILL WARD HENDERSON PRIMROSE CANDY CO, CHICAGO, IL - 483 12/1/10 INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ JEFFREY K. SHAPIRO Hyman, Phelps & McNamara, P.C. KIM HENDERSON SANOFI PASTEUR CDRH UNTITLED LTRS RELATED TO LBLG, ADVERTISING, PROMOTION 1/09 TO PRESENT SMITH KLINE BEECHAM, WORTHING WEST SUSSEX, UK 483 3/11 ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/BLT-DO/CB/ SPOONER, REBECCA B JOHN WALSH JAMES ALEXANDER CORP KEVIN A. KEELING WINSTON & STRAWN LLP FDA/OMPT/CDRH/OCER/DFOI/ SYRINGE MANUFACTURING CO ROBERT MITCHELL JR MD, DOMINION PSYCHIATRIC ASSOCIATES (AFFILIATED WITH MONARCH RESSEARCH ASSOCIATES), VIRGINIA BEACH, VA - EIR, CO RESP 7/00 RESEARCH ORGANICS, CLEVELAND, OH - EIRS, 483S, RECALLS 10/07 TO PRESENT LOPROX CREAM NDA 18-748 - APRVL FDA/OMPT/CDRH/OCER/DFOI/ JOSEPH HUI DENTAL PRODUCTS INC SEWA REUSABLE ALL GLASS SYRINGES - K944542 K070196 (CERTIFIED) FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ KRISTI O SMEDLEY Center for Regulatory Services, Inc. LUUK VAN LANGEN VIAZYM BV BARBARA A BINZAK BUCHANAN INGERSOLL & ROONEY PC VASODILAN NDA 11-832 - SAFETY & EFFECTIVENESS DATA AD HOC EMZYME COMMITTEE (EMZYME TRADE ASSN) GRASP 03G0016 1973 GENENCOR - GRN 372 Signature/ Requester Subject
Page 610 of 1132

Total Records: 12455 Control # 2011-8204 2011-8205 2011-8206 2011-8207 2011-8208 Recd Date / Due Date 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8209 2011-8210 2011-8211 2011-8212 2011-8213 2011-8214 2011-8215 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 2011-8216 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8217 11/10/2011 12/12/2011 ORA/ ORA/ MIKE NORTON NORTH ATLANTIC INC FROZEN MAHI MAHI ENTRY #316-1914604-1 INVESTIGATION BROWN, ANDREW JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (8G2CD-16) MERCK & CO., INC. MICHAELL CLEVELAND CROWN STANLEY & SILVERMAN MEDTRONIC INC - MIDAS REX DRILL, INVESTIGATIONS, RECALLS, CORR 8/10/00, 9/24/01, 8/6/03 PROPECIA - AERS 2011-7127 2011-7109 2011-7025 2011-7023 2011-6818 2011-6532 Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JENNIFER WILEY ALDER BIOPHAMACEUTICALS AVECIA. BILLINGHAM, UK - 483 1/09 2011-6370 2011-6221 2011-6208 Subject 2011-6178
Page 611 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NYK-DO/NYDCB/ 2011-8218 11/10/2011 12/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-8219 2011-8220 2011-8221 2011-8222 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ 2011-8223 2011-8224 2011-8225 2011-8226 2011-8227 2011-8228 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 2011-8229 11/10/2011 12/12/2011 2011-8230 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ALICIA B RICHARDS AQUASOL CORP JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD)-16 MERCK & CO., INC. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS KENNETH REID WASHINGTON INFORMATION FOI DAILY LOG 10/17-21/11 FOI DAILY LOG 10/17-21/11 FOI DAILY LOG 10/24-28/11 FOI DAILY LOG 10/24-28/11 FOI DAILY LOG 10/17-21/11 2011-6083 FCN 512, FCN 540, FCN 794, ETC - FINAL TOXICOLOGY, CHEMISTRY MEMOS 2011-5868 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ MELINDA J GLASS VALLEY MEDICAL CENTER BRIAN SMITH LEXISNEXIS COURTLINK INC LUUK VAN LANGEN VIAZYM BV BENJAMIN LL ENGLAND BENJAMIN L ENGLAND & ASSOC LLC MEKONG SEAFOODS LLC - ENTRY 551-0113423-3 SPL COLLECTION RPTS, SHIPPING & STORAGE RECS, ANALYTICAL DATA, ETC VALLEY MEDICAL CENTER - SIMPLY THICK PRODS THAT WERE IN PACKETS RECALL 6/11 README.DOC - QUARTERLY DATA EXTRACT RECS (CERTIFIED) SOLVAY ENZYMES - GRASP 5G0415 ALEX TOMASEVIC NICHOLAS & BUTLER LLP DKT 1982-0166 - CHASER TABS SUBMISSIONS Signature/ Requester Subject
Page 612 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester SOURCE 2011-8231 11/10/2011 12/12/2011 2011-8232 2011-8233 11/10/2011 12/12/2011 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ 2011-8234 11/10/2011 12/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8235 2011-8236 11/10/2011 12/12/2011 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8237 2011-8238 2011-8239 2011-8240 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ KUCHNICKI, THOMAS A KENDLE INTERNATIONAL INC SINEMET NDA 17-555 - TIME VS DRUG CONCENTRATION RECS BARBBARA JONES DOMINION GROUP INC BARABARA JONES DOMINION GROUP INC FOI DAILY LOG 10/17-21/11 FOI DAILY LOG 10/17-21/11 FOI DAILY LOG 10/24-28/11 S ALBERT EDWARDS, PHARM D GLADYS B TONKIN Center for Regulatory Services, Inc. MORTON GROVE PHARMS - CESSATION OF MFG UNAPPROVED DRUG PRODS 4/30/7 FOI DAILY LOG 10/17-21/11 VAISHALI PATEL TARO PHARMACEUTICALS U.S.A., INC GLENMARK GENERICS - ATOVAQUONE, PROGUANIL HCL NDA 91-211 SBA, MOR, RVWS, ETC KENNETH REID WASHINGTON INFORMATION SOURCE GLADYS B TONKIN Center for Regulatory Services, Inc. ANDREA G FERRENZ EMORD & ASSOCIATES, P.C. VNUS MEDICAL TECHNOLOGIES, COVIDIEN PLC VARICOSE VEIN CATHETER RECS, CORR, ETC 3/12/09 TO PRESENT FOI DAILY LOG 10/24-28/11 FOI DAILY LOG 10/24-28/11 Subject
Page 613 of 1132

Total Records: 12455 Control # 2011-8241 2011-8242 2011-8243 2011-8244 Recd Date / Due Date 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8245 2011-8246 2011-8247 2011-8248 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 2011-8249 2011-8250 2011-8251 2011-8252 2011-8253 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8254 11/10/2011 12/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC UNIPATH LTD - CLEARBLUE EASY EASY READ PREGNANCY TEST K041404 JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. TARRA A. FULLER Hyman Phelps and McNamara PC OFFICE OF GENERIC DRUGS 180-DAY EXCLUSIVITY LIST 2000 - 2011 2011-7918 2011-7847 2011-7846 2011-7836 FRAN KOCH INFORMATION ACCESS JOAN STITT MERCK & CO., INC. FRAN KOCH INFORMATION ACCESS JOHN GILLINGS COLLINS STEWART LLC ZIMMER INC - 483 CORR FOI DAILY LOG 10/17-21/11 2011-7751 FOI DAILY LOG 10/24-28/11 FOI SERVICES INC SHU CHI HSU TLC BIOPHARMACEUTICALS INC HOSPIRA, MULGRAVE, VIC, AUSTRALIA - 483S 2007 TO 2011 FOI SERVICES INC FOI DAILY LOG 10/17-21/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 10/24-28/11 Signature/ Requester Subject FOI DAILY LOG 10/24-28/11
Page 614 of 1132

Total Records: 12455 Control # 2011-8255 2011-8256 2011-8257 2011-8258 Recd Date / Due Date 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8259 2011-8260 11/10/2011 12/12/2011 11/10/2011 12/12/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8261 11/10/2011 12/12/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8262 2011-8263 2011-8264 2011-8265 2011-8266 2011-8267 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ COUNRTY LIFE LLC JOAN STITT (UG2CD-16) MERCK & CO., INC. BRIAN SMITH YASMIN NDA 21-098 - PHARMACOLOGY RVWS, CLNCL FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SANJIV JAIN HUMAN BIOSCIENCES SANJIV JAIN HUMAN BIOSCIENCES LYNETTE ZENTGRAFT KING & SPALDING ABCO LABS INC, FAIRFIELD, CA - 483, EIRS 6/10 TO PRESENT 2011-7681 - REQUEST LTR P010030 BIOCARE INC - MEDIFIL K910944 BIOCARE INC - SKINTEMP K913023 JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL NUMBER OF DRUG & DVC MFRS 2000 TO PRESENT HALEY, JAMES C JOAN STITT (UG2CD-16) MERCK & CO., INC. ADDERRALL, ADDERRALL XR - TRIALS, AER 2011-7673 - REQUEST LTR Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. DR. HANNAH E. LAMBERT H E LAMBERT LILLY, STRATTERA (ATOMOXETINE) - AER 2011-7616 - REQUEST LTR 2011-7333 Subject 2011-7129
Page 615 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/12/2011 2011-8268 2011-8269 2011-8270 2011-8271 2011-8272 2011-8273 2011-8274 2011-8275 2011-8276 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 11/10/2011 12/12/2011 ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ ORA/OCI/ ORA/OCI/ 2011-8277 2011-8278 11/10/2011 12/12/2011 11/10/2011 12/12/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ 2011-8279 11/14/2011 FDA/OF/CFSAN/OCD/EOS/ EDWIN C BISINGER JR PHD DISODIUM EDTA - FAP CBER/OCTMA/DDOM/ALFB/ Doe J PATTI WALLER MARLER CLARK ATTYS JENSEN FARMS - CANTALOUPE S LISTERIA OUTBREAK INVESTIGATION, LAB RESULTS, CORR, ETC 8/11 TO 10/11 INDIVIDUAL RECS Doe J FDA/OF/CFSAN/OCD/EOS/ SPENCER, KATHRYN Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Signature/ Requester LEXISNEXIS COURTLINK INC BRIAN SMITH LEXIS NEXIS COURTLINK INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. BRIAN SMITH LEXIS NEXIS COURTLINK INC BRIAN SMITH LEXIS NEXIS COURTLINK INC JOAN STITT (UG2CD-16) MERCK & CO., INC. UNIPATH LTD - CLEAR BLUE EASY DIGITAL PREGNANCY TEST K060128 LIST OF FOODS AND BEVERAGES, AMOUNTS CONSUMED IN TOLEDO, OH, DETROIT, MI, ST PAUL, MN 10/07 TO 11/07 INDIVIDUAL RECS 2011-7719, 2011-7720 - REQUEST LTRS YAZ TABS NDA 21-676 - CHEMISTRY RVW, CLNCL RVW, PHARMACOLOGY RVW CERTIFIED BEYAZ TABS NDA 22-532 - SUMMARY RVW CERTIFIED 2011-7705, 2011-7706 - REQUEST LTRS Subject PHARMACOLOGY BIOPHARMACEUTICS RVWS (CERTIFIED) SAFYRAL TABS NDA 22-574 - PHARMACOLOGY RVW, STATISTICAL RVW 2011-7695 - REQUEST LTR
Page 616 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/13/2011 2011-8280 11/14/2011 12/13/2011 2011-8281 11/14/2011 12/13/2011 Action Office CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8282 11/14/2011 12/13/2011 2011-8283 11/14/2011 12/13/2011 OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8284 2011-8285 11/14/2011 12/13/2011 11/14/2011 12/13/2011 2011-8286 2011-8287 11/14/2011 12/13/2011 11/14/2011 12/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ COOPER, JACK #328257 ORA/CE-FO/NJ-DO/NJCB/ HENRY, RUSSELL FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ NICHOLE O'NEIL ORTHOMERICA PRODUCTS INC MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION BOBBY CHEZ RESTAURANT AND FOOD OPERATION, CHERRY HILL, NJ - EIR MOST RECENT GAMMA HYDROBUTYRIC ACID, LYSERGIC ACID DIETHYLAMIDE, POLYCHLORINATED BIPHENYL - AERS DIETARY SUPPLEMENTS - CAERS 7/10 TO 6/11 BOSTON BRACE INTERNATIONAL - BOSTON BAND K111609 FDA/OMPT/CDRH/OCER/DFOI/ AMANDA L ENYEART MCGUIRE WOODS LLP MITCHELL S FUERST FUERST ITTLEMAN PL ABIOMED INC - IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYS CORR, SUMMARIES, WARNING LTR, ETC OPERATION CURE-ALL - STAFF MANUALS, INVESTIGATIONS, CONGRESSIONAL CORR, ETC LARA SAY DOUGLAS LONDON PC ATTY AT LAW YAZ NDA 21-676, NDA 21-873, NDA 22-045; YASMIN NDA 21-098 - DDMAC CORR (CERTIFIED) Doe J Signature/ Requester AKZO NOBEL SERVICES INC GARDASIL - VAERS Subject
Page 617 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8288 2011-8289 2011-8290 2011-8291 2011-8292 11/14/2011 12/13/2011 11/14/2011 12/13/2011 11/14/2011 12/13/2011 11/14/2011 12/13/2011 11/14/2011 12/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8293 11/14/2011 12/13/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8294 2011-8295 2011-8296 2011-8297 2011-8298 2011-8299 11/14/2011 12/13/2011 11/14/2011 12/13/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8300 11/15/2011 FDA/OMPT/CDRH/OCER/DFOI/ ERICA LORING JOHNSON & JOHNSON CONSUMER & PERSONAL PRODS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BALAJI SITHARAMAN Stony Brook University FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE ANGELIA D SLAYTON KENDLE INTERNATIONAL INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC BIOMAGNETIC TECHNOLOGIES INC - SOMATOSENSORY STIMULUS SYS K913604 P900009 - NON-CLNCL STUDIES RPT 10/6/94 K101477 ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE JANSSEN ORTHO LLC, MANATI, PR 6/28/10; SAN JUAN, PR 12/16/09; GURABO, PR 6/8/09, ETC - 483, CO RESP PATHEON PUERTO RICO INC, CAGUAS, PR 5/4/10, 4/8/09; MANATI, PR 2/4/09 - 483, CO RESP K103461 CHARLES CELESTE EAS Consulting Group, LLC HYDREA NDA 16-295 - APRVL LTR, LBLG, MOR, ETC ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ CVM/OCD/ CVM/OCD/ DR KEITH REDENBAUGH Arcadia Bioscience DR KEITH REDENBAUGH Arcadia Bioscience JILLIAN NASH ALLTECH INC JILLIAN NASH ALLTECH INC CHARLES CELESTE EAS Consulting Group, LLC UNITED SUPPLIERS INC, ELDORA, IA - 483S, CORR LAST 10 YRS UNITED SUPPLIERS INC, DYERSVILLE, IA - 483S, CORR LAST 10 YRS CYTOXAN NDA 12-141 - APRVL LTR, LBLG, MOR, ETC BORAGE OIL IN DOG & CAT DIETS - RECS ROSEMARY EXTRACT IN ANIMAL FEED - RECS Signature/ Requester Subject
Page 618 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/14/2011 Action Office Signature/ Requester BIOFILM INC Subject WOR, MORRIS PLAINS, NJ - K-Y BRAND LONG LASTTING VAGINAL MOISTURIZER K101585; LIL DRUG STORE PRODUCT INC, CEDAR RAPITS, IA - REPLENS LONGLASTING VAGINAL MOISTURIZER (PRE-FILLED APPLICATOR) K101241, ETC MEDICAL DEVICE TECHNOLOGIES INC - ULTRA BIOPSY DVC K962969; MEDICAL DEVICE TECHNOLOGIES INC MANAN PROMAG AUTOMATIC BIOPSY SYS K980226, K914874 ZYGO INDUSTRIES INC - EPISON ALERTING SYS FOR EPILEPTICS K862766 K891245 LABORATORIOS DEL DR, ESTEVE SA, BARCELONA, SPAIN - QAP
2011-8301
11/15/2011 12/14/2011
TRACY WENTWORTH REMINGTON MEDICAL INC
2011-8302 2011-8303 2011-8304
11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
KAREN B STUEBER CYBERONICS, INC. ROBERRT HILL TERANG NUSA DREW BARLOW VERTEX PHARMACEUTICALS INC
2011-8305 2011-8306
11/15/2011 12/14/2011 11/15/2011 12/14/2011
FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ CTP/OD/ CTP/OD/ OC/COS/OES/ OC/COS/OES/ WASIK, JOHN F CLAIRE PIZZARDI Bio-Botanica NASTALIE N SANDERS LATHAM & WATKINS LLP
GIB LLC DBA BRIZILIAN BLOWOUT - WARNING LTR CO RESP 8/22/11 GAIA HERBS, BREVARD NC; OREGON WILD HARVEST, SANDY, OR; QUANTUM HERBAL PRODUCTS, SAUGERTIES, NY - 483S 2 MOST RECENT WARNINGS FOR CIGARETTE PACKAGES & ADVERTISEMENTS - APRVL OR DENIAL OF WARNING PLANS 6/22/11
2011-8307
11/15/2011 01/05/2012
2011-8308 2011-8309
11/15/2011 12/14/2011 11/15/2011 12/14/2011
FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
CHRISTEN M MOWAD GEISINGER HEALTH SYSTEM
PRESERVATIVE USAGE - CURRENT FREQUENCY RECS CMPLNT #122515 - RESULTS
Doe J DEBI COHEN WOLTERS KLUWER LAW & BUSINESS MEDTRONIC INC - SPRINT FIDELIS LEAD WIRE 510K APRVL WILLIAMS, JUSTIN CLOSED FOIA REQUESTS 11/7-11/11
2011-8310
11/15/2011 12/14/2011
2011-8311
11/15/2011 12/14/2011
Page 619 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8312 2011-8313 11/15/2011 12/14/2011 11/15/2011 12/14/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-8314 2011-8315 11/15/2011 12/14/2011 11/15/2011 12/14/2011 2011-8316 2011-8317 2011-8318 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8319 2011-8320 2011-8321 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 2011-8322 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8323 11/15/2011 FDA/OMPT/CDRH/OCER/DFOI/ KALYPTO MEDICAL, HASTINGS, MN - K080275, POWDERED ROSEN, Ph.D., DAVID FDA/OMPT/CDRH/OCER/DFOI/ SILVER, MARK FDA/OMPT/CDRH/OCER/DFOI/ SILVER, MARK FDA/OMPT/CDRH/OCER/DFOI/ SILVER, MARK INTEGRATED TECHNOLOGIES, WINSFORD CHESIRE, UK K971126, BANDAGES, RECS, SUBMITtALS, RESPS MILLENKEN CHEMICAL, SPARTONBURG, SC - K051445, BANDAGES, RECS, SUBMITTALS, RESPS PREMCO MEDICAL SYS INC, RESEARCH TRIANGLE PARK, NORTH CAROLINA - K082415, POWDERED SUCTION PUMP, RECS, SUBMITTALS, RESPS PULMOZYME - SBA BLA 03-532 ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ W. PATRICK NOONAN STACEY DALTON POWER ROGERS & SMITH PC FOI SERVICES INC 21ST CENTURY HEALTHCARE INC, TEMPE, AZ - CO RESP, EIR, 483 2006 TO PRESENT ADVOCATE GLUCOSE STRIPS - AERS CLOSED FOIA REQUESTS 11/7-11/11 KEVIN WISNIEWSKI NEWSCHANNEL 5 KIM LOPEZ, MD MIZUHO SECURITIES USA INC AMOR VIE HORMONE REPLACEMENT PELLETS - APPL, CORR, CMPLNTS, ETC JAZZ PHARMS - ZYREM 483 5/11 CECELIA FRENCH CanReg, Inc. KEVIN WINSIEWSKI NEWSCHANNEL 5 HRC MEDICAL CENTERS, TN - HORMONE REPLACEMENT CENTERS APPL, CORR CMPLNTS, ETC CLOSED FOIA REQUESTS 11/7-11/11 Signature/ Requester Subject
Page 620 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/14/2011 2011-8324 2011-8325 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8326 2011-8327 2011-8328 2011-8329 2011-8330 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8331 2011-8332 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8333 11/15/2011 12/14/2011 2011-8334 2011-8335 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WHITE, JOHN STEPHEN FDA/OMPT/CDRH/OCER/DFOI/ SINGH, PUSHPINDER ZYPREXA (OLANZAPINE) - CORR 2002 TO 2005 FDA/OMPT/CDRH/OCER/DFOI/ JOEL KRAFT BIRCHWOOD LABORATORIES INC K092547 BIRCHWOOD LABORATORIES INC - K902591 & K90289 WHITE, JOHN STEPHEN FDA/OMPT/CDRH/OCER/DFOI/ PAUL BLACK BIONIX LARSON PRODUCTS INC - KLARITY THERMOPLASTIC K022708 ZYPREXA (OLANZAPINE) - AER FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DONNA R LUNAK ST JUDE MEDICAL BRIAN J. FELLOWS FELLOWS & BLAKE LLC DONNA R LUNAK ST JUDE MEDICAL DONNA R LUNAK ST JUDE MEDICAL DOMINIC TRAN OPTIMA VEIN CARE BIONICHE PHARMA USA - SOTRADECOL (SODIUM TETRADECYL SULFATE) - AER ELECTRODE & PACING CATHETER - K021232 BAXTER HOME CHOICE AUTOMATED PD SYS & HOME CHOICE PRO PD SYS - RECALL, RPTS, INSP ELECTRODE RECORDING & PACING CATHETER - K000277 ELECTRODE RECORDING & PACING CATHETER - K983171 FDA/OMPT/CDRH/OCER/DFOI/ SILVER, MARK TRACYE J. LANHAM SCANLON GROUP Action Office Signature/ Requester SILVER, MARK Subject SUCTION PUMP, RECS, SLUBMITTALS, RESPS ASO LLC, APOLLO BEACH, FL - K082910, BANDAGES, RECS, SUBMITTALS, RESPS ROMAZICON - AER
Page 621 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ OC/OIASI/OIP/IAS/ 2011-8336 11/15/2011 12/14/2011 2011-8337 11/15/2011 12/14/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ 2011-8338 2011-8339 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8340 2011-8341 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8342 2011-8343 11/15/2011 12/14/2011 11/15/2011 12/14/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE SHOEMAKER BOSTON SCIENTIFIC LOIS ZIEBOL PURSUIT VASCULAR ANGEION CORP, PLYMOUTH, MN - ANGEION ENDOSCOPIC VALVE SEAL, K915719 ARROW EVOLUTION - K100635; ARROW ARRO9WG+ARD BLUE PRSSURE INJECTABLE - K071538; ARROW MAC TWO-LUMEN - K011761, ETC FDA/OMPT/CDRH/OCER/DFOI/ CHRISTINE SHOEMAKER BOSTON SCIENTIFIC ERNEST J. SABO LANNETT COMPANY INC APPLIED UROLOGY INC, LAGUNA HILLS, CA - SURESEAL ENDOSCOPIC VALVE K920030 PROBENECID TABS ANDA 80-966 - RECS 1981 TO 2005 SUM, JOSEPH FDA/OMPT/CDRH/OCER/DFOI/ DONNA R LUNAK ST JUDE MEDICAL PROMACTA (ELTROMBOPAG) - AER ELECTRODE RECORDING & PACING CATHETER - K992777 WHITE, JOHN STEPHEN ZYPREXA (OLANZAPINE) - RISKS ASSOCIATED WITH DIABETES, ADDITIONAL WARNINGS 9/03 SINGH, PUSHPINDER K060179 - SUBMISSION, RPTS, ETC Signature/ Requester Subject
Page 622 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-8344 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8345 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8346 2011-8347 2011-8348 2011-8349 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 11/15/2011 12/14/2011 2011-8350 11/15/2011 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8351 11/16/2011 12/15/2011 2011-8352 2011-8353 2011-8354 2011-8355 2011-8356 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JAMES J ROGERS BEST NOMOS JAMES J ROGERS BEST NOMOS RYAN K SIMMONS WARD & SMITH PA RYAN K SIMMONS WARD & SMITH PA DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANDSDOWNE SUNLIGHT MEDICAL INC - INTRACYTOPLASMIC SPERM K072600 COOK OB/GYN - INTRACYTOPLASMIC SPERM K983596 P070015 - IDE STUDY BEST MEDICAL INTERNATIONAL INC (BEST NOMOS) CORVUS RADIATION THERAPY TREATMENT PLANNING SYS K100092 BEST MEDICAL INTERNATIONL INC (BEST NOMOS) - MIMIC MULTILEAF INTENSITY MODULATING COLLIMATOR K940412 P110019 - IDE STUDY ALESHIRE 278999, DAVID CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ RICK GILES SCHROER CAPITAL, L.P. LEAH R. KENDALL EPSTEIN BECKER & GREEN PC ANGELIA SLAYTON KENDLE INTERNATIONAL INC JOSHUA RESNICK AYER CAPITAL RETROSPECTIVE CLAIMS BASED COHORT STUDY OF IMMUNE GLOBULIN ADMINISTRATION AND THE OCCURENCE OF TEES - PRESENTATION RECS MAALOX, ZANAX, SEROQUEL, ETC - AERS ST JUDE MEDICAL INC - RIATA ST & RIATA ST OPTIM TRANSVENOUS DEFIBRILLATION LEADS INTEGRA LIFE SCIENCES CORP, PLAINSBORO, NJ; BURLINGTON, MA - 483 2011 DKT FDA-1995-S-0039 ANNEMIEKE M. TENNIS KANNER & WHITELEY LLC BUPROPION HCL ER TABS - BIOEQV STUDIES, PROTOCOLS, CORR, ETC KELLY, ERIN KREBIOZEN NDA 12-823; ASTRA ZENECA - ELAVIL (AMITRIPTYLINE) NDA 12-703, NDA 12-704; NOVARTIS RITALIN (METHYPHENIDATE) NDA 10-187 ETC Signature/ Requester Subject
Page 623 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/15/2011 2011-8357 11/16/2011 12/15/2011 2011-8358 2011-8359 11/16/2011 12/15/2011 11/16/2011 12/15/2011 2011-8360 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8361 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8362 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8363 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8364 11/16/2011 01/23/2012 2011-8365 11/16/2011 01/23/2012 2011-8366 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV FINAPRES MEDICAL SYS BV - FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1, K023723 LEVOQUIN (LEVOFLOXACIN) - AERS BMEYE BV - NEXFIN MODEL 2, K101123 LARA SAY DOUGLAS LONDON PC ATTY AT LAW YAZ NDA 21-676, NDA 21-873; YASMIN NDA 21-098 APRVL PKG (CERTIFIED) JIM FAUCETT NORTHWEST CLINICAL RESEARCH CTR COREG (CARVEDILOL) NDA 20-297 - SBA JULIE MEANS-POWELL VANDERBILT UNIVERISTY MEDICAL CENTER COPAXONE - AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester RESEARCH INSTRUMENTS LTD PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV ERICA LORING BIOFILM INC PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV LAUREN HOFFMAN Medco Health Solutions Inc CAS MEDICAL SYSTEMS INC - MODEL 7503 SERIES MONITOR K051896 PERSONAL PRODUCTS CO, SKILLMAN, NJ - K-Y BRAND INTRIGUE K062796 CAS MEDICAL SYSTEMS INC - MODIFICATION TO MODEL 750 SERIES MONITOR K063087 LYSTEDIA - AERS 11/13/09 Subject
Page 624 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8367 11/16/2011 12/15/2011 2011-8368 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8369 11/16/2011 12/15/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8370 2011-8371 2011-8372 2011-8373 2011-8374 2011-8375 2011-8376 2011-8377 2011-8378 2011-8379 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 2011-8380 11/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD DC LANSDOWNE RESEARCH INSTRUMENTS LTD ANGELA SMYTH IOVATC HEALTH SCIENCES RESEARCH INC ERIC WALTER CAMIL, SR COOK UROLOGICAL INC - MODIFICATION TO INTRACYTOPLASMIC SPERM ETC K033903 COOK UROLOGICAL INC - PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTE K033904 SWEMED LAB INTERNATIONAL AB - BLASTOMERE BIOPSY PIPETTE, K022643 HUMAGEN FERTILITY DIAGNOSTICS INC - BLASTOMERE BIOPSY PIPETTE, POLAR BODY, K012811 HUNTER SCIENTIFIC LTD - INJECTION PIPETTE, POLOR BODY, K001615 CONCEPTION TECHNOLOGY INC - MICROTOOLS, PLOAR BODY, K991104 SWEMED LAB INTERNATIONAL AB - INTRACYTOPLASMIC SPERM, K991700 HUMAGEN FERTILITY DIAGNOSTICS INC INTRACYTOPLASMIC SPERM, K990847 JIEYING LABORATORY INC - HOLDING PIPETTE, INJECTION PIPETTE K102480 IOVATE, HYDROXYCUT, SMARTBURN, ETC - CAERS, RECS ETC 9/29/11 TO PRESENT ACTHAR - OFF LABEL USE APRVL DANA HAYDEN SIEGFRIED (USA) INC SUBOXONE APPL N020732 - PHARMACOLOGY, TOXICOLOGY RECS FDA/OMPT/CDRH/OCER/DFOI/ PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC FINAPRES MEDICAL SYS BV - FINOMETER MODEL-2 W/ACCESORIES, K063111 ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS, 1/1/10 TO PRESENT Signature/ Requester Subject
Page 625 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/15/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8381 11/16/2011 12/15/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8382 2011-8383 2011-8384 2011-8385 2011-8386 2011-8387 2011-8388 2011-8389 2011-8390 2011-8391 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 11/16/2011 12/15/2011 2011-8392 2011-8393 11/16/2011 12/29/2011 11/16/2011 12/15/2011 2011-8394 11/17/2011 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ CTP/OD/ CTP/OD/ ORA/ ORA/ CTP/OD/ CTP/OD/ ORA/P-FO/SAN-DO/SFCB/ CVM/OCD/ OM/OMP/DODM/ BAYER, RICHARD D DR. KEITH REDENBAUGH Arcadia Bioscience SUZANNE D. JENSEN KLEINFELD KAPLAN & BECKER JENN STRATHMAN WEWS-TV MELISSA A. AIKMAN TROUTMAN SANDERS LLP GREGORY A. PAGE PAGE EICHENBLATT ET AL BENJAMIN L. ENGLAND, Esq. BENJAMIN L ENGLAND & ASSOC LLC AUSTIN NELSON INTER CONTINENTAL TRADING INC - 905 REGISTRATIONS & PROD LISTINGS, 904 INGREDIENT LISTINGS, 905J SUBSTANTIAL EQUIVALENCE RPTS ALIGN TECHNOLOGY INC - INVISALIGN SYS INVESTIGATION WENZHOU AISHI OPTICS INDUSTRY CO LTD - ENTRY NO U79-0077841-7/1/3 UNREDACTED HOSPIRA INC, MULGRAVE, NORTH VICTORIA, AUSTRALIA FLEA AND TICK PRODS - CMPLNTS 1/1/09 TO 11/10/11 OM/OMP/DODM/ CBER/OCTMA/DDOM/ALFB/ OM/OMP/DODM/ BAYER, RICHARD D BAYER, RICHARD D FDA MTG OF BLOOD PRODUCTS ADVISORY COMMITTEE 5/10/89 - TRANSCRIPT FDA MTG OF BLOOD PRODUCTS ADVISORY COMMITTEE 12/15/94 - TRANSCRIPT GAMMA LINOLENIC ACID - SAFETY & USE IN DOG & CAT DIETS SUBSTANTIAL EQUIVALENCE RPTS ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/BLT-DO/CB/ PATRICIA L. REGENYE CELEGENE CORP PATRICIA L. REGENYE CELEGENE CORP PATRICIA L. REGENYE CELEGENE CORP IVANA GOJO, UNIV OF MARYLAND, BALTIMORE, MD - 483 4/05 TO PRESENT LAURA A TEASLEY MD, LOMA LINDA UNIV HEALTH CARE, LOMA LINDA, CA - 483 7/10 TO PRESENT PAREMESWAREN HARI, MEDICAL COLLEGE OF WISCONSIN, MILWAUKEE, WI - 483 2/11 TO PRESENT WHOLE BLOOD REGULATIONS MTG - TRANS 4/20-21/83 ELIZABETH BARBEHENN PUBLIC CITIZEN FORMS LIRAGLUTIDE - ISR #6532353, EXENATIDE - ISR #6534789, METFORMIN - ISR #6541271 ETC Signature/ Requester CAMIL CONSULTING CORP Subject
Page 626 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/16/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8395 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8396 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8397 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8398 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8399 2011-8400 2011-8401 11/17/2011 12/16/2011 11/17/2011 12/16/2011 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DEN-DO/COMP/ ORA/NE-FO/NYK-DO/NYDCB/ AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS DIANE MARKS TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC HOSPIRA INC, BUFFALO NEW YORK, BUFFALO, NY - 483 1/11 HOSPIRA INC, BOULDER COLORADO , BOULDER, CO - 483 1/11 GENOTROPIN (SOMATROPIN RECOMBINANT) NDA 20-280 SBA AUSTIN NELSON RBC CAPITAL MARKETS HOSPIRA INC, LISCATE ITALY - 483 1/11 AUSTIN NELSON RBC CAPITAL MARKETS HOSPIRA INC,IRUNGATTUKOTAI INDIA , TAMIL NADU, INDIA - 483 1/11 AUSTIN NELSON RBC CAPITAL MARKETS FINSKLIN, SLIGO IRELAND MANUFACTURING, SLIGO, IRELAND - 483 1/11 AUSTIN NELSON RBC CAPITAL MARKETS LA AURORA, COSTA RICA COSTA RICA - 483 1/11 Signature/ Requester RBC CAPITAL MARKETS Subject 483 1/11
Page 627 of 1132

Total Records: 12455 Control # 2011-8402 Recd Date / Due Date 11/17/2011 12/16/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8403 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8404 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8405 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8406 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-8407 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8408 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8409 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SHAN RAJU SLAYBACK PHARMA SANDOZ - KENALOG (TRIAMCINOLONE ACETONIDE INJ ANDA 90-164, ANDA 90-166 SBA ERIN O'BOYLE A P PHARMA SANCUSO (GRANISETRON TRANSDERMAL SYS) NDA -22198/S-005 - QT STUDY 392/MD/39/C CARL ELLIOTT UNIV OF MINNESOTA CENTER FOR BIOETHICS FANAPT/LLOPERIDONE TRIALS - IND 36,827, LURASIDONEL/LATUDA TRIALS - IND 61,292, ASENAPINE/SAPHRIIS TRIALS IND 51,641, IND 70,329, OPEN LABEL STUDY, BIOEQV STUDY, ETC FREUDENTHAL, RALPH I 1-NONANOL (NONYL ALCOHOL) - TOXICOLOGY RECS LEE, YEOLAN ORANGE BOOK 1990 TO 2000 SUSAN MAYER EISAI INC BAYER PHARMACEUTICALS CORP - NEXAVAR (SORABENIB) TABS NDA 21-923 - APRVL PKG 11/16/07 DIANE MARKS TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC NORDITROPIN (SOMATROPIN RECOMBINANT) NDA 19-721 - SBA Signature/ Requester DIANE MARKS TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC Subject HUMATROPE (SOMATROPIN RECOMBINANT) NDA 19-640 SBA
Page 628 of 1132

Total Records: 12455 Control # 2011-8410 Recd Date / Due Date 11/17/2011 12/16/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8411 11/17/2011 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8412 2011-8413 11/17/2011 12/16/2011 11/17/2011 12/16/2011 ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8414 11/17/2011 01/23/2012 2011-8415 2011-8416 2011-8417 2011-8418 2011-8419 11/17/2011 12/16/2011 11/17/2011 01/20/2012 11/17/2011 12/16/2011 11/17/2011 12/16/2011 11/17/2011 12/16/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ McGUIGAN, MICHAEL PATRICIA L. REGENYE Celgene Corporation PATRICIA L. REGENYE Celgene Corporation PATRICIA L. REGENYE Celgene Corporation JAVIER CORTES, HOSP GEN UNIV VALL D'HEBRON/SERV DE ONCOL, BARCELONA, SPAIN - 483 7/10 TO PRESENT OMID ZAMANI, PFAFFSTATTEN, AUSTRIA - 483 10/10 TO PRESENT WERNER ABERER, UNIV CLIN GRAZ DEPT ENVIRONMENTAL DERM VENEREAL DISEASES - 483 2/08 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ McGUIGAN, MICHAEL FDA/OMPT/CDRH/OCER/DFOI/ DR. PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV CAS MEDICAL SYS INC - 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS K033048 ACCURO MEDICAL PRODUCTS - WOUND PRO APEX K100823 KALYPTO MEDICAL - NPD-1000 K080275 KUMAR, ROGER AUSTIN NELSON RBC CAPITAL MARKETS INCIVEK (TELAPREVIR) - AERS HOSPIRA INC, MCPHERSON, KS - 483 1/11 MARYLYNN GRAHAM SNELL & WILMER LAW OFCS FLUCYTOSINE - AERS 1/97 TO PRESENT Signature/ Requester AUSTIN NELSON RBC CAPITAL MARKETS Subject HOSPIRA INC, SAN CRISTOBAL DOMINICAN REPUBLIC 483 1/11
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Total Records: 12455 Control # 2011-8420 2011-8421 2011-8422 2011-8423 Recd Date / Due Date 11/17/2011 12/16/2011 11/17/2011 12/16/2011 11/17/2011 12/16/2011 11/17/2011 12/16/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8424 2011-8425 11/17/2011 12/16/2011 11/17/2011 12/16/2011 2011-8426 11/17/2011 12/16/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ ORA/CE-FO/BLT-DO/CB/ 2011-8427 2011-8428 11/17/2011 12/16/2011 11/17/2011 12/16/2011 2011-8429 11/17/2011 12/16/2011 ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8430 2011-8431 11/17/2011 12/16/2011 11/17/2011 12/27/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ STEPHANIE MENCIMER MOTHER JONES RUCHIKA RAVAL GLOBAL BIOPHARMACEUTICAL REGULATIONS INC MERCK - VARICELLA VIRUS VACCINE LIVE; SANOFI PASTEUR - YELLOW FEVER LIVE ATTENUATED; ORGANON TEKNIKA CORP - BCG LIVE VACCINE, ETC SBA, MINS, CLNCL SUMMARY, ETC NU SKIN, PROVO, UT - AERS 1/08 TO PRESENT Doe J LIST OF PHYSICIANS PROVIDED WITH KEVADON; LIST OF PHYSICIANS RECEIVING THALIDOMIDE FROM SMITH, KLINE & FRENCH CBER/OCTMA/DDOM/ALFB/ JOAN STITT MERCK & CO., INC. RYAN OPGENORTH SELMAN BREITMAN MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 426352-1 RUIZ FOOD PRODUCTS - RANCHERO BEEF & CHEESE TORNADOS RECALL ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ GUIDO, DAWN . ELIZABETH J. MAHONEY BAXTER HEALTHCARE CORPORATION MALIK BROWN BLACK WOLF TECHNOLOGIES LLC NATIONAL GENETICS INSTITUTE, LOS ANGELES, CA - EIR 1/11-21/11 BIOELECTRONICS CORP - CORR 2009 TO PRESENT BREG - PAIN CARE 2000 K983454 THOMAS T-67081, KEITH ALEX SLACK MAVERICK CAPITAL SOLIRIS (ECLIZUMAB) - AERS 7/1/11 TO PRESENT CELEGENE CORP Signature/ Requester PATRICIA L. REGENYE Celgene Corporation Subject ERIC HACHULLA, HOSP MED HURIEZ, LILLE CEDEX, FRANCE - 483 2/09 TO PRESENT XAVIER PIVOT, CHU JEAN MINJOZ UNITE D'ONCOLO MED, BESANCON, FRANCE - 483 9/09 TO PRESENT DOW CORNING - SILICONE IMPLANTS APRVL
Page 630 of 1132

Total Records: 12455 Control # 2011-8432 2011-8433 Recd Date / Due Date 11/17/2011 12/16/2011 11/17/2011 12/16/2011 2011-8434 2011-8435 2011-8436 2011-8437 11/17/2011 12/16/2011 11/17/2011 12/16/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 2011-8438 2011-8439 2011-8440 2011-8441 2011-8442 2011-8443 2011-8444 2011-8445 2011-8446 2011-8447 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ ERNEST R. MARTINEZ PATHFINDER MANAGEMENT INC MELODY BRAATEN RIETZ LAW FIRM LLC CHRIS CELESTE EAS Consulting Group, LLC J ROBERT YEOMAN B & R COMPLIANCE ASSOCIATES LLC SUSAN MULLEN AEGIS REGULATORY INC FRAN KOCH INFORMATION ACCESS SUSAN MULLEN AEGIS REGULATORY INC SUSAN MULLEN AEGIS REGULATORY INC DANIEL CUNNINGHAM REED SMITH LLP SUSAN MULLEN AEGIS REGULATORY INC ROBERT WAGNER AEGIS REGULATORY INC ROBERT WAGNER AEGIS REGULATORY INC DEBI ZURAWSKI Ortho Molecular Products PAMELA NG BSC PHARM DAAVLIN DISTRIBUTING INC - FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT K050695 FERTILITY AND MATERNAL HEALTH DRUGS A/C - MINS 6/20-21/91, 5/20/91. 2/8/91, ETC SOLARC SYSTEM - SOLRX E SERIES UV PHOTOTHERAPY LAMP UNIT K103204 NATIONAL BIOLOGICS - HAND/FOOD UVA/UVB USER'S INSTRUCTION MANUALS K872549 SOLARC - SOLRX 500 SERIES USER'S/INSTRUCTION MANUALS K031800 PHARMICHEM TESTING SERVICES INC, TINLEY PARK, IL EIR MOST RECENT ONDANSETRON - AERS PHILIPS LIGHTING - TL 100W/01 UVB LAMP K910767 2011-6849 OSRAM GMBH - UVA LAMP K812853 BIOCARDIA INC - MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER RPT DKT & DKT LOGS OF 1995P-0197, 1996P-0338, 2001Q-0313, ETC. PURITAN PRODUCTS, BETHLEHEM, PA - EIR 8/11 TO 10/11 IRSSYS INC, SAN DIEGO, CA - EIR, CO RESP 3/16/10 - 4/1/10 Action Office ORA/CE-FO/PHI-DO/PCB/ Signature/ Requester NATHAN A. BEAVER FOLEY & LARDNER LLP SACHITH AMARAKOON TESS AGRO LTD Subject AMERICAN RED CROSS, PHILADELPHIA, PA - EIR 2010 TO PRESENT ENTRY #AMG-0087598-3 - TEST RESULTS
Page 631 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8448 2011-8449 2011-8450 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 2011-8451 2011-8452 2011-8453 2011-8454 2011-8455 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8456 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8457 2011-8458 2011-8459 2011-8460 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 ORA/CE-FO/PHI-DO/PCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ OC/COS/OL/ SLEASMAN, JAMES JN - 6376 NANCY WATZMAN SUNLIGHT FOUNDATION AMY T DAILEY REMINGER ATTY DEBI ZURAWSKI INTERAGENCY WORKING GROUP ON FOOD MARKETED TO CHILDREN - CONGRESSIONAL CORR 3/09 TO PRESENT WELL DIFFERENTIATED SQUAMOUS CELL CARCINOMA FROM A TATTOO - RPTS, CONGRESSIONAL CORR MIDI LABS INC, NEWARK, DE - EIR MOST RECENT ROGER B KAPLAN GREENBERG TRAURIG LLP DR REDDY'S LABOATORIES INC, ST LAURENT, BLAINVILLE MDS INC, MONTREAL, CANADA - EMAILS, MEMOS, NOTES, ETC; MOXIFLAXACIN HCL ANDA 76-938, SETRALINE HCL ANDA 76-442, ONDANSETRON ODT ANDA 76-613, ETC 2006, 2007 DAVOL - BRAND MESH PERFIX PLUGS RECALL RECS ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ DEBI ZURAWSKI Ortho Molecular Products DEBI ZURAWSKI Ortho Molecular Products DEBI ZURAWSKI Ortho Molecular Products DOUGLAS N BLUE ZETETIC INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC PACE ANALYTICAL LIFE SCIENCES, OAKDALE, MN - EIR MOST RECENT COVANCE LABORATORIES INC, MADISON, WI - EIR MOST RECENT LIFESCAN SCOTLAND LTD - ONE TOUCH ULTRA STRIPS ENTRY #ARE-4124638-5/1/1 RECS WATSON LABS - MORPHINE SULFATE ER CAPS NDA 200812 APRVL LTR, LBLG, RVWS, ETC ALKEMISTS LABS, COSTA MESA, CA - EIR MOST RECENT ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/BLT-DO/CB/ DEBI ZURAWASKI Ortho Molecular Products DEBI ZURAWSKI Ortho Molecular Products DEBI ZURAWSKI Ortho Molecular Products EUROFINS SCIENTIFC (PETALUMA) NUTRACEUTICAL LABORATORY, PETLUMA; EUROFINS CENTRAL ANALYTICAL LABS, METAIRIE, LA - EIR MOST RECENT CHROMADEX INC, IRVINE, CA - EIR MOST RECENT ENZITECH LABS, TROY, VA - EIR MOST RECENT Signature/ Requester PRINCESS MARGARET HOSPITAL Subject
Page 632 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/19/2011 2011-8461 2011-8462 2011-8463 2011-8464 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8465 2011-8466 11/18/2011 12/19/2011 11/18/2011 12/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ 2011-8467 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8468 11/18/2011 12/19/2011 2011-8469 2011-8470 11/18/2011 12/19/2011 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8471 11/18/2011 12/19/2011 2011-8472 11/18/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ DAVID PAVLICH DEFOAMER INDUSTRY TRADE ASSN KEITH CHASIN ZICAM INTENSE SINUS RELIEF NASAL SPRAY OR GEL 2011-5503 CBER/OCTMA/DDOM/ALFB/ FERNANDEZ, BETSY REBECCA A BERTONE HANFORD PHARMS FRESENIUS KABI ANTI-INFECTIVES SRL, MILAN, ITALY EIR, 483 2/7-11/11 FDA/OMPT/CDRH/OCER/DFOI/ DARREN REEVES PRECEPT MEDICAL PRODUCTS INC PRECEPT MEDICAL PRODUCTS INC - PRECEPT MICROGARD LASER MASK K891409 HEPATITIS B VACCINE - VAERS KEVIN A KEELING WINSTON & STRAWN LLP LOPROX SHAMPOO MDA 21-159 - RECS Doe J THOMAS M BURTON WALL STREET JOURNAL QUORN - CMPLNTS, INQUIRIES, INVESTIGATIONS INDIVIDUAL RECS Linder, David ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/LOS-DO/LACB/ Action Office Signature/ Requester Ortho Molecular Products DEHI ZURAWSKI Ortho Molecular Products DEBI ZURAWSKI Ortho Molecular Products JUNE M SULLIVAN HALLORAN & SAGE LLP COCENSYS INC, IRVINE ,CA - INVESTIGATION RECS 1994 TO 1996 AMT (ALPHAMETHYLTRYPTAMINE) & 5-MEO-DIPT (5METHOXY-DIISOPROPYLTRYPTAMINE) - TEMPORARY BAN STATUS RECS BROOKS RAND LABS, SEATTLE, WA - EIR MOST RECENT ATLAS BIOSCIENCE INC, TUSCON, AZ - EIR MOST RECENT Subject
Page 633 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/19/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8473 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8474 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8475 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8476 2011-8477 2011-8478 11/18/2011 12/19/2011 11/18/2011 12/19/2011 11/18/2011 12/19/2011 ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ 2011-8479 11/18/2011 12/19/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ PAUL STEPHANO SANFORD C BERNSTEIN & CO LLC BARR LABORATORIES INC, FOREST, VA 4/24/09; TEVA WOMENS HEALTH INC, CINCINNATI, OH 7/1/09; WATSON LABORATORIES INC, SALT LAKE CITY, UT 1/14/11, ETC 483S Doe J ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ EDWARD PATT GREER LABORATORIES INC EDWARD PATT GREER LABORATORIES INC ANTIGEN LABORATORIES INC, LIBERTY, MO - 483S 12/10 TO PRESENT ALLERGY LABORATORIES OF OHIO INC, COLUMBUS, OH 483S 10/09 TO PRESENT INDIVIDUAL RECS CRAIG TRAUTMAN INTAGRAS INC ESTABLISHMENT REGISTRATION LIST Doe J NOLVADEX, SOLTAMOX (TOMOXIFEN) - AERS MICHAEL S SINGER TOPOKINE THERAPEUTICS INC PROSTIN F2 ALPHA NDA 17-434 - MEDICAL, PHARMACOLOGY RVWS Signature/ Requester KEITH CHASIN LAW OFC Subject (OXYMETAZOLINE HCL) - AERS 1/05 TO RPESENT
Page 634 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DEN-DO/COMP/ 2011-8480 11/21/2011 12/20/2011 2011-8481 11/21/2011 12/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8482 11/21/2011 12/20/2011 ORA/NE-FO/NYK-DO/NYDCB/ EGG FOI SERVICES INC Copy of the disclosable portions of the 483 and any related correspondence for the inspection of Dr. Howard Donsky, M.D., located at Dermatology and Cosmetic Center of Rochester LLP, 1338 E. Ridge Rd, Rochester, New York, 14621, which took place probably between 2002 and 2008. The Study title was "A Multicenter Double Blind Randomized Placebo-Controlled Parallel Study of the Safety and Efficacy of Repeated Treatment with One or Two Dosages of Botox (Botulinum Toxin Type A Purified Neurotoxin Complex) for the Treatment of Primary Ancillary Hyperhidrosis." Copy of the disclosable portions of the 510(k) for K112384, Abdominal Tourniquet System,manufactured by Compression Works, LLC.; VICTRELIS - AERS SMITH, KIMBERLY NICK DEMCZUK IENJOY TECHNOLOGIES ENDURANCE THERAPUTICS - TENS T1040 K060846 FDA/OMPT/CDRH/OCER/DFOI/ EGG FOI SERVICES INC John Scappini FOI SERVICES INC Copy of the disclosable portions of the 510(k) for K102025, Combat Ready Clamp,manufactured by Combat Medical Systems, LLC.; Date Range: 05/23/2011 - 10/31/2011; Adverse events for Incivek, also known as Telaprevir, manufactured by Vertex Pharmaceuticals, between 05/23/2011 to 10/31/2011.; Signature/ Requester Subject
2011-8483
11/21/2011 12/20/2011
EGG FOI SERVICES INC
2011-8484 2011-8485
11/21/2011 12/20/2011 11/21/2011 12/20/2011
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
2011-8486 2011-8487 2011-8488
11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 12/20/2011
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OM/OSS/OPILS/FDAHO/ OC/COS/OL/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
NICK DEMCZUK IENJOY TECHNOLOGIES NICK DEMCZUK IENJOY TECHNOLOGIES WOODY, MD, JOE H S ALBERT EDWARDS S ALBERT EDWARDS, PHARM D
HI-DOW INTERNTIONAL - TENS JQ-SCTENS & PMS K102598 KOALATY PRODUCTS INC - TENS 700, EMS 7500 & TWIN STIM PRODS K080661 INTRAOCULAR LENSES - TRANS 1980
2011-8489
11/21/2011 12/20/2011
MCNEIL & JOHNSON & JOHNSON - CLISTIN (CARBINOXAMINE) - ADR
Page 635 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8490 11/21/2011 12/20/2011 2011-8491 11/21/2011 12/20/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/CHI-DO/CCB/ 2011-8492 2011-8493 2011-8494 11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 12/20/2011 2011-8495 11/21/2011 12/20/2011 CVM/OCD/ OC/OCC/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2011-8496 11/21/2011 01/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8497 11/21/2011 01/20/2012 2011-8498 11/21/2011 12/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8499 11/21/2011 FDA/OMPT/CDER/ORP/DIDP/ RISPERDAL, SINEQUAN, CELEXA, TEGRETOL - AER FDA/OMPT/CDRH/OCER/DFOI/ JUDY F. GORDON CLINREG CONSULTING SERVICES INC KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES WARNER CHILCOTT LLC - DORYX (DOXYCYCLINE HYCLATE) LTRS, LBLG, RVWS OPTONOL LTD K012852 FOI SERVICES INC SAFETY RPTS - 5914221-X, 6075639-0, 6142340-4 ETC ORA/CE-FO/DET-DO/DCB/ BARBARA J BUHAI JOSEPH D RYAN PC ASHLEY PETERSON NATIONAL CHICKEN COUNCIL BENJAMIN L LENGLAND BENJAMIN L ENGLAND & ASSOC LLC A LUKE SMITH FARUQI & FARUQI LLP RANBAXY - LIPITOR (ATORVASTATIN) ANDA 76-477 SBA; PFIZER - DKT 2005-0452 11/7/05 WHOLE FOODS MARKET, MAPLE TROY, MI INVESTIGATIVE RECS 1/05 TO PRESENT ALPHARMA - ROXTARSONE STUDY IN CHICKENS TRS MEMOS. TEST, ETC ENTRY U79-0078040-5 - TEST RESULTS, ETC DOUGLAS A ALLISON SUNG SONNY SONG; TRINITY ENTERPRISES, MIGWANG (MIKWANG) - CONTACT LENSES MISLABELING, MISBRANDING, INAPROPRIATE MARKETING, ETC DOUGLAS A ALLISON CIBA - SALE COUNTERFEIT CONTACT LENSES INSIDE OR OUTSIDE THE USA RECS Signature/ Requester Subject
Page 636 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/20/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8500 11/21/2011 12/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8501 11/21/2011 12/20/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8502 2011-8503 2011-8504 2011-8505 2011-8506 11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 12/20/2011 CVM/OCD/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ TRISLER, PATSY CHRIS CELESTE EAS Consulting Group, LLC EGG FOI SERVICES INC Center for Veterinary Medicine FOI Office - Correspondence, submissions, petitions, safety or efficacy data, memoranda, opinion letters and notes of meetings, telephone calls or emails between Royal Canin USA, Inc. (Royal Canin) and the Food and Drug Administration (FDA) relating to the products ROYAL CANIN Veterinary Diet canine URINARY SO and ROYAL CANIN Veterinary Diet feline URINARY SO. Our request also includes the following on the attached letter. Our control number is 5246095.; Date Range: 01/01/2009 - 01/31/2009; Copy of the disclosable portions of the EIR, 483, warning letter, company response, and any related correspondence for the January 2009 inspection of Biocon Limited, located in Bangalore, India.; FDA/OMPT/CDRH/OCER/DFOI/ HENSON SR., J. DONALD SYRINGENE ACETIC ACID PRE FILLED SYRINGE K935643; PRE FILLED SYRINGE WITH STERILE ACETIC ACID K943835 DKT 1995P-0197, 1996P-0338, 2001Q-0313, ETC. FDA/OMPT/CDRH/OCER/DFOI/ KATIE HOENER HENDLERLAW CMPLNT - CPT11000031 LAP BAND - AER DOUGLAS E. CHABOT DECOF & DECOF PC ROCHE - CELLCEPT NDA 50-722, 50-723, 50-758, 50-759 APRVL JIM FAUCETT NORTHWEST CLINICAL RESEARCH CTR CATAPRES TTS (CLONIDINE) NDA 18-891 SBA Signature/ Requester Doe J Subject
2011-8507
11/21/2011 12/20/2011
John Scappini FOI SERVICES INC
Page 637 of 1132

Total Records: 12455 Control # 2011-8508 Recd Date / Due Date 11/21/2011 12/20/2011 2011-8509 2011-8510 2011-8511 2011-8512 2011-8513 2011-8514 2011-8515 11/21/2011 01/23/2012 11/21/2011 12/20/2011 11/21/2011 12/20/2011 11/21/2011 02/15/2012 11/21/2011 02/15/2012 11/21/2011 12/20/2011 11/21/2011 12/20/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8516 11/21/2011 12/20/2011 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ 2011-8517 11/22/2011 12/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-8518 11/22/2011 12/21/2011 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & ASSOC LLC ZHEJIANG OUTLOOK OPTICAL MANUFACTORY CO LTD ENTRY #231-2581173-1/57/3 TEST RESULTS, BILLS OF LADING, PACKING LISTS, ETC JENNY YU GREAT LAKES ABITEC CORP, JANESVILLE, WI; ARKEMA FRANCE, LA CHAMBRE, FRANCE; CATALENT PHARMA SOLUTIONS, ST PETERSBURG, FL, ETC - EIRS MOST RECENT John Scappini FOI SERVICES INC Correspondence between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB) and/or Federal Trade Commission (FTC) regarding the combination of caffeine and alcohol from 2001 to present. FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester EGG FOI SERVICES INC John Scappini FOI SERVICES INC EGG FOI SERVICES INC John Scappini FOI SERVICES INC EGG FOI SERVICES INC EGG FOI SERVICES INC EGG FOI SERVICES INC EGG FOI SERVICES INC EIR, 483, Warning Letter, Company Response and any related correspondence for the July 2011 inspection of Purac Biochem, located in Gorinchem,Netherlands. K093070 K102513 K102465 FCN 1103 Subject Copy of the disclosable portions of the 510(k) for K102586, S9 VPAP Adapt with H5i,manufactured by ResMed Ltd. Our Control Number is 5246100.; Copy of the disclosable portions of the Food Additive Petition 4B3780, as well as corresponding Food Additive Master File 272. K071702
Page 638 of 1132

Total Records: 12455 Control # 2011-8519 Recd Date / Due Date 11/22/2011 12/21/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8520 2011-8521 11/22/2011 12/21/2011 11/22/2011 12/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8522 2011-8523 11/22/2011 12/21/2011 11/22/2011 12/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8524 2011-8525 11/22/2011 12/21/2011 11/22/2011 12/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8526 2011-8527 2011-8528 2011-8529 2011-8530 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC LAURA BAUGHMAN BARON BUDD PC APPLE JUICE, GRAPE JUICE, PEACH SLICES, MIXED FRUIT, ETC - TEST RESULTS, RPTS, CORR, ETC FOI SERVICES INC 2009-1297 FOI SERVICES INC 2008-8263 FOI SERVICES INC 2009-118 2008-7826 FOI SERVICES INC JOJENE E MILLS JOJENE MILLS PC INDIVIDUAL RECS 2008-4764 FOI SERVICES INC FOI SERVICES INC LOHMANN THERAPIE SYSTEME, ANDERNACH, GERMANY EIR 6/14-21/11 2008-2430 FOI SERVICES INC ORA/CE-FO/CHI-DO/CCB/ KEITH JACOBSON JACOBSON AND SCHIEFELBEIN ROLF'S PATISSERIE, LINCOLNWOOD, IL - FOOD CONTAMINATION INVESTIGATION CORR, RPTS, MINS, ETC 2006-6990 Signature/ Requester WILLIAM A GARVIN BUCHANAN INGERSOLL & ROONEY PC Subject COMPAZINE SPANSULE CAPS (PROCHLORPERAZINE MALEATE) NDA 21-019 - SAFETY AND EFFECTIVENESS RECS
Page 639 of 1132

Total Records: 12455 Control # 2011-8531 2011-8532 2011-8533 Recd Date / Due Date 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 2011-8534 2011-8535 2011-8536 2011-8537 2011-8538 2011-8539 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 2011-8540 2011-8541 2011-8542 2011-8543 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 2011-8544 11/22/2011 12/21/2011 2011-8545 11/22/2011 12/21/2011 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ MEYER, CAROLYN JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC HAROLD T DODGE JR RUSH HANNULA ET AL JENS CHAPMAN, MD, SPINAL DVCS ADVISORY PANEL RECS OF TIME IN SERVICE, DUTIES/RESPONSIBILITIES, RPTS JACKED, ANARCHY, FORTHAN, ETC - CAERS FASTIN - CAERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ROCKWELL, APARNA H MARILYNN WHITNEY COVINGTON & BURLING LLP SOFTWARE OR MOBILE MEDICAL CLASSIFICATION APPLS, LAST 5 YRS MERCK - PNEUMONIA 23 VACCINE VAERS MW5022819 SLENDER MEDICAL LTD OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DR LIAT TSOREF SLENDER MEDICAL LTD MEDICIS TECHNOLOGIES CORP, WASHINGTON, DC LIPOSONIX SYS MODEL 1 POOXXXX, K100874 ULTHERA INC, MESA, AZ - ULTHERA SYS MODEL 88500001 K072505 FDA/OMPT/CDRH/OCER/DFOI/ ROCKWELL, APARNA H CECELIA FRENCH CanReg, Inc. CLOSED FOI REQUESTS 11/14-18/11 CLOSED FOI REQUESTS 11/14-18/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ROCKWELL, APARNA H MW5022817 Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ MILLS #09-b-1746, JAMES G DEBI COHEN WOLTERS KLUWER LAW & BUSINESS MW5022818 CLOSED FOI REQUESTS 11/14-18/11 LILL, NINA Signature/ Requester Subject NEUROSCIENCE LABS, PHARMASAN LABS, OSCEOLA, WI CMPLNTS, LTRS, ACTIONS, ETC LICORICE ROOT, GINGER ROOT, MILKWEED - STUDIES
Page 640 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OES/ 2011-8546 11/22/2011 12/21/2011 2011-8547 11/22/2011 12/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8548 11/22/2011 12/21/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8549 2011-8550 2011-8551 2011-8552 2011-8553 2011-8554 2011-8555 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/22/2011 12/21/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ HERALD, BRUCE ALAN CHRIS CELESTE EAS Consulting Group, LLC HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION ORA/NE-FO/NWE-DO/NWECB/ HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION ORA/SE-FO/FLA-DO/FCB/ HAIUYEN NGUYEN CREATIONS GARDEN NATURAL PRODUCTS INC, VALENCIA, CA - 8/13/09; FINESSE MILLS LLC, WATSONVILLE, CA 7/24/09; FORMULATION TECHNOLOGY INC, OAKDALE, CA 8/13/10, ETC - EIRS, 483S CEVAN INTERNATIONAL, UNITDRUG CO LLC, 9/8/10; LONGMONT, CO, CENTENNIAL, CO, 10/15/09, ETC - EIRS, 483S THOMPSON BRANDS LLC, MERIDAN, CT 5/18/10; ULTIMATE NUTRITION INC, FARMINGTON, CT, 18/10 ETC - EIRS, 483S FLORIDA SUPPLEMENT LLC, HOLLYWOOD, FL 4/21/10 DKT 1996P-0338 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL A LOCKE IMMUNOSTICS INC MICHAEL A LOCKE IMMUNOSTICS INC MICHAEL A LOCKE IMMUNOSTICS INC MICHAEL A LOCKE IMMUNOSTICS INC VARIAN MEDICAL SYSTEMS INC - TRUEBEAM, K111106 MEDTEK LLC, MORRISVILLE, NC - LIFEGUARD (REAGENT OCCULT BLOOD), K022755 MED TECH PRODUCTS INC, MIAMI, FL - ACCESS HEMA WIPE, K843601 MED TECH PRODUCTS INC, MIAMI FL - ACCESS HEMA WIPE, K843601 MEDTEK LLC, MORRISVILE, NC - LIFEGUARD, K022755 CHARLES GILVARG PRINCETON UNIV/MOLECULAR BIOLOGY BRISTOL MYERS SQUIBB - ONGLYZA AERS 4/11 TO PRESENT FDA/OF/CFSAN/OCD/EOS/ JOHN DOHERTY IOVATE HEALTH SCIENCES RESEARCH INC CAHRLES GILVARG PRINCETON UNIV/MOLECULAR BIOLOGY NOVO NORDISK - VICTOZA AERS 4/11 TO PRESENT HERB ROBERT, RED ROBIN, CRANESBILL, ETC - CAERS Signature/ Requester Subject
2011-8556
11/23/2011 12/22/2011
2011-8557
11/23/2011 12/22/2011
2011-8558
11/23/2011
Page 641 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/22/2011 2011-8559 11/23/2011 12/22/2011 2011-8560 11/23/2011 12/22/2011 2011-8561 11/23/2011 12/22/2011 ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ Action Office Signature/ Requester COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8564 2011-8565 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8566 11/23/2011 12/22/2011 2011-8567 11/23/2011 12/22/2011 2011-8568 2011-8569 2011-8570 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ AMY L GOERESS HODGSON RUSS LLP AMY L GOERSS HODGSON RUSS LLP AMY L GOERSS HODGSON RUSS LLP Z-0080-2007 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC Z-2838-2011 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC Z-2799-2011 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC AMY L GOERSS HODGSON RUSS LLP Z-1150-2010 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC AMY L GOERSS HODGSON RUSS LLP Z-0250-2009 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC AMY L GOERSS HODGSON RUSS LLP AMY LL GOERSS HODGSON RUSS LLP Z-1592-2011 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC Z-0074-2010 - HEALTH HAZARD EVALUATION, RECALL CLASSIFICATION, ETC AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS BERTEK PHARMACEUTICALS, SUGAR LAND, TX - 483 1/11 Subject NATURAL WELLNESS LLC, DEERFIELD BEACH, FL 6/30/10, ETCS; ; LEX INC, MEDLY, FL , 483S 9/28/10, ETC - EIRS, 483S HI TECH PHARMACEUTICAL, NORCROSS, GA - EIRS, 483S 12/8/09 NOW FOODS (THE FRUITFUL YIELD INC), BLOOMINGDALE, IL - EIRS, 483S 2/23/10; OPTIMUM NUTRITION, AURORA, IL EIRS, 483S 4/15/10 BRONSON NUTRITIONALS LLC, FUTUREBIOTIC LLC, HAUPPAUGE, NY 12/8/09 ETC ; COMPLEMAR PARTNERS INC, ROCHESTER, NY 9/7/10, ETC; DANBURY PHARMA LLC, FREEPORT, NY 9/9/10 ETC - EIRS, 483S MYLAN TECHNOLOGIES, ST ALBANS, VT - 483 1/11
2011-8562 2011-8563
11/23/2011 12/22/2011 11/23/2011 12/22/2011
Page 642 of 1132

Total Records: 12455 Control # 2011-8571 2011-8572 2011-8573 2011-8574 2011-8575 2011-8576 2011-8577 2011-8578 Recd Date / Due Date 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8579 2011-8580 2011-8581 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8582 11/23/2011 12/22/2011 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8583 11/23/2011 12/22/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ NIR BARAK MD MOR RESEARCH APPLICATIONS LTD SCHERING - HYPERSTAT (DIAZOXIDE) NDA 16-996 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ AMY L GOERSS HODGSON RUSS LLP MELODY BRAATEN RIETZ LAW FIRM LLC BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & ASSOC LLC JOANNE S HAWANA ARENT FOX LLP BIOCARDIA INC - MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER RPT ZHEJIANG OUTLOOK OPTICAL MANUFACTORY CO LTD ENTRY #231-2581173-1/57/3 TEST RESULTS, BILLS OF LADING, PACKING LISTS, ETC SEPTOCAINE INJ, ARTICAINE HCL - ISRS 7398167, 7407802, 7412373, ETC IVOCLAR VIVADENT INC, BUFFALO, NY - EIR 2011 Signature/ Requester BRIAN SMITH LEXIS NEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC WILLIAM A GARVIN BUCHANAN INGERSOLL & ROONEY PC COMPAZINE (PROCHLORPERAZINE MALEATE) SPANSULE CAPS NDA -21-019 - SBA 2009-870 2008-2701 2009-4284 2010-334 2009-4284 2008-2013 Subject 2008-1900
Page 643 of 1132

Total Records: 12455 Control # 2011-8584 Recd Date / Due Date 11/23/2011 12/22/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8585 11/23/2011 12/22/2011 2011-8586 11/23/2011 12/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8587 11/23/2011 12/22/2011 2011-8588 2011-8589 2011-8590 2011-8591 2011-8592 2011-8593 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ AMBROSIA WALSH STRAUMANN USA LLC SUZANNE D JENSEN KLEINFELD KAPLAN & BECKER NYROBIA FREEMAN CONMED LINVATEC CORP KATHERINE FEDDER NEOGEN CORP NYROBIA FREEMAN CONMED LINVATEC CORP MELISSA A BLANKINSHIP FISHER KANARIS PC NYROBIA FREEMAN CONMED LINVATEC CORP ARTHROCARE CORP, SUNNYVALE. CA - ARTROCARE SYS 2000 CONTROLLER; CABLE, FOOTSWITCH, ETC K001588 SPARHAWK LABORATORIES INC, LEXENA, KS - EIR, 483, CO RESP, ETC MOST RECENT ARTHROCARE CORP, SUNNYVALE, CA - ARTHROCARE SYS, K032504 PHUSION PROJECTS LLC - FOUR LOKO WARNING LTRS, CORR, PROD SEIZURE, ETC ARTHROCARE CORP, SUNNYVALE, CA - ARTHROCARE SYS 15000 CONTROLLER MODEL 72202149; ARTHROCARE ARTHROWANDS, MODEL 72202139, 72202141, 72202143 ETC, K090393 LA LA'S LIQUID HERBS, TORONTO, OH - EIR, 483 9/22/10 OSTEOHEALTH - GEM 21s (GROWTH-FACTOR ENHANCED MATRIX), INVESTIGATION, RPTS, MTG RECS ETC & SALE/MARKETING CLAIMS TOBACCO MFRS - INSP RECS ROGER B KAPLAN ESQ GREENBERG TRAURIG LLP DR REDDY'S LABORATORIES INC - MOXIFLOXACIN HCI ANDA 76-938, SERTRALINE HCI ANDA 76-442, ONDANSETRON ODT ANDA 76-613, ETC MEMOS, NOTES, MINS, ETC 2005-2007 KENYON, TYLER SORIN CRM SAS 6/29/11; STERIGENICS, SMYMA, GA 5/26/11; STERIGENICS, WESTERVILLE, OH 11/8/11 ETC - 483S Signature/ Requester FRANK TRUSLOW SIGMA CAPITAL MANAGEMENT LLC Subject INCIVEK (TELAPREVIFR) - AERS 5/1/11 TO PRESENT
2011-8594
11/23/2011 12/22/2011
ORA/CE-FO/CIN-DO/CCB/
HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION
2011-8595 2011-8596
11/23/2011 12/22/2011 11/23/2011 01/09/2012
NYROBIA FREEMAN CONMED LINVATEC CORP NYROBIA FREEMAN CONMED LINVATEC CORP
ARTHROCARE CORP, SUNNYVALE, CA - ARTHROCARE SYS 12000 K071709 JOHNSON & JOHNSON CO, RAYNHAM, MA - VAPR VUE RADIO FREQUENCY SYS, MODEL 225024; VPR VUE WIRELESS FOOTSWITCH MODEL 227214 K100638
Page 644 of 1132

Total Records: 12455 Control # 2011-8597 Recd Date / Due Date 11/23/2011 12/22/2011 2011-8598 2011-8599 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8600 2011-8601 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8602 2011-8603 2011-8604 11/23/2011 01/09/2012 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8605 11/23/2011 12/22/2011 2011-8606 11/23/2011 12/22/2011 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8607 2011-8608 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8609 11/23/2011 12/22/2011 ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ SUSANNE C PANZERA BIOSTAT INTERNATIONAL INC HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION MARTEK BIOSCIENCES CORP, WINCHESTER, KY - EIR, 483 8/3/10 NEWLANDS CLINICAL TRIALS LTD - VEINWAVE/TC3000 K083352 METABOLIC TECHNOLOGIES INC, AMES, IA - EIR, 483 2/5/09 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/P-FO/SEA-DO/SCB/ Signature/ Requester HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION NYROBIA FREEMAN CONMED LINVATEC CORP HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION NYROBIA FREEMAN CONMED LINVATEC CORP HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION NYROBIA FREEMAN CONMED LINVATEC CORP NYROBIA FREEMAN CONMED LINVATEC CORP NYROBIA FREEMAN CONMED LINVATEC CORP HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION STRYKER ENDOSCOPY, SAN JOSEM, CA - SERFAS ENERGY SYS K041810 NUTRA MANUFACTURING, ANDERSON, SC 7/26/10, GREENVILLE, SC 7/22/10 - EIR, 483 STRYKER ENDOSCOPY, SAN JOSE, CA - STRYKER CROSSFIRE SYS K071859 ARTHREX INC, NAPLES, FL - ELECTRODES & ACCESSORIES, K023986 DEPUY MITEK (JOHNSON & JOHNSON), NORWOOD, MA VAPR 3 ELECTROSURGICAL SYS; VAPR LD & LP SUCTION ELECTRODES K041135 CHISM HARDY ENTERPRISES LLC (HARDY BOTTLING CO), MEMPHIS, TN - EIR, 483 2/12/10 JLM PHARMATECH INC, SEYMOUR, IN - EIR, 483 9/17/09 Subject INDEPENDENT NUTRITION CENTER INC, EUGENE, OR 1/12/10; VITAPURITY CORP, CENTRAL POINT, OR 5/20/10 EIR, 483 MITEK PRODUCTS, NORWOOD, MA - VAPR TC ELECTRODE FOR USE W/VAPR II 3 ELECTROSURGICAL SYS K002402 HVL LLC, PITTSBURGH, PA - EIR, 483 12/17/09
Page 645 of 1132

Total Records: 12455 Control # 2011-8610 Recd Date / Due Date 11/23/2011 12/22/2011 2011-8611 11/23/2011 12/22/2011 Action Office ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/OE/ ORA/OE/ 2011-8612 11/23/2011 12/22/2011 2011-8613 2011-8614 2011-8615 2011-8616 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 12/22/2011 ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8617 2011-8618 11/23/2011 12/22/2011 11/23/2011 12/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ JOAN STITT MERCK & CO., INC. HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/MIN-DO/MCB/ HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION ORA/CE-FO/BLT-DO/CB/ HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION NUTRI SPORT PHARMACAL INC, FRANKLIN, NJ 9/8/10; NUTRO LABS, S PLAINFIELD, NJ 12/23/08; PHARMACHEM LABORATORIES INC, SOUTH HACKENSACK, NJ 9/24/10, ETC - EIR, 483 CENTURY FOOD INTERNATIONAL, SPARTA, WI 9/30/10; LOTUS BRANDS INC, SILVER LAKE, WI 4/8/10 - EIR, 483 CENTURY FOOD INTERNATIONAL, SPARTA, WI 9/30/10; LOTUS BRANDS INC, SILVER LAKE, WI 4/8/10 - EIR, 483 HELMS CANDY COMPANY INC, BRISTOL, VA 5/5/10; HERITAGE STORE INC, VIRGINIA BEACH, VA 9/29/10 - EIR, 483 2011-7332 ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS TYLER KENYON NORTHCOAST RESEARCH BIOMET INC, WARSAW, IN; ZIMMER HOLDINGS INC, WARSAW, IN; ASCENSION ORTHOPEDICS, AUSTIN, TX 483 MYLAN INC, CAGUAS, PUERTO RICO - 483 1/11 TO PRESENT UDL LABS, ROCKFORD, IL - 483 1/11 TO PRESENT INNOVATIVE FULFILLMENT SOLUTIONS LLC, RIVERSIDE, MO 6/11/10; RELIV INTERNATIONAL INC, CHESTERFIELD, MO 9/17/09 - EIR, 483 DEY PHARMA, NAPA, CA - 483 1/11 TO PRESENT Signature/ Requester HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL Subject LIVING ESSENTIALS LLC, FARMINGTON, MI 2/9/10; XELA PACK INC, BRIDGEWATER, MI 10/14/09 - EIR, 483
RECALLS AND EIRS REGULATED BY FDA SINCE 2000
2011-8619
11/23/2011 12/22/2011
2011-8620
11/23/2011 12/22/2011
2011-8621
11/23/2011 12/22/2011
Page 646 of 1132

Total Records: 12455 Control # 2011-8622 Recd Date / Due Date 11/23/2011 12/22/2011 Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester HAIUYEN NGUYEN COUNCIL FOR RESPONSIBLE NUTRITION FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8624 11/23/2011 12/22/2011 2011-8625 2011-8626 11/23/2011 12/22/2011 11/23/2011 02/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-8627 11/23/2011 12/22/2011 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-8628 2011-8629 11/23/2011 12/22/2011 11/23/2011 12/22/2011 ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD O. WOOD WOOD BURDITT GROUP KATHLEEN E. KUNTZ FRIEDMAN GAYTHWAITE WOLF ET AL WEAC PROTOCOL FOR VISUAL TESTING; PASS FAIL CRITERIA JOERNS HEALTHCARE SUNRISE MEDICAL RPT REGARDING THE BIDDEFORD MAINE NURSING HOME 7/27/09 SYDNEY FREEDBERG ST PETERSBURG TIMES FOREIGN DENTAL LABS - INSP, WARNING LTRS, CMPLNTS 2006 TO PRESENT JOAN STITT MERCK & CO., INC. EMILIE R. CAULFIELD SEGAL MCCAMBRIDGE SINGER ET AL CORR FROM NEAL M BENOWITZ MD TO FDA 2011-2570 WEIL, RALPH NEPHROS INC - CORR TYLER KENYON NORTHCOAST RESEARCH Subject SCHIFF NUTRITION INTERNATIONAL INC, SALT LAKE CITY, UT 9/16/09; VMI NUTRITION, SALT LAKE CITY, UT 6/15/10; NELLSON NUTRACEUTICALS POWDER DIVISION, SALT LAKE CITY, UT 1/20/10 - EIR, 483 DEPUY, WARSAW, IN; HILL-ROM, BATESVILLE, IN; INTEGRA, BURLINGTON, MA - 483S
2011-8623
11/23/2011 12/22/2011
Page 647 of 1132

Total Records: 12455 Control # 2011-8630 Recd Date / Due Date 11/23/2011 12/22/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8631 2011-8632 11/23/2011 12/22/2011 11/23/2011 12/22/2011 2011-8633 2011-8634 2011-8635 11/23/2011 12/22/2011 11/23/2011 12/22/2011 11/23/2011 01/18/2012 2011-8636 11/23/2011 12/22/2011 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8637 11/25/2011 12/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8638 2011-8639 2011-8640 11/25/2011 12/23/2011 11/25/2011 12/23/2011 11/25/2011 12/23/2011 ORA/ ORA/ ORA/SWFO/SWID/COMPLIANCE/ 2011-8641 11/25/2011 12/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DR. ANJA OP DE BEKKE DIAPHARM REGULATORY FLUTICASONE PROPIONATE NASAL SPRAY- PSURS SAFETY RELEVANT DATA FDA/OMPT/CDRH/OCER/DFOI/ KOSTELOC, BRYAN ADRIANA KING KING MIDAS ORA/CE-FO/MIN-DO/MCB/ DON WERFELMANN SARA LEE XOMED-TREACE INC, JACKSONVILLE FL TYMPANOSTOMY (VENTILATION) TUBE K941407 ACS/FDA 001/001 HOLA PLUM WITH CHILI ENTRY #1751914329-5 - LAB RESULTS SARA LEE , SIOUX FALLS, SD - EIR 3/9/11 ALDANA, MARK ENTONOX (NITROUS OXIDE/OXYGEN MIX); NITRONOX (NITROUS OXIDEN/OXYGEN MIX); NITROUS OXIDE (100% NITROUS OXIDE) - DESI RVW, DRUG EFFICACY STUDY RECS, NOTICE OPPORTUNITY HEARINGS ETC CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ MELODY BRAATEN RIETZ LAW FIRM LLC MELODY BRAATEN RIETZ LAW FIRM LLC BRADFORD P. KLAGER LAW OFFICES OF DOULGAS A ALLISON RUDYS HONEY, LIVINGSTON, TX - INSP 8/24/10 JETT, CLODIA BIOCARDIA INC - MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER AER 1/14/10 TO PRESENT BIOCARDIA INC - UNIVERSAL DEFLECTABLE GUIDE CATHETER AER 5/26/11 TO PRESENT MW #30000203549-2011-00001 ELLEN GABLER CHICAGO TRIBUNE ANNE MUTASHI HOGAN LOVELLS US LLP CORR BETWEEN FDA & AMERICAN ACADEMY OF AUDIOLOGY - 1/11 TO PRESENT EVANGERS DOG & CAT FOOD - CORR 3/10 Signature/ Requester KAYLEE WHITE SALAMANDRA LLC Subject LUNELLE - PHARMACIA NDA 20-874
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8642 11/25/2011 12/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8643 2011-8644 2011-8645 11/25/2011 12/23/2011 11/25/2011 12/23/2011 11/25/2011 12/23/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8646 11/25/2011 12/23/2011 2011-8647 2011-8648 11/25/2011 12/23/2011 11/25/2011 12/23/2011 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ 2011-8649 2011-8650 2011-8651 2011-8652 11/25/2011 12/23/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC ROBERT M ROSEMAN SPECTOR ROSEMAN KODROFF ABBOTT LABS - DEPAKOTE, DEPAKOTE ER, DEPAKOTE SPRINKLE CAPS (DIVALPROEX SODIUM) WARNING LTRS, EIRS, AERS, ETC FOI SERVICES INC 2009-9888 OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP 2009-6525 DKT FDA-2010-P-0491 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ ORA/SE-FO/SJN-DO/SJCB/ LEN BOSELOVIC PITTSBURG POST-GAZETTE STEPHANIE S WILSON WUSA 9 MYLAN, CAGUAS, PR - EIRS, 483S, CORR ETC, 1/24/11 TO PRESENT DEER PARK BOTTLED WATER - INSPECTION RECS, AERS 11/1/09 TO PRESENT JONATHAN W EMORD EMORD & ASSOCIATES, P.C. ALBION INTERNATIONAL INC (ALBION LABS INC) CHELATES PRODS - CORR, PRESS RELEASES, NOTICES, ETC ORA/OCI/ ORA/OCI/ CBER/OCTMA/DDOM/ALFB/ Doe J LAUREEN E LITTLE BIOTECH LOIS ZIEBOL PURSUIT VASCULAR 3M - PERIDEX 019028; DEXCEL PHARMA - PERIOCHIP 020774; COLGATE - PERIOGARD 073695 CASSS BIOASSAY CONFERENCE - SLIDES INDIVIDUAL RECS DR ANJA OP DE BEKKE DIAPHARM REGULATORY SERVICES GMBH BUDESONIDE NASAL SPRAY - PSURS SAFETY RECS Signature/ Requester SERVICES GMBH Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ 2011-8653 2011-8654 2011-8655 2011-8656 2011-8657 2011-8658 2011-8659 2011-8660 2011-8661 2011-8662 2011-8663 2011-8664 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 ORA/CE-FO/MIN-DO/MCB/ FOI SERVICES INC ORA/CE-FO/MIN-DO/MCB/ FOI SERVICES INC MEDTRONIC, FRIDLEY, MN - EIR, 483, CO RESP 7/10 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FOI SERVICES INC FOI SERVICES INC MEDTRONIC, FRIDLEY, MN - EIR, 483, CO RESP 8/10 TO PRESENT MEDTRONIC, FRIDLEY, MN - EIR, 483, CO RESP 3/09 FOI SERVICES INC 2011-763 FOI SERVICES INC 2011-129 FOI SERVICES INC 2010-8231 FOI SERVICES INC 2010-6940 FOI SERVICES INC 2010-4850 FOI SERVICES INC 2010-4124 FOI SERVICES INC 2010-4119 FOI SERVICES INC 2010-4118 2010-3274 Signature/ Requester & WILLIS PC Subject
Page 650 of 1132

Total Records: 12455 Control # 2011-8665 Recd Date / Due Date 11/28/2011 12/27/2011 Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ 2011-8666 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8667 2011-8668 11/28/2011 12/27/2011 11/28/2011 01/23/2012 2011-8669 11/28/2011 12/27/2011 2011-8670 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8671 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8672 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8673 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8674 11/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ JAMES B OSBORN ALIGN TECHNOLOGY INC - INVISALIGN K081960 NARINE DEMIRCHIAN ODAN LABORATORIES LTD ASTRAZENECA - XYLOCAINE (LIDOCAINE) NDA 14-394, NDA 10-417 SBA SAMSUNG MEDISON CO LTD SAMSUNG MEDISON CO LTD, SEOUL, KOREA - EIR 2008 DENNIS W MORROW DRINKER BIDDLE REATH LLP ZYPREXA - PI 10/03, 8/09, 12/09, 6/11 (CERTIFIED) Doe J ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SEA-DO/SCB/ Doe J TODD A HARRISON VENABLE LLP FRANK TRUSLOW SIGMA CAPITAL MANAGEMENT LLC SEATTLE SPERM BANK LLC - INVESTIGATION RECS, WARNINGS GARDEN STATE NUTRIONALS (VITAQUEST), WEST CALDWELL, NJ - EURSM 483S, CO RESP, ETC 1/09 TO PRESENT VIROPHARMA, SANGUIN - 483S, WARNING LTRS 1/09 TO PRESENT INDIVIDUAL RECS Doe J INDIVIDUAL RECS Signature/ Requester ERIC HAGEMAN PRITZKER OLSEN Subject INDIVIDUAL RECS
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Total Records: 12455 Control # Recd Date / Due Date 12/27/2011 2011-8675 11/28/2011 12/27/2011 2011-8676 2011-8677 2011-8678 2011-8679 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8680 11/28/2011 12/27/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8681 2011-8682 2011-8683 2011-8684 2011-8685 2011-8686 2011-8687 11/28/2011 01/30/2012 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/28/2011 12/27/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. FOI DAILY LOG 114-18/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC Doe J BOSTON SCIENTIFIC NEUROMODULATION, VALENCIA, CA EIR, 483, CO RESP, ETC 2/10 BOSTON SCIENTIFIC NEUROMODULATOR, VALENCIA, CA EIR, 483, CO RESP, ETC 3/10 FOI DAILY LOG 11-21-25/11 FOI SERVICES INC INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC 2009-6163 CR BARD - VENTRALEX ST HERNIA PATCH K101928 AUSTIN NELSON RBC CAPITAL MARKETS HOSPIRA INC, MULGRAVE NORTH VIC, AUSTRALIA - 483 1/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ JAMES B OSBORN A2 LAB JAMES B OSBORN A2 LAB JAMES B OSBORN A2 LAB AUSTIN NELSON RBC CAPITAL MARKETS HOSPIRA INC, TAMIL NADU, INDIA - 483 1/11 TO PRESENT ALLESEE ORTHODONTIC APPLIANCES INC - RED, WHITE & BLUE K040874 ALLESEE ORTHODONTIC APPLIANCES INC - FS ALIGNER K093821 CLEARCORRECT INC - CLEARCORRECT K082556 JAMES B OSBORN A2 LAB ALIGN TECHNOLOGY INC - INVISALIGN K981095 Signature/ Requester A2 LAB Subject
Page 652 of 1132

Total Records: 12455 Control # 2011-8688 2011-8689 2011-8690 2011-8691 2011-8692 2011-8693 Recd Date / Due Date 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 2011-8694 11/29/2011 12/28/2011 2011-8695 11/29/2011 12/28/2011 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8696 11/29/2011 12/28/2011 ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/DET-DO/DCB/ 2011-8697 11/29/2011 12/28/2011 2011-8698 2011-8699 11/29/2011 12/28/2011 11/29/2011 12/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ PAULL KOSTERS DEMCON ADVANCED MECHATRONICS BV PETER D LOFTUS DOW JONES & CO INC CAROLE MITNICK SCD HARVARD MEDICAL SCHOOL DEPT OF GLOBAL HEALTH & SOCIAL MEDICINE FINAPRES MEDICAL SYSTEMS BV - PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR MODEL 2 K023338 BEN VENUE LABORATORIES INC, BEDFORD, OH - 483 7/11 TO PRESENT SANOFI AVENTIS - RIFADIN (RIFAMPIN) NDA 50-627, NDA 62-303 SBA JP DEATON SERVICE CENTER LLC OXYGEN GAS CYLINDER - INVESTIGATION, ATTACHMENTS, SUMMARY RPTS, ETC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. PATRICIA L REGENYE CELEGENE CORP PATRICIA L REGENYE CELEGENE CORP PATRICIA LL REGENYE CELEGENE CORP PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV PAUL KOSTERS DEMCON ADVANCED MECHATRONICS BV DANIELLE SPICER AMWAY CORP FORMOSA LABORATORIES INC, TAOYUAN, TAIWAN - EIRS, 483S 6/15-18/09 ROBERT SCHILZ, CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH - 483S 9/05 TO PRESENT JAMES STOCKS, UNIVERSITY OF TEXAA HEALTH CENTER TYLER, TYLER, TX - 483S 9/09 TO PRESENT CAS MEDICAL SYSTEMS INC - 75OC SERIES NONITOR K050844 BMEYE BV - NEXFIN MODEL 2 K072049 DANIEL LORCH, BRANDON, FL - 483S 2/09 TO PRESENT FOI DAILY LOG 10/31/11-11/4/11 Subject FOI DAILY LOG 11/7-11/11
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Total Records: 12455 Control # 2011-8700 Recd Date / Due Date 11/29/2011 01/31/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-8701 11/29/2011 12/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8702 2011-8703 11/29/2011 12/28/2011 11/29/2011 12/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8704 11/29/2011 12/28/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8705 11/29/2011 12/28/2011 2011-8706 11/29/2011 12/28/2011 CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ 2011-8707 2011-8708 2011-8709 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ DIEDRICH, JOHN DIEDRICH, JOHN DREW BARLOW VERTEX PHARMACEUTICALS INC ROCKLINE INDUSTRIES, SPRINGDALE, AR - WIPES RECALL RPT 2006-2007 ALMAC PHARMA SERVICES, ARMAGH, UK - QUALITY ASSURANCE PROFILE (QAP) COSMETIC ESTABLISHMENT DATABASE SUSAN BASS BIG CAT RESCUE PETAG INC - KMR, ESBILAC INVESTIGATIONS, CORR JILLIAN NASH ALLTECH INC YUCCA SCHIDIGERA EXTRACT - APRVL, NO OBJECTION LTRS Doe J CLARAVIS - AERS Doe J ORA/CE-FO/NJ-DO/NJCB/ VICTORIA SCOTT HEMISPHERX BIOPHARMA HEMISPHERX BIOPHARMA INC, NEW BRUNSWICK, NJISNP MEMO 9/6/11 AMGEN - PROLIA AERS CHRISTINE POLLOCK GALDERMA RESEARCH & DEVELOPMENT AKZO NOBEL CHEMICALS SA DE CV, EDO MEX, MEXICO 483 10/18/07 Signature/ Requester DEBORAH THOMPSON MPH NEW ALLIANCE PHARMACEUTICALS Subject BB-IND 6195 - STUDY RPTS, PROTOCOLS
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8710 2011-8711 2011-8712 2011-8713 2011-8714 2011-8715 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/29/2011 12/28/2011 11/30/2011 12/29/2011 11/30/2011 01/25/2012 11/30/2011 01/11/2012 2011-8716 2011-8717 2011-8718 2011-8719 2011-8720 11/30/2011 12/29/2011 11/30/2011 02/07/2012 11/30/2011 12/29/2011 11/30/2011 02/03/2012 11/30/2011 12/29/2011 2011-8721 2011-8722 11/30/2011 12/29/2011 11/30/2011 12/29/2011 2011-8723 2011-8724 11/30/2011 12/29/2011 11/30/2011 12/29/2011 ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS INTERNATIONAL ISOTOPES INC, IDAHO FALLS, ID - EIRS, 483S, CO RESP 7/18-22/11 GENENTECH, SAN FRANCISCO, CA - EIRS, 483S, CO RESP 6/11 LESLIE E DIAZ MD (INFECTIOUS DISEASE ASSOCIATES OF THE PALM BEACH), NORTH PALM BEACH, FL - EIRS, 483S, CO RESP 1/12/11-3/8/11 BIOGEN IDEC, RESEARCH TRAINGLE PARK, NC - EIRS, 483S, CO RESP 4/10-18/07 MICHAEL DEAN BERGER MD (IMMUNOVATIVE CLINICAL RESEARCH INC), CARLSBAD, CA - EIRS, 483S, CO RESP 4/27/10-6/10/10 POINTCARE TECHNOLOGIES, MARLBOROUGH, MA - EIRS, 483S, CO RESP 3/25/11-4/28/11 ASTRAZENECA, WESTBOROUGH, MA - EIRS, 483S, CO RESP 4/13-27/11 GENENTECH, SAN FRANCISCO, CA - EIRS 9/2-27/11 INVACARE, SANFORD, FL - EIRS 8/2-18/10 CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ PATRICIA L REGENYE CELEGENE CORP PATRICIA L REGENYE CELEGENE CORP PATRICIA L REGENYE CELEGENE CORP WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS CSL BEHRING, MARBURG, DEUTSCHLAND - EIRS, 483S, CO RESP 3/10 ZIMMER, WARSAW, IN - EIRS, 483S, CO RESP 7/6-22/11 RODOLFO POSADAS-VALAY, FACULTAD DE MED HOSP UNIV, MONTERREY NL, MEXICO - 483S 7/09 TO PRESENT WAN-LONG CHUANG, KAOHSIUNG MED UNI HOSPITAL, KAOHSIUNG, TAIWAN - 483S 5/10 TO PRESENT FERNANDO MARTINEZ, UNIV OF MICHIGAN MEDICAL CENTER, ANN ARBOR, MI - 483S 1/10 TO PRESENT OPTILASA SA, MADRID, SPAIN - EIRS, 483S, CO RESP 6/10 Signature/ Requester Subject
Page 655 of 1132

Total Records: 12455 Control # 2011-8725 Recd Date / Due Date 11/30/2011 12/29/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8726 2011-8727 2011-8728 2011-8729 2011-8730 2011-8731 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 01/25/2012 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8732 2011-8733 11/30/2011 01/25/2012 11/30/2011 12/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8734 11/30/2011 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8735 11/30/2011 12/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8736 11/30/2011 FDA/OMPT/CDER/ORP/DIDP/ WALTER E. CHALKLEY OCTAPHARMA AB, STOCKHOLM, SWEDEN - EIR, 483 1/09 WALTER E. CHALKLEY THOMSON REUTERS ELI LILLY & CO LTD, LIVERPOOL, UK - EIR, 483 5/09 LARS GRABERGS SCANDINAVIAN REGULATORY SESRVICES NEURO PEPTIDE Y (NPY) - IND 76.882 NON-CLNCL SAFETY RECS, SAFETY ASSESMENT RECS CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY THOMSON REUTERS WALTER ECHALKLEY THOMSON REUTERS BAXTER BIOSCIENCE, VIENNA, AUSTRIA - EIRS, 483S, CO RESP 1/10 FUJI CHEMICAL INDUSTRY CO LTD, NAKANIIKAWA-GUN, JAPAN - EIRS, 483S, CO RESP 6/10 ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/SJN-DO/SJCB/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/CHI-DO/CCB/ ORA/NE-FO/NYK-DO/NYDCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS PFIZER, NEW YORK, NY - EIRS, 483S, CO RESP 6/26/098/10/09 MEDEFIL INC, GLENDALE HEIGHTS, IL - EIRS, 483S, CO RESP 9/09 BAXTER BIOSCIENCES, LESSINES, BELGIUM - EIRS, 483S, CO RESP 1/14-18/08 BAXTER HEALTHCARE SA (BAXTER HEALTHCARE OF PR), RICO, GUAYAMA, PR - EIRS, 483, CO RESP 8/09 J & INTERNATIONAL INC, ALEXANDRIA, VA - EIRS, 483S, CO RESP 9/06 AVENTIS PHARMA MFG PRIVATE LTD (SANOFI AVENTIS), SINGAPORE - EIRS, 483S, CO RESP 7/10 Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS Subject GLAXOSMITHKLINE, NOTRE DAME DE BONDEVILLE, FRANCE - EIRS, 483S, CO RESP 3/17/09
Page 656 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/29/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8737 2011-8738 11/30/2011 12/29/2011 11/30/2011 12/29/2011 FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8739 11/30/2011 12/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8740 11/30/2011 12/29/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8741 2011-8742 2011-8743 2011-8744 2011-8745 2011-8746 2011-8747 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 03/08/2012 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 01/12/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS XORAN TECHNOLOGIES, ANN ARBOR, MI - EIR, 483 8/410/14/10 CASCADIA MANUFACTURING, BELLEVUE, WA - EIR, 483 11/10 PREPAK SYSTEMS INC, COOKEVILLE, TN - EIR, 483 8/10 BIORELIANCE CORP, ROCKVILLE, MD - EIR, 483 8/11 ASTHMATX INC, SUNNYVALE, CA - EIR, 483 3/11 AMERICAN RED CROSS, GREENVILLE, NC - EIR, 483 4/10 AIRE MASTER OF AMERICA, NIXA, MO - EIR, 483 11/3 - 9/10 WALTER E. CHALKLEY THOMSON REUTERS WYETH MEDICA, DUBLIN, IRELAND - EIR, 483 8/10 WALTER E. CHALKLEY THOMSON REUTERS TEVA CANADA LTD, MARKHAM, CANADA - EIR, 483 7/10 FDA/OMPT/CDRH/OCER/DFOI/ WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS STRYKER IRELAND LTD, ORTHOPAEDICS, CARRIGTOHILL, COUNTRY CORK, IRELAND - EIR, 483 5/09 ROCHE DIAGNOSTICS GMBH, PENZBERG, DEUTSCHLAND EIR, 483 6/10 Signature/ Requester THOMSON REUTERS Subject
Page 657 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2011-8748 2011-8749 2011-8750 2011-8751 2011-8752 2011-8753 2011-8754 2011-8755 2011-8756 2011-8757 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 11/30/2011 12/29/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8758 2011-8759 12/01/2011 12/30/2011 12/01/2011 12/30/2011 2011-8760 2011-8761 12/01/2011 12/30/2011 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/PHI-DO/PCB/ FDA/OF/CFSAN/OCD/EOS/ BRADLEY, BYRON JOAN STITT MERCK & CO., INC. MERCK SHARP DOHME - JUVISYNC (SIMVASTATIN, SITAGLIPTIN PHOSPHATE) AER 10/11 OBTAINING A FOOD LABEL TO SELL A FOOD PROD MATT SCHRADER KOVR-TV CHAD LEWIS Universal Nutrition ANTIBIOTICS, DRUGS, CHEMICALS USED IN CALIFORNIA DAIRY FARMS - RECS 2007-2011 ATF FITNESS PRODUCTS INC - EIR 3/15/11-4/12/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ FOI SERVICES INC CHRIS INGALLS KING 5 TV BAILEY E AXE REED SMITH LLP 2010-8410, 2011-2925; FOI REQUESTS REGARDING THALIDOMIDE 1/06 TO PRESENT SNOKIST, YAKIMA, WA - INSP, CORR, RPTS 2011 FOI SERVICES INC 2011-1000 FOI SERVICES INC 2011-4236 FOI SERVICES INC 2011-4026 FOI SERVICES INC 2011-3872 FOI SERVICES INC 2011-3858 FOI SERVICES INC 2011-3337 FDA/OMPT/CDRH/OCER/DFOI/ WALTER E. CHALKLEY THOMSON REUTERS BUHLMANN LABS AG, SCHONENBUCH, SWITZERLAND EIR, 483 8/10 2011-1842 Signature/ Requester Subject
Page 658 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-8762 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ 2011-8763 12/01/2011 12/30/2011 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/OE/ ORA/OE/ 2011-8764 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8765 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8766 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8767 2011-8768 12/01/2011 12/30/2011 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ DARREN MANSELL OWEN MUMFORD INC PAUL STEPHANO MD SANFORD C BERNSTEIN & CO LLC HOSPIRA INC - 483S 2011 K901803 SHEA B SHAVER REILLY POZNER LLP ZOLOFT (SERTALINE HCL) NDA 19-839 - PREGNANCY SECTION LBLG REVISIONS, CATEGORY CHANGES, CORR 7/1/05 TO 9/14/06 MAYA YSHAIA D AGENCIES UNIPACK LTD COLGATE CAVITY PROTECTION TOOTHPASTE - APRVL RECS JOAN STITT MERCK & CO., INC. SCHERING - DULERA (FORMOTEROL FUMARATE, MOMETASONE FUROATE) AER 6/22/10 TO 10//31/11 JONEL ALECCIA MSNBC.COM LIST OF FOOD PROCESSING FIRMS THAT HAVE SUBMITTED RECONDITIONING PROPOSALS 2009-2011 FRANCIS A DIGIACCO ROBBINS GELLER ET AL AMGEN INC - EPOGEN, ARANSEP TESTING & MARKETING MISCONDUCT INVESTIGATION, STUDY, BLACK BOX WARNINGS, ETC 3/9/07 Signature/ Requester Subject
Page 659 of 1132

Total Records: 12455 Control # 2011-8769 Recd Date / Due Date 12/01/2011 12/30/2011 2011-8770 2011-8771 2011-8772 2011-8773 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8774 2011-8775 12/01/2011 12/30/2011 12/01/2011 12/30/2011 2011-8776 12/01/2011 12/30/2011 2011-8777 12/01/2011 12/30/2011 ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2011-8778 2011-8779 12/01/2011 12/30/2011 12/01/2011 12/30/2011 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ UNDERHILL, JAMES Doe J AERS DATABASE 2001 INDIVIDUAL RECS GARDINER HARRIS NEW YORK TIMES SHORTAGE OF AMPHETAMINE SALTS, METHYLPHENIDATE TO TREAT ADD - CORR 9/11 TO PRESENT MCFARLAND, J OSBORNE FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ EMILY NOORDHOEK FALCON RESEARCH CHRIS WOLKENSTEIN POSH NOSH IMPORTS GREEN MOUNTAIN COFFEE ROASTERS, KEURIG INC FOOD SAFETY, PACKAGING, LBLG, ETC 1/10 TO PRESENT NAME OF COMAPNY THAT HAS A PETITION FILED TO EXPAND THE PERMITTED USE OF COPPER COMPLEXES OF CHLOROPHYLIN IN FOOD CMPLNT 122797 TAYLOR, MATT ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J PAUL B CALLAHAN CHARLES RIVER LABS CHARLES RIVER PATHOLOGY ASSOCIATES ILLINOIS PRECLINICAL SERVICES, CHICAGO, IL - EIR 2/17-24/10 HOSPIRA, MULGRAVE, AUSTRALIA; IRUNGATTUKOTTAI, INDIA - 483 FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester RICHARD H KOSTICK 100 PERCENT PURE MISTY TILLER TILLER MIND BODY, INC CMPLNT CTP1100211 Subject COLUMBIA COSMETICS MANUFACTURING INC, SAN LEANDRO, CA; SUN DEEP COSMETICS, HAYWARD, CA EIRS MOST RECENT COLON CARE PRODUCTS OF PA LLC - GRACE 501K
Page 660 of 1132

Total Records: 12455 Control # 2011-8780 Recd Date / Due Date 12/01/2011 12/30/2011 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8781 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8782 12/01/2011 12/30/2011 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8783 2011-8784 2011-8785 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8786 2011-8787 2011-8788 2011-8789 2011-8790 2011-8791 2011-8792 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 12/30/2011 12/01/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KATHERINE STRONG CARNER SIDLEY AUSTIN LLP KATHERINE STRONG CARNER SIDLEY AUSTIN LLP BRIAN SMITH LEXISNEXIS COURTLINK INC BRIAN SMITH LEXISNEXIS COURTLINK INC THERESA de PRAT COOK ENDOSCOPY BRUCE A. HERALD LAW OFFICE BRUCE A HERALD DUDLEY HARRIS VARIAN MEDICAL SYS - HIGH ENERGY LINEAR ACCELERATOR K100890 PRIMAEVA MEDICAL INC, FREMONT, CA - FINESSE SYS EG SCAN ESOPHAGOSCOPE SYS K111030 2011-7568 2011-7336 PROMOTION OF MEDICAL DEVICES AND BREAST RECONSTRUCTION OR AUGMENTATION PROMOTION OF SURGICAL MESH DEVICE GEYMAN, CATHERINE ZACH CARTER HUFFINGTON POST ZACH CARTER HUFFINGTON POST SMITHKLINE BEECHAM LTD - WARNING LTR RESP LEGITSCRIPT, INTERNET MONITORING & SUPPORT SERVICES - CORR 1/21/09 TO PRESENT LEGIT SCRIPT - CONTRACT #HHSF223201000071C BENJAMIN ADAM DENNIS MD GEORGIA HEALTH SCIENCES UNIV DDAVP, STIMATE (DESMOPRESSION) - AERS ASHLEY AA-3143, AARON METFORMIN; LISINOPRIL; LOVASTIN - AERS 2000 TO PRESENT Signature/ Requester ESTHER CHOI DEPARTMENT OF PHARMACY Subject MEDICATIONS WHICH CONTAIN XYLITOL
Page 661 of 1132

Total Records: 12455 Control # Recd Date / Due Date 12/30/2011 2011-8793 12/01/2011 12/30/2011 FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester HARRIS CONSULTANTS ANDREW LaPIETRA QMETRICS TECHNOLOGIES Subject K072261 ABLE SOFTWARE CORP - 3D DOCTOR K003746; GE HEALTHCARE CORP - GE ADVANTAGE W/FUNCTOOL OPTION K960265; GE HEALTHCARE CORP - READY VIEW K110573 ISRS 7490790, 7577126, 7515100
2011-8794
12/01/2011 12/30/2011
VAL SAWYER ZYMOGENETICS INC
2011-8795
12/01/2011 12/30/2011
ANDREA CALL CROUSE HOSPITAL
IV VANCOMYCIN - MEDWATCH 2009, 2010, 2011
2011-8796
12/01/2011 12/30/2011
ANDREA CALL CROUSE HOSPITAL
INCIDENCE OF IV VANCOMYCIN ASSOCIATED KIDNEY TOXICITY
2011-8797
12/01/2011 12/30/2011
ROGER B. KAPLAN, Esq. GREENBERG TRAURIG LLP
DOCUMENTS IN THE OFFICE OF GENERIC DRUGS WHICH SHOW THE HANDLING OF ANDAS SUPPORTED BY BIOEQUIV STUDIES PERFORMED AT MDS, MONTREAL
2011-8798 2011-8799 2011-8800 2011-8801 2011-8802
12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012
ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/
AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS
WARNER CHILCOTT PUBLIC LTD, FAJARDO, PR - 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACEUTICALS INDUSTRIES LTD, EAST HANOVER, NJ - 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACEUTICALS INDUSTRIES LTD, CINNCINNATI, OH - 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACUTICALS INDUSTRIES LTD, FOREST, VA 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACUTICALS INDUSTRIES LTD, IRVINE, CA 483, WARNING LTR 1/11 TO PRESENT
2011-8803
12/02/2011 01/03/2012
WATSON PHARMACEUTICALS INC, DAVIE, FL - 483, WARNING LTR 1/11 TO PRESENT
Page 662 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8804 12/02/2011 01/03/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8805 2011-8806 2011-8807 2011-8808 2011-8809 2011-8810 2011-8811 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8812 2011-8813 12/02/2011 01/03/2012 12/02/2011 01/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/COS/OES/ OC/COS/OES/ 2011-8814 12/02/2011 01/03/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ TERESA MARSHALL PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS JOE SCHREIBVOGEL, GW EXOTIC ANIMAL FOUNDATION, WYNNEWOOD, OK - TAINTED FORMULA, TEST RESULTS FDA/OF/CFSAN/OCD/EOS/ MICHAEL A CAROME MD PUBLIC CITIZEN STUART M PAPE PATTON BOGGS, L.L.P. ARSENIC & LEAD CONTENT IN FRUIT JUICES MONITORING RECS 1/90 TO PRESENT CENTER FOR SCIENCE IN THE PUBLIC INTEREST - QUORN LTR 11/11 BISBEE, MICHAEL P ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/SJN-DO/SJCB/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/LOS-DO/LACB/ AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS FATIMA ASLAM Keller and Heckman LLP AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS TEVA PHARMACEUTICAL INDUSTRIES LTD, POMONA, NY 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACEUTICALS INDUSTRIES LTD, GUAYAMA, PR - 483, WARNING LTR 1/11 TO PRESENT TEVA PHARMACEUTICALS INDUSTRIES LTD, MEXICO, MO - 483, WARNING LTR 1/11 TO PRESENT ENBREL (ETANERCEPT) - CLNCL TRIAL RESULTS WASTSON PHARMACEUTICALS INC, CORONA, CA - 483, WARNING TEVA PHARMACEUTICALS INDUSTRIES LTD, MIAMI, FL 483, WARNING LTR DUPONT PERFORMANCE ELASTOMERS LLC - FCN 00116 SANDRA BARLETT NATIONAL PUBLIC RADIO TAMIFLU - STAFF RPTS, EMAILS 2009-2010 Signature/ Requester Subject
Page 663 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/MIN-DO/MCB/ 2011-8815 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8816 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8817 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8818 2011-8819 2011-8820 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 2011-8821 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8822 12/02/2011 01/03/2012 2011-8823 12/02/2011 01/03/2012 2011-8824 2011-8825 12/02/2011 01/03/2012 12/02/2011 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ CVM/OCD/ SCOTT ELDER ELECTROMEDICAL PRODUCTS, INTL, INC. KRISTI O SMEDLEY Center for Regulatory Services, Inc. ELAINE M ABDOVEIS ECKELL SPARKS ET AL GISELA CAPITO CRANIAL ELECTROTHERAPY SIMULATOR - A/C, RESUMES, CURRICULUM VITAE, ETC CHOLINE (CHOLINE CHLORIDE, CHOLINE BITRATRATE, CHOLINE PANTOTHENATE, ETC) - AS AN ANIMAL FEED INGREDIENT DA VINCI ROBOT-ASSISTED SURGERY - ANESTHESIA MONITORING RECS DOW CHEMICAL CO, MIDLAND, MI - TOXICITY OF METHYL ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/KAN-DO/COMP/ PAUL W TRIPP LINCARE INC BRENDA M GARTZ ELI LILLY & CO PAUL W TRIPP LINCARE INC DUSTIN BLOCK IPD ANALYTICS LLC AMERICAN HOME RESPIRATORY CARE INC (MONROE OXYGEN AND MEDICAL EQUIPMENT), NY - EIRS, 483S,WARNING LTRS 1/04 TO PRESENT LAMIVUDINE ANDA 20-2032 - EFFECTIVE APRVL LTR 11/17/11 A&B MEDICAL SUPPLIES LLC, MO - EIRS, 483S, WARNING LTRS 1/04 TO RPESENT ELGE INC, ROSENBERG, TX - EIRS 8/12/10-9/8/10 KUMAR, ROGER INCIVEK (TELAPREVIR) - AERS Doe J RISPERIDONE - AERS KUMAR, ROGER ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS Signature/ Requester Subject
Page 664 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/03/2012 2011-8826 2011-8827 2011-8828 2011-8829 2011-8830 2011-8831 2011-8832 2011-8833 2011-8834 2011-8835 2011-8836 2011-8837 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 12/02/2011 01/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8838 12/05/2011 01/04/2012 2011-8839 12/05/2011 01/04/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP WELLDOC INC - DIABETES MANAGER SYS & DIABETES MANAGER RX SYS K112370 WELLDOC INC - DIABETES MANGER SYS & DIABETES MANAGER RX SYS K100066 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FERAHEME (FERUMOXYTOL) - AERS 2/24/10-7/9/10 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office Signature/ Requester SCIENTIFIC CONSULTING CO GMBH AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS COVIDIEN - FORCETRIAD ELECTROSURGICAL GENERATOR K110268 CONMED ELECTROSURGERY DIVISION - ALTRUS THERMAL TISSUE FUSION SYS K101534 LOTUS ULTRASONIC SCALPEL. SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYS - K063531 APERTA - WITTMAN PATCH K093166 Subject ANTHRANILATE - STUDY 1967 WATSON PHARMACEUTICALS INC, COPIAGUE, NY - 483 1/11 TO PRESENT ENDO PHARMACEUTICALS INC, SAN JOSE, CA - 483S 1/11 TO PRESENT WATSON PHARMACEUTICALS INC, CARMEL, NY - 483, WARNING LTR 1/11 TO PRESENT ENDO PHARMACEUTICALS INC, MINNETONKA, MN - 483S 1/11 TO PRESENT ENDO PHARMACEUTICALS INC, HUNTSVILLE, AL - 483S 1/11 TO PRESENT ENDO PHARMACEUTICALS INC, CRANBURY, NJ - 483S 1/11 TO PRESENT ALLERGAN INC, WACO, TX - 483S 1/11 TO PRESENT
Page 665 of 1132

Total Records: 12455 Control # 2011-8840 Recd Date / Due Date 12/05/2011 01/04/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8841 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8842 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8843 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8844 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8845 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8846 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8847 2011-8848 12/05/2011 01/04/2012 12/05/2011 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON AKORN INC, DEACTUR, IL - 483S 1/09 TO PRESENT AKRON INC, SOMERSET, NJ - 483S1/09 TO PRESENT Keethler, Daniel SILENOR (DOXEPIN) NDA 22-036 - NAMES OF PHYSICIANS RESPONSIBLE FOR APRVL 6/1/10 Keethler, Daniel NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE/QUINIDINE) NDA 21-8789 - NAMES OF PHYSICIANS RESPONSIBLE FOR APPRVL 12/1/10 Keethler, Daniel OLEPTRO (TRAZDONE HCL ER) NDA 22-441 - NAMES OF PHYSICIANS RESPONSIBLE FOR APPRVL 2/2/10 Keethler, Daniel ATELVIA (RISEDRONATE SODIUM DELAYED-RELEASE) NDA 22-560 - NAMES OF PHYSICIANS RESPONSIBLE FOR APPRVL 12/1/10 Keethler, Daniel DUEXIS (IBUPROFEN, FAMOTIDINE) NDA 22-519 - NAMES OF PHYISCIANS RESPONSIBLE FOR APPRVL 4/29/11 Keethler, Daniel GRALISE (GABAPENTIN) NDA 22-544 - NAMES OF PHYSICIANS RESPONSIBLE FOR APPRVL 1/28/11 Keethler, Daniel Signature/ Requester Subject ALSUMA (SUMATRIPTAN SUCCINATE) NDA 22-377 - NAMES OF PHYSICANS RESPONSIBLE FOR THE APPRVL 6/29/10
Page 666 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/04/2012 2011-8849 2011-8850 12/05/2011 01/04/2012 12/05/2011 01/04/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester RBC CAPITAL MARKETS ANDREAS F WIDMER UNIV HOSPITAL BASEL KAREN H BEYEA-SCHROEDER FLEMING & ASSOCS LLP SHELHIGH NO-REACT PULMONIC VALVE CONDIUT NR4000-A PORCINE XENOGRAFT (SPVC) - RECS ZIMMER - NEXGEN IN GROWTH NON-CEMENTED HIGH FLEX FEMORAL COMPONENT FOR TOTAL KNEE ARTHROPLASTY NAMES, ADDRESS, TELEPHONE NUMBERS, ETC COMBE - LANACANE ANTI-ITCH CREME CMPLNTS Doe J Subject
2011-8851
12/05/2011 01/04/2012
2011-8852
12/05/2011 01/04/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CROSBY T-50417, COURTNEY
AVANDIA - WARNINGS
2011-8853
12/05/2011 01/04/2012
BRIAN OVERSTREET ADVERSEEVENTS INC
BRILINTA (TICAGRELOR) - AERS 1/11 TO PRESENT
2011-8854
12/05/2011 01/04/2012
ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHALFIK BEN GUESMIA BETH BRICZINSKI NATIONAL MILK PRODUCERS FEDERATION BRIAN OVERSTREET ADVERSEEVENTS INC
HAMOUD BOUALEM, ALGERIA - ENTRY#S 551-972368-8/9/1, 551-9727967-7/9/1, 112-3583074-7/6/2 RPTS
2011-8855
12/05/2011 01/04/2012
CYTOSPORT INC - WARNING LTR COMM 6/29/11
2011-8856
12/05/2011 01/04/2012
BENLYSTA (BILIMUMAB) 1/11 TO PRESENT
2011-8857
12/05/2011 01/04/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ADVERSEEVENTS INC
INCIVEK (TELAPREVIR) AER 1/11 TO PRESENT
2011-8858
12/05/2011
BRIAN OVERSTREET
DIFICID (FIDAXOMICIN) AER 1/11 TO PRESENT
Page 667 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/04/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8859 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8860 2011-8861 2011-8862 2011-8863 2011-8864 2011-8865 2011-8866 2011-8867 2011-8868 2011-8869 2011-8870 2011-8871 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FOI SERVICES INC 2011-6403 FOI SERVICES INC 2011-6402 FOI SERVICES INC 2011-6364 FOI SERVICES INC 2011-6362 FOI SERVICES INC 2011-6451 FOI SERVICES INC 2011-6457 FOI SERVICES INC 2011-6461 FOI SERVICES INC 2011-6460 FOI SERVICES INC 2011-6458 FOI SERVICES INC 2011-6480 FOI SERVICES INC 2011-6477 2011-6475 BRIAN OVERSTREET ADVERSE EVENTS YERVOY (IPILIMUMAB) AER 1/11 TO PRESENT Signature/ Requester ADVERSE EVENTS Subject
Page 668 of 1132

Total Records: 12455 Control # 2011-8872 2011-8873 2011-8874 2011-8875 2011-8876 2011-8877 2011-8878 2011-8879 2011-8880 2011-8881 2011-8882 2011-8883 2011-8884 2011-8885 2011-8886 2011-8887 2011-8888 Recd Date / Due Date 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 01/04/2012 12/05/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC AUSTIN NELSON TEVA PHARMACEUTICALS INC - 483S 2011 FOI SERVICES INC 2011-5879 FOI SERVICES INC 2011-5862 FOI SERVICES INC 2011-5614 FOI SERVICES INC 2011-5607 FOI SERVICES INC 2011-5354 FOI SERVICES INC 2011-5041 FOI SERVICES INC 2011-4770 FOI SERVICES INC 2011-4435 FOI SERVICES INC 2011-1246 FOI SERVICES INC 2011-5949 FOI SERVICES INC 2011-6220 FOI SERVICES INC 2011-6331 FOI SERVICES INC 2011-6307 FOI SERVICES INC 2011-6296 FOI SERVICES INC 2011-6349 Signature/ Requester Subject 2011-6413
Page 669 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/04/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8889 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8890 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8891 12/05/2011 01/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8892 12/06/2011 01/05/2012 2011-8893 12/06/2011 01/05/2012 2011-8894 12/06/2011 01/05/2012 2011-8895 12/06/2011 01/05/2012 2011-8896 12/06/2011 01/05/2012 2011-8897 12/06/2011 01/05/2012 2011-8898 12/06/2011 01/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION BIONICHE - FOIA REQUESTS 1/07 TO PRESENT HICKAM INC - FOIA REQUESTS 1/07 TO PRESENT PENEDERM - FOIA REQUESTS 1/07 TO PRESENT GENPHARM - FOIA REQUESTS 1/07 TO PRESENT MATRIX LABORATORIES LTD - FOIA REQUESTS 1/07 TO PRESENT DOCPHARMA - FOIA REQUESTS 1/07 TO PRESENT MAYLAN INC - FOIA REQUESTS 1/07 TO PRESENT BUCHANAN, DAVID PROLIXIN DECANOCATE - AER TENECIA SULLIVAN SALAMANDRA LLC METHYLTHIONINIUM CLORIDE - ISRS 5909562-6, 59115822, 5911582-2, ETC AUSTIN NELSON RBC CAPITAL MARKETS WATSON PHARMACEUTICALS - 483S 2011 Signature/ Requester RBC CAPITAL MARKETS Subject
Page 670 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester SERVICES 2011-8899 12/06/2011 01/05/2012 2011-8900 12/06/2011 01/05/2012 2011-8901 12/06/2011 01/05/2012 2011-8902 2011-8903 2011-8904 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8905 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-8906 2011-8907 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8908 12/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/DALLOREN LARKIN MYLAN INC, SUGARLAND, TX - 483 6/30/10 ORA/CE-FO/BLT-DO/CB/ LOREN LARKIN SAC CAPITAL ADVISORS LP LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, ROCKFORD, IL - 483 6/30/10 MYLAN INC, MORGANTOWN, WV - 483 6/30/10 MARYLYN OPARAUGO BSC RAC Banner Pharmacaps Inc. USB FARCHIM SA, BULLE, SWITZERLAND - EIR 8/2011 FOI SERVICES INC MARYLYN OPARAUGO Banner Pharmacaps Inc. 2008-6636 - METHOXSALEN ULTRA NDA 9048/S-023 CLNCL PHARMACOLOGYBIOPHARMACEUTICS RVWS FOI SERVICES INC CLOSED FOIA REQUEST 11/28/11-12/2/11 KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES KASTE PURCELL DOCUTRIEVAL INFORMATION SERVICES CLOSED FOIA REQUESTS 11/21-25/11 MERCK GENERICS - FOIA REQUESTS 1/07 TO PRESENT BERTEK - FOIA REQUESTS 1/07 TO PRESENT ALPHAPHARM - FOIA REQUESTS 1/07 TO PRESENT Subject
Page 671 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/05/2012 2011-8909 2011-8910 2011-8911 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8912 2011-8913 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8914 12/06/2011 01/31/2012 2011-8915 2011-8916 2011-8917 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DEN-DO/COMP/ 2011-8918 2011-8919 12/06/2011 01/05/2012 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8920 12/06/2011 01/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ANNE L WEISMANN CITIZENS FOR RESPONSIBILITY GUIDANCE RELATED TO THE DISPOSITION OF RECS GENERATED AS PART OF AN INVESTIGATION CONDUCTED BY THE FDA ORA/SE-FO/FLA-DO/FCB/ MEETA VETE INSITE VISION STEFANIE DECKER ENDO PHARMACEUTICALS INC ZANAFLEX TABS NDA 20-397 - SBA LEONARD R CACIOPPO MD - EIRS 3/29/90, 9/2/03 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ MARCIA FINKELSTEIN GERTLER LAW FIRM SYLVIA SOUTHARD VILEX IN TENNESSEE INC JAMES PELUSO AVID RADIOPHARMACEUTICALS THORATEC CORP - HEARTMATE II LEFT VENTRICULAR ASSIST SYS MDRS. ANNUAL RPTS, CMPLNTS, ETC MEMOMETALL TECHNOLOGIES -MEMOMETAL MEMORY STAPLE K070031 CARDINAL HEALTH, CHARLOTTE, NC; COLTON,CA; EAST HARTFORD, CT, ETC - EIRS LAST 12 MONTHS BRIAN E DEVILLLING COLLINS EINHORN KELLOGG USA/KLELLOGG CO - CORN POPS, APPLE JACKS, FROOT LOOPS, ETC RECALL COMM, EMAILS, CMPLNTS, ETC 6/25/10 MAHAKIAN, JASON CAROLINA M HEAVNER K&L GATES FUJINON INC - EPX-4440HD VIDEO PROCESSOR & LIGHT SOURCE k102466 DRAFT GUIDANCE FOR INDUSTRY: DIETARY SUPPLEMENTS: NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES 7/11 MURDOCK, LARRY ORA/SE-FO/SJN-DO/SJCB/ Action Office DO/COMPLIANCE/ ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester SAC CAPITAL ADVISORS LP LOREN LARKIN SAC CAPITAL ADVISORS LP LOREN LARKIN SAC CAPITAL ADVISORS LP ACAPELLA MEDICAL DVC - K002768 MYLAN INC, CAGUAS, PR - 483 10/13/11 MYLAN INC, ST ALBANS, VT - 483 6/30/10 Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester & ETHICS IN WASHINGTON 2011-8921 2011-8922 2011-8923 2011-8924 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8925 12/06/2011 01/05/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8926 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8927 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8928 12/06/2011 01/05/2012 2011-8929 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8930 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BENJAMIN ADAM DENNIS MCG HEALTH DDAVP, STIMATE (DESMOPRESSON) ORAL, NASAL, IV, ETC - AERS FDA/OF/CFSAN/OCD/EOS/ GARY J BURIN PHD TECHNOLOGY SCIENCES GROUP INC LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, AUSTRALIA - 483 6/30/10 FCN 537 LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, JAPAN - 483 6/30/10 LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, INDIA - 483 6/30/10 JEFFREY D JOHNSON ROBERT W. BAIRD & CO INC ELENA HOWELL HOGAN LOVELLS US LLP KATE B WILSON CENTER FOR PUBLIC INTEGRITY GEORGE A PISANO WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP LOREN LARKLIN SAC CAPITAL ADVISORS LP MYLAN INC, IRELAND - 483 6/30/10 HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION DATABASE INDIVIDUAL RECS COOPER CO (COOPERVISION), JUANA DIAZ, PR; HAMBLE IN HAMPSHIRE, UK - EIRS, 483 2011-7506 Subject
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Total Records: 12455 Control # 2011-8931 Recd Date / Due Date 12/06/2011 01/05/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DEN-DO/COMP/ 2011-8932 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8933 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8934 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-8935 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ 2011-8936 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ JOE MCCANN SAC CAPITAL MANAGEMENT LLC DR REDDY'S LABORATORIES LTD, ANDHRA PRADESH, INDIA; CAMBRIDGE, UK; SHREVEPORT,LA, ETC - EIRS, 483 1/11 TO PRESENT KATLEEN M RHOADS ESQ GORDON & REES LLP WEST COAST NUTRITION - ESTRO-FUSE, TREN-ABOLIX XTREME, 19-NORANDROSTA-4 9 DIENE-3 17 DIONE RECS PIERRE HAFFNER GOTEC SA MEDTHIN 43 - MAF 1647 LARA SAY DOUGLAS LONDON PC ATTY AT LAW YAZ NDA 22-045 - APRVL PKG (CERTIFIED) MARK MATHIEU Parexel International IND SUBMISSIONS - WORKLOAD BREAKDOWN, NUMBER OF CLNCL HOLDS, NUMBER OF RTF ACTIONS, ETC YEAREND 2011 Signature/ Requester ELIZABETH JONES BUFFALO FUNDS Subject HOSPIRA, BOULDER, CO, IRUNGATTUKOTTAL, INDIA, MULGRAVE, VICTORIA, AUSTRIALIA, ETC - 483S
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Total Records: 12455 Control # 2011-8937 Recd Date / Due Date 12/06/2011 01/05/2012 2011-8938 12/06/2011 01/05/2012 2011-8939 12/06/2011 01/05/2012 Action Office ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8940 12/06/2011 01/18/2012 ORA/ORO/DFS/ ORA/ORO/DFS/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-8941 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8942 12/06/2011 01/05/2012 2011-8943 12/06/2011 01/05/2012 2011-8944 12/06/2011 01/05/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8945 12/06/2011 FDA/OF/CFSAN/OCD/EOS/ LINDA LORETZ PHD COSMETIC CAERS - SUMMARY MID-1990S CVM/OCD/ CHLRIS RAMEZANPOUR BIODIMENSIONS RENEWABLE OILS TAD TAKASHIMA INTERNATIONAL LOBSTER AND MAGURO LLC DEZARAE D LACRUE LEVENTHAL BROWN ET AL REMICADE (INFLIXIMAB) - AERS CRAMBEMEAL, RAPESEED MEAN, CARMELINA MEAN, MUSTARD SEED MEAL - FOOD ADDITIVE FILES ENTRY #EVJ-01114803 - LAB RPT NATALIA DIAZ FRIEDIN DOBRINKSY LEVAQUIN - BLACK BOX WARNINGS, CLNCL TRIAL RECS DR BARBARA RANGETINER OCTAPHARMA PHARMAZEUTIKA METHODOLOGY OF THE ONE-STAGE CLOTTING ASSAY; METHODOLOGY OF THE CHROMOGENIC SUBSTRATE ASSAY FOR DETERMINIATION OF COAGULATION FACTOR VIII ACTIVITY - STANDARD OPERATING PROCEDURES (SOP) LAVONNE M PATTON PHD BECKLOFF ASSOCIATES INC CATALENT GERMANY SCHORNDORF GMBH - EIR, CORR 9/09 Signature/ Requester JOE MCCANN SAC CAPITAL MANAGEMENT LLC BRODIE PETERSEN NONIN MEDICAL INC Subject AKORN, LAKE FOREST, IL - EIRS, 483S 1/10 TO PRESENT; DECATUR, IL; SOMERSET, NJ 483S 1/10 TO PRESENT MASIMO CORP - K053477
Page 675 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/05/2012 2011-8946 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8947 2011-8948 12/06/2011 01/05/2012 12/06/2011 01/05/2012 OC/OM/OMP/DDM/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8949 2011-8950 2011-8951 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8952 2011-8953 2011-8954 2011-8955 2011-8956 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 2011-8957 12/06/2011 01/05/2012 2011-8958 12/06/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/KAN-DO/COMP/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ ANN M OXFORD ALBEMARLE CORP ANGELIA SLAYTON KENDLE INTERNATIONAL INC SHEILA ROTH ANGSTROM MANUFACTURING INC LYNN JENSEN HEMERUS MEDICAL LLC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. MARILYNN WHITNEY COVINGTON & BURLING LLP DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS LOREN LARKIN MYLAN INC, CEDEX, FRANCE - 483 6/30/10 TO PRESENT CLOSED FOI REQUESTS 11/21-25/11 CLOSED FOI REQUESTS 11/28/11-12/2/11 NADA-141-327 CLOSED FOI REQUESTS 11/21-25/11 SCIENTIFIC ISSUES IN BLOOD COLLECTION STORAGE & TRANSFUSION WORSHOP - SLIDES10/18/99 CLOSED FOI REQUESTS 11/2811-12/2/11 ANGSTROM MANUFACTURING INC - COMM, EVALUATION OTC VOL 160304,160378 HYPOBROMOUS ACID - FCN 1106 CHRIS TURNER SWANKIN & TURNER PHIL L MILLMAN CHEMIQUE PHARMACEUTICALS BEDFORD PHARMS - BUPRENORPHINE HCL SCHEDULE III ANDA DKT FDA-2010-P-0491 Action Office Signature/ Requester PERSONAL CARE PRODUCTS COUNCIL SHAUANAK DEEPAK JEFFERIES & CO ADCETRIS (BRENWTUXIMAB VEDOTIN) - AERS Subject
Page 676 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/05/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8959 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8960 12/06/2011 01/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ 2011-8961 2011-8962 2011-8963 2011-8964 2011-8965 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/06/2011 01/05/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8966 2011-8967 2011-8968 2011-8969 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ LONG, ANNETTE JOAN STITT (UG2CD-1T6) MERCK & CO INC - GARDASIL HPV VACCINE VAERS 11/1JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ALLIANCE DAIRY, GILCHRIST COUNTY, FL - VIOLATIONS CLOSED FOIA REQUEST 11-28/11-12-2/11 CLOSED FOIA REQUESTS 11/1-30/11 SMITH, KIMBERLY ERIKA MORKEVICH Cerner Galt TIMOTHY P MALARCHICK MALARCHICK LAW OFC SARA BLUM BANK OF MAERICA MERRILL LYNCH GLOBAL RESEARCH TOTAL NDA/BLA PRIORITY FILINGS, APRVLS, MEDIAN NDA/BLA PRIORITY RVW TIME, ETC 2010, FY 2011 2011-4422 - DELETED RECS FOI DAILY LOG 1/1/11 TO 12/2/11 CROWELL & MORING 2011-8368 CVM FOI REQUESTS 10/11 TO 11/11 LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, FOSTER CITY, CA - 483 6/30/10 TO PRESENT LOREN LARKIN SAC CAPITAL ADVISORS LP MYLAN INC, CHINA - 483 6/30/10 TO PRESENT Signature/ Requester SAC CAPITAL ADVISORS LP Subject
Page 677 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/06/2012 2011-8970 12/07/2011 01/06/2012 2011-8971 2011-8972 12/07/2011 01/06/2012 12/07/2011 01/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8973 12/07/2011 01/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8974 12/07/2011 01/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8975 2011-8976 2011-8977 2011-8978 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-8979 12/07/2011 01/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ BOWMAN COX GOLD SHEET OHM LABORATORIES, INC LIVINGSTON, TERMINAL, VANDYKE, NEW BRUNSWICK, NJ ; OHM LABORATORIES INC GLOVERSVILLE, GLOVERSVILLE, NY; RANBAXY LABORATORIES LTD BATAMANDI, BATAMANDI, PAONTA, PRADESH, INDIA. ETC 483S 1/09 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SCHAFER, DEHORAH BOAZ ASSAF COLOGUARD GARY OLIVEROS SYNERGETICS INC KATE B WILSON CENTER FOR PUBLIC INTEGRITY B-D DIGITAL BASAS THERMOMETER - K945427; MEDI-AID BASAL THERMOMETER - K952756 DEKNATEL INC, LAKE SUCESS, NY - COLOSHIELD KIT K855121 STINGRAY ULTRALITE DISPOSABLE IRRIGATING BIPOLAR FORCEPS - K102572 RVW MEMO IMPORT DATABASE JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK SHARP DOHME - JUVISYNC (SIMVASTATIN, SITAGIPTIN PHOSPHATE) AERS JOAN STITT (UG2CD-16) MERCK & CO., INC. SCHERING - DULERA (FORMOTEROL FUMARATE, MOMESTASONE FUROATE) AERS 1/1-30/11 ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MERCK & CO INC -ROTATEQ, ROTAVIRUS VACCINE VAERS 11/1-30/11 SCHERING - VICTRELIS (BOCEPREVIR) AERS 11/1-30/11 Action Office Signature/ Requester MERCK & CO., INC. CHARLES E TEMPIO TEMPIO & RAMOS LLC Subject 30/11 QUALITEST PHARMS, HUNTSVILLE,AL; CHARLOTTE, NC RECALL RECS, 483, CORR
Page 678 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NYK-DO/NYDCB/ 2011-8980 12/07/2011 01/06/2012 2011-8981 2011-8982 2011-8983 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ 2011-8986 12/07/2011 01/06/2012 2011-8987 12/07/2011 01/06/2012 ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8988 12/07/2011 01/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8989 12/07/2011 01/06/2012 2011-8990 12/07/2011 01/06/2012 ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ RALPH F HALL UNIV OF MINNESOTA LAW SCHOOL ANDREW KIRALY NEVADA PUBLIC RADIO IOM COMMITTEE ON THE PUBLIC HEALTH EFFECTIVENESS OF FDA 510K CLEARANCE PROCESS - CERTIFICATIONS OF COMPLIANCE DR NICOLA SPIRTOS - CLNCL TRIAL CLOSE OUT LTR MARIANO, JOSEPHINE VARENICLINE, BUPROPION, NICOTINE TRANSDERMAL RPTS, ISR NUMBERS BANKS DZ-5843, RONALD SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRI) AERS, BLACK BOX WARNINGS JENNA FARR Schwabe North America INDIVIDUAL RECS TOM NELTNER PEW CHARITABLE TRUSTS MONICA ENGEBRETSON BORN FREE USA DAVID CHOONG JFE SHOJI TRADE AMERICA INC TIM LIVINGSTON WKEF/WRGT-TV COLORMATRIX GROUP INC - FCN 145; AMERSHAM BIOSCIENCES - FCN 443; ALCAN PACKAGING - FCNS 772, ETC EXOTIC MEAT MARKET, PERRIS, CA, LAS VEGAS, NV - EIRS 1/10 TO PRESENT CANNED SHRIMP ENTRY #182-0259867-01 - LAB ANALYSIS, W/S DAYTON INTERNATIONAL AIRPORT, DAYTON, OH, PORT COLUMBUS INTERNATIONAL AIRPORT, COLUMBUS, OH, CINCINNATI NORTHERN KENTUCKY INTERNATIONAL AIRPORT, HEBRON, KY, ETC - EIRS SRI INTERNATIONAL, MENLO PARK, CA - EIRS, 483S 2011 LIST OF ALL DOMESTIC & FOREIGN INSPS - DRUG CO, MEDICAL DVC MFRS, BIORESEARCH (BIMO), ETC 10/1-31/11 Signature/ Requester Subject
2011-8984 2011-8985
12/07/2011 01/06/2012 12/07/2011 01/06/2012
JIM SHEETS PTC THERAPEUTICS MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC
Page 679 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8991 12/07/2011 01/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8992 2011-8993 2011-8994 2011-8995 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/07/2011 01/06/2012 12/08/2011 01/09/2012 2011-8996 12/08/2011 01/09/2012 2011-8997 2011-8998 12/08/2011 01/09/2012 12/08/2011 01/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-8999 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9000 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY THOMSON REUTERS CIPLA LTD, MIDC PATALGANGA DIST RAIGAD MAHARASHTRA, INDIA - EIR, 483, CO RESP 2/09 WALTER E CHALKLEY THOMSON REUTERS CIPLA LTD, BANGALORE, KARMATAKA, INDIA - EIR, 483, CO RESP 4/09 CBER/OCTMA/DDOM/ALFB/ HOOKER, BRIAN S KENNEITH REID WASHINGTON INFORMATION SOURCE DEBRA COHEN WOLTERS KLUWER LAW & BUSINESS CECELIA FRENCH CanReg, Inc. WALTER E CHALKLEY THOMSON REUTERS GENZYME CORP, HAVERHIL, UK - EIR, 483, CO RESP 8/09 FOI DAILY LOG 1031/11-11/4/11 FOI DAILY LOGS 1031/11-11/4/11 FOI DAILY LOGS 10/31/11-11/4/11 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ ROSS RENDELMANN HOGAN LOVELLS LLP KATHY MCGOWN FOXKISER DR PAUL THORSEN - RECS, CORR DKT FDA-2006-P-0007 DKT FDA-2008-P-0300 ELAINE S WALTER PHARM D MBA SEATTLE GENETICS INC ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS Signature/ Requester Subject
Page 680 of 1132

Total Records: 12455 Control # 2011-9001 Recd Date / Due Date 12/08/2011 01/09/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9002 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9003 2011-9004 2011-9005 2011-9006 2011-9007 2011-9008 2011-9009 2011-9010 2011-9011 2011-9012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/17/2012 12/08/2011 01/09/2012 2011-9013 2011-9014 12/08/2011 01/09/2012 12/08/2011 01/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INFORMATION ACCESS KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES DEY PHARMA LP - FOI REQUESTS 2007 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WILLIAM R COLE TECHNICAL INC WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS MICHAEL R SLOVIS CUNNINGHAM MEYER & VEDRINE PC GENZYME (DIVISON OF SANOFI CO), RIDGEFIELD, NJ - EIR, 483, CO RESP 9/10 LUMENIS - ULTRAPULSE ENCORE SURGICAL LASER K022060 MFG GUIDELINES 2011-7571 GENZYME CORP, SAN DIEGO, CA - EIR, 483, CO RESP 8/09 IMPORTED CANNED TUNA SPLS 402016, 702018 ANALYTICAL RECS GENZYME CORP, CAMBRIDGE, MA -EIR, 483, CO RESP 6/11 TEVA WOMENS HEALTH INC, CINCINNATI, OH - EIR, 483, CO RESP 11/10 BARR LABORATORIES, INC, FOREST, VA - EIR, 483, CO RESP 4/10 GENZYME CORP, FRAMINGHAM, MA - EIR, 483, CO RESP 12/08 GENZYME CORP, CAMBRIDGE, MA - EIR, 483 CO RESP 10/08 GENZYME CORP, CAMBRIDGE, MA - EIR, 483, CO RESP 6/10 WALTER E CHALKLEY THOMSON REUTERS CIPLA LTDVRNA, SALCETTE, GOE, INDIA - EIR, 483, CO RESP 2/11 Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS Subject CIPLA LTD VERNA, SALCETTE, GOA, INDIA - EIR, 483 CO RESP 4/09
Page 681 of 1132

Total Records: 12455 Control # 2011-9015 2011-9016 Recd Date / Due Date 12/08/2011 01/09/2012 12/08/2011 01/17/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9017 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9018 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9019 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9020 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9021 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICAL INDUSTRIES, KFAR SAVA, ISRAEL - EIR, 483, CO RESP 8/10 WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICA INDUSTRIES, KFAR SAVA, ISRAEL EIR, 483, CO RESP 6/09 WALTER E CHALKLEY THOMSON REUTERS TEVA RUMCORN, CHESHIRE, UK - EIR, 483, CO RESP 11/10 WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICALS IRELAND, WATERFORD, IRELAND - EIR, 483, CO RESP WALTER E CHALKLEY THOMSON REUTERS TEVA CANADA LTD, TORONTO, CANADA - EIR, 483, CO RESP 2/09 Action Office ORA/NE-FO/NWE-DO/NWECB/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS JENNIFER M ALEXANDER BRASSEL LAW GROUP LLC Subject GENZYME CORP, FARMINGTON, MA - EIR, 483, CO RESP 10/10 COOPERVISION - AVAIRA TORIC SOFT CONTACT LENSES CMPLNTS, RECALL RECS, MDRS, ETC
Page 682 of 1132

Total Records: 12455 Control # 2011-9022 Recd Date / Due Date 12/08/2011 01/09/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9023 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9024 12/08/2011 01/09/2012 ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ 2011-9025 2011-9026 2011-9027 2011-9028 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9029 2011-9030 2011-9031 2011-9032 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9033 12/08/2011 FDA/OMPT/CDRH/OCER/DFOI/ YUSU LIN K903073 Doe J ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICALS USA, SELLERSVILLE, PA - EIR, 483, CO RESP 10/08 TEVA PHARMACEUTICALS USA INC, SELLERSVILLE, PA EIR, 483, CO RESP 4/10 TEVA WOMENS HEALTH INC, CINCINNATI, OH - EIR, 483, CO RESP 7/09 SANOFI AVENTIS - LOVENOX AERS; MFRS OF GENERIC ENOZAPARIN SODIUM ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICAL USA, NORTH WALES, PA - EIR, 483, CO RESP 3/10 TEVA PHARMACEUTICALS USA, NORTH WALES, PA - EIR, 483, CO RESP 8/09 TEVA PHARMACEUTICALS USA, SELLERSVILLE, PA - EIR, 483, CO RESP 10/08 TEVA RUNCORN, CHESHIRE, UK - EIR, 483, CO RESP 4/09 BLOOM, CHAZ CONTRACT PHARMACAL, HAUPPAUGE, NY; NUTRO LABS, SOUTH PLAINFIELD, NJ; NUTRI-FORCE NUTRITION, MIAMI LAKES, FL, ETC - 483S WALTER E CHALKLEY THOMSON REUTERS TEVA PHARMACEUTICAL INDUSTRIES, JERUSALEM, ISRAEL - EIR, 483, CO RESP 9/10 Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS Subject TEVA PHARMACEUTICALS, BUICAGO, ITALY - EIR, 483, CO RESP 2/11
Page 683 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/09/2012 2011-9034 12/08/2011 01/09/2012 2011-9035 2011-9036 2011-9037 2011-9038 2011-9039 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9040 2011-9041 2011-9042 2011-9043 2011-9044 2011-9045 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 2011-9046 2011-9047 12/08/2011 01/09/2012 12/08/2011 01/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Center for Regulatory Services, Inc. Center for Regulatory Services, Inc. FOI DAILY LOG 11/7-11/11 CITIZENS FOR RESPONSIBLE CARE & RESEARCH FOI DAILY LOG 11/14-18/11 ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ LOREN LARKIN SAC CAPITAL ADVISORS LP LOREN LARKIN SAC CAPITAL ADVISORS LP AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS 2005-176 VRL LABS, CENTENNIAL, CO - EIRS, 483S 2011 MIDWEST TRANSPLANT NETWORK, WESTWOOD, KS EIRS, 483S LAST TWO YRS LABS INC, CENTENNIAL, CO - EIRS, 483S LAST TWO YRS NOVARTIS INC, BROOMFIELD, CO - 483 NOVARTIS INC, WILSON, NC - 483 ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/CHI-DO/CCB/ MORGAN #70263, JEFFREY P BRENDA M GARTZ ELI LILLY & CO ALEX SILVERSTEIN RIDGEBACK CAPITAL MANAGEMENT LLC REGENERON PHARMS - EYLEA (AFIBERCEPT) AERS FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/SJN-DO/SJCB/ FDA/OMPT/CDRH/OCER/DFOI/ ROBERT YANG BIOLASE TECHNOLOGY INC SUSAN VAUGHAN SPF CONSULTING LABS INC RETAIL QUALITY ASSURANCE, CHICAGO, IL - CMPLNTS, CONTACT, BUSINESS INFO, ETC SMC MEDICAL MFG DIVISION, SOMERSET, WI - EIR 11/17/11 AMD LASER LLC - PICASSO, PICASSO LITE, PICASSO PERIO K102359 SPF CONSULTING LABS INC - 483S, CORR MOST RECENT FOI SERVICES INC Action Office Signature/ Requester INTERNATIONAL LEISURE PRODUCTS INC COOPERVISION, HENRIETTA, NY; HAMBLE, SOUTHAMPTON, UK; JUANA DIAS, PR - 483S 8/11 TO PRESENT Subject
Page 684 of 1132

Total Records: 12455 Control # 2011-9048 2011-9049 2011-9050 2011-9051 Recd Date / Due Date 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 2011-9052 12/08/2011 01/09/2012 2011-9053 2011-9054 2011-9055 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 2011-9056 12/08/2011 01/09/2012 2011-9057 12/08/2011 01/09/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9058 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9059 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ NIKOLAS BURLEW REGULUS PHARMACEUTICAL CONSULTING ORION CORP, ESPOO, FINLAND - EIR 9/6 TO 9/14/10 FEI 3003073605 NARSI RANGACHARI INCARDA THERAPEUTICS INC GRACEWAY PHARMS, NORTHRIDGE, CA - TAMBOCOR (FLECAINIDE) SBA WASHINGTON INFORMATION SOURCE CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS RAYMOND M. PANAS, PhD. SUCAMPO PHARMACEUTICALS INC MACMIS 14190 - DOCUMENTS FOI DAILY LOG 11/7-11/11 FOI DAILY LOG 11/14-18/11 FOI DAILY LOG 11/7-11/11 FOI DAILY LOG 11/14-18/11 WASHINGTON INFORMATION SOURCE FOI DAILY LOG 11/7-11/11 DOMINION GROUP INC FOI DAILY LOG 11/14-18/11 DOMINION GROUP INC FOI DAILY LOG 10/31/11-11/4/11 Center for Regulatory Services, Inc. FOI DAILY LOG 11/7-11/11 Signature/ Requester Subject FOI DAILY LOG 10/31/11-11/4/11
Page 685 of 1132

Total Records: 12455 Control # 2011-9060 2011-9061 2011-9062 2011-9063 2011-9064 2011-9065 2011-9066 2011-9067 2011-9068 Recd Date / Due Date 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9069 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9070 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9071 12/08/2011 01/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9072 12/08/2011 OC/OM/OMP/DDM/ HELLEN OKETCH DKT FDA-1995-S-0316 METCALFE, ROBERT. WELBUTRINE - TEST FINDINGS LOREN LARKIN SAC CAPITAL MANAGEMENT LLC NOVARTIS INC, BOUCHEVILLE, QUEBEC - 483 AMY MITCHELL GLAXO SMITH KLINE BARNARD CASTLE FEI 3003722390, CORK FEI 100170338, DARTFORD FEI 1000338651 - QUALITY ASSURANCE PROFILE MCCANN, JOE ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ Action Office ORA/SW-FO/KAN-DO/COMP/ Signature/ Requester AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS AMANDA NERONE HEARTLAND LIONS EYE BANKS PETER S. HERRICK PETER S HERRICK ATTY QUESTCOR PHARMS INC - HP ACTHER GEL CORR MID AMERICA TRANSPLANT SERVICES, ST LOUIS, MO EIR, 483 MID AMERICA TRANSPLANT SERVICES, ST LOUIS, MO EIR, 483 GOSMANS FISH MARKET - RECS 11/21/08 INDIANA LIONS EYE & TISSUE TRANSPLANT BANK, INDIANAPOLIS, IN 483, EIR IOWA LIONS EYE BANK, IOWA CITY, IA - 483, EIR 2009, 2010 LABS INC, ST LOUIS, MO - 483, EIR 2009, 2010 Subject COMMUNITY BLOOD CTR OF GREATER KANSAS, KANSAS CITY, MO - 483, EIR 2009, 2010 GIFT OF HOPE, ELMHUST, IL - 483, EIR 2009, 2010
Page 686 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/09/2012 2011-9073 2011-9074 2011-9075 2011-9076 2011-9077 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/08/2011 01/09/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9078 12/09/2011 01/10/2012 ORA/ORO/DIOP/ ORA/ORO/DIOP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ 2011-9079 12/09/2011 01/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2011-9080 2011-9081 2011-9082 2011-9083 2011-9084 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC CARDINAL HEALTH 414 LLC, CHARLOTTE, NC - 483S ORA/SW-FO/KAN-DO/COMP/ FOI SERVICES INC CARDINAL HEALTH 414 LLC, ORLANDO, FL - 483 3/15/11 ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC ORA/CE-FO/NJ-DO/NJCB/ FOI SERVICES INC CARDINAL HEALTH 414 LLC, EAST RUTHERFORD, NJ - 483 6/16/11 CARDINAL HEALTH 414 LLC, VAN NUYS, CA - 483S 11/18/10, 5/11/11 CARDINAL HEALTH 414 LLC, ST LOUIS, MO - 483 5/10/11 FOI SERVICES INC ZHEJIANG HISUN PHARM, TAIZHO CITY, ZHEJIANG PROVINCE, CHINA - EIRS, 483S, WARNING LTRS, ETC 2003 TO PRESENT FOI SERVICES INC GAMMA CROMA SPA - EYESHADOW; LF BEAUTY - BODY SHOP DEFINE AND LENGTHEN MASCARA IMPORT DETENTIONS ORA/NE-FO/NWE-DO/NWECB/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ Action Office Signature/ Requester USP PHARMACOPEIA STEPHANIE E. WILLIAMS WILEY REIN LLP STEPHANIE E. WILLIAMS WILEY REIN LLP STEPHANIE E. WILLIAMS WILEY REIN LLP SASBINA KURIAKOSE NBC CONNECTICUT NEWS STEVE GUPTA MD JD PHYSICIANS FOR INTEGRITY IN MEDICAL RESEARCH INC BRADLEY INTERNATIONAL AIRPORT - EIRS, 483S 1/09 TO PRESENT DALIRESP, DAXAS (ROFLIMLAST) - CLNCL STUDIES M2124, M2-125, M2-127, M2-128 DKT 2006N-0454 DKT 2006N-0454 DKT 2006N-0454 Subject
Page 687 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/10/2012 2011-9085 2011-9086 2011-9087 2011-9088 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 2011-9089 2011-9090 2011-9091 2011-9092 2011-9093 2011-9094 2011-9095 2011-9096 2011-9097 2011-9098 2011-9099 2011-9100 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. PETNET SOLUTIONS INC, DALLAS, TX - 483 3/11/11 FOI SERVICES INC JOAN STITT (UGA2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. PETNET SOLUTIONS INC, KNOXVILLE, TN - 483 3/10/11 2011-8050 - REQUEST LTR 2011-8036 - REQUEST LTR 2011-7942 - REQEST LTR ORA/CE-FO/CIN-DO/CCB/ FOI SERVICES INC PETNET SOLUTIONS INC, JACKSONVILLE, FL - 483 3/14/11 ORA/P-FO/SEA-DO/SCB/ FOI SERVICES INC PETNET SOLUTIONS INC, LOUISVILLE, KY - 483 8/23/10 ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC PETNET SOLUTIONS INC, KENT, WA - 483 12/3/10 ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC PETNET SOLUTIONS INC, NORTH WALES, PA - 483 1/12/11 ORA/SW-FO/KAN-DO/COMP/ FOI SERVICES INC PETNET SOLUTIONS INC, ATLANTA, GA - 483 2/7/11 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ FOI SERVICES INC PETNET SOLUTIONS INC, ST LOUIS, MO - 483 2/9/11 PETNET SOLUTIONS INC, PALO ALTO,CA - 483 3/3/11 FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC COOPERVISION, HENRIETTA, NY; HAMBLE, SOUTHAMPTON,UK; JUANA DIAS, PR - 483S 8/11 TO PRESENT ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC CARDINAL HEALTH 414 LLC, FT LAUDERDALE, FL - 483 3/26/10 FCN 982 Action Office Signature/ Requester FOI SERVICES INC Subject 5/14/10, 2/18/11 CARDINAL HEALTH 414 LLC, COLTON, CA - 483 12/17/10
Page 688 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/10/2012 2011-9101 12/09/2011 01/10/2012 Action Office ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9102 2011-9103 12/09/2011 01/10/2012 12/09/2011 01/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ NCTR/OD/ 2011-9104 2011-9105 2011-9106 2011-9107 2011-9108 2011-9109 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9110 2011-9111 12/09/2011 01/10/2012 12/09/2011 01/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9112 12/09/2011 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2011-8277 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. AMY J CRAWFORD MALLINCKRODT INC MALLINCKRODT INC, HAZELWOOD, MO - QUALITY ASSURANCE PROFILE (QAP) 2011-8276 - REQUEST LTR STAHLI, LEIGHANN OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. QUESTCOR PHARMS - HP ACTHAR GEL NDA 08372/S024.S025,S029, ETC LBLG REVISION 2011-8216 - REQUEST LTR 2011-8201 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. STEPAN CO - MEDIUM CHAIN TRIGLYCERIDES GRASP 4G0409 2011-8175 - REQUEST LTR 2011-8161 - REQUEST LTR FOI SERVICES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. CHLORHEXIDINE-ALCOHOL VS POVIDONE-IODINE FOR SURGICAL-SITE ANTISEPSIS - STUDY PROTOCOL, ANNUAL RPTS, AMENDMENTS, ETC 2011-8061 - REQUEST LTR FOI SERVICES INC Signature/ Requester FOI SERVICES INC REGENERON PHARMS - EYLEA BLA 125387 APRVL RECS Subject
Page 689 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/10/2012 2011-9113 2011-9114 2011-9115 2011-9116 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 2011-9117 2011-9118 2011-9119 2011-9120 2011-9121 2011-9122 2011-9123 2011-9124 2011-9125 2011-9126 2011-9127 2011-9128 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/09/2011 01/10/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC 2011-6482 FOI SERVICES INC 2011-6850 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-6820 2011-8643 - REQUEST LTR 2011-8635 - REQUEST LTR 2011-8583 - REQUEST LTR 2011-8542 - REQUEST LTR 2011-8525 - REQUEST LTR 2011-8484 - REQUEST LTR 2011-8478 - REQUEST LTR 2011-8469 - REQUEST LTR 2011-8465 - REQUEST LTR Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. DR ASHLEY BLACK SWEDISH COVENANT HOSPITAL BIRCHWOOD LABS - CONTAMINATED MOUTHWASH BURKOLDERIA CEPACIA OUTBREAK INVESTIGATION RECS 2011-8407 - REQUEST LTR 2011-8381 - REQUEST LTR 2011-8280 - REQUEST LTR Subject
Page 690 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/11/2012 2011-9129 2011-9130 2011-9131 2011-9132 2011-9133 2011-9134 2011-9135 2011-9136 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ 2011-9137 2011-9138 2011-9139 12/12/2011 01/11/2012 12/12/2011 01/11/2012 12/12/2011 01/11/2012 2011-9140 12/12/2011 01/11/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DEN-DO/COMP/ 2011-9141 12/12/2011 FDA/OMPT/CDRH/OCER/DFOI/ MARCIA FINKLESTEIN THORATEC CORP - HEARTMATE II MODEL #1355 RECALL FOI SERVICES INC IULLIA FRIED MARTIN MAGNUSON ET AL ROMAN ROZENFELD POINTSTATE CAPITALL LP VALLEYLAB OR COVIDIEN INC - SINGLE USE ELECTROSURGICAL PENCIL K861112, K961112 AERS, COMM NOVARTIS INTERNATIONAL, BROOMFIELD, CO - 4/19/115/6/11; WILSON , NC - 6/6-22/11; BOUCHERVILLE, QUEBEC 7/26/11-8/4/11 483S FOI SERVICES INC 2011-6819 2011-6748 FOI SERVICES INC FOI SERVICES INC 2011-6715 FOI SERVICES INC 2011-6605 FOI SERVICES INC 2011-6578 FOI SERVICES INC 2011-6572 FOI SERVICES INC 2011-6514 FOI SERVICES INC 2011-6512 FOI SERVICES INC 2011-6511 Signature/ Requester FOI SERVICES INC 2011-6509 Subject
Page 691 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/11/2012 2011-9142 2011-9143 12/12/2011 01/11/2012 12/12/2011 01/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DEN-DO/COMP/ 2011-9144 12/12/2011 01/11/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ 2011-9145 12/12/2011 01/11/2012 ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ MATTHEW SILPE JUNE JACOBS LABS BENTLEY LABS LLC, EDISON, NJ 11/17/09; BIOSCREEN TESTING SERVICES INC, TORRANCE, CA 1/28/10; PRESTIGE COSMETICS INC, HUNTINGTON BEACH, CA - 483 5/19/11, WARNING LTR, EIR REDACTED MEDWATCH RPTS CODED AS MEDICATION ERRORS 11/1/11 TO 12/1/11 AGUILA, RALPH CAREFUSION CORP - CLIO 2 AUTOMATIC OXYGEN CONTROL - CORR, 510K Action Office ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester GERTLER LAW FIRM ELIOT HARRISON LEWIS & HARRISON WILLIAM MESTRANDREA PFIZER INC. HOSPIRA, BOULDER, CO; MELBOURNE, AUSTRALIA; CHENNAI, INDIA -483 1/11 TO PRESENT Subject 4/21/08, 10/08 FCN 178 - TOXICOLOGY RVW, CHEMISTRY RVW
2011-9146
12/12/2011 01/11/2012
MICHAEL R. COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES
2011-9147
12/12/2011 01/11/2012
FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/
E. JAMES GAIDRY, JR. E. JAMES GAIDRY JR ATTORNEY COUNSELOR AT LAW
ALCON 27 GAUGE DISPOSABLE CANNULA - CMPLNTS, INVESTIGATIONS, INQUIRIES, ETC
2011-9148
12/12/2011 01/11/2012
TOM NELTER PEW CHARITABLE TRUSTS
TEXAPOL - MELAMINE; KELLER & HECKMAN HEXAFLUOROISOPROPYLIDENE; KELLER & HECKMAN BROMOCHLORO - FOOD ADDITIVE SAFETY KELLER & HECKMAN - HYDROGENATED CARBON; KELLER & HECKMAN - PET; PURE TECH - PET - FOOD ADDITIVE SAFETY COLOR MATRIX GROUP INC - ETHYLENE PHTHALATE POLYMERS; GREENE TWEED & CO INC PERFLUOROCARBON CURED ELASTOMER; BALZERS AKTIENGESELLSCH AFT - TITANIUM ALUMINUM NITRATE FOOD ADDITIVE SAFETY DKT FDA-2010-P-0491
2011-9149
12/12/2011 01/11/2012
TOM NELTNER PEW CHARITABLE TRUSTS
2011-9150
12/12/2011 01/11/2012
2011-9151
12/13/2011
OC/OM/OMP/DDM/
MARILYNN WHITNEY
Page 692 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/12/2012 2011-9152 2011-9153 12/13/2011 01/12/2012 12/13/2011 01/12/2012 2011-9154 2011-9155 2011-9156 2011-9157 2011-9158 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 2011-9159 12/13/2011 01/12/2012 2011-9160 12/13/2011 01/12/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9161 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9162 2011-9163 12/13/2011 01/12/2012 12/13/2011 01/24/2012 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/NJ-DO/NJCB/ REBECCA MACIEL FoodScience Corporation W E CHALKLEY THOMSON REUTERS BIOCHEM PHARMA INC - PACIS (BCG LIVE); MICRO TYPING SYSTEMS INC - ID MICRO TYPING SYSTEMS BLA 103787/0; ORTHO-CLINICAL DIAGNOSTICS INC - ANTIBODY TO HBSAG ELISA TEST SYS 3 BLA 103901/0 APRVL RECS VITAL HEALTH, CLIFTON, NJ - EIRS 3/11, 4/11 JOHN J HAY SALANS ATTY TEVA PHARMACEUTICAL INDUSTRIES LTD, JERUSALALEM, ISRAEL - EIRS 9/12-16/10 JOHN J HAY SALANS ATTY APOTEX, ETOBICOKE - EIRS, RESULTS, WARNING LTRS 12/10-19/08, 6/25/09, ETC KRISTIN M HICKS ARNOLD & PORTER DKT 2006N-0304 AGUILA, RALPH FDA/OMPT/CDRH/OCER/DFOI/ AGUILA, RALPH FDA/OMPT/CDRH/OCER/DFOI/ AGUILA, RALPH FDA/OMPT/CDRH/OCER/DFOI/ AGUILA, RALPH FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ AGUILA, RALPH IMPACT INSTRUMENTATION INC - MARINE CORPS TRANSPORT VENTILATOR (MCTV) 501K, IDE, PMA, ETC DRAGER MEDICAL AG & CO KGAA - PULMOVISTA 50 510K, IDE, PMA, ETC MAQUET - SERVO-1 WITH NAVA OPTIONS K062793, POSTMARKETING SAFETY RECS FISHER & PAYKEL LTD - INDICATONS OF USE FOR THE MR730 K913368 DRAGER MEDICAL AG & CO KGAA - SMARTCARE K051263, POSTMARKETING SAFETY RECS AGUILA, RALPH OC/OM/OMP/DDM/ Action Office Signature/ Requester COVINGTON & BURLING LLP JENNIFER PELAIA COVINGTON & BURLING LLP CAREFUSION CORP - CLIO2 AUTOMATIC OXYGEN CONTROL 510K, IDE, PMA, ETC OTC VOLS 130134, 130151, 130160, ETC. Subject
Page 693 of 1132

Total Records: 12455 Control # 2011-9164 2011-9165 2011-9166 2011-9167 2011-9168 2011-9169 2011-9170 Recd Date / Due Date 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 02/01/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9171 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9172 2011-9173 12/13/2011 01/12/2012 12/13/2011 01/12/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ VIK BAJNATH ARTHREX INC RAYA MAROM MELNIK RAYA MAROM MELNIK LAW OFC NIDEK CO LTD - EC-5000 EXCIMER LASER SYS P970053; NIDEK TECHNOLOGIES INC - EXCIMER LASER SYS P970053/S001,S002,S003,S005,S006,S007, S008,S009, S010 LBLG CHANGE, APRVL, SS&E OHM LABORATORIES INC TERMINAL, NEW BRUNSWICK, NJ - EIRS 1/09 TO PRESENT DREAMLLIFE LLC, COVINGTON, LA - 483S 6/3,8/11 GERHARDT, NATHAN MW# 5022924 - RPT WARDLAW #31195, TRAVIS XANAX, LORATAB, NEURONTIN, ETC - AERS FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ Action Office ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester REBECCA MACIEL FoodScience Corporation LINDA VALENTINE THE RITEDOSE CORP LINDA VALENTINE THE RITEDOSE CORP LINDA VALENTINE THE RITEDOSE CORP MICHAEL J MASTRANGELO JEFFERSON MEDICAL COLLEGE DANIEL M DRUCKER FARM DESIGN INC JODY L GREEN PHD ROCKY MOUNTAIN POISON & DRUG CENTER INTUITIVWE SURGICAL - DA VINCI SURGICAL SYS HUMAN FACTORS VERIFICATIONS & VALIDATION RECS COUGH & COLD PREPARATIONS - ISRS 7353185-1, 7355936-9, 7356739-1, ETC BB-IND 6486 - RECS RITEDOSE CORP, COLUMBIA, SC - EIRS 2010, 2011 NEPHRON PHARMACERUTICALS CORP, ORLANDO, FL EIRS, 483S 2009, 2011 DEY PHARMA LP, NAPA, CA - EIRS, 483S 2009, 2010, 2011 Subject BACTOLAC, HAUPPAUGE, NY - EIRS 11/11
2011-9174 2011-9175
12/13/2011 01/12/2012 12/13/2011 01/12/2012
ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
BOWMAN COX BOWMAN COX
2011-9176
12/13/2011 01/12/2012
CRAIG ROUSH ROCKLINE INDUSTRIES
NICE-PAK PRODUCTS INC, ORANGEBURG, NY, PROFESSIONAL DISPOSABLES INC, ORANGEBURG, NY EIRS, 483S 4/1-30/11, 6/1-30/11
Page 694 of 1132

Total Records: 12455 Control # 2011-9177 Recd Date / Due Date 12/13/2011 01/12/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9178 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9179 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9180 12/13/2011 01/12/2012 2011-9181 12/13/2011 01/12/2012 ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OF/CFSAN/OCD/EOS/ TOM NELTNER PEW CHARITABLE TRUSTS COLORMATRIX GROUP INC - ETHYLENE PHTHALATE POLMERS FCN 145; AMERSHAM BIOSCIENCES - AGAROSE FCN 443; ENVIRO TECH CHEMICAL SERVICES INC HYPOBROMOUS ACID FCN 1098, ETC TEXAPOL CORP - MELAMINE & TRIPHENYL PHOSPHINE TOR-97-003; HITACHI CHEMICAL COMPANY INC TRIETHYLAMINE TOR-09-003, ETC SIDEL INC - HYDROGENATED CARBON RECY-94; EREMA GMBH - PET RECY-140; PURE TECH PLASTICS INC - PET RECY-54 COOPER VISION INC, NY, PR - 483S, WARNING LTRS 8/11 TO PRESENT DAVID L SPOEDE KABOOM ACTION STRIPS - IMPORT REFUSAL RPT EHP0000248-6/1/1, ANALYSIS RESULTS LOIS ZIEBOL PURSUIT VASCULAR HI TECH PHARMA - NDA 74-356; JOHN O BUTLER CO - NDA 76-434; TEVA - NDA 74-522, ETC RECS JEANNE SHINGLETON ALERE HEALTH LLC K-V PHARMACEUTICAL CO - 17P (HYDROXYPROGESTERONE CAPROATE) SAFETY, TESTING RECS Signature/ Requester LISA CASTRO UCB INC Subject TOPAMAX (TOPIRAMATE) - SBA
2011-9182
12/13/2011 01/12/2012
2011-9183
12/13/2011 01/12/2012
2011-9184
12/13/2011 01/12/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/SJN-DO/SJCB/
LEI HUANG WELLS FARGO SECURITIES
2011-9185 2011-9186 2011-9187
12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 04/09/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ HASANATI #D15084, JAHI ADAM GREENE DEERFIELD MANAGEMENT JOHN R JONES J R JONES INC
PROCEDURES & RULES FOR FILING A CMPLNT HOSPIRA INC, SOMERSET, NJ - 483 5/19/11 PIRAMAL CRITICAL CARE INC, BETHLEHEM, PA - 483S, CORR, FOLLOW-UP INSPS, ETC 2006, 2010, 2011
Page 695 of 1132

Total Records: 12455 Control # 2011-9188 2011-9189 2011-9190 2011-9191 2011-9192 2011-9193 Recd Date / Due Date 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 01/12/2012 12/13/2011 02/09/2012 OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-9194 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9195 12/13/2011 06/07/2012 2011-9196 2011-9197 12/13/2011 01/12/2012 12/13/2011 01/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9198 2011-9199 2011-9200 12/13/2011 01/12/2012 12/14/2011 01/13/2012 12/14/2011 ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ ANNE D. SPIGGLE Patton Boggs LLP WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY ATHEA LABS, MILWAUKEE WI - EIR, 483, CO RESP 3/11 TOBACCO MANUFACTURERS - 483S, EIRS 10/11 TO PRESENT APTUIT, HARRISONVILLE, MO - EIR, 483, CO RESP 5/11 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ OC/OSHC/OPD/ HEIDI KRAUS POLITIS, Esq. ABON PHARMACEUTICALS LLC ANTHONY J. PALUMBO PALUMBO WOLFE BOTOX - AER GRALISE NDA 022544 - RVW TODD WHEELES MORRIS HAYNES & HORNSBY INDIVIDUAL RECS YULLA FRENKEL TRIS PHARMA INC SANOFI AVENTIS USA - BENDECTIN (DOXYLAMINE SUCCINATE) NDA, SBA, LBLG FDA/OF/CFSAN/OCD/EOS/ Action Office ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/ ORA/ OM/OMP/DODM/ PROUDFOOT, ALEX ADRIAN GIRALDO SOTO ECOFLORA SA RICARDO ALONSO-ZALDIVAR ASSOCIATED PRESS ROBERTA JEAN HANSON FAEGRE & BENSON LLP PLAN B EMERGENCY CONTRACEPTION - FDA COMMISSIONER & HHS OFFICE OF THE SECRETARY CORR KAMADA - ANTITYRPSIN NDA Signature/ Requester NAVIN JACOB CITADEL LLC PAULINE BRIDGMAN EMPIRE INTERNATIONAL VACUUM PACKED FROZEN SMOKED EEL ENTRY #9062116235 - LAB RPT GENERIC DRUGS A/C WITH DERMATOLOGIC A/C REPRESENTATION CENTER - TRANS 9/12-13/94 COLOR ADDITIVE PETITION (CAP) 7C0283 Subject AKORN PHARMS - 483S, WARNINGS 1/09 TO PRESENT
Page 696 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/13/2012 2011-9201 2011-9202 2011-9203 2011-9204 2011-9205 2011-9206 2011-9207 2011-9208 2011-9209 2011-9210 2011-9211 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/23/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9212 12/14/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9213 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY CHANGZHOU PHARMACEUTICALS GROUP, CHANGZHOU, WALTER E CHALKLEY THOMSON REUTERS CATALENT PHARMA SOLUTIONS, BRUXELLES, BELGIUM EIR, 483, CO RESP 6/11 ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CHI-DO/CCB/ Action Office Signature/ Requester THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS BRISTOL-MYERS SQUIBB HOLDINGS PHARMA, MANATI, PR - EIR, 483, CO RESP 3/11 CARDINAL HEALTH 414, EAST RUTHERFORD, NJ - EIR, 483, CO RESP 6/11 CARDINAL HEALTH 414, CHARLOTTE, NC - EIR, 483, CO RESP 2/11 CARDINAL HEALTH 200, EL PASO, TX - EIR, 483, CO RESP 5/11 DAIICHI FINE CHEMICAL CO, TOYAMAN, JAPAN - EIR, 483, CO RESP 3/11 BAXTER HEALTHCARE CORP, ROUND LAKE, IL - EIR, 483 CO RESP 3/11 BAXTER HEALTHCARE CORP, CHERRY HILL, NJ - EIR, 483, CO RESP 4/11 BAXTER HEALTHCARE RENAL DIVISION, MCGAW PARK, IL EIR, 483, CO RESP 3/11 BAXTER HEALTHCARE CORP, BUFFALO GROVE, IL - EIR, 483, CO RESP 3/11 BOEHRINGER INGELHEIM ROXANE, COLUMBUS, OH - EIR, 483, CO RESP 1/11 BRAINTREE LABS, HOLBROOK, MA - EIR, 483, CO RESP 1/11 Subject
Page 697 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/13/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9214 2011-9215 2011-9216 2011-9217 2011-9218 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9219 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9220 12/14/2011 01/13/2012 2011-9221 12/14/2011 01/25/2012 2011-9222 2011-9223 12/14/2011 01/13/2012 12/14/2011 01/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MARCRUM #K03391, JEFFREY OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ JOSEPH M AZARY HYDROFERA LLC HYDROFERA - BACTERIOSTATIC NASAL DRESSING K983276 FOUR LOCO, JUNGLE JUICE - CAERS, AERS, STUDIES, ETC WALTER E CHALKLEY THOMSON REUTERS INSTITUTO GRIFOLS, BARCELONA, SPAIN - EIR, 483, CO RESP 3/11 WALTER E CHALKLEY THOMSON REUTERS HEARTHSINE TECHNOLOGIES, BELFAST, GB - EIR, 483, CO RESP 1/11 WALTER E CHALKLEY THOMSON REUTERS APOTEX, TORONTO, CANADA - EIR, 483, CO RESP 2/11 ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS GE MEDICAL SYSTEMS, WILMINGTON, MA - EIR, 483, CO RESP 1/11 JIANGXI KINGNORD INDUSTRIAL LTD, NANCHANG, CHINA EIR, 483, CO RESP 4/11 DENDREON CORP, MORRIS PLAINS, NJ - EIR, 483, CO RESP; 1/11 FSC LABS, CHARLOTTE, NC - EIR, 483, CO RESP 3/11 3M CO, MILFORD, OH - EIR, 483, CO RESP 3/11 Signature/ Requester THOMSON REUTERS Subject CHINA - EIR, 483, CO RESP 4/11
Page 698 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2011-9224 12/14/2011 01/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9225 12/14/2011 01/13/2012 2011-9226 12/14/2011 01/13/2012 CTP/OD/ CTP/OD/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9227 2011-9228 12/14/2011 01/13/2012 12/14/2011 01/13/2012 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9229 2011-9230 2011-9231 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9232 12/14/2011 01/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9233 12/14/2011 FDA/OMPT/CDER/ORP/DIDP/ BRIAN SMITH OUELET-HELLTROM R 201 RVW OF THE FDA- FUNDED ROGER H MIKXAD Wiley ReinLLP COMPLIANCE RPT FOR DESI 2 PECK, CARL C FOI SERVICES INC VIDEX (R) (DIDANOSINE DDL) - APRVL LTR FDA/OMPT/CDRH/OCER/DFOI/ JOSEPH M AZARY HYDROFERA LLC 2011-6876 RETRO-TECH DRESSING - K060832 DAVID P JORDAN THOMSON REUTERS KELLY QUIGLEY DOUGLAS LONDON PC ATTY AT LAW YAZ, YAZMIN - AERS 1/08 TO PRESENT DOMESTIC & FOREIGN DRUG INSPS 6/11 TO PRESENT LEIGHANN STAHLI LEIGHANN STAHLI QUESTCOR PHARMS - HP ACTHAR GEL NDA 08372/S029,S025,S024, ETC LBLG REVISION SELF, LUKE WOODMAN'S FOOD MARKET, CARPENTERSVILLE, IL TOBACCO SALES TO A MINOR 1/1/11 TO 12/6/11 THOMAS A KUCHNICKI KUCHNICKI, THOMAS A SINEMENT NDA 17-555 - TIME VS DRUG CONCENTRATION, TIME DRUG INGESTION TO OBSESRVED MAXIMUM STRENGH, SUMMARY OF PATIENTS & AGE GENDER USED TO DETERMINED THE TIME VS DRUG STUDY Signature/ Requester Subject
Page 699 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/13/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9234 12/14/2011 01/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9235 12/14/2011 01/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9236 2011-9237 2011-9238 2011-9239 2011-9240 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 2011-9241 12/14/2011 02/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ 2011-9242 12/14/2011 01/13/2012 2011-9243 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY THOMSON REUTERS FRESNIUS KABI, ROVIGO, ITALY - EIR, 483, COR RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS AMGEN MANUFACTURING LTD, JUNCOS, PR - EIR, 483, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS ALLERGAN SALES, WACO, TX - EIR, 483, CO RESP 3/11 FOI SERVICES INC WALTER E CHALKLEY THOMSON REUTERS ABBOTT PHARMS, BARCENOLETA, PR - EIR, 483,CO RESP 3/11 FOI SERVICES INC 2011-6965 FOI SERVICES INC 2011-6863 FOI SERVICES INC 2011-7066 2011-6868 DOUGLAS G SCHNEEBECK BIOGEN, KNOPPP - DEXPRAMIPEXOLE REPORTED OR REQUESTED USE OUTSIDE OF FDA APRVD CLNCL TRIALS BRETWT TEAL HBO REAL SPORTS TORADOL (KETOROLAC) - AERS 1991 TO 2010 Signature/ Requester LEXIS NEXIS COURTLINK INC Subject STUDY COMBINED HORMONAL CONTRACEPTIVE & THE RISK OF CARDIOVASCULAR DISEASE ENDPOINTS, RVWS, (CERTIFIED)
Page 700 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9244 12/14/2011 01/25/2012 2011-9245 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9246 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9247 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9248 12/14/2011 01/25/2012 2011-9249 12/14/2011 01/13/2012 2011-9250 12/14/2011 01/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ ORA/ORM/ ORA/ORM/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ JOHNATHAN RICKMAN FDA NEWS YAIME YANEZ BORRELL PRODUCTOS ALIMENTICIOS LA MORENA SA PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG, CLNCL TRIAL FACILITIES INSIDE & OUTSIDE THE US - 483S 10/131/11 PRODUCTOS ALIMENTICIOS LA MORENA - RECS 2/11 TO PRESENT; ENTRY #WFE-0069997-1/3/1, #W43-01300758/1/3, IMPORT ALERT 99-08 - RECS WALTER E CHALKLEY THOMSON REUTERS GLAXOSMITHKLINE BIOLOGICALS, DRESDEN, GERMANY EIR, 483, CO RESP 6/11 WALTER E CHALKLEY THOMSON REUTERS GFPS, AACHEN, GERMANY - EIR, 483, CO RESP 6/11 WALTER E CHALKLEY THOMSON REUTERS GENZYME, HAVERHILL, UK - EIR, 483, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS AVENTIS BULK, BRINDISI, ITALY - EIR, 483, CO RESP 3/11 WALTER E CHALKLEY THOMSON REUTERS BAXTER BIOSCIENCES, LESSINES, BELGIUM - EIR, 483, CO RESP 1/11 Signature/ Requester Subject
Page 701 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-9251 2011-9252 2011-9253 2011-9254 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 2011-9255 12/14/2011 05/07/2012 FDA/OF/CFSAN/OCD/EOS/ NCTR/OD/ OC/COS/OES/ OC/COS/OES/ 2011-9256 2011-9257 12/14/2011 01/13/2012 12/14/2011 01/13/2012 2011-9258 12/14/2011 02/16/2012 2011-9259 12/14/2011 01/13/2012 2011-9260 12/14/2011 01/13/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9261 12/14/2011 OM/OSS/OPILS/DFI/ WALTER E CHALKLEY 3M COMPANY, CORDOVA, IL - EIRS, 483S, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS HANMLI FINE CHEMICAL, SHIHANG CITY, SOUTH KOREA EIRS, 483S, CO RESP 3/11 SANDI HAMMONS PREMIER PIGMENTS INTERNATIONAL ACADEMY OF MICROPIGMENTATION; SOCIETY OF PERMANENT COSMETIC PROFESSIONALS COMM 2001 TO PRESENT FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ ANNA KIEBURTZ Hyman, Phelps & McNamara, P.C. SANDI HAMMONS PREMIER PIGMENTS SANDI HAMMONS PREMIER PIGMENTS DKT FDA-2011-D-0429, FDA-2011-D-0305, FDA-2011-N00020 TATTOOS & COSMETIC TATTOO INKS - SAFETY, CHEMISTRY OF COLORANTS, CAERS, INVESTIGATIONS, ETC 2002 TO PRESENT PREMIER TRUE COLOR CONCENTRATES - CONSUMER ALERTS, RECALL RECS, COMM, ETC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ JENNIFER PELAIA COVINGTON & BURLING LLP SANDI HAMMONS PREMIER PIGMENTS CHRISTOPHER LAHIFF MCDERMOTT WILL & EMERY SANDI HAMMONS PREMIER PIGMENTS SANDI HAMMONS PREMIER PIGMENTS COSTS OF FDA RESEARCH & INVESTIGATION OF THE SAFETY OF TATTOO, MICROPIGMENTATION, DILUENTS, INKS, ETC 2001 TO PRESENT TATTOO & COSMETIC TATTOO INKS RESEARCH COMM RECS 2001 TO RESENT TATTOO AND COSMETIC TATTOO INDUSTRIES - FDA OVERSIGHT COMM 2001 TO PRESENT DKT FDA-1995-S-0039 OTC VOL 130008, 130068, 130067, ETC. Signature/ Requester Subject
Page 702 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/13/2012 2011-9262 12/14/2011 01/13/2012 2011-9263 12/14/2011 01/13/2012 2011-9264 12/14/2011 01/13/2012 2011-9265 2011-9266 2011-9267 2011-9268 2011-9269 2011-9270 2011-9271 2011-9272 2011-9273 2011-9274 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 2011-9275 12/14/2011 ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ FOI SERVICES INC MARLENE L CHURCH PALM BEACH RESEARCH CENTER RACHELLE HEMINGER UNIV OF COLORADO CORD BLOOD BANK - 483S 2010, 2011 2011-7998 - RESP TO 483 3/2/11 FOI SERVICES INC 2011-6967 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ FOI SERVICES INC LINCOLN BEAUREGARD CONNELLY LAW OFCS 2011-7046 INDIVIDUAL RECS FOI SERVICES INC 2011-7004 FOI SERVICES INC 2011-6998 ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/KAN-DO/COMP/ Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ IAN R WALSWORTH SHERIDAN ROSS PC LINDA DODD PB LEINER USA RACHELLE HEMINGER STEMCYTE INC 2011-6971 NEW YORK BLOOD CENTER CORD BAMK - 483S 2010-2011 CAPSTONE SPINAL SYS; PYRAMESH, PYRAMESH-C IMPLANT SYS - RPTS, APRVL, SUMMARIES, ETC PB LEINER USA CORP, DAVENPORT, IA - EIR 6/7/11 WALTER E CHALKLEY THOMSON REUTERS ABBOTT MOLECULAR, DES PLAINES, IL - EIRS, 483S, CO RESPS 5/11 WALTER E CHALKLEY THOMSON REUTERS ABBOTT LABORATORIES, NORTH CHICAGO, IL - EIRS, 483S, CO RESPS 3/11 WALTER E CHALKLEY THOMSON REUTERS ABBOTT BIOTECHNOLOGY LTD, BARCENOLETA, PR - EIRS, 483S, CO RESP 4/11 Signature/ Requester THOMSON REUTERS Subject
Page 703 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/13/2012 2011-9276 2011-9277 2011-9278 12/14/2011 01/13/2012 12/14/2011 01/13/2012 12/14/2011 01/13/2012 2011-9279 12/14/2011 01/13/2012 ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9280 12/14/2011 01/13/2012 2011-9281 12/14/2011 01/13/2012 2011-9282 2011-9283 2011-9284 2011-9285 2011-9286 2011-9287 2011-9288 2011-9289 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LOFTIN, ROBERT J RICK GODDARD ROCHE DIAGNOSTICS ROCHE - COBAS C 311 ANALYZER RECALL #Z-0310-2012, COBAS C 111 HEALTH HAZARD EVALUATION FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ LILNDA LORETZ PERSONAL CARE PRODUCTS COUNCIL MARK PIFKO BARON BUDD PC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. DARI DARABBEIGI PERSYST DEVELOPMENT CORP LIST OF ALL CERTIFIED MANNOGRAPHY FACILITIES PERSYST - REVEAL K0111397 2011-8794 - REQUEST LTR 2011-8781 - REQUEST LTR 2011-8670 - REQUEST LTR FOI DAILY LOG 12/5-9/11 ALEXIA FOODS INC -SAUTE REDS MASHED POTATOES, YUKON GOLD POTATOES, SEA SALT MASHED POTATOES, ETC LAB RECS, LTRS, TRANS, ETC 2011-8666 - REQUEST LTR COSMETICS - CAERS RPT Doe J TANAZUMAB - CO NAME CLINICAL TRIAL DATE, DOSING INFRORMATION Doe J FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ Doe J JEFFREY GLEN JEFFREY D GLENN DDS REUMOFAN PLUS - RECS VITAPREX PRE-LOADED DENTAL SYRINGE - K973667 Action Office Signature/ Requester STEMCYTE INC CMPLNT Subject
Page 704 of 1132

Total Records: 12455 Control # 2011-9290 Recd Date / Due Date 12/15/2011 02/15/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester RUBY MALDONADO SMITH & NEPHEW Subject IASIS MEDICAL INC, HASTINGS, MN - NPD 1000 NEGATIVE PRESSURE WOUND THERAPY K080275; KCI USA INC, SAN ANTONIO, TX - PREVENA INCISION MANAGEMENT SYS K100821 ZOLPIDEM TARTRATE NDA 22-328 - APRVL PKG
2011-9291
12/15/2011 01/17/2012
ELIZABETH BARBEHENN PUBLIC CITIZEN
2011-9292 2011-9293 2011-9294 2011-9295
12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012
ORA/CE-FO/PHI-DO/PCB/ OM/OMP/DODM/ CVM/OCD/ CVM/OCD/
SIDNEY M WOLFE PUBLIC CITIZEN CHARLES A FISHER FISHER WALLACE LABS LLC ANEET PANESAR BURDOCK GROUP ANEET PANESAR BURDOCK GROUP
RED CROSS DCSC, PHILADELPHIA, PA - 483S 9/10, 10/10 DKT FDA-2011-N-0504-0029 CORN OIL, VEGTABLE FAT, VEGETABLE OIL - FAP, GRAS, SAFETY RECS DISTILLERS GRAIN, DISTILLERSSOLUBLES, DISTILLERSGRAIN WITH SOLUBLES, DISTILLERS WET GRAIN, ETC - SAFETY RECS, REGULATORY STATUS, COMSUMPTION USE BNL FOOD INVESTMENTS SARL (BNLFOOD, SALZBAACH, LUXEMBOURG) - OVOLIFE CORR, MEMOS, NOTES, ETC 12/9/11 NEW PARADIGN HEALTH SYSTEMS INC - SOBRIETOL LTR
2011-9296
12/15/2011 01/17/2012
ELENA HOWELL HOGAN LOVELLS US LLP
2011-9297
12/15/2011 01/17/2012
FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
MATT VIRDEN MATT VIRDEN
2011-9298
12/15/2011 01/17/2012
HOSPIRA - MORPHINE SULFATE NDA 202515 APRVL
2011-9299
12/15/2011 01/17/2012
JOAN STITT MERCK & CO., INC.
ISRS 6161835-0, 6245352-5; 6253921-1
Page 705 of 1132

Total Records: 12455 Control # 2011-9300 Recd Date / Due Date 12/15/2011 01/17/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9301 12/15/2011 01/17/2012 2011-9302 2011-9303 12/15/2011 01/17/2012 12/15/2011 01/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9304 12/15/2011 01/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9305 12/15/2011 01/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DEN-DO/COMP/ 2011-9306 2011-9307 12/15/2011 01/17/2012 12/15/2011 01/17/2012 2011-9308 12/15/2011 01/17/2012 2011-9309 2011-9310 12/15/2011 01/17/2012 12/15/2011 01/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ JAMES A. BOIANI, Esq. EPSTEIN BECKER & GREEN PC CASEY NESSELHAUF DEMOCRATIC CONGRESSIONAL CAMPAIGN COMM JAMES H. LOHR WORSFOLD MACFARLANE MCDONALD ELYSSA M. FRIED, Esq. Finkelstein and Partners SCOTT LOVE CLARK BURNETT ET EL GILL CHABRA FARMS, SAN JOAQUIN COUNTY ,CA; GILL FARMS, SAN JOAQUIN COUNTY, CA; JASBIR GILL FAMILY LP, SAN JOAQUIN COUNTY - EIRS, RECS REQUEST FOODS INC, HOLLAND, MI - EIRS, CMPLPNTS, 1/10 TO PRESENT NY GOURMET SALADS INC, BROOKLYN, NY - ENTRIES OF TAINTED CHICKPEAS 4/10 PFIZER INC - ZOLOFT EFFICACY TEAR LAB CORP - PETITION BRENTON L. HORNER HORNER & ASSOCIATES WORLD HEALTH PRODUCTS LLC - DETOXAMIN SUPPOSITORIES APRVL, WARMINGS, LBLG, CP RESP JASON FREEMAN BEST MEDICAL INTL INC MYLAN TECHNOLOGIES - FENTANYL ANDA 076258; WATSON LABS - FENTANYL ANDA 076709; LAVIPHARM LABS - FENTANYL ANDA 066051 ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC REBECCA MACIEL FOOD SCIENCE CORP JOHN WALSH JAMES ALEXANDER CORP TECHNISCHE GLASWERKE ILMENAU GMBH, GERMANY EIR, 483, RECALL 12/08 TO PRESENT PARAGON LABS, TORRANCE, CA - EIR 12/10 CMPNT CPT1100211 Signature/ Requester DANA HAYDEN SIEGFRIED (USA) INC Subject SUBOXONE N020732 - TOXICOLOGY
Page 706 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9311 2011-9312 2011-9313 2011-9314 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 12/15/2011 01/17/2012 CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OPPL/OP/ 2011-9315 12/16/2011 01/18/2012 2011-9316 12/16/2011 01/18/2012 2011-9317 12/16/2011 01/27/2012 2011-9318 12/16/2011 01/18/2012 2011-9319 12/16/2011 01/18/2012 2011-9320 12/16/2011 01/18/2012 2011-9321 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WALTER E CHALKLEY THOMSON REUTERS LEDESMA GILBERT, ARLINGTON, TX - EIRS, 483S, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS MALLINCKRODT, MARYLAND HEIGHTS, MO - EIRS, 483S, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS MERCK SHARP DOHME, WEST POINT, PA - EIRS, 483S, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS MULTIMEX, TUCKER, GA - EIRS, 483S, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS NOVARTIS VACCINES & DIAGNOSTICS, LIVERPOOL, UK EIRS, 483S, CO RESP 3/11 WALTER E CHALKLEY THOMSON REUTERS PATHEON PUERTO TICCO, MANATI, PR - EIRS, 483S, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS ORTHO BIOLOGICS, MANATI, PR - EIRS, 483S, CO RESP 4/11 OC/OIASI/OCP/ OC/OM/OMP/DDM/ OC/COS/OL/ DANIEL NEWMAN MAP LIGHT DANIEL LIN COVINGTON & BURLING LLP JENNIFER M. THOMAS Hyman Phelps and McNamara PC ERIC HOFFMAN FRIENDS OF THE EARTH OCP RESPONSE TO REQUESTS FOR DETERMINATION BETWEEN 1/17/07 TO PRESENT OXITEC, FL - MODIFIED MOSQUITOES NADA, INVESTIGATIONS ALL CORR BETWEEN THE US HOUSE OF REPRESENTATIVES AND FDA FROM 1/1/11 TO 3/31/11 OTC VOL 130008, 130067,130106 Signature/ Requester Subject
Page 707 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DALDO/COMPLIANCE/ 2011-9322 12/16/2011 01/18/2012 2011-9323 12/16/2011 01/27/2012 2011-9324 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9325 12/16/2011 01/18/2012 2011-9326 12/16/2011 01/18/2012 2011-9327 12/16/2011 01/18/2012 2011-9328 12/16/2011 01/18/2012 2011-9329 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9330 12/16/2011 FDA/OMPT/CDER/ORP/DIDP/ CLISTIN (CARBINOXAMINE) - ISRS 3460252-1, 3486971-9, 3882397-4, ETC WALTER E CHALKLEY THOMSON REUTERS PFIZER IRELAND PHARMS, COUNTY CORK, IRELAND EIRS, 483S, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS PURDUE PHARMACEUTICALS, WILSON, NC - EIRS, 483S, CO RESP 1/11 BENJAMIN L ENGLAND BENJAMIN L ENGLAND & ASSOC LLC WALTER E CHALKLEY THOMSON REUTERS SEA DELIGHT LLC - ENTRY #D97-060229-0 SPL SHIPPING AND STORAGE RECS WALTER E CHALKLEY THOMSON REUTERS WYETH PHARMACEUTICALS CO, GUAYAMA, PR - EIRS, 483S, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS MERCK SHARP & DOHME LABS CHIBRET, SAINT GERMAIN LAPRADE, FRANCE - EIRS, 483S, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS MILLPORT UK, LIVINGSTON, UK - EIRS, 483S, CO RESP 6/11 WALTER E CHALKLEY THOMSON REUTERS KV PHARACEUTICAL CO, BRIDGETON, MO - EIRS, 483S, CO RESP 2/11 Signature/ Requester Subject
RIVERS EDGE PHARMACEUTICALS, SUWANEE, GA - EIRS, 483S, CO RESP 4/11
Page 708 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/18/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9331 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9332 2011-9333 2011-9334 2011-9335 2011-9336 12/16/2011 01/18/2012 12/16/2011 01/18/2012 12/16/2011 01/18/2012 12/16/2011 01/18/2012 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9337 12/16/2011 01/18/2012 2011-9338 12/16/2011 01/18/2012 2011-9339 12/16/2011 01/18/2012 2011-9340 12/16/2011 01/18/2012 ORA/P-FO/SEA-DO/SCB/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ WALTER E CHALKLEY THOMSON REUTERS ORGANON TEKNIKA, DURHAM, NC - EIR, 483, CO RESP 5/11 CHRIS L NIELSEN NIELSEN CITRUS PRODUCTS INC KEVIN DYEVICH MICRO LIFE TECHNOLOGIES LLC WALTER E CHALKLEY THOMSON REUTERS PATHEON PHARMS, CINCINNATI, OH - EIR, 483, CO RESP 3/11 ACME FOOD SALES INC, SEATTLE, WA - LEMON JUICE ADULTERATIONS & MISLABELING INVESTIGATION LORI A CARR LORI A CARR INC LORI A CARR LORI A CARR INC LORI CARR LORI A CARR INC LORI A CARR LORI A CARR INC ESTHER URKIN PERRIGO ISRAEL PHARMACEUTICALS LTD AKZONOBE CHEMICALS SA, LOS REYES LA PAZ EDO, MEXICO - LAST 2 EIRS 6/11 2011-845 2011-1031 2011-4996 2011-1030 WALTER E CHALKLEY THOMSON REUTERS PIERRE FABRE MEDICAMENT PRODUCTION, IDRON, FRANCE - EIRS, 483S, CO RESP Signature/ Requester S ALBERT EDWARDS, PHARM D Subject
K060222, K060846
Page 709 of 1132

Total Records: 12455 Control # 2011-9341 Recd Date / Due Date 12/16/2011 01/18/2012 2011-9342 12/16/2011 01/18/2012 2011-9343 12/16/2011 01/18/2012 2011-9344 12/16/2011 01/18/2012 2011-9345 12/16/2011 01/18/2012 2011-9346 12/16/2011 01/27/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-9347 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9348 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY THOMSON REUTERS ZHEJIANG JIUZHOU PHARM, TAIZHOU, CHINA - EIR, 483, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS LABORATORIES HAYMANN, MONTEVIDEO, URUGAY - EIR, 483, CO RESP 5/11 WALTER E CHALKLEY THOMSON REUTERS NOVO NORDISK, KALUNDBORG, DENMARK - EIR, 483, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS KV PHARMACEUTICAL CO, EARTH CITY, MO - EIR, 483, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS LEHIGH VALLEY TECHNOLOGIES, ALLENTOWN, PA - EIR, 483, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS MCNEILL CONSUMER HEALTHCARE, FT WASHINGTON, PA - EIR, 483, CO RESP 6/11 WALTER E CHALKLEY THOMSON REUTERS MERCK & CO, SPRINGFIELD, NJ - EIR, 483, CO RESP 5/11 Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS Subject MYLAN, CAGUAS, PR - EIR, 483. CO RESP 2/11
Page 710 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9349 12/16/2011 01/18/2012 2011-9350 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9351 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9352 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9353 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ WALTER E. CHALKLEY THOMSON REUTERS NOVARTIS PHARMS CORP, EAST HANOVER, NJ - EIR, 483, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS PATHEON, MISSISSAUGA, CANADA - EIR, 483, CO RESP 2/11 WALTER E CHALKLEY THOMSON REUTERS PFIZER PHARMS, VEGA BAJAN, PR - EIR, 483, CO RESP 1/11 WALTER E CHALKLEY THOMSON REUTERS RANBAXY LABS, MOHALI, PUNJAB, INDIA - EIR, 483, CO RESP 4/11 WALTER E CHALKLEY THOMSON REUTERS SCHERING PLOUGH PRODUCTS, LAS PIEDRAS, PR - EIR. 483, CO RESP 3/11 Signature/ Requester Subject
Page 711 of 1132

Total Records: 12455 Control # 2011-9354 Recd Date / Due Date 12/16/2011 01/18/2012 2011-9355 12/16/2011 03/01/2012 2011-9356 12/16/2011 01/18/2012 2011-9357 12/16/2011 01/18/2012 2011-9358 12/16/2011 01/27/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-9359 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9360 12/16/2011 01/18/2012 2011-9361 12/16/2011 01/18/2012 2011-9362 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WALTER E. CHALKLEY THOMSON REUTERS RANBAXY, PRINCETON, NJ - EIR, 483, CO RESP 5/11 WALTER E. CHALKLEY THOMSON REUTERS SUNOVION PHARMS, MARLBOROUGH, MA - EIR, 483, CO RESP 4/11 WALTER E. CHALKLEY THOMSON REUTERS MEDTRONIC EUROPE, TOLOCHENAZ, SWITZERLAND - EIR, 483, CO RESP 2/11 WALTER E. CHALKLEY THOMSON REUTERS MERCK SHARP DOHME, RIOM, FRANCE - EIR, 483, CO RESP 5/11 WALTER E. CHALKLEY THOMSON REUTERS NOVO NORDISK, GENTOFTE, DENMARK - EIR, 483, CO RESP 2/11 WALTER E. CHALKLEY THOMSON REUTERS KV PHARMACEUTICAL CO, WESPORT, MARYLAND HEIGHTS, MO - EIR, 483, CO RESP 2/11 WALTER E. CHALKLEY THOMSON REUTERS LILLY DEL CARIBE, CAROLINA, PR - EIR, 483, CO RESP 4/11 WALTER E. CHALKLEY THOMSON REUTERS MEDTRONIC NAVIGATION, LOUISVILLE, CO - EIR, 483, CO RESP 3/11 Signature/ Requester WALTER E. CHALKLEY THOMSON REUTERS Subject MERCK & CO, ARECIBO, PR - EIR, 483, CO RESP 4/11
Page 712 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/NJ-DO/NJCB/ 2011-9363 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9364 12/16/2011 01/31/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ 2011-9365 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9366 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9367 12/16/2011 01/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9368 12/19/2011 01/19/2012 2011-9369 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OM/OMP/DDM/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION PETER SZ REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP WATSON - INFED IRON DEXTRAN INJ NDA 17-441 AERS 10/09 TO PRESENT DKT FDA-1995-S-0039 LORI A CARR LORI A CARR INC 2010-7828 LORI A. CARR LORI A CARR INC 2011-3262 WALTER E. CHALKLEY THOMSON REUTERS PFIZER HEALTH, STRANGNAS, SWEDEN - EIR, 483, CO RESP 1/11 WALTER E. CHALKLEY THOMSON REUTERS L. PERRIGO CO, ALLEGAN, MI - EIR, 483, CO RESP 3/11 WALTER E. CHALKLEY THOMSON REUTERS ORGANON IRELAND, SWORD, DUBLIN, IRELAND - EIR, 483, CO RESP 6/11 Signature/ Requester Subject
Page 713 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2011-9370 2011-9371 12/19/2011 01/19/2012 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9372 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9373 12/19/2011 01/19/2012 2011-9374 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/BLT-DO/CB/ 2011-9375 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9376 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OER/OPA/ BRIAN SMITH LEXISNEXIS COURTLINK INC ORAL CONTRACEPTIVES & RISK OF BLOOD CLOTS - FDA TALK PAPER 11/14/95 (CERTIFIED) BARBARA A BINZAK BUCHANAN INGERSOLL & ROONEY PC INCIVEK NDA 20-1917 - AERS 5/23/11 TO 12/15/11 FDA/OMPT/CDRH/OCER/DFOI/ KONRAD L TROPE ESQ TROPE & ASSOCIATES ERIC WALTER CAMIL CAMIL CONSULTING CORP COSMOPOLITAN PLASTIC & RECONSTRUCTIVE SURGERY INC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS QUESTCOR PHARMACEUTICALS INC, ANAHEIM, CA - EIRS LAST 5 YRS PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP SANOFI-AVENTIS - FERSRLECIT NDA 17-44 AERS 10/09 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ KONRAD L TROPE ESQ TROPE & ASSOCIATES PETER S REICHERTZ SHEPPARD MULLIN BAKERSFIELD SURGERY INSTITUTE INC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS LUITPOLD PHARMACEUTICALS INC - DEXFERRUM IRON DEXTRAN INJ NDA 40-024 AERS 10/09 TO PRESENT Signature/ Requester Subject
Page 714 of 1132

Total Records: 12455 Control # 2011-9377 Recd Date / Due Date 12/19/2011 01/19/2012 2011-9378 2011-9379 12/19/2011 01/19/2012 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9380 2011-9381 2011-9382 2011-9383 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9384 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9385 2011-9386 2011-9387 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 2011-9388 12/19/2011 01/19/2012 2011-9389 12/19/2011 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ CVM/OCD/ ORA/P-FO/SEA-DO/SCB/ EMILY HEFFER SEATTLE TIMES GREG SIMEK SABER FOODS GEORGE A PISANO WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP ANTHONY OLIVER Medallion Brands International Company PETER S REICHERTZ MEDALLION BRANDS INTERNATIONAL CO - KICK BRAND CIGARETTES REGISTRATION REQUIREMENTS COMPLIANCE LUITPOLD PHARMACEUTICALS INC - VENOFER (IRON SUCROSE) NDA 21-135 AERS 10/09 TO PRESENT QUINAUOT TRIBAL LENTERPRISE (QUINAULT PRIDE) - 483, RESP, CORR DR GEORGE GRABER, NATIONAL ANIMAL SUPPLEMENTS COUNCIL - RESP LTR 6/28/02 KERRY INC - CMPLNT HUDSON, ROHYN CLARAVIS - AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KONRAD L TROPE ESQ TROPE & ASSOCIATES KONRAD L TROPE ESQ TROPE & ASSOCIATES KONRAD L TROPE ESQ TROPE & ASSOCIATES AVANI DESAI ALKERMES GAINESVILLE L LLC VALLEY SURGICAL CENTER LLC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS BEVERLY HILLS SURGERY CENTER LLC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS 1 800 GET THIN LLC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS VIVITROL- ISRS 7450093-2, 7526061-9 FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester KONRAD L TROPE ESQ TROPE & ASSOCIATES KONRAD L TROPE ESQ TROPE & ASSOCIATES DON J MIZERK HUSCH BLACKWELL LLP Subject PALMDALE AMBULATORY SURGERY CENTER LLC LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS TOP SURGEONS LLC - LAPBAND GASTRIC BINDING SYS WARNING LTR ALLEGATIONS SUN PHARMA GLOBAL - RYZOLT NDA 91-607 APRVL LTR
Page 715 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/19/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9390 2011-9391 2011-9392 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9393 2011-9394 12/19/2011 01/19/2012 12/19/2011 01/19/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9395 2011-9396 2011-9397 2011-9398 2011-9399 2011-9400 2011-9401 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 2011-9402 12/19/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN CLOSED FOI REQUESTS 12/12-16/11 CLOSED FOI REQUESTS 12/5-9/11 CLOSED FOI REQUESTS 12/5-9/11 CLOSED FOI REQUESTS 12/12-16/11 FOI SERVICES INC CLOSED FOI REQUESTS 12/12-16/11 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SUE DAHLQUIST SMITH & NEPHEW ENDOSCOPY SUE DAHLQUIST SMITH & NEPHEW ENDOSCOPY CLOSED FOI REQUESTS 12/5-9/11 HARVEST TECHNOLOGIES - SMARTPREP 2 CENTRIFUGE SYS K103340 BIOMET - MARROWSTIM CONCENTRATION KIT K071934 R IAN KLUGE Hyman, Phelps & McNamara, P.C. PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP FROZEN POLLOCK FILETS - ENTRY #316-4665-2 SHIPPING PACKING INFO, LAB ASSESMENT, ETC GENERAMEDIX - NULECIT (SODIUM FERRIC GLUCONATE) ANDA 78-215 AERS 10/09 TO PRESENT CHRIS BERRY ANIMAL LEGAL DEFENSE FUND PAUL W TRIPP LINCARE INC PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP EGG SAFETY, EGG PRODUCTION, PRODUCTION FACILITIES IN TX - COMM 4/26/11 TO PRESENT (CERTIFIED) DALLAS OXYGEN CORP, TX - EIRS, 483S, WARNING LTRS 1/04 TO PRESENT AMAG PHARMACEUTICALS INC - FERAHEME (FERUMOXYTOL INJ) NDA 22-180 AERS 10/09 TO PRESENT Signature/ Requester SHEPPARD MULLIN RICHTER & HAMPTON, LLP Subject
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Total Records: 12455 Control # Recd Date / Due Date 01/19/2012 2011-9403 2011-9404 2011-9405 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9406 2011-9407 2011-9408 2011-9409 2011-9410 2011-9411 2011-9412 2011-9413 2011-9414 2011-9415 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 12/19/2011 01/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9416 12/19/2011 FDA/OF/CFSAN/OCD/EOS/ TAMMY L. BLAKESLEE FCN 772 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ YOUNG X04261, DARRYL LAWRENCE PAROS, Ph.D. NEURO FITNESS LLC THOMAS M. BURTON WALL STREET JOURNAL FINANCIAL DISCLOSURE FORMS SUBMITTED BY AC MEMBERS FOR 12/8/11 JOINT A/C MTG ON DROSPIRENONE CONTRACEPTIVES ELECTRO MEDICAL PRODUCTS INTL 2011-N-0504-0029DA MERCK & CO., INC. FRUIT HISTORY MERCK & CO., INC. JOAN STITT MERCK & CO., INC. 2011-7241 2011-7591 JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. JOAN STITT MERCK & CO., INC. 2011-7587 2011-7586 2011-6899 2011-715 2010-7611 ORA/CE-FO/DET-DO/DCB/ Action Office OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ Signature/ Requester WOLTERS KLUWER LAW & BUSINESS W. PATRICK NOONAN W. PATRICK NOONAN CRAIG ROUSH ROCKLINE INDUSTRIES JOAN STITT MERCK & CO., INC. 2010-6124 SUPPLEMENT & NUTRITION TECHNOLOGIES INC, TEMPE, AZ - 483, EIR, CO RESP 2006 TO PRESENT NICE PAK PRODUCTS INC, MOORESVILLE, IN - EIR, 483 9/08 Subject
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Total Records: 12455 Control # Recd Date / Due Date 01/19/2012 2011-9417 12/19/2011 01/19/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9418 2011-9419 2011-9420 2011-9421 2011-9422 12/19/2011 01/19/2012 12/20/2011 01/20/2012 12/20/2011 01/20/2012 12/20/2011 01/20/2012 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9423 2011-9424 12/20/2011 01/20/2012 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9425 2011-9426 12/20/2011 01/20/2012 12/20/2011 ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ ERIC P SHARVELLE TWO TOWER FRAMES INC MICHAEL R HAMRELL LIST OF CLINCL INSPS CONDUCTED UNDER THE BIMO BAUSCH & LOMB - BPZ02 MULTIPURPOSE SOL K083757 ROGERS, DAVID W ORA/P-FO/SAN-DO/SFCB/ MELISSA M CORICA FOLEY & MANSFIELD ATTY C & H SUGAR REFINERY, CROCKET, CA - EIRS, SAFETY PRECAUTIONS, BUILDING PLANS, ETC 1979 TO 1995 XYLOCAINE, LIDOCAINE, KENALOG - CMPLNTS 2005, 2006 SCHACHTER, STEVEN FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ Doe J AMY S DOLGIN K&L GATES KANAI TARO MIC INTERNATIONAL CORP ROBERT SILVERMAN ESQ SILVERMAN & ASSOCIATES FCI OPHTHALMICS INC - SELF RETAINING BICANALICULUS INTUBATION SET K041869 1 800 GET THIN - LAPBAND GASTRIC BINIDNG SYS WARNING LTR ALLEGATIONS HUPERZINE A IND 63,997 - RECS K083453, K073693, K080432, ETC CMPLNT Action Office Signature/ Requester ENVIRONET LLC MAXIM KISELEV, Ph.D. POSI MED LLC IBA MOLECULAR - FLUDEOXYGLUCOSE Subject
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Total Records: 12455 Control # Recd Date / Due Date 01/20/2012 2011-9427 2011-9428 12/20/2011 01/20/2012 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9429 2011-9430 12/20/2011 01/20/2012 12/20/2011 01/20/2012 2011-9431 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9432 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9433 12/20/2011 01/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9434 2011-9435 12/20/2011 01/20/2012 12/20/2011 01/20/2012 2011-9436 2011-9437 2011-9438 12/20/2011 01/20/2012 12/20/2011 01/20/2012 12/20/2011 CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ZUCKERMAN SPAEDER LLP ELENA HOWELL HOGAN LOVELLS US LLP MATT HYDER CELL THERPY - PETER K LAW INFANT FORMULA - AER 6/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHRISTOPHER BURT Leahy & Hoste CHRISTOPHER BURT Leahy & Hoste OSTEOIMPLANT TECHNOLOGIES INC - MODULAR NECK COMPONENT OF A HIP IMPLANT MDRS OSTEOIMPLANT TECHNOLOGIES INC - MODULAR NECK COMPONENT MODEL OMGEA 2 OR ALPHA 2 PART OF A HIP IMPLANT MDRS DKT 1975N-0203 PHIL L MILLMAN PHARM D CHEMIQUE PHARMACEUTICALS ABBOTT PHARMS - SODIUM THIOPENTAL SCHEDULE III NDA 11-679 RECS PHIL L MILLMAN PHARM D CHEMIQUE PHARMACEUTICALS HOSPIRA PHARMS - PANCURONIUM BROMIDE ANDA 72320 RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SCHROBO, MIKE LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP PHIL L MILLMAN PHARM D CHEMIQUE PHARMACEUTICALS AGAMATRIX INC - IBGSTAR BLOOD GLUCOSE MONITORING SYS K103544 BEDFORD PHARMS - BUPRENORPHONE HCL SCHEDULE III ANDA 76-931 RECS IMAGINING3 - MTG MINS 10/17/11 SIEGEL, ARTHUR D Action Office ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MORIAH CONSULTANTS EVA SALGADO SANCHEZ OPTASIA MEDICAL LTD GENETECH - RUTIXAN INFUSION REACTIONS Subject PROGRAM BY CDRH MIM SOFTWARE INC - MOBILE MIM K112930
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Total Records: 12455 Control # Recd Date / Due Date 01/20/2012 2011-9439 2011-9440 2011-9441 2011-9442 2011-9443 2011-9444 2011-9445 12/20/2011 01/20/2012 12/21/2011 01/23/2012 12/21/2011 01/23/2012 12/21/2011 01/23/2012 12/21/2011 01/23/2012 12/21/2011 01/24/2012 12/21/2011 01/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9446 2011-9447 12/21/2011 01/23/2012 12/22/2011 01/24/2012 2011-9448 2011-9449 12/22/2011 01/24/2012 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9450 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ BLAIR LOOCKE BRACEWELL & GIULIANI DEPAKOTE INDS 11,152, 18,872, 30,673; DEPAKENE ORAL CAPS NDA 18-018, DEPAKENE ORAL SYRUP NDA 18-082, DEPAKOTE DELAYED RELEASE TABS NDA-18-723, ETC AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ Eva Gonsavles FOI SERVICES INC LIANE LA ROCHELLE DEKA RESEARCH & DEVELOPMENT CORP THOMAS H LOUISELL A-DEC INC ANGELIA D SLAYTON KENDLE INTERNATIONAL INC FOREST DENTAL - CPT110048 REGULATORY FINDINGS, CORRECTIVE ACTION, RESP TEVA - ORAP NDA 17-473 APRVL LTR, LBLG, RVWS, ETC Date Range: Gilead Sciences, CA -- EIRs, 483s, Warning Letters, Company Responses, Jan. 2010 to present.; POSTIVEID CORP - IGLUCOSE SYS K111932 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BEVERIDGE & DIAMOND PC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOYCE G SMITH KLINE & SPECTER KEVIN SWISS NURO PHARMA LLC CDRH STAFF COLLEGE - CURRICULUM OR COURSES OFFERED 1/90 TO PRESENT NURO PHARMS - MYSOLINE (PRIMIDONE 25O MG/5ML) ORAL SUSPENSION NDA 10-401 RECS 2011-5587 2011-5036 2011-1841 Action Office Signature/ Requester KRYSIUM ADVISORS LTD GABRIEL B. SHERMAN Hyman, Phelps & McNamara, P.C. FOIA REQUESTS FILED BY CFSAN 11/29/11 TO PRESENT 2006-4517; 2008-9087 Subject
Page 720 of 1132

Total Records: 12455 Control # 2011-9451 2011-9452 Recd Date / Due Date 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9453 12/22/2011 01/24/2012 2011-9454 2011-9455 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9456 2011-9457 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9458 2011-9459 2011-9460 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9461 12/22/2011 01/24/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9462 12/22/2011 01/24/2012 2011-9463 2011-9464 12/22/2011 01/24/2012 12/22/2011 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ NILDA SASTRE COZEN & O'CONNOR ELLYN L STERNFIELD MINTZ LEVIN ET AL RYAN D WATSTEIN WHOLESOME SPICE, DANIELE INTERNATIONAL MINCING TRADING CORP (MINCING OVERSEAS SPICE CO) SALMONELLA IN BLACK PEPPER RECS, PHOTOGRAPHS P&B DISTRIBUTORS OR OLSON INSTITUTIONAL PHARMACY - PRESS RELEASE 1999 NURTURE INC - VOLUNTARY RECALL ON HAPPYTOT ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ TYLER KENYON NORTHCOAST RESEARCH LINDA BOWEN SANOFI AVENTIS NILDA SASTRE COZEN & O'CONNOR ROGER B KAPLAN GREENBERG TRAURIG LLP CENTOCOR - REMICADE (INFLIXIMAB) BLA 103772/S5145 APRVL RECS DANIELE INTERNATIONAL, MINCING RADING CORP (MINCING OVERSEAS SPICE CO) - SALMONELLA IN BLACK PEPPER RECS, PHOTOGRAPHS MOXIFLOXACIN HCI ANDA 76-938, SERTRALINE HCI ANDA 76-442, ONDANSETRON ODT ANDA 76-613, ETC CHEMISTRY RVWS ZIMMER HOLDINGS - 483, CO RESP 12/10/11 MIRMAN, ISAAC ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ DON WERFELMANN SARA LEE CMPLNT #121945 SARA LEE, VALENTINE, NE - EIR 4/26/11 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/SEA-DO/SCB/ ORA/NE-FO/NYK-DO/NYDCB/ ISOLDE AUBUCHON AMERICAN BEVERAGE MARKETERS OLEG KRADIN REDMILE GROUP LLC FRANCES HERROD HERROD, FRANCES DEPUY ORTHOPAEDICS INC, WARSAW, IN - EIRS, WARNING LTR 5/10/11-6/7/11 GLITTERSNIFFER COSMETICS - EIRS 12/9-10/11 TC TROPICAL PRODS, BROOKLYN, NY - AUDIT Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester RICHARD H KOSTICK PURITY COSMETICS STEPHEN H MEYER NICK STEIN LAW OFC CRONOBACTER SAKAZAKII (ENTEROBACTER SAKAZAKII), MI, OH - INVESTIGATION 3/11, 4/11 Subject RENAUD NATURALS, LOVELAND, CO - EIRS MOST RECENT
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Total Records: 12455 Control # Recd Date / Due Date 02/06/2012 Action Office ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/ATL-DO/ACB/ 2011-9465 12/22/2011 01/24/2012 2011-9466 2011-9467 2011-9468 2011-9469 2011-9470 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9471 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9472 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9473 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9474 12/22/2011 ORA/SW-FO/DEN-DO/COMP/ BRENTON HORNER WORLD HEALTH PRODUCTS LLC - MISLABELING, ADVERTISING CORR 10/25/10 TO PRESENT ESTHER URKIN PERRIGO ISRAEL PHARMACEUTICALS LTD AKZONOBEL CHEMICALS SA DE CV, LOS REYES LA PAZ EDO, MEXICO - LAST 2 EIRS ELIZABETH BARBEHENN PHD PUBLIC CITIZEN HEALTH RESEARCH GROUP INTERMEZZO (SOLPIDEM TARTRATE) NDA 22-328 - APRVL RECS ELIZABETH BARBEHENN PHD PUBLIC CITIZEN HEALTH RESEARCH GROUP JUVISYNC (SIMVASTATIN, SITAGLIPTIN) NDA 02-343 APRVL RECS ORA/SW-FO/DALDO/COMPLIANCE/ ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ PARKS, NATHAN DAVID L ROSEN BS PHARM, JD FOLEY & LARDNER LLP ANGELIA D SLAYTON KENDLE INTERNATIONAL INC FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ ALLISON GLASS MD UNIV OF CALIFORNIA SAN FRANCISCO PAUL W TRIPP LINCARE INC DELPHINE JAMES DELPHINE M JAMES PLLC AIR INDUSTRIES - HYPERDRIVE 3.0+ CAPS REFUSAL RPT, LBLG AMERICAN CONTRACT SYSTEMS, TIFFIN, OH - EIRS, CORR, WARNING LTR 4/21/11 FENTANYL TPS ANDA 77-449 - APRVL LTR, LBLG, RVWS, ETC AMERICAN MEDICAL SYSTEMS INC - ARTIFICIAL URINARY SPHINCTER 800 STUDIES ALERT MEDICAL INC, MI - EIRS, 483S, WARNING LTRS 1/04 TO PRESENT GLOBAL HEALING CENTER LP - OXY-POWDER CMPLNTS Signature/ Requester WARGO FRENCH LLP Subject STAGE 4 & HAPPYBAYE STATGE 1 & 2 POUCH MEALS RECS 1/10
Page 722 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/24/2012 2011-9475 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9476 2011-9477 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9478 2011-9479 12/22/2011 01/24/2012 12/22/2011 01/24/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CORONA, DIANA JULIA C FRIED MARTIN MAGNUSON ET AL VALLLEYLAB/COVIDIEN INC - DISPOSABLE HANDSWITCHING PENCIL/ROCKERSWITCH PENCIL/BJTTONSWITCH PENCIL MODEL #E2515H OR E2516, K861112 OR K961112, MDERS DEEPAK PRODUCTS INC, MIAMI, FL - CO RESP 9/09 MERZ PHARMACEUTICALS LLC, /MERZ AESTHETICS INC XEOMIN (INCOBOTULINUMTOXN A) FDA-2253 SUBMISSIONS, CORR, 5/1/10 TO PRESENT ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ ARDAUGH, BRENT CHRIS L NIELSEN NIELSEN CITRUS PRODUCTS INC ACME FOOD SALES INC, SEATTLE, WA - ADULTERATION & MISLABELING INVESTIGATION RESULTS HOW DOES THE FDA WORK K823145, K851422, K902365, ETC POTTER, ANN Action Office Signature/ Requester HORNER & ASSOCIATES ATORVASTIN NDA 20-702 - RECS Subject
2011-9480 2011-9481
12/22/2011 01/24/2012 12/22/2011 01/24/2012
NICK PALMER KEYSTONE INDUSTRIES COLEEN KLASMEIER SIDLEY AUSTIN LLP
2011-9482 2011-9483
12/22/2011 01/24/2012 12/22/2011 01/24/2012
ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
DON WERFELMANN SARA LEE LISA CASTRO UCB INC
SARA LEE, O'NEILL, NE - EIR 5/10/11 TIOANAX (TOPIRAMATE) - SBOA, RVW RECS NDA 20505018
2011-9484 2011-9485
12/22/2011 01/24/2012 12/22/2011 01/24/2012
ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
DON WERFELMANN SARA LEE JOAN STITT (UG2CD-16) MERCK & CO., INC.
SARA LEE, FRESNO, CA - EIR 8/23/11 MERCK & CO INC - ZOCOR (SIMVASTATIN) ISR 1343734
Page 723 of 1132

Total Records: 12455 Control # 2011-9486 Recd Date / Due Date 12/22/2011 01/24/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9487 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9488 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9489 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9490 2011-9491 2011-9492 2011-9493 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9494 12/22/2011 01/24/2012 ORA/OCI/ ORA/OCI/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9495 2011-9496 12/22/2011 01/24/2012 12/22/2011 01/24/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ DON WERFELMANN SARA LEE JOAN STITT (UG2CD-16) MERCK & CO., INC. FOI DAILY LOG 12/12-16/11 SARA LEE, BEND, OR - EIR 7/22/11 KC JINDAL FDC LTD MYLAN (AKA RLD) - TIMOLOL MALEATE TABS & BLOCADREN TABS 20MG SBA'S CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ DON WERFELMANN SARA LEE DON WERFELMANN SARA LEE TRACY SIPMA LIFESERVE BLOOD CENTER VICKIE CARCAISE SHASTA BEVERAGES INC INDIVIDUAL RECS BLOOD CENTER OF IOWA - APRVL LTR SARA LEE, GRANTS PASS, OR - EIR 6/23/11 SARA LEE, WOODINVILLE, WA - EIR 6/6/11 YOUNG, DAVID S EXPIRED/DELISTED PATENTS STEINBRECHER, SUSAN HSIAO SUNG NON-OXYGEN CHEMICAL CO LTD - SORB OO OXYGEN ABSORBERS DMF 23229 STEINBRECHER, SUSAN MULTISORB TECHNOLOGIES INC - STABILOX CANISTER OXYGEN ABSORBING PRODS DMF 21185 STEINBRECHER, SUSAN Signature/ Requester Subject MITSUBISHI GAS CHEMICAL CO INC - OXYGEN ABSORBERS AGELESS TYPES ZPT, ZP (ZPT-C) & SS DMF 16360
Page 724 of 1132

Total Records: 12455 Control # 2011-9497 Recd Date / Due Date 12/22/2011 01/24/2012 2011-9498 2011-9499 2011-9500 2011-9501 2011-9502 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 12/22/2011 01/24/2012 2011-9503 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9504 12/22/2011 01/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ 2011-9505 12/23/2011 01/25/2012 ORA/SE-FO/ATL-DO/ACB/ JOHNATHAN RICKMAN FDA NEWS CUSTOM ASSEMBILIES INC, PINE LEVEL, NC; NORTH AMERICA MEDICAL CORP (NAM), MARIETTA, GA;/ AUGUSTA MEDICAL SYSTEMS LLC, AUGUSTA, GA, ETC - 483S 9/130/11 ADVANTAGEOUS MD LLC, VIRGINA BEACH, VA; AFTON SCIENTIFIC CORP, CHARLOTTESVILLE, VA - 483S 9/1-30/11 MEDEFIL INC, GLENDALE HEIGHTS, IL; CAREFUSION 2200 INC, WAUKEGAN, IL; TOWIC MEDICAL INC, PARK RIDGE, IL, ETC - 483S 9/1-30/11 PHARMACIA HEPAR INC, FRANKL.IN, OH; OHIO VALLEY HERBAL PRODUCTS INC, EAST LIVERPOOL, OH; ACCUPAK MIDWEST INC, CINCINNATI, OH, ETC - 483S 9/1-30/11 AMANDA R TERKEL HUFFINGTON POST TEVA PHARMACUETICAL CO - EMERGENCY CONTRACEPTION PLAN B CORR 1/1/11 TO PRESENT ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester PAUL MACDONALD NOVA BIOMEDICAL CORP DON WERFELMANN SARA LEE DON WERFELMANN SARA LEE DON WERFELMANN SARA LEE DON WERFELMANN SARA LEE STEPHEN W INGLESE QUALITY SOLUTIONS & SUPPORT, LLC Eva Gonsalves FOI SERVICES INC BM KOREA CO LTD, MARIETTA, GA - GUARDIAN INFLATABLE BONE EXPANDER SYS K111593 Date Range: 04/19/2011 - 08/04/2011; Copy of the disclosable portions of the 483s dated July 26 to August 4, 2011 for Sandoz, Inc., located in Boucherville, Quebec, Canada. SARA LEE, TROY, AL - EIRS, RECS 8/6/11 SARA LEE, WHITE CITY, OR - EIRS, RECS 8/5/11 SARA LEE, HASTINGS, NE - EIRS, RECS 8/10/11 Subject IL GEM PREMIER 4000 W/IQM, GEM CVP 1 & 2, CALIBRATION VALUATION PROD W/CO-OX GEM CVP 3 & 4, HEMATOCRIT K061974 SARA LEE, ORANGEBURG, SC - EIRS, RECS 7/19/11
2011-9506 2011-9507
12/23/2011 01/25/2012 12/23/2011 01/25/2012
ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/
JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS
2011-9508
12/23/2011 01/25/2012
Page 725 of 1132

Total Records: 12455 Control # 2011-9509 Recd Date / Due Date 12/23/2011 01/25/2012 Action Office ORA/SW-FO/DALDO/COMPLIANCE/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS Subject CHEMOLEE LAB CORP, IRVING, TX; DEEPWATER CHEMCIALS INC, WOODWARD, OK; PROCORE LABORATORIES LLC, COPPELL, TX; ISO-TEX DIAGNOSTICS INC, FRIENDSWOOD, TX, ETC - 483S 9/1-30/11 HERAEUS KULZER LLC, SOUTH BEND, IN; CENTURY PHARMACEUTICALS INC, INDIANAPOLIS, IN, EMERGENT BIODEFENSE OPERATIONS LANSING LLC, LANSING, MI, ETC - 483S 9/1-30/11 DESERET LABORATORIES INC, SAINT GEORGE, UT - 483S 9/1-30/11 PURE SOURCE INC, MIAMI, FL; HORIZON PHARMACEUTICAL INC, WEST PALM BEACH, FL; AVEVA DRUG DELIVERY SYSTEM INC, MIRAMAR, FL, ETC - 483S 9/1-30/11 BAXTER HEALTHCARE CORP, BAXTERBIOSCIENCE MFG, SARL, NEUCHATEL, SUISSE SANQUIN PLASMA PRODUCTS, AMSTERDAM, NL - 483S 9/1-30/11 GUILIN PHARMACEUTICAL CO LTD, GUILIN, CHINA; ISHIHARA SANGYO KAISHA LTD, YOKKAICHI-SHI, JAPAN, BASF PHARMA (EVIONNAZ) SA EVIONNAZ SUISSE, ETC 483S 9/1-30/11 GE HEALTHCARE BEIJING HANGWEI MEDICAL SYSTEMS CO LTD, BEIJING, CHINA; LES LABORAT ORIES BLANCHARD, SHERBROOKE, CANADA; WUJIANG CITY SHENLING MEDICAL DEVICE CO LTD, WUJIANG CITY, CHINA, ETC - 483S 9/1-30/11 CHEMISPHERE CORP, SAINT LOUIS, MO - 483S 9/1-30/11 ALLERMED LABORATORIES INC, SAN DIEGO, CA; CLLINICAL PHARMACIES INC, HUNTINGTON BEACH, CA; NEOMPS INC, SAN DIEGO, CA, ETC - 483S 9/1-30/11 MODERN PRODUCTS INC, MEQUON, WI; NORTHERN LABS INC, MANITOWOX, WI; GALLIPOT INC, MENDOTA HEIGHTS, MN, ETC - 483S 9/1-30/11 GENZYME CORP, CAMBRIDGE, MA; TEDOR PHARMA INC, CUMBERLAND, RI; PHARMASOL CORP, SOUTH EASTON, MA, ETC - 483S 9/1-30/11 APICORE LLC, SOMERSET, NJ; PEACE MEDICAL INC, ORANGE, NJ; ENDO OPTIKS INC, LITTLE SILVER, NJ, ETC 483S 9/1-30/11
2011-9510
12/23/2011 01/25/2012
2011-9511 2011-9512
12/23/2011 01/25/2012 12/23/2011 01/25/2012
ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/FLA-DO/FCB/
JOHANTHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS
2011-9513
12/23/2011 01/25/2012
JOHANTHAN RICKMAN FDA NEWS
2011-9514
12/23/2011 01/25/2012
2011-9515
12/23/2011 01/25/2012
2011-9516 2011-9517
12/23/2011 01/25/2012 12/23/2011 01/25/2012
ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/
2011-9518
12/23/2011 01/25/2012
2011-9519
12/23/2011 01/25/2012
2011-9520
12/23/2011 01/25/2012
Page 726 of 1132

Total Records: 12455 Control # 2011-9521 Recd Date / Due Date 12/23/2011 01/25/2012 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2011-9522 2011-9523 12/23/2011 01/25/2012 12/23/2011 01/25/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2011-9524 12/23/2011 01/25/2012 2011-9525 12/23/2011 01/25/2012 2011-9526 12/23/2011 01/25/2012 2011-9527 12/23/2011 01/25/2012 2011-9528 2011-9529 2011-9530 2011-9531 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9532 12/23/2011 FDA/OMPT/CDRH/OCER/DFOI/ TRINITY BIOTECH, BRAY, CO WICKLOW, IRELAND - EIRS, FOI SERVICES INC CVM/OCD/ OM/OMP/DODM/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/PHI-DO/PCB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. EDWARD PATT GREER LABORATORIES INC ALLERGY LABS INC, OKLAHOMA CITY, OK - 483 1/10 TO PRESENT CHEMBIO DIAGNOSTICS SYS, MEDFORD, NY - EIRS, 483, WARNING LTR BAYER HEALTHCARE, LEVERKUSEN, GERMANY - EIRS, 483, WARNING LTR SPRAY-TEK INC, BETHELEM, PA; THOMAS MEDICAL PRODUCTS INC, MALVERN, PA; SKLAR CORP, WEST CHESTER, PA - 483S 9/1-30/11 ABCO LABORATORIES INC, FAIRFIELD, CA; THORATEC CORP, PLEASANTON, CA; HELIO MEDICAL SUPPLIES INC, SAN JOSE, CA - 483S 9/1-30/11 NEUROCYBERNETICS INC, BELLEVUE, WA; CASADIA MANUFACTURING INC (ORAMELTS CORP, BELLEVUE, WA) - 483S 9/1-30/11 PFIZER PHARMACEUTICALS LLC, CAGUAS, PR; OMEGA & DELTA CO INC, CAROLINA, PR; ABBOTT BIOTECHNOLOGY LIMITED ABL, BARCELONETA, PR, ETC - 483S 9/1-30/11 NADAS 137-051, 121-200, 098-595 ORA/NE-FO/NYK-DO/NYDCB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS LNK INTERNATIONAL INC, HAUPPAUGE, NY; SCIEGEN PHARMACEUTICALS INC, HAUPPAUGE, NY - 483S 9/1-30/11 PAX-ALL MANUFACTURING INC, MISSISSAUGA, CANADA; TAKEDA PHARMACEUTICAL COMPANY LTD, HIKARI, JAPAN; APC MEDICAL LTD, WELWYN GARDEN CITY, UK, ETC 483S 9/1-30/11 Signature/ Requester JOHNATHAN RICKMAN FDA NEWS Subject EDGE BIOLOGICALS INC, MEMPHIS, TN - 483S 9/1-30/11
Page 727 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/25/2012 2011-9533 12/23/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2011-9534 2011-9535 2011-9536 2011-9537 2011-9538 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9539 12/23/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9540 2011-9541 12/23/2011 01/25/2012 12/23/2011 01/25/2012 2011-9542 2011-9543 2011-9544 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DARSHAN WARIABHARAJ NOVARTIS AMANDA ORLANDO AVALON RISK MANAGEMENT INC CHERYL A. FORREST FISH & RICHARDSON PC CHERYL A. FORREST FISH & RICHARDSON PC STACEY SEIPEL CHUBB AND SON ORANGE BOOK DATA REFLEXION HD MAPPING CATHETER K080179 REFLEXION SPIRAL VARIABLE RADIUS CATHETER K062251 ENTRY NO BYX00057277 NDA 22-068 - SBA, CLNCL, RVW BLAIR LOOCKE BRACEWELL & GIULIANI DR. PAUL LEBER, ABBOTT LABS NDA 18-723/S017 - APRVL ALESHIRE 278999, DAVID ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ FOI SERVICES INC ROXANNE COULON AFFYMAX INC SATELLITE HEALTHCARE INC, SAN JOSE, CA - EIR 9/1419/11 PAYOTE; MUSHROOMS; ECSTACY - AER ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC ORA/CE-FO/CHI-DO/CCB/ FOI SERVICES INC ABBOTT LABS, ABBOTT PARK, ILL - EIRS, 483S, WARNING LTR ORASURE TECHNOLOGIES, BETHLEHEM, PA - EIRS, 483S, WARNING LTRS BIO RAD LABS, HERCULES, CA - EIR, 483S, WARNING LTRS FOI SERVICES INC Action Office Signature/ Requester FOI SERVICES INC Subject 483. WARNING LTR MED MIRA LABS INC, HALIFAX, NOVA SCOTIA, CANADA EIRS, 483S, WARNING LTR
Page 728 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9545 2011-9546 12/23/2011 02/14/2012 12/23/2011 01/25/2012 2011-9547 2011-9548 2011-9549 2011-9550 2011-9551 2011-9552 2011-9553 2011-9554 2011-9555 2011-9556 2011-9557 2011-9558 2011-9559 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/23/2011 01/25/2012 12/27/2011 01/26/2012 ORA/CE-FO/CIN-DO/CCB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ KENDLE INTERNATIONAL INC JOHN H. SCHARMANN DICKINSONS FDA REVIEW WALTER E CHALKLEY THOMSON REUTERS BEN VENUE LABORATORIES INC, BEDFORD, OH - EIR, CO RESP 5/2-25/11 OHM LABS, NEW BRUNSWICK, NJ - 483 KENDLE INTERNATIONAL INC DAILY LOG 11/7-11/11 KENDLE INTERNATIONAL INC DAILY LOG 11/14-18/11 DOMINION GROUP INC DAILY LOG 10/31-11/4/11 INFORMATION ACCESS 11/14-18/11 INFORMATION ACCESS DAILY LOG 10/31-11/4/11 INFORMATION ACCESS DAILY LOG 11/7-11/11 FOI SERVICES INC DAILY LOG 11/14-18/11 FOI SERVICES INC DAILY LOG 10/31-11/4/11 FOI SERVICES INC DAILY LOG 11/7-11/11 JESSICA A. DAVIS GOODWIN PROCTER LLP DAILY LOG 11/14-18/11 INDIVIDUAL RECS PARKS, NATHAN. FDA/OMPT/CDRH/OCER/DFOI/ THAO PHAN CARL ZEISS MEDITEC INC TRU VISION SYS INC - 3D VISUALIZATION & GUIDANCE SYS K101861 REFUSAL XXX-0155960-9/1/1 Signature/ Requester Subject
Page 729 of 1132

Total Records: 12455 Control # 2011-9560 2011-9561 2011-9562 2011-9563 2011-9564 2011-9565 Recd Date / Due Date 12/27/2011 01/26/2012 12/27/2011 01/26/2012 12/27/2011 02/24/2012 12/27/2011 01/26/2012 12/27/2011 01/26/2012 12/27/2011 01/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9566 2011-9567 12/27/2011 01/26/2012 12/27/2011 01/26/2012 2011-9568 12/27/2011 01/26/2012 ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-9569 2011-9570 2011-9571 12/27/2011 01/26/2012 12/27/2011 01/26/2012 12/27/2011 01/26/2012 2011-9572 12/27/2011 01/26/2012 ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KATHERINE STRONG CARNER SIDLEY AUSTIN LLP KATHERINE STRONG CARNER SIDLEY AUSTIN LLP AMNON TALMOR INVIBIO BIOMATERIAL SOLUTIONS BENJAMIN L ENGLAND, ESQ BENJAMIN L ENGLAND & ASSOC FUJIAN DONGSHAN CTY SHUNFA AQUATIC PRODUCT CO LTD - ENTRY #AH5-0137939-2 SPL SHIPPING, STORAGE & INVENTORY RECS ETC MEDICAL DVCS AND BREAST RECONSTRUCTION /AUGMENTATION - UNTITLED PROMOTION LTRS K102026 - SUMMARY SURGICAL MESH DVC - UNTITLED PROMOTION LTRS SHIRLEY ROSS ROANOKE TRADE SERVICES INC GREEN POINT PRODUCE INC - ENTRY #BYX00323406, REDELIVERY NOTICES, REFUSAL RECS ETC Doe J FDA/OMPT/CDRH/OCER/DFOI/ CHARLENE S FALLON LINNAN & FALLON LLP AMSTERDAM MEMORIAL HOSPITAL, AMSTERDAM, NY CERTIFICATION RECS, 7/08 INDIVIDUAL RECS ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ Action Office ORA/CE-FO/NJ-DO/NJCB/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS DON WERFELMANN SARA LEE KATHLEEN PORUPSKI MYLAN INC AKZO NOBEL CHEMICALS, S.A. DE C.V. MEXICO - 483S 6/11 SANDOZ (NOVARTIS INTERNATIONAL AG), BROOMFIELD, CO - EIRS, CO RESPS 4/19/11 TO 5/6/11 BEN VENUE LABORATORIES INC, BEDFORD, OH - EIRS, CO RESPS, 11/7/11 TO 12/2/11 SARA LEE, OAKLAND, CA - EIR, RECS 5/5/11 Subject INTEGRA LIFESCIENCES CORP, PLAINSBORO, NJ - EIRS, CO RESPS 7/27/11 TO 8/25/11 SANDOZ, WILSON, NC - EIRS, CO RESPS, 5/11
Page 730 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NWE-DO/NWECB/ 2011-9573 12/27/2011 01/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9574 2011-9575 12/27/2011 01/26/2012 12/27/2011 01/26/2012 2011-9576 12/27/2011 01/26/2012 2011-9577 12/27/2011 01/26/2012 2011-9578 12/27/2011 03/22/2012 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ CBER/OCTMA/DDOM/ALFB/ 2011-9579 12/28/2011 01/27/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ANDREW HACK MD PHD MILLENNIUM MANAGEMENT LLC QUESTCOR PHARMACEUTICALS INC, ABIOMED INC, AKORN INC, ETC - 483S, UNTITLED LTRS ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL A D'AMICO D'AMICP GRIFFIN & PETTINICCHI, LLC MITCHELL S FUERST, ESQ FUERST ITTLEMAN PL MEDICAL COMPONENTS INC, HARLEYSVILLE, PA - HEMOFLOW DOUBLE LUMEN CATHETER K994105 DRAFT GUIDANCE FOR INDUSTRY: CELL SELECTION DVCS FOR POINT OF CARE PRODUCTIONS OF MINIMALLY MANIPULATED AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS - WITHDRAWAL RECS, POLICY STATEMENTS, CORR, ETC FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ BATES, KATHY ALISON BROWN CENTER FOR SCINECE IN THE PUBLIC INTEREST TYLER KENYON NORTHCOAST RESEARCH HILL-ROM HOLDINGS, BATESVILLE, IN - 483, CO RESP, 10/11/11; SMITH & NEPHEW, ST PETERSBURG, FL - 483S, CO RESPS, 8/15/11 & 8/31/11 MYCOPROTEIN - FAP, AMENDMENTS, CORR ETC REP JOHN D DINGELL LTR 10/14/08 Signature/ Requester LLC MICHELLE PEASE WOODFIELD DISTRIBUTION, LLC TRANEXAMIC ACID FORMULATIONS PATENT 7,947,739 & 8,022,106 - SUBMISSION RECS Subject
Page 731 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ 2011-9580 12/28/2011 01/27/2012 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ 2011-9581 12/28/2011 01/27/2012 2011-9582 12/28/2011 01/27/2012 2011-9583 12/28/2011 01/27/2012 2011-9584 12/28/2011 01/27/2012 2011-9585 12/28/2011 01/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC ANGELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC JEREMY BECKHAM PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS JENNIFER POLLACK SAC CAPITAL MANAGEMENT LLC CAHRLES RIVER LABS, MONTREAL, QUEBEC; EDINBURGH, UK; NV, ETC - 483S, WARNING LTRS LAST 5 YRS BIOQUAL - ACTIVE FDA CONTRACTS AND AWARDS CAERS 114708 CAERS 146120 CAERS 144598 VEN JOHNSON JOHNSON LAW PLC INDIVIDUAL RECS Signature/ Requester Subject
Page 732 of 1132

Total Records: 12455 Control # 2011-9586 Recd Date / Due Date 12/28/2011 01/27/2012 2011-9587 12/28/2011 01/27/2012 2011-9588 12/28/2011 01/27/2012 2011-9589 12/28/2011 01/27/2012 2011-9590 2011-9591 2011-9592 2011-9593 2011-9594 2011-9595 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9596 12/28/2011 01/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2011-9597 2011-9598 12/28/2011 01/27/2012 12/28/2011 01/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KENDLE INTERNATIONAL INC KENDLE INTERNATIONAL INC FOI DAILY LOG 11/21-25/11 FOI DAILY LOG 11/28/11-12/2/11 WILLIAM A OLSON PHD Center for Regulatory Services, Inc. FOI DAILY LOG 11/28/11-12/2/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester RACHEL COUBAN INSTITUTE FOR WORK & HEALTH RACEHL COUBAN INSTITUTE FOR WORK & HEALTH RACHEL COUBAN INSTITUTE FOR WORK & HEALTH RACHEL COUBAN INSTITUTE FOR WORK & HEALTH CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. BARBARA JONES DOMINION GROUP INC LESLIE PAUL PERRIGO CO BARBARA JONES DOMINION GROUP INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. FOI DAILY LOG 11/21-25/11 NOVARTIS CONSUMER HEALTH, LINCOLN, NE - EIR, (LATEST), 483S FOI DAILY LOG 11/28/11-12/2/11 FOI DAILY LOG 11/21-25/11 FOI DAILY LOG 11/28/11-12/2/11 Subject STRYKER SPINE - FLEXICORE INTERVERTEBRAL DISC STUDY PROTOCOL MEDTRONIC - MAVERICK ARTIFICIAL DISC STUDY PROTOCOL SYNTHES SPINE - PRODISC L TOTAL DISC REPLACEMENT DVC P050010 STUDY PROTOCOL DEPUY SPINE INC - CHARITE ARTIFICIAL DISC P040006 STUDY PROTOCOL FOI DAILY LOG 11/21-25/11
Page 733 of 1132

Total Records: 12455 Control # 2011-9599 Recd Date / Due Date 12/28/2011 01/27/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9600 2011-9601 2011-9602 2011-9603 2011-9604 2011-9605 2011-9606 2011-9607 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9608 2011-9609 2011-9610 2011-9611 2011-9612 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 12/28/2011 01/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INFORMATION ACCESS KEN REID WASHINGTON INFORMATION SOURCE FOI DAILY LOG 11/21-25/11 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FRAN KOCH INFORMATION ACCESS MATTHEW WHITAKER WESTLAW COURTEXPRESS CLEARCORRECT INC - CLEARCORRECT SYS SEQUENTIAL ALIGNER 510K FOI DAILY LOG 11/28/11-12/2/11 FOI DAILY LOG 11/21-25/11 FOI DAILY LOG 11/28/11-12/2/11 FOI SERVICES INC JOHN A HELLMANN LATHAM & WATKINS LLP INJECTAPAP (ACTAMINOPHEN) INJECTION - NDA 17-785, SBA, CORR, WITHDRAW RECS, ETC MARTIN, DEREK FOI DAILY LOG 11/21/-25/11 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/KAN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RAINER MAAS NEUROMETRIX INC DARCY SELBY POLYMER SCIENCE INC QUYNH C SPERRAZZA FAEGRE & BENSON LLP QUYNH C SPERRAZZA FAEGRE & BENSON LLP QUYNH C SPERRAZZA FAEGRE & BENSON LLP EMPI INC - ACTIVE TRANSCUTANEOUS NERVE STIMULATOR K090922 MEDICAL DVC MASTER FILE (MAF) #1260 - SAFETY AND EFFICACY RECS QUALITY EGG LLC, GALT, IA - SALMONELLA ENTERITIDIS RECALL RECS, EIRS, 483S, ETC 8/10 QUALITY EGG LLC, ALDEN, IA - SALMONELLA ENTERITIDIS, 8/10 RECALL, EIRS, 483S, CO RESPS ETC HILLANDALE FARMS OF IOWA INC, NEW HAMPTON, IA - EIR 5/17/11 RECALL #D-158-2008, #D-021-2009, #D-003-2010, ETC KEITH CHASIN LAW OFC Signature/ Requester Subject ZICAM INTENSE SINUS RELIEF NASAL SPRAY OR GEL (OXYMETAZOLINE HCL) - AERS 1/1/00 TO 11/1/06
Page 734 of 1132

Total Records: 12455 Control # 2011-9613 Recd Date / Due Date 12/28/2011 01/27/2012 2011-9614 12/28/2011 01/27/2012 2011-9615 12/28/2011 01/27/2012 2011-9616 2011-9617 12/28/2011 01/27/2012 12/29/2011 01/30/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9618 2011-9619 12/29/2011 01/30/2012 12/29/2011 01/30/2012 2011-9620 12/29/2011 01/30/2012 2011-9621 12/29/2011 01/30/2012 ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/DET-DO/DCB/ 2011-9622 12/29/2011 CVM/OCD/ ANA KOSTIC PHARMACIA & UPJOHN - LINCOMIX SOLUBLE POWDER FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ JUDITH HILL INTERTEK CANTOX AMNON TALMOR INVIBIO BIOMATERIAL SOLUTIONS MICHAEL A D'AMICO D'AMICO GRIFFIN PETTINICCHI LLC DAVID L MAZAROLI DAVID L MAZAROLI LAW OFCS PERRIGO CO - PHARMACEUTICALS, DIETARY SUPPLEMENTS THEFT RECS 3/3/10 MEDCOMP - HEMO-FLOW CATHETER K994105 K112361 L-CAMITINE - SAFETY & UTILITY RECS ALESHIRE 278999, DAVID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS JODY E O'BRIEN BASS BERRY & SIMS PLC PEYOTE, ECSTASY, MARIJUANA, ETC - AERS 2009-9605 - 15 SUPPLEMENTAL PAGES (CERTIFIED) FOI DAILY LOG 11/28/11-12/2/11 FOI DAILY LOG 11/21-25/11 Signature/ Requester Subject FOI DAILY LOG 11/28/11-12/2/11
Page 735 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/30/2012 2011-9623 2011-9624 12/29/2011 01/30/2012 12/29/2011 01/30/2012 2011-9625 2011-9626 12/29/2011 01/30/2012 12/29/2011 01/30/2012 FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2011-9627 12/29/2011 01/30/2012 2011-9628 2011-9629 12/29/2011 01/30/2012 12/29/2011 01/30/2012 2011-9630 2011-9631 2011-9632 12/29/2011 01/30/2012 12/29/2011 01/30/2012 12/29/2011 01/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9633 12/29/2011 01/30/2012 ORA/ ORA/ HARRY LIU CQ INTERNATIONAL CO INC NEW NORTH RIVER PHARMACEUTICAL CO LTD TOBRAMYCIN IMPORTER FIRM NAME FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ SNYDER, ERIC M Eva Gonsalves FOI SERVICES INC Eva Gonsalves FOI SERVICES INC Copy of the disclosable portions of the 510(k) for K111201, C7 XR Imaging System, manufactured by LightLab Imaging, Inc. MedWatch forms for Sanctura: ISR # 4733019. FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ JANE THORNTON MASTRUCCI QUINTAIROS PRIETO WOOD & BOYER PA YVONNE DEBARTOLO FENWAL INC JOHN B HALLAGAN JOHN B HALLAGAN LAW OFCS SENSIENT COLORS LLC - BLUE COLOR ADDITIVES DERIVED FROM THE HUITO FRUIT (GENIPA AMERICANA) CORR 2010, 2011 BATTELLE, COLUMBUS, OH - 483 12/12/11 INFUPHARMA LLC, HOLLYWOOD, FL - EIRS, SURVEYS, CMPLNTS, ETC 9/27/11 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ GERHARDT, NATHAN CHRISTINE A RINGLER RN LNCC ESDAILE BARRETT JACOBS & MONE CHARLES H KYPER KYPER & ASSOCIATES SHIRLEY ROSS INDUMEX LLC - ENTRY #BYX00287700 NOTICE OF FDA ROANOKE TRADE SERVICES INC ACTION, REDELIVERY NOTICES, NOTICES OF REFUSAL CYTOMEDIX INC - AUTOGEL SYS BK060007 Action Office Signature/ Requester VETMEDIC Subject (LINCOMYCIN HCL) NADA 111-636 EFFICACY & TOLERABILITY RECS GOLDEN TEMPLE OF OREGON LLC, SPRINGFIELD, OR 483 5/16-19/11 INDIVIDUAL RECS
FENWAL INTERNATIONAL INC, MARICAO, PR - EIR 3/23/10
Page 736 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2011-9634 12/29/2011 01/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9635 2011-9636 12/29/2011 01/30/2012 12/29/2011 01/30/2012 ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ 2011-9637 2011-9638 12/29/2011 01/30/2012 12/29/2011 01/30/2012 2011-9639 12/29/2011 01/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9640 12/29/2011 01/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9641 12/29/2011 01/30/2012 2011-9642 2011-9643 2011-9644 12/29/2011 01/30/2012 12/29/2011 01/30/2012 12/29/2011 OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRISTINE L MACAULEY KIMBERLY-CLARK CORP OSRAM SYLVANIA - WARNING LTR 1986 ASPIRA PERITONEAL DRAINAGE SYS K110396 ASPIRA PLEURAL DRIANAGE SYS K110409 CMPLNT CPT1100211 FLEISCHER, DEBBIE AMGEN - PROLIA; ELI LILLY - FORTEO; NOVARTIS RECLAST AERS, CLNCL TRIALS, POST-MARKETING RPTS ROBERTS, TONYA FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ MIKE RUSSELL DELAVAL MANUFACTURING LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP GRAHAM DAIRY SUPPLY INC, GREENSBURG, PA - EIR, 483 9/4/09 TANDEM DIABETES CARE INC - T-SLIM INSULIN DELIVERY SYS K111210 METHADONE - AERS 1/04 TO 12/11 ORA/CE-FO/BLT-DO/CB/ NENA CHANDLER PPD CLAUDIA HORNBACK PPD BIOANALYTICAL LAB, RICHMOND, VA - EIRS,483S, CORR, ETC 4/25-19/11, 11/2-4/11, 11/14-18/11 SHAW #085161, STEVE LORENZO EFFEXOR, SSRIS - MEDWATCH DRUG ALERT 6/3/04 Signature/ Requester Subject
ANDAPHARM LLC - ENTRY #BGZ00149264 NOTICES OF ROANOKE TRADE SERVICES INC REFUSAL, NOTICE OF REDELIVERY
Page 737 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/30/2012 2011-9645 2011-9646 12/30/2011 01/31/2012 12/30/2011 01/31/2012 2011-9647 2011-9648 2011-9649 2011-9650 2011-9651 2011-9652 12/30/2011 01/31/2012 12/30/2011 03/05/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ 2011-9653 2011-9654 2011-9655 2011-9656 2011-9657 2011-9658 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 2011-9659 12/30/2011 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ CRAIG ROUSH ROCKLINE INDUSTRIES NYROBIA FREEMAN CONMED LINVATEC CORP SUSAN ANTHONEY AEGIS REGULATORY INC SUSAN ANTHONEY AEGIS REGULATORY INC SUSAN ANTHONEY AEGIS REGULATORY INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER PHAROS LIFE CORP - TANDA SKINCARE SYS PLC-001, TANDA BLUE 141-001, TANDA RED 660-001 K070185 MEDITEK INC - MEDITEK STAIRLIFTS CORR, MINS, TRANS, ETC ACORN INC - SUPERGLIDE STAIRLIFT CORR, MINS, TRANS, PHAROS LIFE CORP - TANDA SKINCARE SYS K080591 PHAROS LIFE CORP - TANDA MAX OTC SYS K110735 VVF KANSAS SERVICES LLC, KANSAS CITY, KS - EIR, 483, RECS 1/10 TO 6/10 SMITH & NEPHEW - INSTRUMENT TRAY K092551 FDA/OMPT/CDRH/OCER/DFOI/ HILL, ROBERT CHRIS CHEN GUNNELL INC ROBERT R WILSON FDA REGULATORY GUIDANCE GUNNELL INC, MILLINGTON, MI - 483S 1984 TO PRESENT; PROD LISTING NUMBER Q025229 - RECS, ETC TRIPLE T FOODS INC - AFLATOXIN RFR AND/OR PFR FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ Doe J K103220 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester FUKSA, ANTONIN JULIA FRIED MARTIN MAGNUSON ET AL NANDAKUMARA D SARMA RPH PHD USP PHARMACOPEIA BRIAN R BOWMAN AMERIWATER BOBAE KIM SYNERONBEAUTY INDIVIDUAL RECS TANGO3 WATER STORAGE TANK WITH OZONE DISINFECTION SYS K093641 SHASAR IPL HAIR REMOVALL SYS K103560 VALLEYLAB, COVIDIEN - ELECTROSURGICAL PENCIL MDRS JACK3D - CAERS 1/00 TO 10/11 Subject
Page 738 of 1132

Total Records: 12455 Control # Recd Date / Due Date 01/31/2012 2011-9660 12/30/2011 01/31/2012 2011-9661 12/30/2011 01/31/2012 2011-9662 12/30/2011 01/31/2012 2011-9663 2011-9664 2011-9665 2011-9666 2011-9667 12/30/2011 01/31/2012 12/30/2011 02/24/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 12/30/2011 01/31/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9668 12/30/2011 01/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9669 12/30/2011 01/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2011-9670 12/30/2011 01/31/2012 FDA/OF/CFSAN/OCD/EOS/ ORTAV YEHUDAI GREAT POINT PARTNERS LLC LUBRIZOL INC - NOVEON AA-1 POLYCARBOPHIL 483 4/11 TO PRESENT ORTAV YEHUDAI GREAT POINT PARTNERS LLC PRODUITS CHIMIQUES AUXILIARES ET DE SYNTHES SA, AVIGNON, FRANCE - 483 4/11 TO PRESENT ORTAV YEHUDAI GREAT POINT PARTNERS LLC FLEET LABORATORIES LTD, WATFORD, HERTS, UK - 483 4/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC ANDREW NGUYEN BOSTON SCIENTIFIC ORTAV YEHUDAI GREAT POINT PARTNERS LLC MAROPACK AG, ZELL, SWITZERLAND - 483 4/11 TO PRESENT REPROCESSED COLD BIOPSY FORCEPS K042648 Subject ETC BRUNO - ELAN SRE-3000 STAIRLIFT CORR, MINS, TRANS, ETC STERLING STAIRLIFTS INC - STERLING STAIRLIFTS CORR, MINS, TRANS, ETC STANNAH STAIRLIFTS INC - STANNAH STAIRLIFTS CORR, MINS, TRANS, ETC VANGUARD - REPROCESSED ELECTRIC BIOPSY FORCEPS K011800 VANGUARD - REPROCESSED NON-ELECTRIC BIOPSY FORCEPS K042594 REPROCESSED HOT BIOPSY FORCEPS K050136
Page 739 of 1132

Total Records: 12455 Control # 2011-9671 Recd Date / Due Date 12/30/2011 02/15/2012 2012-1 2012-2 01/03/2012 02/01/2012 01/03/2012 02/01/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/LOS-DO/LACB/ 2012-3 01/03/2012 02/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ 2012-4 01/03/2012 02/01/2012 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DEN-DO/COMP/ 2012-5 2012-6 01/03/2012 02/01/2012 01/03/2012 02/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ DREW BARNHOLTZ INVACARE CORP DREW BARNHOLTZ INVACARE CORP PRIDE MOBILITY PRODUCTS CORP - EIRS, 483S, TITLED & UNTITLED LTRS, ETC 1/00 TO PRESENT MEDICAL DEPOT INC (DRIVE MEDICAL) - EIRS, 483S, TITLED & UNTITLED LTRS, ETC 1/00 TO PRESENT DREW BARNHOLTZ INVACARE CORP SUNRISE MEDICAL - EIRS. 483S, TITLED & UNTITILED LTRS, ETC 1/00 TO PRESENT DREW BARNHOLTZ INVACARE CORP RESPIRONICS INC - EIRS, 483S, TITLED & UNTITLED LTRS, ETC 1/00 TO PRESENT MERCK & CO., INC. DREW BARNHOLTZ INVACARE CORP PHILIPS HEALTHCARE - EIRS, 483S, TITLED & UNTITLED LTRS, ETC 1/00 TO PRESENT Signature/ Requester KATHYRN PURCELL DOCUTRIEVAL INFORMATION SERVICES FOI DAILY LOG 12/19-23/11 Subject MYLAN INC - FOI REQUESTS 1/07 TO PRESENT
Page 740 of 1132

Total Records: 12455 Control # 2012-7 2012-8 Recd Date / Due Date 01/03/2012 02/01/2012 01/03/2012 02/27/2012 2012-9 01/03/2012 02/01/2012 2012-10 01/03/2012 02/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-11 01/03/2012 02/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-12 01/03/2012 02/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-13 01/03/2012 02/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-14 01/03/2012 02/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-15 01/03/2012 02/01/2012 2012-16 2012-17 01/03/2012 02/10/2012 01/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ BEATRICE A BRICKELL THARRETTS PALEY CARTER ETAL MARK D LURIE LURIE LAW FIRM LLC ELLYN STERNFIELD MAQUET INC, MAQUET CARDIOVASCULAR INC - EIRS, 483S, RESP TO 483S, ETC 1/08 TO PRESENT P&B DISTRIBUTORS, OLSON INSTITUTIONAL PHARMACY GREEN IMPORTS INC - FRESH GINGER LAB RPT 12/7/11 JOEL F GRAHAM MERCHANT & GOULD INJECTAPAP NDA 17-785 - CHEMISTRY RVWS, ADMINISTRATIVE RECS, CORR ANDREW J CAMPANELLI CAMPANELLI & ASSOCIATES PC PFIZER INC - PHYLLIS SCHNEPS LTRS, FAXES, COMM, ETC 1/09 TO PRESENT KLARA ROMBAUTS SCIENTIST RELIABLE CANCER THERAPIES BESPOKE BIOSCIENCE - ALOE VERA RECS ANDREW KELLY ODOM & DES ROCHES LLP HOFFMAN LAROCHE INC (ROCHE NUTLEY) - XELODA TABS ANDA 90-943, MYLAN - ANDA 91-648, TEVA - ANDA 20-483, ETC APRVL LTRS, ADMINISTRATIVE RECS, CORR, ETC DAVID G PERKINS ABBOTT LABORATORIES, INC. CPGM 7356.021 -DRUG QUALITY REPORTING SYS Doe J Action Office FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DREW BARNHOLTZ INVACARE CORP MARK E LOSTROM MERCHANT-TAYLOR INTERNATIONAL Subject DEVILBISS HEALTHCARE LLC - EIRS, 483S, TITLED & UNTITLED LTRS, ETC 1/00 TO PRESENT DIMENSIONAL DOSING SYSTEMS, WEXFORD, PA - MY INSULIN DOSER K082512 OLYMPUS/GRYUS ACMI - RESECTOSCOPE MDRS
Page 741 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/01/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/OCI/ ORA/OCI/ 2012-18 01/03/2012 02/01/2012 2012-19 01/03/2012 02/01/2012 2012-20 01/03/2012 02/01/2012 2012-21 01/03/2012 02/01/2012 2012-22 2012-23 2012-24 2012-25 2012-26 2012-27 2012-28 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 2012-29 01/04/2012 02/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. CECELIA FRENCH CanReg, Inc. FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION FOI DAILY LOG 12/12-16/11 FOI DAILY LOG 12/5-9/11 FOI DAILY LOG 12/19-23/11 FOI DAILY LOG 12/12-16/11 FOI DAILY LOG 12/5-9/11 FOI DAILY LOG 12/19-23/11 FOI DAILY LOG 12/12-16/11 FOI DAILY LOG 12/5-9/11 CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ SIEGEL, JONATHAN B GREGORY N CONNOLLY HARVARD SCHOOL OF PUBLIC HEALTH ANGVELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC DREW BARNHOLTZ INVACARE CORP STICHTING SANQUIN BLOEDVOORZICNING (SANQUIN BLOOD SUPPLY FOUNDATION), AMSTERDAM - EIRS, 483S, PRE APRVL INSP RECS 1/10 TO PRESENT FAMILY SMOKING PREVENTION & TOBACCO CONTROL ACT - APPL, M FR 1/`0 TO PRESENT CAERS 14608 - RECS RECEIVED AFTER CMPLNT DATE 11/11/10 PERMOBILL INC - EIRS, 483S, TITLED & UNTITILED LTRS, ETC 1/00 TO PRESENT Signature/ Requester MINTZ LEVIN ET AL Subject PRESS RELEASE, COURT RECS 1999
Page 742 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester SOURCE 2012-30 01/04/2012 02/02/2012 2012-31 01/04/2012 02/02/2012 2012-32 01/04/2012 02/02/2012 2012-33 01/04/2012 02/02/2012 2012-34 2012-35 2012-36 2012-37 2012-38 2012-39 2012-40 2012-41 2012-42 2012-43 2012-44 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 02/02/2012 01/04/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KENDLE INTERNATIONAL INC FOI DAILY LOG 12/19-23/11 KENDLE INTERNATIONAL INC FOI DAILY LOG 12/12-16/11 FOI SERVICES INC FOI DAILY LOG 12-5-9/11 FOI SERVICES INC FOI DAILY LOG 12/12-16/11 KEN REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 12/5-19/11 FOI DAILY LOG 12/19-23/11 FOI DAILY LOG 12/12-16/11 FOI DAILY LOG 12/5-9/11 FOI DAILY LOG 12/19-23/11 FOI DAILY LOGH 12/12-16/11 FOI DAILY LOG 12/5-9/11 FOI DAILY LOG 12/19-23/11 FOI DAILY LOG 12/12-16/11 FOI DAILY LOG 12/5-9/11 FOI DAILY LOG 12/19-23/11 Subject
Page 743 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/02/2012 2012-45 2012-46 01/04/2012 02/02/2012 01/04/2012 02/02/2012 2012-47 01/04/2012 02/02/2012 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/CIN-DO/CCB/ 2012-48 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-49 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-50 2012-51 01/04/2012 03/22/2012 01/04/2012 02/02/2012 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-52 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-53 01/04/2012 02/02/2012 2012-54 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ GREGORY KAUFFMAN PENNSYLVANIA DEMOCRATIC PARTY SHAWN P. FOX TRACEY LAW FIRM MITOS TECHNOLOGIES INC, PHOENIXVILLE, PA - 483 1/1/00 TO 1/2/12 WYETH PHARMACEUTICALS INC - EFFEXOR (VENLAFAXINE) INTEGRATED SAFETY & EFFICACY GREG HARMAN SAN ANTONIO CURRENT DR CHANDRA TIWARY - AER SUBMITTED TO FDA, CORR 1996 SCOTT C. BYRD BYRD LAW FIRM MARCUS PETOYAN GIANNI PETOYAN ATTY ZOLOFT (SERTRALINE) - PREGNANCY EXPOSURE REGISTRY GREEN VALLEY FOOD CORP - RECS 2006 TO 2011 MOHAMMED SIDDIQUI INTERNATIONAL TRADING PHARMACEUTICALS LABORATORIES INC TAXOL - NDA MARY B. SZALKOWSKI PRISMA CORP INDAPAMIDE; PERINDOPRIL - AER 9/14/11 TO PRESENT Action Office OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ Signature/ Requester KENDLE INTERNATIONAL INC STEVEN RENAUT A&A LTD JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL WILLIAM R. COLE TECHNICAL INC SPLS 702016, 702017, 702016 - ANALYTICAL RECS H&P INDUSTRIES; RECALL, RECS SEA BORN PRODUCTS INC - 038-0627257-5 Subject
Page 744 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DEN-DO/COMP/ 2012-55 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-56 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-57 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-58 2012-59 01/04/2012 02/02/2012 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ CHARMAINE SIDES RODEY DICKASON SLOAN ET AL RAVI TIRLANGI BELCHER PHARMACEUTICALS INC GORE TEX VASCULAR GRAFTS/SHUNTS - MDRS, WARNING LTRS, INVESTIGATIONS BELCHER PHARMS LLC - DESLORATADINE NDA 78-355; SCHERING PLOUGH - CLARINEX NDA 21-165/S-014 APPL SHAWN P. FOX TRACEY LAW FIRM FOREST LABS - CELEXA (CITALOPRAM) - SAFETY, EFFICACY, CORR BETWEEN FDA & 5 DAY ALERTS SHAWN P. FOX TRACEY LAW FIRM FOREST LABS - LEXAPRO (ESCITALOPRAM) INTEGRATED SUMMARIES OF SAFETY & EFFICACY, CORR ,15 DAY ALERTS, ETC SHAWN P. FOX TRACEY LAW FIRM PFIZER - ZOLOFT (SERTRALINE) - SAFETY, EFFICACY, CORR BETWEEN FDA & PFIZER, 15 DAY ALERTS Signature/ Requester Subject SUMMARIES, 15 DAY ALERTS , CORR, ETC
Page 745 of 1132

Total Records: 12455 Control # 2012-60 Recd Date / Due Date 01/04/2012 02/02/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-61 01/04/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/SJN-DO/SJCB/ 2012-62 01/04/2012 02/02/2012 2012-63 01/04/2012 02/02/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ Eva Gonsalves FOI SERVICES INC Eva Gonsalves FOI SERVICES INC Copy of the disclosable portions of the EIR and 483 for the 08/03/2010 inspection of Proportional Technologies, Inc., located in Houston, Texas.; Copies of the disclosable portions of the EIRs and 483s for both the 01/19/2010 AND the 01/18/2011 inspections of PETNET Solutions, Inc., located in Omaha, Nebraska; AND the 11/23/2010 inspection of PETNET Solutions, Inc., located in Des Plaines, Illinois; AND the 12/08/2010 inspection of PETNET Solutions, Inc., located in Aurora, Colorado; AND the 01/18/2011 inspection of PETNET Solutions, Inc., located in Overland Park, Kansas. Copies of the disclosable portions of the EIRs and 483s for the 06/30/2010 inspection of Cardinal Health 414, located in Birmingham, Alabama; AND the 03/10/2011 inspection of Cardinal Health 414, located in Ft. Lauderdale, Florida; AND the 04/11/2011 inspection of Cardinal Health 414, located in Sharon Hill, Pennsylvania. Copy of the disclosable portions of the EIR and 483 for the 08/11/2010 inspection of IBA Molecular, located in Sterling, Virginia; and the EIR for the 09/14/2010 inspection of IBA Molecular, located in Somerset, New Jersey. Copy of the disclosable portions of the EIR and 483 for the 10/01/2010 inspection of Cardinal Health 420, located in West Chester, Ohio. VIROPHARMA, SANGUIN, CAF-DCF - DENDREON, CINRYZE UNTITLED LTRS, 483S 1/07 TO PRESENT Doe J INDIVIDUAL RECS Signature/ Requester BARBARA A. BINZAK BUCHANAN INGERSOLL & ROONEY PC Subject PREVACID NAPRAPAC 250, 375, 500 (LANSOPRAZOLE & NAPROXEN TABS) NDA 21-507; PREVACID IV (LANSOPRAZOLE INJ) NDA 21-566 - SAFETY & EFFICACY RECS
2012-64
01/04/2012 02/02/2012
ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/
Eva Gonsalves FOI SERVICES INC
2012-65
01/04/2012 02/02/2012
ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/
2012-66
01/04/2012 02/02/2012
Eva Gonsalves FOI SERVICES INC
2012-67
01/05/2012 02/03/2012
CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/PHI-DO/PCB/
ANDREW HACK MD PHD MILLENNIUM MANAGEMENT LLC
Page 746 of 1132

Total Records: 12455 Control # 2012-68 2012-69 Recd Date / Due Date 01/05/2012 02/03/2012 01/05/2012 02/03/2012 2012-70 01/05/2012 02/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-71 01/05/2012 02/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-72 2012-73 01/05/2012 02/03/2012 01/05/2012 02/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-74 2012-75 01/05/2012 02/03/2012 01/05/2012 02/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-76 01/05/2012 02/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHRISTOPHER BOTH CETERO RESEARCH TEMOVATE OINTMENT NDA 19-323 - SBA ORA/NE-FO/NWE-DO/NWECB/ ROBERT L KAVANAUGH AMERICAN HEALTH PACKAGING CHRISTOPHER BOTH CETERO RESEARCH AMERIDOSE - EIRS, 483S, WARNING LTRS, ETC LAST FIVE YRS TEMOVATE CREAM NDA 19-322 - SBA FDA/OMPT/CDRH/OCER/DFOI/ PASTORE, MIKE ROBERT L KAVANAUGH AMERICAN HEALTH PACKAGING PHARMEDIUM - EIRS, 483S, WARNING LTRS, ETC LAST FIVE YRS HERNIA PATCHES - RECS DENIS C MITCHELL ESQ STEIN MITCHELL & MUSE LLP PRADAXA (DABIGATRAN ETEXILATE) - AERS Action Office CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/PHI-DO/PCB/ ORA/SW-FO/KAN-DO/COMP/ Signature/ Requester BRIAN SKORNEY BREAN MURRAY CARRET & CO JIM LEONG CIVCO MEDICAL INSTRUMENTS CO INC NARSI RANGACHARI INCARDA THERAPEUTICS INC CIVCO MEDICAL SOLUTIONS INC, KALONA, IA - EIR 2/811/11 GLAXOSMITHKLINE LLC - RYTHMOL TABS NDA 19-151 SBA Subject VIROPHARMA INC - 483S 7/09 TO 9/09, 9/10, 5/11
Page 747 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-77 01/05/2012 02/03/2012 2012-78 01/05/2012 02/03/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/ ORA/ 2012-79 2012-80 2012-81 01/05/2012 02/03/2012 01/05/2012 02/03/2012 01/05/2012 02/03/2012 CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/LOS-DO/LACB/ 2012-82 01/05/2012 02/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-83 01/05/2012 02/03/2012 CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OM/OMP/DODM/ 2012-84 2012-85 2012-86 2012-87 01/05/2012 02/03/2012 01/05/2012 02/03/2012 01/05/2012 02/03/2012 01/05/2012 02/03/2012 2012-88 01/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 12/26-30/11 CanReg, Inc. CECELIA FRENCH CanReg, Inc. CLOSED FOI REQUESTS 12/19-23/11 CLOSED FOI REQUESTS 12/19-23/11 CanReg, Inc. CLOSED FOI REQUESTS 12/26-30/11 CLOSED FOI REQUESTS 12/5-9/11 JENNIFER SORENSON NATURAL RESOURCES DEFENSE COUNCIL PENICILLIN AND ANTIBIOTICS USED IN ANIMAL FEED SAFETY RVWS, ANALYSIS BRIAN SMITH LEXISNEXIS COURTLINK INC JOINT MTG OF THE A/C FOR REPRODUCTIVE HEALTH DRUGS AND THE DRUG SAFETY & RISK MANAGEMENT A/C - BRIEFING RECS & ADDENDUM 12/8/11 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ Gumpert, David JONEL ALECCIA MSNBC.COM KATE B WILSON RAINBOW ACRES FARMS, KINZERS, PA - SPL 570826, 570827 SUMMARY RPTS TRIAD GROUP, H&P INDUSTRIES, HARTLAND, WI RECONDITIONING PROPOSALS FDA/OF/CFSAN/OCD/EOS/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC TONY CORBO Food & Water Watch CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, CENTER FOR VETERINARY MEDICINE, OFFICE OF REGULATORY AFFAIRS - EMPLOYEE AWARD CEREMONY COSTS FY 2009 TO FY 2011 NEXIRA - FAP 1A4784 Signature/ Requester Subject
CRYOLIFE - RECALL RECS 2002; DONOR REFERRAL CENTER FOR PUBLIC INTEGRITY SERVICES - RECALL RECS 2006
Page 748 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/03/2012 2012-89 2012-90 2012-91 01/05/2012 02/03/2012 01/05/2012 02/03/2012 01/06/2012 02/06/2012 2012-92 01/06/2012 02/06/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FOI SERVICES INC ETHICON ENDO-SURGERY LLC - ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD BLACK MODEL ECR6OT, ECHELEN 45 ENDOSCOPIC LINE K112056 NORPLANT TROCAR - K903490: LIFE PULSE HIGH FREQUENCY JET VENTILATOR - P850064; PURITAN BENNETT 72O00 VENTILATOR - K902506, K9023809, K92002, ETC WELLBUTRIN NDA 21-515/S10 - SBA FOI SERVICES INC CLOSED FOI REQUESTS 12/26-30/11 Signature/ Requester WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 12/19-23/11 Subject
2012-93
01/06/2012 02/06/2012
MARY ANDERSON SHIRE INC
2012-94
01/06/2012 02/06/2012
SYMBYAX NDA 21-520/S12 - SBA
2012-95
01/06/2012 02/06/2012
NDA 20-151/S000 - SBA
2012-96 2012-97 2012-98
01/06/2012 02/06/2012 01/06/2012 02/06/2012 01/06/2012 02/06/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/
JOHN G ROONEY ROONEY & ROONEY PA DARI DARABBEIGI PERSYST DEVELOPMENT CORP AMNON TALMOR INVIBIO BIOMATERIAL SOLUTIONS
VAX-D MEDICAL TECHNOLOGIES LLC - K951622, K053503, K071347, ETC (CERTIFIED) NATUS - NEUROWORKS K090019 K102026
2012-99
01/06/2012 02/06/2012
KEITH D BODOH ROBERTSON BODOH NASRALLAH
QUALITEST PHARMACUTECALS -CYCLAFEM 1/35, GILDESS FE 1.5/30, PREVIFEN, ETC RECALL RECS 9/15/11
Page 749 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-100 01/06/2012 02/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-101 2012-102 2012-103 2012-104 01/06/2012 02/06/2012 01/06/2012 02/06/2012 01/06/2012 02/06/2012 01/06/2012 02/06/2012 2012-105 2012-106 01/06/2012 02/06/2012 01/06/2012 02/06/2012 CVM/OCD/ OC/COS/OES/ OC/COS/OES/ 2012-107 2012-108 01/06/2012 02/06/2012 01/06/2012 02/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-109 01/06/2012 02/06/2012 2012-110 01/06/2012 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ FDA/OF/CFSAN/OCD/EOS/ GRACE SHEEDY WALMART STORES INC - VISITOR LOGS, CALENDARS, MTG JEFFERS, TEENA IDAHO SPUD CANDY BARS SPL 653395 - TEST RESULTS FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FARABAUGH, MATTHEW JEFF RUCH PUBLIC EMPLOYEES FOR ENVIRONMENTAL RESPONSIBILITY ANN M OXFORD ALBEMARLE CORP JEANNE LENZER BMJ DANIEL SHAMES - DROSPIRENONE APRVL, WARNINGS, MTGS, ETC 12/8/11 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ MIKE RUSSELL DELAVAL MANUFACTURING BRENDA M GARTZ ELI LILLY & CO PAULL W TRIPP LINCARE INC WAYNE SADOWSKI NOVARTIS PHARMACEUTICAL CORP GRAHAM DAIRY SUPPLY INC, GREENSBURG, PA - 6328 EIRS, 483S 9/4/09 AVID RADIOPHARMACEUTICALS, PHILADELPHIA, PA - EIRS 1/4/11 FAMILY RESPIRATORY & MEDICAL SUPPLY INC, MD - EIRS, 483S, WARNING LTRS, ETC 1/05 TO PRESENT DR MARVIN ZELKOWITZ, FLOSSMOOR, IL 6/26/08 DR ROBERT LADA, AKRON, OH 5/9/08; DR STEVEN FREEDMAN, RALEIGH, NC 6/29/09, ETC - EIRS, 483S, 482S, ETC PROPYLENE GLYCOL AS GENERALLY REGARDED AS SAFE (GRAS) - RECS WITHDRAWAL OF NOTICES OF OPPORTUNITY FOR HEARING: PENICILLIN & TETRACYCLINE USED IN ANIMAL FEED - RPTS, COMM 1/10 TO PRESENT HYPOBROMOUS ACID - FCN 1098 SWOPE, CARL T ZOCOR, SIMVASTATIN - AERS Signature/ Requester Subject
Page 750 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/06/2012 Action Office OC/COS/OES/ OC/COS/OES/ Signature/ Requester UNITED FOOD AND COMMERICAL WORKERS INTERNATIONAL UNION - SAFE FOOD COALITION MEHRABAN, OMID Subject NOTES, ETC 1/09 TO PRESENT
2012-111
01/06/2012 02/06/2012
ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/
CMPLNT 123545
2012-112
01/06/2012 02/06/2012
MARY FRANCES BROUGHMAN BROWN & CROUPPEN PC WILLIAM R. COLE TECHNICAL INC JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL
INDIVIDUAL RECS
2012-113 2012-114
01/06/2012 02/06/2012 01/06/2012 02/06/2012
IOM REPORTS TRIAD/H&P INDUSTRIES - CONSENT DECREE CORR
2012-115
01/09/2012 02/07/2012
ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/
JULIA MOUSER CANNON & NELMS
WEGIS RANCH, BUTTONWILLOW, CA - ICEBERG LETTUCE ESCHERICHIA COLI OUTBREAK INVESTIGATION RECS 2006-2008
2012-116
01/09/2012 02/07/2012
ELIZABETH WOECKNER CITIZENS FOR RESPONSIBLE CARE & RESEARCH
RAJIV CHANDRA MD, MELBOURNE, FL - EIR, 483 4/12/10
2012-117 2012-118 2012-119 2012-120 2012-121 2012-122
01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012
ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
QUYNH C SPERRAZZA FAEGRE & BENSON LLP MERCK & CO., INC.
QUALITY EGG LLC, GALT,IA; CLARION, IA; ALDEN, IA , ETC PFGE & MLVA TEST RESULTS, ANALYSES 8/10 TO PRESENT FOI DAILY LOG 12/26/30/11 FOI DAILY LOG 1/2-6/12
MERCK & CO., INC. 2011-9471 REQUEST LETTER MERCK & CO., INC. 2011-9195 REQUEST LETTER MERCK & CO., INC. CLOSED FOIA REQUESTS 12/1-31/11 MERCK & CO., INC.
Page 751 of 1132

Total Records: 12455 Control # 2012-123 2012-124 2012-125 2012-126 2012-127 Recd Date / Due Date 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 2012-128 01/09/2012 02/07/2012 2012-129 01/09/2012 02/07/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-130 01/09/2012 02/07/2012 ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2012-131 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-132 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO., INC. SCHERING - VICTRELIS (BOCEPREVIR) AERS 12/1-31/11 JOAN STITT (UG2CD-16) MERCK & CO., INC. SCHERING - DULERA (FORMOTEROL FUMARATE, MOMESTASON FUROATE) AERS 12/1-31/11 MARY FRANCES BROUGHMAN BROWN & CROUPPEN PC INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ FRISBIE, JEFFREY JOAN STITT (UG2CD-16) MERCK & CO., INC. FDA/OMPT/CDRH/OCER/DFOI/ FRISBIE, JEFFREY Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ CROWELL & MORING BRIAN SMITH LEXIS NEXIS COURTLINK INC BRIAN SMITH LEXIS NEXIS COURTLINK INC CLAYON HUNTLEY MORRISON CLAYTON H MORRISON LLC FRESENIUS MEDICAL CARE HOLDLINGS INC, WALTHAM, MA - EIR 6/15/10-8/6/10, 483 6/14/10 TO 1/1/11 VASCULAR OCCLUSION SYS - K983483; TRUFILL DCS ORBIT DETACHABLE COIL & TRUFILL DCS SYRINGE (TRUFILLL DCS ORBIT DETACHABLE COIL SYS) - K032553 MICRUS STRETCH-RESISTANT MICROCOIL SYS MSR0I K022420; MICRUS MICROCOIL SYS - K032872; MICRUS MICROCOIL SYS CASHMERE MODEL SRC - K063653 MERCK SHARP & DOHME - JUVISYNC (SIMVASTATIN, SITALIPTIN PHOSPHATE) AERS 12/1-31/11 2009-6581 Signature/ Requester Subject FOIA REQUESTS FOR CENTER FOR VETERINARY MEDICINE 12/1-21/11 2009-7825
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-133 2012-134 01/09/2012 02/07/2012 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-135 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-136 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-137 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-138 2012-139 01/09/2012 02/07/2012 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-140 2012-141 01/09/2012 02/07/2012 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-142 01/09/2012 02/07/2012 FDA/OMPT/CDRH/OCER/DFOI/ RONALD L BATE NATIONAL BIOLOGICAL CORP AVEX INDUSTRIES LTD - K935525, K933952, K933953, ETC ORA/NE-FO/NYK-DO/NYDCB/ RONALD L BATE NATIONAL BIOLOGICAL CORP DON J MIZERK HUSCH BLACKWELL LLP AVEX INDUSTRIES LTD, HUDSON FALLS, NY - EIRS 1990 TO 2011 SUN PHARMA GLOBAL - RYZOLT NDA 91-607 APRVL LTR 12/30/11 FDA/OMPT/CDRH/OCER/DFOI/ RONALD L BATE NATIONAL BIOLOGICAL CORP ROBERT E SHAPIRO UNIV OF VERMONT COLLEGE OF MEDICNE AVEX INDUSTRIES LTD - PHOTOTHERAPEUTIX K935525, K933952, K933953, ETC ONABOTULINUMTOXIN A - APRVL 10/15/10 KEITH CHASIN KEITH CHASIN LAW OFC ZICAM OXYMETAZOLINE HCL SINUS RELIEF NASAL SPRAY OR GEL - AERS 1/1/00 TO 11/1/06 ROSIERE, SHAUN WHAT DRUG OR DRUG PROD APPL ARE AVAILABLE - NDA, PIONEER NDA; APRVLS ARE POSTED ON WHAT WEB ADDRESS - PENDING APRVLS, ENACTMENT DATES LAST 5 YRS; DECISION DATES - WEBSITE ADDRESS, ETC ROBERT V PRONGAY GLANCY BINKOW & GOLDBERG LLP INSMED INC - ARIKACE (LIPOSOMAL AMIKACIN FOR INHALATION) CLNCL TRIAL, IND, CORR, ETC FDA/OMPT/CDRH/OCER/DFOI/ SUE CORBETT RESEARCH INVESTMENT INC MARCUS PETOYAN GIANNI PETOYAN ATTY ETHICON INC - COATED VICRYL (POLYGLACTIN) SUTURE LBLG 1994 PROZAC, FLUOXETINE - PREGNANCY EXPOSURE REGISTRY RECS Signature/ Requester Subject
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Total Records: 12455 Control # 2012-143 Recd Date / Due Date 01/09/2012 02/07/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-144 2012-145 01/09/2012 02/07/2012 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-146 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-147 2012-148 2012-149 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-150 2012-151 2012-152 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 2012-153 01/09/2012 02/07/2012 ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SEA-DO/SCB/ KRISTINA FRYE FRYE ELECTRONICS MINA KIMES FORTUNE MAGAZINE TRAVIS SCHAFTENAAR UBS GLOBAL ASSET MANAGEMENT JOEL FUREY NOBLE BIOMATERALS INC MASTER FILE MAF 1260 - NON- REDACTED CORR, NOTES INTEGRA LIFESCIENCES - 483 7/11 SYNTHES, WEST CHESTER, PA - EIRS 1/00 TO 1/06 FRYE ELECTRONICS, TIGARD, OR - EIR 7/14-21/09 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RONALD L BATE NATIONAL BIOLOGICAL CORP MICHAEL C THEODORAKIS FDA/CDER NTEU CHAPTER 282 JOE PETTIGREW SCOTT & SCOTT LLP MEDTEK LIGHTING, HUDSON FALLS, NY - EIRS 1990 TO 2011; K051330 CDRH NTEU COOPERATION COUNCIL - MINS, AGENDAS 2009-2012, SIGNED COUNCIL CHARTER, ETC PAIN THERAPEUTICS INC, KING PHARMACEUTICALS INC REMOXY (EXTENDED-RELEASE OXYCODONE) COMPLETE RESP LTR 6/11; CORR, PRTS 12/08 TO PRESENT Doe J ISR 4660267-1 ORA/NE-FO/NYK-DO/NYDCB/ RONALD L BATE NATIONAL BIOLOGICAL CORP WILLIAM A GARVIN BUCHANAN INGERSOLL & ROONEY PC AVEX INDUSTRIES LTD, GLENS FALLS, NY - EIRS 1990 TO 2011 COMPAZINE SPANSULE NDA 21-019 - APRVL RECS Signature/ Requester DUSTIN BLOCK IPD ANALYTICS LLC Subject TRAMADOL HCL ANDA 91-607 - APRVL LTR 12/30/11
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDRH/OCER/DFOI/ 2012-154 2012-155 2012-156 2012-157 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 2012-158 2012-159 2012-160 2012-161 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/09/2012 02/07/2012 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-162 2012-163 01/10/2012 02/16/2012 01/10/2012 03/29/2012 2012-164 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-165 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-166 01/10/2012 OM/OSS/OPILS/DFI/ 2011-9281 SANJAY NAYAK, MD, PhD. MEDITREC LLC REGENERON PHARMS INC - EYLEA APRVL, CMC RVW, CLNCL RVW Doe J FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ REGINA HARPER MILLIKEN & COMPANY REGINA HARPER MILLIKEN & COMPANY FCN 5,7 (1,1 -DIMETHYLETHYL)-3-HYDROXY-2(3H)BENZOFURANONE, REACTION PRODUCTS WITH OXYLENE AMERICAN CELLULAR LABS - TREN XTREME AER FCN 310, 377, 544 BANKS DZ-5843, RONALD CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ Doe J JULIE SCHOELL STRYKER INCUBATION OF MEDICAL TECHNOLOGY CENTERPULSE ORTHOPEDICS INC - NATURAL KNEE II UNCOMPARTMENTAL KNEE SYS K033810 BAXTER HEALTHCARE CORP - CONTROL-A-FLO REGULATOR K940867 MERCK & CO INC - ROTATEQ (ROTAVIRUS VACCINE) VAERS 12/1-31/11 MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 12/131/11 SELECTIVE SEROTONIN REUPTAKE INHIBITORS - AER CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ ELILOT HARRISON LEWIS & HARRISON BRIAN SKORNEY BREAN MURRAY CARRET & CO VIROPHARMA/LEV, SANQUIN, CAF - CINRYZE EIRS, 483S, CORR FLU MIST - RECS POLYLACIDE POLYMERS CAS 9051-89-2 - FCN 178 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 02/08/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-167 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-168 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-169 01/10/2012 02/08/2012 2012-170 2012-171 01/10/2012 02/08/2012 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ OM/OMP/DODM/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ELIOT HARRISON LEWIS & HARRISON ANGELA ERICKSON INSTITUTE FOR JUSTICE CORR TO & FROM STATE DENTAL BAORDS 2008 TO PRESENT FCN 178 HUMAN CELL & TISSUE ESTABLISHMENTS 7/1/11 TO 12/31/11 CAROLE D. MITNICK HARVARD MEDICAL SCHOOL DEPT OF GLOBAL HEALTH & SOCIAL MEDICINE SANOFI AVENTIS - RIFADIN NDA SUMMARIES HELGESON, STEVE ISRS 6905005, 6986289 Signature/ Requester FOI SERVICES INC Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SWFO/SWID/COMPLIANCE/ 2012-172 2012-173 01/10/2012 02/08/2012 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-174 2012-175 01/10/2012 02/08/2012 01/10/2012 02/08/2012 2012-176 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ELENA HOWELL HOGAN LOVELLS LLP DIANE R. WHITWORTH DRW RESEARCH & INFORMATION SERVICES LLC CHRIS LETTER ODOM & DES ROCHES LLP DKT 2005P-0315, RANBAXY - ANDA 76-477 CORR, APRVL RECS MEDICAL ENTERPIRSES LTD - SYNERGO P010045 2011-8648 FDA/OMPT/CDRH/OCER/DFOI/ EVAN BALLAN STEIN MITCHELL & MEZINES LLP DAVID B. HOFFMAN WOODCOCK WASHBURN LLP SORIN GROUP USA INC - CARBOMEDICS PROSTHETIC HEART VALVE - APRVL, LBLG MALLINCKRODT INC - OXYMORPHONE PRODUCTS PROCESS OF PRODUCTION Signature/ Requester Subject
Page 757 of 1132

Total Records: 12455 Control # 2012-177 2012-178 Recd Date / Due Date 01/10/2012 02/08/2012 01/10/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-179 01/10/2012 02/08/2012 2012-180 01/10/2012 02/08/2012 2012-181 2012-182 01/11/2012 02/09/2012 01/11/2012 02/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-183 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-184 2012-185 2012-186 01/11/2012 02/09/2012 01/11/2012 02/09/2012 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-187 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ COLEMAN, MIRA A QT PROLONGATION, TORSADES DE POINTES & SUDDEN CARDIAC DEATH - AERS FOX, KAREN FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ WPATRICK NOONAN W PATRICK NOONAN MONIKA MCDOLE-RUSSELL SYNTHES SPINE ACCUTANE - AERS K-Y BRAND INTRIGUE INTENSE WARMING SENSATION K072360 SYNTHES USA - LIGHT GUIDE K993314 BRENDA M GARTZ ELI LILLY & CO BOEHRINGER INGLEHEIM - EIRS MOST RECENT KEVIN BOOT Embria Health Sciences LLC BRENDA M GARTZ ELI LILLY & CO BOEHRINGER INGLEHEIM - 483 MOST RECENT DKT 1995S-0039 - DRAFT 7590 RPT 689 ORA/SW-FO/KAN-DO/COMP/ BARBARA FRAZIER LEHL THE LAW OFFICES OF DENNIS BONNER & ASSOCIATES LLC RACHEL LEVEN THE HILL CORR BETWEEN HHS & THE WHITE HOUSE CHIEF OF STAFF SINCE 1/1/11 TO PRESENT INDIVIDUAL RECS Action Office ORA/SE-FO/ATL-DO/ACB/ Signature/ Requester MATTHEW W. COOK MCDONALD CODY ET AL CHLOE BIRD PCCA LIST OF FOREIGN IMPORTED DRUGS PRODS, NDC NUMBERS ISSUED TO US DRUG MFRS Subject SUN HONG KAI HOLDING INC - INSP 9/22/10 TO 10/1/10
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-188 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-189 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-190 01/11/2012 02/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-191 2012-192 2012-193 2012-194 2012-195 2012-196 01/11/2012 02/09/2012 01/11/2012 02/09/2012 01/11/2012 02/09/2012 01/11/2012 02/09/2012 01/11/2012 02/09/2012 01/11/2012 02/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OC/OER/OPA/ OM/OMP/DODM/ 2012-197 2012-198 01/11/2012 02/09/2012 01/12/2012 02/10/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RALPH AGUILA GEORGE R KINGSLEY KINGSLEY & KINGSLEY PC CAREFUSION CORP - CLIO2 AUTOMATIC OXYGEN CONTROL IDE, PMA PRODISC L DVC SURGERY - APRVL RECS FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ MOLE, BETH HENRY DAO HSP USA LLC CHARLES G BROWN CONSUMERS FOR DENTAL CHOICE JEFF SHUREN, ANTHONY WATSON, DR MARY SUSAN RUNNER, ETC - DENTAL AMALGAM RECS 10/10 TO PRESENT ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ROBERT LL KAVANAUGH AMERICAN HEALTH PACKAGING AUSTIN NELSON RBC CAPITAL MARKETS JAMES PELUSO AVID RADIOPHARMACEUTICALS ANTIMICROBIAL DRUG SPONSOR RPTS BY THE CENTER FOR VETINARY MEDICINE 2009, 2010 FCN 692 BIOMED IRB, SAN DIEGO, CA - EIRS RESOURCE OPTIMIZATION & INNOVTION LLC - EIRS, 483S, WARNING LTRS LAST 4 YRS HOPSIRA INC - 483 1/4/12 ELEN HOWELL HOGAN LOVELLS LLP NATIONAL ACADEMY OF SCIENCES NATIONAL RESEARCH COUNCIL - CALCIUM LEUCOVORIN INJ - RPT KENNETH O JOBSON KENNETH O JOBSON MD 30 DRUG COMBINATIONS WITH PHARMACOGENOMICS IN THER LBLG - LIST OF MEDICATIONS APRVD LEE, SHARON L DARVACET - AERS Signature/ Requester Subject
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Total Records: 12455 Control # 2012-199 2012-200 2012-201 Recd Date / Due Date 01/12/2012 02/10/2012 01/12/2012 02/10/2012 01/12/2012 02/10/2012 2012-202 01/12/2012 02/10/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2012-203 01/12/2012 02/10/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/ATL-DO/ACB/ 2012-204 2012-205 01/12/2012 02/10/2012 01/12/2012 02/10/2012 2012-206 2012-207 2012-208 2012-209 01/12/2012 02/10/2012 01/12/2012 02/10/2012 01/12/2012 02/10/2012 01/12/2012 02/10/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ VICTORIA SCOTT HEMISPHERX BIOPHARMA GERALDINE E EDENS MCKENNA LONG & ALDRIDGE LLP STEVEN L BRAMER PHD FIRST-STOP CONSULTING KAY A SETZER Abbott Vascular BARBARA RICH STERIS CORP ANDRENE HERON ROCHE DIAGNOSTICS CORP AGAMATRIX - IPHONE GLUCOSE METER K103544 HEMISPHERX BIOPHARMA INC, NEW BRUNSWICK, NJ MEMO 9/15/11 EMERALD CAROLINA CHEMICALS LLC POLYOXYETHYLENE SORBITAN MONOSTEARATE USE IN DRIED & WET DISTILLERS GRAINS GRAS CHIRON INTRAOPTICS - OPTISOL-GS CORNEAL STORAGE MEDIA K924165 TERUMO MEDICAL CORP - RUNTHROUGH GUIDE WIRE K063695 STERIS CORP, MONTGOMERY, AL - EIR 10/25-27/11 COMBS, ANDREW UNITED THERAPEUTICS - REMODULIN NDA 21-272, TYVASO NDA 22-387 RECS COMBS, ANDREW FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester LISA HOSSABI SYBRON DENTAL SPECIALTIES DAWN TINDALL COVIDIEN EMILY K STRUNK AKIN GUMP STRAUSS HAUER & FELD, LLP NOVARTIS - AFINITOR NDA 22-334; AMTURNIDE NDA 20045; CATAFLAM NDA 20-142, ETC RECS ASCENT HEALTHCARE SOLUTIONS - REPROCESSED HAND ACTIVATE SEALER/DIVIDER K111600 MIDMARK CORP, VERSAILLES, OH - EIR 8/23/11-9/12/11 Subject METREX RESEARCH LLC - ALLRAP/SLIP-N-GRIP K960352
Page 760 of 1132

Total Records: 12455 Control # 2012-210 2012-211 2012-212 Recd Date / Due Date 01/12/2012 02/10/2012 01/12/2012 02/10/2012 01/12/2012 02/10/2012 2012-213 01/12/2012 02/10/2012 CTP/OD/ CTP/OD/ ORA/ ORA/ ORA/ORM/ ORA/ORM/ 2012-214 01/12/2012 02/10/2012 2012-215 2012-216 2012-217 01/12/2012 02/10/2012 01/12/2012 02/10/2012 01/12/2012 02/10/2012 2012-218 2012-219 2012-220 2012-221 2012-222 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FISHER, CASSANDRA ADRIENNE HAMMOND VUCOMP INC JOAN STITT (UG2CD-16) MERCK & CO., INC. FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS JOAN STITT (UG2CD-16) MERCK & CO., INC. MARILYN WIHTNEY COVINGTON & BURLING LLP COOPER VISION - NAME OF INVESTIGATOR OR PREFORMED AUDIT 10/14-24/11 MATAKINA TECHNOLOGY LTD - VOLPARA IMAGING SOFTWARE K102556 MERCK - JANUVIA (SITAGLIPTIN PHOSPHATE) ISR 7830521-0, 7809243-8, 7812490-2, ETC DKT FDA-2010-P-0491 2011-8901 - REQUEST LTR CLOSED FOI REQUESTS 1/2-6/12 LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 1/2-6/12 CLOSED FOI REQUESTS 1/2-6/12 DAVID WAGERS IDAHO CANDY CO CMPLNT 123913 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CYNTHIA FRANCIS COLDSTAR INTERNATIONAL INC CINDY ZWART SYNTHES SPINE RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP TOBACCO MFRS INSPS - RECS CMPLNT CPT1100211 - CORR, RECS 12/14/11 TO PRESENT Subject COLDSTAR INTERNATIONAL INC - REGISTRATION & LISTING RECS SOTEIRA INC - SHIELD KYPHOPLASTY SYS K093477
Page 761 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-223 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-224 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-225 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-226 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-227 2012-228 2012-229 2012-230 2012-231 2012-232 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-233 01/13/2012 02/13/2012 FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL CONRAD LUCERO MEDICAL LLC ENDURAMESH K093207 BENTLE, JANE OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ ELAINE S WALLER SEATTLE GENETICS INC JOHN WALSH JAMES ALEXANDER CORP ADRIENNE L BUCKMAN SMITH BAKKE ATTY ELIOT HARRISON LEWIS & HARRISON BRENDA M. GATRZ ELI LILLY & CO BONIVA - AERS FXM RESEARCH CORP, MIAMI, FL - 483 5/13/09, 2/7/05 ADCETRIS (BTRENTUXIMAB VEDOTIN) - IRS 7728607-4, 7819592-5, 7906053-8, ETC SHELL CHEMCIAL LP, HOUSTON, TX - EIRS, 483S, RECALL 1/09 TO PRESENT CENTRAL FARMERS COOPERATIVE, MARION, SD - FEED SPL 6/09, 7/09 FCN 643 - TOXICOLOGY RVW, CHEMISTRY RVW RANDALL L TACKETT RANDALL L LTACKETT PHD DKT 2005--0072/CPI - IBUPROFEN RVWS, POSTMARKETING AERS JOHN M ENGEL ENGEL & NOVITT, LLP LEVETIRACETAM TABS - ANDAS 76-919, 76-920, 77-319, ETC APRVL PKG MARK BRUNSWICK PROTOX THEAPEUTICS CIALIS (TADALAFIL) NDA 21-368/S020 - STATISTICAL & MEDICAL RVWS 10/6/11 MICHAEL R COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 12/1/11 TO 1/1/12 Signature/ Requester Subject
Page 762 of 1132

Total Records: 12455 Control # 2012-234 2012-235 Recd Date / Due Date 01/13/2012 02/13/2012 01/13/2012 02/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-236 2012-237 2012-238 2012-239 2012-240 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/13/2012 02/13/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-241 01/17/2012 02/14/2012 ORA/P-FO/LOS-DO/LACB/ WELCH, JOSEPH EVOFEM INC - SOFTCUP CLASS 11 DVC; AMPHORA CONDOM CLASS 11 DVC; AMPHORA - LUBRICANT CLASS 1 DVC, ETC - RECALLS, POST-MARKET SRVEILLLANCE, CORR, ETC SPECTRASCIENCE INC, DIEGO, CA - SBIOPSY FORCEPTS CLASS 1 DVC; REUSABLE FORCEPTS CLASS 1 DVC;WAVSTAT OPTICAL BIOPSYS SYS CLASS III DVC, ETC CYTORI THERAPEUTICS INC, SAN DIEGO, CA - CELUTION CONCENTRATION DVC CLASS II DVC; STEMSOURCE REAGENT A & B CLASS I DVC; CELBRUSH - IRRIGATION NON DENTAL SYRINGE CLASS I DVC, ETC ACCLARENT INC - RELIEVA SPIN SINUS DILATION SYS K111875 CORR, MINS SANOFI-SYNTHELABO INC - AMBIEN NDA 19-908 PI, MEDICATION GUIDES (CERTIFIED) WELCH, JOSEPH ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ADRIENNE HAMMOND VUCOMP INC ELIZABETH DUDLEY, Esq. DUDLEY FIRM LLC PAMELA HOPKINS MEDTRONIC SOFAMOR DANEK BRIAN SMITH LEXIS NEXIS COURTLINK INC BODY COMPOSITION ANALYZER CLASS II DVC - RECALLS, POST-MARKETING SERVEILLANCE, CORR, ETC MEDRAD INC - AVANTA FLUID MANAGEMENT INJECTION SYS K050456 DOCTORS RESEARCH GROUP INC - KRYPTONITE BONE CEMENT K091382 2011-9228 HOLOGIC INC - QUANTRA K082483 Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester BOBBY SCHOCHET OFW LAW JOHN M. ENGEL ENGEL & NOVITT, LLP LEVETIRACETAM SOLUTION - ETC, APRVL RECS Subject INFANT FORMULA NOTIFICATIONS (IFN) 7/11 to 12/11
2012-242
01/17/2012 02/14/2012
FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ WELCH, JOSEPH WELCH, JOSEPH
2012-243
01/17/2012 02/14/2012
2012-244 2012-245
01/17/2012 02/14/2012 01/17/2012 02/14/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
CHRISTOSPHER M SLOAN QUINTILES CONSULTING ANNE E HANOCK MCINTOSH LAW FIRM PC
Page 763 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-246 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-247 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-248 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-249 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-250 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-251 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-252 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-253 2012-254 01/17/2012 02/14/2012 01/17/2012 02/14/2012 FDA/OF/CFSAN/OCD/EOS/ CS WATERS FDA/OF/CFSAN/OCD/EOS/ SZABO, DAVID BROMINATED VEGETABLE OIL - SAFETY ASSESSMENT LATE 1970S, EARLY 1980S FOOD ADDITIVES THAT ARE SAFE - GRAS LIST 1958 TO PRESENT JOANN DAWSON ELI LILLY & CO NPIATE (ROMIPLOSTIM; BLA 125268/S077 - REMS MODIFCATION LTR 11/30/10 HALL #332268, TARRENCE SYNTHETIC CANNABANOIDS MARIJUANA, FAKE MARIJUANA;SPICE K2, HERBAL INCENSE, POTPORRI RECS ZWIRN, MARY LIPITOR, CRESTOR - AERS NANCY YUEN GlaxoSmithKline METHADONE - ISRS 3847412-2, 5006449-0, 5090927-2, ETC ANNA NORTH GAWKER MEDIA QNEXA - RVWS ANNA NORTH GAWKER MEDIA LORCASERIN - RVWS ANE E HANCOCK MCINTOSH LAW FIRM PC ZOLPIDEM- PI, MEDICATION GUIDES 2007, 2008 (CERTIFIED) Signature/ Requester Subject
Page 764 of 1132

Total Records: 12455 Control # 2012-255 Recd Date / Due Date 01/17/2012 02/14/2012 Action Office OC/OM/OSS/OEEODM/ OM/OMP/DODM/ Signature/ Requester SUSAN L MOFFITT BROWN UNIV - DEPT OF POLITICAL SCIENCE JOANN DAWSON ELI LILLY & CO Subject CARDIO-RENAL DRUGS A/C - PEPCID NDA 19-462 1/16/86; ENDOCRINOLOGIC & MEDTOBOLIC DRUGS A/C - UCEPHAN NDA 19-530 912/86; CARDIO-RENAL DRUGS A/C SBREVIBLOC NDA 19-386 9/30/86, ETC GLAXOSMITHKLINE, DIVISION OF HEMATOLOGY PRODS TELECONFERENCE 2/11/11, PROMACTA (ELTROMBOPAG) NDA 22-291/S006 REMS MODIFICATION LTR 11/12/10
2012-256
01/17/2012 02/14/2012
2012-257 2012-258 2012-259
01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/27/2012
FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/
CHRISTOPHER SLOAN QUINTILES CONSULTING HERRERA, MICHELLE BERNARDI, GENE C
ACCLARENT INC - CYCLOPS MULTI-ANGLE ENDOSCOPE K100577 ROBERT GERTIE B & B PHARMACEUTICALS - MEMOS OF INTERVIEW KNEE IMPLANT - RECALL 1/08 TO PRESENT
2012-260
01/17/2012 02/14/2012
ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/ATL-DO/ACB/ Doe J SANDRA F SELVAGGI ABBOTT MEDICAL OPTICS INC
CMPLNT 123465
2012-261
01/17/2012 02/14/2012
ABBOTT MEDICAL OPTICS INC - EASY RUB MULTIPURPOSE CONTACT LENS SOL SPL 629813 ANALYTICAL RESULTS
2012-262
01/17/2012 02/14/2012
CAHNDRA RAMCHARAN FUJI MEDICAL SYSTEMS USA INC
LIST OF CERTIFIED MAMMOGRAPHY SITES 12/31/11
2012-263
01/17/2012 02/14/2012
ANNE E HANCOCK MCINTOSH LAW FIRM PC
FOREST LABS - CELEXA NDA 02-0822 PI, MEDICATION GUIDELINES
2012-264
01/17/2012
ANNA NORTH
NUVARING - RVW PROCESS
Page 765 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/14/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-265 01/17/2012 02/14/2012 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-266 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-267 01/17/2012 02/14/2012 2012-268 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-269 01/17/2012 02/14/2012 2012-270 01/17/2012 02/14/2012 2012-271 01/17/2012 02/14/2012 2012-272 01/17/2012 02/14/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ WELCH, JOSEPH WELCH, JOSEPH FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ WELCH, JOSEPH WELCH, JOSEPH MEDCO HEALTH SOLUTIONS, FRANKLIN LAKES, NJ MEDCO PHARMACY MOBILE APP RECALL RECS, POSTMARKETING SURVEILLANCE, CORR, ETC PICIS INC (OPTIMUMINSIGHT), WAKEFIELD, MA CARESUITE RECALL RECS, POST-MARKETING SURVEILLANCE, CORR, ETC CLEVELAND HEARTLAB LLC, CLEVELAND, OH CARDIOMPO RECALL RECS, POST-MARKETING SURVEILLANCE, CORR, ETC AGA MEDICAL CORP, MINNEAPOLIS, MN - AMPLATZER TORQVUE DX CATHETER, GUIDEWIRES, NOODLEWIRE, ETC RECALL RECS, POST-MARKETING SURVEILLANCE, CORR, ETC EASOTIC (HYDROCORTISONE ACEPONATE, MICONAZOLE NITRATE, GENTAMICIN SULFATE) OTIC SUSPENSION NADA 141-330 RECS VYVANSE (LISDEXAMFETAMINE) - SCHEDULE II CORR FDA/OMPT/CDRH/OCER/DFOI/ RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC DAVID ARMSTRONG BLOOMBERG NEWS BRISTOL-MYERS SQUIBB - KENALOG LBLG CHANGE RECS ACORN STAIRLIFTS - CMPLNT, CORR GULLAH, CHASE COCAINE, LSD, HEROIN, ETC - CHEMICAL MAKEUP, AERS Doe J INDIVIDUAL RECS Signature/ Requester GAWKER MEDIA Subject
2012-273
01/17/2012 02/14/2012
CVM/OCD/
LAURIE PHARIS NOVARTIS ANIMAL HEALTH
2012-274
01/17/2012 02/14/2012
CLOREY TOOMBS RECKITT & COLMAN PHARMACEUTICALS
Page 766 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-275 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-276 2012-277 2012-278 2012-279 2012-280 2012-281 2012-282 01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-283 01/17/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-284 2012-285 2012-286 2012-287 01/17/2012 02/14/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MIKE DRUCKMAN HOGAN LOVELLS LLP RAYMOND LEE TRIA BEAUTY INC RAYMOND LEE TRIA BEAUTY INC THOMAS J QUINN Medical Resources Alliance XORAN - MINICAB CT SCANNER K032243 PHOTO THERAPEUTICS INC - OMNILUX CLEAR-U K081307 PHAROS LIFE CORP - TANDA SKINCARE SYS K080591 ODAC MTG - MINS 7/1/91 ANNA NORTH GAWKER MEDIA ALLI (OLRISTAT) - NDA FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SHOSHANA FRIEDMAN PUSH-MED LTD CHRISTINE L MACAULEY KIMBERLY-CLARK CORP RAFE LEWIS NORTH RUN CAPITAL LP GREGORY HERTZ CITIGROUP WILLIAM A OLSON PHD Center for Regulatory Services, Inc. IN SAM SONG INFOPIA CO LTD ANNA NORTH GAWKER MEDIA BIOSITE INC - INRATIO, INRATIO2 TEST STRIPS K092987; ROCHE DIAGNOSTICS - COAGUCHEK XS SYS K060978 CONTRAVE (BUPROPRION,NALTREXONE) - RVW PROCESS CIBA SPECIALTY CHEMICALS CORP - FCN 554 INVACARE CORP, ELYRIA, OH - 483S 12/19/08, 12/17/10, 8/8/11, ETC HOSPIRA, MCPHERSON, KS - 483 1/12 BRAHMS PCT SENSITIVE KRYPTOR TEST SYS K070310 EASYGLIDE LTD - CLEARPATH DVC K091305 DANIELLE SPICER AMWAY CORP MERCK KGAA, DARMSTADT, GERMANY - EIR, 483 Signature/ Requester Subject
Page 767 of 1132

Total Records: 12455 Control # 2012-288 2012-289 Recd Date / Due Date 01/18/2012 02/15/2012 01/18/2012 02/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ GORLACH, IGOR Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester TANIA LUPU CASE MEDICAL INC Subject AESCULAP INC - STERILCONTAINER WITH PRIMELINE LIDS K073168 ANESTESIOLOGY & RESPIRATORY THERAPE DVC PANEL; CLINICAL CHEMISTRY &CLINCICAL TOXICOLOGY DVC PANEL; CIRCLATORY SYS DVS PANEL - 12/18/98, 7/16/01, 5/13/05; 3/20/97, 3/21/97, 9/25/197, ETC; 12/4/97, ETC 1/1/97 TO 12/31/05 HOUVA 3 PHOTOTHERAPY SYS - K041212; PANOSOL II TRU-BLU MODEL UBL-417 - K070934; PHOTOTHERAPY TIMER - K924969, ETC MILLIPORE, MOLSHEIM, FRANCE - EIR 11/89
2012-290
01/18/2012 02/15/2012
FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/
RONALD L BATE NATIONAL BIOLOGICAL CORP ELIZABETWH DOWNEY JOHNSON & JOHNSON VISION CARE INC
2012-291
01/18/2012 02/15/2012
2012-292 2012-293
01/18/2012 02/15/2012 01/18/2012 02/15/2012
MELISSA R GAYNOR CHEMENCE MEDICAL INC W PATRICK NOONAN W PATRICK NOONAN
SURGISEAL TOPICAL SKIN ADHESIVE - K082993; LIQUIDBAND FLOW CONTROL - K110184 UNITED CONSORTIUM INC, BEVERLY HILLS, CA - SYSTEM JO PERSONAL LUBRICANT CLITORAL STIMULATION GELS 510K BSL BIOSERVICE SCIENTIFIC LABORATORIES GMBH, GERMANY - QUALITY ASURANCE PROFILE (QAPS) 7/06, 7/11, 8/11
2012-294
01/18/2012 02/15/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
PAM LARSON MEDIGENE, INC
2012-295
01/18/2012 02/15/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LECHER, SHIRLEY
MEFLOQUINE - AERS
2012-296
01/18/2012 02/15/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ GORLACH, IGOR
ANTI INFECTIVE DRUGS A/C; ANETHETIC & ANALGESIC DRUG PRODS A/C- 11/19-20/97, 2/19-98, 7/29/98, ETC 1/30/02; ALSDAC 1/31/02, 5/16/02, 9/9/03, ETC CONFLICT OF INTEREST WAIVERS 1/1/97 TO 12/31/05 NEXIUM - AERS
2012-297
01/18/2012 02/15/2012
JOHN J MASTRANTONIO AARONSON RAPPAPORT ET AL
Page 768 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-298 2012-299 2012-300 2012-301 2012-302 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-303 01/18/2012 02/15/2012 2012-304 2012-305 01/18/2012 02/15/2012 01/18/2012 02/15/2012 2012-306 2012-307 01/18/2012 02/15/2012 01/18/2012 02/15/2012 2012-308 01/18/2012 02/15/2012 CBER/OCTMA/DDOM/ALFB/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2012-309 01/18/2012 02/15/2012 ORA/ ORA/ Abell, Joseph W OXYGEN TANK SUPPLIER, TESTING LAB, VALVE ASSEMBLY, ETC - FACTS #460653 ATWOOD, KIMBALL C CVM/OCD/ ORA/CE-FO/CHI-DO/CCB/ ORA/P-FO/SEA-DO/SCB/ CBER/OCTMA/DDOM/ALFB/ SCHARBERG, DAVID L KIMBERLY A GRABBE MAGLIO CHRISTOPHER & TOALE LAW FIRM KELLY A MAGURANY NALCO CHEMICAL CO THOMAS MAIER NEWSDAY MEDIA GROUP POLYSORBATE 80, ETHOXYLATED SORBITAN MONOOLEATE - ENFORCEMENT DISCRETION LTR 5/21/08 SUNRISE MEDICAL LABORATORIES INC, HICKSVILLE, NY ORDER TO CEASE MANUFACTURING OF HCT/P, RVWS, CORR, ETC DESIGN OF THE TRIAL TO ASSESS CHELATION THERAPY MINS, CORR, RVWS,, ETC FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC FACILITY PERFORMING GLP NON-CLNCL OR BIOANALYTICAL TESTING - USA 7/11, 10/1/11-12/31/11 VAERS RPTS - INDIVIDUAL RECS CAERS 146840 ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ TIFFANY JENKINS ACUMED LAUREN CUTLER GILEAD SCIENCES INC KEVIN HORKY IPAX INC JEFF JORGENSON SMITH BAKKE ATTY ANGELIA D SLAYTON KENDLE INTERNATIONAL INC CPPI CV - SUTENT NDA 21-938/S013 APRVL LTR, LBLG, RVWS, ETC CENTRAL FARMERS COOPERATIVE - FEED SPLS 6/09, 7/09 MARQUEZ FARID, PALM SPRINGS RESEARCH INSTITUTE, HIALEAH, FL - EIR, 483 6/6/11 IPAX INC, ENGLEWOOD, CO - EIR 8/2/07 ACUMED - DRILL BIT MDR Signature/ Requester Subject
Page 769 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/BLT-DO/CB/ 2012-310 2012-311 01/18/2012 02/15/2012 01/18/2012 03/20/2012 2012-312 2012-313 01/18/2012 02/15/2012 01/18/2012 02/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OSHC/OPD/ 2012-314 01/18/2012 02/15/2012 2012-315 2012-316 01/18/2012 02/15/2012 01/18/2012 02/15/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ OC/COS/OL/ OC/OCC/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ 2012-317 2012-318 01/18/2012 03/16/2012 01/18/2012 02/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ RONALD L BATE NATIONAL BIOLOGICAL CORP RONALD L BATE NATIONAL BIOLOGICAL CORP DAAVLIN DISTRIBUTING CO, BRYAN, OH - K110912, K111172, K103708 DAAVLIN DISTRIBUTING CO, BRYAN, OH - ML24000 UVA-1 PHOTOTHERAPY CABINET K082731, DERMAPAL WITH DIGITAL TIMER K073587, 2 SERIES PHOTOTHERAPY CABINET K063621, ETC DAAVLIN DISTRIBUTING CO, BRYAN, OH - 1 SERIES T2, SERIES, X2, 1 SERIES, T4, ETC ANNUAL & SUPPLEMENTAL RPTS ENTRY #ED5-0045410-0 - ANALYTICAL W/S ENTRY #ED5-0045411-8 - ANALYTICAL W/S CBER/OCTMA/DDOM/ALFB/ ALEXANDER D DEBLIECK CONWAY HOMER & CHINCAPLAN PC JAMES B RATON MICHAEL BEST & FREIDRICH MITCHELL S FUERST FUERST ITTLEMAN PL ALEXIA FOODS - USE OF THE TERM NATURAL OR ALL NATURAL WARNING LTRS, CORR, RESP, ETC SUPREME MANUFACTURING COMPANY INC CONGRESSIONAL CORR, REGULATORY ACTIONS, TESTING, ETC INDIVIDUAL RECS CBER/OCTMA/DDOM/ALFB/ GORLACH, IGOR DIANNE L CHAMBERS HOGAN LOVELLS US LLP MARY MORAN POLICY CURES FDA/OF/CFSAN/OCD/EOS/ ELIOT HARRISON LEWIS & HARRISON ALLERGENIC PRODS A/C; BIOLOGICAL RESP MODIFIERS A/C; BLOOD PRODS A/C 4/7/05, 9/17/97, 10/17/97 7/24/ 3/13/97, ETC CONFLICT OF INTEREZT WAIVERS 1/1/97 TO 12/31/05 SECTION 912 OF THE FDA AMENDMENTS ACT 2007 CORR, MEMOS, NOTES OF MEETINGS 2/18/10 TO PRESENT LIST OF GRANTS OR PROJECTS FUNDED BY CBER INTRAMURAL & EXTERAMURAL 2000, 2004, 2007, 2008, ETC SILOXANES & SILICONES DIMETHYI - FCN 643 Signature/ Requester Subject
2012-319
01/18/2012 02/15/2012
RONALD L BATE NATIONAL BIOLOGICAL CORP
2012-320 2012-321
01/18/2012 02/15/2012 01/18/2012
ORA/ ORA/ ORA/
CAMIE COX TOWN DOCK INC CAMIE COX
Page 770 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/15/2012 2012-322 2012-323 2012-324 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 2012-325 01/18/2012 02/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-326 01/18/2012 02/15/2012 2012-327 01/18/2012 02/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-328 01/18/2012 02/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-329 2012-330 2012-331 2012-332 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/18/2012 02/15/2012 01/19/2012 02/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ MINA KIMES FORTUNE MAGAZINE MINA KIMES FORTUNE MAGAZINE CHRIS CELESTE EAS Consulting Group, LLC ETAN YESHUA ENVIRONMENTAL WORKING GROUP DKT 1977P-0315 EMC 140, DKT 7610-052N SYNTHES, WEST CHESTER, PA - 483 2002 SYNTHES - JOHN J WALSH LTR 7/2/04 REEVES, MICHAEL DOCTOR'S HOSPTIAL, DALLAS, TX - AED DEIFBRILLATOR DVCS RECALLS 2002-2003; SEROQUEL, RESPERDAL AERS, RECALLS, ETC ERIC KEISMAN JR CAPITAL GROUP COMPANIES INC FRANK FAUNCE ABBOTT LABORATORIES, INC. IND 010835 - RECS NOVARTIS AG - FOI REQUESTS FOR 483S 9/1/11 TO 1/13/12 FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester TOWN DOCK INC CAMIE COX TOWN DOCK INC DONNA LUNAK ST JUDE MEDICAL ROY HARMAN RIGHT TIME BUSINESS JOSEPH REISMAN PHD ESQ KNOBBE MARTENS OLSON & BEAR WHIP MIX CORP - CHANGE FROM REGISTERED MEDICAL DVC MFR OF DENTAL ABUTMENT TO REPACKAGER/RELABELER RANBAXY - ORTHO TRICYCLEN LO NDA 21-241, SEASONALE NDA 21-544, SEASONIQUE NDA 21-840 NAME,ADDRESS OF APPL HOLDERS K102588 ENTRY #ED5-0045412-6 - ANALYTICAL W/S Subject
Page 771 of 1132

Total Records: 12455 Control # 2012-333 Recd Date / Due Date 01/19/2012 02/16/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-334 2012-335 01/19/2012 02/16/2012 01/19/2012 02/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-336 2012-337 01/19/2012 02/16/2012 01/19/2012 02/16/2012 2012-338 2012-339 2012-340 2012-341 2012-342 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ 2012-343 2012-344 01/19/2012 05/08/2012 01/19/2012 02/16/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ CBER/OCTMA/DDOM/ALFB/ PHILIP COELHO SYNGEN INC MELISSA ALLISON SEATTLE TIMES IMPORT REFUSAL RPT 10/01 TO PRESENT BIOSAFE SEPAX - CELL SEPARATION SYS BK060036 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ CRAIG DAVIS NEOGENIX LLC MICHAEL THOMPSON AMNISURE INTERNATIONAL LLC RAYMOND LEE TRIABEAUTY PHILIP COELHO SYNGEN INC AARON D LINDSTROM WARNER NORCROSS & JUDD LLP THERMOGENESIS - AXP AUTO EXPRESS PLATFORM BK070006 SANCON COSTA LIGURE SNC, BRUNO SCHEIDT - OLIVES, OLIVE OIL, OLIVE PASTE SHIPMENT INVESTIGATION 2010 PHOTO THERAPEUTICS INC - OMNILUX CLEAR U K081307 ROM PLUS FETAL MEMBRANES RUPTURE TEST K110605 TRANSCU 02 K090681 FDA/OMPT/CDRH/OCER/DFOI/ VESA VUORINEN FINNMEDI OY RYAN BULLIS BERKLEY NORTH PACIFIC ORTHOFIX INC - ISKD (intramedullary skeletal kinetic distractor)K010322 INDIVIDUAL RECS KOLOWSKI, LEONARD JOE NEEL NPR TYLOX - AERS FOI REQUESTS 2011 TO PRESENT TEDESCHI, BARBARA Signature/ Requester Subject NOVARTIS - EXCEDRIN RECALL
Page 772 of 1132

Total Records: 12455 Control # 2012-345 Recd Date / Due Date 01/19/2012 02/16/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-346 01/19/2012 02/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-347 2012-348 2012-349 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-350 01/19/2012 02/16/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ 2012-351 2012-352 01/19/2012 02/16/2012 01/19/2012 02/16/2012 2012-353 01/19/2012 02/16/2012 2012-354 2012-355 2012-356 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ RAYMOND LEE TRIABEAUTY PAUL W TRIPP LINCARE INC ALLSTAR OXYGEN SERVICES INC, CA - EIRS, 483S, WARNING LTRS ETC 1/1/04 TO PRESENT ALISO VIEJO, CA - MEDICAL DEVICE DATA SYS RECALL, K080591 WELCH, JOSEPH NOVARTIS, SAN CARLOS, CA - PDDS CLNCL LPT 100 NEBULIZER; T326 DRY POWDER INHALER RECALLS, CLNCL TRIALS, CORR FDA/OMPT/CDRH/OCER/DFOI/ HARRIS, HELEN CLAUDIA HORNBACK ABOUBACAR DIALLO - ENTRY #DL8000429144, FDA ROANOKE TRADE SERVICES INC REFUSAL & REDELIVERY NOTICES, CF28 &29 REFERENCE CLAIMS MONARCH VAGINAL BLADDER MESH - MDRS BECKY COOSEMAN BROWN & CROUPPEN PC INDIVIDUAL RECS Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ PETER B. NESBITT QUASAR BIO TECH RONALD L BATE NATIONAL BIOLOGICAL CORP GILENYA (FINGOLIMOD) - SAFETY RVW LED INTELLECTUAL PROPERTIES - LIGHSTIM ANTI WRINKLE OTC MODEL AAL OTC K101190 K051330 SHAUNAK DEEPAK JEFFERIES & CO ADCETRIS - ISR #7808761-6. 7919663-9, 7954114-X Signature/ Requester SHAUNAK DEEPAK JEFFERIES & CO Subject ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS
Page 773 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/16/2012 2012-357 01/19/2012 02/16/2012 2012-358 2012-359 01/19/2012 02/16/2012 01/19/2012 02/16/2012 Action Office ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-360 01/19/2012 02/16/2012 2012-361 2012-362 2012-363 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 2012-364 01/19/2012 02/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ 2012-365 01/19/2012 02/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-366 2012-367 2012-368 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ ORA/P-FO/SAN-DO/SFCB/ JULIA A. MOUSER CANNON & NELMS CHRIS CELESTE EAS Consulting Group, LLC AINAT MARGALIT DKT FDA-2006-D-0298 FDA-1995-S-0039 DKT LOG SAMPLE 290134, 290135, 290136 Doe J WELLBUTRIN (BUPROPIOM) - AERS ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/OM/OMP/DDM/ JOURNAL OF CLINICAL RESEARCH BEST PRACTICES DAVID MCEACHERN RALLY LABS JOE KLESNEY Oracle Corporation JERILYN J SPENCER HORIZON PHARMACEUTICALS INC ERIC KEISMAN JR CAPITAL GROUP COMPANIES INC ELECTRONIC MDR SUBMISSION STATISTICS 2006 TO PRESENT HORIZON PHARMACEUTICALS INC, RIVIERA BEACH, FL EIR, 9/19-26/11 NOVARTIS AG - 483 2009 TO PRESENT ANSWERS TO QUESTIONS FROM GCPQUESTIONS@OC.FDA.GOV DKT 1982N-0166, 1993N-0164 WELCH, JOSEPH G MICHAEL WALL O-RAY PHARMA INC OPTIMUM INSIGHT, ROSEMONT, IL - CARE SUITE RECALL, CORR, CLNCL TRIAL ESTRING NDA 20-472 - RVWS, RISK ASSESSMENT RISK MITIGATION Signature/ Requester WELCH, JOSEPH DENISE SMITH Morton Salt Subject CORR, CLNCL TRIALS MORTON SALT INC, RITTMAN, OH - EIR, 483 MOST RECTNT
Page 774 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/16/2012 2012-369 2012-370 2012-371 2012-372 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 01/19/2012 02/16/2012 2012-373 2012-374 01/19/2012 02/16/2012 01/19/2012 02/16/2012 2012-375 01/19/2012 02/16/2012 2012-376 01/19/2012 02/16/2012 2012-377 01/20/2012 02/17/2012 2012-378 01/20/2012 02/17/2012 2012-379 01/20/2012 02/17/2012 ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-380 2012-381 01/20/2012 02/17/2012 01/20/2012 OM/OMP/DODM/ ORA/CE-FO/CIN-DO/CCB/ MATTHEW MONTGOMERY SCOTT & SCOTT LLP ORTHOPEDIC AND REHABILITATION DVCS FDA ADVISORY INVACARE CORP, ELYRIA, OH - 483S 2010-2011 JONES, TRACI MARGARET R GROEL LACHMAN CONSULTANT SERVICES INC FOREIGN & DOMESTIC DRUG COMPANIES, MEDICAL DVC MFRS, BIORESEARCH MONITORING (BIMO), ETC - INSPS 11/1-30/11 RISPERDAL CONSTA - AERS OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ MITCHELL A. CHEESEMAN STEPTOE & JOHNSON VESA VUORINEN AALTO UNIVERSITY SCHOOL OF TECHNOLOGY BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC SANDRA F SELVAGGI ABBOTT MEDICAL OPTICS INC AMO - COMPLETE EASY RUB MULTIPURPOSE CONTACT LENS SOL SPL 629813 RECS DKT 1982N-0293 SANITIZING SOLUTIONS CHEMISTRY GUIDELINES FOR FOOD ADDITIVE PETITION ELLIPSE TECHNOLOGIES INC - INTRAMEDULLARY LIMB LENGTHENING SYS K101997 DKT 1982N-0293 FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ Action Office Signature/ Requester Center for Science in the Public Interest CHRIS CELESTE EAS Consulting Group, LLC KEVIN BOOT Embria Health Sciences LLC DAN DAHLMAN ECOLAB INC LEX J. PEARCE ICU MEDICAL INC EDWARDS LIFESCIENCES LLC, IRVINE, CA - VIGILANCE CCO K040287; VIGILANCE II K043103 FCN 1035 - CORR DKT FDA-1995-S-0039 DKT 1976N-0052N Subject
Page 775 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/17/2012 Action Office Signature/ Requester YAHIRO, MARTIN Subject PANEL MTG - CLASSIFICATION AND RECLASSIFICATION OF PEDICLE SCREW SPINAL SYSTEMS TRANS 8/20/93, 7/22/94 AMT G-J TUBE K110804 PHARMAVITE, OTSUKA - S-EQUOL CORR, NEW DIETARY INGREDIENT (NDI), GRAS NOTIFICATIONS, ETC 1/02 TO PRESENT CANTALOUPE - SPL ANALYSIS RESULTS FY 2007 TO FY 2011 FANTASY COOKIE CO, SYLMAR, CA - EIR 11/8-10/11 ELI LILLY, INDIANAPOLIS, IN; GREENWOOD, SC; SLIGO, IRELAND, ETC - 483S LAST THREE YRS
2012-382 2012-383
01/20/2012 02/17/2012 01/20/2012 02/17/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/
CHRISTINE L MACAULEY KIMBERLY-CLARK CORP CHRIS CELESTE EAS Consulting Group, LLC
2012-384 2012-385 2012-386
01/20/2012 02/17/2012 01/20/2012 02/17/2012 01/20/2012 02/17/2012
ORA/ORM/ ORA/ORM/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ KAMAS, KRISTEN DR WILMA PRETORIUS I & W RESEARCH INC LOREN LARKIN SAC CAPITAL MANAGEMENT LLC
2012-387
01/20/2012 02/17/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/SJN-DO/SJCB/
LOREN LARKIN SAC CAPITAL MANAGEMENT LLC
WARNER CHILCOTT, MANATI, PR; LARNE, NORTHEN IRELAND; ROCKAWAY, NJ, ETC - 483S LAST THREE YRS
2012-388
01/20/2012 02/17/2012
DR BRIGITTE DRENO, NANTES LOIRE ATLANTIQUE, FRANCE - 483 4/2/98
2012-389
01/20/2012 02/17/2012
DR SRIKANTA, JHANA SANJEEVINI MEDICAL CENTER, BANAGLORE, INDIA - PROTOCOL BI1218.46 483 8/26-30/11
2012-390
01/20/2012
OM/OSS/OPILS/DFI/
2011-8914
Page 776 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/17/2012 2012-391 2012-392 2012-393 2012-394 01/20/2012 02/17/2012 01/20/2012 02/17/2012 01/20/2012 02/17/2012 01/20/2012 02/17/2012 2012-395 2012-396 01/20/2012 02/17/2012 01/23/2012 02/21/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-397 01/23/2012 02/21/2012 2012-398 2012-399 01/23/2012 02/21/2012 01/23/2012 02/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ AMANDA ORLANDA AVALON RISK MANAGEMENT INC ELENA HOWELL HOGAN LOVELLS US LLP LATESHA R BAKER HINSHAW & CULBERTSON LLP FOI SERVICES INC BARBARA A BINZAK BUCHANAN INGERSOLL & ROONEY PC DR REDDY'S LABS LTD - LANSOPRAZOLE DELAYED RELEASE CAPS ANDA 91-269; MATRIX LABS LTD LANSOPRAZOLE DELAYED RELEASE CAPS AND 90-763; SANDOZ - LANSPRAZOLE DELAYED RELEASE CAPS ANDA 90-331, ETC SBA ENTRY #FN501191491 - ENTRY SUMMARY, INVOICE & PACKING LIST, ETC WENDY WEIHE STORLIE INC, SPRING PARK, MN - EIR, 483, CORR 2/23/11, 3/11/11 AVASTIN - STREPTOCOCCAL ENDOPHTHALMITIS OUTBREAK RECS FOI DAILY LOG 12/19-23/11 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC WRIGHT MEDICAL TECHNOLOGY - PRO-DENSE BONE VOID FILLER K070437 TARGET THERAPEUTICS - TRACKER-25 INFUSION CATHETER K874751 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ENDOCHOICE - BONASTENT BILIARY K093003 Signature/ Requester FOI SERVICES INC TAEWOONG MEDICAL - NITI-S BILIARY STENT K073667 Subject
Page 777 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2012-400 2012-401 01/23/2012 02/21/2012 01/23/2012 02/21/2012 2012-402 2012-403 2012-404 2012-405 2012-406 2012-407 2012-408 01/23/2012 02/21/2012 01/23/2012 02/21/2012 01/23/2012 02/21/2012 01/23/2012 02/21/2012 01/23/2012 02/21/2012 01/23/2012 02/21/2012 01/23/2012 02/21/2012 CTP/OD/ CTP/OD/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-409 01/23/2012 02/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-410 01/23/2012 02/21/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-411 01/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ MINA KIMES SYNTHES - NORIAN XR 510K LEON B KAPLAN PHD PRINCETON RESEARCH & CONSULTING CENTER INC MERCK & CO INC -REBETOL (RIBAVIRIN) HEPATITIS C VACCINE RISK EVALUATION & MITIGATION STRATEGY (REMS) ASSESSMENT MEDICATION GUIDE COMPREHENSION RPT DANIELLE SPICER AMWAY CORP SUNLIT FLUO CHEMICAL, TAOYUAN COUNTY, TAIWAN EIR, 483 MOST RECENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ RAYMOND K KELLY IV ATRIUM MEDICAL CORP RAYMOND J KELLY IV ATRIUM MEDICAL CORP RAYMOND J KELLY IV ATRIUM MEDICAL CORP RAYMOND J KELLY IV ATRIUM MEDICAL CORP RAYMOND J KELLY IV ATRIUM MEDICAL CORP RAYMOND J KELLY IV ATRIUM MEDICAL CORP SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP STAR SCIENTIFIC - ARIVA-BDL, STONEWALL-BDL MODIFIED RISJ TOBACCO PRODS APPL; DISSOLVABLE TOBACCO QUALIFIES AS SMOKELESS TOBACCO RECS, ETC ATRIUIM - ULTRAMAX GRAFTS K991813 ATRIUM - IVENA PATCH K060396 ATRIUM - CLEARWAY RX K061680 ATRIUM - FLIXENE GRAFTS K051332, K060124, K071923, ETC ATRIUM - ADVANTA GRAFTS K992441, K992443, K992958, ETC ATRIUM - CLEARWAY OTW K093431 Doe J BARTHOLOMEW, DEBBIE GREAT PLAINS EYE BACK, LIFE GIDT, COVENANT MEDICAL CENTER - EIRS, MEMOS, INVESTIGATION, ETC INDIVIDUAL RECS Signature/ Requester Subject
Page 778 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/21/2012 2012-412 2012-413 01/23/2012 02/21/2012 01/23/2012 02/21/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/SJN-DO/SJCB/ 2012-414 01/23/2012 02/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/SJN-DO/SJCB/ 2012-415 01/24/2012 02/22/2012 2012-416 01/24/2012 02/22/2012 ORA/ORM/ ORA/ORM/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ 2012-417 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-418 01/24/2012 02/22/2012 2012-419 01/24/2012 02/22/2012 ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ JOHN J HAY SALANS ATTY JONATHAN RICKMAN FDANEWS FOREIGN AND US MFG FACILITIES OF US-BASED AND NON-US BASED PHARMACEUTICAL COMPANIES - INSPS 9/1/08 TO 7/1/11 PHARMACEUTICAL, BIOLOGIVS, MEDICAL DVC MFG, CLNCL TRIAL FACILITIES IN AND OUTSIDE THEUS - 483S 12/1ALEXANDER MIRONOV TIGRIS PHARMACEUTICALS INC JANSSEN PHARMS - ELMIRON (PENTOSAN POLYSULFATE SODIUM) NDA 20-193/S002 SBA JONATHAN RICKMAN FDANEWS TERESA MARSHALL PEOPLE FOR THE ETHICAL TREATMENT OF ANIMALS PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFRS, CLNCL TRIAL FACILITIES IN & OUTSIDE THE US - 483S 11/1-30/11 GW EXOTICS - KMR FORMULA CMPLNTS, CORR, LAB TESTS, ETC LOREN LARKIN SAC CAPITAL MANAGEMENT LLC AMGEN, THOUSAND OAKS, CA; FREMONT,CA, BOULDER, CO, ETC - 483S LAST THREE YRS MINA KIMES FORTUNE MAGAZINE LOREN LARKIN SAC CAPITAL MANAGEMENT LLC BRISTOL-MYERS SQUIBB, LATINA, ITALY; MANATI,PR; DEVENS, MA, ETC 483S LAST THREE YRS SYNTHES - CONFERENCE CALL MINS 5/8/02 Signature/ Requester FORTUNE MAGAZINE Subject
Page 779 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject 31/11 2012-420 2012-421 01/24/2012 02/22/2012 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-422 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-423 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-424 2012-425 01/24/2012 02/28/2012 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-426 01/24/2012 02/22/2012 2012-427 2012-428 01/24/2012 02/22/2012 01/24/2012 02/22/2012 2012-429 01/24/2012 02/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DEN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ TREVI PIES NUTRITIONAL LABORATORIES INTL ANN M OXFORD ALBEMARLE CORP LEX PEARCE ICU MEDICAL INC JAMES FARES NURO PHARMA LLC HAIN NORTH AMERICA, BOULDER, CO 3/31/10-4/14/10; SOMA LABS, MIDDLESEX, NJ 6/28/10-7/8/10 - EIRS FCN 880 - CHEMISTRY, TOXICOLOGY AND ENVIRONMENTAL ASSESSMENT RVWS, ETC EDWARDS LIFESCIENCES LLC - VIGILANCE CCO/SVO2/CEDV MONITOR K040287; VIGILANCE II CCO/SVO2/CEDV MONITOR K043103 NURO PHARMA LLC - MYSOLINE (PRIMIDONE) ORAL SUSPENSION NDA 10-401 FORMULATION, DRUG PROD TEST METHODS, CONTAINER CLOSURE SYS, ETC PHINNY, C WENDY CBER/OCTMA/DDOM/ALFB/ RIVA, CATHERINE GARDASIL - EFFICACY STUDIES STATISTICAL DATA ANALYSIS PLAN SUCAMPO PHARMACEUTICALS INC - AMITZA (LUBIPROSTONE); R-TECH UENO LTD, CIBA VISION RESCULA (UNOPROSTONE ISOPROPYL) STAFF GUIDANCE, CORR, ATTACHMENTS, ETC MICHAEL P MANAPOL BRIAN D WITZER INC MEDICIS PHARMACEUTICAL CORP - SOLODYN ER TABS 50-808 LBLG CHANGE 3/18/11 MICHAEL P MANAPOL BRIAN D WITZER INC MEDICIS PHARMACEUTICAL CORP - SOLODYN ER TABS NDA 50-808 APRVL RECS FDA/OF/CFSAN/OCD/EOS/ CARLA R SCARMAZZI KING & SPALDING JOHN J HAY SALANS ATTY CITREM, MAGNESIUM L-ASPARTATE IN INFANT FORMULA - GRAS 1980 TO PRESENT TEVA PHARMACEUTICAL INDUSTRIES LTD, JERUSALEM, ISRAEL - 483 9/12-16/10
Page 780 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-430 01/24/2012 02/22/2012 CVM/OCD/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/OCC/ 2012-431 01/24/2012 02/22/2012 2012-432 2012-433 2012-434 2012-435 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-436 2012-437 2012-438 2012-439 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES BAXTER HEALTHCARE CORP - MULTI THERAPY PUMP MODEL 2M9832; EPIDURAL PUMP MODEL 2L9351 K002679 SORENSON MEDICAL INC - 30 PUMP CONTINUOUS LOW FLOW K991363 SORENSON MEDICAL INC - AMBIT CONTINUOUS SORENSON MEDICAL INC - PALM PUMP K002434 FREEDBERG, SYDNEY FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MAOLIN WANG ALCOHOL COUNTERMEASURE SYSTEMS CORP THOMAS F. THATCHER THATCHER PHARMACEUTICAL THOMAS F. THATCHER THATCHER PHARMACEUTICAL THOMAS F. THATCHER THATCHER PHARMACEUTICAL HEALTH SCIENCES PRODUCTS INC, AL; GRESCO PRODUCTS INC, TX; CMP INDUSTRIES LLC, NY, ETC - EIRS 2006 TO PRESENT DYNAREX CORP - ULTRASOUND GEL K102637 NATIONAL THERAPY PRODUCTS - WAVELENGTH ULTRASOUND LOTION K013212 VIVOSONIC - MICROTEK MEDICAL K020956 K063443 JAYDEE HANSON CENTER FOR FOOD SAFETY AQUABOUNTY TECHNOLOGIES INC, FISHERIES & OCENAS CANADA - GENETICALLY ENGINEERED SALMON, ATLANTIC SALMON, FARM-RAISED SALMON INFECTIOUS SALMON ANAEMIA (ISA) RECS Signature/ Requester Subject
Page 781 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/22/2012 2012-440 01/24/2012 02/22/2012 2012-441 01/24/2012 02/22/2012 2012-442 01/24/2012 02/22/2012 2012-443 2012-444 2012-445 2012-446 2012-447 2012-448 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 01/24/2012 02/22/2012 2012-449 2012-450 01/24/2012 02/22/2012 01/25/2012 02/23/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2012-451 01/25/2012 02/23/2012 OM/OMP/DODM/ CHARLES AVERY FISHER FISHER WALLACE LABORATORIES LLC FDA/OF/CFSAN/OCD/EOS/ KELLY A MAGURANY NEUROLOGICAL DVCS PANEL - RECOMMENDATION OF CES TO BE CLASSIFIED AS CLASS 2 TO TREAT SITUATIONAL ANXIETY, INDENTITY OF PANEL MEMBERS, ETC 7/22-23/77 EPI-DMA COPOLYMER - GRAS EVALUATION RECS OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER MIKE DRUCKMAN HOGAN LOVELLS US LLP THOMAS FITZGERALD FSI RESEARCH & SERVICES, INC. AMY JOHNSON SIDLEY AUSTIN LLP DIANNE L CHAMBERS HOGAN LOVELLS US LLP SECTION 912 OF THE FDA AMENDMENTS ACTS OF 2007 CORR, MINS, NOTES, ETC 2/18/11 TO PRESENT DKT FDA-2008-A-0619, 2010-A-0154, ETC. DKT 1991N-0384 NELLCOR PURITAN BENNETT - SUZANNE PORTABLE POLYSOMNOGRAPH SYS K030611 ODAC TRANS & MINS 7/1/1991 SABERATEK CORP - 6060 HOMERUN VOLUMETRIC INFUSION PUMP K941984 MICROJECT INC - MODEL PCA-1 K965222 STRYKER INSTRUMENTS - PAINPUMP PCA K003543 DIDI BOWLES PARSONS BEHLE & LATIMER STRYKER INSTRUMENTS - STRYKER PAINPUMP2 K030661 DIDI BOWLES PARSONS BEHLE & LATIMER STRYKER INSTRUMENTS - MODIFICATION TO STRYKER PAINPUMP2 K030885 Action Office Signature/ Requester PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER Subject AMBULATORY INFUSION PUMP K033325 STRYKER CORP - PAINPUMP1 K042405
2012-452
01/25/2012
Page 782 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/23/2012 2012-453 2012-454 01/25/2012 02/23/2012 01/25/2012 02/23/2012 2012-455 01/25/2012 02/23/2012 CBER/OCTMA/DDOM/ALFB/ ORA/OE/ ORA/OE/ ORA/P-FO/SEA-DO/SCB/ ORA/CE-FO/PHI-DO/PCB/ 2012-456 01/25/2012 02/23/2012 2012-457 2012-458 01/25/2012 03/12/2012 01/25/2012 02/23/2012 2012-459 01/25/2012 02/23/2012 2012-460 01/25/2012 04/20/2012 2012-461 01/25/2012 02/23/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ ORA/ORM/ ORA/ORM/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ERIC KEISMAN JR CAPITAL WORLD INVESTORS DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC CHRISTINA CIAMPOLILLO ESQ CONWAY HOMER & CHINCAPLAN PC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ROBIN WINCHESTER KESSLERTOPAZ MELTZERCHECK LLP CAROLINA BONE & TISSUE INC, GREENVILLE, SC - 483, 8/01/11 MERCK & CO INC - GARDASIL (HUMAN PAPILLOMAVIRUS QUADRIVALENT VACCINE) BLA 125126 RECS ALABAMA ORGAN CTR, BIRMINGHAM, AL - 483, 7/22/11; DCI DONOR SERVICES TISSUE SERVICES DIV, NASHVIOLLE, TN - 483, 12/19/11; NATIONAL EMBRYO DONATION CTR, KNOXVLLE, TN - 483, 11/10/11 ABBOTT - DEPAKOTE LBLG CHANGES, WARNING LTRS, AERS, ETC LONE STAR LIONS EYE BANK, MANOR, TX - 483, 7/25/11 NOVARTIS AG - EIRS 1/1/09 TO 1/20/12 RTI BIOLOGICS INC, ALACHUA, FL - 483, 10/25/11 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester Nalco Company ANNA DEMKOVIC ABBOTT LABORATORIES, INC. BOBBY S SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC DAMON J BRINSON BOWMAN AND BROOKE LLP GENERAL MILLS - SCIENTIFIC BASIS FOR CHEERIOS CHOLESTEROL CLAIMS CORR, MINS TOTAL DIET STUDY (TDS) FOR DIOXIN - ANALYTICAL PROCEDURES, QUALITY CONTROL DATA, LAB RESULTS, ETC MERCK & CO INC - PEDVAXHIB, COMVAX (HAEMOPHLIUS B CONJUGATE VACCINE), HEPATITIS B (RECOMBINANT VACCINE) RECALL, TESTING, MFG, ETC LAST TEN YRS Subject
2012-462
01/25/2012 02/23/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/
Page 783 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/CE-FO/CHI-DO/CCB/ 2012-463 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-464 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-465 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-466 01/25/2012 02/23/2012 2012-467 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-468 01/25/2012 02/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ 2012-469 01/25/2012 02/23/2012 2012-470 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ELSPETH CALLAHAN INDEPENDENCE LEGAL SUPPORT DRAFT GUIDANCE FOR INDUSTRY IN DESIGNING CLINICAL PROGRAMS FOR DEVELOPING HUMAN DRUGS, MEDICAL DEVICES, OR BIOLOGICAL PRODUCTS INTENDED FOR THE TREATMENT OF RHEUMATOID ARTHRITIS - WORKSHOP 3/27/96, ETC ABIOMED - IMPELLA MDRS 1/1/08 TO PRESENT OM/OMP/DODM/ BRIAN SMITH LEXISNEXIS COURTLINK INC ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC COMBINED HORMONAL CONTRACEPTIVE (CHC) AND THE RISK OF CARDIOVASCULAR DISEASE ENDPOINTS RVW 11/2/11 NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE & QUINIDINE SULFATE) - AERS 1/1/11 TO PRESENT ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC PONATINIB - AERS 1/1/11 TO PRESENT ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC LESINURAD - AERS 1/1/09 TO PRESENT ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC QUESTCOR PHARMACCURICALS - ACTHAR GEL AERS, 1/1/08 TO PRESENT Signature/ Requester Subject
ELLIOT FAVUS FAVUS INSTITUTIONAL RESEARCH LLC SHERI O COVINGTON K & L GATES
DR RICARDO RODRIGUEZ, COSMETIC SURGERY FACILITY LLC, MANUFACTURERS ASSISTANCE & TRAINING BRANCH, TISSUE REFERENCE FROUP - PURIFIED STEM CELLS CORR, MINS, RVWS, ETC
Page 784 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ 2012-471 2012-472 01/25/2012 02/23/2012 01/25/2012 02/23/2012 CBER/OCTMA/DDOM/ALFB/ OC/OCC/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-473 01/25/2012 02/23/2012 2012-474 2012-475 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-476 01/25/2012 02/23/2012 2012-477 01/25/2012 02/23/2012 2012-478 2012-479 01/25/2012 02/23/2012 01/25/2012 02/23/2012 2012-480 01/25/2012 02/23/2012 2012-481 01/25/2012 02/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC BRUCE E. STEVENS CATALENT ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC KEITH A. BARRITT FISH & RICHARDSON PC MAKO RIO; RESTORIS MCK; MAKOPLASTY KNEE PROCEDURES - MDRS 1/1/07 TO PRESENT ABIOMED - IMPELLA MDRS 1/1/08 TO PRESENT-------------DUPE OF 2012-469 POSITIVE ID CORP - IGLUCOSE SYS K111932 EDWARDS LIFESCIENCES - SAPIEN, MDRS 1/1/11 TO PRESENT HEARTWARE - HVAD PUMP (VENTRICULAR ASSIST DEVICE) MDRS 1/1/09 TO PRESENT CATALENT PHARMA SOLUTIONS, MORRISVILLE, NC - EIR FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ RENATA NORONHA IOVATE HEALTH SCIENCES RESEARCH INC JAVIER BAYONA BODEGAS LARCHAGO SA ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC DIFICID (FIDAXOMICIN) - AERS 1/1/90 TO PRESENT FDA 173 432 487 68 - RECS CAERS 144708 SHERI O COVINGTON K & L GATES ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC TISSUE REFERNCE GROUP - ADIPOSE TISSUE PROD REGULATION CORR, MINS, RVWS, ETC IDX184 - AERS 1/1/09 TO PRESENT Signature/ Requester Subject
Page 785 of 1132

Total Records: 12455 Control # 2012-482 2012-483 Recd Date / Due Date 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-484 2012-485 01/25/2012 02/23/2012 01/25/2012 02/23/2012 2012-486 01/25/2012 02/23/2012 ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ 2012-487 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-488 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-489 2012-490 01/25/2012 02/23/2012 01/25/2012 02/23/2012 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-491 2012-492 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ KEITH S. ERBSTEIN YOUNG RICCHIUTI ET AL FRANCISCO X ROSAS CONVENTUS BIOMEDICAL SOLUTIONS INC COSMO TECHNOLOGIES, LAINATE, MILAN, ITALY - EIRS, RECS 11/7-11/11 CATHETER - AER Doe J TAMI UJIIE TEIKOKU PHARMA USA INC SUN PHARMA GLOBAL - DOCEFREZ NDA 22-534 DRUG APRVL PKG , RVW RECS, CORR INDIVIDUAL RECS TAMI UJIIE TEIKOKU PHARMA USA INC SANDOZ - DOCETAXEL NDA 20-1525 DRUG APRVL PKG, RVW RECS. CORR TAMI UJIIE TEIKOKU PHARMA USA INC ACCORD HEALTHCARE - DOCETAXEL NDA 20-1195 DRUG APRVL PKG, RVW RECS, CORR FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ JOHN WALSH JAMES ALEXANDER CORP ALISON BROWN CENTER FOR SCIENCE IN THE PUBLIC INTEREST CLAUDIA HORNBACK ANACHEMIA CHEMICALS INC - ROUSES POINT, NY EIR, 483, RECALL 1/10 TO PRESENT SENOMYX INC - FLAVOR-ENHANCING COMPOUNDS GRAS NOTIFICATION, CORR, RESP, ETC Action Office CBER/OCTMA/DDOM/ALFB/ MEYERS, MICHAEL E TAMI UJIIE TEIKOKU PHARMA USA INC Signature/ Requester Subject SANQUIN BLOOD SUPPLY FOUNDATION - CINRYZE 483, WARNING LTRS 9/28/11 APOTEX INC - DOCETAXEL NDA 22-312 DRUG APRVL PKG, RVW RECS. CORR
AMERICAL CORP - ENTRY #WCJ02738679 NOTICE OF ROANOKE TRADE SERVICES INC REFUSAL, NOTICE REDELIVERY, CF28 AND/OR CF29
Page 786 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-493 2012-494 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-495 2012-496 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-497 2012-498 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-499 2012-500 2012-501 2012-502 01/25/2012 02/23/2012 01/25/2012 02/23/2012 01/25/2012 02/23/2012 01/25/2012 02/23/2012 2012-503 01/25/2012 02/23/2012 2012-504 01/25/2012 02/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TATSUHIRO SAIDO SAYA WAVETECH INC BRENDAN FAULKNER DAMICO GRIFFIN ET AL BRENDAN FAULKNER DAMICO GRIFFIN ET AL VIVKI E. HART JAMES DARK & BRILL ATTY AT LAW KATHY L. KOTTOS KATTEN MUCHIN ROSENMAN LLP ELENA HOWELL HOGAN LOVELLS US LLP VORAXAZE (GLUCARPIDASE) INJ BLA 125327 - SBA, RECS ARTHRO CARE CORP - D SPINEWARD 510K SYNTHES MATRIX MANDIBLE PLATE & SCREW SYS K063790 PHILLIP MUCCLO, BIOFLEX INC - WARNING LTR 8/18/03 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR K103472 UNIVERSAL LOCKING PLATE SYS K961421 RICHARDSON #271264, ALFONZO FDA/OMPT/CDRH/OCER/DFOI/ TATSUHIRO SAIDO SAYA WAVETECH INC VISTARIL, 50 MG; LACTULOSE 10GM/15MG; DOCUSATE 50MG W/SENNAPLUS 8;6MG - MEDICATION RECS, GUIDE, LBLG ETC FACEMASTER FACIAL TONING SYS, IRVINE, CA - K040871 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DENNIS R. GUMBERT, PhD INDIANA UNIVERSITY CARL BEAURLINE CMB REGULATORY SPECIALTIES C. CALVIN WARRINER, III SEARCY DENNEY ET AL JENN NORRIS BENSON AREA MEDICAL CENTER VPRO STERILIZATION TRAY K070769; CONMED LINVATEC INSTRUMENT STERIZATION TRAY K052992; OLYMPUS STERILIZATION TRAYS K033222; APTIMAX INSTRUMENT TRAY K013003 SULZER NATURAL KNEE I & II - SUMMARY & EFFECTIVENESS PRADAXA (DABIGATRAN) - AERS IMAGE WISELY BROCHURES Signature/ Requester Subject
Page 787 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-505 2012-506 01/25/2012 02/23/2012 01/25/2012 02/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-507 2012-508 2012-509 2012-510 2012-511 2012-512 01/25/2012 02/23/2012 01/25/2012 02/23/2012 01/25/2012 02/23/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 2012-513 2012-514 01/26/2012 02/24/2012 01/26/2012 02/24/2012 ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-515 2012-516 01/26/2012 02/24/2012 01/26/2012 ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ DON WERFELMANN SARA LEE WAYNE SADOWSKI STEVEN FREEDMAN MD, RALIEGH, NC 6/29/09, HARTLEY SARA LEE, SIOUX CITY, IA - EIR CVM/OCD/ OC/OCC/ CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANNA DEMKOVIC ABBOTT LABORATORIES, INC. DAVID BRUCE ERIE TIMES NEWS BOBBY SCHOCHET OFW LAW GENNA REED Food & Water Watch MARILYNN WHITNEY COVINGTON & BURLING LLP ANGELA SMYTH IOVATE HEALTH SCIENCES RESEARCH INC ROBERT LOWES MEDSCAPE WAYNE SADOWSKI NOVARTIS PHARMACEUTICALS CORP ROBERT SILVERMAN, JULIAN OMIDI, MICHAEL OMIDI, 1800-GET-THIN LLC - CORR, RECS 12/1/11 TO PRESENT STEVEN R DROSMAN MD, SAN DIEGO, CA 5/19/05, THOMAS W ROSSITER MD, SPRINGFIELD, MO 2/23/06, HARVEY RESNICK MD, LAKE JACKSON, TX 2/21/06, ETC - EIRS, 483S, CORR, ETC CORPAK MEDSYS - FARRELL VALVE WITH CORFLO ANTI IV CONNECTORS K100365 CORR BETWEEN FDA & JOHN KANZIUS; BETWEEN FDA & STEVEN A CURLEY MD CORR BETWEEN FDA & NEUROSCIENCE INC RE WARNING LTR OF 11/19/11 OXITEC - A AEGYPTI CORR, MTG NOTES, CALENDARS, ETC CENTER FOR TOBACCO PRODUCTS - STANDARD OPERATING PROCEDURE (SOP), POLICY, METRICS, ETC CAERS 142534 FDA/OMPT/CDRH/OCER/DFOI/ BRANDY SCHNAUTZ MANN JACKSON WALKER LLP STEFANIE DECKER ENDO PHARMACEUTICALS INC ZANAFLEX CAPS - NDA 21-447 SBA K063744 Signature/ Requester Subject
Page 788 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/24/2012 2012-517 01/26/2012 02/24/2012 2012-518 01/26/2012 02/24/2012 Action Office ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-519 2012-520 2012-521 2012-522 2012-523 2012-524 2012-525 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 2012-526 2012-527 01/26/2012 02/24/2012 01/26/2012 02/24/2012 2012-528 01/26/2012 02/24/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OC/COS/OL/ DEMOCRATIC CONGRESSIONAL CAMPAIGN COMMITTEE KEVIN STRANGE WELLS FARGO SECURITIES STEVEN WAGNER DR MARGARET HAMBURG, DR LAWRENCE PARK, JEFF SHUREN, ETC - DISCLOSURE OF CONFLICTS OF INTEREST CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL RECS NICK LAGRANGE WFIE 14 NEWS FARM BOY, EVANSVILLE, IN - EIR, 483 LAST 30 DAYS THORATEC CORP - WARNING LTR ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OO/OFBA/OAGS/ OM/OMP/DODM/ RUTH LYDDY GRADIENT CORP DON WERFELMANN SARA LEE ELISABETH S. GRAY MIDDLETON & REUTLINGER JEFF STACHEWICZ FOIA GROUP INC ELISABETH S. GRAY MIDDLETON & REUTLINGER ELISABETH S. GRAY MIDDLETON & REUTLINGER ALTERNATIVE BRANDS INC, MOCKSVILLE, NC - EIR, 483, CO RESP MOST RECENT TAYLOR BROTHERS, WINSTON-SALEM, NC - EIR MOST RECENT CONGRESSIONAL CORR 1/1/08 TO PRESENT CONTRACT #HHSF223200850024I UST, NASHVILLE, TN - EIR SAFETY OF AMINO ACIDS USED AS DIETARY SUPPLEMENTS - DKT 1990N-0379 SARA LEE, TWIN FALLS, ID - EIR Signature/ Requester NOVARTIS PHARMACEUTICALS CORP WAYNE SADOWSKI NOVARTIS PHARMACEUTICALS CORP WAYNE SADOWSKI NOVARTIS PHARMACEUTICALS CORP Subject COHEN MD, LOS ANGELES, CA - EIRS, 483S, CORR, ETC JAMES MELI DO, HENDERSON, NV 1/27/11, STEVEN WEINSTEIN MF, HUNTINGTON BEACH, CA 1/10/11, JAMES PEARLE MF, FULLERTON, CA - EIRS, 483S, CORR, ETC CURTIS BROWN MD, OKLAHOMA CITY, OK 2/9/10, KARL BAUM MD, HENNIGSDORF, GERMANY 5/3/10, IAN FLINN, BALTIMORE, MD 5/10/10, ETC - EIRS, 483S, CORR, ETC
Page 789 of 1132

Total Records: 12455 Control # 2012-529 2012-530 Recd Date / Due Date 01/26/2012 02/24/2012 01/26/2012 02/24/2012 2012-531 01/26/2012 02/24/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2012-532 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-533 01/26/2012 02/24/2012 2012-534 01/26/2012 02/24/2012 ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-535 2012-536 2012-537 2012-538 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 02/24/2012 01/26/2012 03/19/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-539 01/26/2012 02/24/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ HOOTNICK, ALEXANDRA ARSENIC - RECS 1/1/06 TO 1/1/12 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. MEGAN B PICKEL BEVERIDGE & DIAMOND PC LOREN LARKIN SAC CAPITAL MANAGEMENT LLC ICON PLC, LEOPARDSTOWN, DUBLIN, REPUBLIC OF IRELAND - 483S LAST 3 YRS CFSAN FOIA REQUESTS 12/19/11 TO 1/20/12 FOI DAILY LOG 1/9-13/12 FOI DAILY LOG 1/16-20/12 DELILLO, MIRIAM CIPRO - AER CLAUDIA HORNBACK ROANOKE TRADE SERVICES INC ENTRY #AGT00052952 - NOTICES OF REFUSAL, NOTICE OF REDELIVERY, CF28 AND/OR CF29 ROBERT BENINCASA NATIONAL PUBLIC RADIO ISRS 4960867, 4968103, 5214211 FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester TYLER KENYON NORTHCOAST RESEARCH TOM ALLEN CARDIAC OUTPUT TECHNOLOGIES INC MICHELLE RYBAK Subject DEPUY ORTHOPEDICS, WARSAW, IN - 483, CO RESP MOST RECENT RHYTHM TECHNOLOGIES INC - RHYTHM CATHETER PMA, CORR 2001 TO 2010
ENTRY #U72 0516358-8 - NOTICES OF REFUSAL, FDA ROANOKE TRADE SERVICES INC ACTION, NOTICE OF MARK/REDELIVER
Page 790 of 1132

Total Records: 12455 Control # 2012-540 Recd Date / Due Date 01/26/2012 02/24/2012 Action Office FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2012-541 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-542 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-543 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-544 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-545 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-546 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-547 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC WOCKHARDT - FLUTICASONE PROPIONATE ANDA 78-492 SBA BRENDA SOUZA ONO PHARMA USA INC SINEMET - SBA CAITRIONA CONNEELY PROXY BIOMEDICAL PROXY BIOMEDICAL LTD, GALWAY IRELAND - EIR 7/2023/09 PRICE CLARK COOK MOTLEY RICE LLC NOVARTIS - TEKTURNA APRVL, MEDICAL RVWS, CLNCL STUDIES DORON FRIEDMAN HEBREW UNIVERSITY HADASSAH MEDICAL SCHOOL EXPAREL (LIPOSOMAL BUPIVACINE HCI) SBA CHARLES CELESTE EAS Consulting Group, LLC TOPICORT OINTMENT NDA 18-594 - MED RVW, CHEMISTRY RVW, STATISTICAL RVW MARC JACOBS MD GABAPENTIN - AER HOOTNICK, ALEXANDRA Signature/ Requester Subject ARSENIC IN FOOD AND WATER - STANDARDS, TOXICITY, INTERAGENCY COMMENTS, ETC
Page 791 of 1132

Total Records: 12455 Control # 2012-548 Recd Date / Due Date 01/26/2012 02/24/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-549 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-550 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-551 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-552 01/26/2012 02/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-553 2012-554 2012-555 01/26/2012 02/24/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 2012-556 01/27/2012 02/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ JASON, JANINE AMANDA ORLANDO AVALON RISK MANAGEMENT INC DR JAVIER GUZMAN LONDON INTERNATIONAL DEVELOPMENT CENTER NEGLECTED DISEASE R&D FUNDING GIVEN BY FDA FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BIOGEN IDEC - ANTI-JCV ANIBODY ASSAY MTG RECS 11/18/10 (CERTIFIED) CRONOBACTER SAKAZAKII - INVESTIGATIONS, TESTING, CORR, ETC 1/08 TO PRESENT ENTRY #22010540056 - NOTICE OF FDA ACTION #1 FOI SERVICES INC BIOGEN IDEC - NATALIZUMAB IND 006895 MTG MINS 9/8/10 ( CERTIFIED) HAREL, ZIV KAYEXALATE - AER FILA, JOHN WATSON PHARMS - SILODOSIN (RAPAFLO) NDA 22-206 WAYNE SADOWSKI NOVARTIS DR RAIMUND JAKESZ, DEPT OF GENERAL SURGERY, VIENNA, AUSTRIA - EIR, 483 WINFIELD JF8770, MICHAEL Signature/ Requester Subject LEUOTHYROXINE - AERS
Page 792 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ NCTR/OD/ OC/OSHC/OPD/ 2012-557 01/27/2012 02/27/2012 2012-558 01/27/2012 02/27/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-559 2012-560 2012-561 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 2012-562 2012-563 2012-564 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-565 01/27/2012 02/27/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SWFO/SWID/COMPLIANCE/ 2012-566 01/27/2012 FDA/OMPT/CDER/ORP/DIDP/ WALTER E CHALKLEY SANDOZ (NOVARTIS INTERNATIONAL AG),QUEBEC, CANADA - EIR, 483, CO RESP 7/26/11-8/4/11 LISA KELLY KEYE TV TX FIRMS THAT CREATE, PROCESS, SELL, OR DISTRIBUTE FOOD PRODS THAT HAVE REQUESTED PERMISSION TO RECONDITION ANY PROD 1/10 TO PRESENT ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ GERALYN MURRAY VITAL SIGNS INC GARY HANLEY ASEPT PAK INC SONIA KHANA ALL-WAYS FORWARDING OF NY INC STEPHEN BEEKMAN ALCON LABORATORIES INC DIANA L GESEKING SEDGWICK LLP ADAM ARANYOS SWEDISH TRADE COUNCIL MEAD JOHNSON & COMPANY LLC - CRONOBACTER SSP CORR 1/05 TO PRESENT USE OF NITROUS OXIDE AS A PAINKILLER - US STATISTICS PRO-PAKS LLC, MIDDLETOWN, CT - 483 5/11 MATERNA MEHADRIN FORMULA - LAB ANALYSIS NAGEL CO - NALGENE EMERGENCY EYE WASH K760820 K082217 FREDERIC C FONDREN FREDERIC C FONDREN LAW OFCS KEISHAN J DAVIS ESQ TOWNES DAVID & ASSOCIATES LLC JENSEN TUNA INC - ENTRY #AMG-0083700-9 REQUEST FOR REDELIVERY PRECAUTIONS NECESSARY WITH CENTRAL VENOUS CATHETERS, FDA TASK FORCE - FDA DRUG BULLETIN 7/89 Signature/ Requester Subject
Page 793 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/27/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-567 2012-568 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-569 2012-570 2012-571 2012-572 2012-573 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-574 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-575 2012-576 2012-577 2012-578 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS NOVARTIS CONSUMER HEALTH, LINCOLN, NE - EIR, 483,CO RESP 4/5-16/10 HOSPIRA, CALYTON, NC - EIR, 483, CO RESP 6/9-13/08 ALPHATEC SPINES, CARLSBAD, CA - EIR, 483, CO RESP 1/1/10-2/11/10 A L & S, DEKALB, MS - EIR, 483, CO RESP 7/12-26/10 WALTER E CHALKLEY THOMSON REUTERS ANTIBIOTICOAS SA, LEON, SPAIN - EIR, 483, CO RESP 7/2124/11 ORA/CE-FO/BLT-DO/CB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS BRUCE BERWALD MD, CREVE COEUR, MO - EIR, 483, CO RESP 3/23/10-4/6/10 BELL-MORE LABORATORIES,HAMPSTEAD, MD - EIR, 483,CO RESP 3/29/10-4/9/10 AVECIA, BILLINGHAM, UK - EIR, 483, CO RESP 1/09 DELTA PHARMA, RIPLEY, MS - EIR, 483, CO RESP 9/1417/10 CORELINK, ST LOUIS, MO - EIR, 483, CO RESP 11/9-12/10 ORA/SE-FO/FLA-DO/FCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS BECKMAN COULTER INC, MIAMI, FL - EIR, 483, CO RESP 2/28/11-6/2/11 AKZO NOBEL CHEMICAL, LOS REYES LA PAZ, EDO, MEXICO - EIR, 483, CO RESP 6/11 Signature/ Requester THOMSON REUTERS Subject
Page 794 of 1132

Total Records: 12455 Control # 2012-579 2012-580 2012-581 Recd Date / Due Date 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 2012-582 2012-583 2012-584 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 2012-585 2012-586 2012-587 2012-588 2012-589 2012-590 2012-591 2012-592 2012-593 2012-594 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS MEDEFIL INC, GLENDALE HEIGHTS, IL - EIR, 483, CO RESP 1/11 AMERICAN RED CROSS, GREATER ALLEGHENIES REGION, HUNTINGTON, WV - EIR, 483, CO RESP 3/11 ZHEJIANG HISUN PHARMS, TAIZHOU CITY, CHINA - EIR, 483, CO RESP 7/20-23/09 COVANCE LABS, PORTSMOUTH, NH - EIR, 483, CO RESP 4/12-16/10 NATIONAL GENETICS INSTITUTE, LOS ANGELES, CA - EIR, 483, CO RESP 1/11-21/11 STORZ MEDICAL, TAGERWILEN, SWITZERLAND - EIR, 483, CO RESP 3/15-19/10 APOTHECA INC, WOODBINE, IA - EIR, 483, CO RESP 3/11 PATHEON PUERTO RICO, CAGUAS, PR - EIR, 483, CO RESP 5/10 HOSPIRA PHARMA, AUSTIN, TX - EIR, 483, CO RESP 4/11 KENDLE INTERNATIONAL INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS BARBARA JONES DOMINION GROUP INC LISA TARRISON-SCHRAMP CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 1/9-13/12 CLOSED FOI REQUESTS 1/9-13/12 CLOSED FOI REQUESTS 1/9-13/12 FOI DAILY LOG 12/26-30/11 FOI DAILY LOG 12/26-30/11 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS Subject POLY IMPLANTS PROTHESES SA, LA SEYNE SUR MER, FRANCE - EIR, 483,CO RESP 5/11-17/00 FOI DAILY LOG 12/26-30/11
Page 795 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-595 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-596 2012-597 2012-598 2012-599 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-600 2012-601 2012-602 2012-603 2012-604 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-605 01/27/2012 02/27/2012 2012-606 01/27/2012 02/27/2012 ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ DOUGLAS N. BLUE ZETETIC DOUGLAS N. BLUE ZETETIC ABBOTT IRELAND, SLIGO IRELAND - FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS ENTRY NO ARE4127536811 ABBOTT IRELAND, SLIGO, IRELAND - FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS ENTRY NO ARE4125206031 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/NJ-DO/NJCB/ WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS JOHN J. MALLOY MALLOY & ASSOCIATES INC MATT CLAUSEN MEDLINE INDUSTRIES INC ERIC KEISMAN, JR. CAPITAL WORLD INVESTORS GILENYA (FINGOLIMOD) AER 8/11 TO PRESENT G&W LABS, SOUTH PLAINFIELD, NJ - EIR, 483, CO RESP 4/20/10 T0 5/17/10 FORMATECH, ANDOVER, MA - EIR, 483, CO RESP 8/25/10 TO 10/10/10 ROCHE MOLECULAR SYS INC - COBAS 4800 BRAF V600 MUTATION TEST PMA P110020 MEDLINE - PREVENTION SURGICAL GOWNS K043017 ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS WALTER CHALKLEY THOMSON REUTERS MEDTRONIC NEUROMODULATION, MINNEAPOLIS, MN EIR, 483, CO RESP 11/17/10 - 1/21/11 MEDTRONIC PUERTO RICO OPERATIONS, VILLALBA, PA EIR, 483, CO RESP 4/26/10 TO 5/14/10 HOSPIRA, MULGRAVE, AUSTRALIA - EIR, 483, CO RESP 2011 RANBAXY, PRINCETON, NJ - EIR, 483, CO RESP 12/3-19/07 WALTER CHALKLEY THOMSON REUTERS RANBAXY LABS, MADHYA PRADESH, DEWAS, INDIA - EIR, 483, CO RESP 1/28/08-2/12/08 Signature/ Requester Subject
Page 796 of 1132

Total Records: 12455 Control # 2012-607 2012-608 Recd Date / Due Date 01/27/2012 02/27/2012 01/27/2012 02/27/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ 2012-609 01/27/2012 03/15/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ OC/OCM/EMOPS/ 2012-610 01/30/2012 02/28/2012 2012-611 01/30/2012 02/28/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-612 01/30/2012 02/28/2012 2012-613 2012-614 2012-615 2012-616 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 2012-617 01/30/2012 02/28/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/CE-FO/CIN-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ CVM/OCD/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/PHI-DO/PCB/ Doe J TIM SCHWAB Food and Water Watch BENJAMIN L ENGLAND ESQ BENJAMIN L ENGLAND & ASSOCIATES LLC AQUABOUNTY TECHNOLOGIES - MONEY SPENT BY FDA CONSULTING AND REVIEWING GENETICALLY ENGINEERED SALMON 1/93 TO PRESENT WENZHOU AISHI OPTICS INDUSTRY CO LTD - IMPORT ALERT 86-07, CORR, LAB RESULTS, ETC ORA/P-FO/SEA-DO/SCB/ MARQUARDT, STEVE JASON A CHERKIS HUFFINGTON POST ORA/SW-FO/KAN-DO/COMP/ SUSAN TODD WEST-WARD PHARMACEUTICAL CORP UWAJIMAYA (KUSTOM FOODS), SEATTLE,WA - 483S 1/26/00, 7/11/00, 11/28/00, ETC LEGITSCRIPT - CONTRACT #HHSF223201000071C CORR 1/21/09 CMPLNT #12284 KV PAHRMACEUTICAL CO - 483 2/7/00-3/3/00 FOI SERVICES INC KATHERINE NEEDLEMAN EMAIL WITH ATTACHMENTS 4/3/06 (CERTIFIED) ANDREW C BRISCOE III SUGAR ASSOCIATION INC CORN REFINERS ASSN - HIGH FRUCTOSE CORN SYRUP CORR, MTGS, RPTS, ETC 1/11 TO PRESENT SUSAN B. MILLS WEINBERG WHEELER ET AL MULTISTATE OUTBREAK OF SALMONELLA ENTERITIDIS INFECTIONS - RECS KEN RAY UNDERWOOD Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester STEPHEN BEEKMAN ALCON LABORATORIES INC Subject EXCELVISION SAS, ANNONAY, FRANCE - EIR, 483 MOST RECENT ANGIODYNAMICS INC - THERMOPAD MDRS 2007 TO 2009
Page 797 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-618 01/30/2012 02/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-619 01/30/2012 02/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-620 2012-621 2012-622 2012-623 2012-624 2012-625 2012-626 2012-627 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DIDI BOWLES PARSONS BEHLE & LATIMER DIDI BOWLES PARSONS BEHLE & LATIMER HELLEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA HELEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA KATHLEEN PERSON CONSUMER REPORTS PROSTHESIS HIP FEMORAL COMPONET CEMENTED META; PROSTHESIS HIP SEMI-CONSTRAINTED (METAL CEMENTED ACETABULAR COMPONET); PROSTHESIS HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABAULAR COMPONET, ETC MDRS LAST 15 YRS JENSEN TUNA INC - ENTRY #AMG-0083700-9 REQUEST FOR REDELIVERY BREG INC - EIRS, MEMOS, WARNINGS, ETC 1/08 TO 4/08, GANODERMA LUCIDUM - CAERS 1/05 TO 2/12 TOCOTRIENOLS - CAERS 1/05 TO 2/12 BETA CLUCANS - CAERS 1/05 TO 2/12 ROSMARINUS OFFICINALS - CAERS 1/05 TO 2/12 SORENSON MEDICAL INC, WEST JORDON, UT - AMBIT INTERMITTENT AMBULATORY INFUSION PUMP K033425 QRS DIAGNOSTIC LLC, PLYMOUTH, MN - SENSAIRE DIAGNOSTIC SPIROMETER K001278 CREATINE - CAERS 1/05 TO 2/12 FOI SERVICES INC SANDOZ - OMNITROPE (SOMATROPIN RECOMBINANT) NDA 21-426/S07,08 APRVL RECS 4/23/10 FOI SERVICES INC ANTARES PHARMA - ANTUROL (OXYBUTYNIN) NDA 202513 APRVL RECS 12/7/11 Signature/ Requester Subject
2012-628
01/30/2012 02/28/2012
ORA/ ORA/ OM/OSS/OPILS/DFI/
FREDERIC C FONDREN FREDERIC C FONDREN LAW OFCS JONATHAN A KNOLL ESQ
2012-629
01/30/2012
Page 798 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/28/2012 2012-630 2012-631 2012-632 2012-633 2012-634 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 2012-635 2012-636 01/30/2012 02/28/2012 01/30/2012 02/28/2012 2012-637 01/30/2012 02/28/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-638 01/30/2012 02/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-639 01/30/2012 02/28/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ REININGER, PETER CYTYC (HOLOGIC) - THINPREP LIQUID BASED PAP TEST CITIZENS PETITION, ACCEPTANCE & DENIAL LTRS; QIAGEN (DIGENE) - DIGENE HYBRID CAPTURE II HPV TEST ACCEPTANCE & DENIAL LTRS, ETC BEAR MEDICAL SYSTEMS INC - PENLON TRANSPORT VENTILATOR SERIES 350 K842362, SERIES 300 K842363 PENLON INC - NUFFIELD ANASTHESIA VENTILATOR SERIES 400 K803052 TOBACCO MFR INSPS - ASSIGNMENT LTRS 12/1/11 TO ALEXANDER MIRONOV TIGRIS PHARMACEUTICALS INC GLAXOSMITHKLINE - WELLBUTRIN (BUPROPION HCL) NDA 20-358 SBA SPIVY, ART . LILLY - BETAZOLE HCL N003944 APRVL, PI, SUMMARY, ETC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ LOVELL, KATHLEEN P MICHAEL CANTOR AMERICAN BRIDGE VI-JON CORP,VI-JOHN LABS, VI-JON INC, ST LOUIS, MO CMPLNTS, VIOLATIONS, INVESTIGATIONS, FOI REQUESTS, ETC 2010 TO PRESENT SONDREX P A L SYS - K010388 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester COHEN & MALAD LLP KATHLEEN PERSON CONSUMER REPORTS JOHNATHAN A KNOLL ESQ COHEN & MALAD LLP KATHLEEN PERSON CONSUMER REPORTS JOHNATHAN A KNOLL ESQ COHEN & MALAD LLP DIDI BOWLES PARSONS BEHLE & LATIMER LIST OF MFR & DVC THAT ARE EXEMPT - MDRS LAST 15 YRS MCKINLEY MEDICAL - BEELINE K042228, ACCUFUSER K023098, K033039, ETC (CERTIFIED) SORENSON MEDICAL INC, WEST JORDAN, UT - AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP K052221 SGARLATO - K990101, K043204 (CERTIFIED) Subject 7/25/03-8/6/03 (CERTIFIED) TOP LIST OF 50 MEDICAL DVC - MDRS LAST 15 YRS
2012-640 2012-641 2012-642
01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/
ANGELA DUNFORD PENLON ANGELA DUNFORD PENLON
Page 799 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/28/2012 2012-643 2012-644 2012-645 2012-646 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-647 01/30/2012 02/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-648 01/30/2012 02/28/2012 FDA/OMPT/CDRH/OCER/DFOI/ STANLEY J ROGASKI CONTACT LENS INSTITUTE CLAO SYMPOSIUM & CONGRESS, LAS VEGAS, NV SILICONE HYDROGEL LENS GROUPINGS AND TESTING STRATAGIES, FDA STEPS TO IMPROVE SAFETY FOR CONTACT LENS USERS, ETC 123 BIOSSENCE - BLOCKING RECS Doe J LAURIE MCCLAIN JANET, JENNER & SUGGS, LLC EPIDURAL INJ - AERS FOI SERVICES INC LAURIE MCCLAIN JANET, JENNER & SUGGS, LLC CELESTONE (BETAMETHASONE SODIUM PHOSHETE & BETAMETHASONE ACETATE INJ SUSPENSION) - AERS FOI SERVICES INC CLOSED FOI REQUESTS 1/16-20/12 Action Office CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC TOBACCO PROD LISTINGS 12/11 TO PRESENT Signature/ Requester FOI SERVICES INC Subject 1/23/12 FCN 852
2012-649
01/30/2012 02/28/2012
FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/
2012-650
01/30/2012 02/28/2012
ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ OC/OM/OMP/DDM/
CARL C KLEIN FRIEDENTHAL HEFFERNAN & KLLEIN LLP MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION
FINE MEXICAN FOODS, ONTARIO, CA. SUNSHINE EXPORTS, PERU - FROZEN AVACADO PULP LTRS, CORR, TESTING RECS DKT FDA-1995-S-0039
2012-651
01/30/2012 02/28/2012
Page 800 of 1132

Total Records: 12455 Control # 2012-652 2012-653 2012-654 2012-655 2012-656 Recd Date / Due Date 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/30/2012 02/28/2012 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-657 01/31/2012 02/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-658 01/31/2012 02/29/2012 ORA/ ORA/ OC/OCM/EMOPS/ FDA/OF/CFSAN/OCD/EOS/ 2012-659 2012-660 2012-661 2012-662 01/31/2012 02/29/2012 01/31/2012 02/29/2012 01/31/2012 02/29/2012 01/31/2012 02/29/2012 2012-663 2012-664 2012-665 01/31/2012 02/29/2012 01/31/2012 02/29/2012 01/31/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FORNETTI, VERENA JOAN STITT (UG2CD-16) ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ MINA KIMES FORTUNE MAGAZINE NICK BUDNICK OREGONIAN MITCHELL S FUERST FUERST ITTLEMAN PL JASON R ANDERS AJUBITA LEFTWICH & SALZER JOAN STITT (UG2CD-16) MERCK & CO., INC. CARBENDAZIM RESIDUES IN ORANGE JUICE - MTG RECS 1/26/12 2011-6843 LLORENS PHARMACEUTICAL INTL, MIAMI, FL - EIRS 8/6/109/30/10 BASIC FOOD FLAVORS INC, NORTH LAS VEGAS, NV HYDROLZED VEGETABLE PROTEIN RECALL CORR ANALYTICAL RESULTS, FINAL AGENCY RESP (CERTIFIED) FOI DAILY LOG 1/23-27/12 BIOTRONIK, PORTLAND, OR - EIRS 1/07 TO PRESENT NORIAN (SYNTHES) - PHONE CALL MINS 7/8/99 JAMES ANDREWS FOOD SAFETY NEWS SALMONELLA ENTERITIDIS OUTBREAK IN TX, OK, KS, ETC - NAME & LOCATION OF THE RESTAURANT CHAIN 10/31/11 JODY L GREEN ROCKY MOUNTAIN POISON DRUG CTR COUGH & COLD PREPARTIONS - ISRS 7482033-4, 7482036X, 74866118-8 AERS 2011 OC/OM/OMP/DDM/ Action Office OC/OM/OMP/DDM/ Signature/ Requester AMY JOHNSON SIDLEY AUSTIN LLP MARILYNN WHITNEY COVINGTON & BURLING LLP Joan Stitt MERCK & CO., INC. Joan Stitt MERCK & CO., INC. JODY L GREEN ROCKY MOUNTAIN POISON DRUG CTR COUGH & COLD PREPERATIONS - ISRS 7389114-4, 7395402-8, 7403265-7, ETC AERS 2011 2011-9649 (request letter) 2012-59 (requester letter) DKT FDA-2010-P-0491 Subject DKT 1994N-0308, 1998P-0035, 1992N-0072
Page 801 of 1132

Total Records: 12455 Control # Recd Date / Due Date 02/29/2012 2012-666 2012-667 01/31/2012 02/29/2012 01/31/2012 02/29/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-668 2012-669 01/31/2012 02/29/2012 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-670 2012-671 01/31/2012 02/29/2012 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-672 01/31/2012 02/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-673 01/31/2012 02/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-674 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-675 01/31/2012 02/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SUSANN REILLY RAINBURST LLC HYDRIODIC ACID SYRUP - AERS JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-7679 NATALIA DIAZ FRIEDIN DOBRINKSY LEVAQUIN - AERS STEVE WALTER UMBRIA PHARMACEUTICALS LLC EISAI INC - LUSEDRA (FOSPROPOFOL DISODIUM) NDA 22244 SBA JOAN STITT (UG2CD-16) MERCK & CO., INC. ERIC L KEISMAN JR CAPITAL WORLD INVESTORS NOVARTIS AG - MTG MINS, ATTENDEES NAMES 1/17/12 2011-7585 BOUREY, ALISON JOAN STITT (UG2CD-16) MERCK & CO., INC. ACTAVIS - METHYLPHENIDATE HCL CAPS ER 20MG, 30MG, 40MG ANDA 78458 LBLG 2011-7464 Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. ELIZABETH BARBEHENN PUBLIC CITIZEN BYDUREON (EXENDATIDE) NDA 22-200 - APRVL PKG, RVWS, ADMINISTRATIVE RECS, ETC 1/27/12 2011-7004 Subject
Page 802 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-676 2012-677 2012-678 2012-679 01/31/2012 02/29/2012 01/31/2012 02/29/2012 01/31/2012 02/29/2012 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2012-680 01/31/2012 02/29/2012 2012-681 2012-682 01/31/2012 02/29/2012 01/31/2012 02/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-683 2012-684 2012-685 2012-686 2012-687 2012-688 02/01/2012 03/01/2012 02/01/2012 03/06/2012 02/01/2012 03/01/2012 02/01/2012 03/01/2012 02/01/2012 03/01/2012 02/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ JAMES E SWAUGER RJReynolds JAMES E SWAUGER RJReynolds JAMES E SWAUGER RJReynolds KATHLEEN PERSON CONSUMER REPORTS TORU FUJINAMI USHIO AMERICA INC ANNE K WALSH ANGIODYNAMICS INC - NANOKNIFE SYS K102329 AMERICAN SNUFF COMPANY LLC, CLARKSVILLE, TN - EIR 1/10-11/12 AMERICAN SNUFF COMPANY LLC, WINSTON-SALEM, NC EIR10/3-6/11 AMERICAN SNUFF COMPANY LLC, CLARKSVILLE, TN 1/1213/12 LIST OF PATIENT EVENT CODES - MDRFOI RECS LAST 15 YRS STRAUMANN - K033984, K053088 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CARLA SCARMAZZI KING & SPALDING LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 1/16-20/12 DKT 1994N-0418 CLOSED FOI REQUESTS 1/16-20/12 JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. CLAUDIA HORNBACK ANGEL MEDINA (3 BROTHERS) - ENTRY #BYX00293963 ROANOKE TRADE SERVICES INC NOTICES OF FDA REFUSAL, NOTICE OF REDELIVERY, CF28 AND/OR CF29 2011-9322 2011-8847 2011-8062 Signature/ Requester Subject
Page 803 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/01/2012 2012-689 02/01/2012 03/01/2012 2012-690 2012-691 02/01/2012 03/01/2012 02/01/2012 03/01/2012 2012-692 02/01/2012 03/01/2012 2012-693 2012-694 02/01/2012 03/01/2012 02/01/2012 03/01/2012 2012-695 2012-696 02/01/2012 03/01/2012 02/01/2012 03/01/2012 CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ OC/OM/OFM/ CBER/OCTMA/DDOM/ALFB/ 2012-697 02/01/2012 03/01/2012 2012-698 02/01/2012 03/01/2012 2012-699 02/01/2012 03/15/2012 2012-700 02/01/2012 03/01/2012 CBER/OCTMA/DDOM/ALFB/ OM/OMP/DODM/ OM/OMP/DODM/ OM/OMP/DODM/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ KEVIN RAMBKE KMR ENTERPRISES JOHN B CLASSEN CLASSEN IMMUNOTHERAPIES, INC. DIANE HORWITZ MANDELL HORWITZ POWDERED BABY FORMULA MFRS IN THE USA REGISTERED WITH FDA - NAMES, ADDRESSES, CONTACT RECS VACCINES & RELATED BIOLOGICAL PRODS A/C - TRANS, BRIEFING RECS 7/11/96 ERIK BAUER STERLING PACIFIC - FLEXIBLE PACKAGING PRODS LTRS OF GUARANTEE ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ TED LAWTON JOSE M BAGGI JUNQUERA BIAGGI & BIAGGI PSC ATTY AT LAW LORI MANSUR GROUP DEKKO KATE WILLSON GROUP DEKKO MEDICAL DVC, AVILLA, IN; GROUP DEKKO, GARRETT, IN - AUDITS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DERBY, COLLEEN DAVID R SHOOP SHOOP HARRY SHULMAN SHULMAN LAW COCHLEAR AMERICAS - NUCLEUS 24 COCHLEAR IMPLANT SYS MEDICAL DVC SUPPL, DVC ALTERATIONS, PREMARKET NOTIFICATION, ETC MAYER LABORATORIES INC - WARNING LTR CMS #167292 INVESTIGATION, FOLLOW UP INVESTIGATION, CO RESP, ETC BATTERY RECYCLING CORP - CONTAMINATION OF COWS MILK WITH LEAD RECS TYLENOL EXTRA STRENGTH - TEST RESULTS Action Office ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SUSAN CLARK MEDICAL PREDICTIVE SCIENCE CORP DEPUY SPINE INC - CHARITE DISC RECS 10/04 MEDICAL PREDICTIVE SCIENCE CORP - K103543 Signature/ Requester Hyman Phelps and McNamara PC Subject
BUDGET ALLOTTED FOR INSP & OVERSIGHT OF FDAREGISTERED HUMAN CELL & TISSUE ESTABLISHMENTS CENTER FOR PUBLIC INTEGRITY RECS
97P-0048/CCP, 1986P-D426
Page 804 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester CONSULTANTS LLC 2012-701 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-702 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-703 2012-704 02/01/2012 03/01/2012 02/01/2012 03/01/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-705 2012-706 02/01/2012 03/01/2012 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-707 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-708 2012-709 02/01/2012 03/01/2012 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-710 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ROBERT F. MURDOCK MURDOCK AND ASSOCIATES SUICIDE WITH ZOLPIDEM, ZALEPON, AND ESZOPICLONE OSE RVW 8/31/06 OC/OM/OMP/DDM/ SRIVIDYA SRINIVASAN HERBAL HEALTH INSTITUTE NANCY ZHANG, Ph.D. QUANTITATIVE SOLUTIONS INC LASIX (FUROSEMIDE) NDA 16-273 - MEDICAL & STATISTICAL RVWS OTC VOLS. 210334, 210335, ETC. WEBBER, WALTER PHENTERAMINE - APRVL LTRS, RVWS, RESEARCH, ETC OC/OM/OMP/DDM/ CARLA SCARMAZZI KING & SPALDING CAROLINE GILMORE SACRED HEART SCHOOL CLINDAMYCIN - LINE LISTING DKT FDA-1994-N-0036 KAI FALKENBERG FORBES CHARLES CELESTE EAS Consulting Group, LLC FOSAPREPITANT NDA 22-023/S004 - LBLG, APRVL LTR, MOR, ETC AMBIEN - AER 3/14/07 TO PRESENT CARLOS MEDINA EXPONENT LIORESAL (BACLOFEN) NDA 17-851 - SBA YUAN, ADAM NOVARTIS - TRIAMINIC THIN STRIPS DAY TIME COLD & COUGH; THIN STRIPS COUGH & RUNNY NOSE; THIN STRIPS ALLERGY APRVL, RVWS, CLNCL TRIAL Subject
Page 805 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-711 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-712 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-713 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-714 02/01/2012 03/01/2012 2012-715 02/01/2012 03/01/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-716 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-717 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-718 02/01/2012 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JI, JUNZHI AVASTIN (BEVACIZUMAB) - AERS JAMI S. OLIVER OLIVER LAW OFFICES INC DAVOL INC/C R BARD INC - BARD PERFIX PLUG AERS, WARNING LTRS, CMPLNTS, ETC MATTHEW D. BIRD DRINKER BIDDLE REATH LLP RISPERDAL NDA 20-272/S036, NDA 20-588/S024, NDA 21444/S008 - APRVL RECS KARYN M. SCHMIDT AMERICAN CHEMISTRY COUNCIL KATHRYN A. PRYOR, Esq. SIMON GREENSTONE ET AL NATURAL RESOURCES DEFENSE COUNCIL (NRDC) - FOI REQUEST REGARDING BISPHENOL A (BPA) IN FOOD PACKAGING 10/14/11 IBUPROFEN (MOTRIN, ADVIL) - AERS SARA E. ROSENBAUM, Ph.D. UNIVERSITY OF RHODE ISLAND, COLLEGE OF PHARMACY METHOTREXATE - AER POCHODYLO, JOHN AXIRON - AER NANCY ZHANG, Ph.D. QUANTITATIVE SOLUTIONS INC BUMEX (BUMETANIDE) NDA 18-226, NDA 18-225 STATISTICAL & MEDICAL RVWS Signature/ Requester CHTD Subject
Page 806 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-719 2012-720 02/02/2012 03/02/2012 02/02/2012 03/02/2012 2012-721 02/02/2012 03/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-722 02/02/2012 03/02/2012 2012-723 2012-724 02/02/2012 03/02/2012 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-725 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2012-726 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-727 2012-728 2012-729 02/02/2012 03/02/2012 02/02/2012 03/02/2012 02/02/2012 FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ RACHEL A BOND Keller and Heckman LLP DOUGLAS N BLUE ZETETIC SHERI O COVINGTON JOHNSON & JOHNSON VISION CARE INC - ACCUVUE OASYS CONTACT LENS ENTRY #BDD-0712296-9/7/1 RECS ACCUCAPS INDUSTRIES LTD, WINDSOR, ONTARIO, FCN 1040 LEIFFER, LYDIA MDS PHARMA SERVICES, ST LAURENT, QUEBEC, CANADA - EIR, 483 2006-2007, IRB NAME, ETC MATT MAXWELL ATLANTA INSTITUTE FOR MEDICAL RESEARCH INC BAYER, JOHNSON & JOHNSON - INSP 1/31/11-2/7/11 TORMA #07B1783, STEPHEN J ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/DET-DO/DCB/ EMILY E HUGHES ESQ MILLER LAW FIRM LIQUID MANUFACTURING LLC, BRIGHTON, MI - EIR 1/914,19.21/10, WARNING LTR 3/26/10, CO RESP PHARMACIA & UPJOHN INC - MEDROXYPROGESTERONE ACETATE AERS Doe J INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ KARIM, IMRAN CAROLINE W HERRINGTON ADAMS & JORDAN DIANA GESEKING SEDGWICK LLP PERRY HOSPITAL RADIOLOGY DEPT, PERRY, GA MAMMOGRAPHY QUALITY STANDARDS ACT VIOLATIONS, RPTS, CMPLNTS, ETC 2008 TO 2011 MEAD JOHNSON, ZEELAND, MI - EIR 8/26/04 PHAROS LIFE CORP - TANDA MAX OTC SYS K110735 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 03/02/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-730 2012-731 02/02/2012 03/02/2012 02/02/2012 03/02/2012 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-732 2012-733 02/02/2012 03/02/2012 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-734 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-735 02/02/2012 04/18/2012 2012-736 02/02/2012 03/02/2012 CBER/OCTMA/DDOM/ALFB/ OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-737 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-738 02/02/2012 03/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ KARIM, IMRAN LED TECHNOLOGIES LLC - DPL NUVE K101382 WILLIAMS, PEGGY L FORTEO - AERS 2008 TO PRESENT RUCHIKA RAVAL GLOBAL BIOPHARMACEUTICAL REGULATIONS INC CHARLES CELESTE EAS Consulting Group, LLC SANOFI - H5N1 INFLUENZA SBA, CLNCL SUMMARY, VACCINE A/C MTG MINS, ETC NAPROXEN SODIUM ER TABS ANDA 75-416 - APRVL TR, LBLG, MOR, ETC ELAINE S WALLER PHARM D MBA SEATTLE GENETICS INC SEATTLE GENETICS - ADCETRIS (BRENTUXIMAB VEDOTIN) ISRS 7728607-4, 7819592-5, 7906053-8, ETC AERS FDA/OMPT/CDRH/OCER/DFOI/ DONOVAN, JAMES SCOTT A HANNA ZUCKERMAN SPAEDER LLP BEAM LIMITING DVC, TABLES - MFR, MODEL NUMBER, DATE MANUFACTURED, ETC CIPLA LTD - 483 2/17/11-9/22/11 ORA/SE-FO/ATL-DO/ACB/ SHERI O COVINGTON K & L GATES SHERI O COVINGTON K & L GATES BANNER PHARMACAPS INC, HIGH POINT, NC - EIRS, 483S, WARNING LTRS, ETC 1/06 TO 1/12 CATALENT PHARMA SOLUTIONS, ST PETERSBURG, FL EIRS, 483S, WARNING LTRS, ETC 1/06 TO /12 Signature/ Requester K & L GATES Subject CANADA - EIRS, 483S, WARNING LTRS, ETC 1/06 TO 1/12
Page 808 of 1132

Total Records: 12455 Control # 2012-739 2012-740 2012-741 Recd Date / Due Date 02/02/2012 03/02/2012 02/02/2012 03/02/2012 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-742 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-743 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-744 2012-745 2012-746 2012-747 2012-748 02/02/2012 03/02/2012 02/02/2012 03/02/2012 02/02/2012 03/02/2012 02/02/2012 03/02/2012 02/02/2012 03/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-749 2012-750 02/03/2012 03/05/2012 02/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ ANICE N. JAMISON MCDERMOTT WILL & EMERY SUZANNE D JENSEN K933327, K971392 DKT 1998N-0583 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC SAJJAN ARYAL ACCUCAPS INDUSTRIES LTD MATRIX LABORATORIES LTD, ANDHRA, PRADESH, INDIA LORATADINE EIR 3/30/09-4/3/09 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC REDMED LTD - MIRAGE MICRO K110444 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC RESMED LTD - PIXI PEDIATRIC MASK K102224 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC CIRCADIANCE LLC - SLEEPWEAVER NASAL CPAP MASK K092362 RESMED LTD - SWIFT FX K090244 FOI SERVICES INC FEINSTEIN - AMMONIA N-13 NDA 22-119/S001 APRVL RECS MIKE CLOTHIER PERRIGO CO DPT LABORATORIES LTD, SAN ANTONIO, TX; DPT BROOKS, SAN ANTONIO, TX - EIR, 48S MOST RECENT; G PRODUCTION INC, QUEBEC, CANADA - 2 MOST RECENT ORA/NE-FO/NYK-DO/NYDCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ KARIM, IMRAN LESLIE PAUL PERRIGO CO HOLLY KORTEWAY PERRIGO PLANT 5 GLAXOSMITHKLINE PANAMA SA; GLAXOSMITHKLINE COSTA RICA SA - EIRS, 483S MOST RECENT PERRIGO NEW YORK, BRONX, NY - EIR 10/09 Signature/ Requester Subject PHAROS LIDE CORP - TANDA MAX K103415
Page 809 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/05/2012 2012-751 2012-752 02/03/2012 03/05/2012 02/03/2012 03/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-753 02/03/2012 03/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-754 02/03/2012 03/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-755 02/03/2012 03/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-756 2012-757 2012-758 02/03/2012 03/05/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-759 2012-760 2012-761 2012-762 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ RALPH AGUILA RALPH AGULIA RALPH AGUILA RALPH AGUILA RALPH AGUILA RALPH AUGILIA RALPH AGUILA RALPH AGUILIA FISHER & PAYKEL HEALTHCARE INC, IRVINE, CA - EIR, 483, DRAEGER MEDICAL AG - OXYLOG 3000 PLUS K103625 FISHER & PAYKEL - M4730 HIMIDIFIERS K913368 SCOTT C LABARRE LABARRE OFC JARED MACCLEARY CROWELL MORING FISHER & PAYKEL HEALTHCARE LTD, AUCKLAND, NEW ZEALAND - EIRS, 483S, INTERNAL DIALOUGE, ETC 11/1619/09 FISHER & PAYKEL - MR850 HUMIDIFIERS K033710 SECTION 508 OF THE REHABILITATION ACT - TESTS, EVALUATIONS RPTS, ETC 1/03 TO PRESENT CENTER FOR VETERINARY MEDICINE - FOI REQUESTS 1/12 Doe J LIST OF APRVD FACILITIES OF PHARMACEUTICAL MFRS IN INDIA MARIE-PIERRE EKOKA MSC JUBILANT DRAXIMAGE INC GE HEALTHCARE - CERETEC (TECHNETIUM TC-99M EXAMETAZIME KIT) NDA 19-829/S04, S05, S06 SBA REDLUND, PAUL G ORLEANS MED CENTER, ORLEANS, MA - AVANDARYL SPL RECS Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ RANDALL RICH RANDALL RICH LAW OFC JENNIFER NEWBERGER Hyman Phelps and McNamara PC WRIGHT MEDICAL TECHNOLOGY - CONSERVE TOTAL FEMORAL HEAD K051348 NICTRIC OXIDE - BIOEQV GUIDANCE RECS Signature/ Requester KLEINFELD KAPLAN & BECKER Subject
Page 810 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/06/2012 2012-763 2012-764 2012-765 2012-766 2012-767 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-768 2012-769 2012-770 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-771 02/06/2012 03/06/2012 2012-772 02/06/2012 03/06/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/DET-DO/DCB/ 2012-773 2012-774 2012-775 2012-776 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JENKINS, KRIS GLADYS B TONKIN Center for Regulatory Services, Inc. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2012-100 2012-61 BIODIESEL DERIVED GLYCERIN DERRIVED FROM REFINED VEGTABLE OIL BACKGROUND RECS FOI DAILY LOG 12/26-30/11 ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC FRANK YIANNAS Walmart MEAD JOHNSON - ENFAMIL PREMIUM INFANT FORMULA SPLS 487854, 487855 RESULTS 1/9/12 CAERS 144083 10/25/11 ORA/CE-FO/NJ-DO/NJCB/ SATIJA, ALBERT LINDA LEHMKUHL MEDVET MEDVET MEDICAL CENTER FOR PETS (MEDVET MEDICAL & CANCER CENTERS), WORTHINGTON, OH - EIR 2006 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ GONZALES, TODD AYA AMEMIYA SEIKO EPSON CORP DOUGLAS N BLUE ZETETIC DENISE M POWERS FULBRIGHT & JAWORSKI LLP DEPUY MITEK INC (JOHNSON & JOHNSON CO), RAYNHAM, MA - CLEARFIX RASP ENTRY 112-2967990-2/1/11 PHOTOGRAPHS SONAR PRODUCTS INC, CARLSTADT, NJ - EIRS, 483S, 482S, ETC 1/09 TO PRESENT MAQUET CARDIOVASCULAR, WAYNE, NJ - 483S 4/1/11 ERBE USA INC - ERBEJET 2 SYS K072404 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester RALPH AGUILA J ELOY CRUZ UNOMEDICAL INC JANET COOPER WESTMED INC. Subject CORR TO WARNING LTR, ETC 10/25/06-12/6/06, 2/2/07 UNOMEDICAL S A DE C V, REYNOSA TAMAULIPAS, MEXICO - EIR 6/11-14/07 SIMPLEX MEDICAL CORP, RIVERSIDE, CA - UNIVERSAL HEATED TUBING SLSEEVE K881451 MISBRANDING ACUPUNCTURE NEEDLES - RECS
Page 811 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/06/2012 2012-777 2012-778 2012-779 2012-780 2012-781 2012-782 2012-783 2012-784 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-785 2012-786 2012-787 2012-788 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-789 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ BRENDA M GARTZ ELI LILLY & CO PATHEON ITALIA SPA, FERENTINO, ITALY - EIR 5/11 OC/OM/OMP/DDM/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ JOAN STITT (UG2CD-16) MERCK & CO., INC. SETH GORDON NEWBERG GRAPHIC MARILYN WHITNEY COVINGTON & BURLING LLP BRENDA M GARTZ ELI LILLY & CO PATHEON ITALIA SPA, FERENTINO, ITALY - EIR, 6/09 & 11/11 GEORGE PACKING CO INC, NEWBERG, OR - EIR, CO RESP, WARNING LTR DKT FDA-2010-P-0491 2012-314 - REQUEST LTR Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. jOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. KATHIE BARDWELL STERIS CORP STEVE L. MARKS MAIN STREET GOURMET ANNA YUKHANANOV THOMSON REUTERS SILIMED INC, TX - 483 2003, 2007 CMPLNT 122701 STERIS CORP, MONTGOMERY, AL - EIR 10/09 TO 10/27 2012-305 - REQUEST LTR 2012-264 - REQUEST LTR 2012-255 - REQUEST LTR 2012-167 - REQUEST LTR 2012-146 Subject
Page 812 of 1132

Total Records: 12455 Control # 2012-790 Recd Date / Due Date 02/06/2012 03/06/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-791 02/06/2012 03/06/2012 2012-792 02/06/2012 03/06/2012 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-793 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-794 2012-795 02/06/2012 03/06/2012 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-796 2012-797 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-798 02/06/2012 03/06/2012 ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-799 02/06/2012 03/06/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ DOUGLAS N. BLUE ZETETIC INC ENTRY NO 112-2967990-2/1/10 CLEARFIX CALIBRATION TOOL SQUAILIA, WILLIAM SINQUAN DOXEPIN - AER ORA/CE-FO/CHI-DO/CCB/ BRENDA M GARTZ ELI LILLY & CO ANNA YUKHANANOV THOMSON REUTERS SGS LIVE SCIENCE SERVICES, LINCOLNSHIRE, IL - EIR, 8/09 TO PRESENT POLY IMPLANT PROTHESE, LA SEYNE SUR MER, FRANCE 2001 TO 2005 ORA/P-FO/LOS-DO/LACB/ BRENDA M GARTZ ELI LILLY & CO BRENDA M GARTZ ELI LILLY & CO IRVINE PHARMACEUTICAL SERVICES, IRVINE, CA - EIR, 11/09 TO PRESENT DSM FINE CHEMICALS, LINZ, AUSTRIA - EIR 5/09 TO PRESENT BRENDA M GARTZ ELI LILLY & CO CARBOGEN AMCIS, SWITZERLAND (AARAU, NEULAND & BUBENDORF) - EIR 2008 TO PRESENT BRENDA M GARTZ ELI LILLY & CO BASF ORGAMOL PHARMA SOLUTIONS SA IN - EVIONNAZ, SWITZERLAND - EIR, 11/08 TO PRESENT BRENDA M GARTZ ELI LILLY & CO HECTOR WILTZ, MD; FMX RESEARCH CORP, MIAMI, FL 483S 5/13/09 & 2/7/05 Signature/ Requester BRENDA M GARTZ ELI LILLY & CO Subject MERCK KGAA, DARMSTADT, GERMANY - EIRS, 2009 TO PRESENT
Page 813 of 1132

Total Records: 12455 Control # 2012-800 Recd Date / Due Date 02/06/2012 03/06/2012 Action Office ORA/ ORA/ CVM/OCD/ OC/OCM/EMOPS/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/ORO/ ORA/ORO/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ 2012-801 02/06/2012 03/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-802 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-803 02/06/2012 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-804 02/06/2012 03/06/2012 2012-805 02/06/2012 03/06/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ JASON D'SOUZA Professional Disposables International, Inc. DENISE M. POWERS FULBRIGHT & JAWORSKI LLP ROCKLINE INDUSTRIES - 483, EIR, WARNING LTR, CO RESP STRATUS PHARMS INC, MIAMI, FL - EIR, 483, WARNING LTR 1/09 TO PRESENT RHONDA P. CHAMBERS TAYLOR & TAYLOR ATTORNEYS AT LAW EVAMIST - CLNCL TRIALS, SAFETY, LBLG, PKG HARTWELL P. MORSE, III HUSCH BLACKWELL LLP TEVA PHARMS - RISEDRONATE SODIUM NDA 79-215 KYRIAKIDIS, JOANNA DOCKET 2005N-0403 Signature/ Requester SCOTT PHILLIPS INSIDE EDITION Subject CHICKEN JERKY PRODUCTS 1/11
Page 814 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-806 2012-807 2012-808 02/06/2012 03/06/2012 02/06/2012 03/06/2012 02/06/2012 03/06/2012 2012-809 02/06/2012 03/06/2012 2012-810 02/07/2012 03/07/2012 2012-811 02/07/2012 03/07/2012 2012-812 02/07/2012 03/07/2012 2012-813 02/07/2012 03/07/2012 2012-814 02/07/2012 03/07/2012 2012-815 02/07/2012 03/07/2012 2012-816 02/07/2012 03/07/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELLIA D SLAYTON INC REGULATORY CONSULTING K102494 K110301 K103368 K110233 K111714 LEXINGTON INTERNATIONAL - HAIRMAX K081668 NSE LTR 12/19/08; KAREEN S BURNEY TO CASPER ULDRIKS LTR 1/3/11; RESP TO K103368, ETC K112524 DAVID M. DEUTSCH DAVID M DEUTSCH CO LPA MEDTRONIC ATLANTIS CERVICAL PLATE - CORR DAVID M DEUTSCH CO LPA FDA/OF/CFSAN/OCD/EOS/ THOMPSON, CLARENCE LD CBER/OCTMA/DDOM/ALFB/ HUBER, MARIE CFSAN EMPLOYEES SUBJECT TO INVESTIGATION 1/10 TO PRESENT MEDTRONIC LEGACY RODS - RECALL, AER PROVENGE - CMC RVW Signature/ Requester Subject
Page 815 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester & SUBMISSIONS 2012-817 02/07/2012 03/07/2012 2012-818 2012-819 2012-820 2012-821 2012-822 2012-823 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-824 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-825 02/07/2012 03/07/2012 2012-826 2012-827 02/07/2012 03/07/2012 02/07/2012 03/07/2012 2012-828 02/07/2012 03/07/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ JUDITH HILL INTERTEK CANTOX RANDALL C WHATTOFF GOODSILL ANDERSON QUINN & STIFEL JOHN A HELLMAN LATHAM & WATKINS LLP SELENIUM ENRICHED YEAST - SAFETY & UTILITY RECS 6/4/87, 6/4/87, 4/19/89, ETC KONA BLUE WATER FARMS INC, KEAHOLE POINT FISH LLC - NOTES, MEMOS, EMAILS, ETC BENAVENTE, MARIA LLORENS PHARMACEUTICAL INTERNATIONAL, MIAMI, FL EIR 8/10 TO 9/10 DEBRA HATHAWAY THINC ODAC A/C - AGENDA, MINS, TRANS, ETC 1/31/92; ODAC AGENDA, MINS, TRANS, ETC 6/9/95; NDA 20-221/S000 APRVL LTR, RVWS, CORR, ETC 12/8/95 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation PATRICIA L REGENYE Celgene Corporation AMBER R JOHNSON BOSTON SCIENTIFIC SUSAN SULLIVAN OMEROS CORP JAMES STOCKS (UNIV OF TEXAS HEALTH CENTER TYLER), TYLER, TX - 483S 9/09 TO PRESENT ROBERT SCHILZ (CLEVELAND CLINIC FOUNDATION), CLEVELAND, OH - 483S 9/05 TO PRESENT FERNANDO MARTINEZ (UNIV MICHIGAN MEDICAL CENTER), ANN ARBOR, MI - 483S 1/10 TO PRESENT NAVILYST MEDICAL INC - MULTIPURPOSE DRAINAGE CATHETER K111315 NEVANAC (NEPAFANAC) NDA 21-862 - PROTOCOL C-0253, PROTOCOL C-03-32, PROTOCOL C-95-93 SS&E, SAFETY UPDATE DANIEL LORCH, BRANDON, FL - 483S 2/09 TO PRESENT K072459 Subject
INJECTAPAP (ACETAMINOPHEN INJ) NDA 17-785 - RECS, APPLICANTS SUBMISSIONS, CORR, ETC
Page 816 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-829 02/07/2012 03/07/2012 2012-830 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ 2012-831 2012-832 2012-833 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-834 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-835 2012-836 2012-837 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ Doe J ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ LORI ROOF PERRIGO CO BRENDA M GARTZ ELI LILLY & CO S A EVIAN CO - CMPLNT 7/26/11 WELCH, HOLME & CLARK CO INC, NEWARK, NJ - 483 10/10 BIO-CONCEPT, SALEM, NH - LAST 2 483S SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP BIOGEN INC - AVONEX UNTITLED LTR 12/5/00; ICN PHARMACEUTICALS INC - VIRAZOLE REGULATORY LTR 3/24/86; PFIZER INC - FELDENE REGULATORY LTR 7/13/82, ETC FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ CHARLES H KYPER KYPER & ASSOCIATES IKRAM KORESHI NETHOST INC MARILYN A APFEL PHD XFDA INC LILLY - NDA 00-734 TOXICOLOGY RECS ETEX CORP - EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTANCES K090855 BOOZ ALLEN & HAMILTON - CONTRACT #HHSF22301004T FDA/OO/OFBA/OAGS/ MICHAEL R PRANZATELLI MD SOUTHERN ILLINOIS UNIV SCHOOL OF MEDICINE MARK C AUBUCHON ADVANCING REGULATORY SCIENCE THROUGH NOVEL BIOMARKER RESEARCH AND SCIENCE-BASED TECHNOLOGIES - RECPIENT GRANT #1U01 FD004197-01 Signature/ Requester Subject
MYOGENIX INC - MYOGENIX SPAWN CORR, STUDIES, AUBUCHON RANIERE & PANZERI PUBLIC HEALTH ADVISORY WARNING 7/28/09, ETC
Page 817 of 1132

Total Records: 12455 Control # 2012-838 Recd Date / Due Date 02/07/2012 03/07/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-839 2012-840 2012-841 2012-842 2012-843 2012-844 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/07/2012 02/07/2012 03/09/2012 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-845 02/07/2012 03/07/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-846 02/07/2012 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-847 02/07/2012 03/13/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION HI TECH PHARMS, NORCROSS, GA 4/13/09-12/8/09; BALCHEM CORP, CHANNAHON, IL 5/20/09-6/10/09; LIVING ESSENTIALS LLC, FARMINGTON, MI 11/22/10-12/3/10, ETC EIRS, 483S WILLIAM C VINCEK PHD PHARMA CMC INC DIETHYLSTILBESTROL ORAL TABS NDA 04-041 - APRVL RECS WILLIAM C VINCEK PHD PHARMA CMC INC DIETHYLSTILBESTROL VAGINAL SUPPOSITORY NDA 04040 - APRVL RECS ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ MELANIE COTE MEDISCA INC MELANIE COTE MEDISCA INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. WILLIAM A OLSON PHD Center for Regulatory Services, Inc. WILLIAM A OLSON PHD Center for Regulatory Services, Inc. WILLIAM C VINCEK PHD PHARMA CMC INC DIETHYLSTILBESTROL DELAYED RELEASE TABS NDA 04039 APRVL RECS FCN 1090 2011-6905 2011-3504 ATTIX PAHRMS, WEATHERFORD, TX - EIRS MEDISCA INC, PLATTSBURGH, NY - EIR 9/14-15/10 Signature/ Requester MELANIE COTE MEDISCA INC Subject ATTIX PHARMS, ONTARIO, CANADA - ERIS
Page 818 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-848 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-849 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-850 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2012-851 02/08/2012 03/08/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWMICHELLE RYBAK ROANOKE TRADE SERVICES INC ENTRY #U720516383-6 - NOTICES OF REFUSAL, FDA ACTION, NOTICE OF MARK/REDELIVER NICHOLAS J PELLICCIONE PHD AETERNA ZENTARIS BERNA BIOTECH LTD - VIVOTIF TYPHOID VACCINE PHARMACOKINETICS, SAFETY, TOXICOLOGY RECS, ETC SHIN KANG PHD WACHOVIA BANK NA REVLIMID (LENALIDOMIDE) - SAFETY RVW RECS XAVIER BONHOMME ALGORITHME PHARMA INC ALGORITHME PHARMA INC, MONTREAL, QUEBEC, CANADA - EIRS 2/6-10/06, 4/3-5/07, 4/9-12/07, ETC Signature/ Requester Subject
Page 819 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FO/SWID/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2012-852 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-853 02/08/2012 03/08/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OC/COS/OES/ OC/COS/OES/ 2012-854 02/08/2012 03/08/2012 CVM/OCD/ DAVID WALLINGA MD MPA INSTITUTE FOR AGRICULTURE AND TRADE POLICY FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-856 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-857 2012-858 02/08/2012 03/08/2012 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-859 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-860 02/08/2012 OM/OSS/OPILS/DFI/ PATRICIA L. REGENYE RODOLFO POSADAS VALAY, MONTERREY NL, MEXICO 483 7/09 TO 11/11 SANJAY H SHARMA PHD HETERO USA INC XENAZINE (TETRABENAZINE TABS) - CHEMISTRY & BIOEQV RVWS, CORR OC/OSHC/OPD/ G MICHAEL WALL PHD O-RAY PHARMA INC SANJAY H SHARMA PHD HETERO USA INC FAIRfIELD CLINICAL TRIALS LLC - TRACONAZOLE SUSPENSION ORPHAN DRUG DESIGNATION SILODOSIN CAPS - CHEMISTRY & BIOEQV RVWS, CORR DORON FRIEDMAN HEBREW UNIVERSITY HADASSAH MEDICAL SCHOOL EXPAREL (LIPOSOMAL BUPIVACAINE HCI) - SBA SACHIN AHUJA VERSEON CORP NATIONWIDE SURVEY OF DISTILLERS GRAINS FOR ANTIBIOTIC RESIDUES FY 2010 - SPL DESCRIPTIONS OF ANTIBIOTICS USED IN ETHANOL PRODUCTION, TEST RESULTS, ETC BOEHRINGER-INGLEHEIM GMBH - PRADAXA (DABIGATRAN) NDA 22-512 IND APPL DAVID WALLINGA MD MPA INSTITUTE FOR AGRICULTURE AND TRADE POLICY ETHANOL PRODUCERS & COMPANIES USE OF ANTIMICROBIALS CORR; SUBMISSIONS FROM SUPPLIERS OF ANTIBIOTIC ADDITIVES FOR USE IN ETHANOL PRODUCTION; POLICY GUIDELINES, ETC DARSHAN WARIABHARAJ NOVARTIS PHARMACEUTICALS CORP NDA 22-068/S005,S008 - CLNCL & MEDICAL RVWS, CORR Signature/ Requester Subject
2012-855
02/08/2012 03/08/2012
Page 820 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/08/2012 2012-861 02/08/2012 03/08/2012 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-862 2012-863 2012-864 2012-865 02/08/2012 03/08/2012 02/08/2012 03/08/2012 02/08/2012 03/08/2012 02/08/2012 03/08/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-866 02/08/2012 03/08/2012 2012-867 02/08/2012 03/08/2012 2012-868 2012-869 2012-870 2012-871 2012-872 02/08/2012 03/08/2012 02/08/2012 03/08/2012 02/08/2012 03/08/2012 02/08/2012 03/08/2012 02/08/2012 FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ RIPPER, ERIC B DAVID H. DANOWIT MITCHELL CLAIMS SERVICE INC ALEXANDER MIRONOV NOVARTIS - TRANSDERM SCOPE NDA 17-874 SBA INDIVIDUAL RECS FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ PROJECT ON GOVERNMENT OVERSIGHT ANDREW WYNER PROJECT ON GOVERNMENT OVERSIGHT DOUGLAS N. BLUE ZETETIC DOUGLAS N. BLUE ZETETIC POLYACRYLAMIDE HYDROGEL ENTRY NO 112-2967990-219 DELOITTE & TOUCHE SLIDE PRESENTATION - CONTRACT GS23F9796H ENTRY NO 112-2967990-127 MCKINSEY & CO PRESENTATION - CONTRACT GS10F0118S TORMA, STEPHEN J ORA/P-FO/LOS-DO/LACB/ CHRISTINE M BURNS DISCOVERY LABORATORIES INC PATRICIA L. REGENYE Celgene Corporation CHRISTINE M BURNS DISCOVERY LABORATORIES INC UNIV OF CALIFORNIA SAN DIEGO, CLNCL TEACHING FACILITY, SAN DIEGO, CA - EIR, 482 12/12-16/11 WAN LONG CHUANG, KAOHSUUNG, TAIWAN - 483 5/10 TO 11/11 DISCOVERY LABORATORIES INC, WARRINGTON, PA 12/1921/11; TOTOWA, NJ 1/24-31/12 - EIRS PHARMACIA & UPJOHN INC - MEDROXYPROGESTERONE ACETATE AER, WARNINGS Signature/ Requester Celgene Corporation CHRISTINE M BURNS DISCOVERY LABORATORIES INC CORDEN PHARMA SWITZERLAND LLC, LIESTAL, SWITZERLAND - EIR, 483S 12/19-22/11 Subject
Page 821 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/08/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-873 02/08/2012 03/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ 2012-874 02/09/2012 03/09/2012 2012-875 02/09/2012 03/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-876 02/09/2012 03/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-877 02/09/2012 03/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-878 02/09/2012 03/09/2012 ORA/CE-FO/BLT-DO/CB/ ORA/P-FO/LOS-DO/LACB/ JUNG JAE-YOON JTBC NONGSHIM HOOROOROOKKUKSOO LA - 8/24/10; NONGSHIM POTATO NOODLE SOUP LA - 4/7/09; LOTT SAMKANG CHOCOLATE FLAVORDED ICE BAR (PAPICO) LA 3/16/09, ETC SPL LACTIC ACID CAS 50-21 - FAP ORDINANCE & CODE REGULATING EATING & DRINKING ESTABLISHMENTS - RECS 3/38 MATRIXX INITATIVES INC - ZICAM COLD REMEDY INTRANSAL PRODS CORR, DIRECTIVE ISSUED, ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ARCHMEDES - LAZANDA (FENTANYL CITRATE) NDA 22-569 APRVL LTR, LBLG, RVWS 6/30/11 RUBY HOLDER STRAUS PARTNERS REGENERON PHARMS - EYLEA BLA 12-5387 AERS FDA/OMPT/CDRH/OCER/DFOI/ A ROBERT DEPALMA SAMSUNG MEDISON AMERICA INC RUBY HOLDER STRAUS PARTNERS VERTEX PHARMS - INCIVEK NDA 20-1917 AERS SAMSUNG MEDISON CO LTD, SEOUL , KOREA - EIR 7/3/08 SHELDON T. BRADSHAW HUNTON & WILLIAMS LLP FDA WORK PLAN SENT TO SEATTLE DISTRICT Signature/ Requester TIGRIS PHARMACEUTICALS INC Subject
2012-879 2012-880 2012-881
02/09/2012 03/09/2012 02/09/2012 03/09/2012 02/09/2012
FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/
ANEET PANESAR BURDOCK GROUP MIKE VANDERHEIJDEN YALE LAW SCHOOL WILLISTON C WHITE
Page 822 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/09/2012 2012-882 02/09/2012 03/09/2012 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-883 02/09/2012 03/09/2012 2012-884 02/09/2012 03/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-885 02/09/2012 03/09/2012 2012-886 02/09/2012 03/09/2012 2012-887 02/09/2012 03/09/2012 2012-888 02/09/2012 03/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-889 02/09/2012 03/09/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-890 02/09/2012 03/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OWEN GARRICK, MD MBA BRIDGE CLINICAL RESEARCH CLNCL INVESTIGATORS WHO PERFORM PHASE 3 STUDIES IN THE US 1/06 TO 12/31/11 LESLIE B. ROSE PHARMAVISION CONSULTING LTD ANTINEOPLASTON - EFFICACY GAIL LESSICK LACHMAN CONSULTANT SERVICES INC JUSTIN P. STALPES, Esq. BECK & AMSDEN PLLC ABILIFY- AERS DOMESTIC & FOREIGN INSP 12/11 FDA/OMPT/CDRH/OCER/DFOI/ ROBIN L. ROWE STRYKER INCUBATION OF MEDICAL TECHNOLOGY MARTHA GUZMAN AMSINO INTERNATIONAL INC AMSINO - DISPOSABLE VAGINAL SPECULUM K951528 ORTHOMET INC - AXIOM TOTAL KNEE SYS K926334 Cutler, Charles OC/OSHC/OPD/ MARILYNN WHITNEY COVINGTON & BURLING LLP ORPHAN DRUG DESIGNATION - EXEMESTANCE, EPIRUBICIN NON-CONFIDENTIAL PORTIONS, CORR, WRITTEN DECISIONS FREEZING TUMORS PHASE I TRIALS - ADDRESS TO DOCTORS IN FL Signature/ Requester WILLISTON C WHITE & ASSOC PC ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS Subject ADMINISTRATIVE ORDER QUINTILES IRELAND LTD, DUBLIN 3, IRELAND - 483, CO RESP 5/17/10
Page 823 of 1132

Total Records: 12455 Control # 2012-891 2012-892 Recd Date / Due Date 02/09/2012 03/09/2012 02/09/2012 03/09/2012 2012-893 02/10/2012 03/12/2012 2012-894 02/10/2012 03/12/2012 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-895 2012-896 02/10/2012 03/12/2012 02/10/2012 03/12/2012 2012-897 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-898 2012-899 02/10/2012 03/12/2012 02/10/2012 03/12/2012 FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ KATHERINE STRONG CARNER SIDLEY AUSTIN LLP PATTI WALLER MARLER CLARK ATTYS MEDICAL DVC PROD CODE DXT, IZQ, FPK 0R NEP UNTITLED LTRS WEGMANS FOOD MARKETS, SUNRISE COMMODITIES, BADIA SPICES, ETC - TURKISH PINE NUTS SALMONELLA ENTERIDITIS OUTBREAK LAB RESULTS, CORR, RECALL RECS, ETC 8/11 TO 10/11 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ SMITH, VIRGIL L ELLEN GABLER MILWAUKEE JOURNAL SENTINEL VAL SAWYER ZYMOGENETICS INC AMERICAN RED CROSS, OSHKOSH, WI, BLOOD CENTER OF WISCONSIN INC, INTERSTATE BLOOD BANK OF WISCONSIN INC, ETC - EIRS 1/09 TO PRESENT ISR 7563149 INDIVIDUAL RECS SARAH M JOHNSON GIEGER LABORDE & LAPEROUSE LLC NATHAN A BEAVER FOLEY & LARDNER LLP CHISESI BROTHERS MEAT PACKING COMPANY INC - EIRS, CMPLNTS, WARNING LTRS, ETC Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester NICK DEMCZUK IENJOY TECHNOLOGIES ROBERT F. CLARKE, Esq. CLARKE LAW OFFICES Subject ADVANTAGEOUS MEDICAL DEVICES - AMD 6605 PRODUCT K092990 BRAIN STATE TECHNOLOGIES CMPLNTS
JANSSEN PHARMS - ELMIRON (PENTOSAN POLYSULFATE SODIUM) NDA 20-193 SBA
Page 824 of 1132

Total Records: 12455 Control # 2012-900 Recd Date / Due Date 02/10/2012 03/12/2012 2012-901 02/10/2012 03/12/2012 FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OM/OMP/DODM/ 2012-902 2012-903 02/10/2012 03/12/2012 02/10/2012 03/12/2012 2012-904 02/10/2012 03/12/2012 2012-905 2012-906 02/10/2012 03/12/2012 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-907 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-908 02/10/2012 03/12/2012 2012-909 02/10/2012 03/12/2012 2012-910 02/10/2012 03/12/2012 2012-911 02/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON ENTRY #S 2009-5201-20018301/NS100040022 - NOTICE TO MARK &/OR REDELIVER; FDA NOTICE OF ACTION 1 RECS 2009-5201-20013301/ASA10135097 - NOTICE TO MARK &/OR REDELIVE; FDA NOTICE OF ACTION #1 2009-5201-20029801/U16514028' 2009-520120031401/U1652147046 - NOTICE TO MARK &/OR RECELIVER, fda NOTICE OF ACTION #1 2010-5201-20026901/U1652158258 - NOTICE OF MARK &/OR DANIEL GETTS TOLERA THERAPEUTICS INC CENTOCOR ORTHO BIOTECH PRODUCTS LP ORTHOCLONE OKT3 (MUROMAB-CD3) BLA 103463/0 RECS ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ WILLIAM J GORMAN GORMAN CONSULTING INC MARY B SZALKOWSKI PRISMA CORP ZOLOFT (SERTRALINE) - AERS CIRCA SCIENTIFIC - K112376 FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ DEBRA HATHAWAY THINC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC JERRY BALDINO JR NORTHEAST PRODUCE INC ONCOLOGIC DRUGS A/C - TRANS, MINS, AGENDA, ETC 12/12/94 iOVATE, HYDROXYCUT, SMARTBURN ETC - PRODUCTION & CAERS RECS, 11/14/11 TO PRESENT CMPLNT #123942 Action Office OM/OMP/DODM/ Signature/ Requester TINA WOLFSON AHDOOT & WOLFSON PC LAURA KNOLL KNOLL LAW FIRM LLC Subject GUIDANCE FOR INDUSTRY: JUICE HACCP HAZARDS & CONTROLS GUIDANCE FIRST EDITION; FINAL GUIDANCE 3/3/04 - MINS, TOXICOLOGICAL RECS, CORR ETC ATT&T WIRELESS SERVICES INC, SOUTHWESTERN BELL MOBILE SYSTEMS LLC, SBC WIRELESS INC, ETC BIOLOGOICAL AND/OR PSYCHOLOGICAL EFFECTS OF CELL PHONE USE CORR, TEST DATA, MTG MINS, ETC
Page 825 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/12/2012 2012-912 02/10/2012 03/12/2012 2012-913 02/10/2012 03/12/2012 2012-914 02/10/2012 03/12/2012 2012-915 2012-916 2012-917 2012-918 2012-919 2012-920 2012-921 02/10/2012 03/12/2012 02/10/2012 03/12/2012 02/10/2012 03/12/2012 02/10/2012 03/12/2012 02/10/2012 03/12/2012 02/10/2012 03/12/2012 02/10/2012 03/12/2012 ORA/CE-FO/MIN-DO/MCB/ CBER/OCTMA/DDOM/ALFB/ OSBORNE, KAREN AMY TRENTHAM-DIETZ PHD UNIV OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-924 02/10/2012 03/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DEVANE, HEATHER LIST OF FDA FOI REQUESTS 12/1-31/99 NOAH PRANSKY WTSP-TV MICHAEL R COHEN RPH MS SCD INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 1/1/122/1/12 WISCONSIN MAMMOGRAPHY FACILITIES - EIRS 2002 TO PRESENT ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ Signature/ Requester AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC ANTOINETTE JACKSON AVALON RISK MANAGEMENT INC MEGAN JURGENS Celgene Corporation MEGAN JURGENS Celgene Corporation W PATRICK NOONAN W PATRICK NOONAN MARIA F MUNOZ SEADCO USA CORP JULIA YEH SHL PHARMA VENOM IMMUNOTHERAPY - VAERS Subject REDEKUVER, FDA NOTICE OF ACTION #1 2010-5201-20015201/DM402619835 - NOTICE TO MARK &/OR REDELIVER' FDA NOTICE OF ACTION #1 ENTRY #S 2010-5201-20039001/AFP10001468 - NOTICE TO MARK &/OR REDELIVER, FDA NOTICE OF ACTION #1 ENTRY NO EPS09846203M CASE #2010-2809-20026401 BOND (CF301) SUBGKE, NOTICE OF FDA ACTION #1 APP PHARMACEUTICALS LLC, MELROSE PARK, IL EIRS,1/15/10, 1/20/10, 1/29/10, ETC 2010-2011 APP PHARMACEUTICALS LLC, GRAND ISLAND, NY - EIRS 9/9-11/09, 9/14-17/09, ETC 9/09-8/29/11 21ST CENTURY HEALTHCARE INC, TEMPE, AZ - EIRS, 483S, CORR ETC, 8/3/11 TO PRESENT ENTRY # E4P-0018031-5 - FROZEN PASTEURIZED EXTRA JUMBO U-130 SAMPLES LAB RESULTS OWEN MUMFORD USA INC, MARIETTA, GA - K013362
2012-922 2012-923
02/10/2012 03/12/2012 02/10/2012 03/12/2012
PYURWATER, AKIN ASHEKUN - INVESTIGATION RECS
Page 826 of 1132

Total Records: 12455 Control # 2012-925 Recd Date / Due Date 02/10/2012 03/12/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-926 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ 2012-927 02/10/2012 03/12/2012 OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-928 02/10/2012 03/26/2012 2012-929 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-930 02/10/2012 03/12/2012 2012-931 02/10/2012 03/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SYLVESTER & MALEY, INC FDA/OMPT/CDRH/OCER/DFOI/ THOMAS J HUNTER BIORESOURCE TECHNOLOGY INC BIORESOURCE TECHNOLOGY INC - NOVA-ONE LIPID CONTROL K040352 THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN) - AERS, 2007 SIEGEL, JONATHAN B FDA/OMPT/CDRH/OCER/DFOI/ LINDA KO TAIDOC TECHNOLOGY CORP OMRON HEALTHCARE INC - MICRO-AIR VIBRATING MESH NEBULIZER, K062263; HEALTH & LIFE CO LTD ULTRASONIC NEBULIZER SYS, K081738 NISSHIN PHARMA INC, NAGANO, JAPAN - EIRS, 483S, PREAPRVL INSP RECS KORENVAES, MAX NOVARTIS - SYNACTHEN DEPOT A/C TRNAS HENRY F BAYARD COOLE SCOTT KISSANE PA AVASTIN (BEVACIZUMAB) - AERS Signature/ Requester HENRY F BAYARD COOLE SCOTT KISSANE PA Subject AVASTIN - ISRS 7624779, 7624881, 7625926, ETC
Page 827 of 1132

Total Records: 12455 Control # 2012-932 Recd Date / Due Date 02/10/2012 03/12/2012 2012-933 02/10/2012 03/12/2012 2012-934 02/10/2012 03/12/2012 2012-935 2012-936 02/10/2012 03/12/2012 02/10/2012 03/12/2012 ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-937 02/10/2012 03/12/2012 ORA/ ORA/ ORA/ORM/ ORA/ORM/ 2012-938 02/10/2012 03/12/2012 2012-939 2012-940 02/10/2012 03/12/2012 02/10/2012 03/12/2012 2012-941 2012-942 02/13/2012 03/13/2012 02/13/2012 03/13/2012 ORA/CE-FO/CHI-DO/CCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ ORA/CE-FO/CIN-DO/CCB/ TRAVIS SCHAFTENAAR UBS GLOBAL ASSET MANAGEMENT MARC J PAULSON SCOULAR CO RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC CRIAG ROUSH ROCKLINE INDUSTRIES PAUL W TRIPP LINCARE INC ACORN STAIRLIFTS INC - NON-WORKLOAD OBLIGATION ESTABLISHMENT INTEGRA LIFESCIENCES, AKRON, OH - 483S, 1/10 TO PRESENT LISTING OF APRVD MEDICATED FEED MILL LICENSES THOMPSON, RAY GMP, GLP & GCP INSPECTIONS - SITES OF INSPS, 6/1112/11 & F/U RECS KORENVAES, MAX FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester THOMAS J HUNTER PHD BIORESOURCE TECHNOLOGY INC THOMAS J HUNTER PHD BIORESOURCE TECHNOLOGY INC THOMAS J HUNTER PHD BIORESOURCE TECHNOLOGY INC STUART PFEIFER LOS ANGELES TIMES Subject BIORESOURCE TECHNOLOGY INC - LIQUITROL LIQUID HUMAN GLYCOSYLATED HEMOGLOBIN (A1C) CONTROL K023032 BIORESOURCE TECHNOLOGY INC - NOD CHEMISTRY CONTROL K060850 BIORESOURCE TECHNOLOGY INC - LIQUID HUMAN PROTEIN ELECTROPHORESIS CONTROL K944728 1-800-GET-THIN LAP-BAND SURGERIES MISLEADING ADS - CORR, CO RESPS FARMACIA CERATI - SYNACTHEN DEPOT A/C TRANS
US NONWOVENS CORP, BRENTWOOD, NY - CORR 11/3010-2/9/12 MIDWEST SOLUTIONS FOR SLEEP INC, IL - EIRS, 483S, WARNING LTRS 1/05 TO PRESENT
Page 828 of 1132

Total Records: 12455 Control # 2012-943 Recd Date / Due Date 02/13/2012 03/13/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-944 02/13/2012 03/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-945 2012-946 02/13/2012 03/13/2012 02/13/2012 03/13/2012 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-947 02/13/2012 03/13/2012 2012-948 02/13/2012 03/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-949 2012-950 2012-951 02/13/2012 03/13/2012 02/13/2012 03/13/2012 02/13/2012 03/13/2012 ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/MIN-DO/MCB/ BOGUE, JIM TED JOACHIMOWSKI GLOBAL PHARMACEUTICAL SUPPLY GROUP LLC ORA/CE-FO/PHI-DO/PCB/ Doe J GALLIPOT (FAGRON) - ACTIVE PHARMACEUTICAL INGREDIENT (API) QUALITY CONTROL CMPLNTS GLOBAL PHARMACEUTICAL SUPPLY GROUP LLC, MALVERN,PA - EIR 5/20/11 INDIVIDUAL RECS SWOPE, CARL T FDA/OMPT/CDRH/OCER/DFOI/ RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC ZOCOR, SIMVASTATIN - WARNINGS TRADE CMPLNT 7/20/05 FDA NEWS ROBERT H TOURTELOT ROBERT H TOURTELOT PLC PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG, CLNCL TRIAL FACILITIES IN AND OUTSIDE THE US - 483S 1/-31/12 MELANOCORP INC, HENDERSONVILLE, TN - MELANOTAN II CMPLNTS DR PAUL HUTTON GREATER MANCHESTER WEST LUNDBECK - QUETIAPINE IR CLNCL TRIAL RECS CANACCORD GENUITY Signature/ Requester Subject AVANIR - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE) - AERS 1/11 TO PRESENT
Page 829 of 1132

Total Records: 12455 Control # 2012-952 Recd Date / Due Date 02/13/2012 03/13/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester CRAIG ETHEN SPENCER TECHNOLOGIES Subject CARDIOYNAMICS - BIOZ RX MODEL 7101-SYS K090602; BIOZDX HEMODYNAMIC MONITOR K041294; IMPEDIMED EXTRACELLULAR FLUID ANAYZER MODEL L-DEX U400 K100811, ETC NOVACARE LLC, SALT LAKE CITY, UT - EIR 3/8-22/10; AMERICAN PHARMACEUTICAL & NATURAL FOODS CORP, BILLINGS, MT - EIRS 8/5-6/10 IMAGYN TECHNOLOGIES - REFLEX ESC 5MM SCISSORS K924200/A PAXIL (PAROXETINE) - AERS DAVIS #149193, RICHARD
2012-953
02/13/2012 03/13/2012
ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
TREVI PIES NUTRITIONAL LABORATORIES INTL LISA ANDERSON CONMED CORP
2012-954 2012-955
02/13/2012 03/13/2012 02/13/2012 03/13/2012
2012-956
02/13/2012 03/13/2012
JOANNE S HAWANA ARENT FOX LLP
SEPTOCAINE INJ, AREICAINE HCL - ISR 747802, 7701835, 7600666, ETC
2012-957 2012-958 2012-959 2012-960
02/13/2012 03/13/2012 02/13/2012 03/13/2012 02/13/2012 03/13/2012 02/13/2012 03/13/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/
AMY L GOERSS HODGSON RUSS LLP TOMAS JOHANSSON PHD ASTRA TECH AB TOMAS JOHANSSON PHD ASTRA TECH AB TOMAS JOHANSSON PHD ASTRA TECH AB
3M ESPE DENTAL PRODUCTS - LAVA ULTIMATE IMPLANT CROWN RESTORATIVE K110131 COLOPLAST A/S - PERISTEEN ANAL IRRIGATION SYS K083770 COLOPLAST A/S - PERISTEEN ANAL IRRIGATION SYS K103254 ROSTAM LTD - SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS K102445 SCHIYOPHRENIA
2012-961
02/13/2012 03/13/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FAUST 01B2507, BRIAN
2012-962 2012-963
02/13/2012 03/13/2012 02/13/2012 03/13/2012
OC/COS/OL/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
JIM BRUNNER SEATTLE TIMES
CORR BETWEEN FDA & US REP JAY INSLEE 1/06 TO 2/9/12 LIST OF LABS THAT MAKE GENERIC KEPPRA
Doe J
Page 830 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-964 02/14/2012 03/14/2012 2012-965 02/14/2012 03/14/2012 2012-966 02/14/2012 03/14/2012 2012-967 02/14/2012 03/14/2012 2012-968 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-969 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-970 02/14/2012 03/14/2012 2012-971 02/14/2012 03/14/2012 2012-972 02/14/2012 03/14/2012 2012-973 02/14/2012 03/14/2012 2012-974 02/14/2012 03/14/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE ROBBI PERRY NORTH AMERICAN RESCUE LLC DENTAL TENCHOLOGIES INC, LINCOLNWOOD, IL - EIR, 483 3/11-4/11 SEMLER TECHNOLOGIES INC - COMPRESSAR FEMORAL ACCESS COMPRESSION DVC K002767 PACE TECH, CLEARWATER, FL - EIR, 483 7/11 MEDICAL COMPRESSION SYSTEM, OR-AKIVA, ISRAEL EIR, 483 6/11 PN MEDICAL, ORLANDO, FL - EIR, 483 2011 KEN REID WASHINGTON INFORMATION SOURCE AKZXO NOBEL CHEMICALS, LOS REYES LA PAZ, MEXICO EIR, 483 6/11 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE NOVARTIS INTERNATIONAL, BASEL, SWITZERLAND - EIR, 483 8/11 INTERNATIONAL ISOTOPES INC, IDAHO FALLS, ID - EIR, 483 7/11 CRESCENDO THERAPEUTICS, VISTA, CA - EIR, 483 4/11 KBS, CRESCENT SPRINGS, KY - EIR, 483 7/11 BECKMAN COULTER, MIAMI, FL - EIR, 483 2/11-6/11 Signature/ Requester Subject
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Total Records: 12455 Control # 2012-975 Recd Date / Due Date 02/14/2012 03/14/2012 Action Office ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ 2012-976 2012-977 02/14/2012 03/14/2012 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-978 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-979 02/14/2012 03/14/2012 2012-980 2012-981 02/14/2012 03/14/2012 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-982 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-983 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ JOSHUA SILVERMAN WILLIAMSON PETTY LC RECOMP PERFORMANCE NUTRITION - HAVOC AERS, MEDWATCH FORMS, COMM, ETC FREDERICK A STEARNS Keller and Heckman LLP FLUORIDE DRUG PRODS - APPL, SUPPL, CERTIFICATES 1/09 TO PRESENT FLOYD SKEREN & KELLY LLP ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ RODRIGUEZ, JUAN COCA LEF EXTRACT (ERYTHROXYN COCA) - ANALYSES, TEST RESULTS, GRAS RECS DIFLUCAN (FLUCONAZOLE) TABS - AERS CLAUDIA HORNBACK ASIAN EXOTIC GROWERS - ENTRY #FE700049490, ROANOKE TRADE SERVICES INC FE700050597, FE700049854, ETC NOTICES OF REFUSAL, NOTICE OF REDELIVERY, CF28 & CF29 DANIEL R EVANS MERCHANT & GOULD CASPOFUNGIN ACETATE INJ ANDA 91-598 - WITHDRAWAL RECS Doe J FDA/OF/CFSAN/OCD/EOS/ NATHAN A BEAVER FOLEY & LARDNER LLP FENTANYL 72 HR PATCHES - AERS GCJ CHEILJEDANG - D-PSICOSE GRAS 400 Doe J Signature/ Requester Subject INDIVIDUAL RECS
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Total Records: 12455 Control # 2012-984 2012-985 2012-986 Recd Date / Due Date 02/14/2012 03/14/2012 02/14/2012 03/14/2012 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-987 02/14/2012 03/14/2012 ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-988 02/14/2012 03/14/2012 ORA/CE-FO/BLT-DO/CB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ 2012-989 02/14/2012 03/14/2012 2012-990 02/14/2012 03/14/2012 2012-991 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-992 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-993 2012-994 02/14/2012 03/14/2012 02/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ BARRY MEIER NEW YORK TIMES PAMELA SCHANEEN VAGIFEM - APRVL LTR SENT FROM FDA TO DEPUY ORTHOPAEDICS 8/13/09 PAMELA SCHANEEN SHIONOGI INC ESTRING - VAGINAL RING SBA ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ KENNETH REID WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE PAMELA SCHANEEN SHIONOGI INC ROCKET MEDICAL, TYNE & WEAR, UK - 483, EIR, CO RESP 7/11 LESLIE E DIAZ MD, NORTH PALM BEACH - 483, EIR, CO RESP 1/11 TO 3/11 ESTRACE - VAGINAL CREAM ANDA 86-069 SBA KENNETH REID WASHINGTON INFORMATION SOURCE MEASUREMENT SPECIALTIES INC, HAMPTON, VA - EIR, 483, CO RESP 5/11 TO 7/11 KENNETH REID WASHINGTON INFORMATION SOURCE JAZZ PHARMS, PALO ALTO, CA - 483, EIR, CO RESP 4/11 TO 5/11 CVM/OCD/ Action Office ORA/SE-FO/FLA-DO/FCB/ BENAVENTE, MARIA KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. KENNETH REID WASHINGTON INFORMATION SOURCE SMITHKLINE BEECHAM, WORTHING, UK - 483, EIR, CO RESP 3/11 CORR BETWEEN FDA & DSM NUTRITIONAL PRODUCTS Signature/ Requester Subject ADVANCE GENERIC CORP, MIAMI, FL - EIRS, 483S 8/10
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Total Records: 12455 Control # Recd Date / Due Date 03/14/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-995 02/14/2012 03/14/2012 2012-996 02/14/2012 03/14/2012 ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ CBER/OCTMA/DDOM/ALFB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-997 02/14/2012 03/14/2012 2012-998 02/14/2012 03/14/2012 2012-999 02/14/2012 03/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1000 2012-1001 2012-1002 02/14/2012 03/14/2012 02/15/2012 03/15/2012 02/15/2012 03/15/2012 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-1003 02/15/2012 ORA/ ANUJ DESAI JITC LLC, ROBERT JANITZEK, I-GRAIN LLC, ETC - CHIA ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDRH/OCER/DFOI/ MIKE NIKITAS NEW ENGLAND CABLE NEWS WILLIAM R. PINIZIO WOLFF SAMSON PC ANNA DEMKOVIC ABBOTT LABORATORIES, INC. CMPLNT 123977 NUCLEA BIOTECHNOLOGIES , WILMINGTON, DE - PRESS RELEASE RAM MEDICAL, WAYNE, NJ - EIR 9/18-25/07 CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DIETMAR WITTMANN, MD, PhD, FACS APERTA LLC LAUREN TORNETTA ENDO PHARMACEUTICALS NUCYNTA ER (TAPENTADOL HYDROCHLORIDE) NDA 00533 APRL K093166 BRAD RACINO INVESTIGATIVE NEWSOURCE EMAILS SENT TO CBER STAFF REGARDING BLOOD PRODUCTS FROM MEXICO BRAD RACINO INVESTIGATIVE NEWSOURCE IMPORTED & EXPORTED WHOLE HUMAN BLOOD PRODUCTS 3002905110 GISSENDANNER, ROBIN CMPLNT 120110 Signature/ Requester SHIONOGI INC Subject
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Total Records: 12455 Control # Recd Date / Due Date 03/15/2012 Action Office ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-1004 02/15/2012 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1005 02/15/2012 03/15/2012 2012-1006 02/15/2012 03/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1007 02/15/2012 03/15/2012 2012-1008 02/15/2012 03/15/2012 2012-1009 02/15/2012 03/15/2012 2012-1010 02/15/2012 03/15/2012 2012-1011 02/15/2012 03/15/2012 2012-1012 02/15/2012 03/15/2012 2012-1013 02/15/2012 03/15/2012 2012-1014 02/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID 2011-5831, 2011-5832, 2011-5837, ETC 2011-5328, 2011-5331, 2011-5342, ETC 2011-4963, 2011-5033, 2011-5034, ETC 2011-4142, 2011-4269, 2011-4296, ETC 2011-3869, 2011-3871, 2011-3872, ETC 2011-9339, 2011-9342, 2011-9345, ETC 2011-9081, 9082, 9083, ETC 2011-2934, 2011-2951, 2011-3200, ETC KEN REID WASHINGTON INFORMATION SOURCE ARETA KUPCHYK NIXON PEABODY LLP AMERICAN REGENT - VENOFER (IRON SUCROSE), DEXFERRUM (HIGH MOLECULAR WEIGHT IRON DEXTRAN); SANOFI-AVENTIS - FERRLECIT (SODIUM FERRIC GLUCONATE) AERS 10/09 TO 6/10 2011-2016, 2011-5188, 2011-5375, ETC ARETA L KUPCHYK NIXON PEABODY LLP WARTSON - INFED (LOW-MOLECULAR WEIGHT IRON DEXTRAN); AMAG - FERAHEME (FERUMOXYTOL) AERS 10/09 TO 6/10 Signature/ Requester ARNALL GOLDEN & GREGORY, LLP Subject SEEDS (SALVIA HISPANICA) SHIPMENT PERMITS, LICENCES, PACKING LISTS, ETC
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Total Records: 12455 Control # Recd Date / Due Date 03/15/2012 2012-1015 02/15/2012 03/15/2012 2012-1016 02/15/2012 03/15/2012 2012-1017 02/15/2012 03/15/2012 2012-1018 02/15/2012 03/15/2012 2012-1019 02/15/2012 03/15/2012 2012-1020 2012-1021 02/15/2012 03/15/2012 02/15/2012 03/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1022 2012-1023 02/15/2012 04/25/2012 02/15/2012 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1024 02/15/2012 03/15/2012 2012-1025 02/15/2012 03/15/2012 ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ CHARLES LIU DONGGUAN NTC CO LTD NANCY HIGLEY PHD PEPSICO DONGGUAN GOLDYIP ELECTRONIC SCIENCE & TECH CO LTD - PORTABLE STEREO CD/MP3 PLAYER WITH AM/FM RADIO LASER PROD RPT PEPSICO, BRADENTON, FORT PIERCE - SPLS 687768, 687769, 68770, ETC SUMMARY RPTS FDA/OMPT/CDRH/OCER/DFOI/ KALVARIA, HYLTON DAVID PATTON PATTON LAW PRACTICE LIDOCAINE INJ - AERS 2004 TO 2012 NATURE'S CRADLE - K9702334, K951024, K901763, ETC Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CARRELL, SCOTT H SUSAN H WEINKLE MD American Society for Dermatologic Surgery Association DERMATEND - INVESTIGATION CORR 9/11 Signature/ Requester WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE OTC TENS - K063660 2011-8315, 2011-8347, 2011-8613, ETC 2011-6843, 2011-6996, 2011-7036, ETC 2011-6509, 2011-6510, 2011-6511, ETC 2011-6402, 2011-6403, 2011-6404, ETC 2011-6349, 2011-6364, 2011-6365, ETC Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SE-FO/FLA-DO/FCB/ 2012-1026 2012-1027 02/15/2012 03/15/2012 02/15/2012 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1028 02/15/2012 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1029 2012-1030 02/15/2012 03/15/2012 02/15/2012 03/15/2012 2012-1031 02/15/2012 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1032 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1033 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1034 02/16/2012 FDA/OMPT/CDER/ORP/DIDP/ JOHN J HAY PFIZER GMBH, MOOSWALDALLE, GERMANY - 6/30/11; PFIZER HEALTH AB, STRANGNAS, SWEDEN - 1/27/11; JOHN J HAY SALANS ATTY WATSON PHARMA PRIVATE LTD, VERNA, GOA, INDIA - 483 2/2/11 JOHN J HAY SALANS ATTY WYETH MEDICA, IRELAND - 483 4/24/09 CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ CARRELL, SCOTT H RUTH LAMLEY BAYER HEALTHCARE ANIMAL HEALTH DIVISION CHARLES CELESTE EAS Consulting Group, LLC NOVARTIS ANIMAL HJEALTH US INC - SENTINEL SPECTRUM (MILBEMYCIN OXIME, LUFENURON, PRAZIQUANTEL) NADA 141-333 FOI SUMMARY ISOSORBIDE MONOITRATE ER TABS ANDA 75-155 - APRVL LTR, LBLG, MOR, ETC OTC TENS - K052785 SHIPMAN, KIM ISRS 3011056, 3022350, 3030326, ETC OC/OM/OMP/DDM/ ANICE N. JAMISON MCDERMOTT WILL & EMERY SUZIE KESCHAMRUS AVANIR PHARMS AVANIR PHARMS - NUEDEXTA AERS, SAFETY RPTS DKT LOG 1990N-0165 Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 03/16/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1035 2012-1036 02/16/2012 03/16/2012 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1037 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1038 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1039 02/16/2012 03/16/2012 2012-1040 02/16/2012 03/16/2012 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1041 2012-1042 2012-1043 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1044 02/16/2012 ORA/ INDIVIDUAL RECS FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ MCKEEVER, STEVE ANNA DEMKOVIC ABBOTT LABORATORIES, INC. JOHN J HAY SALANS ATTY JOHN F FINNERTY JR FINNERTY LAW OFC DEPUY ORTHOPAEDICS INC - ASR XL ACETUBULAR SYS ARTIFICAL HIP IMPLANTS, PINNACLE SECTOR II ACETABULAR CUP SYS ARTIFICAL HIP IMPLANTS - NAMES, ADDRESSES, INDIVIDUALS WHO HAVE SUBMITTED CMPLNTS A- AMERICAN SELF STORAGE, CHERRY VALLEY, IL CERTIFICATION OR REGISTRATION NUMBER NESTLE - GOOD START SOOTHE PROD ATTACHMENTS, EXHIBITS, MINS, ETC BRISTOL-MYERS SQUIBB, ANAGNI, ITALY - 483 3/15/11 HENRY F BAYARD CSK Labs CHRONISCRIPT INC, WALGREENS, MIAMI, FL - INCIDENT RPTS, INVESITIGATION RPTS, CALLS, ETC FREDERICK A STEARNS Keller and Heckman LLP FLUORIDE DRUG PRODS NOT APRVD FOR MARKETING IN USA & NOT COVERED BY AN OTC DRUG MONOGRAPH APPL, SUPPL. CORR, ETC HUANG, ED ACCORD - TAROLIMUS ANDA 91-195; ACCORD MYCOPHENOLATE MOFETIL ANDA 90-253; ABBOTT CYCLOSPORINE ANDA 65-003, ETC BIOEQV FDA/OMPT/CDRH/OCER/DFOI/ M RHEA LEE DUFFY & PARTNERS HARTWELL P MORSE III HUSCH BLACKWELL LLP MYLAN PHARMA - IBANDRONATE SODIUM TABS ORAL NDA 78-995 APRVL LTR 12/28/09 I-FLOW CORP - K97217, K980558, K982946, ETC Signature/ Requester SALANS ATTY Subject PFIZER, IRELAND PHARMA, ETC - 483S 6/17/11
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Total Records: 12455 Control # Recd Date / Due Date 03/16/2012 2012-1045 02/16/2012 03/16/2012 Action Office ORA/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1046 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1047 02/16/2012 03/16/2012 2012-1048 2012-1049 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1050 02/16/2012 03/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1051 2012-1052 02/16/2012 03/16/2012 02/16/2012 03/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1053 02/16/2012 03/16/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-1054 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ M WADE SPARKS JENSEN & ASSOCIATES PLLC IBUPROFEN - AERS ALLEN WELCH MARS PETCARE US MARS PETCARE US, FORT SMITH, AR - SPL 677735 SUMMARY Doe J JOHN J HAY SALANS LLP ADDERALL - AERS 2011-6955 CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ MICHAEL GIVEL UNIV OF OKLAHOMA POLITICAL SCIENCE DEPT GRREG THOMPSON GENERAL MILLS FRANCES WONG CANACCORD GENUITY JOHN J HAY SALANS ATTY AVANIR - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE & QUINIDINE SULFATE), FOIA REQUESTS 1/1/11 TO PRESENT MERCK SERONO SPA, MODUGNO, ITALY 7/16/10; MERCK SHARP & DOHME (SINGAPORE) LTD, SINGAPORE 7/3/09; LABORATORIES MERCK SHARP & DOHME-CHIBRET, SAINT GERMAIN LAPRADE, FRANCE 5/27/11, ETC - 483S TOBACCO PROD SCIENTIFIC A/C RPT, 7/21/11 POLICY/PLANNING RECS, RPTS, COMM ETC MARS INC - DKT # FDA-2011-C-0878 PETER GALLAGHER ZIFF BROTHERS INVESTMENTS HEALTH CARE PROFESSIONAL CMPLNT LTRS - DRUG, DATE OF CMPLNT, MARKETING VIOLATION 2008 TO PRESENT JOHN J HAY SALANS ATTY HOSPIRA AUSTRALIA PTY, MULGRAVE, AUSTRALIA 3/21/11; HOSPIRA HEALTHCARE INDIA PVT LTD, SRIPERUMBUDUR, INDIA 3/30/11; ZYDUS HOSPIRA ONCOLOGY PVT LTD, AHMEDABAD, INDIA 11/10/09 - 483S Signature/ Requester Doe J Subject
Page 839 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1055 2012-1056 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1057 2012-1058 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1059 02/16/2012 03/16/2012 2012-1060 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1061 2012-1062 02/16/2012 03/16/2012 02/16/2012 03/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-1063 2012-1064 02/16/2012 03/16/2012 02/16/2012 03/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1065 2012-1066 02/16/2012 03/16/2012 02/16/2012 ORA/OCI/ FDA/OF/CFSAN/OCD/EOS/ HALEY CURTIS STEVENS PHD CALORIE CONTROL COUNCIL SHAUN ASSAEL LANCE ARMSTRONG INVESTIGATION CLOSURE RECS; CALORIE CONTROL COUNCIL MTG - MINS 2/7/12 CBER/OCTMA/DDOM/ALFB/ ALAN KATZ BLOOMBERG NEWS GREG POWELL GlaxoSmithKline TCA CELLULAR THERAPY - WARNING LTR RESP, CO RESP 4/19/11, TRANS, EMAILS, ETC BELIMUMAB - ISRS 7635482, 7729932, 7730830, ETC DR PETER D FOSTER HUHTAMAKI INC ALLEN WELCH MARS PETCARE US MARS PETCARE US, FORT SMITH, AR - SPL 728890 SUMMARY 2008-3976, 2008-3977 SCOTT #JY1512/L-27, SEAN FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DEN-DO/COMP/ AMANDA NERONE HEARTLAND LIONS EYE BANKS JOHN DOHERTY IOVATE HEALTH SCIENCES INTERNATIONAL INC JOHN DOHERTY IOVATE HEALTH SCIENCES INTERNATIONAL INC JACKED, HEMO RAGE, HEMORUSH, ETC - CAERS 11/11/11 TO PRESENT HERB ROBERT, RED ROBIN, CRANESBILL, ETC - CAERS 11/11/11 TO PRESENT SEROQUEL, AMBIEN, ATIVAN, DEPAKOTE - AERS VRL LABS, CENTENNIAL, CO - EIRS, 483S 2001 FDA/OMPT/CDRH/OCER/DFOI/ RICHARD BALL QIIMAGING LLC JOHN GILLINGS COLLINS STEWART LLC ZIMMER INC - 483S, (FEI:1000220733), CORR GEN1100056 - INVESTIGATION RESULTS Signature/ Requester Subject
Page 840 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/16/2012 2012-1067 02/16/2012 03/16/2012 Action Office ORA/OCI/ CBER/OCTMA/DDOM/ALFB/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/ ORA/ 2012-1068 2012-1069 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1070 02/16/2012 03/16/2012 2012-1071 02/16/2012 03/16/2012 2012-1072 02/16/2012 03/16/2012 2012-1073 02/16/2012 03/16/2012 2012-1074 02/16/2012 03/16/2012 ORA/ ORA/ OC/OCM/EMOPS/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ ORA/ ORA/ CVM/OCD/ OC/OCM/EMOPS/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ 2012-1075 02/16/2012 03/16/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Joan Stitt, UG2CD-16 MERCK & CO., INC. "A list of all FOIA requests closed 1/1-31/2012" on CD JoNel Aleccia MSNBC.COM Date Range: 06/01/2011 - 02/10/2012; FDA Office of Regulatory Affairs assignment for sampling and testing chicken jerky treats imported from China. Msnbc.com seeks any and all documents related to the ORA assignment to sample and test chicken jerky pet treats imported from China. SALES, BEN CASTLEBERRY FOOD PRODUCT 7/07 - FOOD SAFETY AUDIT SALES, BEN CONTAMINATION OF RAW ALFALFA SPROUTS 4/09 - FOOD SAFETY AUDIT SALES, BEN NESTLE SA, E COLI OUTBREAK 6/09 - SAFETY AUDIT SALES, BEN TACO BELL CORP, E. COLI OUTBREAK 11/06 - SAFETY AUDIT SALES, BEN FDA/OMPT/CDRH/OCER/DFOI/ ANDREW PROCHAZKA REHABTRONICS INC NESS H200 WIRELESS HAND REHAB SYS USER KIT & CLINICAN KIT - K111767 PISTACHIO PRODUCT OUTBREAK 6/09 - SAFETY AUDIT Signature/ Requester ESPN THE MAGAZINE DIANE HEMINWAY UNITED STEELWORKERS Subject JEFF NOVITZKY EXPENSE RECS, 2011 TO PRESENT AMERICAN RED CROSS - CORR 1/14/12 TO PRESENT
Page 841 of 1132

Total Records: 12455 Control # 2012-1076 Recd Date / Due Date 02/16/2012 03/16/2012 2012-1077 2012-1078 2012-1079 2012-1080 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1081 2012-1082 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1083 2012-1084 2012-1085 2012-1086 2012-1087 2012-1088 2012-1089 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1090 02/16/2012 ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OIASI/OCP/ OC/OIASI/OCP/ OC/OIASI/OCP/ OC/OIASI/OCP/ OC/OIASI/OCP/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OF/CFSAN/OCD/EOS/ TAMI L. WAHL Traditional Medicinals, Inc. LEAH R. KENDALL EPSTEIN BECKER & GREEN PC LEAH R. KENDALL EPSTEIN BECKER & GREEN PC LEAH R. KENDALL EPSTEIN BECKER & GREEN PC LEAH R. KENDALL EPSTEIN BECKER & GREEN PC LEAH R. KENDALL EPSTEIN BECKER & GREEN PC J. ROBERT YEOMAN B & R COMPLIANCE ASSOCIATES LLC PATRICK J. HIGGINS REQUEST FOR DISIGNATION (RFD) REDACTED JURISDICTIONAL DECISION LTS 2007 REQUEST FOR DESIGNATION (RFD) REDACTED JURISDICTIONAL DECISION LTRS FOR 2008 REQUEST FOR DESIGNATION (FRD) REDACTED JURISDICTIONAL DECISION LTRS 2009 REQUEST FOR DESIGNATION (RFD) REDACTED JURISDICTIONAL DECISION LTRS 2010 REQUEST FOR DESIGNATION (RFD) REDACTED JURISDICTIONAL DECISION LTRS 2011 GENERAL CHEMICAL LLC, MIDLOTHIAN, TX; BERKELEY HEIGHTS, NJ -EIRS 6/03 TO 1/12 INVACARE, SANFORD, FL - CORR 8/10 TO PRESENT CAERS # 146931 SALES, BEN PANAMERICAN FOOD CORP - ENTRY NO J3700068268 ROANOKE TRADE SERVICES INC NOTICES OF REFUSAL, FDA ACTION, NOTICE OF MARK/REDELIVER MICHELLE RYBAK SHELL EGG UPDATE 8/10 - AUDIT REPORT SALES, BEN Action Office ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ Joan Stitt, UG2CD-16 MERCK & CO., INC. Joan Stitt, UG2CD-16 MERCK & CO., INC. ANICE JAMISON MCDERMOTT WILL & EMERY SALMONELLA SAINTPAUL 6/08 - FOOD SAFETY AUDIT DKT FDA-1990-N-0033 FOI DAILY LOG 1/30/2012- 2/3/2012 FOI DAILY LOG 2/6-10/2012; SALES, BEN Signature/ Requester Subject DOLE FOOD COMPANY, E COLI IN SPINICH 9/06 - FOOD SAFETY AUDIT
Page 842 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/16/2012 Action Office ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1091 2012-1092 2012-1093 2012-1094 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 02/16/2012 03/16/2012 2012-1095 02/16/2012 03/21/2012 2012-1096 2012-1097 2012-1098 02/16/2012 03/20/2012 02/17/2012 03/19/2012 02/17/2012 03/19/2012 2012-1099 2012-1100 02/17/2012 03/19/2012 02/17/2012 03/19/2012 2012-1101 02/17/2012 03/19/2012 2012-1102 02/17/2012 03/19/2012 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DEN-DO/COMP/ ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ CBER/OCTMA/DDOM/ALFB/ BAYER, RICHARD D R IAN KLUGE Hyman, Phelps & McNamara, P.C. JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDANEWS JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDA NEWS JONATHAN ROCKMAN FDANEWS XLEAR INC, OREM,UT; ORALABS INC, PARKER, CO; BIOMERIDIAN INTL INC, SALT LAKE CITY, UT - 483S 11/130/11 CUSTOM INTERVENTIONAL PAIN MANAGEMENT LLC, SAN ANTONIO, TX - 483S 11/1-30/11 ALKERMES INC, WILMINGTON, OH; OSTEOSYMBIONICS LLC, CLEVELAND, OH; TRANSMOTION MEDICAL INC, SHARON CENTER, OH, ETC - 483S 11/1-30/11 SAGE PRODUCTS, CARY, ILL; ORGAN RECOVERY SYSTEMS INC, ITASCA, IL; THYSSENKRUPP ACCESS MFG LLC, ROANOKE,IL, ETC - 483S 11/1-30/11 AMERICAN RED CROSS DIAGNOSTIC MFG DIV, GAITHERSBURG,MD; CHEMPACIFIC CORP, BALTIMORE, MD; C-CARE LLC, LINTHICUM HEIGHTS, MD, ETC - 483S 11/1-30/11 ANDERSEN STERILIZERS INC, HAW RIVER, NC; SMISSONCARTLEDGE BIOMEDICAL LLC,MACON,GA; SHERTECH 2008-6691, 2008-4833, 2007-6715, ETC BLOOD PRODUCT A/C - EMAILS 7/08 TO 9/08; 6/10 TO 7/10 BECKY COOSEMAN BROWN & CROUPPEN PC INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ AYA AMEMIYA SEIKO EPSON CORP GEORGE REED MEDICA HEALTH SERVICES LLC CYNTHIA C. LLAMAS HICKS AND LLAMAS MICHAEL B. KIVORT BREWER LAW GROUP PLLC CMPLNT 124462 HAKOMED - ELECT PROELECDT K980892 RC CORNET MODEL 44F50 K983308 ERBE USA INC - ERBEJET 2 SYS K072404 Signature/ Requester POWERS & SANTOLA Subject
2012-1103
02/17/2012 03/19/2012
JONATHAN RICKMAN FDA NEWS
Page 843 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject LABORATORIES LLC, DUNCAN, SC, ETC - 483S 11/1-30/11 2012-1104 2012-1105 02/17/2012 03/19/2012 02/17/2012 03/19/2012 2012-1106 2012-1107 02/17/2012 03/19/2012 02/17/2012 03/19/2012 2012-1108 02/17/2012 03/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1109 2012-1110 02/17/2012 03/19/2012 02/17/2012 03/19/2012 ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DR SHELLY KAFKA MD, ALTOONA ARTHRITIS AND OSTEOPOROSIS CENTER ALTOONA CENTER FOR CLINICAL RSEARCH, DUNCANSVILLE, PA - 483S 2/00 TO 8/05 PAINEXX CORP, DETROIT, MI; CORIUM INTL INC, GRAND RAPIDS, MI; MICH CLONE ASSOC INC, MADISON HEIGHTS, MI - 483 11/11 DEEPAK PRODUCTS INC, MIAMI, FL; VIRTUAL IMAGING INC, DEERFIELD BEACH, FL; AVOTEC INC, STUART, FL - 483 11/11 MEKOS LABS APS, HILLEROD, DENMARK; MEDMIRA LABS INC, HALIFAX, CANADA; ALK ABELLO AS, HORSHOLM, DENMARK - 483 11/11 MITSUBISHI TANABE PHARMA FACTORY LTD, SANYO ONODA, JAPAN; MERCK SHARP & DOHME, SINGAPORE; JURON PTY LTD, RUTHERFORD, AUSTRALIA - 483 11/11 INNOVAMED USA INC - DETRUSAN 500 K994109 FOI SERVICES INC ORA/CE-FO/CHI-DO/CCB/ FOI SERVICES INC OM/OMP/DODM/ FOI SERVICES INC OM/OMP/DODM/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC SORIN GROUP DEUTSCHLAND GMBH, MUNCHEN, GERMANY - EIR, 483, WARNING LTR, ETC 4/11-13/11 JOINT MTG OF THE GASTROINTESTINAL DRUGS A/C & THE DRUG SAFETY & RISK MANAGEMENT A/C - TYSABRI (NATALIZUMAB) FOR CROHN'S DISEASE 7/31/07 PERIPHERAL AND CENTRAL NERVOUS SYSTEMS DRUGS A/C - TRANS 3/7-8/06 DR EDWARD KAPLAN MD, RUSH-PRESBYTERIAN ST LUKES MEDICAL CENTER, CHICAGO, IL - EIR, 483, WARNING LTR, ETC 2/6/91 TO 10/27/05 JANSSEN PHARMS - NUCYNTA ER (TAPENTADOL HCL) NDA 200-533 APRVL RECS
2012-1111
02/17/2012 03/19/2012
2012-1112
02/17/2012 03/19/2012
2012-1113
02/17/2012 03/19/2012
2012-1114
02/17/2012 03/19/2012
2012-1115
02/17/2012 03/19/2012
ANSAMED LTD, BOYLE, IRELAND; FUKUDA DENSHI CO LTD, TOKYO, JAPAN; SUHOU SEN SEN MEDICAL SUPPLIES LTD, SUZHOU, JIANGSU, CHINA - 483 11/11 GLAXO SMITH KLINE CONSUMER HEALTHCARE, ST. LOUIS,
2012-1116
02/17/2012
JOHNATHAN RICKMAN
Page 844 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/19/2012 Action Office Signature/ Requester FDA NEWS Subject MO; C&S ELECTRONICS INC, COLUMBUS, NE; MASTERCARE PATIENT EQUIP INC, COLUMBUS, NE - 483 11/11 MERIT CABLES INC, SANTA ANA, CA; CRANIAL TECHNOLOGIES INC, TEMPE, AZ; KERR CORP, ORANGE, CA - 483 11/11 TUFCO TECHNOLOGIES INC, GREEN BAY, WI; BIRCHWOOD LABS INC, EDEN PRAIRIE, MI; CHEM RITE COPAC INC, LANNON, WI - 483 11/11 AGFA HEALTHCARE CORP, WESTERLY, RI; FRESENIUS MEDICAL CARE HOLDINGS INC, WALTHAM, MA; ZOLL MEDICAL CORP, CHELMSFORD, MA - 483 11/11 CLOSED FOI REQUESTS 2/6-10/12
2012-1117
02/17/2012 03/19/2012
2012-1118
02/17/2012 03/19/2012
2012-1119
02/17/2012 03/19/2012
2012-1120
02/17/2012 03/19/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/
DEBI COHEN WOLTERS KLUWER LAW & BUSINESS
2012-1121 2012-1122
02/17/2012 03/19/2012 02/17/2012 03/19/2012
FOI CLOSED REQUESTS 1/30/12-2/3/12 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS JOHNATHAN RICKMAN FDA NEWS ROCHE MOLECULAR SYS INC, BRANCHBURG, NJ; ELECTRIC MOBILITY CORP, SEWELL, NJ; AUROLIFE PHARMA LLC, DAYTON, NJ - 483 11/11 FOI CLOSED REQUESTS 1/23-27/12 FOI SERVICES INC JOHNATHAN RICKMAN FDA NEWS LISA TARRISON-SCHRAMP CanReg, Inc. CROWN LABS INC, JOHNSON CITY, TN; HEALZ PLUS INC, SULPHUR, LA; ORALDNA LABS, BRENTWOOD, TN - 483 11/11 CLOSED FOI REQUESTS 1/23-27/12 FOI CLOSED REQUESTS 1/30/12-2/3/12 FOI CLOSED REQUESTS 1/23-27/12
2012-1123
02/17/2012 03/19/2012
2012-1124
02/17/2012 03/19/2012
2012-1125 2012-1126
02/17/2012 03/19/2012 02/17/2012 03/19/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
2012-1127
02/17/2012 03/19/2012
2012-1128
02/17/2012 03/19/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
LISA TARRISON-SCHRAMP CanReg, Inc.
CLOSED FOI REQUESTS 1/30/12-2/3/12
Page 845 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2012-1129 2012-1130 2012-1131 02/17/2012 03/19/2012 02/17/2012 03/19/2012 02/17/2012 03/19/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1132 02/17/2012 03/19/2012 2012-1133 02/17/2012 03/19/2012 2012-1134 02/17/2012 03/19/2012 2012-1135 2012-1136 02/21/2012 03/20/2012 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1137 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1138 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1139 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC COPAXONE (GLATRAMER ACETATE) - AERS (CERTIFIED) FOI SERVICES INC GILENYA (FINGOLIMOD) - AERS (CERTIFIED) FOI SERVICES INC REBI (NTERFERON BETA-1A)- AERS (CERTIFIED) FOI SERVICES INC OM/OMP/DODM/ FOI SERVICES INC ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SAN-DO/SFCB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS BIO MARIN PHARMS INC, NOVATO, CA; BIOZONE LABS INC, PITTSBURG, CA; XEMAX SURGICAL PRODUCTS INC, NAPA, CA - 483 11/11 NEUROCYBERNETICS INC, BELLVUE, WA; CASCADIA MANUFACTURING INC, BELLVUE, WA; MELALUECA INC, IDAHO FALLS, ID - 483 11/11 BAXTER HEALTHCARE CORP, JAYUYA, PR; CLINICAL MEDICAL SERVICES INC, CAROLINA, PR; ETHICON LLC, SAN LORENZO, PR - 483 11/11 PERIPHERAL & CENTRAL NERVOUS SYSTEM DRUGS A/C MINS 3/7-8/06 (CERTIFIED) EXTAVIA (INTERFERON BETA-1B) - AERS (CERTIFIED) ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICHMAN FDA NEWS LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 2/6-10/12 INFIMED INC, LIVERPOOL, NY; IVOCLAR VIVADENT INC, BUFFALO, NY; REICHART INC, DEPEW, NY - 483 11/11 BOEHRINGER LABS INC, PHOENIXVILLE, PA - 483 11/11 Signature/ Requester Subject
Page 846 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1140 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1141 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1142 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1143 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1144 02/21/2012 03/20/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FDA DRUG SAFETY PODCAST FOR HEALTHCARE POFESSIONAL; SAFETY UPDATES ON PROGRSSIVE MULTIFOCAL LEUKONENCEPHALOPAHTY (PAL) ASOCIATED WISTH TYSABRI (NATAIZUMAB) 4/26/11 (CERTIFIED) FDA DRUG SAFETY PODCAST FOR HEALTHCARE PROFESSIONAL; SAFETY UPDATES ON PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PAL) ASSOCIATED WITH TYSABRI (NATAZUMAB) 4/26/11 (CERTIFIED) COBALT LABS INC - IBANDRONATE SODIUM TABS ORAL NDA 79-002 APRVL LTR 3/15/11 FOI SERVICES INC WOCKHARDT - BROMFED-DM (BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HCL) ANDA 88-811 APRVL PKG 6/7/85 FOI SERVICES INC ADCETRIS (BRENWTUXIMAB VEDOTIN) - AERS (CERTIFIED) FOI SERVICES INC BETASERON (INTERFERON BETA-1B) - AERS (CERTIFIED) FOI SERVICES INC AVONEX (INTERFERON BETA 1-A) - AERS (CERTIFIED) Signature/ Requester Subject
2012-1145
02/21/2012 03/20/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC
2012-1146
02/21/2012 03/20/2012
HARTWELL P MORSE III HUSCH BLACKWELL LLP
2012-1147
02/21/2012 03/20/2012
HARTWELL P MORSE III HUSCH BLACKWELL LLP
COBALT LABS INC - IBANDRONATE SODIUM TABS ORAL NDA 79-003 APRVL LTR 3/15/11
2012-1148
02/21/2012
HARTWELL P MORSE III
ORCHID HEALTHCARE - IBANDRONATE SODIUM TABS
Page 847 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/20/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1149 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1150 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1151 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1152 02/21/2012 03/20/2012 2012-1153 02/21/2012 03/20/2012 2012-1154 02/21/2012 03/20/2012 2012-1155 02/21/2012 03/20/2012 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1156 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1157 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC CELLCEPT (MYCOPHENOLATE MOFETIL) - AERS (CERTIFIED) FOI SERVICES INC CAMPATH (ALEMTUZUMAB) - AERS (CERTIFIED) FOI SERVICES INC KATE WILSON THE CENTER FOR PUBLIC INTEGRITY ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS KRISTOPHER P DIULIO GIBSON DUNN ET AL AVANIR PHARMACEUTICALS INC, NUDEXTRA; FAVUS INSTITUTIONAL RESEARCH LLC, ELLIOT FAVUS REQUESTS, RESPS ARZERRA (OFATUMUMAB) - AERS (CERTIFIED) LIST OF HUMAN CELL & TISSUE ESTABLISHMENT REGISTRATIONS - EIRS 1/00 TO PRESENT K090820 HARTWELL P MORSE III HUSCH BLACKWELL LLP SUN PHARM INC LTD - IBANDRONATE SODUME INJ NDA 90-853 APRVL LTR 12/29/10 HARTWELLL P MORSE III HUSCH BLACKWELL LLP MUTUAL PHARM CO INC - IBANDRONATE SODIUM TABS ORAL NDA 78-996 APRVL LTR 12/13/11 HARTWELL P MORSE III HUSCH BLACKWELL LLP COBALT LABS INC - IBANDRONATE SODIUM TABS ORAL NDA 79-003 APRVL LTR 1/4/10 Signature/ Requester HUSCH BLACKWELL LLP Subject ORAL NDA 78-998 APRVL LTR 12/29/09
Page 848 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1158 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1159 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1160 02/21/2012 03/20/2012 2012-1161 02/21/2012 03/20/2012 2012-1162 02/21/2012 03/20/2012 2012-1163 2012-1164 2012-1165 02/21/2012 03/20/2012 02/21/2012 03/20/2012 02/21/2012 03/20/2012 ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1166 2012-1167 2012-1168 02/21/2012 03/20/2012 02/21/2012 03/20/2012 02/21/2012 03/20/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2012-489 - REQUEST LTR 2012-460 - REQUEST LTR 2012-455 - REQUEST LTR JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG-CD-16) MERCK & CO., INC. 2012-424 - REQUEST LTR 2012-410 - REQUEST LTR 2012-401 - REQUEST LTR Doe J INDIVIDUAL RECS Doe J INDIVIDUAL RECS Doe J INDIVIDUAL RECS FOI SERVICES INC RITUXAN (RITUXIMAB) - AERS (CERTIFIED) FOI SERVICES INC RAPTIVA (EFALIZUMAB) - AERS (CERTIFIED) Signature/ Requester Subject
Page 849 of 1132

Total Records: 12455 Control # 2012-1169 2012-1170 Recd Date / Due Date 02/21/2012 03/20/2012 02/21/2012 03/20/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-1171 2012-1172 02/21/2012 03/20/2012 02/21/2012 03/20/2012 2012-1173 02/21/2012 03/20/2012 2012-1174 2012-1175 02/21/2012 03/20/2012 02/21/2012 03/20/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1176 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1177 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1178 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC PROGRAF (TACROLIMUS) - AERS (CERTIFIED) FOI SERVICES INC NULOJIX (BELATACEPT) - AERS (CERTIFIED) FOI SERVICES INC MYFORTIC (MYCOPHENOLIC ACID) - AERS (CERTIFIED) FOI SERVICES INC VASSILIOS CHRISTODOULOPOULOA SANDOZ CANADA INC. FOI SERVICES INC KENNETH REID WASHINGTON INFORMATION SOURCE FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA NEWS RELEASE: FDA PERMITS MARKETING OF FIRST TEST FOR RISK OF RARE BRAIN INJECTIONS 1/20/12(CERTIFIED) 2010-7611, 2010-7085, 2010-8719 ETC - EIRS, 483S, & CO RESPS TYSABRI RISK MINIMIZATION ACTION PLAN SUMMARY OF TOUCH - RECS (CERTIFIED NDA 20-2514 - RECS MOLNLYCKE HEALTH CARE INC - MEPILEX K983184 FOI SERVICES INC Signature/ Requester JOAN STITT (UG2CD-16) MERCK & CO., INC. MEMO TO LANDS FROM FP LUDENA COMPARATIVE STUDY; MEMO TO BLACKMOLRE FROM NA; HULME, ORAL NEOSYNEPHINE CINTEST STUDY 2 Subject 2012-532 REQUEST LTR
Page 850 of 1132

Total Records: 12455 Control # 2012-1179 Recd Date / Due Date 02/21/2012 03/20/2012 Action Office ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ SALLEE, YARBI Signature/ Requester Subject TN HEALTH DEPARTMENT - HEPARIN POISONING RESULTS, CMPLNTS; SALLY HARDY - INVESTIGATION #23242 RECS, NOTES, ETC; METHODIST MEDICAL CENTER - MMCOR CMPLNTS, CORRECTION OF DEFICIENCY RPT, ETC RAPAMUNE (SIROLIMUS) - AERS (CERTIFIED) FOI SERVICES INC
2012-1180
02/21/2012 03/20/2012
2012-1181
02/21/2012 03/20/2012
LILLY ELIZABETH DWARKA EQUIPMENTS PVT LTD
SPECTRA GLASS LOR SYRINGES - K082671; TOP HYPODERMIC SYRING PISTON - K843414; TOP HYPODERMIC SYRING LUER LOCK - K843415, ETC REGENERON, RENSSELEAR, NY - REGENERON'S EYLEA (AFIBERCEPT INJ) BLA 125387 483S 5/20/11, 3/31/10, 9/21/07 1,2-DIMYRISTOYL-SN-GLYCERO-3(PYOSPHO-S-(1GLYCEROL); 1,2-DIMYRISTOYL-SN-GLYCERO-3PHOSPHOCHOLINE; 1,2-DIMYRISTOYL-SN-GLYERO-3PHOSPHOCHOLINE ETC - DRUGS USING THESE INACTIVE INGREDIENTS SANOFI-AVENTIS, SANOFI PASTEUR - HAEMOPHILUS INFLUENZAE TYPE B (HIB) VACCINE SHORTAGE EXIBITS 1 & 2 COMM 2007; MERCK & CO INC - PEDVAX HIB, COMVAX COMM, REDUCE OR HALT PRODUCTION 2007 TO 2010; ETC
2012-1182 2012-1183
02/21/2012 03/20/2012 02/21/2012 03/20/2012
ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
JOHN M BISHAI JP MORGAN GABRIEL ZIMMERMAN TEL-AVIV UNIV
2012-1184
02/21/2012 03/23/2012
CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/CE-FO/PHI-DO/PCB/ CBER/OCTMA/DDOM/ALFB/
ZACHARY D CAPLAN BERGER & MONTAGUE PC
2012-1185
02/21/2012 03/20/2012
CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/
JILLIAN NASH ALLTECH INC GARY J BURIN TECHNOLOGY SCIENCES GROUP INC
YUCCA SCHIDIGERA - NO OBJECTION LTRS LAST4 15 YRS
2012-1186
02/21/2012 03/20/2012
FCN #556
2012-1187 2012-1188
02/21/2012 03/20/2012 02/21/2012 03/20/2012
ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
MARIA F MUNOZ SEADCO USA CORP PETER DOSHI JOHNS HOPKINS UNIV SCHOOL OF MED
ENTRY #E4P-0018031-5 - EXTRA JUMBO U-130 LAB RESULTS GLAXOSMITH KLINE & F HOFFMAN-LA ROCHE ZANAMIVIR, NDA 021036 & OSELTAMIVIR, NDAS 021087 & 021246 INDEX
Page 851 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1189 2012-1190 02/21/2012 03/20/2012 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1191 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1192 02/21/2012 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1193 02/21/2012 03/20/2012 2012-1194 02/21/2012 03/20/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ 2012-1195 02/21/2012 04/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/DET-DO/DCB/ 2012-1196 2012-1197 02/21/2012 03/20/2012 02/22/2012 03/21/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ANTHONY H ANIKEEFF WILLIAM MULLEN MARK W TADER PICCIONE KEELEY & ASSOCICATES LTD DIDION MILLING INC, CAMBRIA, WI - EIRS, 483S, COMM ETC 9/09 - 7/1/10 FDA PUBLIC HEALTH ADVISORY: NEED FOR CAUTION WHEN USING VACUUM ASSISTED DELIVERY DEVICES (CERTIFIED) RONALD A MARCHESANI ONYX PHARMACEUTICALS ENZON INC - ONCASPER (PEGASPARGASE) WARNING LTRS, RECALLS, CORR ETC KENNETH WILTENBERG COMMERCIAL LEGAL OPERATIONS RONALD A MARCHESANI ONYX PHARMACEUTICALS CELLAY INC - PROMOTIONAL ACTIVITIES DOCUMENT NUMBER GEN1100561 & GEN110528, WARNING LTRS, UNTITLED LTRS, ETC SIGMA-TAU PHARMACEUTICALS - ONCASPER (PEGASPARGASE) WARNING LTRS, RECALLS, CORR ETC NED FEDER PROJECT ON GOVERNMENT OVERSIGHT PROJECT ON GOVERNMENT OVERSIGHT (POGO) CONCERNS ABOUT DRUG INTERACTIONS BTWN SEROQUEL AND METHADONE - CDER EVALUATION & RVWS JULIE FRANK REXAHN PHARMACEUTICALS INC TAXOMERE - NDA 20-449 APRVL LTR RVWS, SBA SHIPMAN, KIM CVM/OCD/ BIRGIT PUSCHNER UNIV OF CALIFORNIA XYLITOL ACTIVE INGREDIENT IN MEDS, (PRESCRIPTION & OTC) - RECS ISR #3229074 Signature/ Requester Subject
Page 852 of 1132

Total Records: 12455 Control # 2012-1198 Recd Date / Due Date 02/22/2012 03/21/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1199 02/22/2012 03/21/2012 2012-1200 02/22/2012 04/20/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/ ORA/ 2012-1201 02/22/2012 03/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1202 2012-1203 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1204 02/22/2012 03/21/2012 2012-1205 02/22/2012 03/21/2012 ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ELENA HOWELL HOGAN LOVELLS US LLP JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDA NEWS S&S PRIMELINE CHEMICAL SYSTEMS LLC,GRAPEFIEW,WA; TEC LABORATORIES INC, ALBANY, NY; ACUTE INNOVATIONS LLC, HILLSBORO, OR, ETC - 483S 10/1-31/11 INTRAOP MEDICAL CORP, SUNNYVILLE, CA; AFFYMETRIX INC, SANTA CLARA, CA; FRESENIUS USA INC, WALNUT CREEK, CA - 483S 10/1-31/1 SURGICAL DESIGN CORP, ARMONK, NY; PROFESSIONAL DISPOSABLES INTERNATIONAL INC, ORANGEBURG, NY; HI-TECH PHARMACAL CO INC, AMITYVILLE, NY, ETC - 483S 10/1-31/11 WISCONSIN PHARMACAL COMPANY LLC, JACKSON, WI; STERLING CRITICAL PRODUCTS LLC, MINNEAPOLIS, MN; BEMIS MANUFACTURING CO, SHEBOYGAN FALLS, WI, ETC - 483S 10/1-31/11 SUNRISE PHARMACEUTICAL INC, RAHWAY, NJ; ALLCARE MEDICAL, SAYREVILLE, NJ - 483S 10/1-31/11 KNOLL MEDICAL LLC, ANNAPOLIS, MD; HUMAN BIOSCIENCES INC, GAITHERSBURG, MD - 483S 10/1-31/11 OVOLIFE - GRAS 411 MATTHRE W LAMB WARNER CHILCOTT MDS PHARMA SERVICES, MONTREAL, QUEBEC, CANADA EIR, 483S 2003 TO PRESENT ORA/CE-FO/MIN-DO/MCB/ MICHAEL P CROOKS PETERSON JOHNSON & MURRAY SC LUCY I KOLO PHD Patton Boggs LLP WISCONSIN CHEESE GROUP LLC, MONROE, WI - EIRS, 483S, WARNINGS, ETC 1/11 TO PRESENT BETA ALANINE - IMPORT RECS, BILLS OF LADING 1/10 TO 12/11 SCOTT, BEVERLY A Signature/ Requester Subject NOVARTIS - EXCEDRIN, NODOZ, BUFFERIN, ETC RECALL RECS, CMPLNTS, AERS, ETC
2012-1206
02/22/2012 03/21/2012
2012-1207 2012-1208
02/22/2012 03/21/2012 02/22/2012
ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/BLT-DO/CB/
JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN
Page 853 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/21/2012 2012-1209 02/22/2012 03/21/2012 2012-1210 02/22/2012 03/21/2012 2012-1211 02/22/2012 03/21/2012 2012-1212 02/22/2012 03/21/2012 FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/DET-DO/DCB/ Action Office Signature/ Requester FDA NEWS JONATHAN RICKMAN FDANEWS JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDA NEWS JONATHAN RICKMAN FDA NEWS INNOVATECH MEDICAL RESOURCES LP, MIDLOTHIAN, TX; VUCAMP INC, PLANO, TX; HEALTHTRONICS INC, AUSTIN, TX, ETC - 483S 10/1-31/11 ALLEN MEDICAL INC, MINTICELLO, IN; BRISTOL-MYERS SQUIBB CO INC, MOUNT VERNON, IN; HILL-ROM INC, BATESVILLE, IN, ETC - 483S 10/1-31/11 BIIORELIANCE LTD, GLASGOW, SCOTLAND, UK; WYETH FARMA SA, SAN SEBASTIAN DE LOS REYES, SPAIN - 483S 10/1-31/11 GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO LTD, WUXI, CHINA; OMRON (DALIAN) CO LTD (PLANT 1), DALIAN, CHINA; HEMOCUE AB, ANGELHOLM, SWEDEN, ETC - 483S 10/1-31/11 BIO-CONCEPT LABORATORIES INC, SALEM, NH; IWALK INC, BEDFORD, MA; CANDELA CORP, WAYLAND, MA, ETC 483S 10/1-31/11 MARTEK BIOSCIENCES CORP - ALGAL OIL GRAS 137; SOLAZYME INC - ALGAL OIL GRAS 384; NUTRASOURCE CHLORELLA VULGARIS GRAS 396 AVANIR PHARMACEUTICALS INC - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE, QUIDINE SULFATE) NDA 21-879 AERS Subject
2012-1213
02/22/2012 04/09/2012
2012-1214
02/22/2012 03/21/2012
KRISTEN GREEN ALLTECH INC
2012-1215
02/22/2012 03/21/2012
SUZIE KESCHAMRUS MD MBA AVANIR PHARMS
2012-1216 2012-1217 2012-1218 2012-1219 2012-1220
02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012
FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/
SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP JILLIAM NASH ALLTECH INC HOHLOWSKI, RICHARD Joan Stitt UG2CD-16 MERCK & CO., INC. JOHNSON, JILL JOHN DARNALL DAILY MEDICAL PRODUCTS INC
CRYOSURGERY INC - VERNUCA-FREEZE CRYOSURGICAL DELIVERY SYS K955083 LAKELAND NUTRITION GROUP LLC, EATON PARK, FL 483S LAST 10 YRS JUDGE MICHAEL MALIHI - BIOGRAPHY FOI DAILY LOG 2/13-17/12 DESERET LABORATORIES INTL, SAINT GEORGE, UT - 483S LAST 18 MONTHS
2012-1221
02/22/2012 03/21/2012
K896393, K896971, K896972, ETC
Page 854 of 1132

Total Records: 12455 Control # 2012-1222 2012-1223 Recd Date / Due Date 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1224 2012-1225 2012-1226 2012-1227 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1228 2012-1229 2012-1230 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1231 2012-1232 02/22/2012 03/21/2012 02/22/2012 03/21/2012 CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CTP/OD/ CTP/OD/ 2012-1233 02/22/2012 03/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ RAHUL GUPTA PIRAMAL LIFE SCIENCES PHARMACIA - MEDROXYPROGESTERONE ACETATE INJECTION NDA 20-246 BIOEQUIV STUDY, DISSOLUTION STUDY FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/CIN-DO/CCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/FLA-DO/FCB/ JILLIAN NASH ALLTECH INC MATTHEW W. LAMB WARNER CHILCOTT DIANE R. WHITWORTH DRW RESEARCH & INFORMATION SERVICES LLC BARRY MEIER NEW YORK TIMES CHRISTOPHER HENDEL CONSUMER REPORTS ALLENDALE INSTITUTIONAL RVW BOARD, OLD LYME, CT 483 2/23/11 WITHDRAWN NON APRVL LTR PMA APPLICATIONS 1/1/05 TO PRESENT E-CIGARETTE - AER LAKELAND ANIMAL NUTRITION INC, LAKELAND, FL - 483 2002 TO 2012 PROCTER & GAMBLE PHARMS INC, MASON, OH - EIR, 483 SQUIRE, PERCY ARETA KUPCHYK NIXON PEABODY LLP ARETA KUPCHYK NIXON PEABODY LLP FRAN KOCH INFORMATION ACCESS LTR FROM EVELYN BONNIN TO J CHRIS HROUDA 1/13/12 & 6/17/10 FOI DAILY LOG 1/9-13/12 FRESENIUS MEDICAL CATE - FOI REQUESTS & RESP 7/10 TO 12.11 VIFOR PHARMA LTD - FOI REQUESTS & RESP 7/10 TO 12/11 ESTHER C S DEZUBE LAW OFC ESTER C S DEZUBE ESTHER C S DEZUBE LAW OFC Signature/ Requester Subject MEDEX INFUSION PUMP - MDRS, CORRECTION LTRS, INCIDENT RPTS, ETC 1/09 TO 10/09 ALARIS SYS PUMP - RECALL RECS, MDRS, CORRECTION LTRS, ETC 10/09
Page 855 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1234 2012-1235 2012-1236 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ 2012-1237 2012-1238 2012-1239 2012-1240 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1241 02/22/2012 03/21/2012 2012-1242 2012-1243 02/22/2012 03/21/2012 02/22/2012 03/21/2012 2012-1244 02/22/2012 03/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1245 02/22/2012 ORA/SE-FO/FLA-DO/FCB/ JOHNATHAN RICKMAN LAR MANUFACTURING LLC, PORT RICHEY, FL; COMMAND ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ INFORMATION ACCESS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS STRAIGHT ARROW PRODUCTS INC, BETHLEHEM, PA; CATALENT PHARMA SOLUTIONS LLC, PHILADELPHIA, PA 483 10/11 CHATTEM CHEMICALS INC, CHATTANOOGA, TN; KENTRON HEALTH CARE INC, SPRINGFIELD, TN; INNOVISION INC, MEMPHIS, TN - 483 10/11 IRISYS INC, SAN DIEGO, CA; SKY SYS CO INC, ONTARIO, CA; DIAMOND WIPES INTL INC, CHINO, CA - 483 10/11 CHEM TECH LTD, PLEASANTVILLE, IA; DERMATOLOGIC LAB & SUPPLY INC, COUNCIL BLUFFS, IA; RAINING ROSE INC, CEDAR RAPIDS, IA - 483 10/11 EUROGENTEC, SERAING, BELGIUM; KOWA COMPANY LTD, NAGOYA SHI, JAPAN; KYOWA HAKKO BIO CO LTD, HOFU CITY, JAPAN - 483 10/11 ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/DEN-DO/COMP/ JOHNSON, JILL JOHNSON, JILL CORNERSTONE RESEARCH & DEVELOPMENT, OGDEN, UT - 483 2010 DAILY LOG 1/2-6/12 VMI NUTRITION INC, SALT LAKE CITY, UT - 483 2010 ESTHER C.S. DEZUBE ESTHER C S DEZUBE LAW OFC ESTHER C.S. DEZUBE ESTHER C S DEZUBE LAW OFC KATHLEEN M. SANZO MORGAN LEWIS & BOCKIUS LLP GENENCOR - AFFCO DEFINITION RVW BAXTER INFUSION PUMP - AER OVERINFUSION OF BUSULFAX - AER 2009 Signature/ Requester Subject
Page 856 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/21/2012 2012-1246 02/22/2012 03/21/2012 2012-1247 02/22/2012 03/21/2012 2012-1248 2012-1249 2012-1250 2012-1251 02/22/2012 03/21/2012 02/22/2012 03/21/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1252 02/23/2012 03/22/2012 2012-1253 02/23/2012 03/22/2012 2012-1254 02/23/2012 03/22/2012 2012-1255 02/23/2012 03/22/2012 2012-1256 2012-1257 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1258 2012-1259 02/23/2012 03/22/2012 02/23/2012 03/22/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FOI SERVICES INC SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION ALAN EVANS ESTRIDGE LABORATORIES INC CARGILL INC, CALIFORNIA, MO - FORM 2481, ENDORSEMENT PAGE, INSPECTOR'S NARRATIVE RPT 10/12/11 CARGILL ANIMAL NUTRITION, ANKENY, IA - FORM 2481, ENDORSEMENT PAGE, INSPECTOR'S NARRATIVE RPT 9/28/11 CARGILL ANIMAL NUTRITION, KANSAS CITY, KS - FORM 2481, ENDORSEMENT PAGE, INSPECTOR'S NARRATIVE RPT 9/22/11 CARGILL ANIMAL NUTRITION, WEST BRANCH, IA - FORM 2481, ENDORSEMENT PAGE, INSPECTOR'S NARRATIVE RPT 9/19/11 CARGILL ANIMAL NUTRITION, ALBANY , NY - FORM 2481, ENDORSEMENT PAGE, INSPECTOR''S NARRATIVE RPT 7/27/11 CARGILL INC, LONDON, AR - FORM 2481, ENDORSEMENT PAGE, INSPECTOR'S NARRATIVE RPT 7/26/11 CARGILL ANIMAL NUTRITION, GUYMON, OK - FORM 2481, ENDORSEMENT PAGE, INSPECTORS NARRATIVE RPT 7/19/11 CARGILL INC, TEMPLE, TX - FORM 2481, ENDORSEMENT PAGE, INSPECTORS NARRATIVE RPT 8/9/11 WESTRIDGE INC - ONE PERSONAL LUBRICANT K110691, MAYER LABORATORIES INC - AQUA LUBE (TX 407) K110325 ORA/SE-FO/SJN-DO/SJCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/DEN-DO/COMP/ Action Office Signature/ Requester FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS CLOSED FOIA REQUESTES 2/6-10/12 MCNEIL HEALTHCARE LLC, LAS PIEDRAS, PR - 483 10/11 Subject MEDICAL PRODUCTS INC, ORMOND BEACH, FL; ARBANA GROUP LLC, OVIEDO, FL - 483 10/11 MOOG MEDICAL DEVICES GROUP, SALT LAKE CITY, UT; CARIDIAN BCT INC, LAKEWOOD, CO; FMC CORP, GREEN RIVER, WY - 483 10/11 NORMAN NOBLE INC, HIGHLAND HEIGHTS, OH; THEKEN SPINE LLC, MEDINA OH; GYRUS ACMI INC, NORWALK, OH 483 10/11 KIK CUSTOM PRODUCTS INC, GAINESVILLE, GA - 483 10/11
Page 857 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2012-1260 2012-1261 2012-1262 2012-1263 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1264 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1265 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1266 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2012-1267 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1268 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1269 02/23/2012 ORA/NE-FO/NYK-DO/NYDCB/ JOHN BISHAL REGENERON PHARMACEUTICAL INC, RENSSELAER, NY WILLIAMS G GAINER TOLIVER & GAINER MCNEIL-PPC INC - EXTRA STRENGTH TYLENOL NDA 17053 (ANTIPYRETIC ANTIRHEUMATIC) TENATIVE OR FINAL APRVL LTRS JEANNE JARZABEK ASTELLAS PHARMA US INC MYCAMINE NDA 21-506, 21-506/S008- MEDICAL RVWS, CHEMISTRY RVWS, PHARMACOLOGY RVWS, ETC 3/16/05, 1/22/08 THOMAS C MCENTEE EI DU PONT DE NEMOURS & CO EKA CHEMICALS INC - CHLORINE DIOXIDE (SLIMICIDE) FAP 0A-4716 RECS TIMOTHY P WALBERT HORIZON PHARMA INC DUEXIS (FAMOTIDINE 26.6MG, IBUPROFEN 800 MG) NDA 22-519 APRVL PKG 4/23/11 RAHUL GUPTA PIRAMAL HEALTHCARE LTD MEDROXPROGESTERONE ACETATE INJ ANDA 20-246 BIOEQV STUDIES, IN-VITRO DISSOLUTION STUDIES, ANALYTICAL METHODS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ALAN EVANS ESTRIDGE LABORATORIES INC ALAN EVANS ESTRIDGE LABORATORIES INC ESTHER CS DEZUBE ESTHER C S DEZUBE LAW OFC S ALBERT EDWARDS S ALBERT EDWARDS, PHARM D CHILDREN'S HOSPITAL, BOSTON, MA - INFUSION PUMP RECALL; MDRS 6/09 TO 10/09 MORTON GROVE PHARMACEUTICALS INC CARBINOXAMINE, PSEUDOEPHEDRINE, DEXTROMETHORPHAN ORAL LIQUID AERS WESTRIDGE INC - ONE PERSONAL LUBRICANT (WATER BASED) K110691 MAYER LABORATORIES INC - AQUA LUBE (TX 407) K110325 Signature/ Requester Subject
Page 858 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/22/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ 2012-1270 2012-1271 2012-1272 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1273 02/23/2012 03/28/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ OC/OCM/EMOPS/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ 2012-1274 02/23/2012 03/22/2012 2012-1275 02/23/2012 03/22/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL A CAROME PUBLIC CITIZEN'S HEALTH RESEARCH GROUP MICHAEL A CAROME PUBLIC CITIZEN'S HEALTH RESEARCH GROUP EVALUATION OF AUTOMATIC CLASS III DESIGNATION (DE NOVO)_ DECISION SUMMARIES - GUIDANCE RECS RE REDACTIONS & PERSONS W/AUTHORITY TO REDACT AUTOMATIC CLASS III DESIGNATION (DE NOVO) DECISIONS, TEARSCIENCE INC - LIPIFLOW THERMAL PULSATION SYS SUMMARY RVW MEMO 6/23/11....ETC..., 6/23/11; HEM-AVERT PERIANAL STABILIZER (PLEXUS BIOMEDICAL), 1/7/11; DERMAL COOLING DEVICE (ZELTIQ AETHETICS INC) 6/1/10 NURTURE INC, BROOKLYN, NY - HAPPY-TOT STAGE 4 & SWANN, JACOB ARETA KUPCHYK NIXON PEABODY LLP PATTI WALLER MARLER CLARK ATTYS IRON SURCOSE, SODIUM FERRIC GLUCONATE, HIGH INOLECULAR WEIGHT IRON DEXTRAN, ETC - FOI REQUESTS 6/10 TO 12/11 ROMAINE LETTUCE E COLI OUTBREAK - COMM, LAB TEST RESULTS, INVOICES, ETC ORA/CE-FO/PHI-DO/PCB/ GEOFFREY T MISCOE MIR-COM PRODUCTS LLC ARMEDICA MANUFACTURING & METTLER TRACTION HEAD - KDT 650 KENNEDY TABLE CMPLNT AMERICAN PROTEINS INC - EIRS 12/5/10 TO 12/16/12 Signature/ Requester JOHN BISHAL PHD Subject EYLEA (AFLBERCEPT) BLA 12-5387 483S 5/20/11, 3/31/10, 9/21/07, ETC
2012-1276
02/23/2012
ORA/
WILLIAM ALLRED
Page 859 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/22/2012 2012-1277 2012-1278 02/23/2012 03/22/2012 02/23/2012 04/10/2012 2012-1279 02/23/2012 03/22/2012 Action Office ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ CARLA R SCARMAZZI King & Spalding LLP FDA, OFFICE OF INTERNATIONAL PROGARMS & WHO TOBACCO FREE INITIATIVE, LEESBURG, VA INTERNATIONAL TOBACCO REGULATORS' CONF RECS, CORR, PRESENTATIONS ETC 11/14-16/11 BOSTON SCIENTIFIC CORP - EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE K040018; BOSTON SCIENTIFIC CORP - TBAN K963252; MILL ROSE LABORATORY TRANSBRONCHIAL ASPIRATION NEEDLE K014181 K053052 - RECS IN MATERIAL USED & MATERIAL SAFETY & TESTING REMESENSE K082594 SPECTOR, GILBERT FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1284 2012-1285 02/23/2012 03/22/2012 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ NCTR/OD/ OC/COS/OES/ OC/COS/OES/ ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN MARK GREENBLATT ABC NEWS, INC. DHA IN TANNING BOOTHS - AERS, CORR, RECS ETC BRIAN SMITH LEXIS NEXIS COURTLINK INC OFFICE OF SURVELLIANCE & EPIDEMIOLOGY STUDIES RVW - OSE RCM 2011-1328, EPIDEMIOLOGIST STUDY COMPARISON RVW 6/6/11, LIDEGAAARD O ET AL HORMONAL CONTRACEPTION & RISK OF VENOUS THROMBOEMBOLISM & VAN HYLCKAMA VLIEG A, ET AL, RESULTS OF MEGA CASE STUDY, 4 COPIES (CERTIFIED) UNIVERSAL SUPPLEMENT INC, VISTA, CA - 483 7/14-29/11 Signature/ Requester BARRICKMAN ALLRED & YOUNG LLC BOBBY SCHOCHET OFW LAW RICHARD J PEARL MORGAN LEWIS & BOCKIUS LLP Subject HAPPY-BABY STAGE 1 & 2 RECALL 11/10 & 1/11 CANDY TREASURE LLC, LEBANON, NJ - CHOCO TREASURE RECS, RPTS, COMM ETC INHALATION PLASTICS INC (AKA IPI), CHICAGO,IL - EIRS, RECS, CORR ETC
2012-1280
02/23/2012 03/22/2012
FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
IGAL GIGI ARCH MEDICAL INNOVATIVE MEDICAL DEVICES MATTHEW KHO CUTE BABY INC
2012-1281 2012-1282 2012-1283
02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012
Page 860 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OC/OPPL/OP/ FDA/OF/CFSAN/OCD/EOS/ CTP/OD/ CTP/OD/ 2012-1286 2012-1287 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1288 02/23/2012 03/22/2012 ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1289 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1290 2012-1291 2012-1292 2012-1293 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1294 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1295 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WARD, JEANIE POLYETHYLENE GLYCOL - AER ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ BAYER, RANGE (RICHARD) D STEPHEN A GARBARINI MARCOR DEVELOPMENT CORP CHRISTINE L MACAULEY KIMBERLY CLARK CORP DANIEL ALBAHARI BIOLINE INNOVATIONS JERUSALEM ORA/P-FO/LOS-DO/LACB/ JENNIFER CONNER INVESTIGATION SOLUTIONS INC BLOOD PRODUCTS ADVISORY COMM (BPAC) - MTG TRANSCRIPT, 4/29/11 eNTRY #609-0322008-9 - PANCREATIN 10X (LOT 110813) LAB TEST RESULTS PMA SUBMISSION - NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (W/BINDING) MODEL HUCKCR17AX27MH,H, K094016 SANOFI PHARMS INC -PLAQUENIL NDA 09-768 APRVL RECS NOVITAS MEDICAL LLC, BREA, CA - 483 5/6/11 ANDRAS BRATINCSAK UNIV OF CALIFORNIA SAN DIEGO SCHOOL OF MED, DEPT OF PEDIATRICS DOXYCYCLINE - MEDICAL RPTS, SAFETY RECS, SIDE EFFECTS ETC Doe J PRADAXA - AER RESULTS (7/11) FDA/OMPT/CDRH/OCER/DFOI/ BERRYMAN, THOMAS J PETER D LOFTUS DOWJONES & CO jOHNSON & JOHNSON & PFIZER - USE OF BEN VENUE LABS, BEDFORD, OH, EIRS, 483S, CO RESP ETC 1/1/10 TO PRESENT MINIGUARD FEMALE CONTINENCE DVC K954215 Signature/ Requester Subject
Page 861 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1296 02/23/2012 03/22/2012 2012-1297 2012-1298 02/23/2012 03/22/2012 02/23/2012 03/22/2012 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1299 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1300 2012-1301 02/23/2012 03/22/2012 02/23/2012 03/22/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1302 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1303 2012-1304 2012-1305 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1306 02/23/2012 OM/OSS/OPILS/DFI/ AMANDA ORLANDO ENTRY NO W939061994 ORA/OCI/ ORA/OCI/ CBER/OCTMA/DDOM/ALFB/ CHAD MAZUREK JM2 CONSULTING LLC TIFFANY MILLER ORA SURE TECHNOLOGIES INC BARBARA WILSON LUNG LLC UNITED THERAPEUTICS - REMODULIN NDA 21-272/S-005 APRVL, CHEMISTRY RVW, STATISTICAL RVW, MEDICAL RVW MIDWEST RESEARCH SWINE, GIBBON, MN - RECS 1/10 TO 7/11 HIV OTC BPAC CLOSED SESSION - TRANS11/17/09 BRENDA SOUZA ONO PHARMA USA INC LODOSYN (CARBIDOPA) SBA SIEGLER, SARA FDA/OMPT/CDRH/OCER/DFOI/ SYLVESTER WILLIAMS III WUXIAPPTEC INC VALLEY MEDICAL INC, SAN DIEGO, CA - WARNING LTRS, CLOSE OUT LTR 3/24/11 BURZYNSKI CLINIC, BURZYNSKI RESEARCH INSTITUTE PHASE II ANTINEOPLASTON CLNCL TRIAL RECS JOY PARRIS HUMAN GENOME SCIENCES INC. ISRS - ABATACEPT, 6491498; NATALUZUMAB, 6426037, 7654659, & 5213865, TOCILIZUMAB, 7270424 ETC NELSON, MARGOT ORA/CE-FO/MIN-DO/MCB/ SUE CARLSON CARGILL ANIMAL NUTRITION SUE CARLSON CARGILL ANIMAL NUTRITION CARGILL ANIMAL NUTRITION, BIG LAKE, MI - MEDICATED FEED MILL INSPECTION/BSE INSPECTION EIR, 483, FORM 2481 10/29/11 CARGILL INC, SPRINGDALE,M AR - MEDICATED FEED MILL INSPECTION/BSE INSPECTION EIR, 483, FORM 2481 10/11/11 RECLAST - AERS, RPTS ETC Signature/ Requester Subject
Page 862 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/22/2012 2012-1307 2012-1308 2012-1309 2012-1310 2012-1311 02/23/2012 04/12/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 02/23/2012 03/22/2012 2012-1312 2012-1313 2012-1314 2012-1315 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1316 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1317 2012-1318 02/24/2012 03/23/2012 02/24/2012 03/23/2012 2012-1319 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL WARRENER SIRTOLOGY PTY LTD KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION FOI DAILY LOG 1/2-6/12 FOI DAILY LOG 1/9-13/12 SIR-SPHERESR - P990065 DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 1/2-6/12 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 1/9-13/12 FOI SERVICES INC FOI DAILY LOG 1/9-13/12 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ GERHARDT, NATHAN ANNA T. FLOOD Keller and Heckman LLP ELIZABETH DUDLEY, Esq. DUDLEY FIRM LLC WILLIAM J. SKINNER MUSCATATUCK PUBLISHERS INC MEGAN B PICKEL BEVERIDGE & DIAMOND PC MEDRAD INC - AVANTA FLUID MGMT INJECTION SYS K050456 WARNING LTR, RECALL 2005 TO PRESENT 75 DAY PREMARKETING NOTICES FILED BY DISTRIBUTORS OF DIETARY SUPPLEMENTS 1/08 TO PRESENT ALL FOIA REQUEST FOR CENTER FOR FOOD SAFETY & APPLIED NUTRITION 1/20/12 TO 2/22/12 FOI DAILY LOG 1/2-6/12 CIBA SPECIALTY CHEMICALS CORP - FCN 330 Action Office OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ Signature/ Requester AVALON RISK MANAGEMENT INC JEROME A. KONKEL SAMSTER KONKEL ET AL PURE ENCAPSULATIONS INC, SUDBURY, MA - 483 8/4-24/11 INDIVIDUAL RECS Subject
Page 863 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester SOURCE 2012-1320 2012-1321 2012-1322 2012-1323 2012-1324 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ 2012-1325 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1326 02/24/2012 03/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1327 2012-1328 02/24/2012 03/23/2012 02/24/2012 03/23/2012 2012-1329 2012-1330 2012-1331 02/24/2012 03/23/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INC REGULATORY CONSULTING & SUBMISSIONS BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC KAREN L LTHOMISON AMUSA IVERA MEDICAL CORP - CUROS PORT PROTECTOR K110826 FOI DAILY LOG 1/9-13/12 FOI DAILY LOG 1/2-6/12 FDA/OMPT/CDRH/OCER/DFOI/ CARLA A TAYLOR LOPEZ LOPEZ & FANTEL MEDTRONIC - MODEL 8540 CATHETER ACCESS PORT KIT LBLG CHANGES FOI DAILY LOG 1/2-6/12 SAMUEL GEISLER AYLSTOCK WITKIN KREIS & OVERHOLTZ PLLC SHIRE US INC, VALIDUS PHARMACEUTICALS INC EQUETRO LBLG CHANGES, WARNING LTRS, EIRS, ETC INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 1/9/13/12 GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. KIM M RUDER CARLOCK COPELAND & STAIR LLP RAM MEDICAL INC - COUNTERFEIT POLYPROPYLENE SURIGCAL MESH INVESTIGATION RECS FOI DAILY LOG 1/2-6/12 FOI DAILY LOG 1/9-13/12 FOI DAILY LOG 1/9-13/12 FOI DAILY LOG 1/2-6/12 Subject
Page 864 of 1132

Total Records: 12455 Control # 2012-1332 Recd Date / Due Date 02/24/2012 03/23/2012 2012-1333 02/24/2012 03/23/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1334 02/24/2012 03/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1335 2012-1336 02/24/2012 03/23/2012 02/24/2012 03/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ OC/OCC/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ 2012-1337 02/24/2012 03/23/2012 2012-1338 02/24/2012 03/23/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/DET-DO/DCB/ 2012-1339 02/24/2012 03/23/2012 2012-1340 2012-1341 02/24/2012 03/23/2012 02/24/2012 03/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ RAJKUMAR VINNAKOTA SKIERMONT PUCKETT LLP STACEY ELLUL NEUROPACE INC STACEY ELLUL NEUROPACE INC AZTECA MILLING LP, GRUPO INDUSTRIAL MASECA SA DE CV, GRUMA CORP, ETC - FOOD ADDITIVE PETITIONS FOR ENZYME PREPARATIONS AD-TECH MEDICAL INSTRUMENT CORP - SUBDURAL ELECTRODE K970587 AD-TECH MEDICAL INSTRUMENT CORP - CORTICAL MAPPING UNIT MODEL CMU K992194 AMANDA ORLANDO AVALON RISK MANAGEMENT INC LAWRENCE J BUCKFIRE BUCKFIRE & BUCKFIRE PC EG PIAZZA INTERNATIONAL - ENTRY #80501222261 NOTICE OF FDA ACTION #1 INDIVIDUAL RECS JEFFREY N GIBBS Hyman Phelps and McNamara PC PETER S HERRICK PETER S HERRICK PA WIRELESS AIR-CONDUCTION HEARING AID CLASSIFICATION AS CLASS II DVCS RECS MILKY WAY INTERNATIONAL TRADING CORP - HONEY ENTRY #GV8-0150233-9 RECS KRISTOPHER P DIULIO GIBSON DUNN ET AL NUEDEXTRA - MEDWATCH RPTS 10/29/10 TO PRESENT; AVANIR PHARMACEUTICALS INC - NUEDEXTRA FOI REQUESTS 2/5/12 TO PRESENT SCHONHOFT, BRAD REGENERON, TARRYTOWN, NY - EYLEA (AFIBERCEPT) AERS 12/1/11 TO 2/22/12 Signature/ Requester KAREN L THOMISON AMUSA Subject IVERAL MEDICAL CORP - CUROS PORT PROTECTOR K080466
Page 865 of 1132

Total Records: 12455 Control # 2012-1342 Recd Date / Due Date 02/24/2012 03/23/2012 2012-1343 02/24/2012 03/23/2012 2012-1344 2012-1345 2012-1346 02/24/2012 04/12/2012 02/24/2012 03/23/2012 02/24/2012 03/23/2012 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-1347 02/24/2012 03/23/2012 ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ 2012-1348 2012-1349 02/24/2012 03/23/2012 02/24/2012 03/23/2012 ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2012-1350 2012-1351 02/24/2012 03/23/2012 02/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ALTHEA BURTON PATH TAYLOR J BASSETT FEMALE HEALTH COMPANY - FEMALE CONDOM SAFETY & EFFECTIVENESS DATA SANOFI-AVENTIS US LLC, SANOFI-AVENTIS US INC, AVENTIS PHARMACEUTICALS INC, AVENTIS INC, BRISTOLCRAIG ROUSH ROCKLINE INDUSTRIES SAMUEL GEISLER ALYSTOCK WITKIN ET AL PROFESSIONAL DISPOSABLES INTL, ORANGEBURG, NY; NICE PAK PRODUCTS INC, MOORESVILLE, IN - 483, EIR SHIRE US INC - EQUETRO LBLG, WARNING LTRS, CORR, AER, 483, EIR MICHAEL P. CROOKS PETERSON JOHNSON & MURRAY SC NUESTRO QUESO LLC, ELK GROVE VILLAGE, IL; HACKENSACK, NK; SACRAMENTO, CA - 483, EIR, WARNING LTRS FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KAREN L THOMISON AMUSA BOBBY SCHOCHET OFW LAW DIANA L. GESEKING SEDGWICK LLP LTRS BETWEEN FDA & ELISA ELLIOTT, BENSON SILVERMAN, DO ZINK REGARDING CRONOBACTER SPP MARS INC - CAP 2C0293 EXCELSIOR MEDICAL CORP - SWABCAP K083508 Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester ROBERT E ARMSTRONG ROBERT E ARMSTRONG LAW OFCS KAREN L THOMISON AMUSA Subject AMERICAN BIOTECH LABS LLC - EIRS, 483S 2010, 2011, 2012 APLICARE INC - ALCOHOL PREP PAD K833182
Page 866 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/26/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1352 2012-1353 2012-1354 02/27/2012 04/17/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FOI SERVICES INC ORA/CE-FO/DET-DO/DCB/ DOUGLAS N BLUE ZETETIC LIFESCAN SCOTLAND LTD - ONETOUCH ULTRA STRIPS RECS TYSABRI (NATALIZUMAB) - SAFETY RECS 9/17/09 (CERTIFIED) SAFETY COMMUNICATION: SAFETY UPDATE ON PROGRSSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) ASSOCIATED WITH TYSABRI (NATALIZUMAB) 4/22/11 (CERTIFIED) ETHICON INC - PDS BARBED SUTURES K113004 FOI SERVICES INC ELIZABETH DUDLEY ESQ DUDLEY FIRM LLC FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/SE-FO/ATL-DO/ACB/ WALTER E CHALKLEY THOMSON REUTERS FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1362 2012-1363 2012-1364 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 ORA/CE-FO/CHI-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FATIMA ASLAM Keller and Heckman LLP WALTER E CHALKLEY UNIPATH LTD - CLEARBLUE EASY EASY READ PREGNANCY TEST K041404 SHELL OIL CO - POLYALKYL ACRYLATE POLYMER FAP 2A3653 CHEMISTRY AND TOXICOLOGY MEMO ANCHOR PRODUCTS CO, ADDISON, IL - EIRS, 483S, CO FOI SERVICES INC FATIMA ASLAM Keller and Heckman LLP BIOTEQUE - DOUBLE PIGTAIL URTERAL STENT SET K033210 SHELL OIL CO - POLYALKYL ACRYLATE POLYMER FAP 2A3653 SPD DEVELOPEMNT COMPANY LTD - CLEARBLUE EASY PREGNANCY TEST K110433 THOMAS MENDOLIA, DO (NORTHWEST PIEDMONT CLINICAL RESEARCH), LOUISVILLE, NC - EIRS, 483S, CO RESPS 10/18/10- 11/1/10 UNIPATH LTD - CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST K040341 2012-237 - DELETED RECS Signature/ Requester MORROW MORROW RYAN & BASSETT Subject MYERS SQUIBB - PLAVIX RECS 1997 TO PRESENT
2012-1355
02/27/2012 03/26/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/
2012-1356 2012-1357 2012-1358 2012-1359 2012-1360
02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012
2012-1361
02/27/2012 03/26/2012
Page 867 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/26/2012 2012-1365 2012-1366 02/27/2012 03/26/2012 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1367 2012-1368 2012-1369 2012-1370 2012-1371 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/28/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1372 2012-1373 2012-1374 2012-1375 2012-1376 2012-1377 2012-1378 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/DET-DO/DCB/ WALTER E CHALKLEY THOMSON REUTERS ELENA HOWELL HOGAN LOVELLS US LLP WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS XORAN TECHNOLOGIES, ANN ARBOR, MI - EIRS, 483S, CO RESPS 3/11-4/11 NORDIMEX, LLC, SAN DIEGO, CA - EIRS, 483S, CO RESPS 5/11 ROBERT CYWES, MD, JACKSONVILLE, FL - EIRS, 483S, CO RESPS, 3/11 ROCHE MOLECULAR SYSTEMS INC, SOMMERVILLE, NJ EIRS, 483S, CO RESPS 1/11 TYSABRI (NATALIZUMAB) BLA 125104 - APRVL HISTORY, LBLG, LTR (CERTIFIED) BAXTER PHARMACEUTICALS SOLUTIONS, BLOOMINGTON, IN - EIRS, 483S, CO RESPS 3/11 2012-315 ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS TIMOTHY B MCALLISTER KIRKLAND & ELLIS LLP DELTEX PHARMACEULTICALS, ROSENBERG, TX - EIRS, 483S, CO RESPS, 3/22/10-4/16/10 PHARMACEUTICAL ASSOCIATES INC, GREENVILLE, SC EIRS, 483S, CO RESP 4/11 PROMEGA BIOSYSTEMS SUNNYVALE INC, SUNNYVALE, CA - EIRS, 483S, CO RESP 10/10 DEPUY ORTHOPAEDICS, WARSAW, IN - EIRS, 483S, CO RESPS - 5/10/11-6/7/11 ALLAN PHARM, WATSON LABS, EXCELLIUM PHARM, ETC QUININE SULFATE LABELS 1/94 TO 12/04 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC TYSABRI (NATALIXUMAB) - BLA 12-5104 LTR , LABEL 1/14/08 (CERTIFIED) Action Office Signature/ Requester THOMSON REUTERS Subject RESPS, 5/26/10-6/4/10 STRYKER ENCOSCOPY - CASSETTE PUMP K042454
Page 868 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1379 2012-1380 02/27/2012 03/26/2012 02/27/2012 03/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1381 02/27/2012 03/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FDA DRUG SAFETY COMMUNICATION: NEW RISK FACTOR FOR PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) ASSOCIATED WITH TYSABRI (NATALIZUMAB) 1/20/12 (CERTIFIED) TYSABRI (NATALIZUMAB) - SAFETY ALERT 8/25/08 (CERTIFIED) FDA DRUG SAFETY COMMUNICATION: RISK OF PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WITH THE USE OF TYSABRI (NATALIZUMAB) 2/5/10 (CERTIFIED) THEROKOS INC, JOHNSON & JOHNSON - UVAR PHOTOPHERESIS SYS P860003 ENSEAL G2 SUPER JAW TISSUE SEALER - K112033 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ JOSEPH KICEINA ABBOTT POINT OF CARE INC ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY SORIN GROUP DEUTSCHLAND GMBH, MUCHEN, GERMANY NOVARTIS CONSUMER HEALTH, LINCOLN, NE - EIR, CO RESP 1/14/11 TO 1/20/12 HOSPIRA, AUSTIN, TX - EIR, CO RESP 4/24-27/11 UNIPATH LTD - CLEARBLUE EASY DIGITAL PREGNACY TEST K060128 INTERNATIONAL TECHIDYNE CORP (ITC) - HEMOCHRON CITRATE APTT K972831, HEMOCHRON JR CITRATE APTT CUVETTE K014008 AMPAC FINE CHEMICALS LLC, RANCHO CORDOVA, CA EIR, 483 CO RESP 3/11 NYCOMED US INC, MELVILLE, NY - EIR, 483, CO RESP 2/11 FOI SERVICES INC FOI SERVICES INC TYSABRI (NATALIZUMAB) BLA 125104 - LTR & LBL DOCS, 6/5/06 (CERTIFIED) TYSABRI (NATALIZUMAB) INJ - RECS (CERTIFIED) Signature/ Requester Subject
2012-1382 2012-1383
02/27/2012 03/26/2012 02/27/2012 03/26/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FOI SERVICES INC
2012-1384 2012-1385 2012-1386 2012-1387
02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012
FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/
2012-1388 2012-1389 2012-1390 2012-1391 2012-1392
02/27/2012 03/27/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012
Page 869 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/26/2012 2012-1393 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1394 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1395 2012-1396 2012-1397 02/27/2012 03/26/2012 02/27/2012 03/26/2012 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1398 02/27/2012 03/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1399 02/27/2012 03/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1400 02/27/2012 03/26/2012 2012-1401 2012-1402 02/28/2012 03/27/2012 02/28/2012 ORA/ ORA/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ SUZAN ANN MOSER RN, BSN, MBA DANIEL M DELANGE JUICE SOURCE LLC LIST OF ADDITIVES ALLOWED FOR TOBACCO PRODS ENTRY #032-0419322-5 - TEST RESULTS DAKO CYTOMATION - PMA 030044 JOHN A. CLARK, MD RISKBENEFITS LLC MEDWATCH 5247186-7, 5290514-7, 5354972-1 MATTHEW P. MORIARTY TUCKER ELLIS & WEST LLP ACTAVIS - DIGITEK (AMIDE) 484 CERTIFIED FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ WALTER E. CHALKLEY THOMSON REUTERS JONATHAN M. PETTY WILLIAMSON PETTY LC WEST WARD PHARMS CORP, WEST EATONVILLE, NJ - EIR, 483, CO RESP 6/13-30/11 DEPUY ASR - ACETABULAR CUP; TOTAL HIP SYS; TAPER SLEEVE ADAPTER MANUFATURE, DATE TYSABRI (NATALIZUMAB) BLA 125104 - LTR, LBG CERTIFIED WALTER E. CHALKLEY THOMSON REUTERS MERCK SERONO SA, CORSIER SUR VEVEY, FENIL SUR CORSIER, SWITZERLAND; MERCK SERONO SA, AUBONNE, SWITZERLAND; MERCK SERONO, ROME, ITALY - EIR, 483, CO RESP 6/11 Action Office Signature/ Requester THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS Subject - EIR, 483, CO RESP 4/11-13/11 LABOR L+S AG, GROSSENBRACH, GERMANY - EIR, 483, CO RESP 7/18-21/11
Page 870 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/27/2012 2012-1403 2012-1404 2012-1405 2012-1406 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ 2012-1407 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1408 2012-1409 2012-1410 2012-1411 2012-1412 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 04/30/2012 02/28/2012 03/27/2012 2012-1413 2012-1414 2012-1415 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ MORROW, LEN W BRANDEN DEROCHE RIGHTBRAIN NETWORKS LLC JOCELYN RAPOSO CODMAN & SHURTLEFF INC LISA ANDERSON CONMED CORP ANICE N. JAMISON MCDERMOTT WILL & EMERY MARILYNN WHITNEY COVINGTON & BURLING LLP LAUREN PRIMIANO PONO PHARMA BORTEZOMIB (VELCADE) NDA DKT FDA-2010-P-0491 MEDTRONIC - ARES ANTIBIOTIC-IMPREGNATED CATHETER K110560 MODULAP RESUABLE UNIPOLAR ELECTROSURGICAL PROBES AND INSERTS - K983623; MODULAP ASPIRATION/IRRIGATION CANNULA - K982445 DKT 1990N-0165 AUROTECH INC - CONTRACT #HHSF22320120013A LUIS E VERA BONAMAR CORP PASTEURIZED CRABMEAT ENTRY #D97-0621287-2 ANALYTICAL RESULTS DKT 1995S-0158 JOSEPH L GODFREY MD CATAWBA PSYCHIATRIC SERVICES PLLC CELEXA - AERS FDA/OMPT/CDRH/OCER/DFOI/ Action Office CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester KLEIN, LISA JOHN BOVIS BODDINGTONS GLEN FEYE ACCURATE CONSULTANTS INC PETER J CREEDON CREEDON & GILL PC KATE PURCELL DOCUTRIEVAL INFORMATION SERVICES COCHLEAR NUCLEUS C1512 SERIES OF COCHLEAR IMPLANTS - PMA, APRVL LTR, NOTES, ETC RANBAXY, PAONTA, SAHIB, BATAMANDI, DEWAS, INDIA CONSENT DECREE; RANBAXY OHM LABS, GLOVERSVILLE, NY - VIOLATIONS, CONSENT DECREE XPEREX CORP - HEALTH CHECK KIOSK K063008 OLYMPUS ENDOTHERAPY - ENDOSCOPE 510K Subject
Page 871 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1416 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1417 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1418 02/28/2012 03/27/2012 2012-1419 02/28/2012 03/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DEN-DO/COMP/ 2012-1420 2012-1421 02/28/2012 03/27/2012 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1422 02/28/2012 03/27/2012 2012-1423 02/28/2012 03/27/2012 2012-1424 02/28/2012 03/27/2012 2012-1425 2012-1426 02/28/2012 03/27/2012 02/28/2012 03/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ INC REGULATORY CONSULTING & SUBMISSIONS WILLIAM A OLSON PHD Center for Regulatory Services, Inc. GUILLERM ENRIQUE GONZALEZ LABORATORIOS PISA MEXICO CERTIFIED RECS FOI DAILY LOG 1/30/12-2/3/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 1/30/12-2/3/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 1/23-27/12 FOI DAILY LOG 1/16-20/12 FDA/OMPT/CDRH/OCER/DFOI/ PRINCE, APRIL MURIS DEMIROVIC MANNING & NAPIER ADVISORS INC FRESENIUS KABI ONCOLOGY LTD, NADIA, IN 11/6/09; FRESENIUS KABI NORGE AS BERG, OSTFOLD, NO 11/17/09; FRESENIUS KABI, VILLADOSE, ROVIGO, IT,E TC - 483S, WARNING LTRS DUFF WILSON REUTERS MURIS DEMIROVIC MANNING & NAPIER ADVISORS INC INTERAGENCY WORKING GROUP ON FOOD MARKETED TO CHILDREN - CONGRESSIONAL CORR, MTGS, RECS 1/09 TO PRESENT FRESENIUS MEDICAL CARE, LIVINGSTON,CA 2/12/10; FRESENIUS MEDICAL CARE HOLDINGS INC,WALTHAM, MA 8/6/10; FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN, UT 2/4/11 - 483S, WARNING LTRS SYNERONS - EMAX MACHINE 510K PRIME AID PHARMACY PEGASYS (PEG-INTERFERON ALFA-2A) - AERS HOFER, STEVE ATENOLOL, KLOR-CON, NIACIN, ETC - AERS Signature/ Requester Subject
Page 872 of 1132

Total Records: 12455 Control # 2012-1427 2012-1428 2012-1429 2012-1430 2012-1431 2012-1432 2012-1433 2012-1434 2012-1435 Recd Date / Due Date 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 02/28/2012 03/27/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ 2012-1436 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1437 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1438 02/28/2012 03/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1439 02/28/2012 OM/OSS/OPILS/DFI/ 2012-13 JOHN P. MALEY SYLVESTER & MALEY, INC THYMOGLOBULIN (THYMOCYTE GLOBULIN) ISR 5573023 JULIE FRANK, PhD. REXAHN PHARMACEUTICALS INC PRAMIPEXOLE NDA 22-421 - APRVL, MEDICAL RVW, CLNCL RVW MASSEY, ERIN RITALIN - CLNCL TRIALS FOI SERVICES INC JUSTIN PIERSON STATE FARM INSURANCE CO VISIONCARE LABCOLORED CONTANT LENSES - CLAIM 13B429-560 FOI SERVICES INC FOI DAILY LOG 1/16-20/12 FOI SERVICES INC FOI DAILY LOG 1/23-27/12 Signature/ Requester FRAN KOCH INFORMATION ACCESS LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 1/30/12-2/3/12 FOI DAILY LOG 1/23-27/12 FOI DAILY LOG 1/30/12-2/3/12 FOI DAILY LOG 1/23-27/12 FOI DAILY LOG 1/30/12-2/3/12 Subject FOI DAILY LOG 1/20/12-2/3/12
Page 873 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/27/2012 2012-1440 2012-1441 02/28/2012 03/27/2012 02/28/2012 03/27/2012 2012-1442 02/29/2012 03/28/2012 Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1443 02/29/2012 03/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1444 2012-1445 2012-1446 2012-1447 2012-1448 2012-1449 2012-1450 2012-1451 02/29/2012 04/10/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ R IAN KLUGE Hyman Phelps and McNamara PC MIKE MEDINA LANX MIKE MEDINA LANX MIKE MEDINA LANX MIKE MEDINA LANX MIKE MEDINA LANX MIKE MEDINA LANX MIKE MEDINA SPINE FRONTIER INC - VEGA SPAN SPINOUS PROCESS PLATE SYS K100220 W L GORE & ASOCIATES INC, FLAGSTAFF, AZ - GORE EMBOLIC FILTER K103500 PIONEER SURGICAL TECHNOLOGY - SPINOUS PROCESS FUSION PLATE K101525 X-SPINE SYSTEMS INC - AXLE INTERSPINOUS FUSION SYS K101471 MEDTRONIC SOFAMOR DANEK USA INC - CD HORIZON SPINAL SYS K092325 PARAGIGM SPINE LLC - INTERSPINOUS FUSION PLATE K093438 OSTEOMED SPINE INC - PRIMAL OK SP INTERSPINOUS FUSION SYS K100354 LIFE SPINE INC - INTERSPINOUS FIXATION SYS K100407 ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS PATHEON, MISSISSAUGA, ONTARIO, CANADA - EIRS, 483S CO RESP 8/1/11 TO 1/31/12 Doe J MURIS DEMIROVIC MANNING & NAPIER ADVISORS INC ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS APP PHARMS, GRAND ISLAND, NY; RALEIGH, NC - 483, WARNING LTR 6/30/11 TO PRESENT AEROCAN FRANCE SAS (ALCAN CEBAL AEROSOLS), BELLEGRADE, FRANCE - EIRS, 483S, CO RESP 8/1/11 TO 1/31/12 Signature/ Requester SCHNEPS, PHYLLIS INDIVIDUAL RECS Subject
Page 874 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/28/2012 2012-1452 2012-1453 2012-1454 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 2012-1455 2012-1456 2012-1457 02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012 2012-1458 02/29/2012 04/11/2012 2012-1459 02/29/2012 03/28/2012 ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/OE/ ORA/OE/ 2012-1460 02/29/2012 03/28/2012 2012-1461 2012-1462 02/29/2012 03/28/2012 02/29/2012 03/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1463 02/29/2012 03/28/2012 FDA/OF/CFSAN/OCD/EOS/ HOLLY J BAYNE BAYNE & ASSOCIATES CORN REFINERS ASSOC/FDA MTG - LBLG USING "NATURAL", 4/16/08; "NATURAL" USE IN LBLG PRE-4/16/08 MET; GERALDINE JUNE LTR (EVALUATION & LBLG TEAM, & DIETARY SUPPLEMENTS TO CORN REFINERS ASSOC, ORA/SW-FO/DALDO/COMPLIANCE/ OC/OCM/EMOPS/ CVM/OCD/ SHAWN E SEILER GISLASON MARTIN VARPNESS ET AL ANEET PANESAR BURDOCK GROUP DONALD J FARER DONALD J FARBER ATTY AGRRCOLA ZARAGOZA INC, MCALLEN TX SALMONELLASAINTPAUL OUTBREAK INVOICES, RECS, COMM, ETC 7/08 CAS #107-92-6 (BUTURIC ACID) - USES, SAFETY, COMM ETC "WORSENING DEPRESSION & SUICIDALITY IN PATIENTS BEING TREATED W/ANTIDEPRESSANT MEDICATIONS" FDA PUBLIC HEALTH ADVISORY3/22/04 CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ TONJA NICHOLS PAYNE MITCHELL LAW GROUP ALICE MEIKLE Vital Pharmaceuticals, Inc. JOSHUA A MAYES SUTHERLAND ASBILL & BRENNAN MICHAEL W CZACK CARAVONA & CZACK LLC LAUREN SILVIS SIDLEY AUSTIN LLP INFORMATION DISCLOSURE MANUAL (IDM) - CURRENT NEW ENGLAND CRYOGENIC CENTER - REGISTRATION #3002733251, #3005374514 8/11 TO PRESENT CYTO SPORT INC - MUSCLE MILK IRESP TO WARNING LTR, INVESTIGATION RVWS 8/11 TO PRESENT PHARMACAL CORP, HAUPPAGE, NY - EIRS, 483S, WARNING LTRS, ETC 1/10 TO PRESENT INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester LANX MIKE MEDINA LANX MIKE MEDINA LANX CHAD MESSER PIPER JAFFRAY & CO GLOBUS MEDICAL INC - SP-FIX SPINOUS PROCESS FIXATION PLATE K102195 ALPHATEC SPINE INC BRIDGEPOINT SPINOUS PROCESS CLAP--POSTERIOR FIXATION SYS K103205 SANQUIN BLOOD SUPPLY, BRUSELS - 483 5/11; SANQUIN BLOOD SUPPLY, AMSTERDAM - 483S 9/11 Subject
Page 875 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject 7/3/08, ETC 2012-1464 2012-1465 02/29/2012 03/28/2012 02/29/2012 03/28/2012 2012-1466 02/29/2012 03/28/2012 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/CHI-DO/CCB/ INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1468 02/29/2012 03/28/2012 2012-1469 02/29/2012 03/28/2012 2012-1470 02/29/2012 03/28/2012 2012-1471 02/29/2012 03/28/2012 2012-1472 02/29/2012 03/28/2012 2012-1473 02/29/2012 03/28/2012 2012-1474 2012-1475 02/29/2012 03/28/2012 02/29/2012 03/28/2012 ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC GRANT RASALEY ASEPTICO INC ASI MEDICAL INC, ENGLEWOOD,CO - EIR, 483 MOST RECENT FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ ANGELIA D SLALYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS CARL BEAURLING CMB REGULATORY SPECIALTIES ABC LABORATORIES, COLUMBIA, MO - EIRS, 483S, CO RESP 8/1/11 TO PRESENT DOW CHEMICAL CO, MIDLAND, MI - EIRS, 483S, CO RESP 8/1/11 TO PRESENT HOLOPACK, COLUMBIA, SC - EIRS, 483S, CO RESP 8/1/11 TO PRESENT PATHEON, CINCINNATI, OH - EIRS, 483S, CO RESP 8/1/11 TO PRESENT PPD LABORATORIES, MIDDLETON, WI - EIRS, 483, CO RESP 8/1/11 TO PRESENT KIMBERLY-CLARK CORP - KIMGUARD ONE STEP STERILIZATION WRAP K092167 ETHICON INC - PDS BARBED SUTURES K113004 ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ORA/NE-FO/NWE-DO/NWECB/ GETZ, STEPHEN M CELLAR AT JASPER HILL (JASPER HILL CREAMERY), GREENSBORO, VT - EIRS, 2010 & 2011 3M PHARMACEUTICALS, 3M DRUG DELIVERY SYS DIV, NORTHRIDGE, CA - EIRS, 483S, CO CORR 8/1/11 TO PRESENT CATALENT PHARMA SOLUTIONS (FORMERLY CARDINAL HEALTH PKGING SERVICES, STERILE TECHN0LOGIES), WOODSTOCK, IL - EIRS, 483S, CO CORR 8/1/11 TO PRESENT DAINIPPON SUMITOMO PHARMA, SUZUKA, MIE, JAPAN EIRS, 483S, cCOCORR 8/1/11 TO PRESENT
2012-1467
02/29/2012 03/28/2012
Page 876 of 1132

Total Records: 12455 Control # 2012-1476 Recd Date / Due Date 02/29/2012 03/28/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester BRENT M ARDAUGH NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ GRONER, STEFANIE ORA/ ORA/ OC/OCM/EMOPS/ FDA/OF/CFSAN/OCD/EOS/ 2012-1480 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1481 2012-1482 03/01/2012 03/29/2012 03/01/2012 03/29/2012 2012-1483 2012-1484 2012-1485 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1486 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1487 03/01/2012 FDA/OMPT/CDER/ORP/DIDP/ HAILEY M BENTON NDA 19-949 - APRVL RECS JEANNE JARZABEK ASTELLAS PHARMA US INC NDA 21-754 - RVWS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ LI ZHANG PHD BASF CORP STACI M TROLIAN BIOMET, INC. JOSEPH CICCONE CHURCH & DWIGHT CO INC JOHNNY NGUYEN PERPPERMINT DENTAL NATHAN P CHANEY CHANEY LAW FIRM PA MARCAINE SPINAL NDA 18-692 - FDA-APPROVED LBLG (FOR PHYSICIANS) (CERTIFIED) ARIBEX NOMAD - PORTABLE X-RAY SYS FORM FDA 2579 DVC MASTER FILE (DMF) MAF-382 DOUGLAS P SINN DDS - WARNING LTR 1/23/03, CORR ASHLAND INC - FCN 979 3/10 TO 8/10 HARPER, JENNA INACTIVE INGREDIENT GUIDE - OLOPATADINE, SODIUM CHLORIDE (NACL), EDENTATE DISODIUM, ETC PATTI WALLER MARLER CLARK ATTYS KRISTI O SMEDLEY Center for Regulatory Services, Inc. PHUSION PROJECTS LLC - TEST RESULTS, APRVL, COMM ETC, LAST 5 YRS TACO BELL CORP - MULTI-STATE SALMONELLA ENTERIDITIS INVESTIGATION RECS, CORR, TEST RESULTS, ETC 10/11 TO 1/12 MASCOMA SUBMISSION - BIOENGINEERED YEAST Subject K022236, K031328, K944353 ETC
2012-1477 2012-1478 2012-1479
02/29/2012 03/28/2012 02/29/2012 03/28/2012 02/29/2012 03/28/2012
Page 877 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/29/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1488 03/01/2012 03/29/2012 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ 2012-1489 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1490 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1491 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1492 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1493 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1494 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JOHN J. HAY SALANS LLP TEVA PHARMS, WATERFORD, IRELAND - 483 3/13/09 JOHN J. HAY SALANS LLP TEVA PHARMS, WATERFORD, IRELAND - 483 3/6/09 JOHN J. HAY SALANS LLP TEVA CANADA LTD, MARKHAM, CANADA - 483 7/29/10 JOHN J. HAY SALANS ATTY TEVA PHARMS FINE CHEMICALS, BULCIAGO, COMO, ITALY - 483 2/3/11 JOHN J. HAY SALANS LLP TEVA CANADA LTD, TORONTO, CANADA - 483 2/27/09 JOHN. J. HAY SALANS LLP TEVA PHARMS INDUSTRIES LTD, KFAR SAVA, ISRAEL - 483 8/26/10 ABRAHAM PAYTON AMERICAN BRIDGE ICON HEALTH & FITNESS (1994-2006), LEINER HEALTH PRODUCTS (1992-2004), MEDICAL SPECIALTIES GROUP (1995-2003), ETC - CMPLNTS, INVESTIGATION FILES, FINES, ETC Signature/ Requester FLOYD SKEREN & KELLY LLP Subject
Page 878 of 1132

Total Records: 12455 Control # 2012-1495 Recd Date / Due Date 03/01/2012 03/29/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1496 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1497 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1498 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1499 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1500 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1501 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1502 03/01/2012 03/29/2012 2012-1503 03/01/2012 03/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE DAILY LOG 1/23-27/12 DAILY LOG 1/16-20-12 LAVONNE M PATTON PHD BECKLOFF ASSOCIATES INC DOXORUBICIN HCL NDA 50-718 - APPROVABLE LTR, LBLG, MOR, ETC JOHN J. HAY SALANS LLP TEVA PHARMS INDUSTRIES LTD, KFAR, ISRAEL - 483 6/11/09 JOHN J. HAY SALANS LLP TEVA PHARMS, JERUSALEM, ISRAEL - 483 9/25/08 JOHN J. HAY SALANS LLP TEVA RUNCORN, CHESHIRE, UK - 483 11/19/10 JOHN J. HAY SALANS LLP TEVA RUNCORN, CHESHIRE, UK - 483 4/22/09 JOHN J. HAY SALANS LLP ASSIA CHEMICAL INDUSTRIES, BEER SHEVA, ISRAEL - 483 9/18/08 Signature/ Requester JOHN J. HAY SALANS LLP Subject TEVA PHARMS, WATERFORD, IRELAND - 483 9/2/10
Page 879 of 1132

Total Records: 12455 Control # 2012-1504 Recd Date / Due Date 03/01/2012 03/29/2012 2012-1505 03/01/2012 03/29/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1506 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1507 03/01/2012 03/29/2012 2012-1508 2012-1509 2012-1510 2012-1511 2012-1512 2012-1513 2012-1514 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ 2012-1515 2012-1516 03/01/2012 03/29/2012 03/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ STACEY ELLUL NEUROPACE INC DAWN HAAKE INFORMATION ACCESS LISA TARRISON SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP SWEDISH MATCH AB - NEW TOBACCO PRODS SUBSTANTIAL EQUIVALENCE RPTS AND EXEMPTIONS; FDA DETERMINIATONS ON RPTS SUBMITTED UNDER THE SUBSTANTIAL EQUIVALENCE RPTS NEOS SURGERY SL - CRANIAL LOOP CRANIAL BONE FIXATION SYS K101235 SANDVIK MEDICAL SOLUTIONS, SHEFFIELD, UK - EIR DAILY LOG 1/16-20/12 DAILY LOG 1/16-20/12 INFORMATION ACCESS DAILY LOG 1/23-27/12 Center for Regulatory Services, Inc. DAILY LOG 1/16-20-12 Center for Regulatory Services, Inc. DAILY LOG 1/23-27/12 ORA/P-FO/LOS-DO/LACB/ CHRISTINE LITTLE RHO INC DR LYDIE HAZAN, AXIS CLINICAL TRIALS, IMPACT CLINICAL TRIALS, LOS ANGELES, CA - EIRS, 483S, CO RESP 2007 TO PRESENT DAILY LOG 1/16-20/12 Doe J FERRING PHARMS - EUFLEXXA RECS Doe J Signature/ Requester KENNETH REID WASHINGTON INFORMATION SOURCE USA FAR OCEAN GROUP INC - FEMALE ONE TYPE I & TYPE II RECALL, VAGIFRESH BALL & VAGIFRESH GEL AERS RPT Subject DAILY LOG 1/30/12-2/3/12
Page 880 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/29/2012 2012-1517 2012-1518 2012-1519 2012-1520 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 03/01/2012 03/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1521 2012-1522 03/01/2012 03/29/2012 03/01/2012 03/29/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/OCI/ ORA/OCI/ CHRISTOPHER ORNAD BIONUCLEONICS INC JAKE PEARSON NBC NEWS RBM CO, KNOXVILLE, TN - CARDIOGEN-82, RUBIDIUM-82 INFUSION AND GENERATORS 483S 2008 TO 2012 INVESTIGATION OF GOOGLE REGARDING THE PURCHASING OF ADVERTISING FOR THE ILLEGAL SALE OF PERSCRIPTION DURGS WITHOUT PERSCRIPTIONS 2009 TO 2011 BESPAK EUROPE LTD, NORFOLK, ENGLAND - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester NUVASIVE INC DAWN HAAKE NUVASIVE INC GABRIELA ANCHONDO MEDTRONIC NEUROSURGERY GABRIELA ANCHONDO MEDTRONIC NEUROSURGERY CHRISTOPHER ORAND BIONUCLEONICS INC CODMAN - CERTAS PROGRAMMABLE VALVE SYS, CERTAS THERAPY MANAGEMENT SYS K112156 NORDION - CARDIOGEN-82 AND/OR RUBIDIUM-82 GENERATORS AND COLUMNS WITH STRONTIUM-82 483 2008 TO 2012 Subject 1/24/11 GAMMA SERVICE GMBH, RADEBERG, GERMANY - EIR 2/7/11 CODMAN - CERTAS PROGRAMMABLE VALVE SYS K113526
2012-1523
03/02/2012 03/30/2012
ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS
2012-1524
03/02/2012 03/30/2012
3M HEALTH CARE LT, LEICESTERSHIRE, UK - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT
2012-1525
03/02/2012 03/30/2012
SHASUN PHARMA SOLUTIONS (RHODIA PHARMA SOLUTIONS), NORTHUMBERLAND, ENGLAND - EIRS, 483S CO RESP 8/1/11 TO 1/31/12
2012-1526
03/02/2012 03/30/2012
NYCOMED GMBH, SINGEN, GERMANY - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT
Page 881 of 1132

Total Records: 12455 Control # 2012-1527 Recd Date / Due Date 03/02/2012 03/30/2012 2012-1528 03/02/2012 03/30/2012 2012-1529 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1530 03/02/2012 03/30/2012 2012-1531 03/02/2012 03/30/2012 2012-1532 03/02/2012 03/30/2012 2012-1533 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1534 03/02/2012 03/30/2012 2012-1535 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1536 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1537 03/02/2012 ORA/CE-FO/BLT-DO/CB/ ANGELIA D SLAYTON NEXT BREATH LLC, BALTIMORE, MD - EIRS, 483S, CO ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS MICRONISIERUNGS-KONTOR OBERROT GMBH (MCKO), OBERROT, GERMANY - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT ORA/P-FO/SAN-DO/SFCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS DAVID B REDWINE DAVID B REDWINE MD MEDCOMM SOLUTIONS, EMERYVILLE, CA - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT TAP (ABBOTT) - LUPRON DEPOT (LELUPROLIDE ACETATE) STUDY M84-042, M86-031, M86039, ETC ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS CELSIS LABORATORY GROUP, ST LOUIS, MO - EIRS, 483S, CO RESP 8/1/11 TO 1/31/12 KNIPPER & COMPANY INC, LAKEWOOD, NJ -EIRS, 483S, CO RESP 8/1/11 TO 1/31/12 LANCASTER LABS, LANCASTER, PA - EIRS, 483S, CO RESP 8/1/11 TO 1/31/12 LABOR L & S AG, BAD BOCKLET-GROSSENBRANCH, GERMANY - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/SE-FO/SJN-DO/SJCB/ Signature/ Requester ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS Subject PATHEON (MOVA PHARMACEUTICAL CORP), MANATI, PR EIRS, 483S CO RESP 8/1/11 TO 1/31/12 ALMAC CLINCIAL SERVICES, AUDUBON, PA - EIRS, 483S, CO RESP 8/1/11 TO 1/31/12 DYNAMIT NOBEL GMBH, LEVERKUSEN, GERMANY - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT
Page 882 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/30/2012 2012-1538 03/02/2012 03/30/2012 2012-1539 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1540 03/02/2012 03/30/2012 2012-1541 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1542 03/02/2012 03/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1543 03/02/2012 03/30/2012 2012-1544 03/02/2012 04/10/2012 2012-1545 2012-1546 2012-1547 2012-1548 2012-1549 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/02/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ CVM/OCD/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS MARINA GLAZMAN BAINBRIDGE INC KRISTI O SMEDLEY Center for Regulatory Services, Inc. DAWN HAAKE NUVASIVE INC JOANNE HOGAN FOI SERVICES INC DOUGLAS N BLUE MARCS INC - ENTRY AV300242573, AV300242581 2007-2771, 2007-6972, 2007-10869, ETC NADAS - FOI SUMMARIES, LBLG, ENVIRONMENTAL ASSESSMENTS 1990, 1995 DOT - CHARLES-DARWIN-RING , EIR 1/31/11 PACE ANALYTICAL LIFE SCIENCES LLC, OAKDALE, MN EIRS, 483S, CO RESPS 8/1/11 TO PRESENT PFIZER INC, KALAMAZOO, MI - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT ORMCO - FS ALIGNER 510K 1/09 TO 1/1/12 ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS PATHEON INC, WHITBY, ONTARIO, CANADA - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ MATTHEW ERJAVEE MATHEW ERJAVEC PA ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS STRYKER CORP - STRYKER ORTHOPEDICS CERAMIC ON CERAMIC HIP WITH TRIDENT ACETABULAR SHELL & STANDARD ALUMINA-CERAMIC LINER MDRS PATHEON INC, ONTARIO, CANADA - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT ORA/NE-FO/NYK-DO/NYDCB/ Action Office Signature/ Requester INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS Subject RESPS, 8/1/11 TO PRESENT NORWICH PHARMACEUTICALS INC, NORWICH, NY - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT PATHEON INC, CEDEX, FRANCE - EIRS, 483S, CO RESPS 8/1/11 TO PRESENT
Page 883 of 1132

Total Records: 12455 Control # Recd Date / Due Date 03/30/2012 2012-1550 03/02/2012 03/30/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1551 03/02/2012 03/30/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1552 2012-1553 2012-1554 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/02/2012 03/30/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1555 2012-1556 03/02/2012 03/30/2012 03/02/2012 03/30/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1557 2012-1558 2012-1559 2012-1560 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/02/2012 03/30/2012 03/05/2012 04/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC SMITH, VIRGIL L TYSABRI ( NATALIZUMAB) - UPDATE OF HEALTHCARE PROFESSIONAL RECS 4/22/11 (CERTIFIED) CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ MATT CLAUSEN MEDLINE INDUSTRIES INC KATE WILLSON ICIJ INDIVIDUAL RECS TISSUE BANK REGISTRY LIST STRYKER - STERI-SHIELD FLYTE TOGAS K073017 ORA/NE-FO/NYK-DO/NYDCB/ BRIAN HARTIMAN ABC NEWS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS AAP PHARMACUTICALS LLP, GRAND ISLAND, NY - EIRS, PHOTOGRAPHS, VIDEO, ETC FOI CLOSED REQUESTS 2/20-24/12 WOLTERS KLUWER LAW & BUSINESS FOI SERVICES INC FOI CLOSED REQUESTS 2/13-17/12 FOI SERVICES INC FOI CLOSED REQUESTS 2/13-17/12 FOI CLOSED REQUESTS 2/20-24/12 LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 2/20-24/12 Action Office Signature/ Requester ZETETIC LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 2/13-17/12 Subject
Page 884 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1561 2012-1562 2012-1563 2012-1564 2012-1565 2012-1566 2012-1567 03/05/2012 04/02/2012 03/05/2012 04/02/2012 03/05/2012 04/02/2012 03/05/2012 04/02/2012 03/05/2012 04/02/2012 03/05/2012 04/02/2012 03/05/2012 04/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1568 03/05/2012 04/02/2012 2012-1569 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1570 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1571 2012-1572 03/06/2012 04/03/2012 03/06/2012 04/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ANDREW LA PIETRA QMETRICS TECHNOLOGIES CHANDRAN TIRVATTAR DR REDDY'S LABORATORIES INC GLENMARK - CICLOPIROX ANDA 09-1595 - SBA K924810, K060845, K961144, ETC FOI SERVICES INC TYSABRI (NATALIZUMAB) BLA 12-5104 - LTR, LBLG 10/3/08 (CERTIFIED) FOI SERVICES INC FDA/OO/OFBA/OAGS/ MARILYN W ANDRULIS MARALINA CORP FOOD & DRUG ADMIN (FDA), CENTER FOR DISEASE CONTROL (CDC) & PROGRAM SUPPORT CENTER ( PSC) PURCHASE CARD HOLDERS LISTS TYSABRI (NATALIZUMAB) BLA 12-5104 - SUPPLEMENT APRVL LTR 10/7/11 (CERTIFIED) ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/BLT-DO/CB/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ KALANGE, JOHN T JOHN J HAY SALANS LLP JOHN J HAY SALANS LLP JOHN J HAY SALANS ATTY JOHN J HAY SALANS LLP JOHN J HAY SALANS LLP MARYLYNN GRAHAM SNELL & WILMER LAW OFCS TEVA PHARMACEUTICALS USA INC, SELLERSVILLE, PA 483S, 10/20/08 & 4/28/10 TEVA PARENTAL MEDICINES INC, IRVINE, CA - 483S, 9/4/08, 7/24/09, & 5/14/10 TEVA WOMENS HEALTH INC, CINCINNATI, OH - 483S, 7/1/09 & 11/8/10 ISRS 3236328-0, 3880852-4, 5778643-2 ETC IVAX PHARMACEUTICALS INC (AKA TEVA), CONGERS, NY 483, 11/3/08 BARR LABORATORIES INC, FOREST, VA - 483, 4/8/10 K060126 Signature/ Requester Subject
Page 885 of 1132

Total Records: 12455 Control # 2012-1573 Recd Date / Due Date 03/06/2012 04/03/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1574 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1575 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1576 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1577 03/06/2012 04/03/2012 2012-1578 2012-1579 03/06/2012 04/03/2012 03/06/2012 04/03/2012 2012-1580 2012-1581 2012-1582 2012-1583 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 2012-1584 03/06/2012 ORA/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CIN-DO/CCB/ FOI SERVICES INC LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP RICARDO RONQUILLO NEUROGESX WENDY BARNHART PERKINELMER INC RICHARDO RONQUILLO NEUROGESX SHAWN H HUBER PROFESSIONAL HOSPITAL SUPPLY INC ORA/SW-FO/KAN-DO/COMP/ LAURENCE D MASS LAWRENCE D MASS ATTY AT LAW PARTICLE DYNAMICS INTERNATIONAL, ST LOUIS, MO - EIR 2/27/10 CAMPUS PUB, LEXINGTON, KY - EIRS, 483S, CO RESP, ETC 2/15-16/12 ORTHOTICS & PROSTHETICS ONE INC, WATERLOO, IA EIR 11/29/11-12/1/11 HK PLASTICS ENGINEERING INC, OCEANSIDE, CA - EIRS, 483S, WARNING LTRS, ETC 1/07 TO PRESENT NEW JERSEY STATE DEPARTMENT OF HEALTH & SENIOR SERVICES, EWING, NJ - 482, 483, RPTS 1/26/12 PINTA FOAMTEC, MINNEAPOLIS, MN - EIRS, 483S, WARNING LTRS 1/07 TO PRESENT AMERICAN CONTRACT SYSTEMS, TIFFIN, OH - EIR, CLOSE OUT LTR 1/5/12, 1/5-14/11 INDIVIDUAL RECS DANIEL NEWMAN NEWMAN LEVOTHYROXINE SODIUM - STUDY FARAH MORGAN FARAH MORGAN MD KORLYM - APRVL PKG CRYSTAL LSPINKS GLENMARK PHARMACEUTICAL INC HERCEPTIN - SBA Signature/ Requester JESSICA SMYTH MARTIN DIAZ LAW FIRM Subject AMERICAN PHARMACEUTICAL PARTNERS INC (APP PHARMACEUTICALS LLC) - OXYTOCIN PI 4/25/07
Page 886 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/03/2012 2012-1585 2012-1586 03/06/2012 04/03/2012 03/06/2012 04/03/2012 Action Office ORA/ ORA/NE-FO/NWE-DO/NWECB/ OC/COS/OES/ OC/COS/OES/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1587 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1588 2012-1589 2012-1590 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2012-1591 03/06/2012 04/03/2012 2012-1592 03/06/2012 04/23/2012 2012-1593 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/SAN-DO/SFCB/ KRISTEN CHANDLER UT HEALTH SCIENCE CENTER AT SAN ANTONIO KRISTINE A CROSSWHITE CROSSWHITE LIMBRICK & SINCLAIR LLP MICHAEL P MANAPOL ESQ BRIAN D WITZER INC SK FOOD GROUP INC, RENO, NV - INSPS, ANALYSES, FOOD REGISTRY RPTS, ETC 1/08 TO PRESENT SOLODYN ER TABS NDA 50-808 - SAFETY RVW 6/3/10 ALLO-ADVANTAGE, BOERNE, TX - EIR, 483 MOST RECENT BRAD SCHONOHOFT OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/ATL-DO/ACB/ SANDRA S MATSUMOTO ADVANCED BIOHEALING CHARLOTTE HUFFMAN NBC-17 GENERAL & PLASTIC SURGERY DVC PANEL A/C - BRIEFING BOOK 1/29/98 DUKE UNIV HEALTH SYSTEM IRB - DEAN'S LTR REFERENCED IN EIR 1/31/11 BULK HYDROXPROGESTERONE CAPROATE ACTIVE PHARMACEUTICAL INGREDIENT (APIS) & COMPOUNDED HYDROXPROGESTERONE CAPROATE PRODS - RESULTS CHRISTY MENG INNOPHARMA INC JANSEN PHARMS - ELMIRON (PENTOSAN POLYSULFATE SODIUM CAPS) NDA 20-193 SBA STEVEN B TOENISKOETTER FAEGRE BAKER DANIELS JOSEPHINE TORRENTE Hyman Phelps and McNamara PC GEONOME ANNOUNCEMENT EXHIBIT A - ANALYSIS RECS, COMPARATIVE ANALYSIS OMEGA-3-ACID ETHYL ESTERS - SUBMISSSIONS ESTABLISHING BIOEQV, RESP, GUIDANCE TO ESTABLISH BIOEQV Signature/ Requester Doe J Subject
Page 887 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1594 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1595 03/06/2012 04/03/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/LOS-DO/LACB/ 2012-1596 2012-1597 2012-1598 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1599 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1600 2012-1601 03/06/2012 04/03/2012 03/06/2012 04/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ HUDA YUSUF BOSTON SCIENTIFIC CORP CR BARD INC - BARD DUAL LUMEN URETERAL CATHETER K032521 2012-610 FOI SERVICES INC TYSABRI (NATALIZUMAB) BLA 125014 LBG 4/1/11 FOI SERVICES INC ORA/SW-FO/DEN-DO/COMP/ Doe J TYBABRI (NATALIZUMAB) BLA 125104 LBLG, CERTIFIED FDA/OF/CFSAN/OCD/EOS/ WILLIAM A OLSON PHD Center for Regulatory Services, Inc. SNUGZ USA, SALT LAKE CITY, UT - AUDITS PAPER PAK INDUSTRIES - FCN 1125 CHRISTOPHER T LEE DICKIE MCCAMEY & CHILCOTE CFSAN HEALTH HAZARD EVALUATION (HHE #8065) - RECS CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC GLENMARK GENERICS - MARLISSA (ETHINYL ESTRADIOL, LEVONORGESTREL) ANDA 91-452 SBA Signature/ Requester Subject
Page 888 of 1132

Total Records: 12455 Control # 2012-1602 2012-1603 2012-1604 Recd Date / Due Date 03/06/2012 04/27/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1605 2012-1606 2012-1607 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/06/2012 04/03/2012 2012-1608 03/06/2012 04/03/2012 2012-1609 03/06/2012 04/03/2012 2012-1610 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1611 03/06/2012 04/03/2012 2012-1612 03/06/2012 04/03/2012 2012-1613 03/06/2012 04/03/2012 2012-1614 03/06/2012 FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/NJ-DO/NJCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON PHARMAGISTICS LLC, SOMERSET, NJ - EIRS, 483S, CO RESP 8/11 TO 1/12 UNIV OF IOWA, PHARMACEUTICAL SERVICES DIVISION, COLLEGE OF PHARMACY, IOWA CITY, IA - EIRS, 483S, CO RESP 8/11 TO 1/12 UNIV OF IOWA, PHARMACEUTICAL SERVICES DIVISION, COLLEGE OF PHARMACY, IOWA CITY, IA - EIRS, 483S, CO RESP 8/11 TO 1/12 MYLAN - BUDESONIDE ANDA 90-410 APRVL LTR, LBLG, ORA/CE-FO/CIN-DO/CCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ HUDA YUSUF BOSTON SCIENTIFIC CORP HUDA YUSUF BOSTON SCIENTIFIC CORP ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS MICHAEL P. MANAPOL, Esq. BRIAN D WITZER INC APPLIED MEDICAL RESOURCES CORP - URETERAL CATHETER K020577 PHARMACEUTICS INTERNATIONAL INC, HUNT VALLEY, MD - EIRS, 483S, CO RESP 8/11 TO 1/12 UPS SUPPLY CHAIN SOLUTIONS, RENO, NV - EIRS, 483S CO RESP 8/11 TO 1/12 UPS SUPPLY CHAIN SOLUTIONS, LOUISVILLE, KY - EIRS, 483S, CO RESP 8/11 TO 1/12 SOLODYN EXTENDED RELEASE TABS NDA 50-808 COOK UROLOGICAL INC - URETERAL CATHETER K923729 FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC HUDA YUSUF BOSTON SCIENTIFIC CORP TOBACCO MANUFACTURERS - EIRS, WARNING LTRS, 483S, CO RESP 10/1/11 TO 2/29/12 Signature/ Requester Subject TRANSENTERIX INC - SPIDER STANDARD & ADVANCED K102839 ACMI CORP - DUAL LUMEN URETERAL CATHETER K043581
Page 889 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/03/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1615 03/06/2012 04/03/2012 2012-1616 2012-1617 03/06/2012 04/03/2012 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1618 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1619 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1620 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1621 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1622 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1623 03/06/2012 CBER/OCTMA/DDOM/ALFB/ STEPHANIE KALBERER TRANSCRIPT OF HCMV WORKSHOP 1/10/12 NANCY ZHANG, Ph.D QUANTITATIVE SOLUTIONS INC LUPRON DEPOT (LEUPROLIDE ACETATE) NDA 20011-S000 MARY ANDERSON SHIRE INC PROZAC - SBA 18-936/S-065; 20-101/S-027; 20-974/S-001 FOI SERVICES INC TYSABRI (NATALIZUMAB) BLA 125104 - LBLG 9/16/11 (CERTIFIED) FOI SERVICES INC TYSABRI (NATALIZUMAB) BLA 125104 - LBLG 1/21/10 (CERTIFIED) ELLIOT FAVUS, M.D. FAVUS INSTITUTIONAL RESEARCH LLC ADCETRIS (BRENTUXIMAB VEDOTIN) AER 10/11 TO PRESENT FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/CE-FO/CIN-DO/CCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS WEST ANALYTICAL SERVICES LLC, MAUMEE, OH - EIRS, 483S, CO RESP 8/11 TO 1/12 TRANSENTERIX INC - SPIDER SURGICAL INSTRUMENTS K091697 TEVA PHARMS - TESTOSTERONE NDA 20-2763 APRVL RECS Signature/ Requester INC REGULATORY CONSULTING & SUBMISSIONS Subject RVWS, ETC
Page 890 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/03/2012 2012-1624 03/06/2012 04/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1625 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1626 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1627 2012-1628 03/06/2012 04/03/2012 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1629 03/06/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1630 2012-1631 2012-1632 03/06/2012 04/03/2012 03/06/2012 04/03/2012 03/07/2012 04/04/2012 2012-1633 03/07/2012 04/04/2012 2012-1634 03/07/2012 ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ Joan Stitt, UG2CD-16 MERCK & CO., INC. Joan Stitt, UG2CD-16 MERCK & CO., INC. JOHNATHAN RICKMAN FDA NEWS JOHANTHAN RICKMAN FDA NEWS JOHANTHAN RICKMAN DHAIWAL LABORATORIES LLC, DALLAS, TX, CLAVEL CORP, ABILENE, TX, MEDICALTECHNOLOGY INC, GRAND PRAIRE, TX - 483S 12/-31/11 BEN VENUE LABS, BEDFORD, OH; PIEZOSURGERY INC, COLUMBUS, OH; MP BIOMEDICALS DIAGNOSTICS DIVISION, SOLON, OH - 483S 12/1-31/11 PRIME TECHNOLOGICAL SERVICES, SUWANEE, GA, PIE MEDICAL INTL, BUFORD, GA - 483S 12/1-31/11 FOI DAILY LOG 2/27/2012 to 3/2/2012 A list of all FOIA requests closed 2/1-29/2012"on CD TAKAHASHI, HELEN FORTEO - AER ZIMMERMAN, NOAH FDA/OMPT/CDRH/OCER/DFOI/ GOYAL, RAJU ALL NEW DRUG APPLICATIONS INFO 2010-2011 MOBILE MIM K112930 PAMELA SCHANEEN SHIONOGI INC KAPVAY (CLONIDINE) SBA NDA 22-331/S001,002 PAMELA SCHANEEN SHIONOGI INC VAGIFEM (ESTRADIOL VAGINAL TABS) SBA SAFETY Action Office Signature/ Requester REDBIOTEC AG JIM NIENDORFF CASSIDAY SCHADE LLP INDIVIDUAL RECS Subject
Page 891 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/04/2012 2012-1635 03/07/2012 04/04/2012 2012-1636 03/07/2012 04/04/2012 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/CHI-DO/CCB/ Action Office Signature/ Requester FDA NEWS JOHANTHAN RICKMAN FDA NEWS JOHANTHAN RICKMAN FDA NEWS BLUE SKY BIO, GRAYSLAKE, IL, ACCUMEDIX INC, GRAYSLAKE, IL; ASTRON DENTAL CORP, LAKE ZURICH, IL 483S 12/1-31/11 FERNDALE LABORATORIES INC, FERNDALE, MI; CARACO PHARMACEUTICAL LABORATORIES LTD, DETROIT, MI; CAYMAN CHEMICAL CO, ANN ARBOR, MI, ETC - 483S 12/31/11 HEi INC (ADVANCED MEDICAL DIVISION), BOULDER, CO, PUSLEEP INC, SOUTH JORDAN, UT; PERSONAL PERFORMANCE MEDICAL CORP, SALT LAKLE CITY, UT, ETC - 483S 12/1-31/11 BELCHER PHARMACEUTICALS LLC, LARGO, FL, STINGRAY SURGICAL PRODUCTS LLC, BOCA RATON, FL, ARJ MEDICAL INC, OLDSMAR, FL, ETC - 483S 12/1-31/11 CAMBRIDGE MAJOR LABS, GERMANTOWN, WI, LIFE CORP, MILWAUKEE, WI - 483S 12/1-31/11 CITRA LABS LLC, BRAINTREE, MA, CUBIST PHARMACEUTICALS INC, LEXINGTON, MA, MILLENNIUM MILLENUIM PHARMSCEUTICALS INC, MA, ETC - 483S 12/131/11 ALPHA OMEGA SERVICES INC, BELLFLOWER, CA, THERA LIGHT INC, CARLSBAD, CA, DREAM WRX DENTAL LAB, LOS ANGELES, CA, ETC - 483S 12/1-31/11 FOREST PHARMACEUTICALS INC, EARTH CITY, MO, FLEMING & CO PHARMS, FENTON, MO, ORTHOTICS & PROSTHETICS ONE INC, WATERLOO, IA, ETC - 483S 12/131/11 BIOSPHERE MEDICAL SA, ROISSY EN FRANCE, FRANCE, MECTRON SPA, CARASCO, ITALY, BEIJING TOPLASER TECHNOLOGY CO LTD, BEIJING,CHINA, ETC - 483S 1/131/11 CIPLA LTD, KURKUMBH VILLAGE, DISTRICT PUNE, MAHARASHTRA, INDIA, ENTERPRISE IMPORTFAB INC, POINTE-CLAIRE, CANADA, ALPHORA RESEARCH INC, OAKVILLE, CANADA, ETC - 483S 12/1-31/11 A LIST OF PPHARMACUETICAL, BIOLOGICS & MEDICAL DEVICES MFG & CLINICAL TRIAL FACILITIES IN THE USA & OUTSIDE THE USA - 483S 2/1-29/12 EX-LAX, INC, HUMACAO, PR, LILNDE GAS PUERTO RICO Subject
2012-1637
03/07/2012 04/04/2012
ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
2012-1638
03/07/2012 04/04/2012
2012-1639 2012-1640
03/07/2012 04/04/2012 03/07/2012 04/13/2012
ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/
JOHANTHAN RICKMAN FDA NEWS JOHNATHAN FDA NEWS
2012-1641
03/07/2012 04/04/2012
JOHATHAN RICKMAN FDA NEWS
2012-1642
03/07/2012 04/04/2012
2012-1643
03/07/2012 04/04/2012
2012-1644
03/07/2012 04/04/2012
2012-1645
03/07/2012 04/04/2012
ORA/ORM/ ORA/ORM/ ORA/SE-FO/SJN-DO/SJCB/
JOHNATHAN RICKMAN FDA NEWS JOHANTHAN RICKMAN
2012-1646
03/07/2012
Page 892 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/04/2012 2012-1647 03/07/2012 04/04/2012 2012-1648 03/07/2012 04/04/2012 2012-1649 03/07/2012 04/04/2012 2012-1650 03/07/2012 04/04/2012 2012-1651 03/07/2012 04/04/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS Subject INC, CATANO, PR - 483S 12/1-31/11 SOLUM & HERBE, PORT TOWNSEND, WA, MICRO CURRENT TECHNOLOGY INC, SEATTLE, WA, PHILIPS ULTRASOUND INC, BOTHELL, WA - 483S 12/1-31/11 CARDICA INC, REDWOOD CITY, CA, AQUEDUCT MEDICAL INC, SAN FRANCISCO, CA, SIEMENS INDUSTRY INC, MILPITAS, CA, ETC - 483S 12/1/31/12 SIGMAPHARM LABORATORIES LLC, BENSALEM, PA, INTERLETRIC CORP, WARREN, PA, REX MEDICAL LLP, CONSHOHOCKEN, PA - 483S 12/1-31/11 INTELLICELL BIOSCIENCES INC, NEW YORK, NY, ASEPT PAK INC, MALONE, NY, ADVANCE PHARMACEUTICAL INC, RONKONKOMA, NY, ETC - 483S 12/1-31/11 HAUSTED PATIENT HANDILNG SYSTEMS LLC, MONTGOMERY, AL, ODYSSEY MEDICAL INC, BARLETT, TN, PETER SCHIFF ENTERPRISES, COOKESVILLE, TN, ETC 483S 12/1-31/11 DENTSPLY PROSTHETICS, BURLINGTON, NJ, LINGRAPHICARE AMERICA INC, PRINCETON, NJ, PROSEC PROTECTION SYSTEMS INC, LAKEWOOD, NJ, ETC - 483S 12/1-31/11 2010-7537 2011-5850
2012-1652
03/07/2012 04/04/2012
2012-1653 2012-1654
03/07/2012 04/04/2012 03/07/2012 04/04/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
(JOAN STITT (UG2CD-16) MERCK & CO., INC. (JOAN STITT (UG2CD-16) MERCK & CO., INC.
2012-1655 2012-1656 2012-1657 2012-1658 2012-1659
03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
JOA N STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC.
2011-6996 2011-7588 20118984 2011-9166 2011-9188
Page 893 of 1132

Total Records: 12455 Control # 2012-1660 2012-1661 2012-1662 2012-1663 2012-1664 2012-1665 2012-1666 2012-1667 2012-1668 2012-1669 Recd Date / Due Date 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1670 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1671 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1672 03/07/2012 FDA/OMPT/CDER/ORP/DIDP/ JONATHAN KIMMELMAN SUNITINIB - EFFICACY JONATHAN KIMMELMAN MCGILL UNIVERSITY BIOMEDICAL ETHICS UNIT BORTEZOMIB - EFFICACY JONATHAN KIMMELMAN MCGILL UNIVERSITY BIOMEDICAL ETHICS UNIT ROTIGOTINE - EFFICACY Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JOAN STTITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. GABRIELA ANCHONDO MEDTRONIC NEUROSURGERY CHANDRAN TIRUVATTAR DR REDDY'S LABORATORIES INC TEVA PHARMS - TESTOSTERONE NDA 20-2763 SBA, CHEM, MFG & CONTROLS RECS, PKG RECS, ETC CODMAN ISOCOOL BIPOLAR FORCEPS - K023566 2012-419 FOI DAILY LOG 2/20-24/12 2011-9349 2011-9342 2011-9340 2011-9319 2012-378 Subject 2011-9216
Page 894 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/04/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1673 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1674 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1675 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1676 2012-1677 03/07/2012 04/04/2012 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1678 03/07/2012 04/04/2012 2012-1679 03/07/2012 04/04/2012 CTP/OD/ CTP/OD/ FDA/OO/OFBA/OAGS/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1680 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ PREVOR, CHERYL HUMAN CLNCL TRAILS FOR T CELL USE KRISTEN L. FLAHERTY MORRISON MAHONEY LLP INDIVIDUAL RECS CAROLINE WINTER BLOOMBERG BUSINESS NEWS CIGARETTE LABEL - DESIGN ORA/NE-FO/NYK-DO/NYDCB/ JAYE McGINN HOSPIRA INC ANIL SACHDEVA STRIDES INC APOTHECON - KENALOG 40 (TRIAMCINOLONE ACETONIDE) NDA 14-901 SBA APP PHARMACEUTICALS LLC - WARNING LTR, 483 2/22/12 ALI MOSTAGHIMI DYNAVAX TECHNOLOGIES ERWIN RENTSCHLER, LAUPHEIM, GERMANY - EIR, 483, WARNING LTR 2001 TO PRESENT JONATHAN KIMMELMAN MCGILL UNIVERSITY BIOMEDICAL ETHICS UNIT ZICONOTIDE - EFFICACY JONATHAN KIMMELMAN MCGILL UNIVERSITY BIOMEDICAL ETHICS UNIT GEFETINAB - EFFICACY Signature/ Requester MCGILL UNIVERSITY BIOMEDICAL ETHICS UNIT Subject
Page 895 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1681 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1682 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1683 2012-1684 2012-1685 2012-1686 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 03/07/2012 04/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ 2012-1687 2012-1688 2012-1689 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/08/2012 04/05/2012 2012-1690 03/08/2012 04/05/2012 2012-1691 03/08/2012 04/05/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ DOUGLAS N BLUE ZETETIC INC CHRIS HOGAN AIR LIQUIDE USA LLC BEN MA GLOBAL TREASURE INDUSTRIES LTD BEN MA GLOBAL TREASURE INDUSTRIES LTD BEN MA GLOBAL TREASURE INDUSTRIES LTD FLEXIBLE TIP THERMOMETER - K030673 RAPID DIGTAL THERMOMETER - K062010 MARS - CONFECTIONERY ENTRY #AV300241294, #AV300241302 WESTERN ENTERPRISES, AVON, OH - EIR, COVERSHEET ENDORSEMENT MOST RECENT GLOBAL TREASURE FLUID FILLED TEETHER - K043033 ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/FLA-DO/FCB/ COLLIN J. PENG-SUE HOGAN LOVELLS US LLP GARANCE BURKE ASSOCIATED PRESS DAVID W. PRYOR GALLAGHER GAMS ET AL DAVID E. McCRAW NEW YORK TIMES COMPANY DLITES ENTERPRISES, GAINESVILLE, FL - DLITES CMPLNTS, COMM ALL FIELDS OF INFO COLLECTED IN THE DATABASE 2004 TO PRESENT SHANES GOURMET; CATERING BY SCOTT; PERFECT CATERING - RECS ZHEJIANG CASING ANIMAL BY PRODUCTS CO LTD, HANGZOU, CHINA - IMPORT ALERT JOHN J. HAY SALANS ATTY TEVA CZECH INDUSTRIES, OPAVA, CZECH REPUBLIC A483 9/18/08 Doe J TEVA CANADA LTD, STOUVILLE, CANADA - 483 2/27/09 Signature/ Requester Subject
Page 896 of 1132

Total Records: 12455 Control # 2012-1692 Recd Date / Due Date 03/08/2012 04/05/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/CE-FO/NJ-DO/NJCB/ ORA/OCI/ ORA/OCI/ 2012-1693 03/08/2012 04/05/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1694 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1695 03/08/2012 04/05/2012 2012-1696 03/08/2012 04/05/2012 2012-1697 03/08/2012 04/05/2012 2012-1698 2012-1699 03/08/2012 04/05/2012 03/08/2012 04/05/2012 2012-1700 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KOEPCKE, EDWARD STEVEN B SEAL WILLIAMS LOVE O'LEARY & POWERS PC CARTICEPT MEDICAL INC - NAVIGATOR DELIVERY SYS K101194 PFIZER - XANAX AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ BEN MA GLOBAL TREASURE INDUSTRIES LTD BEN MA GLOBAL TREASURE INDUSTRIES LTD BEN MA GLOBAL TREASURE INDUSTRIES LTD REVITALITE - K033765 ELETRONIC THERMOMETER - K021028 DIGITAL THERMOMETER - K001297 ELECTRONIC THERMOMETER - K021052 HAILEY M BENTON FLOYD SKEREN & KELLY LLP ISRS 3004334-7, 3070602-6, 3138085-5, ETC BEN MA GLOBAL TREASURE INDUSTRIES LTD STANDARD THERMOMETER - K030658 Doe J Signature/ Requester Subject GARY NULL'S ULTIMATE POWER MEAL, TRIARCO INDUSTRIES, ARCON VITAMINS, ETC - RECS 2010-2011
Page 897 of 1132

Total Records: 12455 Control # 2012-1701 Recd Date / Due Date 03/08/2012 04/05/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1702 2012-1703 2012-1704 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/08/2012 04/05/2012 2012-1705 03/08/2012 04/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ 2012-1706 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1707 2012-1708 2012-1709 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/08/2012 04/05/2012 2012-1710 2012-1711 2012-1712 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/08/2012 04/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ CARPENTER, MURRAY CTP/OD/ CTP/OD/ FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ MYODA, T TIMOTHY KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. GREEN MOUNTAIN , KEURIG, ETC COFFEE ADDED TO COFEE IN K-CUPTS RECS 1/09 TO 12/21/11 ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ STEPHEN H MEYER NICK STEIN LAW OFC CHRIS HOGAN AIR LIQUIDE USA LLC WILLIAM WILSON AMERICANS FORLIMITED GOVERNMENT JOHN J HAY SALANS ATTY PFIZER GMBH, MOOSWALDALLE, FREIBURG, GERMANY 6/30/11; PFIZER IRELAND PAHRM, LITTLE ISLAND, COUNTY CORK, IRELAND 6/17/11; PFIZER IRELAND PHARMACEUTICALS INC, RINGASKIDDY, COUNTY CORK, IRELAND 6/24/11, ETC - 483S ENTEROBACTER SAKAZAKII, CRONOBACTER SAKAZAKII IN INDIANA - MEMOS, RPTS, EMAILS, ETC 2010 WESTERN ENTERPRISES, WESTLAKE, OH - EIR MOST RECENT ANTI-SMOKING CAMPAIGNS - REQUESTS FOR PROPOSAL (RFP) ON OR AFTER 11/1/11 TRONIC, ELAINE H ANNA KEIBURTZ Hyman Phelps and McNamara PC NATHAN PAUL MEHRENS AMERICANS FORLIMITED GOVERNMENT MARK PIFKO BARON & BUDD PC EXISTING MODIFIED OR NEW TOBACCO PRODS SUBSTANTIAL EQUIVALENCE RPTS, NUMBER OF RPTS, BACKLOG 1/11 TO PRESENT PROCTOR & GAMBLE - CREST PRO-HEALTH CLINCAL RINSES RECS, INVESTIGATIONS NAS LLC, MEMPHIS, TN - EIR 1/12 2004-10600 Signature/ Requester MICHAEL R COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES Subject MEDWATCH RPTS CODED AS MEDICATION ERRORS 2/1/123/1/12
GRAS NOTICE GRN000094 - THIRD PARTY INQUIRIES, FDA RESP, PUBLIC KNOWLEDGE 2011-9295
Page 898 of 1132

Total Records: 12455 Control # 2012-1713 Recd Date / Due Date 03/08/2012 04/05/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1714 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1715 2012-1716 03/08/2012 04/05/2012 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1717 2012-1718 03/08/2012 04/05/2012 03/08/2012 04/05/2012 2012-1719 03/08/2012 04/05/2012 2012-1720 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1721 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1722 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHARLES CELESTE EAS Consulting Group, LLC NORPACE CR NDA 18-655 - APRVL LTR, LBLG, RVWS, ETC G SRIVINAS ZYDUS PHARMACEUTICALS USA INC TEVA PHARMS - TRIAMCINOLONE ACETONIDE NASAL SPRAY ANDA 78-104 SBA OC/COS/OL/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J RICH BLY ENVIRONMENTAL HEALTH SERVICES LINDSAY YOUNG SUNLIGHT FOUNDATION G SRINIVAS ZYDUS PHARMACEUTICALS USA INC QUINAULT PRIDE SEAFOOD, TAHOLAH, WA - RECALLED PROD PHOTOGRAPHS 2/28-29/12 P & D DAIRY - REP KEN CALVERT CORR, DAIRY FEED SUBSIDIES, SULFADIMETHOXINE OR PENICILLIN G PROCAINE CORR 2/9/10 GD SEARLE LLC - NORPACE CR (DISOPYRAMIDE ER CAPS) NDA 18-655 SBA MENTOR - SALINE-FILLED MAMMARY PROSTHESIS RPTS FDA/OMPT/CDRH/OCER/DFOI/ G MICHAEL WALL PHD O-RAY PHARMA INC SEAN BRYNJELSEN AKORN INC MED-EL CORP - COMBI 40+ COCHLEAR IMPLANT SYS LBLG, SS&E, APRVL ORDER HOSPIRA - PROPOFOL ANDA 77-908 RECS WHITE #1028750, MATTHEW LEXAPRO (ESCITALOPRAM) - AERS Signature/ Requester THOMAS KROENKE SPEED TO MARKET INC Subject KAVO DENTAL - HEALZONE 510K, PMA REQUIREMENTS, DVC CLASSIFICATION, ETC
Page 899 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1723 03/08/2012 04/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1724 2012-1725 2012-1726 2012-1727 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/08/2012 04/05/2012 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1728 03/09/2012 04/06/2012 2012-1729 03/09/2012 04/06/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1730 2012-1731 03/09/2012 04/06/2012 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2012-1732 03/09/2012 04/06/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MICHAEL A CAROME MD PUBLIC CITIZEN INSTITUTIONAL REVIEW BOARD (IRB) REQUIREMENTS FOR SPECIFIC RESEARCH ACTIVITIED INITIATED UNVER AN INVESTIGATIONAL NEW DRUG APPL (IND) - DECISION LTRS, MEMOS, EMAILS, ETC ORA/CE-FO/DET-DO/DCB/ COLLEEN BOSWELL SYBRON DENTAL SPECIALTIES WILBUR JOHNSON JR COSMETIC INGEDIENT REVIEW CHLORPHENSIN - AERS, CAERS KERR CORP, ROMULUS, MI - EIR 2010 NICOLE CELLA ALL-WAYS FORWARDING INTERNATIONAL KYLE D SMITH JEFFERIES & COMPANY INC K-V PHARMS - BULK HYDROXYPROGESTERONE CAPROATE COVER LTR, ANALYSES, PHOTOGRAPHS, ETC SIMILAC ISOMIL ENTRY #DP4-0553996-7 LAB RESULTS ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ G MICHAEL WALL PHD O-RAY PHARMA INC G MICHAEL WALL PHD O-RAY PHARMA INC L WALSH WPTV-TV EMILY C JOHNSON AKIN GUMP STRAUSS HAUER & FELD, LLP HOUSE/3M - COCHLEAR IMPLANT LBLG, SS&E, APRVL ORDER COCHLEAR AMERICAS - COCHLEAR NUCLEUS FREEDOM 24 COCHLEAR IMPLANT SYS LBLG, SS&E, APRVL ORDER DIRTY MEDICAL INSTRUMENTS IN FL - INVESTIGATIONS, CMPLNTS 2005 TO PRESENT MOMENTA PHARMACEUTICALS INC, SANDOZ INC ENOXAPARIN SODIUM USP 207 TEST DEVELOPMENT, APRVL RECS, CORR, ETC CHARLES CELESTE EAS Consulting Group, LLC ROSUVASTATIN ZINC NDA 20-2172 - APRVL LTR, LBLG, RVWS, ETC Signature/ Requester Subject
Page 900 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1733 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-1734 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1735 2012-1736 2012-1737 03/09/2012 04/06/2012 03/09/2012 04/06/2012 03/09/2012 04/06/2012 2012-1738 03/09/2012 04/06/2012 2012-1739 2012-1740 03/09/2012 04/06/2012 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/NE-FO/NWE-DO/NWECB/ 2012-1741 2012-1742 03/09/2012 04/06/2012 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FOI SERVICES INC ORA/CE-FO/BLT-DO/CB/ WEBB, JACQUELINE INOVA ALEXANDRIA HOSPTIAL, ALEXANDRIA, VA - X-RAY EQUIPMENT INSPS 2008 TO PRESENT ELIZABETH BIOCHEMICAL - NASAL DECONGESTANT STUDY MEMO TO SUTER FROM N A HULME ORA/CE-FO/MIN-DO/MCB/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ ELISABETH S GRAY MIDDLETON & REUTLINGER WILLIAM MESTRANDREA PFIZER INC ED SILVERMAN PHARMALOT TAYLOR BROTHERS (AMERICAN SNUFF COMPANY LLC, RJ REYNOLDS TOBACCO CO), WINSTON-SALEM, NC - EIRS MOST RECENT SCIENTIFIC PROTEIN LABORATORIES LLC, WAUNAKEE,WI - EIRS 1/00 TO PRESENT MARY HOLLOWAY - DECISION NOT TO DEBAR Doe J FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NYK-DO/NYDCB/ DOUGLAS N BLUE ZETETIC ERIN E SEDER VENABLE LLP LIFESCAN SCOTLAND LTD - ONE TOUCH ULTRA 50S BLOOD GLUCOSE TEST STRIPS ENTRY #ARE-4122974-6/1/1 ALIGN, FLORASTER, CENTRUM PRONUTRIENTS PROBIOTIC, ETC - CAERS INDIVIDUAL RECS ELENA HOWELL HOGAN LOVELLS US LLP TEVA PHARMS - TESTOSTERONE NDA 20-2763 APRVL RECS HAINES, DAVID S MEFLOQUINE - APRVL RECS, TEST DATA Signature/ Requester Subject
Page 901 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OMP/DODM/ 2012-1743 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-1744 03/09/2012 04/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-1745 2012-1746 2012-1747 2012-1748 2012-1749 2012-1750 2012-1751 2012-1752 2012-1753 2012-1754 2012-1755 03/09/2012 04/06/2012 03/09/2012 04/06/2012 03/09/2012 04/06/2012 03/09/2012 04/06/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC WILBUR JOHNSON JR COSMETIC INGEDIENT REVIEW JOAN STIT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. 2011-9344 2011-4299 2010-7685 2011-9025 2011-9221 2011-9585 TIN - TOXICITY, PHYSICAL PROPERTIES, DERMAL PENETRATION, ETC 2012-418 FOI SERVICES INC CORTECHS LABS INC - NEUROQUANT K061855 FOI SERVICES INC WHOLE WHEAT FLOUR MFG PROCESS - CORR; PUBLIC HEARING TRANS RELATED TO DKT FDC-21 8/1/40 2011-9281 FOI SERVICES INC OBJECTIVE AND SUBJECTIVE EVALUATION OF PHENYLEPHRINE HCI VS PLACEBO TABS - MEMO FOI SERVICES INC ELIZABETH BIOCHEMICAL - NASAL DECONGESTANT STUDY MEMO TO WESSINGER FROM N A HULME Signature/ Requester Subject
Page 902 of 1132

Total Records: 12455 Control # 2012-1756 Recd Date / Due Date 03/12/2012 04/09/2012 2012-1757 03/12/2012 04/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1758 03/12/2012 04/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/PHI-DO/PCB/ 2012-1759 03/12/2012 04/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1760 03/12/2012 04/09/2012 ORA/CE-FO/CIN-DO/CCB/ BRANDON BROWN MACUGA LIDDLE & DUBIN PC KROGER CO, MI, NC, TN - PET PRIDE CAT FOOD 3,5 LB, 18 LB PKG 10/24/11; PET PRIDE TASTY BLEND POULTRY & SEAFOOD CAT FOOD 3.5 LB, 18 LB, PET PRIDE KITTEN FORMULA 3.5 LB PKG, ETC 10/10 TO PRESENT INOVA ALEXANDRIA HOSPITAL; - X-RAY EQUIPMENT MFRS & MODEL NUMBERS ANDRE PEARSON BIOTECH GENERICS LLC TYLENOL (ACETANINOPHEN) - NDA & USE: CMC SECTION FOR THE IND & NDA SUBMISSIONS LAUREN SIROIS WEITZ & LUXEMBERG PC AMGEN INC, AMGEN MANUFACTURING LTD, JANSSEN BIOTECH INC (CENTOCOR ORTHO BIOTECH PRODUCTS LP), ETC - EPOGEN, PROCRIT (EPOETIN ALFA) RECALL STUDIES, TEST EVALUATIONS KIM SHIPMAN Action Office FDA/OMPT/CDRH/OCER/DFOI/ PETTHY, JONATHAN M Signature/ Requester Subject DEPUY - ASR ACETABULAR CUP, S-ROM TOTAL HIP SYS FEMORAL STEM STANDARD, S-ROM TOTAL HIP SYS ZTT PROXIMAL SLEEVE, ETC - POINT & DATE OF MFG ISR CO17883740795
2012-1761
03/12/2012 04/09/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ WEBB, JACQUELINE
2012-1762
03/12/2012 04/09/2012
ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
GAIL LESSICK LACHMAN CONSULTANT SERVICES INC FRAN KOCH INFORMATION ACCESS
LIST OF DOMESTIC & FOREIGN INSP - DRUG COMAPNIES, MEDICAL DVC MFR, BIOESEARCH MONTORING, ETC 1/131/12 2011-9372
2012-1763
03/12/2012 04/09/2012
Page 903 of 1132

Total Records: 12455 Control # 2012-1764 Recd Date / Due Date 03/12/2012 04/09/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1765 2012-1766 2012-1767 2012-1768 03/12/2012 04/09/2012 03/12/2012 04/09/2012 03/12/2012 04/16/2012 03/12/2012 04/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/SJN-DO/SJCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1769 03/12/2012 04/09/2012 2012-1770 03/12/2012 04/09/2012 2012-1771 03/12/2012 04/09/2012 2012-1772 2012-1773 2012-1774 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 ORA/CE-FO/NJ-DO/NJCB/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ OC/OM/OMP/DDM/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION MARILYNN WHITNEY COVINGTON & BURLING LLP GLORIA GASKINS KLEINFELD KAPLAN & BECKER KIM C CAPONE SUN PHARMACEUTICAL INDUSTRIES INC, CRANBURY, NJ DKT 1987P-0118, 1995P-0366, 1997P-0079 DKT 1995N-0371, 1995N-0411 DKT FDA-1995-S-0039 ASHA LAMBATOS AVALON RISK MANAGEMENT INC JOHN ALTHEN JUDICIAL WATCH AMERICAN ACADEMY OF PEDIATRICS - POLICY STATEMENT HPV VACCINE RECOMMENDATIONS 3/12 ENTRY #M85-00508733 - NOTICE OF FDA ACTION #1 ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/NJ-DO/NJCB/ MARIO CADAVID CANFIELD SCIENTIFIC INC DIANA L. GESEKING SEDGWICK LLP MELISSA F. CURRY HELPER BROOM LLC BRIANNE RIDEOUT ASHCRAFT AND GEREL LLP SCHNUCKS SUPERMARKETS - E COLI INVESTIGATION CORR, CERTIFIED 9/11 TO 11/11 CORDIS CORP, MIAMI LAKES, FL - 483, CO RESP 9/2-12/03; SAN GERMAN, PR - 483, CO RESP 10/10/03-12/1/03; WARREN, NJ - 483, CO RESP 10/29/03-12/4/03 MEAD JOHNSON, ZEELAND, MI - EIR 8/26/04 CANFIELD SCIENTIFIC INC - EIR 11/28-30/11, 12/1, 5-6/11 Signature/ Requester JENNIFER SORENSON NATURAL RESOURCES DEFENSE COUNCIL Subject 2012-83 - MINOR DELETIONS
Page 904 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/10/2012 2012-1775 2012-1776 2012-1777 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1778 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1779 2012-1780 2012-1781 2012-1782 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 2012-1783 03/13/2012 04/10/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ 2012-1784 03/13/2012 04/13/2012 FDA/OMPT/CDRH/OCER/DFOI/ JAMES R WELSH WELSH & WELSH PC LLO AGA MEDICAL CORP - AMPLATZER SEPTAL OCCLUDER DISCLOSURES TO FDA PATRICIA N SYVERSON BONNETT FAIRBOURN ET AL CHATTEM INC - ACT TOTAL CARE ANTICAVITY FLUORIDE MOUTHWASH PRDS INVESTIGATION MEMO, RPTS, STUDIES, ETC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ HEATHER-GRACE A EBANKS ELEKTA INC LYNN P TORDO THOR SPECIALTIES INC LYNN P TORDO THOR SPECIALTIES INC SUZETTE MESKELL KINERK SCHMIDT & SETHI, PLLC MIZUHO OSI MODULAR TABLE, MODEL #5803 RECALL, INVESTIGATION RPTS, CORR ETC LANXESS - FCN 560 LANXESS CORP - FCN 1078 CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYS - K102650 CANDICE DURRENCE OPTIMER PHARMACEUTICALS INC DIFICID (FIDAXOMICIN) TABS NDA 201-699 PHARMACOLOGY, TOXICOLOGY & MICROBIOLOGY RVWS FDA/OMPT/CDRH/OCER/DFOI/ ROLING, DIANNE M ALAN BECKMAN MOBIUS THERAPEUTICS LLC ISRS 8085764, 8100418, 7797470, ETC ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester PORZIO PHARMACEUTICAL SERVICES LLC CHRIS INGALLS KING 5 TV Subject EIRS, 483S SNOKIST GROWERS, YAKIMA, WA - FDA FORM 766 RECS 3/09 DOCUMENT #CPT 1100163
Page 905 of 1132

Total Records: 12455 Control # 2012-1785 Recd Date / Due Date 03/13/2012 04/10/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester BRENT M ARDAUGH NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1789 03/13/2012 04/10/2012 ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ MARTIN N ZAIAC, MD MOUNT SINAI MEDICAL CENTER GREATER MIAMI SKIN & LASER CTR BILL MOBERLY WISCONSIN COUNCIL 40, AFSCME, AFL-CIO BECKY DITTY STRYKER INCUBATION OF MEDICAL TECHNOLOGY (IMT) FDA/OMPT/CDRH/OCER/DFOI/ AGUILA, JOSE ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1796 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ KUMAR, ROGER AMPYRA (DALFAMPRIDINE) - AERS DINESH SAXENA B BRAUN MEDICAL INC GENARO GARCIA GARCIA DEVELOPMENTS INC TYRAH L MILES DJA GLOBAL PHARMACEUTICALS INC SCIENTICFIC PROTEINS LABORATORIES LLC, WAUNAKEE, WI - EIR, WARNING LTR, ETC 1/20/11 TO PRESENT EIDAM DIAGNOSTICS CORP, RICHMOND, CANADA - CRT 2000 THERMOGRAPHIC SYS K971956 EIR, 483, CO RESP EPIPEN, TWINJECT, INTELLIJECT - FINAL RVWS, SBAS DR MARTIN ZAIAC - EIR, 483 (OBSERVATION 2) 4/22/107/14/10 SPECTOR, GILBERT MICHELE SIMON MUCKROCK NEWS SEAN BUNDY COCHLEAR AMERICAS ADVANCED BIONICS CORP - AURIA HARMONY HIRESOLUTION BIONIC EAR SYS P960058/S089 PERRIGO R&D CO - GUAIFENESIN RT TABS ANDA 78-912 RECS FACTS UP FRONT LBLG SCHEME LTR 12/11 Subject K901235, K870729, K852097
2012-1786 2012-1787 2012-1788
03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012
2012-1790
03/13/2012 04/10/2012
ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/
AMERICAN RED CROSS - RESP TO ADVERSE DETERMINATION LTR 1/13/12, CORR, CO RESPS ETC MAKO SURGICAL CORP, FORT LAUDERDALE, FL RESTORIS PARTIAL KNEE APPLICATION (PKA) RIO STANDARD SYS K112507 FISHER & PAYKEL HEALTHCARE - MR 880 K100554
2012-1791
03/13/2012 04/10/2012
2012-1792 2012-1793 2012-1794 2012-1795
03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012
Page 906 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-1797 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1798 2012-1799 03/13/2012 04/10/2012 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1800 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1801 2012-1802 2012-1803 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ ORA/P-FO/SEA-DO/SCB/ ORA/OCI/ ORA/OCI/ 2012-1804 2012-1805 2012-1806 2012-1807 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JON C GARITO LifeSciences JON C GARITO LifeSciences MATTO TULIKOURA PALODEX GROUP BENDA M GARTZ ELI LILLY & CO GULF PHARMACEUTICALS INDUSTRIES, RAS AL KHAIMAH, UNITED ARAB EMIRATES - 483 9/25/11-10/3/11 ELLMAN INT'L INC - NON-ABLATIVE WRINKLE TREATMENT HANDPIECE K102368 ELLMAN INT'L INC - NON-ABLATIVE WRINKLE TREATMENT HANDPIECE MODEL PELLEVE K101967 SOREDEX, TUUSULA, FINLAND - EIRS (UNREDACTED) 9/09 Doe J OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FRAN KOCH INFORMATION ACCESS JON C GARITO LifeSciences ELLMAN INT'L INC - NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC K082834 CMPLNT 120720 2011-9015 FRAN KOCH INFORMATION ACCESS 2011-9009 FULLER, STEPHEN FRAN KOCH INFORMATION ACCESS TORADOL (KETOROALC); MOTRIN, ADVIL (IBUPROFEN) AERS 1/89 TO 12/11 2011-9006 FRAN KOCH INFORMATION ACCESS 2011-9007 Signature/ Requester Subject
Page 907 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1808 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1809 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ 2012-1810 03/13/2012 04/10/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ 2012-1811 2012-1812 03/13/2012 04/10/2012 03/13/2012 04/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1813 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1814 03/13/2012 04/10/2012 2012-1815 2012-1816 03/13/2012 04/10/2012 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MERCK & CO., INC. FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ DANIELLE IVORY BLOOMBERG FINANCIAL MARKETS COMMODITIES NEWS NYROBIA FREEMAN CONMED LINVATEC CORP AMERICAN MEDICAL DEPOT, AMERICAN PURCHASING SERVICES, APS TECHNOLOGIES, ETC - BIDS LOOK INC, ADA, OK - POLYVIOLENE SURGICAL SUTURE K943949 2012-709 FRAN KOCH INFORMATION ACCESS 2011-9005 ORA/SW-FO/KAN-DO/COMP/ JULIE PEAK INTERCON CHEMICAL CO KATHLEEN STERGIOPOULOS STONY BROOK UNIVERSITY MEDICAL CTR SIMAVASTATIN, ATORVASTATIN, CRESTOR, ETC - AERS B&G LABS, ST LOUIS, MO - 483S ANTHONY SAMBROTTO NORMAN G. JENSEN NORMAN G JENSEN INC - AGENT UNDER STATUTES US DEPT OF JUSTICE V TAX ANALYSIS, CASTANEDA V US, AIR FORCE V ROSE, ETC RUSSELL V RANDLE Patton Boggs LLP DR LEWIS P STOLMAN - CONSENT AGREEMENT, EIR 1990, FDA RESP, ETC BRENDA M GARTZ ELI LILLY & CO UNIMARK REMEDIES LTD, VAPI GUJARAT, INDIA - EIR 9/25/09 Signature/ Requester Subject
Page 908 of 1132

Total Records: 12455 Control # 2012-1817 2012-1818 2012-1819 2012-1820 Recd Date / Due Date 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1821 2012-1822 2012-1823 2012-1824 2012-1825 2012-1826 2012-1827 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 2012-1828 2012-1829 2012-1830 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ MERCK & CO., INC. MERCK & CO., INC. 2011-9357 MERCK & CO., INC. 2012-294 Doe J 2011-9630 MERCK & CO., INC. INDIVIDUAL RECS MERCK & CO., INC. 2011-9026 MERCK & CO., INC. 2012-415 MERCK & CO., INC. 2012-1559 MERCK & CO., INC. 2012-1458 MERCK & CO., INC. 2012-1440 2012-1416 KUMAR, ROGER MERCK & CO., INC. AMPYRA (DALFAMPRIDINE) - AERS MERCK & CO., INC. 2012-1399 MERCK & CO., INC. 2012-1394 Signature/ Requester Subject 2012-897
Page 909 of 1132

Total Records: 12455 Control # 2012-1831 2012-1832 2012-1833 2012-1834 Recd Date / Due Date 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1835 2012-1836 2012-1837 2012-1838 2012-1839 2012-1840 2012-1841 2012-1842 2012-1843 2012-1844 2012-1845 2012-1846 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/13/2012 04/10/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON PHD, LEROY L GABRIEL SHERMAN Hyman, Phelps & McNamara, P.C. CHRIS CELESTE EAS Consulting Group, LLC JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) 2011-6866 2012-588 2012-577 2012-414 DKT 1978N-7830 DKT FDA-1995-S-0039 FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON PHD, LEROY L DIATHERMY SHORTWAVE FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON PHD, LEROY L STIMULATOR CRANIAL ELECTROTHERAPY OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, Ph.D., LEROY IONTOPHORESIS DEVICE MERCK & CO., INC. TRANSILLUMINATOR FOR BREAST EVALUATION MERCK & CO., INC. 2011-8163 2011-8717 LANGE, VERA MERCK & CO., INC. CARBATROL - AERS MERCK & CO., INC. 2011-8724 MERCK & CO., INC. 2011-8772 Signature/ Requester Subject 2011-9030
Page 910 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/11/2012 2012-1847 2012-1848 2012-1849 2012-1850 2012-1851 2012-1852 2012-1853 2012-1854 2012-1855 2012-1856 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 2012-1857 03/14/2012 04/11/2012 2012-1858 03/14/2012 04/11/2012 2012-1859 2012-1860 2012-1861 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC FOI SERVICES INC FOI DAILY LOG 2/6-10/12 FOI SERVICES INC FOI DAILY LOG 2/13-17/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 2/20-24/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 2/6-10/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 2/13-17/12 Signature/ Requester MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (8G2CD-16 MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (8G2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STITT (UG2CD-16) MERCK & CO., INC. JOAN STIT (UG2CD-16) MERCK & CO., INC. FOI DAILY LOG 2/20-24/12 2012-937 2012-825 2012-796 2012-661 2012-68 2011-9519 2011-9446 2011-9264 2011-9263 Subject
Page 911 of 1132

Total Records: 12455 Control # 2012-1862 2012-1863 2012-1864 2012-1865 2012-1866 2012-1867 2012-1868 Recd Date / Due Date 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 2012-1869 03/14/2012 04/11/2012 2012-1870 03/14/2012 04/11/2012 2012-1871 03/14/2012 04/11/2012 2012-1872 03/14/2012 04/11/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1873 03/14/2012 04/11/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1874 03/14/2012 04/11/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 2/6/-10/12 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 2/13-17/12 Signature/ Requester FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 2/20-24/12 FOI DAILY LOG 2/6-10/12 FOI DAILY LOG 2/13-17/12 FOI DAILY LOG 2/20-24/12 FOI DAILY LOG 2/20-24/12 FOI DAILY LOG 2/6-10/12 FOI DAILY LOG 2/13-17/12 FOI DAILY LOG 2/20-24/12 FOI DAILY LOG 2/6-10/12 FOI DAILY LOG 2/13-17/12 Subject FOI DAILY LOG 2/20-24/12
Page 912 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1875 2012-1876 2012-1877 2012-1878 2012-1879 2012-1880 2012-1881 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 03/14/2012 04/11/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1882 2012-1883 03/14/2012 04/11/2012 03/14/2012 04/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1884 2012-1885 2012-1886 2012-1887 03/14/2012 04/11/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ MARTIN GABLER RADIOMETER MEDICAL APS SANTO PEREZ CONCORD FOODS THERESA DE PRAT COOK ENDOSCOPY ANNAMIEKE M TENNIS KANNER & WHITELEY LLC SHIRE PHARMACEUTICALS INC - VYVANSE (LISDEXAMFETAMINE DIMESYLATE) CAPS NDA 21-977 RESP TO DDMAC LTR 5/6/11, CMPLNTS, ETC LEMON JUICE - ENTRY NOS 231-3344531-0; 231-33276273 INVENDO C20 COLONOSCOPY SYS - K100624 NOVA BIOMEDICAL CORP - CRT ANALYZER K924547 CAROL POLLACK-NELSON PHD FDA/OMPT/CDRH/OCER/DFOI/ MARY HOLMES LANDON-IP INC INTERNAL NASAL DILATORS - AER LAST 10 YRS APERTA LLC - K093166 RAYMOND, WALTON K31994 DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC HEALTHY EYES SUPERVISION SFTGL CAPSULE - AER FOI DAILY LOG 2/6-10/12 FOI DAILY LOG 2/13-17/12 LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. FOI DAILY LOG 2/20-24/12 FOI DAILY LOG 2/6-10/12 FOI DAILY LOG 2/13-17/12 FOI DAILY LOG 2/20-24/12 Signature/ Requester Subject
Page 913 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1888 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1889 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1890 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1891 2012-1892 2012-1893 2012-1894 2012-1895 2012-1896 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1897 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1898 03/15/2012 FDA/OMPT/CDER/ORP/DIDP/ ABBOTT LABS - SYNTHROID AERS THOMAS COTTER BOSTON UNIVERSITY SCHOOL OF/PUBLIC HEALTH DRUG STABILITIY TESTING & RESLUTS UNDER THE SHELF LIFE EXTENSION PROGRAM (SLEP), DEPLOYMENT LOGISTICS OF SLEP DRUGS, ETC 2002 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ DOUGLAS N BLUE II ZETETIC INC DOUGLAS N BLUE II ZETETIC INC ANDREA P DEMERS MAYNARD O'CONNOR ET AL KEITH A BARRITT FISH & RICHARDSON PC DON MIZOTA SANARUS TECHNOLOGIES LLC CHARLES CELESTE EAS Consulting Group, LLC DIHYDROCODEINE, BPM, PHENYLEPH HCL LIQUID (DIHYDROCODEINE BITARTRATE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) - AERS AGAMATRIX INC - IBGSTAR BLOOD GLUCOSE MONITORING SYS K103544 ARBEL MEDICAL LTD - ICE-BENSE K072883 JOHNSON & JOHNSON - SHOWER GEL ENTRY #M5001850259 RECS ZIMMER - LPS-FLEX GSF PROSTHETIC KNEE MDRS HEALTH CARE PRODS ENTRY # 82301494447 - RECS JOHN A CLARK MD MSPH RISKBENEFITS LLC ISRS 6233952-8, 6254515-4, 6353969-2, ETC THOMAS M MORTON CPMG INC ARMOUR PHARMS - ACTHAR GEL-SYNTHETIC NDA 17-861 DISCONTINUATION OF MARKETING, CURRENT OWNERSHIP, LABEL ACTIONS, ETC TYRAH L MILES DJA GLOBAL PHARMACEUTICALS INC EPIPEN, TWINJET, INTELLIJECT - SBA Signature/ Requester Subject
Page 914 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/12/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1899 2012-1900 2012-1901 2012-1902 2012-1903 2012-1904 2012-1905 2012-1906 2012-1907 03/15/2012 04/12/2012 03/15/2012 04/25/2012 03/15/2012 04/25/2012 03/15/2012 04/25/2012 03/15/2012 04/25/2012 03/15/2012 04/25/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1908 2012-1909 2012-1910 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 2012-1911 03/15/2012 04/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/KAN-DO/COMP/ FOI SERVICES INC KIM C. CAPONE PORZIO PHARMACEUTICAL SERVICES LLC RHIANNON MEYERS CORPUS CHRISTI CALLER COUNTERFEIT AVASTIN - INVESTIGATION FOREST PHARMS INC, EARTH CITY, MO - EIR, 483 12/21/10 FOI SERVICES INC CLOSED FOI REQUESTS 2/27/12-3/2/12 CLOSED FOI REQUESTS 3/5-9/12 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. JAE H KIM GENORAY AMERICA INC JAE H KIM GENORAY AMERICA INC JAE H KIM GENORAY AMERICA INC JAE H KIM GENORAY AMERICA INC JAE H KIM GENORAY AMERICA INC LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. RHIANNON MEYERS CORPUS CHRISTI CALLER TIMES MOHAMED AYMAN GHRAWI MD, SOUTH TEXAS COMPREHENSIVE CANCER CENTERS - CORR CLOSED FOI REQUESTS 2/27/12-3/2/12 CLOSED FOI REQUESTS 3/5-9/12 TRIANA K103182 - ACCESSION NUMBER VOLUX K092171 - ACCESSION NUMBER ZEN-7000 K103425 - ACCESSION NUMBER ZENIS K103181 - ACCESSION NUMBER HUVEPHARMA, ST LOUIS, MO - EIRS, 483S 6/08 TO PRESENT PORT-X II K063121 - ACCESSION NUMBER Signature/ Requester FERA, SHARON Subject
Page 915 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ 2012-1912 03/15/2012 04/12/2012 2012-1913 03/15/2012 04/12/2012 ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1914 03/15/2012 04/12/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1915 03/15/2012 04/12/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1916 2012-1917 03/15/2012 04/12/2012 03/15/2012 04/12/2012 2012-1918 03/15/2012 04/12/2012 2012-1919 2012-1920 2012-1921 03/15/2012 04/12/2012 03/15/2012 04/12/2012 03/15/2012 04/12/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ CVM/OCD/ CVM/OCD/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ LeAnn Runke MICHAEL FOODS INC JEFFREY J. HARRINGTON MICHAEL FOODS INC WILLIAM J. HARTIG PRESCRIPT PHARMACEUTICALS INC KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. QUYNH C. SPERRAZZA FAEGRE BAKER DANIELS SALMONELLA HEIDELBERG PFGE PATTERN XBAL METHODS FOR CONDUCTING RECALL EFFECTIVENESS CHECKS - COPY USE OF NISIN IN LIQUID EGGS, EGG PRODS, HARDCOOKED EGGS - STUDIES, VIOLATIONS; M G WALDBAUM CO - DKT 1994G-0027 (GRAS PETITION 4G0405), ETC PRECRIPT PHARMACEUTICALS INC - EIR 2000, 2003, 2006, 2009, 2011 HUVEPHARMA, PESHTERA, RAZRAD, BOTEVGRAD, BULGARIA - EIR, 483 1/2010 HUVEPHARMA, SHIP, MACEDONIA - EIR, 483 1/08 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 3/5-9/12 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 2/27/12-3/2/12 KRISTINE BURGESS TUFTS UNIV CUMMINGS SCHOOL OF VETERINARY MEDICINE GLUCOPHAGE - TOXICOLOGY RVW Doe J INDIVIDUAL RECS Signature/ Requester TIMES Subject
Page 916 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-1922 2012-1923 03/15/2012 04/12/2012 03/15/2012 04/12/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-1924 03/15/2012 04/12/2012 2012-1925 03/15/2012 04/12/2012 2012-1926 03/15/2012 04/12/2012 CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1927 2012-1928 2012-1929 2012-1930 2012-1931 03/16/2012 04/13/2012 03/16/2012 04/13/2012 03/16/2012 04/13/2012 03/16/2012 04/13/2012 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-1932 2012-1933 03/16/2012 04/13/2012 03/16/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC MEDTRONICS - ASSURANT COBALT ILIAC BALLOONEXPENDABLE STENT SYS P110011 APRVL RECS ABBOTT VASCULAR - RX HERCULINK ELITE RENAL STENT FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ABBOT VASCLAR - ABSOLUTE PRO VASCULAR SELFEXPANDING STENT SYS P110028 APRVL RECS COOK MEDICAL - FORMULA BALLOON-EXPANDABLE RENAL STENT SYS -P100028 APRVL RECS BOSTON SCIENTIFIC - EXPRESS SD RENAL MONORAIL PREMOUNTED TENT SYS P060006 APRVL RECS BOSTON SCIENTIFIC - EXPRESS LD LILIAC PREMOUNTED STENT SYS P090003 APRVL RECS AMPLIFY RHBMP-2 MATRIX - P050036 NON-APRVL LTR, REJECTED - APRVL LTR CHANDRAN TIRUVATTAR PROMIUS PHARMA LLC TENEX NDA 19- 032 - RECS ORA/CE-FO/BLT-DO/CB/ MICHELE JONES HUMAN GENOME SCIENCES INC. MIKE McGRAW THE STAR CVM SUBMISSION TRACKING & REPORTING SYS (STARS) DATABASE HUMAN GENOME SCIENCES - BENLYSTA EIR, 483 9/7-30/10 QUYNH C. SPERRAZZA FAEGRE BAKER DANIELS ALEX TOMASEVIC NICHOLAS & BUTLER LLP GASS WEBER MULLINS LLC; MARLER CLARK LLP - FOI REQUESTS 7/11 TO 12/11 DREAM PRODUCTS LLC, GOLDEN BEACH, FL - DREAM WATER RECS Signature/ Requester Subject
Page 917 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/13/2012 2012-1934 2012-1935 03/16/2012 04/13/2012 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1936 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1937 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1938 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1939 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1940 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1941 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1942 03/16/2012 04/13/2012 ORA/SW-FO/DALDO/COMPLIANCE/ STEPHANIE ELSBERRY BIODEN INC BIOEDEN INC, AUSTIN, TX - EIR, 483, CO RESP 1/12-18/12 LIESELOTTE L BLOSS KYOWA PHARMACEUTICAL INC NOVARTIS - PARLODEL NDA 17-962 SBA, CLNCL RVWS 7///28/78 CHARLES CELESTE EAS Consulting Group, LLC DONATUSS DC (DIHYDROCEDEINE BITARTRATE, PHENYLEPHRINE HCL, GUAIFENSIN) SYRUP - AERS 1/07 TO PRESENT CHRLES CELESTE EAS Consulting Group, LLC ENDACOF DH (DIHYDROCODEINE BITARTATE, BROMPHENIRAMINE MALEATE & PHENYLEPHRINE HCL) LIQUID - AERS 1/07 TO PRESENT CHARLES CHRIS EAS Consulting Group, LLC POLY HIST DHC (DIHYDROCODEINE BITARATE, PHENYLEPHRINE HCL, PYRILAMINE MALEATE) LIQUID AERS 1/07 TO PRESENT CHARLES CHRIS EAS Consulting Group, LLC POLY-TUSSIN EX (DIHYDROCEDEINE BITARTARTE, PHENYLEPHRINE HCL & GUAIFENSIN) SYRUP - AERS 1/07 TO PRESENT CHARLES CELESTE EAS Consulting Group, LLC CENTUSSIN DHC (DIHYDROCEDEINE BITARTATE, BROMPHENIRAMINE MALEATE & PHENYLEPHRINE HCL) LIQUID - AERS 1/O7 TO PRESENT ORA/SE-FO/ATL-DO/ACB/ FOI SERVICES INC CHARLES CELESTE EAS Consulting Group, LLC ALDARA NDA 20-723/S001 - APRVL LTR, LBLG MOR ETC Action Office Signature/ Requester FOI SERVICES INC Subject SYS P110001 APRVL RECS HOSPIRA, CLAYTON, NC - 483 4/6-29/09
Page 918 of 1132

Total Records: 12455 Control # 2012-1943 2012-1944 2012-1945 Recd Date / Due Date 03/16/2012 04/13/2012 03/16/2012 04/13/2012 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1946 03/16/2012 04/13/2012 2012-1947 03/16/2012 04/13/2012 2012-1948 2012-1949 03/16/2012 04/13/2012 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1950 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1951 03/16/2012 04/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1952 03/16/2012 04/13/2012 2012-1953 03/16/2012 04/13/2012 2012-1954 03/16/2012 OC/OCC/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OCC/ FOI SERVICES INC FOI SERVICES INC BIOGEN - AVONEX PRODUCT LICENSE APPLICATION (PLA) AND ESTABLISHMENT LICENSE (ELA) APPEAL NUMBER 96-A-084 LTR 8/20/96 AVONEX PLA - WILLIAM C BRASHARES ESQ, MINTZ, LEVIIN, COHN, FERRIS, GLOVSKY & POPEO PC; KATE C BEARDSLEY ESQ, BUC & BEARDSLEY LTR 9/11/96 BERLEX - AVEONEX PLA WILLIAM C BRASHARES ESQ, JESSICA LAM HOSPITAL FOR SICK CHILDREN EXPOSURE TO CODEINE VIA BREAST MILK - AERS GRUBER, SHEILA G ACCUTANE (ISOTRETINOIN) - AERS ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS BREANNE WANDERMEER MUELLER LAW OFC CHARLES CELESTE EAS Consulting Group, LLC LESLIE DIAZ, INFECTIOUS DISEASE ASSOCIATION OF THE PALM BEACHES, N PALM BEACH, FL - EIR, 483, CO RESP 1/12/11 C R BARD INC, DAVOL INC - PERFIX PLUG MDRS, CORR, APRVL RECES, ETC ALDARA NDA 20-723/S016 - APRVL LTR, LBLG, RVWS, ETC B BRAUN MEDICAL INC - ULTRASITE VALVES PS100006 LUK, CHEE PHUN Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester CHERYL L BUNEVICH TUCKER ELLIS LLP LI ZHANG PHD BASF CORP PROTON PUMP INHIITORS (PPI) - RVWS, AERS Subject DIGITEK - SPL 157503, 157504, 178890, ETC RECS (CERTIFIED) BUCKMAN LABORATORIES INTERNATIONAL INC - FCN 871
Page 919 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/13/2012 2012-1955 03/19/2012 04/16/2012 2012-1956 03/19/2012 04/16/2012 2012-1957 03/19/2012 04/16/2012 2012-1958 03/19/2012 04/16/2012 2012-1959 03/19/2012 04/16/2012 2012-1960 03/19/2012 04/16/2012 2012-1961 03/19/2012 04/16/2012 2012-1962 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1963 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/SJN-DO/SJCB/ PATRICIA SABATINI PITTSBURGH POST-GAZETTE MYLAN INC - EIRS, 483S, CORR, ETC 2011, 2012 ORA/SW-FO/DEN-DO/COMP/ FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ LILY HO NEPHOSITY LLC AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC ANETTE KRAUS LEO PHARMA CALGARY SCIENTIFIC INC - RESOLUTION MD MOBILE; GENERAL ELECTRIC HEALTHCARE - CENTRICITY RADIOLOGY MOBILE ACCESS 2.0 - 510K COLORADO CENTER FOR REPRODUCTIVE MEDICINE, LONE TREE, CO - EIR, 483, CO RESP 5/05 TO PRESENT FRAGMIN NDA 20-287/S035 RVW ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ Action Office Signature/ Requester FOI SERVICES INC AMY ERICKSON CRYOGENIC LABORATORIES INC AMY ERICKSON CRYOGENIC LABORATORIES INC AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC AMY EKICKSON HAGEN CRYOGENIC LABORATORIES INC BRIANNA L. SILVERSTEIN DRINKERBIDDLE & REATH LLP Subject MINTX, LEVIN,COHN, FERRIS, GLOVSKY & POPEO PC LTR 9/18/96 CRYOGAM COLORADO LLC, LOVELAND, CO - EIR, 483, CO RESP 5/05 TO PRESENT FERTILITY CRYOBANK LLC, ENCINCO, CA - EIR, 483, CO RESP 5/05 TO PRESENT MIDWEST FERTILITY CENTER, DOWNERS GROVE, IL - EIR, 483, CO RESP 5/05 TO PRESENT REPORDUCTIVE MEDICINE ASSOCIATES OF NY LLP, NEW YORK, NY - EIR, 483, CO RESP 5/05 TO PRESENT GRAS NO 94 - RECS PRIOR TO 2004
Page 920 of 1132

Total Records: 12455 Control # 2012-1964 Recd Date / Due Date 03/19/2012 04/16/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1965 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1966 2012-1967 2012-1968 03/19/2012 04/16/2012 03/19/2012 04/16/2012 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1969 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1970 2012-1971 03/19/2012 04/16/2012 03/19/2012 04/16/2012 2012-1972 2012-1973 2012-1974 03/19/2012 04/16/2012 03/19/2012 04/16/2012 03/19/2012 04/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/MIN-DO/MCB/ CHARLES, GAITHER TSURUTA ERIKO, MD OSAKA UNIV GRADUATE SCHOOL OF MEDICINE ORA/SE-FO/ATL-DO/ACB/ Doe J NESTLE USA INC, LITTLE, CHUTE, WI; MEDFORD, WI - INSP, ENFORCEMENT ACTIONS PROPYLTHIOURACIL - AER ORA/CE-FO/BLT-DO/CB/ CVM/OCD/ ARLENE MORALES BURDOCK GROUP AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC SELENIUM FAP 2238 - REGULATORY STATUS, CONSUMPTION, USES, ETC SHADY GROVE FERTILITY REPRODUCTIVE SCIENCE CTR, ROCKVILLE, MD - EIR, 483, CO RESP 5/05 TO PRESENT INDIVIDUAL RECS DAN HIMMELFARB Mayer Brown LLP TEVA PHARMS - TESTOSTERONE APRVL, MEDICAL RVW, CHEMISTY RVW, LBLG FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/SE-FO/SJN-DO/SJCB/ PETER KRASUCKI FERMATRIX LLC PATTI SABATINI PITTSBURGH POST-GAZETTE A. LUKE SMITH FARUQI & FARUQI LLP RANBAXY - LIPITOR (ATORVASTATIN) ANDA 76-477, SBA MYLAN INC - EIRS, 483S, CORR, ETC SINCE 10/13/11 MASCOMA DROP-IN MGT YEAST PROD - GRAS PATRICK MORIARTY, Ph.D. HEALTHCOR MANAGEMENT LP MERCK - VICTRELIS (BOCEPREVIR) AER Signature/ Requester PATRICK MORIARTY Ph.D. HEALTHCOR MANAGEMENT LP Subject VERTEX - INCIVEK (TELAPREVIR) AERS
Page 921 of 1132

Total Records: 12455 Control # 2012-1975 2012-1976 2012-1977 Recd Date / Due Date 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 05/17/2012 2012-1978 2012-1979 03/20/2012 04/17/2012 03/20/2012 04/17/2012 ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE ABOTT BIOTECHNOLOGY LTD, BARCELONETA, PR; ABBOTT PHARMACERUTICALS LTD, BARCELONETA, PR; ABBOTT DIAGNOSTICS INTERNATIONAL, BARCELONETA, PR, ETC 483S 9/20/11, 3/11/14, 6/17/09, ETC IOWA STATE UNIVERSITY COLLEGE VET MED, AMES, IA; VETERINARY RESOURCES INC, AMES, IA; CARDIOVASCULAR RESEARCH FOUNDATION, ORANGEBURG, NY, ETC - 483S 1/1/12-2/29/12 ACNE FOOD SALES INC, SEATTLE, WA - LEMON JUICE RESULTS MYLAN, CAGUAS, PR - 483S 2/24/11, 3/29/10 FOI SERVICES INC FOI SERVICES INC Action Office ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC Signature/ Requester Subject PHARMACOVIGILANCE (MCNEIL CONSUMER HEALTHCARE DIVISION) - EIRS, 483S, CO RESP, ETC 2/08 TO PRESENT PHARMACOVIGILANCE (GLAXOSMITHKLINE CONSUMER DIVISION) - EIRS, 483S, CO RESP, ETC 2/08 TO PRESENT PHARMACOVIGILANCE (NOVARTIS CONSUMER HEALTHCARE DIVISION) - EIRS, 483S, CO RESP 2/08 TO PRESENT
2012-1980
03/20/2012 04/17/2012
ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ SCHARBERG, DAVID L
2012-1981
03/20/2012 04/17/2012
ORA/P-FO/SEA-DO/SCB/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/SJN-DO/SJCB/
CHRIS L NIELSEN NIELSEN CITRUS PRODUCTS INC THOMAS J KARDOS COOK VASCULAR INC CORTES, DAVE
2012-1982 2012-1983
03/20/2012 04/17/2012 03/20/2012 04/17/2012
COOK VASCULAR INC, VANDERGRIFT, PA - EIR 3/23-26/10 BRISTOL-MYERS SQUIBB HOLDINGS PHARMA LLC, MANATI, PR;/ BRISTOL MYERS SQUIBB MANUFACTURING CO, HUMACAO, PR - 483S 3/28/11, 8/13/10/6/25/10 INFUPHARMA LLC - EIRS, INCIDENT RPTS, STATEMENTS, ETC 1/11 TO PRESENT
2012-1984
03/20/2012 05/10/2012
ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
HENRY F BAYARD CSK Labs
2012-1985 2012-1986
03/20/2012 04/17/2012 03/20/2012 04/17/2012
ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/SAN-DO/SFCB/
MARIA HINKLIN Beutlich Pharmaceuticals LP MICHALE A CHIBBARO PROMEGA BIOSYSTEMS SUNNYVALE
UNIQUE LABS, CHATSWORTH, GA - EIRS 4/21/11-5/4/11 PROMEGA BIOSYSTEMS, SUNNYVALE, CA - EIRS 10/5-8/10
2012-1987
03/20/2012
FRANK P AGELLO ESQ
VELCADE (BORTEZO) - INVESTIGATION RESULTS
Page 922 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/17/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ 2012-1988 03/20/2012 04/17/2012 2012-1989 2012-1990 03/20/2012 04/17/2012 03/20/2012 04/17/2012 2012-1991 03/20/2012 04/17/2012 ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ JOHNSON, JILL KAREN GULLO BLOOMBERG FINANCIAL MARKETS COMMODITIES NEWS KAREN GULLO BLOOMBERG FINANCIAL MARKETS COMMODITIES NEWS CAROL ZAMOJCIN HARTZ MOUNTAIN CORP JAMIE R MOGIL FARUQI & FARUQI LLP FEDERAL CRIMINAL CONDUCT BY MEMBERS & ASSOCIATES OF A PROCESSIONAL BICYCLE RACING TEAM OWNED IN PART BY LANCE ARMSTRONG -CLOSED INVESTIGATIONS,, MEMOS, DIARIES, ETC 4/10 TO PRESENT CHICKEN JERKY PRODS FROM CHINA - VENDOR NAMES, FACTORY NAMES, ADDRESSSES OC/COS/OL/ KAREN GULLO BLOOMBERG NEWS REP JACK KINGSTON, REP JOE BARTON - LANCE ARMSTRONG RACING TEAM CRIMINAL INVESTIGATION CORR 1/10 TO PRESENT ASEPTIC SOLUTIONS USA, CORONA, CA - 483S LAST 18 MONTHS JEFF NOVITIZKY - TRAVEL RECS 1/10 TO 2/12 Signature/ Requester ROY LEGAL GROUP Subject
2012-1992
03/20/2012 04/17/2012
ORA/ ORA/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/
2012-1993
03/20/2012 04/17/2012
LIFEWAY FOODS INC, MORTON GROVE, IL - LIFEWAY PROBOOST, BIOKEFIR BLACKBERRY, GOO-BERRY PIE, ETC MARKETING VIOLATIONS, PROD MISBRANDING, INVESTIGATION RECS
2012-1994 2012-1995
03/20/2012 04/17/2012 03/20/2012 04/17/2012
BURT'S BEES NATURAL ACNE SOLUTIONS MAXIMUM MANATT PHELPS & PHILLIPS LLP STRENGTH SPOT TREATMENT CREAM - RECS, CORR LA TOYA SUTTON SHANNON HOUGH PHARM D UNIV OF MICHIGAN HOSPITALS & HEALTH CENTERS CABAZITAXEL - AERS
2012-1996
03/20/2012 04/17/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J
REUMOFAN PLUS - AERS
2012-1997
03/20/2012 04/17/2012
LAUREN BRIESE PHYSICIANS COMMITTEE FOR
ZOLOFT NDA 19-839, PROZAC NDA 18-936, PAXIL NDA 20031, ETC - LBLG, LTR, RVWS
Page 923 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-1998 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/SJN-DO/SJCB/ 2012-1999 03/20/2012 04/17/2012 2012-2000 03/20/2012 04/17/2012 2012-2001 2012-2002 2012-2003 2012-2004 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 2012-2005 2012-2006 03/20/2012 04/17/2012 03/20/2012 04/17/2012 2012-2007 03/20/2012 04/17/2012 2012-2008 03/20/2012 04/17/2012 2012-2009 03/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ANTHONY E. AUSIELLO AMNISURE INTERNATIONAL LLC RAMONA KULIK STRYKER SUSTAINABILTY SOLUTIONS MICHELLE L WELLS METRO CUSTOMS BROKERS INC MARC C. SANCHEZ CONTRACT IN HOUSE COUNSEL AND CONSULTANTS LLC ALEX JOHN LONDON BORTEZOMIB - PRECLNCL EFFICACY STUDIES MARIETTA VISION K002647, K052606, K992339 ROM PLUS FETAL MEMBRANES RUPTURE REST; ROM PLUS QUALITY CONTROL KIT K110605 MEDTRONIC XOMED INC, JACKSONVILLE, FL - XPS 3000 SYS K041413 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ THOMAS, JEFFREY G PEGGY McLAUGHLIN MPM ADVISORS PEGGY McLAUGHLIN MPM ADVISORS K912824 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ PEGGY McLAUGHLIN MPM ADVISORS NEUROLOGICAL DVCS PANEL MTG, ROCKVILLE, MD TRANS 5/14/09 K112235 K110503 PEGGY McLAUGHLIN MPM ADVISORS K090269 PEGGY McLAUGHLIN MPM ADVISORS K090061 CORTES, DAVE LILLY DE CARIBE, CAROLINA, PR 4/28/11, 9/23/10; GUAYAMA, PR 12/3/10, ETC - 483S Signature/ Requester RESPONSIBLE MEDICINE Subject
LISTING AS AGENT
Page 924 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/17/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2010 2012-2011 03/20/2012 04/17/2012 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2012 2012-2013 03/20/2012 04/17/2012 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2014 2012-2015 2012-2016 2012-2017 2012-2018 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2019 2012-2020 03/20/2012 04/17/2012 03/20/2012 04/17/2012 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ BRIAN TODT CAREFUSION CORP KRISTINE BURGESS MS DVM TUFTS UNIV CUMMINGS SCHOOL OF VETERINARY MEDICINE GLUCOPHAGE - NONCLNCL TOXICOLOGY RECS 10 ML BDLUER LOK TIP SYRINGE MW5021694 Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SEAN BUNDY COCHLEAR AMERICAS BRIAN TODT CAREFUSION CORP BRIAN TODT CAREFUSION CORP BRIAN TODT CAREFUSION CORP CIPROFLOXACIN - RECS ALARIS PUMP - MEDWATCH RPT SMART SITE INFUSIONSET - MEDWATCH RPT COCHLEAR BONE ANCHORED SOLUTIONS AB. MOLNLYCKE, SWEDEN - EIR 6/9-12/08 ARARIS SMART PUMP - MEDWATCH RPT FDA/OMPT/CDRH/OCER/DFOI/ SEAN BUNDY COCHLEAR AMERICAS ALEX JOHN LONDON CARNEGIE MELLON UNIV PHILOSOPHY DEPT COCHLEAR LTD, LANE COVE, NSW AUSTRALIA - EIR 11/817/04 GEFETINIB - PRECLNCL EFFICACY STUDIES FDA/OMPT/CDRH/OCER/DFOI/ DOLLY MISTRY COVIDIEN ALEX JOHN LONDON CARNEGIE MELLON UNIV PHILOSOPHY DEPT HEURISTIC MEDICAL SYS INC, HERRIN, IL - CONTOUR ELECTRODE K844345 ROTIGOTINE - PRECLNCL EFFICACY STUDIES Signature/ Requester CARNEGIE MELLON UNIV PHILOSOPHY DEPT Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-2021 2012-2022 2012-2023 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2024 03/20/2012 04/17/2012 2012-2025 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2012-2026 2012-2027 2012-2028 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/ ORA/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ KATHERINE STRONG CARNER SIDLEY AUSTIN LLP KATHERINE STRONG CARNER SIDLEY AUSTIN LLP ELISABETH NEUBERG Bingham McCutchen LLP DVC USED IN BREAST SURGERY - CDRH UNTITLED LTRS, INQUIRY LTRS, CORR, ETC LAST 5 YRS SURGICAL MESH DVCS - CHRH UNTITLED LTRS, INQUIRY LTRS, CORR, ETC LAST 5 YEARS LAST 5 YRS QUESTCOR PHARMACEUTICALS INC - CMPLNTS, INVESTIGATIONS, SETTLEMENTS WILLYARD #503162, DEWAYNE FDA/OMPT/CDRH/OCER/DFOI/ LIANE LaROCHELLE DEKA RESEARCH & DEVELOPMENT CORP ABBOTT LABS - FREE STYLE INSULINX BLOOD GLUCOSE MONITORING SYS K111874 LIPOIC ACID, ALPHA LIPOIC ACID - AERS FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L SARAH HUTCHINS VIRGINIAN-PILOT FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, Ph.D., LEROY CONCERNS ABOUT THE MEDICAL DEVICE AMENDMENTS CDRH VIDEO SEMINAR 10/3/83 BIAXIN (CLARITHROMYCIN) - AERS MEDICAL DVC CLASSIFICATION QUESTIONNAIRE Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/KAN-DO/COMP/ 2012-2029 03/20/2012 04/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2030 03/20/2012 04/17/2012 2012-2031 03/20/2012 04/17/2012 2012-2032 2012-2033 2012-2034 2012-2035 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/20/2012 04/17/2012 03/21/2012 04/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2036 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2037 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2038 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2039 03/21/2012 FDA/OF/CFSAN/OCD/EOS/ ANITA RASMUSSEN PIMURSA, MURCIA, SPAIN - AUDIT 1/23/12 ALEX JOHN LONDON CARNEGIE MELLON UNIV PHILOSOPHY DEPT ZICONOTIDE - PRE-CLNCL STUDIES ALEX JOHN LONDON CARNEGIE MELLON UNIV PHILOSOPHY DEPT SUNITINIB - PRE-CLNCL STUDIES FOI SERVICES INC ETANERCEPT - ISR 3718371, 5212086, 5280079, ETC FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ DIANA DOBRIN IOVATE HEALTH SCIENCES INTERNATIONAL INC DR DAVID SMITH FRESHWATER FARMS OF OHIO INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. MEGAN B PICKEL BEVERIDGE & DIAMOND PC BRIAN SMITH LEXISNEXIS COURTLINK INC EFALIZUMBA - ISR 5960794, 5964686, 6107859, ETC FOI DAILY LOG 3/5-9/12 CFSAN FOI REQUESTS 2/17/12-3/16/12 ANTIOXIDANT FOR POLYMER - GRAS PICHIA PASTORIS (DRIED YEAST) - FAP CAERS 147168, 147174, 147177 MARY SHINN PHOENIX BUSINESS JOURNAL PHARMACEUTICAL SHORTAGE LAST 5 YRS Signature/ Requester Subject
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Total Records: 12455 Control # Recd Date / Due Date 04/18/2012 2012-2040 2012-2041 03/21/2012 04/18/2012 03/21/2012 04/18/2012 2012-2042 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2043 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2044 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2045 03/21/2012 04/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2046 2012-2047 03/21/2012 04/18/2012 03/21/2012 04/18/2012 2012-2048 03/21/2012 04/18/2012 ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INVESTIGATOR ID NO 374038 - 483 11/1/94 FISHER, BRIEANNA ASHA LAMBATOS AVALON RISK MANAGEMENT INC WILLILAM II IIRANCHAK NEAL R GROSS & CO ENTRY M42-12335648 - FAILURE TO DEDELIVER NOTICE OF FDA ACTION #1 OFFICE OF ACQUISITION & GRANTS, CENTR FOR BIOLOGICS EVALUATION & RESEARCH, CENTER FRO DEVICES & RADIOLOGICAL HEALTH, ETC - LIST OF ALL GOVERNMENT CARD HOLDERS KENTUCKY CUT RAG, LEXINGTON, KY - FORMSS, LISTINGS FOR OWNERS & OPERATORS OF DOMESTIC TOBACCO PROD ESTABLISHMENTS 2011 INFLIXIMAB ISRS 5530158, 5612356, 6223108 ELIZABETH BARBEHENN PUBLIC CITIZEN IRS 7399370, 7402390, 7423077, ETC VERONICA-ADELE R CAO WEISS & MOY PC LATISSE (BIMATOPROST) - SAFTEY RECS, REQUEST TO PERMIT OTC SALE CHANDRAN TIRVATTAR DR REDDY'S LABORITORIES INC GLENMARK - CICLOPIROX ANDA 91-595 SBA FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office Signature/ Requester MCCORMICK & COMPANY INC ANITA RASMUSEN MCCORMICK & COMPANY INC VICTOR J BARANOWSKI SCHMEISER OLSEN & WATTS LLP ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC TEVA, APP, BEDFOR - GENERIC INJECTABLE LEUCOVORIN- COMPANIES PLANNING TO SELL DRUG APPL DOMAIN SURGICAL, SALT LAKE CITY, UT - K110439 RAMON SABATER, MURCIA, SPAIN - AUDIT 1/26-27/12 Subject
2012-2049
03/21/2012 04/18/2012
CTP/OD/ CTP/OD/ FDA/OMPT/CDER/ORP/DIDP/
GREGORY S KEVER KENTUCKY CUT RAG LLC
2012-2050
03/21/2012
Page 928 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/18/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2051 2012-2052 03/21/2012 04/18/2012 03/21/2012 04/26/2012 2012-2053 03/21/2012 04/18/2012 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2054 2012-2055 2012-2056 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 2012-2057 2012-2058 2012-2059 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 2012-2060 03/21/2012 04/18/2012 2012-2061 03/21/2012 04/18/2012 2012-2062 2012-2063 03/21/2012 04/18/2012 03/21/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC PAIVI MESIRANTA CONMED LINVATEC BIOMATERIALS LTD BARBARA FRAZIER LEHL LAW OFFICES OF DENNIS BONNER & ASSOCIATES LLC DAVID J. FISCHMAN JAROSLAWICZ & JAROS LAW OFCS LaTOYA SUTTON MANATT PHELPS & PHILLIPS LLP LaTOYA SUTTON ACMI - IGLESIAS RESECTOSCOPE WARNING LTR, RPTS, PRODUCT MANUAL BURTS BEES - NATURAL ACNE SOLUTIONS CLARIFYING TONER CORR BURTS BEES - NATURAL ACNE SOLUTIONS PURIFYING 2012-179 REDACTED ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC OC/OM/OMP/DDM/ ORA/P-FO/LOS-DO/LACB/ FOI SERVICES INC MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION CENTOCOR, MALVERN, PA - EIR, 483, WARNING LTR, CO RESP 4/14-18/08, 11/10-13/08 PROCTER & GAMBLE PRINGLES POTATO CHIPS FORTIFIED WITH CALCIUM CORR STRYKER LEIBINGER RESORBABLE FIXATION SYS K993061 ORA/CE-FO/NJ-DO/NJCB/ FOI SERVICES INC JOHNSON & JOHNSON, RARITAN, NJ - EIR, 483, WARNING LTR, CO RESP 3/18-27/09 J MURPHY, SOUTHWESTERN RESEARCH, BEVERLY HILLS, CA - EIR, 483, WARNING LTR, CO RESP 2/20/09 DKT FDA-1995-S-0039 FOI SERVICES INC FOI SERVICES INC ORA/SE-FO/SJN-DO/SJCB/ FOI SERVICES INC PFIZER MANUFACTURING, CAROLINA, PR - EIR, 482, 483, WARNING LTR, CO RESP 3/14/10 TO PRESENT SOLUBLE SYSTEMS LLC, SKIN AND WOUND ALLOGRAFT INSTITUTE (SWAI), LIFENET HEALTH INC (LHI) - THERASKIN HUMAN SKIN ALLOGRAFT REMICADE ISR 6121836 Signature/ Requester FOI SERVICES INC Subject
Page 929 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/18/2012 2012-2064 2012-2065 2012-2066 2012-2067 2012-2068 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ ORA/CE-FO/CHI-DO/CCB/ 2012-2069 2012-2070 2012-2071 2012-2072 03/21/2012 05/07/2012 03/21/2012 04/18/2012 03/21/2012 04/18/2012 03/21/2012 06/12/2012 2012-2073 03/22/2012 05/11/2012 2012-2074 03/22/2012 ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/ DENNIS BABJACK SAMPLE #720483 - TEST RESULTS 9/10/12 ORA/OCI/ ORA/OCI/ CBER/OCTMA/DDOM/ALFB/ HERRERA, MICHELLE . ROBERT D. KING, Jr. LAW OFFICE OF ROBERT D KING JR PC CINDY RYAN ACTAVIS LORAZAPAM 2MG,CLONAXAPAM 2M TABS PHOTOGRAPHS INDIVIDUAL RECS FDA/OF/CFSAN/OCD/EOS/ THOMPSON, CLARENCE LD FDA/OF/CFSAN/OCD/EOS/ MOTEN, LAVEETA RECORD OF OVERTIME PAID TO CFSAN EMPLOYEES 1/10 TO 3/9/12 PMAP RATINGS FOR CFSAN EMPLOYEES BUDGET ANALYSTS, SENIOR BUDGET ANALYST EMPLOYEES 2011 INDIVIDUAL RECS Signature/ Requester Subject
MANATT PHELPS & PHILLIPS LLP GEL CLEANSER CORR LaTOYA SUTTON LaTOYA SUTTON LaTOYA SUTTON MANATT PHELPS & PHILLIPS LLP LaTOYA SUTTON PATTI WALLER MARLER CLARK ATTYS BURTS BEES - NATURAL ACNE SOLUTIONS TARGETED MANATT PHELPS & PHILLIPS LLP SPOT TREATMENT CREAM CORR BURTS BEES - NATURAL ACNE SOLUTIONS DAILY MANATT PHELPS & PHILLIPS LLP MOISTURIZING LOTION CORR BURTS BEES - NATURAL ACNE SOLUTIONS REGIMEN KIT CORR
BURTS BEES - NATURAL ACNE SOLUTIONS PORE MANATT PHELPS & PHILLIPS LLP REFINING SCRUB CORR MULTI STATE OUTBREAK OF E COLI 026 LINKED TO RAW CLOVER SPROUTS AT JIMMY JOHNS RESTAURANTS TEST RESULTS, RPTS, ETC 12/11 TO 2/12
Page 930 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/19/2012 2012-2075 03/22/2012 04/19/2012 Action Office ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/FLA-DO/FCB/ MARTIN N ZAIAC MOUNT SINAI MEDICAL CENTER GREATER MIAMI SKIN & LASER CTR FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ 2012-2079 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2080 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2081 2012-2082 03/22/2012 04/19/2012 03/22/2012 04/19/2012 2012-2083 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2084 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHRISTINA PEDRO CORNELL UNIV VESICARE - DRUG DEVELOPMENT/RESEARCH INFO, CONTROLLED TRIAL RECS, ETC OM/OMP/DODM/ ORA/CE-FO/CIN-DO/CCB/ Doe J SUE MCGOVERN JUST LABEL IT ORGANIC VOICES ACTION FUND CHARLES VAN DER HORST UNIV OF NORTH CAROLINA AT CHAPEL HILL TOBACCO PETITION FDA-1995-N-0397 - NUMBER OF SIGNATURES SYSTEMIC VASCULITIS (RENAL & RETINAL DISEASE & PANCYTOPENIA) - AERS , DES/PLAVIX RELATED? MIKE SELLS POTATO CHIP CO - CMPLNTS DOW, KATELYN STATIN PRODUCTS - AERS 1/1/00 TO PRESENT RALPH R TURNER PHASE V TECHNOLOGIES INC LIST OF FDA PERSONNEL WHO ACCESSED DRUG MASTER FILE #22780 MITCHELL A GOLDSTEIN BABENER & ASSOCS MITCHELL A GOLDSTEIN BABENER & ASSOCS KATE B WILLSON CENTER FOR PUBLIC INTEGRITY CERTIFICATE TO FOREIGN GOVERNMENT REQUESTS EXPORT CERTIFICATE DATA FROM FORM FDA 3613 MAX INTERNATIONAL - CELLGEVITY CAERS GREATER MIAMI SKIN & LASER CTR, MIAMI BEACH, FL 483, OBSERVATION #2, MISSING CHART & COPIES OF 0270309 4/22/10-7/14/10 MAX INTERNATIONAL - MAXONE CAERS Signature/ Requester ADYA INC Subject
2012-2076 2012-2077 2012-2078
03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012 04/19/2012
Page 931 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2085 2012-2086 03/22/2012 04/19/2012 03/22/2012 04/19/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-2087 2012-2088 2012-2089 03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012 04/19/2012 2012-2090 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2012-2091 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2092 2012-2093 2012-2094 2012-2095 2012-2096 03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012 04/19/2012 FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA HEM-O-LOK LIGATING CLIPS - K062914 FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA HEM-O-LOK LIGATING CLIP - K030311 FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA HEM-O-LOK LIGATING CLIPS - K003337 FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220 K993157 HEM-0-LOK LIGATING CLIPS - K982944 WEBSTER, DOROTHY LISINOPRIL, LIPTOR, ATENOLOL, ETC - AERS SPALLA, SHANE FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER RUETHER VASCULAR SOLUTIONS JASON KYUNG-SOO HONG MD CAROLINAS PAIN INSTITUTE PA CHARLES CELESTE EAS Consulting Group, LLC AMBULATORY MONITORING INC - WRIST ACTIGRAPH K854030B MICHAEL JACOBSON, CENTER FOR SCIENCE IN THE PUBLIC INTEREST (CPI) - WHOLE GRAIN LABLG MTG MINS, CORR 2/8/12 BIOVECGTRA INC, BIOCHEM FACILITY, CHARLOTTETOWN, PE; BIOVECTRA INC, BIOEXTRACTION FACILITY, CHARLOTTETOWN, PE - 483S 2002 TO 2012 ZENUSA LTD - GUARDIAN NC K101113 FDA/OMPT/CDRH/OCER/DFOI/ PATRICIA SCHNOOR PHILIPS CONSUMER LIFESTYLE MARK BROOKS UTILITY WORKERS UNION OF AMERICA CITY BREWING CO, LACROSSE, WI, LATROBE PA & MEMPHIS, TN - EIRS, 483S, RECALLS ETC 1/1/10 TO PRESENT K110349 Signature/ Requester Subject
Page 932 of 1132

Total Records: 12455 Control # 2012-2097 2012-2098 Recd Date / Due Date 03/22/2012 04/19/2012 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-2099 03/22/2012 04/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2012-2100 03/22/2012 04/19/2012 FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ 2012-2101 03/22/2012 04/19/2012 2012-2102 03/22/2012 04/19/2012 ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ DEBORAH KLOOS MEDICAL ACTION INDUSTRIES INC MARTIN N ZAIAC MOUNT SINAI MEDICAL CENTER GREATER MIAMI SKIN & LASER CTR CAROLINA M HEAVNER K & L GATES OM/OMP/DODM/ SUE MCGOVERN JUST LABEL IT ORGANIC VOICES ACTION FUND FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ MARTHA GUZMAN AMSINO INTERNATIONAL INC MARTHA GUZMAN AMSINO INTERNATIONAL INC LISA TARRISON-SCHRAMP CLOSED FOI REQUESTS 3/12-16/12 HYDROPHILIC ANTIBACTERIAL INTERMITTENT CATHETER K033477 BARDEX LUBRI-SIL 3-WAY FOLEY CATHETER K070558 GREATER MIAMI SKIN & LASER CTR, MIAMI BEACH FL - EIR 4/22/10 -7/14/10 MEDICAL ACTION INDUSTRIES, ARDEN, NC - EIR 3/26-31/09 PATTI WALLER MARLER CLARK ATTYS FAMILY COW FARM, CHAMBERSBURG, PA UNPASTURIZED MILK CAMPYLOBACTER JEJUNI OUTBREAK NOTES, TEST RESULTS, COMM ETC 1/12 -2/12 CONNER, MARYBETH BIOVECTRA INC, CHATLOTTETOWN, PE - 483S LAST 10 YRS Action Office FDA/OMPT/CDRH/OCER/DFOI/ MARK YOUNG PA JOHN R RAPOZA MD RPH JR RAPOZA ASSOCIATES INC OXYCODONE HCL DMF 16399 - RECS Signature/ Requester Subject HEM-O-LOK LIGATING CLIPS - K982941
2012-2103 2012-2104
03/22/2012 04/19/2012 03/22/2012 04/19/2012
INNOTEQ INC, STRATFORD, CT - EIR, 483S, CORR ETC 3/06 TO 3/12 DKT 1995N-0259
2012-2105 2012-2106 2012-2107
03/22/2012 04/19/2012 03/22/2012 04/19/2012 03/22/2012
Page 933 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/19/2012 2012-2108 2012-2109 03/22/2012 04/19/2012 03/22/2012 04/19/2012 2012-2110 03/22/2012 04/19/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2111 2012-2112 2012-2113 2012-2114 2012-2115 03/22/2012 04/19/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 2012-2116 03/23/2012 04/20/2012 2012-2117 03/23/2012 04/20/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/SJN-DO/SJCB/ 2012-2118 03/23/2012 04/20/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2119 03/23/2012 04/20/2012 FDA/OMPT/CDRH/OCER/DFOI/ ANDREA P DEMERS MAYNARD O'CONNOR ET AL PRECISION MEDICAL - EASY PULSE 5 OXYGEN CONSERVING REGULATOR INVESTIGATION, PHOTOGRAPHS, RPTS, ETC JASON SCHNEIDER JASON T SCHINEIDER PC BARD PV, TEMPE, AZ - G2 FILTER SYS EIRS, WARNING LTRS, 510K 1/00 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID MCFARLAND FDA WEBVIEW/FERDIC AMY L GOERSS HODGSON RUSS LLP AMY L GOERSS HODGSON RUSS LLP AMY L GOERSS HODGSON RUSS LLP ROBIN PAYNTER OREGON HEALTH & SCIENCE UNIV ROBIN PAYNTER OREGON HEALTH & SCIENCE UNIV JASON T SCHNEIDER JASON T SCHINEIDER PC NT-TRADING GMBH & CO KG - TI-BASE ABUTMENT, 1 CONNECT ABUTMENT K111935 3M ESPE AG DENTAL PRODUCTS - LAVA FRAME LAVE FRAME SHADE K072055 MEDTRONIC - INFUSE BONE GRAFT P050053 ORAL MAXILLOFACIAL PROTOCOL, SUMMARY, CASE HISTORIES WYETH - INFUSE BONE GRAFT P000054 ORTHOPEDIC TRAUMA PROTOCOL. SUMMARY, CASE HISTORIES BARD, MURRAY HILL, NJ - G2 FILTER SYS EIRS WARNING LTRS, 510K, 1/00 TO PRESENT SIRONA DENTAL SYSTEMS GMBH - CAD/CAM SYS k100152 CLOSED FOI REQUESTS 3/5-9/12 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DAVID MCFARLAND FDA WEBVIEW/FERDIC INC CLOSED FOI REQUESTS 3/12-16/12 CLOSED FOI REQUESTS 3/12-16/12 Signature/ Requester CanReg, Inc. CLOSED FOI REQUESTS 3/12-16/12 Subject
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Total Records: 12455 Control # 2012-2120 2012-2121 2012-2122 2012-2123 Recd Date / Due Date 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 2012-2124 2012-2125 03/23/2012 04/20/2012 03/23/2012 06/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ 2012-2126 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2127 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2128 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2129 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ NEWMAN, ARIEL REGU-MATE (ALLYL TRENBOLORE) - AERS GARY HAIGHT ETHYPHARM INC PERCOCET, OXYCODONE TABS - PRE-CLNCL, CLNCL RECS ANDREA S FRANKS UNIV OF TENNESSEE/COLLEGE OF PHARMACY VICTOZA (LIRGLUTIDE ) AERS COLAS, BRIAN ABBOTT LABS - BAXIN (CLARITHROMYCIN) AERS FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID JONES BERLINHEART JESSICA L MONSELI MOTLEY RICE LLC A-MED SYSTEMS INC - LARGE CENTRIFUGAL BLOOD PUMP K020529 DR THOMAS LITTLEJOHN III - CLNCL STUDIES, TRIALS, SUBMISSIONS, ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester KRISTIN R DAVEPORT GOODWIN PROCTER LLP JEFFERY P FISHER EZ PEDO DAVID B JONES BERLINHEART DAVID B JONES BERLINHEART TUFF KID CROWNS LLC - ZIRCONIUM-BASED CERAMIC PEDIATRIC PREFORMED CROWNS CMPLNTS A-MED SYSTEMS, WEST SACRAMENTO, CA - AMINIATURE CENTRIFUGAL BLOOD PUMP SYS K992592 A-MED SYSTEMS INC - VASCULAR CANNULA - K99154131 Subject OTTO BOCK HEALTHCARE LP - SENSOR WALK K052771
Page 935 of 1132

Total Records: 12455 Control # 2012-2130 2012-2131 2012-2132 2012-2133 Recd Date / Due Date 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 2012-2134 2012-2135 2012-2136 2012-2137 2012-2138 2012-2139 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2140 03/23/2012 04/20/2012 2012-2141 2012-2142 2012-2143 2012-2144 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ R. LEONARD VANCE, Ph.D. VIRGINIA COMMONWEALTH UNIVERSITY MITCHELL A. CHEESEMAN STEPTOE & JOHNSON AMY L. GOERSS HODGSON RUSS LLP AMY L. GOERSS HODGSON RUSS LLP BRIANNA L. SILVERSTEIN NOBEL BIOCARE AB - PROCERA IPS E MAX CROWN K100512 WILLIAMS GOLD REFINING CO INC - SRARTAN SOLDER K854738 GRAS NO 94 - RECS PRIOR TO 1/1/04 FCN 000852 - CHEMISTRY RVW, TOXICOLOGY RVW ROXARSONE (3 NITROARSINILIC) RECS FAM, PAULINA FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ CVM/OCD/ ORA/ ORA/ ORA/OCI/ ORA/OCI/ ORA/SE-FO/ATL-DO/ACB/ FDA/OO/OFBA/OAGS/ JEFF STACHEWICZ, Esq. FOIA GROUP INC LAURIE PHARIS NOVARTIS ANIMAL HEALTH LAURIE PHARIS NOVARTIS ANIMAL HEALTH JOSEPH KICEINAY ABBOTT POINT OF CARE INC JOSEPH KICEINA ABBOTT POINT OF CARE INC AMERICAN BIOPRODUCTS CO - STA AUTOMATED COAGULATION ANALYZER K942117 FELODIPINE; HYDRALAZINE; LEVOTHYROXINE - AER DRONCIT ( PRAZIQUANTEL) NADA 111-607 INJECTIBLE CESTOCIDE DRONCIT (PRAZIQUANTEL) NADA 111-798 CESTOCIDE TABS DIAGNOSTICA STAGO INC - XA TEST K111822 HHSF22301002T Action Office CTP/OD/ CTP/OD/ ORA/CE-FO/CHI-DO/CCB/ Signature/ Requester SUZANNE D JENSEN KLEINFELD KAPLAN & BECKER COLLEEN GRACE DONOFRIO PQ CORP ADRIANA MCKINNON DENNICK FRUITSOURCE GEORGIA L MCGOWAN EVERAGE LAW FIRM PLLC 13 DRUMS - ENTRY #EDA-000-1177-1 ANALYTICAL RESULTS MOUSE FOUND IN MS BUTTERWORTH SYRUP - RECS Subject TOBACCO ESTABLISHMENTS REGISTERED WITH FDA MFGS OR IMPORTERS, SECTION 905 (J) RPTS PQ CORP, UTICA, IL - EIR 7/11
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Total Records: 12455 Control # Recd Date / Due Date 04/20/2012 2012-2145 03/23/2012 04/20/2012 2012-2146 2012-2147 2012-2148 03/23/2012 04/20/2012 03/23/2012 04/20/2012 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2149 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2150 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2151 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2152 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2153 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2154 03/23/2012 FDA/OMPT/CDER/ORP/DIDP/ AMNEAL PHARMS NY - PHENYTOIN NDA 40-765, LBLG 1/07 TO 3/12 JAY HENDERSON PLLC TARO - PHENYTOIN NDA 40-684, LBLG 1/07 TO 3/12 JAY HENDERSON PLLC TARO - PHENYTOIN NDA 40-521, LBLG JAY HENDERSON PLLC PARKE DAVIS - DILANTIN NDA 84-349 LBLG JAY HENDERSON PLLC PARKE DAVIS - DILANTIN NDA 84-427, LBLG JAY HENDERSON PLLC PARKE DAVIS - DILANTIN NDA, LBLG 1/07 TO 3/12 JAY HENDERSON PLLC FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SEA-DO/SCB/ Action Office Signature/ Requester DRINKERBIDDLE & REATH LLP ROSS S. LANDERMAN KOWA RESEARCH INSTITUTE INC VASILIKI BEGKOU CERAMTEC TRUUS TIEMERSMA DSM AHEAD BV PARKE DAVIS - DILANTIN LBLG, NDA 1/07 TO 3/12 XUE QIAO ZHAO MD, LAKE UNION PLACE, SEATTLE, WA EIR, 483 12/10 PROTEK - CERAMIC FEMORAL HEADS; RECASSIFICATION PETITION 10/15/86, MTG MINS TRIMETHYMELLITATE - PETITION Subject
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Total Records: 12455 Control # Recd Date / Due Date 04/20/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2155 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2156 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2157 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2158 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2159 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2160 03/23/2012 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ 2012-2161 03/23/2012 04/20/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ ROBERT A. DeCAMP DERINGER LOGISTICS CONSULTING GROUP AN DERINGER INC - RECS Doe J DIETARY SUPPLEMENTS - AER 1/1/08 TO 3/1/12 JAY HENDERSON PLLC ACTAVIS MID ATLANTIC LLC - PHENYTOIN NDA 89-892, LBLG JAY HENDERSON PLLC WATSON - PHENYTOIN NDA 85-894, LBLG JAY HENDERSON PLLC SUN PHARMS INDS - PHENYTOIN NDA 40-621, LBLG JAY HENDERSON PLLC SUN PHARM INDS - PHENYTOIN NDA 40-731, LBG JAY HENDERSON PLLC MYLAN - PHENYTOIN NDA 40-298, LBLG 1/07 TO 3/12 Signature/ Requester JAY HENDERSON PLLC Subject
Page 938 of 1132

Total Records: 12455 Control # 2012-2162 2012-2163 2012-2164 2012-2165 2012-2166 2012-2167 Recd Date / Due Date 03/23/2012 04/20/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 2012-2168 2012-2169 2012-2170 2012-2171 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 2012-2172 03/26/2012 04/23/2012 2012-2173 03/26/2012 04/23/2012 2012-2174 03/26/2012 04/23/2012 2012-2175 03/26/2012 04/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ LIEBERMAN, MARC S FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ GREGORY LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP DORENE MARKWIESE ST JUDE MEDICAL DORENE MARKWIESE ST JUDE MEDICAL CHELSIE KING GARZA ABRAHAM WATKINS ET AL CHELSIE KING GARZA ABRAHAM WATKINS ET AL ADVANCED BONICS CORP - PRECISION SPINAL CORD STIMULATION (SCS) SYS - P030017/S008, S010, S011, S018, S022 MEDTRONIC INC - RESTORE PRIME, PRIMEADVANCED RESTORE RECHARGEABLE, RESTORE ADVANCED, ETC P840001/S126 SIEMENS HEALTHCARE DIAGNOSTICS INC, BAYER HEALTHCARE - ADVIA CLNCL CHEMISTRY SYS 1800 APRVL RECS, MDRS, COMM, ETC SIEMENS HEALTHCARE, BAYER HEALTHCARE - ADVIA CLNCL CHEMISTRY SYS 1650 APRVL RECS, MDRS, COMM, ETC ALL CRYOSURGERY INC - VERRUCA FREEZE SYS K982506, K944221, K881349 RADIANCY (ISRAEL) LTD - K102477 SILVER BAY LLC - K093963 PHOTO THERAPEUTICS INC - K081307 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester AMY L. GOERSS HODGSON RUSS LLP GREGORY H LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP GREGORY LEVINE ROPES & GRAY LLP PHOTO THERAPEUTICS INC - K072459 LED INTELLECTUAL PROPERTIES LLC - K101190 HOME SKINOVATIONS LTD - K103184 SHASER INC (REMINGTON) - K103560 CLRS TECHNOLOGY CORP (SOLTA MEDICAL) - K09744 Subject IVOVLAR - GOLDEN CERAMIC SOLDERS K905419
Page 939 of 1132

Total Records: 12455 Control # 2012-2176 Recd Date / Due Date 03/26/2012 04/23/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2177 03/26/2012 05/02/2012 2012-2178 03/26/2012 04/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2179 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2180 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2181 03/26/2012 04/23/2012 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ 2012-2182 03/26/2012 04/23/2012 ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/OCI/ ORA/OCI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2183 2012-2184 03/26/2012 04/23/2012 03/26/2012 ORA/ FDA/OF/CFSAN/OCD/EOS/ PAULINA DO EXPONENT ELENA HOWELL FOOD INSPECTOR TRAINING MATERIALS FY 2011, FY 2012 ABBOTT LABS - DKT 2012F-0138 NINOS SAROUKHANNIOFF MARANGA MORGENSTERN LAW CORP WINDSOR QUALITY FOOD CO, HUNTINGTON PARK, CA EIRS, RPTS, PHOTOGRAPHS, ETC 3/20/12 MATT SCHRADER KOVR-TV LEVELS OF ANTIBIOTICS, DRUGS FOUND IN RESIDUE TESTS IN DAIRY CATTLE MEAT FROM CALIFORNIA 20072011 JOHN D'ANGELO FERA PHARMACEUTICALS FERA PHARMACEUTICAL LLC - DAPIPRAZOLE HCL 0.5% OPHTHALMIC SOL IND 27286 RECS KEVIN PYUN CONSONANCC CAPITAL SEATTLE GENETICS - ADCETRICS (BRENTUXIMAB VEDOTIN) AERS, SAFETY RECS DONNA R CORCORAN COOLEY MANION MOORE & JONES PC MARILYNN WHITNEY COVINGTON & BURLING LLP CADD-LEGACY INFUSION PUMP MODEL 6400 - RPTS, INTERVIEWS, FINDINGS, ETC AESICA QUEENBOROUGH LTD, KENT, UK - EIRS, 483S 3/18/10 Signature/ Requester EJ SMITH SMITH ASSOCIATES Subject LIFELINES TRACKIT RECORDED - K010460
Page 940 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/23/2012 Action Office ORA/ ORA/ORM/ ORA/ORM/ 2012-2185 03/26/2012 04/23/2012 CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ OC/OER/OPA/ 2012-2186 03/26/2012 04/23/2012 2012-2187 2012-2188 03/26/2012 04/23/2012 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2189 03/26/2012 04/23/2012 2012-2190 03/26/2012 04/23/2012 2012-2191 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2192 03/26/2012 04/23/2012 2012-2193 03/26/2012 04/23/2012 2012-2194 2012-2195 03/26/2012 04/23/2012 03/26/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ ORA/CE-FO/PHI-DO/PCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON DAVID H HENRY III, PENNSYLVANIA ONCOLOGY HEMATOLOGY ASSOCIATES, PHILADELPHIA, PA - EIRS, 483S,CO RESP 10/10/96 DAVID H HENRY III, PENNSYLVANIA ONCOLOGY HEMATOLOGY ASSOCIATES, PHILADELPHIA, PA - EIRS, 483S, CO RESP 2/5/02 K020110 - SUBSTANTIALLY EQUIVALENT APRVL LTR 4/3/02 (CERTIFIED) K081275 - SUBSTANTIALLY EQUIVALENT APRVL LTR 8/27/08 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/DEN-DO/COMP/ MARIO C PALERMO WOODRUFF JOHNSON & PALERMO ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS STRYKER CORP - MX-PRO AMBULANCE COTS MDRS; INDIVIDUAL RECS EDUARDO R PAJON, ROCKY MOUNTAIN CANCER CENTER, DENVER, CO - EIRS, 483S,CO RESP 8/4/04 PRONOVA BIOPHARMA, SANDEFJORD, NORWAY - EIRS, 483S, CO RESP 2004 TO 2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ A SMYTH IOVATE HEALTH SCIENCES RESEARCH INC SUZANNE O'SHEA FAEGRE BAKER DANIELS KEVIN PYUN CONSONANCC CAPITAL AVANIR PHARMS - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE) AERS HAMAMATSU PHOTONICS KK - PDE K110480 CAERS 148279, 148276, 145980, ETC KATE B WILLSON TISSUE BANK INSP PROTOCOLS, REGULATIONS ON CENTER FOR PUBLIC INTEGRITY IMPORTING HUMAN TISSUE, DISTRIBUTION & TRANSPLANTATION RECS, ETC Signature/ Requester HOGAN LOVELLS US LLP Subject
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Total Records: 12455 Control # Recd Date / Due Date 04/23/2012 2012-2196 2012-2197 2012-2198 2012-2199 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2200 2012-2201 2012-2202 2012-2203 2012-2204 2012-2205 2012-2206 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2012-2207 03/26/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2208 03/27/2012 ORA/ SUSAN BROWN SAFFRON ENTRY #UPS-2765756-4 - LAB ANALYSIS BRENDA M GARTZ ELI LILLY & CO PATHEON ITALIA SPA, FERENTINO, ITALY - EIR 6/09 ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE BRENDA M GARTZ ELI LILLY & CO ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE ORA/SE-FO/SJN-DO/SJCB/ CORTES, DAVE FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ BOWMAN COX GOLD SHEET BREANNE VANDERMEER MUELLER LAW OFC DIANE C MCENROE SIDLEY AUSTIN LLP MERCK & CO, ARECIBO, PR 4/14/11; BARCELONETA, PR 3/31/11, 5/21/09, ETC - 483S TAPI PUERTO RICO INC, GUAYAMA, PR 9/30/11, 5/19/09; HUMACAO, PR 8/6/09 - 483S WARNER CHILCOTT COMPANY LLC, FAJARDO, PR - 483S 12/29/09, 7/29/11 PATHEON ITALIA SPA, FERENTINO, ITALY - EIR 5/11 ETHICON INC, JOHNSON & JOHNSON - GYNECARE PROLIFT CORR, APRVL 2005-2007 HERBALIFE - CAERS, CMPLNTS AIDAPAK SERVICES LLC, VANCOUVER, WA - 483 1/6/11 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC DR YA PING LEE CURTIN UNIV SCHOOL OF PHARMACY Subject (CERTIFIED) K081048 - SUBSTANIALLY EQUIVALENT APRVL LTR 8/22/08 (CERTIFIED) K040787 - SUBSTANIALLY EQUIVALENT APRVL LTR 4/14/04 (CERTIFIED) K071957 - SUBSTANTIALLY EQUIVALENT APRVL LTR 1/13/09 (CERTIFIED) ORAL PROTON PUMP INHIBITORS (OMEPRAZOLE, ESOMEPRAZOLE, RABEPRAZOLE, ETC) - AERS
Page 942 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/24/2012 2012-2209 03/27/2012 04/24/2012 2012-2210 03/27/2012 04/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2211 2012-2212 03/27/2012 04/24/2012 03/27/2012 04/24/2012 2012-2213 2012-2214 03/27/2012 05/03/2012 03/27/2012 05/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ 2012-2215 03/27/2012 04/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2216 03/27/2012 04/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2217 2012-2218 03/27/2012 04/24/2012 03/27/2012 04/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/FLA-DO/FCB/ HALTER, PAUL BRENDA M GARTZ ELI LILLY & CO NOBILUS ENT, KUTNO, POLAND - 483 9/12-15/11 PURE SOURCE INC, MIAMI, FL - 483, CO RESP 9/22/11 DORAIS, JULIE ROCHE PALO - CYTOVENE (GANCICLOVIR SODIUM) NDA 19-661 MEDICAL & STATISTICAL RVWS DORAIS, JULIE PALADIN LABS - ANTIZOL (FOMEPIZOLE) NDA 20-696 MEDICAL, STATISTICAL RVWS ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/KAN-DO/COMP/ JULIE PEAK INTERCON CHEMICAL CO KATHY MCINTOSH PHD SASKATOON COLOSTRUM COMPANY LTD LATESHA R BAKER HINSHAW & CULBERTSON LLP CHRISTOPHER MARLBOROUGH FARUQI & FARUQI LLP SASKATOON COLOSTRUM COMPANY LTD - BOVINE DRIED COLOSTRUM ENTRY #112-6413972-1 TESTING RECS GENENTECH INC - EIRS, 483S, DEVIATION RPTS, ETC 6/11, 9/2-27/11 HYLAND'S INC - HOMEOPATHIC PRODS AERS, CORR, SAFETY & EFFICACY RECS, ETC B & G LABS, ST LOUIS, MO - ENFORCEMENT ACTIONS Action Office ORA/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/SAN-DO/SFCB/ TERESA WEBSTER ARMANINO FOODS OF DISTINCTION INC VICKIE SEEGER Reckitt Benckiser Pharmaceuticals ARMANINO FOODS OF DISTINCTION INC, HAYWARD, CA 482 9/30/11 THE BASIS FOR RESCHEDULING OF BUPRENORPHINE AS A SCHEDULE V NARCOTIC UNDER THE CONTROLLED SUBSTANCES ACT Signature/ Requester MCCORMICK & COMPANY INC Subject
Page 943 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-2219 2012-2220 2012-2221 2012-2222 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 2012-2223 2012-2224 2012-2225 2012-2226 2012-2227 2012-2228 2012-2229 2012-2230 2012-2231 2012-2232 2012-2233 2012-2234 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DEN-DO/COMP/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC DAVOL INC - HYDRO-SURG LAPARASCOPIC IRRIGATION SYS K961492 DAVOL INC - NAZHAT-DORSEY REUSABLE ELECTROSURGICAL ATTACHMENTS K003674 STRYKER ENDOSCOPY - STRYKERFLOW SUCTION IRRIGATOR K954726 STRYKER ENDOSCOPY - STRYKER IRRIGATION TUBE SET K000493 CIRCON CORP - CIRCON SURGIFLEX WAVE TSUNAMI SUCTION IRRIGATION SYS K992126 GYRUS MEDICAL INC - GYRUS PLASMACISION LAPAROSCOPIC SPATULA K041633 ETHICON ENDO-SURGERY INC - ENSEAL LCJ TISSUE SEALER K101520 VALLEYLAB - LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER-DIVIDER K092879 ETHICON ENDO-SURGERY - ETHICON ENDO-SURGERY GENERATOR G-11 K101990 OLYMPUS MEDICAL SYSTEMS CORP - SURGICAL TISSUE MANAGEMENT SYS K111202 BIOZONE LABS, PITTSBURG, CA - 483, WARNING LTR, CO RESP, ETC 1/11 OSO BIOPHARMACEUTICALS MANUFACTURING LLC, FOI SERVICES INC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CTP/OD/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FOI SERVICES INC FOI SERVICES INC CENTER FOR TOBACCO PRODUCT SITE TOUR PROGRAM VISITS - RECS, SUMMARIES 7/1/11 TO 3/16/12 DAVOL INC - DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYS K003790 DAVOL INC - HYDRO-FLEX LI LAPAROSCOPIC IRRIGATION SYS K961224 2012-1074 Signature/ Requester Subject
Page 944 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/24/2012 2012-2235 2012-2236 2012-2237 2012-2238 2012-2239 2012-2240 2012-2241 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/27/2012 04/24/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2242 03/28/2012 04/25/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2243 03/28/2012 04/25/2012 2012-2244 03/28/2012 04/25/2012 2012-2245 2012-2246 2012-2247 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ KEN REID WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE GLADYS B TONKIN Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 2/27/12-3/2/12 FOI DAILY LOG 3/5-9/12 FOI DAILY LOG 3/5-9/12 FOI DAILY LOG 3/5-9/12 FOI DAILY LOG 2/27/12-3/2/12 DEBRA L COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 3/5-9/12 FOI SERVICES INC DEBRA COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 2/27/12-3/2/12 FOI SERVICES INC FOI DAILY LOG 3/5-9/12 OC/OM/OMP/DDM/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ WILCOX 0955193, RAS TORREY ZACH ROTHSTEIN ZACH ROTHSTEIN FOI DAILY LOG 2/27/12-3/2/12 DKT 2006P-0068, DKT & DKT LOG OF 1978N-0065 FOI SERVICES INC JULIE PEAK INTERCON CHEMICAL CO VEGAN DIET FOR INMATES Action Office Signature/ Requester FOI SERVICES INC Subject ALBUQUERQUE, NM - EIR, 483, WARNING LTR, ETC 8/1116/11 BIOZONE LABS, PITTSBURG, CA - CO RESP, CORR 4/2228/09 B & G LABS, ST LOUIS, MO - WARNING LTRS
Page 945 of 1132

Total Records: 12455 Control # 2012-2248 2012-2249 2012-2250 2012-2251 Recd Date / Due Date 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 2012-2252 03/28/2012 04/25/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2253 2012-2254 03/28/2012 04/25/2012 03/28/2012 04/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2255 03/28/2012 04/25/2012 CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SEAN DUNAGAN JUDICIAL WATCH LARIAM, MEFAQUIN (MEFLOQUINE) - VAERS FDA/OMPT/CDRH/OCER/DFOI/ ANNA DEMKOVIC ABBOTT LABORATORIES, INC. RACHEL DEPOMPA WWBT/NBC12 METHYLPHENIDATE & METHADONE MIX-UPS BY PHARMACIES SINCE 1995 - RECS BIOPORTO - NGAL TEST CORR, MINS, RECS, ETC Signature/ Requester LISA TARRISON-SCHRAMP CanReg, Inc. LISA LARRISON-SCHRAMP CanReg, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. THOMAS E CRENNEY THOMAS E CRENNEY & ASSOCIATES LLC TRINA M MCPHERSON GREEN & GREEN BRUNTON DAIRY, BEAVER COUNTY, PA - RECS 1/11 TO PRESENT EXCEDRIN MIGRAINE - AERS, RECALLS, FINDINGS OF INVESTIGATION, ETC 1/11 TO PRESENT FOI DAILY LOG 2/27/12-3/2/12 FOI DAILY LOG 3/5-9/12 Subject FOI DAILY LOG 3/27/12-3/2/12
Page 946 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2012-2256 2012-2257 2012-2258 2012-2259 2012-2260 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 2012-2261 03/28/2012 04/25/2012 2012-2262 2012-2263 2012-2264 2012-2265 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 03/28/2012 04/25/2012 2012-2266 03/28/2012 04/25/2012 2012-2267 03/28/2012 04/25/2012 2012-2268 03/29/2012 04/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ INC REGULATORY CONSULTING & SUBMISSIONS STEPHANIE BEBUSK DEROYAL CORPORATE PIONEER SURGICAL TECHNOLOGY - INTERVERTEBRAL FUSION DVC SYS K073177; PIONEER SURGICAL INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 2/27/12-3/2/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 3/5-9/12 FOI SERVICES INC LISA TARRISON-SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC WILLIAM A OLSON PHD Center for Regulatory Services, Inc. KEN REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 2/27/12-3/2/12 FOI DAILY LOG 3/5-9/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 FOI DAILY LOG 3/12-16/12 Signature/ Requester Subject
Page 947 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject TECNOLOGY INC - CROSSFUSE 11 1BF/VBR SYS K112496 2012-2269 2012-2270 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2271 2012-2272 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2273 2012-2274 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2275 2012-2276 03/29/2012 04/26/2012 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2277 2012-2278 03/29/2012 04/26/2012 03/29/2012 04/26/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHANIE DEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL CORPORATE GLOBAL (GLOBUS) MEDICAL INC - RISE SPACER K113447, PATRIOT SPACERS - K072970 MEDTRONIC SOFAMOR DANEK - CAPSTONE R SPINAL SYS K103731; MEDTRONIC SOFAMOR DANEK USA INC CAPSTONE SPINAL SYS K073291, MODIFICATION TO: CAPSTONE SPINAL SYS - K082732 ISRS 375073, 3781222, 3842799, ETC FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHANIE DEBUSK DEROYAL CORPORATE LISA CASTRO UCB INC DIFUSION TECHNOLOGIES - XIPHOS INTERBODY FUSION SYS K100042 LLAMICTAL XR (LAMOTRIGINE) - SBA, RVWS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHANIE DEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL STEPHANIE DEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL STEPHANIE BEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL CORPORATE SPINAL ELEMENTS INC - LUCENT K071724, MODIFICATION TO LUCENT K081968 STRYKER CORP - AVSALIGN PEEK SPACERS K093864, AVS ANTERIOR LARGE PEEK SPACERS K090166, AVS PL PEEK SPACERS K093704, ETC AMEDICA (NOW) US SPINE - PHANTOM PLUS CAGE SYS K082801 BIOMET (NOW) EBI LP - IBEX SPINAL SYS K091381; BIOMET SPINE - ZYSTON STRAIGHT SPACER SYS K112014; BIOMET SPINE (EBI LLC) - K110650 CUSTOM SPINE - PATHWAY K111774; CUSTOM SPINE INC PATHWAY K080281 DEPUY (NOW) JOHNSON & JOHNSON) - CONCORDE BULLET SPINAL SYS K110694, CONCORDE CURVE SYS K103743, CONCORDE BULLET CAGE SYS - K103488, ETC
2012-2279
03/29/2012 04/26/2012
GREG POWELL GlaxoSmithKline
2012-2280
03/29/2012 04/26/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LINDER, DAVID W
STUDY DETERMINED THAT 1,4 BUTANEDIOL CONVERTS TO GHB IN HUMANS
Page 948 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-2281 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2282 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2283 2012-2284 03/29/2012 04/26/2012 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2285 03/29/2012 04/26/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ ORA/NE-FO/NWE-DO/NWECB/ 2012-2286 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2287 2012-2288 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2289 03/29/2012 04/26/2012 2012-2290 2012-2291 03/29/2012 04/26/2012 03/29/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OSHC/OPD/ DIANE SCHULMAN DIANE SCHULMAN STEPHANIE DEBUSK DEROYAL CORPORATE FERMANDO VIGIL QUESTCOR PHARMS - H P ACTHAR GEL (REPOISTORY CORTICOTROPIN OR ADRENOCORITICOTROPIC HORMONE) CORR, RVWS MEDICAL CONCEPTS INC - INTERBODY FUSION SYS, K110659 LEGALY OF DMAA (1,3 DIMETHYLAMYLAMINE) AS A FDA/OMPT/CDRH/OCER/DFOI/ Doe J STEPHANIE DEBUSK DEROYAL CORPORATE MEDTRONIC SOFAMOR DANEK - CAPSTONE R SPINAL SYS K103731 & K073291; MODIFICATION TO CAPSTONE SPINAL SYS - K082732 INDIVIDUAL RECS GERRIE OLIVER DAVA PHARMACEUTICAL INC CLONMEL HEALTHCARE LTD, IRELAND - CHORTHALIDONE TABS ANDA 87-450 50 MG TABS, ANDA 87-451 25 MG TABS FERNANDO, VIRGIL USP LABS - OXYELITE PRO RECS, JACK3D FDA/OMPT/CDRH/OCER/DFOI/ JASON T SCHNEIDER JASON T SCHINEIDER PC DEAN A FERGUSSON OTTAWA HOSPITAL RESEARCH INSTITUTE C R BARD INC - BARD G2 FILTER SYS CORR, 510K, RPTS TO CONSUMERS, ETC BORTEZOMIB, GEFETINIB, ROTIGOTINE, ETC - PRECLNCL (ANIMAL) EFFICACY STUDIES GERRIE OLIVER DAVA PHARMACEUTICAL INC LEDERLE LABS, PEARL RIVER, NY - DOXEPIN CAPSULES, 50 MG, 75MG, 100 MG ETC, ANDA 71-673, ANDA 71-674, ANDA 71-675 ETC LAUREN D COHEN DONALD A SHAPIRO LTD BENLYSTA - AERS Signature/ Requester Subject
Page 949 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/26/2012 2012-2292 2012-2293 2012-2294 2012-2295 03/29/2012 04/26/2012 03/29/2012 04/26/2012 03/29/2012 04/26/2012 03/29/2012 05/23/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-2296 03/29/2012 04/26/2012 2012-2297 03/29/2012 04/26/2012 2012-2298 2012-2299 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2300 2012-2301 03/29/2012 04/26/2012 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2302 03/29/2012 04/26/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ LEVIN, R SHIITAKE-YA GOURMET SHIITAKE SLICES - NAMES OF FARMS, CHEMICAL SPRAYS, US DISTRIBUTORS, ETC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ NORA COLEMAN HAWORTH COLEMAN GERSTMAN LLC STEPHANIE DEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL CORPORATE STEPHANIE DEBUSK DEROYAL CORPORATE LAWRENCE C FARRAR RESODYNE CORPORATION NUVASIVE INC - COROENT XLR STANDALONE SYS, K100043; NUVASIVE COROENT NO-PROFILE SYS, K112561; NUVASIVE COROENT SYS, K071795 ADVANCED VERTEBRAL SOLUTIONS LLC - EXPRESS BFD, K100037 IND 14107 - SUBMISSION RECS, SAFETY/EFFECTIVENESS RECS, TRANSFER OF SAID INFO TO RESODYN'S APPL ORTHO DEVELOPMENT - VUSION(R) OS, K111965 POWERS & SANTOLA LLP, ALBANY, NY - RECS STEPHANIE DEBUSK DEROYAL CORPORATE SYNTHES SPINE - ORACLE SPACER (OPAL SPACER), K072791; SYNTHES T-PAL SPACER, K100089 FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ Action Office OC/COS/OL/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ STEPHANIE DEBUSK DEROYAL CORPORATE TAMRA BARRICK NEOGEN CORP STEPHANIE DEBUSK DEROYAL CORPORATE AVITAL VARLEV ALPHA BIO TEC LTD HANS BIOMED CORP, REPUBLIC OF KOREA - AERS, AUDITS, RECALLS, ETC Signature/ Requester FERNANDO VIGIL Subject SUPPLEMENT - PETITIONS, CMPLNTS, CONGRESSIONAL CORR K2M INC - ALEUTIAN IBF SYS, K082698 & K101302, ALEUTIAN SPACER SYS, K119843; ALEUTTIAN, K103169 ETC PEGASUS LABORTORIES, INC - PHENYLPROPANOLAMINE HCL NADA 141-324 LTRS ZIMMER (ABBOTT SPINE INC) - ARDIS SPACER, K073202
Page 950 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ 2012-2303 2012-2304 03/29/2012 04/26/2012 03/29/2012 04/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2305 03/29/2012 04/26/2012 2012-2306 03/29/2012 04/26/2012 2012-2307 03/29/2012 05/31/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2308 03/29/2012 04/26/2012 2012-2309 2012-2310 03/29/2012 04/26/2012 03/29/2012 04/26/2012 2012-2311 03/29/2012 04/26/2012 2012-2312 2012-2313 03/29/2012 04/26/2012 03/29/2012 04/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ OM/OMP/DODM/ OM/OMP/DODM/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/FLA-DO/FCB/ KRISTEN C GUNTER MACFARLANE FERGUSON & MCMULLEN RICARDO RONQUILLO NEUROGESX INC SUE MCGOVERN JUST LABEL IT ORGANIC VOICES ACTION FUND SUE MCGOVERN JUST LABEL IT ORGANIC VOICES ACTION FUND MARILYNN WHITNEY COVINGTON & BURLING LLP SIMI Z BOTIC DINSMORE & SHOHL LLP INDIVIDUAL RECS DKT FDA-2010-P-0491 DKT 1995N-0397 TAMPA JUICE SERVICE INC, TAMPA FL - FROZEN CONCENTRATED ORANGE JUICE ENTRY #032-0421151-4 ANALYTICAL RESULTS CORE RX PHARMA, TAMPA, FL - EIRS, 483S, WARNING LTRS, ETC 1/07 TO PRESENT DKT 1995N-0259 ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MATTHEW ERJAVEC PA NORA COLEMAN HAWORTH COLEMAN GERSTMAN LLC STRYKER ORTHOPEDICS - TIRDENT CERAMIC ACETABULAR SYS; TRIDENT ACETABULAR SYS; TRIDENT PSL ACETABULAR SHELLS, PMA STANDARDS INVACARE CORP - BED RAILS INVESTIGATION RECS FOI SERVICES INC INFUPHARMA LLC, HOLLYWOOD, FL - EIR, 483S, CORR 9/27/11 ORA/CE-FO/CHI-DO/CCB/ JOHN WALSH JAMES ALEXANDER CORP ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS MASON CHEMICAL CO, ARLINGTON HEIGHTS, IL - EIRS, 483S, RECALLS 8 FACTOR ANALYSIS DATA REGARDING THE 4/9/99 SCHEDULES OF CONTROLLED SUBSTANCES: PROPOSED PLACEMENT OF KETAMINE INTO SCHEDULE III Signature/ Requester Subject
Page 951 of 1132

Total Records: 12455 Control # 2012-2314 2012-2315 Recd Date / Due Date 03/29/2012 04/26/2012 03/29/2012 04/26/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2316 2012-2317 03/29/2012 04/26/2012 03/29/2012 04/26/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2318 03/29/2012 04/26/2012 2012-2319 03/29/2012 04/26/2012 2012-2320 03/29/2012 04/26/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2321 2012-2322 2012-2323 2012-2324 2012-2325 2012-2326 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ MICHAEL WEBER MICHAEL WEBER DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND 2012-1229 2012-1211 2012-1206 2012-1205 2012-1566 DKT FDA-2011-N-0842 SEWARD #973383, THADDAEUS H DENNIS W RAISCH UNIV OF MEXICO, COLLEGE OF PHARMACY THROMBOTIC THROMBOCYTOPENIC PURPURA - AERS FDA - PROGRAMS AND RECS ADRIENNE HOTCHKISS BOSTON SCIENTIFIC CORP BOSTON SCIENTIFIC CORP - ROTABLATOR ROTATIONAL ANGIOPLASTY SYS K970296 DAVID MCFARLAND FDA WEBVIEW/FERDIC INC LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED FOI REQUESTS 3/19-23/12 CLOSED FOI REQUESTS 3/19-23/12 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 3/19-23/12 Signature/ Requester Subject CLOSED FOI REQUESTS 3/19-23/12
Page 952 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/27/2012 2012-2327 2012-2328 2012-2329 2012-2330 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2331 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2332 03/30/2012 04/27/2012 2012-2333 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2334 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2335 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2336 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CHRISTINE LIVOTI BIOPHARM INSIGHT MERCK SHARP & DOHME - JANVIA, JANUMET NDA 22-044 POSTMARKETING STUDIES THAT RESULTED IN THE WARNING LTR CINDY HSU CINDY HSU MARCAINE HCL NDA 16-964 - CLNCL PHARMACOLOGY, BIOPHARMACETICS RVWS, CHEMISTRY RVWS, PHARM, TOXICOLOGY, ETC CINDY HSU CINDY HSU EXPAREL NDA 22-496 - CLNCL PHARMACOLOGY, BIOPHRMACEUTICS RVWS, CHEMISTRY RVWS, PHARM, TOXICOLOGY RVWS, ETC FDA/OMPT/CDRH/OCER/DFOI/ RANDOLPH L COOKE WASHINGTON REGULATORY SERVICES MARK STOVEKEN WISCONSIN ANALYTICAL & RESEARCH HAKKO SHOJI CO LTD - TUOHY EPIDURAL NEEDLES K961152 UPJOHN CO - CALDEROL (CALCIFEDIOL CAPS) NDA 18312, APRVL PKG DARREL MAAG SOUTHWESTERN RESEARCH INC PFIZER - PD-0332334 TRIALS & SAFETY STUDIES Signature/ Requester FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DARRELL MAAG SOUTHWESTERN RESEARCH INC jOHNSON & JOHNSON - R228060 TRIALS & SAFETY STUDIES 2012-1465 2012-1308 2012-1290 Subject
Page 953 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-2337 2012-2338 2012-2339 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 2012-2340 03/30/2012 04/27/2012 ORA/ ORA/ ORA/SW-FO/DEN-DO/COMP/ ORA/ ORA/ ORA/ORM/ ORA/ORM/ 2012-2341 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2342 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ CBER/OCTMA/DDOM/ALFB/ OC/OCC/ OC/OER/OPA/ 2012-2343 03/30/2012 04/27/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ SUSAN M SUTTER Elsevier Business Intelligence ONCOLOGIC DURGS A/C - TRAVEL INVOICES, PER DIEM EXPENSES, LODGING 6/28-29/11 SUSAN M SUTTER Elsevier Business Intelligence ROCHE/GENENTECH - AVASTATIN (BEVACIZUMAB) JANET WOODCOCK, DENISE ESPOSITO, JAYNE PETERSON, ETC CORR, MINS, CALENDAR ENTRIES, ETC JEFFREY A KRAWITZ STARK & STARK TEVA - SEASONIQUE BLACK BOX WARNINGS, AERS, CMPLNTS, ETC LADENHEIM, BENNETT EGG PRODUCING FACILITIES IN AL, AR, CA, CT, ETC INSPS Doe J FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ AFIA ASAMOAH COVINGTON BURLING LLP GILBERT WEINER ADVANCED PHARMA CR LLC INDIVIDUAL RECS CYTOCELL LTD/ RAINBOW SCIENTIFIC INC - DIAGNOSTIC TEST LTRS 11/11 TO 3/23/12 SFBC INTERNATIONAL INC - CORR, 483 10/19/05, 11/7/05 Signature/ Requester Subject
Page 954 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OM/OSS/OPILS/DFI/ 2012-2344 03/30/2012 04/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2345 03/30/2012 04/27/2012 2012-2346 2012-2347 2012-2348 2012-2349 2012-2350 2012-2351 2012-2352 2012-2353 2012-2354 2012-2355 2012-2356 2012-2357 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 03/30/2012 04/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ CBER/OCTMA/DDOM/ALFB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NYK-DO/NYDCB/ DIEDRICH, JOHN THOMAS MCGRATH AMRI BURLINGTON JOSEPH P SCHWARTZ LEERINK SWANN & CO DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC YU YANG RONGCHENG ZHENGHAI AQUATIC FOODS CO RONGCHENG ZHENCHAI AQUATIC FOODS CO LTD FROZEN PREPARED MACKEREL ENTRY #481-0167223-S/3/1 2012-1132 2012-1130 2012-1002 2012-989 2011-9579 2012-805 2012-964 ALTHEA TECHNOLOGIES INC, SAN DIEGO, CA - 483 MOST RECENT EXEMPLAR PAHRMACEUTICALS LLC - LEVADEX (DIHYDROERGOTAMINE) 483 2012-970 PDI, NY - EIRS, 483S, CO RESP, ETC MICHELLE RYBAK WAH SUN INTERNATIONAL INC - ENTRY #BRI 0061772-0 NOTICES OF REFUSAL, FDA ACTION, NOTICE OF ROANOKE TRADE SERVICES INC MARK/REDELIVER Doe J METHOTREXATE - LONG TERM DAMAGE Signature/ Requester Subject
Page 955 of 1132

Total Records: 12455 Control # 2012-2358 2012-2359 Recd Date / Due Date 04/02/2012 04/30/2012 04/02/2012 04/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2360 2012-2361 04/02/2012 04/30/2012 04/02/2012 04/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2012-2362 04/02/2012 04/30/2012 2012-2363 2012-2364 04/02/2012 04/30/2012 04/02/2012 04/30/2012 2012-2365 2012-2366 2012-2367 04/02/2012 04/30/2012 04/02/2012 04/30/2012 04/02/2012 04/30/2012 2012-2368 2012-2369 04/02/2012 04/30/2012 04/02/2012 04/30/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ TRONIC, ELAINE H ANDRENE HERON Roche Diagnostic Corporation FDA/OMPT/CDRH/OCER/DFOI/ TRONIC, ELAINE H FDA/OMPT/CDRH/OCER/DFOI/ TRONIC, ELAINE H INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS INTUITIVE ENDOSCOPIC INSTRUMENTS CONTROL SYS K990149 KARL STORZ - KSEA CLEARVISION LENS IRRIGATION SYS K013838 MEDTRONIC - NEW ONE TOUCH ULTRALINK BLOOD GLUCOSE METER K100130; ABBOTT - FREESTYLE NAVIGATOR; MINIMED - PARADIGM REAL TIME REVEL SYS, ETC PARKE-DAVIS/PFIZER - DILANTIN NDA 84-4227, NDA 84349, NDA 10-151, ETC; TARO - ANDA 40-521 ANDA 40-684, FDA/OMPT/CDRH/OCER/DFOI/ TRONIC, ELAINE H VYKOR MEDICAL - SURGICAL ACCESS SYS K060973 FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L COMM BTWN CDRH OMBUDSMAN & OTHER CDRH PERSONNEL - EMAILS, INTERNAL MEMOS, NOTES, ETC 2/14/12-3/30/12 XOMED - EDNO-SCRUB/ENDO-SCRUB 2 K982594 CDRH OMBUDSMAN - POSITION DESCRIPTION FOI SERVICES INC INFUPHARMA LLC, HOLLYWOOD, FL - EIRS, 483S, CO RESP, ETC 9/27/11 FOI SERVICES INC ORA/CE-FO/DET-DO/DCB/ FOI SERVICES INC DR SAMYA Z NASR, ANN ARBOR, MI - EIR, 483, CO RESP, ETC 11/11 DR ANDRE VETRUYEN, CAMPUS SINTVINCENTIUSZIEKENHUIS, ANTWERP, BELGIUM - 483 4/11 FOI SERVICES INC Action Office OC/OM/OMP/DDM/ Signature/ Requester DOREEN FRANK ENVISAGE CONSULTING LLC VALEANT INTERNATIONAL - ZOVIRAX (ACYCLOVIR) NDA 18-604 APRVL RECS 3/29/82 Subject OTC VOLS. 210296, 210297, 210298, ETC.
2012-2370
04/02/2012
JAY H HENDERSON
Page 956 of 1132

Total Records: 12455 Control # Recd Date / Due Date 04/30/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2371 04/02/2012 04/30/2012 2012-2372 04/02/2012 04/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NWE-DO/NWECB/ 2012-2373 2012-2374 04/02/2012 04/30/2012 04/02/2012 04/30/2012 2012-2375 04/02/2012 04/30/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OC/COS/OES/ OC/COS/OES/ 2012-2376 04/02/2012 04/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2377 04/02/2012 04/30/2012 2012-2378 2012-2379 04/02/2012 04/30/2012 04/02/2012 04/30/2012 ORA/ ORA/ ORA/SW-FO/DALDoe J FDA/OF/CFSAN/OCD/EOS/ BASF SE CMPLNT OM/OMP/DODM/ FOI SERVICES INC ISTA PHARMS - APPL FOR OPTHALMIC NON-STEROIDAL ANTI-INFLAMMATORY DRUG PRODS 2 CITIZEN PETITIONS 5/11/11 FCN 064 Doe J PROPYLTHLOURACIL (PTU) - APRVD LBLG ISSLER, MACKENZIE ISSLER, MACKENZIE FDA/OF/CFSAN/OCD/EOS/ LYNN P TORDO MS THOR SPECIALTIES INC ZENCA BIOCIDES - THRESHOLD OF REGULATION EXEMPTION #96-004 NON-CONFIDENTIAL RECS ARSENIC IN RISE & RICE PRODS - RFPS STUDY, STAKEHOLDERS RECS AT MEETINGS, SUMMARY OF FINDINGS, ETC 10/11 ARSENIC IN RICE - MEMOS, RPTS, COMMENTS, ETC 1/00 TO PRESENT; ARSENIC STANDARDS & HEALTH EFFECTS FOR ANY FEDERAL & STATE AGENCIES SCHEDULES, NOTES PRESENTATIONS, ETC 2010, 2011 DOWDA, STEPHAINE ORA/NE-FO/NWE-DO/NWECB/ LIANE LAROCHELLE DEKA RESEARCH & DEVELOPMENT CORP FRESENIUS MEDICAL CARE, WALTHAM, MA - EIRS 8/1/11 TO 2/29/12 MAP PHARMS - LEVADEX (DIHYDROEROTAMINE) 483, RESP LTR 3/12 Signature/ Requester JAY HENDERSON PLLC Subject AMNEAL - ANDA 40-765 AERS 1/06 TO PRESENT
Page 957 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office DO/COMPLIANCE/ 2012-2380 04/02/2012 04/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-2381 2012-2382 04/02/2012 04/30/2012 04/02/2012 04/30/2012 OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ 2012-2383 04/02/2012 05/14/2012 2012-2384 2012-2385 04/03/2012 05/01/2012 04/03/2012 05/01/2012 CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ OC/OM/OMP/DDM/ DOREEN FRANK ENVISAGE CONSULTING LLC BECCA CRITSER CGBT LLC MEDSEP CORP - MEDSEP FREEZING BAG BK980030 OTC VOLS. 180008,18009, 05AFM DAVID LEVINE R1 TECHNOLOGIES LLC SMITHS HEALTHCARE MANUFACTURING SA DE CV, CHICAGO, IL; OH; SMITHS MEDICAL ASD INC, GARY, IN EIRS, 483S 1/05 TO 10/10 LYNN P TORDO MS THOR SPECIALTIES INC JOSEPH COHEN SCOTT & SCOTT LLP WAGGIN TRAIN LLC, NESTLE PURINA PETCARE CO CHICKEN JERK DOG TREATS INVESTIGATION, CMPLNTS, ETC 1/07 TO PRESENT DKT 2006F-0058 KEVIN WISNIEWSKI NEWS CHANNEL 5 HRC MEDICAL CLINICS (HORMONE REPLACEMENT CENTER) - AMOR VIE HORMONE REPLACEMENT PELLETS INTERNAL COMM, APPLS, CMPLNTS, ETC 11/15/11 TO PRESENT Signature/ Requester Subject
Page 958 of 1132

Total Records: 12455 Control # 2012-2386 Recd Date / Due Date 04/03/2012 05/01/2012 2012-2387 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2388 04/03/2012 05/01/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ 2012-2389 2012-2390 04/03/2012 05/01/2012 04/03/2012 05/01/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2391 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2392 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2393 2012-2394 2012-2395 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS SUNRISE PHARMS, RAHWAY, NJ - EIR, 483, CO RESP 12/920/10 PROXI BIOMEDICAL, GALWAY, IRELAND - EIR, 483,CO RESP 7/20-23/09 LABORATORIOS JALOMA, GUADALAJARA, MEXICO - EIR, 483, CO RESP 9/26-29/11 WALTER E CHALKLEY THOMSON REUTERS DR NANCY OLIVIERI MD, TORONTO, ONTARIO,CANADA EIR, 483, CO RESP 7/6-10/09 WALTER E CHALKLEY THOMSON REUTERS PAX-ALL MANUFACTURING INC, MISSISSAUGA, ONTARIO, CANADA - EIR, 483, CO RESP 9/19-23/11 TONY CHEN FDAZILLA DONALD P COX Clinsmart NAPROXEN SODIUM TABS - AERS 7/11 TO 9/11 LIST OF 483S 2012 SUSAN KOHN ROSS MITCHELL SILBERBERG & KNUPP LLP ORE-CAL CORP; SUPERIOR SEAFOOD, KENTWOOD, MI HARVEST OF THE SEA FROZEN SHRIMP INVESTIGATION RECS; INDIVIDUAL RECS Action Office FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC JAY H HENDERSON JAY HENDERSON PLLC LEVAQUIN (LEVOFLOXACIN) NDA 20-634, NDA 20-635, NDA 21-721 - AERS, LBLG. POST-MARKETING SAFETY RVWS, ETC Subject CAERS 149322
Page 959 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2396 04/03/2012 05/01/2012 2012-2397 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2398 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2399 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2400 2012-2401 2012-2402 2012-2403 2012-2404 2012-2405 2012-2406 2012-2407 04/03/2012 05/01/2012 04/03/2012 05/14/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/17/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ CBER/OCTMA/DDOM/ALFB/ ORA/P-FO/SEA-DO/SCB/ R. CHRISTOPHER PRESTON SMITH HARTVIGSEN PLLC WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS WALTER E CHALKLEY THOMSON REUTERS ROTECH HEALTHCARE INC (CAREMED SOUTHAVEN MS) EIR, 483, CO RESP 9/10 CSL BEHRINGER, MARBURG, DEUTSCHLAND - EIR, 483S, CO RESP MOST RECENT IBA MOLECULAR, SOMERSET, NJ - EIR, 483, CO RESP 8/4/10-9/14/10 BIOGENESIS INC, HACKENSACK, NJ - EIR, 483, CO RESP 6/2310-8/5/10 H & P INDUSTRIES, LAWRENCEVILLE, NJ - EIR, 483,CO RESP 9/20/10-11/10/10 PIONEER SURGICAL TECHNOLOGY,MARQUETTE, MI - EIR, 483, CO RESP 12/7-21/10 RTI BIOLOGICS, ALACHUA, FL - EIR, 483, CO RESP 10/25/11 RANGEN INC - 483, CO RESP, WARNING LTR 2/10 WALTER E CHALKLEY THOMSON REUTERS FARMA QUIMIA SA DE CV, CUAMATLA CUAUTITLAN IZCALLI, MEXICO - EIR, 483 CO RESP 9/12-15/11 WALTER E CHALKLEY THOMSON REUTERS WINTAC LTD, BANGALORE, INDIA - EIR, 483, CO RESP 9/1220/11 ORA/CE-FO/CIN-DO/CCB/ DREW BARLOW VERTEX PHARMACEUTICALS INC WALTER E CHALKLEY THOMSON REUTERS PATHEON PHARMSACEUTICALS INC, CINCINNATI, OH - EIR 2/22-3/24/11 NOBILUS ENT, KUTNO, POLAND - EIR, 483, CO RESP 9/1215/11 Signature/ Requester Subject
Page 960 of 1132

Total Records: 12455 Control # 2012-2408 2012-2409 2012-2410 2012-2411 2012-2412 2012-2413 Recd Date / Due Date 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 ORA/CE-FO/BLT-DO/CB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2414 2012-2415 2012-2416 2012-2417 2012-2418 2012-2419 2012-2420 2012-2421 2012-2422 2012-2423 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/14/2012 04/03/2012 05/02/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 05/01/2012 04/03/2012 FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/PHI-DO/PCB/ WALTER CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS MERCK SHARP & DOHME CORP, NORTH WALES, PA - EIR, 483, CO RESP MOST RECENT GABRIEL PEREZ LASALA MD, TCA CELLULAR THERAPY LLC, COVINGTON, LA - EIR, 483, CO RESP 2/22-3/31/11 SANQUIN PLASMA PRODUCTS, AMSTERDAM, NETHERLANDS - EIR, 483, CO RESP 9/19-28/11 THORATEC CORP, PLEASANTON, CA - EIR, 483, CO RESP 8/22-9/7/11 WARNER CHILCOTT CO LLC, ROCKAWAY, NJ - EIR, 483, CO RESP 6/22-29/11 INTELLICELL BIOSCIENCES INC, NEW YORK, NY - EIR, 483, CO RESP 11/8-12/12/11 SPINAL SOLUTIONS LLC, MURRIETA, CA - EIR, 483, CO RESP 7/11-9/15/11 APP PHARMS, GRAND ISLAND, NY - EIR, CO RESP 6/137/8/11 REGENERON PHARMS, RENSSELAER, NY - EIR, CO RESP 3/23-31/10 CYMBALTA (DULOXETINE HYDROCHLORIDE) - AER, ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SEA-DO/SCB/ Action Office ORA/P-FO/SEA-DO/SCB/ Signature/ Requester WALTER E CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS WALTER E. CHALKLEY THOMSON REUTERS Subject HOLLISTER STIER LABS, SPOKANE, WA - EIR, 483, CO RESP 1/13/09 HOLLISTER STIER LABS, SPOKANE, WA - EIR, 483, CO RESP 5/28/10 NAVILYST MEDICAL INC, GLEN FALLS, NY - EIR, 483, CO RESP 9/8-21/09 NAVILYST MEDICAL INC, GLEN FALLS, NY - EIR, 483, CO RESP 5/10 ELMORE ALEXANDER DO, - EIR, 483, CO RESP 11/13/0910/20/10 GULF PHARMACEUTICAL INDUSTRIES, DIGDAGA AREA RAS AL KHAIMAH, UNITED ARAB EMIRATES - EIR, 483, CO RESP 9/25-10/3/11
Page 961 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/01/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2424 04/03/2012 05/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2425 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2426 04/03/2012 05/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2427 2012-2428 2012-2429 2012-2430 2012-2431 2012-2432 2012-2433 2012-2434 2012-2435 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/BLT-DO/CB/ DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC JOHNATHAN RICKMAN FDA NEWS H&H ASSOCIATES, ORDINARY, VA, CREATIVE TECHNOLOGIES INC, CHESAPEAKE, VA - 483S 1/1-31/12 2011-9192 2011-9005 2011-8627 2011-7611 2012-1642 2012-1645 2012-1393 2012-1113 ANGELIA D. SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS APP PHARMS - OXYTOCIN NDA 18-248 ANGELIA D. SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ROBERTS PHARMS- DOXOFYLLINE APRVL, MEDICAL RVW, CHEMISTRY RVW, LBLG 1988 TO 1998 MICHAEL R. HAMRELL, Ph.D. MORIAH CONSULTANTS MERCY MEDICAL CTR-DES MOINES IRC, DES MOINES, IA EIR, 483 11/13/08 Signature/ Requester JAY HENDERSON PLLC Subject SAFETY RVW, LBLG
Page 962 of 1132

Total Records: 12455 Control # 2012-2436 Recd Date / Due Date 04/04/2012 05/02/2012 2012-2437 04/04/2012 05/02/2012 2012-2438 04/04/2012 05/02/2012 2012-2439 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2440 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2441 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-2442 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2443 2012-2444 2012-2445 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ DIANE B MCGINNESS ALLSTATE INSURANCE CO DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC 2011-9015 2011-8917 RS MEDICAL, VANCOUVER, WA - EIRS 1/06 TO 12/31/11 BECKUM, LISA HYDROXCHLOROQUINE RESTASIS (CYCLOSPORINE) OPHTHALMIC EMULISON) - RECS JEANNE DOUKAS GOLDBERG SIMPSON RHBMP-2 - AERS 1/02 TO PRESENT SEPHY PHILIP PHARMD SCIENTIFIC EXCHANGE LLC TEVA PHARMS, PADDOCK LLC - HYDROCORTISONE RECTAL ENEMA 100 MG, 60 ML ANDA 74-17, ANDA 75-172 SBA Action Office ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ M ELIZABETH BIERMAN MORGAN LEWIS COUNSELORS AT LAW MEINDA K PLAIKSER WASHINGTON ACTION FOR SAFE WATER FLUORIDE (SODIUM FLUORIDE OR SILLICOFLUORIDES) QUESTIONS PALOMAR MEDICAL TECHNOLOGIES INC - K111840 Signature/ Requester JOHNATHAN RICKMAN FDA NEWS MARTHA GUZMAN AMSINO INTERNATIONAL INC Subject QUADRANT CHEMICAL CORP, GARLAND, TX, NEURO RESOURCE GROUP INC, PLANO, TX, ORTHOFIX INC, LEWISVILLE, TX, ETC - 483S 1/1-31/12 MEDLINE - SILVERTOUCH 100% SILICONE FOLEY CATHETER K052168
Page 963 of 1132

Total Records: 12455 Control # 2012-2446 2012-2447 2012-2448 2012-2449 2012-2450 2012-2451 2012-2452 2012-2453 Recd Date / Due Date 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2454 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2455 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ 2012-2456 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2457 04/04/2012 ORA/CE-FO/DET-DO/DCB/ TIM SULOLLI DR MARLO CORACI, MACOMB, MI - RECALL LTRS, LOT MARK FRANZEN PRECISION DOSE INC RISPERIDONE ORAL SOLUTION ANDA 76-797 SUBMISSION LOVKO, RAE KENDALL - Q-TRACE ECG TABS AERS RACHEL DePOMPA WWBT/NBC12 METHYLPHENIDATE; METHADONE PHARMACY ERRORS SINCE 1995 Signature/ Requester DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAVID McFARLAND FDA WEBVIEW/FERDIC INC DONALD P. COX Clinsmart ALEVE OTC NDA 20-204 2010-6977 2012-1056 2012-1475 2012-1219 2010-5814 2011-7886 Subject 2011-9521
Page 964 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/04/2012 2012-2458 04/04/2012 05/02/2012 2012-2459 04/04/2012 06/08/2012 2012-2460 2012-2461 04/04/2012 05/02/2012 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2462 2012-2463 04/04/2012 05/02/2012 04/04/2012 05/02/2012 ORA/OCI/ ORA/OCI/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ 2012-2464 04/04/2012 05/02/2012 2012-2465 04/04/2012 05/02/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/NE-FO/NYK-DO/NYDCB/ 2012-2466 04/04/2012 05/02/2012 CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2467 04/04/2012 05/02/2012 ORA/CE-FO/CIN-DO/CCB/ JOHNATHAN RICKMAN FDA NEWS FERRO CORP, CLEVELAND, OH; SCOTTCARE CORP, CLEVELAND, OH; CLEVELAND HEARTLAB INC, CLEVELAND, OH - 483 1/12 MARILYNN WHITNEY COVINGTON & BURLING LLP LIST OF TOBACO PRODS WHICH HAVE BEEN ISSUED A SUBSTANTIAL EQUIVALENCE ORDER FOR APPLICATIONS SUBMITTED TO SECTION 905 OF THE FEDERAL FOOD, DRUG, & COSMETIC ACT - AERS FDA/OF/CFSAN/OCD/EOS/ WEI WEI TIANJIN GOURMET SELECT FOOD CO LTD YU YANG RONGCHENG ZHENGHAI AQUATIC FOODS CO FROZEN PREPAIRED MACKEREL - IMPORT REFUSAL RPT 1/24/12 FFR 11997439292, FEI 3006330759 ANDERSON, MIKE PROFESSOR LISA HEINZERLING GEORGETOWN UNIVERSITY LAW CENTER PUBLIC HEARING ON AMMONIUM HYDROXIDE TRANS FEDERAL REGISTER (FR) 34219 1974 PHONE INTERVIEW WITH JEFF NOVITZKY WOOSTER, ANNALEE Action Office ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ ORA/NE-FO/NYK-DO/NYDCB/ OC/OCC/ FDA/OF/CFSAN/OCD/EOS/ MARSHALL P LEVINE SOROS FUND MANAGEMENT MEDICIS - DYSPORT AER GNC HOLDINGS - DMAA RECS MITCHELL LS FUERST FUERST ITTLEMAN PL INTELLCELLL BIOSCIENCES INC - CBER ADMINISTRATIVE ENFORCEMENT ACTION IN WARNING LTRS 12/01, EIRS, 483S, ETC 3/13/12 KUSTKA, DENISE Signature/ Requester GOODMAN ACKER PC Subject NUMBERS 2/1/10 TO 2/1/12 CMPLNT
Page 965 of 1132

Total Records: 12455 Control # 2012-2468 2012-2469 2012-2470 2012-2471 2012-2472 Recd Date / Due Date 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/04/2012 05/02/2012 ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2473 04/04/2012 05/02/2012 2012-2474 04/04/2012 05/02/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SEA-DO/SCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2475 04/04/2012 05/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2476 2012-2477 2012-2478 04/04/2012 05/02/2012 04/04/2012 05/02/2012 04/05/2012 05/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ 2012-2479 04/05/2012 OM/OSS/OPILS/DFI/ BOBBY SCHOCHET 2012-2183 - REQUEST LTR FDA/OMPT/CDRH/OCER/DFOI/ ARDAUGH, BRENT M LUCY A. DALGLISH REPORTERS COMMITTEE TERESA GREEN NATIONAL CONSUMERS LEAGUE NU VAL NUTRITION RATING SYS, OVERALL NUTRITIONAL QUALITY INDEX - RECS 2004 TO PRESENT 10 OLDEST PENDING REQUESTS K922276, K837347, K837152 ELIZABETH A. KURTZ HEWITT WOLENSKY LLP LISTERINE ANTISEPTIC - CMPLNTS, AER 1987 TO PRESENT Doe J OM/OMP/DODM/ ANGELIA D. SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS 2011-7930 DKT FDA-2012-N-171 ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ Action Office ORA/SW-FO/DEN-DO/COMP/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS GERLAD J. OREHOSTKY ANTARES PHARMA INC INSP FOR DEVICE MANUFACTURING, CLNCL TRIAL FACILITIES IN US 3/12 HUZHOU ZHANWANG PHARMACEUTICAL CO LTD WARNING LTR, EIR, CO RESP Subject AMGEN INC, LONGMONT, CO; AMGEN INC, BOULDER, CO; FMC CORP, GREEN RIVER, WY - 483 1/12 MONITOR INSTRUMENTS INC, HILLSBOROUGH, NC; UNISPLINT CORP, BUFORD, GA - 483 1/12 SAGEMAX BIOCERAMICS INC, AUBURN, WA - 483 1/12
Page 966 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/03/2012 2012-2480 2012-2481 2012-2482 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ Signature/ Requester OLSSON FRANK WEEDA TERMAN MATZ PC JARED MACCLEARY CROWELL & MORING DAVID MCFARLAND FDA WEBVIEW/FERDIC INC PATTY LOVERA Food & Water Watch SADEX CORP - CORR; FOOD ADDITIVE PETITION (ANIMAL USE) ELECTRON BEAM AND X-RAY SOURCES FOR IRRADIATION OF POULTRY FEED AND POULTRY FEED INGREDIENTS 2012-1104 2012-1124 2012-1129 B BRAUN MEDICALINC - PS100006 INITIAL ORDER LTR 7/10, STUDY PROTOCOL, STUDY RPT 2012-1207 2012-1240 DKT 1980N-0042 2012-1210 2012-1633 CBER A/C WEBCAST - PRODUCTION COSTS, 508 COMPLIANCE, NETWORK RECS, ETC 2012-1372 CVM FOI REQUESTS 3/12 Subject
2012-2483 2012-2484 2012-2485 2012-2486 2012-2487 2012-2488 2012-2489 2012-2490 2012-2491 2012-2492
04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/
DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC LEX J PEARCE ICU MEDICAL INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC NANCY MARCHANT LUBRIZOL CORP DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC ALEX VEIZIS FDALIVE.COM
2012-2493
04/05/2012 05/03/2012
ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/
AMCOL HEALTH & BEAUTY SOLUTIONS INC, LAFAYETTE, LA; TITEREK INSTRUMENTS INC, HUNTSVILLE, AL; LEISURE PRODUCTS INC, KINGSPORT, TN, ETC - 483S 1/1-31/12
Page 967 of 1132

Total Records: 12455 Control # 2012-2494 Recd Date / Due Date 04/05/2012 05/03/2012 2012-2495 04/05/2012 05/03/2012 2012-2496 04/05/2012 05/03/2012 2012-2497 04/05/2012 05/03/2012 2012-2498 04/05/2012 05/03/2012 ORA/NE-FO/NWE-DO/NWECB/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS AMANDA ORLANDO AVALON RISK MANAGEMENT INC JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS INVAGEN PHARMACEUTICALS INC, HAUPPAUGE, NY; ARCH CHEMICALS, ROCHESTER, NY; CONTRACT PHARMACAL CORP, HAUPPAGE, NY, ETC - 483S 1/1-31/12 BIO DATA CORP, HORSHAM, PA; ZOLL LIFECOR CORP, PITTSBURGH, PA; CUSTOM ULTRASONICS INC, IVYLAND, PA - 483S 1/1-31/12 SHIRE HUMAN GENTICS THERAPIES INC, CAMBRIDGE, MA; EXEMPLAR PHARMACEUTICALS LLC, FALL RIVER, MA; IMMUEX RHODE ISLAND CORP, WEST GEENWICH, RI, ETC - 483S 1/1-31/12 ROCKLINE INDUSTRIES INC, SHEBOYAN, WI; NATIONAL CREATIVE ENTERPRISES INC, BURNSVILLE, MN; AD-TECH MEDICAL INSTRUMENT CORP, RACINE, WI, ETC - 483S 1/131/12 HOSPIRA INC, MCPHERSON, KS; NOVARTIS CONSUMER HEALTH, LINCOLN, NE - 483S 1/1-31/12 MEDIAGNOST GMBH, REULINGEN, GERMANY; ITEM INDUSTRIES LTD, SHENZHEN, GUANGDONG, CHINA; COPAN ITALIA, BRESCIA, ITALY, ETC - 483S 1/1-31/12 APPLIED LABORATORIES INC, COLUMUS, IN; ROYAL OAK MEDICAL DEVICES LLC, OXFORD, MI; ACUMEDIA MANFACTURERS INC, LANSING, MI, ETC - 483S 1/1-31/12 MEDOP INC, OLDSMAR, FL; CERAGROUP INDUSTRIES INC, FORT LAUDERDALE, FL; CHAMCO INC, LAUDERDALE, FL, ETC - 483S 1/1-31/12 LIPITOR (ATORVASTATIN), LESCOL (FLUVASTATIN), CRESTOR (ROSUVASTATIN), ETC - AERS 1/1/12-3/27/12 Subject LIBBY LABORATORIES INC, BERKELEY, CA; CELERA CORP, ALAMEDA, CA; CEPHEID, SUNNYVALE, CA, ETC - 483S 1/131/12 ENTRY #AZO00448054 - NOTICE OF FDA ACTION #1
2012-2499
04/05/2012 05/03/2012
2012-2500 2012-2501
04/05/2012 05/03/2012 04/05/2012 05/03/2012
ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/
2012-2502
04/05/2012 05/03/2012
2012-2503
04/05/2012 05/03/2012
2012-2504
04/05/2012 05/03/2012
RITA F REDBERG MD UNIV OF CALIFORNIA SAN FRANCISCO
2012-2505
04/05/2012 05/03/2012
ESTEVE HUAYI PHARMACEUTICAL CO LTD, SHAOXING, CHINA; SANDOZ PRIVATE LTD, NAVI MUMBAI, INDIA; S A AJINOMOTO OMICHEM NV - LOVAIN LA NEUVE, BELGIUM, ETC - 483S 1/1-31/2
Page 968 of 1132

Total Records: 12455 Control # 2012-2506 Recd Date / Due Date 04/05/2012 05/03/2012 2012-2507 04/05/2012 05/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2508 04/05/2012 05/03/2012 ORA/CE-FO/NJ-DO/NJCB/ JOHNATHAN RICKMAN FDA NEWS MYCONE DENTAL SUPPLY CO INC, CHERRY HILL, NJ; CASE MEDICAL, SOUTH HACKENSACK, NJ; GLAXOSMITHKLINE CONSUMER HEALTHCARE LP, CLIFTON, NJ, ETC - 483S 1/1-31/12 FCN 140 - CHEMISTRY, TOXICOLOGY, ENVIRONMENTAL RVWS NOVARTIS - SYNACTHEN, SYNACTHEN DEPOT (SYNACTHEN)- APRVL PKG, APRVL, WITHDRAWL Action Office ORA/P-FO/LOS-DO/LACB/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS MARTIN S MASAR KATTEN MUCHIN ROSENMAN LLP Subject 3M DRUG DELIVERY SYSTEMS, NORTHIDGE, CA; LEE PHARMACEUTICALS INC, SOUTH EL MONTE, CA; NUTRI GRANULATIONS, LA MIRADA, CA, ETC - 483S 1/1-31/12 LUMIGAN (BIMATOPROST OPHTHALMIC SOL) NDA 21-275 RECS
2012-2509 2012-2510
04/05/2012 05/03/2012 04/05/2012 05/03/2012
GEORGE SADLER PHD PROVE IT LLC BRADLEY J SHISLER CPMG INC
2012-2511
04/05/2012 05/03/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LAROCCA, PAT
SUCAMPO PHARMA AMERICAS - AMITIZA NDA 21-908/S008 CLNCL STUDIES, RVWS, NDA FORMS, ETC
2012-2512
04/05/2012 05/03/2012
WILLIAM R COLE TECHNICAL INC
STAPHYLOCOCCUS AUREUS GROWTH AND TOXIN FORMATION PERTINENT TO THE CLEANING, LOINING AND PACKING STEPS IN A FROZEN LOIN/CANNED TUNA PROCESSING FACILITY - RECS MICROMAXX HIGH-RESOLUTION ULTRASOUND SYS K053069
2012-2513
04/05/2012 05/03/2012
FRANCES RICHMOND PHD UNIV OF SOUTHERN CALIFORNIA SCHOOL OF PHARMACY
2012-2514 2012-2515
04/05/2012 05/03/2012 04/05/2012 05/03/2012
SHERYL HIGGINS DENTIUM USA RAJAN EMBRAN JUBILANT CADISTA PHARMACEUTICALS INC
MEGAGEN CO LTD - RESCUE INTERNAL IMPLANT SYS K073058, K063216; RESCUE IMPLANT SYS K053353 WARNER CHILCOTT - ACTONEL (RISEDRONATE SODIUM) TABS NDA 20-835 SBA
2012-2516
04/05/2012
NORBERT GOTTESMAN
EXEMPLAR PHARMS, EXEMPLAR PHARMA LLC, FALL
Page 969 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/03/2012 2012-2517 2012-2518 2012-2519 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 2012-2520 2012-2521 2012-2522 2012-2523 2012-2524 2012-2525 2012-2526 2012-2527 2012-2528 2012-2529 2012-2530 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/05/2012 05/03/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 2012-2531 04/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MATT CLAUSEN MEDLINE INDUSTRIES INC JONATHAN C WILK THERMO FISHER SCIENTIFIC JONATHAN C WILK THERMO FISHER SCIENTIFIC JONATHAN C WILK THERMO FISHER SCIENTIFIC JONATHAN C WILK THERMO FISHER SCIENTIFIC JONATHAN C WILK THERMO FISHER SCIENTIFIC DAIVE MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS ANGELIA D SLAYTON K103560 K091496 2010-4246 2012-67 2011-9206 WATERS TECHNOLOGIES CORP, WYTHENSHAWE, UK EIRS, 483S AGILENT TECHNOLOGIES, WALDBRONN, GERMANY - EIRS, 483S WATERS TECHNOLOGIES IRELAND LTD, DRINAGH, IRELAND - EIRS, 483S 2012-935 AGILENT TECHNOLOGIES, SINGAPORE - EIRS, 483S MERIDIAN MEDICAL SYSTEMS - BREATHING FILTER K025217 WATERS CORP, MILFORD, MA - EIRS, 483S LOFGREN, DON FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office Signature/ Requester AVET CAPITAL MANAGEMENT LLC MATT MORTENSEN PHD CARDIOCOM LLC NARGES GHAZI CITY COLLEGE OF NEW YORK Subject RIVER, MA - EIRS, 483S HONEYWELL HOMMED LLC - GENESIS TOUCH SYS K112858 NEURONETICS INC - NON-INVASIVE, NON-SYSTEMIC TREATMENT FOR DEPRESSION CLNCL TRIAL RECS 3M - FILTERING FACEPIECE RESPIRATOR K062070 GUIDANCE FOR INDUSTRY RECS
Page 970 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/04/2012 2012-2532 2012-2533 04/06/2012 05/04/2012 04/06/2012 05/04/2012 ORA/CE-FO/PHI-DO/PCB/ THOMPSON, RAY Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester INC REGULATORY CONSULTING & SUBMISSIONS BARBARA LIPPERT GLYDE USA INC ASTRAZENCA PHARMACEUTICAL LP, NEWARK, DE 6/27/117/5/11; APTER INDUSTRIES INC, MCKEESPORT, PA 6/30/117/5/11; BOEHRINGER LABORATORIES INC, PHOENIXVILLE, PA 10/24/11-11/7/11, ETC - 483S ACUTE INNOVATIONS LLC, HILLBORO, OR 10/13-21/11; INOVISE MEDICAL INC, BEAVERTON, OR 4/27/11-6/1/11; CASCADIA MANUFACTURING INC (ORAMELTS CORP), BELLEVUE, WA 8/24/11-9/7/11, ETC - 483S CHEM-TECH LTD, PLEASNTVILLE, LA 10/18-19/11; HERITAGE LABS INTERNATIONAL LLC, OLATHE, KS 6/1317/11; CHEMISPHERE CORP, SAINT LOUIS, MO 9/7-16/11, ETC - 483S AUGUSTA MEDICAL SYSTEMS LLC, AUGUSTA, GA 9/1923/11; OPHTHAL MED LLC, ROSWELL, GA 7/27/11-8/2/11; PRIME TENHNOLOGICAL SERVICES, SUWANEE, GA 12-512/11, ETC - 483S ABBOTT LABS, ABBOTT PARK, IL 7/11-15/11; ACQUAMED TECHNOLOGIES INC, WEST CHICAGO, IL 5/24/11-6/6/11; CORPAK MEDSYSTEMS, WHEELING, IL 5/3/11-7/8/11, ETC 483S EV3 INC, PLYMOUTH, MN 8/4-24/11; LIFECORE BIOMEDICAL LLC, CHASKA, MN 7/13-21/11; ALLIANCE PACKAGING GROUP INC, SAUKVILLE, WI 12/15-21/11, ETC - 483S ONE INC - ONE PERSONAL LUBRICANT (SILICONE) K110690 K091769 Subject
2012-2534
04/06/2012 05/04/2012
ORA/P-FO/SEA-DO/SCB/ THOMPSON, RAY
2012-2535
04/06/2012 05/04/2012
ORA/SW-FO/KAN-DO/COMP/ THOMPSON, RAY
2012-2536
04/06/2012 05/04/2012
ORA/SE-FO/ATL-DO/ACB/ THOMPSON, RAY
2012-2537
04/06/2012 05/04/2012
ORA/CE-FO/CHI-DO/CCB/ THOMPSON, RAY
2012-2538
04/06/2012 05/04/2012
ORA/CE-FO/MIN-DO/MCB/ THOMPSON, RAY FDA/OMPT/CDRH/OCER/DFOI/ ALAN EVANS WESTRIDGE LABORATORIES INC ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ Doe J NARGES GHAZI CITY COLLEGE OF NEW YORK KATHERINE STRONG CARNER SIDLEY AUSTIN LLP SANDRA BARTLETT NATIONAL PUBLIC RADIO
2012-2539
04/06/2012 05/04/2012
2012-2540
04/06/2012 05/04/2012
INDIVIDUAL RECS
2012-2541 2012-2542 2012-2543
04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012
NEURONETICS INC - PON SYSTEMIC TREATMENT IDE, PMA APPL CDRH UNTITLED LTRS LAST 5 YRS IMPORTED TISSUE PRODUCT CODES 57JH01, 57JH02, 57JI03, ETC - COUNTRY OF ORIGIN, VALUE OF GOODS,
Page 971 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-2544 2012-2545 2012-2546 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2547 04/06/2012 05/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2548 04/06/2012 05/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2549 04/06/2012 05/04/2012 2012-2550 04/06/2012 05/04/2012 ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SWFO/SWID/COMPLIANCE/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-2551 2012-2552 2012-2553 04/06/2012 05/31/2012 04/06/2012 05/04/2012 04/06/2012 OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ SANDRA BARLETT NATIONAL PUBLIC RADIO COREY PHELPS PHD HEC PARIS JHO1-FASCIA, JHO2 - CARTLAGE, JHO - BONE, ETC DEVIATION RPTS 1/02 TO PRESENT ESTABLISMENT REGISTRATION & DVS LISTING, PROD RECALLS, PMA, ETC 1995 TO 2012 DKT 1995S-0316 JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL MICHELLE RYBAK ROANOKE TRADE SERVICES INC PROFESSIONAL DISPOSABLE INC, ORANGEBURG, NY WIPES TEST RESULTS 9/11 TO 10/11 NOTICES OF REFUSAL/MARK/REDELIVER - ENTRY BYX 0039009-D ALICE CHEN UNIV OF CHICAGO BOTH SCHOOL OF BUSINESS DRUG SHORTAGES - NDC 1/99 TO 12/09 ELI D EHRENPREIS MD ACCUTANE - ISR 5752495, 6023192, 6023920, ETC EDWARDS, SANDRA FDA/OMPT/CDRH/OCER/DFOI/ BASNETT, JEANNA LEVOFLOXACIN, MOXIFLOXACIN - AERS FDA/OMPT/CDRH/OCER/DFOI/ SIDLEY AUSTIN LLP PEAK MOTUS MOTION MEASUREMENT - K030714 CDRH UNTITLED LTRS, INQUIRY LTRS, CORR LAST 5 YRS Signature/ Requester Subject UNIT OF MEASURE, ETC
Page 972 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/04/2012 2012-2554 2012-2555 2012-2556 2012-2557 2012-2558 2012-2559 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 OM/OMP/DODM/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2560 04/06/2012 05/04/2012 2012-2561 04/06/2012 05/04/2012 ORA/CE-FO/BLT-DO/CB/ THOMPSON, RAY ORA/SE-FO/SJN-DO/SJCB/ THOMPSON, RAY ETHICON LLC, SAN LORENZO, PR 9/27/11-11/15/11; BAXTER HEALTHCARE COR, JAYUYA, PR 10/24/11-11/3/11; CORDIS LLC, SAN GERMAN, PR 8/9-16/11, ETC - 483S ACTION PRODUCTS INC, HAGERSTOWN, MD 8/4-9/11; AVANZA LABORATORIES LLC, GAITHERSBURG, MD 7/1127/11; KNOLL MEDICAL LLC, ANNAPOLIS, MD 10/12-20/11, ETC - 483S ASI MEDICAL INC, CENTENNIAL, CO 12/19-22/11; SANDHILL SCIENTIFIC INC, LITTLETON, CO 6/27/11-7/6/11; BIOMERIDIAN INTERNATIONAL INC, SALT LAKE CITY,UT 11/10-22/11, ETC - 483S BRISTOL-MYERS SQUIBB COMPANY INC, MOUNT VERNON, IN 10/24-28/11; DEPUY ORTHOPAEDICS INC, WARSAW, IN 5/10/11-6/7/11; SIGMA-TAU PHARMASOURCE INC, INDIANAPOLIS, IN 5/7/11-6/7/11, ETC - 483S DEEPWATER CHEMICALS INC, WOODWARD, OK 8/29/119/6/11; EAGLE DIAGNOSTICS INC, CEDAR HILL, TX 10/1114/11; HEALTHTRONICS INC, AUSTIN, TX 10/11-19/11, ETC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OSS/OEEODM/ Doe J MARIAN S ROSEN MARIAN S ROSEN & ASSOCIATES LISTERINE MOUTHWASH - CMPLNTS FDA/OMPT/CDRH/OCER/DFOI/ BASNETT, JEANNA JONEL ALECCIA MSNBC FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ Doe J BRADLEY C BHROW ZIMMERMAN REED PLLP STANDARD IDENITY FOR YOGURT - 21 RESP OBJECTIONS FILED CHARNWOOD DYNAMICS LTD - CODA CX1 MOTION ANALYSIS SYS K033514 PACIFIC DISPOSABLES INTERNATION INC, ORANGEBURG, NY - 483S 8/11 TO PRESENT INDIVIDUAL RECS Action Office Signature/ Requester YATES, RANDAL W SOY - RECS Subject
2012-2562
04/06/2012 05/04/2012
ORA/SW-FO/DEN-DO/COMP/ THOMPSON, RAY
2012-2563
04/06/2012 05/04/2012
ORA/CE-FO/DET-DO/DCB/ THOMPSON, RAY
2012-2564
04/06/2012 05/04/2012
THOMPSON, RAY
Page 973 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester Subject 483S 2012-2565 04/06/2012 05/04/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ THOMPSON, RAY VINTAGE PHARMACEUTICALS LLD (QUALITEST PHARMS), HUNTSVILLE, AL 11/2911/12/7/11; CAGENIX, MEMPHIS, TN 8/9-16/11; AOSS MEDICAL SUPPLY INC, MONROE, LA 8/411/11, ETC - 483S BIOMET INC - M2A MAGNUM HIP IMPLANT, M2A-38 HIP IMPLANT MDRS, PMA, MDA APPL MITSUBISHI CHEMICAL MEDIENCE - PATHFAST CTNL-II TEST K100130 AVASTIN - INFECTIONS, CONTAMINATIONS IN MINNEAPOLIS, MN 2011 TO PRESENT
2012-2566 2012-2567 2012-2568
04/06/2012 05/18/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012
FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/MIN-DO/MCB/
ELLEN RELKIN ESQ WEITZ & LUXEMBERG PC NOEL M RELYEA PHD SINGULEX INC HENRY F BAYARD COLE SCOTT AND KISSANE
2012-2569
04/06/2012 05/04/2012
ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
DR KATHY MCINTOSH SASKATOON COLOSTRUM COMPANY LTD DONNA R CORCORAN COOLEY MANION JONES LLP SEPHY PHILIP RPH PHARM D SCIENTIFIC EXCHANGE LLC
BOVINE DRIED COLOSTRUM ENTRY #112-6413972-1 TEST RESULTS ALARMS AND MONITORING DVCS - INVESTIGATION RPTS, INTERVIEWS, FINDINGS, ETC 2005 TO 2012 ABLE LABORATORIES INC TRIMETHOPRIM/SULFAMETHOXAZOLE NDA 21-105; WYETH PHARMACEUTICALS INC - PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE (HBR) ELIXIR ANDA 86-661, ETC SBA K113097
2012-2570 2012-2571
04/06/2012 05/04/2012 04/06/2012 05/04/2012
2012-2572
04/06/2012 05/04/2012
2012-2573 2012-2574 2012-2575 2012-2576 2012-2577
04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012 05/04/2012 04/06/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC NARGES GHAZI
2012-1101 2012-836 2011-8001 2012-864 K061053
Page 974 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/04/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2578 04/09/2012 05/07/2012 2012-2579 04/09/2012 05/07/2012 2012-2580 2012-2581 2012-2582 2012-2583 2012-2584 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 2012-2585 2012-2586 2012-2587 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2588 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2589 04/09/2012 05/07/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ HENRY F BAYARD CSK Labs VETERNANS AFFAIRS HOSPITAL, NASHVILLE, TN AVASTIN INCIDENT RPTS, INVESTIGATION RPTS, FINAL RPTS, ETC 1/11 TO PRESENT A LUKE SMITH FARUQI & FARUQI LLP TEVA PHARMACEUTICALS USA INC - ANDA 76-565; IMPAX LABS - ANDA 78-057; MYLAN ANDA 78-789 SBA TRUONG, TONY FDA/OMPT/CDRH/OCER/DFOI/ QUINN, TOM FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NWE-DO/NWECB/ KLELLY MCALLISTER ST JOSEPH/BREAST CARE CNETER KELLY MCALLISTER ST JOSEPH/BREAST CARE CNETER G RICHARD JAMES LUCERNE FARMS G RICHARD JAMES LUCERNE FARMS JONN M EBERSOLE BAVER & BOOKWATER CO LPA THOMAS O'MALLEY ESQ OSHMAN & MIRSOLA LLP YANG YANG PAC-DENTAL INTERNATIONAL INC JOVAN IVOSEVIC IVOSEVIC LAW CORP MAQUET GMBH & CO KG - ALPHSTAR (ALPH STAR) MDRS 556121, 679461, 721784, ETC MR ROMANELL DETERMINATION OF K801407 ASSIGNMENT - PHILIPS CORR, MTGS, PHONE LOG ANAGRELIDE, ANASTROZOLE, AZACITIDINE, ETC SUBMISSION DATES ANITA COONS (LUERNE FARMS FORAGE FEED) - HI FIBER EIRS 3/11 TO 5/11 DOVER SADDLERY RETAIL INC (LUCERNE FARMS), CONCORD, NH - HI FIBER EIRS 3/11 - 5/11 DIALYSIS OR HEMODIALYSIS EQUIPMENT - CMPLNTS, RPTS, INVESTIGATIONS, ETC MERK, COMUMED - OSTERGRAM DVC CORR, APPL FOR APRVL K031588 ST JOSEPH HOSPITAL (MILFORD CAMPUS), MILFORD, NH EIR 9/7/11 ST JOSEPH HOSPITAL, NASHUA, NH - EIR 9/9/11 Signature/ Requester CITY COLLEGE OF NEW YORK Subject
Page 975 of 1132

Total Records: 12455 Control # 2012-2590 Recd Date / Due Date 04/09/2012 05/07/2012 2012-2591 2012-2592 04/09/2012 05/07/2012 04/09/2012 05/07/2012 2012-2593 2012-2594 2012-2595 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2596 2012-2597 04/09/2012 05/07/2012 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/SAN-DO/SFCB/ 2012-2598 04/09/2012 05/07/2012 ORA/ ORA/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ 2012-2599 04/09/2012 05/07/2012 ORA/ ORA/ ORA/OE/ ORA/OE/ 2012-2600 2012-2601 04/09/2012 05/07/2012 04/09/2012 ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ BRAD BREZDEN ENDURANCE THERAPEUTICS DALENA DEGREZIA ESOTERIX - EIR, 482, 483 ETC 11/1-9/07 HI-DOW INTERNATIONAL INC, SAINT LOUIS, MO - K101598 EADDY, LASHONDA L JOHNSON & JOHNSON (ADVANDED SSTERIXATION PRODS, ANIMAS CORP, CORDIS, CORP), ETC - RECALLS 11/109 TO 3/22/12 SCOTT HAIRSCH SUREYOR CAPITALL CITCEL LLC MAP PHARMS, EXEMPLAR PHARMS - 483S, WARNING LTRS, CORR 1/09 TO PRESENT OC/OM/OMP/DDM/ CHRIS CELESTE EAS Consulting Group, LLC MARK A NASCHE OPPENHEIMER & CO INC MAP PHARMACEUTICALS INC - LEVADEX, NDA COMPLETE RESPONSE LTR DKT 2004D-0466 FDA/OMPT/CDRH/OCER/DFOI/ Doe J YANG YANG PACDENT INTERNATIONAL INC DAVID MOSSBURG MOSSBURG MEDIA INC PROGENICS PHARMACEUTICALS; SALIX PHARMACEUTICALS - RELISTOR (METHYLNALTREXONE) PHASE 3 COMM 11/1/11-12/31/11 K050145 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Action Office ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester HENRY F BAYARD CSK Labs JAMIE A KOUFMAN MD NEW YORK MEDICAL GAILL LESSICK LACHMAN CONSULTANT SERVICES INC WALGREENS - CMPLNT Subject CALIFORNIA DEPATMENT OF VETERANS AFFAIRS AVASTIN INCIDENT RPTS, INVESTIGATION RPTS, FINAL RPTS, ETC 1/11 TO PRESENT ACID AS A PRIMARY FOOD PRESERVATIVE - PEER RVW STUDIES LIST OF ALL DOMESTIC & FOREIGN INSP 2/1-29/12
Page 976 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/07/2012 2012-2602 2012-2603 2012-2604 04/09/2012 05/07/2012 04/09/2012 05/07/2012 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2605 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2606 04/09/2012 05/07/2012 2012-2607 04/09/2012 05/07/2012 2012-2608 04/09/2012 05/07/2012 2012-2609 04/09/2012 05/07/2012 2012-2610 04/09/2012 05/07/2012 2012-2611 04/09/2012 05/07/2012 2012-2612 2012-2613 04/09/2012 05/07/2012 04/09/2012 05/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/KAN-DO/COMP/ TRAVIS SIVERSON BIRCHWOOD LABORATORIES INC TRAVIS SIVERSON BIRCHWOOD LABORATORIES INC SHERRY FRIEDT SOMNETICS INTERNATIONAL INC SHERRY FRIEDT SOMNETICS INTERNATIONAL INC SHERRY FRIEDT SOMNETICS INTERNATIONAL INC SHERRY FRIEDT SOMNETICS INTERNATIONAL INC THOMAS J CONLIN CONLIN LAW FIRM LLC KEVIN A ZAK PARTNERS HEALTHCARE INC MEDTRONIC - CONSULTA DEFIBRILATTOR W/CARDIAC RESYNCHRONIZATION THERAPY MODEL D224TRK EXPAREL (LIPOSOME INJECTABLE SUSPENSION) SUMMARY, MEDICAL/CLINICAL & STATISTICAL RVWS PHILLIPS REMSTAR AUTO W/C-FLEX - K031460 RESMED S8 ESCAPE II AUTO - K080079 PHILLIPS REMSTAR AUTO W/C-FLEX - K041010 CARELINE INC, GREENBRIER, TN - EIRS, 483S, 10/22/1111/2/11 TRADEMARK MEDICAL LLC, BALDWIN, MO - EIRS, 483S 10/22/11-11/2/11 PHILLIPS REMSTAR AUTO M SERIES W/C-FLEX - K09024 PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP LUITPOLD PHARMACEUTICALS INC - SPRIX (KETOROLAC TROMETHAMINE NASAL SPRAY) NDA 022-382, AERS 5/1/11 TO PRESENT ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office Signature/ Requester PROSTRAKAN INC LESLIE SHOJI INTEREX INDUSTRIES LTD G RICHARD JAMES LUCERNE FARMS DAVID C BONNIN DLA PIPER US LLP CARGILL ANIMAL NUTRITION, ALBANY, NY - LUCERNE FARMS (FORAGE FEED - LUCERINE HI FIBER) 3/11 TO 5/11 HORMONE REPLACEMENT THERAPY - AERS DHALIWAL LABS, DALLAS TX - EIR, 483 11/11 Subject
Page 977 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2614 2012-2615 04/09/2012 05/07/2012 04/09/2012 05/07/2012 2012-2616 04/09/2012 05/07/2012 2012-2617 2012-2618 2012-2619 2012-2620 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/SAN-DO/SFCB/ 2012-2621 04/10/2012 05/08/2012 2012-2622 2012-2623 2012-2624 2012-2625 2012-2626 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDRH/OCER/DFOI/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DAWN M COULSON ESQ EPPS YONG & COULSON LLP DAWN M COULSON ESQ EPPS YONG & COULSON LLP DAWN M COULSON ESQ EPPS YONG & COULSON LLP MELISSAN G ABBOTT SPECTRANETICS CORP MELISSA G ABBOTT SPECTRANETICS CORP MDR RPT #2017865-2012-00088 MW5023502 CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL K041425 CONSERVE TOTAL FEMORAL HEAD K051348 HUMAN CELL AND TISSUE ESTABLISHMENTS - 483S 1/12 TO 3/12 METAL TRANSCEND ARTICULATION SYS K004043 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ COLLINS, MELISSA NELSON LOPEZ GRIFOLS BIOLOGICALS INC NOOSHIN AZIZI ABBOTT MEDICAL OPTICS INC WILLIAM TANNER LAZARD CAPITAL MARKETS EXEMPLAR PHARMS - LEVADEX 483, RECS RUGER CHEMICAL CO, LINDEN, NJ - EIRS, 483S 1/09 TO 3/12 K884251, K861642, K861643 FDA/OF/CFSAN/OCD/EOS/ JONES, VERNON A FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ EDWARDS, MARY CHRISTOPHER M SLOAN QUINTILES CONSULTING EDWARDS LIFESCIENCES LLC - EDWARDS BOVINE PERICARDIAL PATCH K082139 CORR CORR, MTGS, RVWS ETC 10/23/08 GREAT MEADOW CPRRECTONAL FACILITY MEALS INGREDIENTS & NUTRITIONAL FACTS PAMPHLETS, MATERIAL, RECS ETC DKT 2010P-0091 K042523 - SUMMARY & CLEARANCE LTR. Signature/ Requester Subject
Page 978 of 1132

Total Records: 12455 Control # 2012-2627 2012-2628 Recd Date / Due Date 04/10/2012 05/08/2012 04/10/2012 05/08/2012 2012-2629 04/10/2012 05/08/2012 2012-2630 2012-2631 2012-2632 2012-2633 2012-2634 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2635 04/10/2012 05/08/2012 2012-2636 04/10/2012 05/08/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ 2012-2637 04/10/2012 05/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MARY BETH CONNER FALCON RESEARCH DMAA (1,3 DIMETHYLAMYLAMINE) - AERS MICHELE SINOWAY, Ph.D. LACHMAN CONSULTANT SERVICES INC TRAVIS SCHAFTENAAR USB GLOBAL ASSET MANGEMENT ASTRA ZENECA - NEXIUM (ESOMEPRAZOLE MAGNESIUM) NDA 21-153/S-008 RVW, APRL ANGIODYNAMIC, QUEENSBURY, NY - 483 1/4-13/11, 1/12 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/MIN-DO/MCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MELISSA G ABBOTT SPECTRANETICS CORP JOHN R MOORE LIND JENSEN SULLIVAN & PETERSON JOHN R MOORE LIND JENSEN SULLIVAN & PETERSON DAVID MCFARLAND FDA WEBVIEW/FERDIC INC MELISSA G. ABBOTT SPECTRANETICS CORP MELISSA G. ABBOTT SPECTRANETICS CORP MICHAEL R. HAMRELL, Ph.D. MORIAH CONSULTANTS MIKE CLOTHIER PERRIGO CO LEO LABS LTD, DUBLIN, IRELAND - 483, EIR 2 MOST RECENT MERCY MEDICAL CTR, DES MOINES, IA - 483, EIR 11/13/08 MDR RPT # 2134265-2012-00131 MDR RPT # 2017865-2012-00061 WILLMAR POULTRY FARMS INC - EVER CAT VEGETABLE BOTTOMS INVESTIGATION RECS WILLMAR POULTRY FARMS INC - EVER CAT FUELS INVESTIGATION RECS CLSOED FOI REQUESTS 3/26-30/12 Subject MDR RPT #2938836-2006-00420
Page 979 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OF/CFSAN/OCD/EOS/ 2012-2638 2012-2639 2012-2640 2012-2641 2012-2642 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 04/10/2012 05/08/2012 2012-2643 04/10/2012 05/08/2012 2012-2644 2012-2645 04/10/2012 05/08/2012 04/10/2012 05/08/2012 2012-2646 04/10/2012 05/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2647 04/10/2012 05/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2648 2012-2649 04/10/2012 05/08/2012 04/11/2012 05/09/2012 2012-2650 04/11/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/NJ-DO/NJCB/ ORA/ OC/OM/OMP/DDM/ TARRA FULLER Hyman Phelps and McNamara PC CAITLIN WILCOX IOVATE HEALTH SCIENCES INTERNATIONAL INC TRAVIS HULL GARDEN STATE NUTRIONAL, VITAQUEST INTERNATIONAL - DIETARY SUPPLEMNT FACILITIES US OR FOREIGN 483S LIVINGSTON INTERNATIONAL, PBB GLOBAL LOGISTICS INC, GREAT LAKES CUSTOMS BROKERAGE INC, ETC - US DKT FDA-1995-S-0039 AMY EICHNER, Ph.D. UNITED STATES ANTI-DOPING AGENCY ELI LILY - FORTHANE (METHYLHEXANAMINE) AERS, CORR, ANNUAL RPTS, ETC CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DAWN M. COULSON, Esq. EPPS YONG & COULSON LLP DAWN M. COULSON, Esq. EPPS YONG & COULSON LLP MATTHEW MONEY PELLEGRINO AND ASSOCIATES LLC LATESHA R. BAKER HINSHAW & CULBERTSON LLP WRIGHT MEDICAL TECHNOLOGY - CONSERVE PLUS SPIKED SHELL & CONSERVE TOTAL 56MM FEMORAL HEAD K031963 WRIGHT MEDICAL TECHNOLOGY - CONSERVE PLUS HA ACETABULAR SHELL K042530 NEW ANIMAL DRUG APPLICATIONS (NADA) - TOTAL NUMBER SUBMITTED AND TOTAL NUMBER APRVD 2001 TO 2011 AVASTIN INJ STREPTOCOCCAL ENDOPHTHALMITIS OUTBREAK - RECS FOI SERVICES INC DAWN M. COULSON, Esq. EPPS YONG & COULSON LLP WRIGHT MEDICAL TECHNOLOGY - METAL TRANSCEND ARTICULATION SYS K021349 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANNE SAVAS MAGSTIM COMPANY US LLC ANNE SAVAS MAGSTIM COMPANY US LLC LISA TARRISON-SCHRAMP CanReg, Inc. DAILY LOG 3/26-30/12 DAILY LOG 3/26-30/12 MAGSTIM - K051864 NEXSTIM - K091457 Signature/ Requester Subject
Page 980 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/09/2012 Action Office ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OF/CFSAN/OCD/EOS/ 2012-2651 04/11/2012 05/09/2012 2012-2652 04/11/2012 05/09/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/ORO/ ORA/ORO/ 2012-2653 2012-2654 04/11/2012 05/09/2012 04/11/2012 05/09/2012 2012-2655 04/11/2012 05/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/CE-FO/MIN-DO/MCB/ 2012-2656 04/11/2012 05/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2657 04/11/2012 05/09/2012 2012-2658 04/11/2012 05/09/2012 2012-2659 2012-2660 04/11/2012 05/09/2012 04/11/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ALISON D KENNAMER COLVIN CHANEY SAENZ & RODRIGUEZ LLP ALISON D KENNAMER COLVIN CHANEY SAENZ & RODRIGUEZ LLP NELSON LAM INTUITY MEDICAL SANNI RAJU PHD RPH EMBLICA OFFICINALIS GRAS 000322, 000295 - MEMOS, KCI VACUUM ASSISTED THERAPY FREEDOM SYS - MDRS PRIOR TO 9/5/08 KCI VACUUM ASSISTED THERAPY ATS SYS - MDRS PRIOR TO 9/5/08 ARKRAY INC - K110709 DANIEL KOCH WALKER SMITH CAPITAL LP SYNACTHEN DEPOT (TETRACOSACTRIN SINCE PHOSPHATE COMPLEX, SYNTHETIC ACTH) - 505(B) FILING, APRVL FILINGS FDA/OO/OFBA/OAGS/ GARY GEIMAN KRELLER CONSULTING GROUP MARK A J FASSOLD WATTS GUERRA CRAFT LLP JENNIFER NEWBERGER Hyman Phelps and McNamara PC DONJOY INC, CARLSBAD, CA; DJ ORTHOPEDICS LLC, VISTA, CA; DJO LLC, VISTA, CA, ETC - DONJOY ICEMAN, AIRCAST CRYO/CUFF EIRS, WARNING LTRS, CORR, ETC UNITED HEALTH, HEALTINNOVATIONS - ONLINE HEARING TEST CORR CONTRACT #HHSF223200950158G FDA/OMPT/CDRH/OCER/DFOI/ M CASEY MATTOX ALLIANCE DEFENSE FUND ELENA HOWELL HOGAN LOVELLS US LLP CURRENTLY ACTIVE CERTIFICATES, SUBMISSION TO OPERATE MAMMOGRAPHY FACILITES FROM PLANNED PARENTHOOD OF AMERICA LAST 5 YRS FOOD FACILITY INSP PILOT PROJECTS 1/11 TO PRESENT Signature/ Requester LIVINGSTON INTERNATIONAL INC Subject AGENTS UNDER VARIOUS ACTS
Page 981 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/09/2012 2012-2661 04/11/2012 05/09/2012 2012-2662 04/11/2012 05/09/2012 ORA/ ORA/ ORA/CE-FO/PHI-DO/PCB/ CBER/OCTMA/DDOM/ALFB/ BAYER, RANGE (RICHARD) D HEMOGLOBIN STANDARDS AND MAINTAINING ADEQUATE IRON STORES IN BLOOD DONORS PUBLIC WORKSHOP PRESENTATIONS - REDS II DONOR IRON STUDY 11/8/11; IRON STORES AND IRON DEFICIENCY IN BLOOD DONORS 11/9/11; IRON STORES AND IRON REPLACEMENT IN BLOOD DONORS 11/9/11, ETC MICRO CONNECTION ENTERPRISES, TORRANCE, CA EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS ACCU-BIO CHEM LABS, GLENDALE, CA - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS PACIFIC BIOLABS, HERCULES, CA - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS TRADEMARK MEDICAL LLC, BALDWIN, MO - EIR, 483 10/22/11-11/2/11 IRVINE PHARMACEUTICAL SERVICES, IRVINE, CA - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS SUNCARE RESEARCH LABORATORIES, WINSTON SALEM, NC - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS AMA LABS, NEW CITY, NEW YORK - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS CELSIS LABS, ST LOUIS, MO - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS MICRO QUALITY LABS INC, BURBANK, CA - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS Doe J Action Office Signature/ Requester Natreon, Inc. Subject CORR CANYON CREEK RANCH - YAM DOG TREATS CONTAMINATION INVESTIGATION RECS
2012-2663
04/11/2012 05/09/2012
RANIL M FERNANDO BIOSCREEN TESTING SERVICES INC
2012-2664
04/11/2012 05/09/2012
2012-2665
04/11/2012 05/25/2012
2012-2666
04/11/2012 05/09/2012
TRAVIS SIVERSON BIRCHWOOD LABORATORIES INC
2012-2667
04/11/2012 05/09/2012
2012-2668
04/11/2012 05/09/2012
2012-2669
04/11/2012 05/09/2012
2012-2670
04/11/2012 05/09/2012
2012-2671
04/11/2012 05/09/2012
Page 982 of 1132

Total Records: 12455 Control # 2012-2672 Recd Date / Due Date 04/11/2012 05/09/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ 2012-2673 04/11/2012 05/09/2012 2012-2674 04/11/2012 05/09/2012 2012-2675 2012-2676 04/11/2012 05/09/2012 04/11/2012 05/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2677 2012-2678 2012-2679 2012-2680 04/11/2012 05/09/2012 04/12/2012 05/10/2012 04/12/2012 05/10/2012 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2681 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2682 2012-2683 04/12/2012 05/10/2012 04/12/2012 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ MICHAEL LEDEBOER AS RESEARCH LLC TZU-HSUAN YANG ASPEN SURGICAL PRODUCTS, CALEDONIA, MI - EIR ATF SCI-FIT, PITTSBURG, PA - EIR 11/11, 3/12 MARY B SZALKOWSKI PRISMA CORP INDAPAMIDE, PERINDOPRIL - AERS 1/19/12 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ MARSHALL, WAYNE DON J MIZERK HUSCH BLACKWELL LLP MEGACE OS MDULE 2.7 ORAL SUSPENSION - NDA 20-264, ANDA 77-404, 75-671 BIOEQV PRODS, DEFICIENCES, AMENDMENTS, ETC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ MARSHALL, WAYNE ADJUSTABLE PM POSITIONER - K955503 FLETCHER, MARY JANE ZIMMER - CONTOUR PROVISONAL COPING K113092 ACRYLAMIDE IN MCDONALD'S FOOD - RECS OM/OMP/DODM/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/CHI-DO/CCB/ RANIL M FERNANDO BIOSCREEN TESTING SERVICES INC RANIL M FERNANDO BIOSCREEN TESTING SERVICES INC CHARLES COOPER BERENBERG BANK BYOUNGIN JUNG SAMSUNG BIOEPIS CO LTD NELSON LABS, ELK GROVE VILLAGE, IL - EIRS, 483S, WARNING LTRS ETC, LAST FIVE YRS EXOVA, SANTA FE SPRINGS, CA - EIRS, 483S, WARNING LTRS, ETC, LAST FIVE (5) YRS PERIPHERAL AND CNS A/C - BETASERON 1993, AVONEX 1995, COPAXONE 1996, ETC RECS CENTOCOR - REMICADE PK STUDY RESULTS Signature/ Requester THOMAS M BURTON WALL STREET JOURNAL Subject ST JUDE MEDICAL INC - RIATA, RIATA ST DEFIBRILLATOR LEAD RPTS, CORR, ANALYSES, ETC
Page 983 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/10/2012 2012-2684 2012-2685 04/12/2012 05/10/2012 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2686 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ ORA/ ORA/ 2012-2687 04/12/2012 05/10/2012 2012-2688 04/12/2012 05/10/2012 2012-2689 04/12/2012 05/10/2012 ORA/ ORA/ CVM/OCD/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CTP/OD/ CTP/OD/ CVM/OCD/ OC/COS/OES/ OC/COS/OES/ ORA/ CAUSE OF ACTION ACQUISITION OF COMMEMORATIVE COINS, TROPHIES, CERTICATES, ETC - EXPENDITURES FOR FISCAL YR, COMM, CRITERIA FDA/OF/CFSAN/OCD/EOS/ SYLVIA L BRIDGES CANTOX Health Sciences International MINDY LARCOM FOX 5 NEWS ATLANTA MITSUBISHI CHEMICAL GAS CO INC - PYROLOQUINOLINE QUINONE DISOODIUM SALT, DKT NO 6/11/07 CHICKEN JERKY DOG TREATS - CMPLNTS ERIC H WEINBERG EIRC H WEINBERG ESQ ATTY PRADAXA, DABIGATRAN ETEXILATE MEYSLATE - AERS, INDS, NDAS, ETC ORA/NE-FO/NYK-DO/NYDCB/ Action Office Signature/ Requester PRO PHARMA TAIWAN INC MICHELLE THOMAS OCuSOFT, Inc. KEVIN PYUN CONSONACC CAPITAL ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY - EIRS 8/10 TO PRESENT BENLYSTA (BELIMUMAB) - AERS Subject
Page 984 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/ORM/ ORA/ORM/ OC/OIASI/OIP/IAS/ CTP/OD/ CTP/OD/ 2012-2690 04/12/2012 05/10/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-2691 2012-2692 04/12/2012 05/10/2012 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2693 2012-2694 2012-2695 2012-2696 04/12/2012 05/10/2012 04/12/2012 05/10/2012 04/12/2012 05/10/2012 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2697 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS PURIFYING GEL CLEANSER CORR, RECS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CLARICE ARRUDA PROCEDURE PRODUCTS INC KELLY JABBAL ACCESS CLOSURE SCOTT HUNTSMAN BIOCARE MEDICAL BARRY SUGARMAN DIVERSTECH CO INO THERAPEUTICS (IKARIA) - INOMAX NDA 20-845 FDA FORM 3542, 3542A PROCEDURE PRODUCTS INC - 10CC SYRINGE CONTROL RING SET K874747 BOSTON SCIENTIFIC CORP - OCCLUSION BALLOON CATHETER K062202 K042884, K103818 ORA/SE-FO/ATL-DO/ACB/ BRENDA MICHAEL DUANE MORRIS LLP KRISTEN H STRAIN VENABLE LLP CAGLE'S INC, ROCKMART, GA; PINE MOUNTAIN VALLEY, GA - VIOLATIONS, FINES, PENALTIES REGLAN INJ NDA 17-862 - LBLG, PI STEPHANIE ARMOUR BLOOMBERG NEWS IMPORT REFUSAL RPTS 2001 TO PRESENT Signature/ Requester Subject
Page 985 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2698 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2699 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2700 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS CLARIFYING TONER CORR, RECS LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS DAILY MOISTURIZING LOTION CORR, RECS LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS TARGETED SPOT TREATMENT CREAM CORR, RECS Signature/ Requester Subject
Page 986 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2701 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2702 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2703 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS REGIMEN KIT CORR, RECS LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS PORE REFINING SCRUB CORR, RECS LA TOYA SUTTON MANATT PHELPS & PHILLIPS BURT'S BEES - NATURAL ACNE SOLUTIONS MAXIMUM STRENGTH SPOT TREATMENT CREAM CORR, RECS Signature/ Requester Subject
Page 987 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ 2012-2704 2012-2705 04/12/2012 05/10/2012 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2706 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2707 04/12/2012 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2708 04/13/2012 05/11/2012 2012-2709 2012-2710 04/13/2012 05/11/2012 04/13/2012 05/11/2012 ORA/ ORA/ ORA/SW-FO/KAN-DO/COMP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-2711 04/13/2012 05/11/2012 FDA/OF/CFSAN/OCD/EOS/ RON SIMON SIMON & LUKE LLP MULTISTATE OUTBREAK OF HUMAN SALMONELLA ENTERITIDIS ASSOCIATED WITH SHELL EGGS 5/10 TO 12/10; MULTISTATE OUTBREAK OF HUMAN SALMONELLA CHESTER ASSOCIATED WITH MARIE CALLENDER'S CHEESY CHICKEN & RICE 4/4/10-12/31/10. ETC TYSABRI (NATALIZUMAB) A/C - MEMO 7/20/07 (CERTIFIED) FOI SERVICES INC ORA/CE-FO/NJ-DO/NJCB/ OC/OM/OMP/DDM/ JONATHAN R. LUTINSKI WILSON SOSINI GOODRICH & ROSATI SYRON A JACK MASHEL LAW LLC BECKY COOSEMAN BROWN & CROUPPEN PC INDIVIDUAL RECS DPT LAKEWOOD INC, LAKEWOOD, NJ - 483 2/12 TO 3/12 DKT FDA-2006-P-0346 BRENDA M GARTZ ELI LILLY & CO UNICHEM LABS, ROHA, INDIA 5/22/09; PITHAMPUR, INDIA 5/28/09; GOA, INDIA 5/15/09 - 483S BRENDA M GARTZ ELI LILLY & CO IPCA, SILVASA, INDIA - 483S 5/28/09 ORA/CE-FO/DET-DO/DCB/ RONALD A MARCHESANI ONYX PHARMACEUTICALS BRENDA M GARTZ ELI LILLY & CO ENZON INC - ONCASPER (PEGASPARGASE) WARNING LTRS, RECALLS, CORR ETC 2009 TO PRESENT EMCURE PHARMS, PUNE, INDIA - 483S 2/19/09, 8/19/09, 11/10/09, 11/22/09 Signature/ Requester Subject
2012-2712
04/13/2012 05/11/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
Page 988 of 1132

Total Records: 12455 Control # 2012-2713 2012-2714 2012-2715 2012-2716 2012-2717 2012-2718 Recd Date / Due Date 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 2012-2719 2012-2720 2012-2721 2012-2722 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 2012-2723 04/13/2012 05/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2724 2012-2725 2012-2726 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 ORA/ ORA/ ORA/ORM/ ORA/ORM/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/LOS-DO/LACB/ PAMELA LOCATELL SAGE QUALITY SERVICE PAMELA LOCATELL SAGE QUALITY SERVICE JOHN DIEDRICH MILWAUKEE JOURNAL SENTINEL FACTS DATABASE COBE CHEMICAL CO INC, PICO RIVERA, CA - 483 8/25/10 GUTHY RENKER, SANTA MONICA, CA - 483 2011 OM/OMP/DODM/ CVM/OCD/ FOI SERVICES INC TERI S KREBS NORWEGIAN UNIV OF SCIENCE AND TECHNOLOGY BRENDA M GARTZ ELI LILLY & CO OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ FOI SERVICES INC FOI SERVICES INC J M SMUCKER, RIPON, WI - EIR, 483, WARNING LTR, ETC 1/12 MASCOMA GRAIN TECHNOLOGY (MGT) - MEMOS, LTRS, TOXICOLOGY RVWS, ETC JOINT FDA/NIMH PSYCHOTOMIMETIC A/C - MEMBER NAMES, RESERACH PROJECTS, PROGRESS RPTS,E TC 1967 TO 1975 SIFAVITOR, ITALY - 483 3/27/09 FOI SERVICES INC FOI SERVICES INC IDENTITY OF TOBACCO PRODS FOR WHICH FDA ISSUED AN ORDER OF SUBSTANTIAL EQUIVALANCE 3/22/11 TO PRESENT 2012-1479 FOI SERVICES INC DKT FDC 21 - WHOLE WHEAT STANDARD REGULATIONS ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC 2008-678 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FOI SERVICES INC Signature/ Requester Subject SCREENSHOT OF FDA WEBPAGE REGARDING TYSABRI (CERTIFIED) NEUROMED INC - MULTIPROGRAMMABLE INPLANTABLE NEUROLOGICAL STIMULATOR K833813 APP PHARMS, GRAND ISLAND, NY - CO RESP, 483 7/8/11
Page 989 of 1132

Total Records: 12455 Control # 2012-2727 2012-2728 Recd Date / Due Date 04/13/2012 05/11/2012 04/13/2012 05/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2729 04/13/2012 05/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2730 04/13/2012 05/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2731 04/13/2012 05/11/2012 CBER/OCTMA/DDOM/ALFB/ Joan Stitt (UG2CD-16) MERCK & CO., INC. PLEASE PROVIDE A VAERS LINE LIST REPORT OF ALL ADVERSE EXPERIENCES RECEIVED BY FDA for GARDASIL, (HPV VACCINE, MERCK & CO., INC.), FROM 1/1/2012 to 3/31/2012 ON CD ; REQUEST LETTER ONLY 2012-1307 REQUEST LETTER 2012-1190 REQUEST LETTER 2012-1184 REQUEST LETTER 2012-1114 REQUEST LETTER 2012-1050 REQUEST LETTER 2012-1338 REQUEST LETTER 2012-1175 REQUEST LETTER 2012-1028 ERIC VARMA, M.D. ORACLE INVESTMENT MANAGEMENT MAP PHARMS - LEVADEX (DIDYDROERGOTAMINE) 3/26/12 KRISTEN H. STRIN VENABLE LLP REGLAN NDA 17-862 LBLG 1/02 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester ROBERTA LEE ACUEITY HEALTHCARE INC BRENDA M. GARTZ ELI LILLY & CO CHANGZHOU PHARMACEUTICAL FACTORY, JIANGSU, CHINA - 483 Subject EXCISOR BIOPTOME K032847
2012-2732 2012-2733 2012-2734 2012-2735 2012-2736 2012-2737 2012-2738 2012-2739
04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC.
Page 990 of 1132

Total Records: 12455 Control # 2012-2740 2012-2741 2012-2742 2012-2743 Recd Date / Due Date 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012 05/11/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ Signature/ Requester Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. JoNel Aleccia MSNBC.COM Date Range: 11/01/2011 - 03/28/2012; Msnbc.com requests copies of FDA Form 483 inspection documents issued to IntelliCell Biosciences Inc., of New York, after FDA inspections conducted in November and December 2011. Msnbc.com also requests copies of any other Form 483s that may have been issued to the firm. Correspondence between FDA and the firm would have gone to: Dr. Steven Victor Chief Executive Officer IntelliCell Biosciences, Inc. 30 East 76th Street New York, NY 10012 PLEASE PROVIDE A LINE LISTING OF ALL ADVERSE EXPERIENCES REPORTED TO THE FDA for JUVISYNC, (SIMVASTATIN; SITAGLIPTIN PHOSPHATE: MERCK SHARP DOHME), FROM 1/1/2012 to 3/31/2012 ON CD PLEASE PROVIDE A VAERS LINE LIST REPORT OF ALL ADVERSE EXPERIENCES OF INTUSSUSCEPTION AND KAWASAKI DISEASE RECEIVED BY FDA for ROTATEQ, (ROTAVIRUS VACCINE, LIVE ORAL PENTAVALENT, MERCK & CO., INC.), FROM 1/1/2012 to 3/31/2012 ON CD PLEASE PROVIDE A LINE LISTING OF ALL ADVERSE EXPERIENCES REPORTED TO THE FDA for DULERA, (FORMOTEROL FUMARATE; MOMETASONE FUROATE, SCHERING), FROM 1/1/2012 to 3/31/2012 ON CD PLEASE PROVIDE A LINE LISTING OF ALL ADVERSE EXPERIENCES REPORTED TO THE FDA for VICTRELIS, (BOCEPREVIR, SCHERING), FROM 1/1/2012 to 3/31/2012 ON CD FOI DAILY LOG 3/12-16/2012; FOI DAILY LOG 3/19-23/2012; FOI DAILY LOG 3/26-30/2012 FOI DAILY LOG 3/5-9/2012 REQUEST LETTER 2012-948 Subject REQUEST LETTER 2012-949
2012-2744
04/13/2012 05/11/2012
Joan Stitt (UG2CD-16) MERCK & CO., INC.
2012-2745
04/13/2012 05/11/2012
2012-2746
04/13/2012 05/11/2012
2012-2747
04/13/2012 05/11/2012
2012-2748 2012-2749 2012-2750
04/13/2012 05/11/2012 04/13/2012 05/11/2012 04/13/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16)
Page 991 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/11/2012 2012-2751 04/13/2012 05/11/2012 Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2752 2012-2753 04/13/2012 05/11/2012 04/13/2012 05/11/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-2754 2012-2755 04/13/2012 05/11/2012 04/13/2012 05/11/2012 2012-2756 04/13/2012 05/11/2012 ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/OCI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/NJ-DO/NJCB/ 2012-2757 04/13/2012 06/04/2012 CBER/OCTMA/DDOM/ALFB/ TIFFANY K. HANNUS LOMMEN ABDO COLE KING INDIVIDUAL RECS, CERTIFIED PETER G ANGELOS LAW OFC SANOFI AVENITS - ELOXATIN AER, RECALL Doe J Doe J 2012-1692 2012-1692 SCHUMAN, AUSTIN L Joan Stitt (UG2CD-16) MERCK & CO., INC. P890046/S020,S027; K002703, K954124 "A list of all FOIA requests closed 3/1-31/2012" on CD Signature/ Requester MERCK & CO., INC. BRODY MULLINS WALL STREET JOURNAL CORR BETWEEN FDA & MICHAEL SULLIVAN 1/09 TO 4/1/12 Subject
Page 992 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester STAGEBERG PA 2012-2758 04/13/2012 05/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2759 2012-2760 2012-2761 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2762 04/16/2012 05/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2763 04/16/2012 05/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2764 2012-2765 04/16/2012 05/14/2012 04/16/2012 05/14/2012 ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ JOHN WALSH JAMES ALEXANDER CORP CORI SCHRADER BIOQUALITY PHARMACO-AAPER PRODUCTS INC, BROOKFIELD, CT EIRS, 483S, RECALLS 4/09 TO PRESENT APP PHARMACEUTICALS LLC, GRAND ISLAND, NY 1/13/10; AMGEN INCORP, LONGMONT, CO 9/3/10; AMGEN INC, BOULDER, CO 9/3/10 - 483S, ETC NICOLE BEARCE ALBANO LOWENSTEIN SANDLER ATTY BRISTOL-MYERS SQUIBB - AMPHO B LOT NDA 60-570; AMPHOTERCIN - B (FUNGIZONE) NDA 50-341, NDA 61-144, NDA 62-259, ETC; CHOLOGRAFIN (MEGLUMINE) NDA 9-321, ETC ALBERRT C BEATTY JR MD AZILECT - AERS ALBERRT C BEATTY JR MD FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ HARVEY M ARBIT ARBIT CONSULTING LLC NANCH SCHON OXUS THERADOME INC, SUMMERVILLE, NC - LASER HELMENT LH80 PRO K113097 RESPIRONICS - SIMPLY GO PORTABLE OXYGEN CONCENTRATOR K112886 MIRAPEX (PRAMIPEXOLE) - AERS YEOLAN LEE OHIO STATE UNIVERSITY ORANGE BOOK 1985 TO 1989 Subject
Page 993 of 1132

Total Records: 12455 Control # 2012-2766 2012-2767 2012-2768 2012-2769 2012-2770 Recd Date / Due Date 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 2012-2771 04/16/2012 05/14/2012 2012-2772 04/16/2012 05/14/2012 2012-2773 2012-2774 04/16/2012 05/14/2012 04/16/2012 05/14/2012 2012-2775 2012-2776 2012-2777 2012-2778 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2779 2012-2780 04/16/2012 05/23/2012 04/16/2012 05/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/ TONY CHEN FDAZILLA STEPHANIE ARMOUR BLOOMBERG NEWS SAINTPAUL SALMONELLA OUTBREAK 2008; MEXICO PAPAYAS SALMONELLA OUTBREAK 2011 - EIRS, NAMES 483S - 9/1/11 TO PRESENT SHIPMAN, KIM OC/OSHC/OPD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OSHC/OPD/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ CTP/OD/ CTP/OD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OSHC/OPD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC LISA TARRISON-SCHRAMP CanReg, Inc. DAVID MCFARLAND FDA WEBVIEW/FERDIC INC RICHARD F TAYLOR TC Associates Inc. RICHARD F TAYLOR TC Associates Inc. SUZANNE D JENSEN Kleinfeld, Kaplan and Becker, LLP JASON SMATHERS MUCKROCK NEWS JAMES A BOIANI EPSTEIN BECKER & GREEN PC JASON SMATHERS MUCKROCK NEWS JAMES A BOIANI EPSTEIN BECKER & GREEN PC JAMES A BOIANI EPSTEIN BECKER & GREEN PC HYPERION THERAPEUTICALS INC - GLYCEREL TRI (4PHENYLBUTYRADE) LTRS, MINS, DESIGNATION APPL 4/27/09 DIVESTITURE OF PROHIBITED HOLDINGS - VINCE TOLINO MEMOS, LAST 60 DAYS ORPHAN DRUG DESIGNATION - IMPROVEMENTS IN PROD TASTE LTRS, MINS, DECISION RECS, ETC NAVINTA LLC - SODIUM PHENYLBUTYRATE LTRS, MINS, APPL 1/19/10 NOVARTIS - AREDOA ISRS 3977064, 3977066, 3977038 ETC FUJI HEALTH SCIENCE INC, BURLINGTON, NJ ASTAXANTHIN 12 MG NEW DIETARY INGREDIENT NOTIFICATION (NDIN), COMM 12/7/11 GRAS ASSOCIATES LLC, BEND, OR - ASTAXANTHIN 12 MG NEW DIETARY INGREDIENT NOTIFICATION (NDIN), COMM 12/7/11 HBI TECHNOLOGIES,, HBI HERBAL BAR INDUSTRIES, HBI INTERNATIONAL, ETC - REGULATORY SUBMISSIONS LIST, PRODUCTS INVOLVED, EIRS ETC PINK SLIME - RECS CLOSED FOI REQUESTS 4/2-6/12 CLOSED FOI REQUESTS 4/2-6/12 Action Office ORA/P-FO/SAN-DO/SFCB/ Doe J Signature/ Requester Subject GENENTECH MFG PLANT, SOUTH SAN FRANCISCO, CA EIRS 1/07 TO PRESENT CLOSED FOI REQUESTS 4/2-6/12
Page 994 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ OC/OCM/EMOPS/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-2781 2012-2782 2012-2783 2012-2784 2012-2785 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/16/2012 05/14/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012 2012-2786 2012-2787 04/17/2012 05/15/2012 04/17/2012 05/15/2012 2012-2788 2012-2789 2012-2790 2012-2791 2012-2792 04/17/2012 05/17/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012 2012-2793 04/17/2012 05/15/2012 2012-2794 04/17/2012 ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OO/OFBA/OAGS/ FDA/OO/OFBA/OAGS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ROACH, ALICE AMY MARTEL CYNTHIA R CHIHAK & ASSOCS LENA D GIANGROSSO PROVOSTY & GANKENDORFF LLC BECKY COOSEMAN BROWN & CROUPPEN PC DEBORAH LAVOIE GRAYESKI M SQUARED ASSOCIATES INC GARY GEIMAN KRELLER CONSULTING GROUP GARY GEIMAN KRELLER CONSULTING GROUP MARTIN HERZOG MED-EL MEDICAL ELECTRONICS PAUL MOSTYN WESTWAY FEED PRODUCTS LLC MED-EL ELEKTROMEDIZINISCHE GERAETE, INNSBRUCK AUSTRIA - EIR 11/23/09 BIODIESEL-DERIVED GLYCERIN - TENTATIVE DEFINITION RECS NEW YORK SHELLFISH SANITATION PROGRAM - ANNUAL DUN & BRADSTREET - CONTRACT #HHSF223200950158G INVOICES DUN & BRADSTREET - CONTRACT #HHSF223200950158G OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC AMY KINCANON LEXISNEXIS COURTLINK INC CAROL NAKAGAWA MERGE HEALTHCARE MONSANTO CO - MON 87701 LEPIDOPTERAN INSECTRESISTANT SOYBEAN GRAS, SAFETY & NUTRITIONAL FILINGS, ETC ALLEZ SPINE LLC (PHYGEN LLC), IRVINE, CA - EIRS, 483S, CORR, ETC 2007 TO PRESENT TEXAMERICAN, DALLAS, TX; HOT SPRINGS, AR VIOLATIONS, CMPLNTS, RPTS, ETC MIM SOFTWARE INC - MOBILE MIM K112930 2010-1738 2010-1737 2010-1736 Signature/ Requester Subject OF FARMS, PACKING HOUSES, ETC
SPLS 614606, 614607, 614808, ETC - NOTES, RESULTS, W/S, ETC CYNOSURE - CELLULAZE LASER K102541
Page 995 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/15/2012 Action Office Signature/ Requester CREAN, SARAH Subject EVALUATION RPT (APER) FY 2011; NEW YORK SHELLFISH GROWING AREA CLASSIFICATION ELEMENT - PROGRAM ELEMENT EVALUATION RPT (PEER) 2009, 2011 WARNING LTRS ISSUED TO COMPANIES REGARDING ARSENIC IN JUICE LAST 2 YRS IMAGYN TECHNOLOGIES - TISSUE ISOLATION & RETRIEVAL BAG K931886 NAVILYST MEDICAL INC - MULTIPURPOSE DRAINAGE CATHETER K093392 ENTRY #916-2189404-6, #916-2189453-3 - LAB RESULTS JAKAFI (RUXOLITINIB) - AERS 7/11 TO PRESENT
2012-2795 2012-2796 2012-2797 2012-2798 2012-2799
04/17/2012 05/15/2012 04/17/2012 06/05/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012 04/17/2012 05/15/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ PICHE, JESSICA LISA ANDERSON CONMED CORP AMBER R JOHNSON BOSTON SCIENTIFIC CORP PAULINE MARALIT MEDLINE INDUSTRIES INC ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC
2012-2800
04/17/2012 05/15/2012
ELLIOT FAVUS MD FAVUS INSTITUTIONAL RESEARCH LLC
ADCETRIS (BRENTUXIMAB VEDOTIN) - AERS 3/15/12 TO PRESENT
2012-2801
04/17/2012 05/15/2012
FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DEN-DO/COMP/ SIDNEY M WOLFE PUBLIC CITIZEN HOWELL ARNOLD PARALLON BUSINESS SOLUTIONS ORA/CE-FO/BLT-DO/CB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ CONNER, MARYBETH
DVCS WHICH ARE CONSIDERED TO PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY PART3 DVCS WHICH ARE CONSIDERED TO PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY PART2 DVCS WHICH ARE CONSIDERED TO PRESENT A POTENTIAL UNREASONABLE RISK OF ILLNESS OR INJURY PART1 CARRAGEENAN EFFECTS ON ANIMALS & HUMANS - RECS, MEMOS PARALLON BUSINESS SOLUTIONS, DENVER, CO - EIRS, 483S GREEN MOUNTAIN COFFEE, CASTROVILLE, CA; KNOXVILLE, TN, WATERBURYY, VT ETC - EIRS, 483 LAST 2 YRS
2012-2802
04/17/2012 05/15/2012
2012-2803
04/17/2012 05/15/2012
2012-2804 2012-2805
04/18/2012 05/16/2012 04/18/2012 05/16/2012
2012-2806
04/18/2012 05/16/2012
Page 996 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/P-FO/SAN-DO/SFCB/ 2012-2807 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2808 2012-2809 04/18/2012 05/16/2012 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2810 2012-2811 04/18/2012 05/16/2012 04/18/2012 05/16/2012 2012-2812 04/18/2012 05/16/2012 2012-2813 2012-2814 2012-2815 04/18/2012 05/16/2012 04/18/2012 05/16/2012 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2816 2012-2817 04/18/2012 05/16/2012 04/18/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ DEBRA F MANNING COEUR INC TERRY ASBERT COEUR - COEUR 16" LONG CATHETER W/ADAPTOR, 14FR & 12 FR, K885202 (UNREDACTED) FMD DEPUY PINNACLE 100 SERIES - 52 MM OUT DIAMETER TITANIUM CUP, PINNACLE IDE METAL INSERT, 36MM ID, 52 ORA/CE-FO/DET-DO/DCB/ ORA/ ORA/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/ATL-DO/ACB/ CTP/OD/ CTP/OD/ FDA/OF/CFSAN/OCD/EOS/ NATALIE N SANDERS LATHLAM & WATKINS LLP JEFF SPEDDING API-ADDITIVES FOR PAPER INDUSTRY GMBH MELISSA MANDELL PAUL SANDLER TRAVIS & ROSENBERG PA DANA THOMPSON FULBRIGHT & JAWORSKI LLP JANET R NAAS ST MARY'S MEDICAL CENTER KARIMAH S LYNUM DEPT OF VETERANS AFFAIRS MEDICAL CTR AMBIEN (ZOLPIDEM)/AMBIEN XR ( ZOLPIDEM XR) - SUDDEN DEATH AERS ACELLA PHARMACUTICALS LLC, ALPHARETTA, GA - EIRS, 483S, 482S ETC 11/09 TO PRESENT ST MARYS MEDICAL CTR, EVANSVILLE, IN - 482 9/12/11 REQUESTS FOR EXEMPTIONS FOR TOBACCO PRODUCTS, COMM RECS ICL-IP AMERICA INC - APIGARD 01 (AMMONIUM BROMIDE 35% AQUEOUS SOL) FCN 959 ENTRY #BAO-00136668-9 - INVESTIGATIVE RPT FDA/OMPT/CDRH/OCER/DFOI/ LISA BURNS CHURCH & DWIGHT CO INC JOHN LDIEDRICH MILWAUKEE JOURNAL SENTINEL PDI, ORANGEBURG, NY - MED WATCH CMPLNTS #US193105 & US-FDA-456119 K070054 & K100355 MARGARET FILIPIAK PHARMACEULTICAL REGULATORY AFFAIRS SCINOPHARM TAIWAN LTD - EIRS 10/20-23/08 Signature/ Requester Subject
Page 997 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/16/2012 2012-2818 04/18/2012 05/16/2012 Action Office ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2819 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2820 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2821 04/18/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/ATL-DO/ACB/ FDA/OF/CFSAN/OCD/EOS/ 2012-2822 04/18/2012 05/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2823 04/18/2012 05/16/2012 FDA/OF/CFSAN/OCD/EOS/ NCTR/OD/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-2824 04/18/2012 05/16/2012 ORA/ ORA/ ORA/ORO/DIOP/ PICHE, JESSICA ARSENIC IN JUICE BLOCKED SHIPMENTS - MFR, COUNTRY OF ORIGIN, BRAND NAMES, ETC LAST 2 YRS PICHE, JESSICA ARSENIC IN JUICE COMPLIANCE/INFRACTION NOTICES MFR, COUNTRY OF ORIGIN, BRAND NAMES, ETC LAST 2 YRS STEPHEN E. BRANDT, R.Ph. Garden State Phamacy Owners, Inc. NUMBER OF APRVD SPECIALTY DRUGS THAT CAN BE DISPENSED BY LICENSED COMMUNITY PHARMACIES LA TOYA SUTTON BURT'S BEES NATUAAL ACNE SOLUTIONS MAXIMUM STRENGTH SPOT TREATMENT CREAM, PURIFYING GEL MANATT PHELPS & PHILLIPS LLP CLEANSER, DAILY MOISTURIZING LOTION ETC - RECS, CORR HARTWELL P MORSE, III HUSCH BLACKWELL LLP WATSON LABS INC, ABBREVIATED NEW DRUG APPL #079003 RLD: IBANDRONATE SODIUM EQ 150MG BASE, TABLET/ORAL - FDA APRVL LTR 3/20/12 HARTWELL P MORSE, III HUSCH BLACKWELL LLP ORCHID HEALTHCARE, ABBREVIATED NEW DRUG APPL #078998 RLD: IBNDRONATE SODIUM EQ 150MG BASE, TABLET/ORAL - FDA APRVL LTR 3/19/12 Signature/ Requester LEEMON+ROYER PLLC HARTWELL P MORSE, III HUSCH BLACKWELL LLP Subject MM OD, 10.5 MM SMALL STATUTE AMS FEMORAL STEM ETC, AERS MYLAN PHARMS INC ABBREVIATED NEW DRUG APPL #078995, RLD:IBANDRONATE SODIUM EQ 150MG BASE TABLET, ORAL - FDA APRVL LTR 3/19/12
Page 998 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ORO/DIOP/ 2012-2825 04/19/2012 05/17/2012 2012-2826 04/19/2012 05/17/2012 2012-2827 04/19/2012 05/17/2012 2012-2828 04/19/2012 05/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-2829 04/19/2012 05/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2830 04/19/2012 05/17/2012 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-2831 2012-2832 04/19/2012 05/17/2012 04/19/2012 05/17/2012 2012-2833 04/19/2012 05/17/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2834 04/19/2012 05/17/2012 ORA/NE-FO/NYK-DO/NYDCB/ JANET DIXON, RN, JD CHILDRENS HOSPITAL OF KENDALL HEALTHCARE - EIR 2011, 2012 RICHARDSON MD, KARL STATIN - AER FDA/OF/CFSAN/OCD/EOS/ MADHU SONI SONI & ASSOCIATES INC PETER DiGASBARRO TRADEMARK MEDICAL BIRCHWOOD LABS, EDIN PRAIRIE, MN - MOTHWASH INVESTIGATION 10/25/11-11/4/11 GREEN TEA - AER 1/05 TO 3/12 PARIS, CASSANDRA . CMPLNT 123465 RIVERA AS-2743, ROBERTO PROZAC, PAXIL, TRAZADONE, REMERON - AER ORAM, MATTHEW FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ DR. PAUL KOSTERS FINAPRES MEDICAL SYSTEMS BV DR. PAUL KOSTERS FINAPRES MEDICAL SYSTEMS BV FINAPRES MEDICAL SYS BV - FINOMETER NONINVASIVE HEMODYNAMIC MONITOR MODEL 1 K023723 FINAPRES MEDICAL SYS BV - FINOMETER MODEL 2 W/ACCESORIESK063111 LSD CLNCL THERAPEUTIC RESEARCH 1950-1975 SHIRLEY ROSS ROANOKE TRADE SERVICES INC NAVIGATORS INSURANCE - ENTRY #AR820069334 Signature/ Requester Subject
Page 999 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester WISCONSIN 2012-2835 2012-2836 2012-2837 2012-2838 2012-2839 2012-2840 04/19/2012 05/17/2012 04/19/2012 05/17/2012 04/19/2012 05/17/2012 04/19/2012 05/17/2012 04/19/2012 05/17/2012 04/19/2012 05/17/2012 2012-2841 04/19/2012 05/17/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2842 2012-2843 2012-2844 2012-2845 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2846 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-2847 04/20/2012 OM/OSS/OPILS/DFI/ KEN REID FOI DAILY LOG 3;/26/30/12 DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 3/19-23/12 FOI SERVICES INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 3/26-30/12 FOI SERVICES INC FOI DAILY LOG 3/19-23/12 OC/OM/OMP/DDM/ KRISTI SMEDLEY Center for Regulatory Services, Inc. FOI DAILY LOG 3/26-30/12 DKT 1995G-0039 GREGORY J. WOOD O'LEARY WOOD ET AL LLP ARTCAINE - AER, APRVL FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/ ORA/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ TAYLOR X51082, MILMUS DANA THOMPSON FULBRIGHT & JAWORSKI LLP DANA THOMPSON FULBRIGHT & JAWORSKI LLP CAROL NAKAGAWA MERGE HEALTHCARE CAROL NAKAGAWA MERGE HEALTHCARE ULTIMATE FORMULATIONS INC, CITY OF INDUSTRY, CA 482, 483 2/10 TO PRESENT CAPTEK SOFTGEL INTL INC, CERRITOS, CA - 482, 483 2/10 TO PRESENT CARESTREAM HEALTH INC - LIGHTWEIGHT VIEWER K110919 MIM SOFTWARE INC - MOBILE MIM K103785 MATT SCHRADER KOVR-TV BENEFITS AVAILABLE TO PRISONERS CHICKEN JERKY TREAT CMPLNTS 2011 TO PRESENT Subject
Page 1000 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/18/2012 2012-2848 04/20/2012 05/18/2012 2012-2849 2012-2850 2012-2851 2012-2852 2012-2853 2012-2854 2012-2855 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 2012-2856 04/20/2012 05/18/2012 2012-2857 2012-2858 2012-2859 2012-2860 2012-2861 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/FLA-DO/FCB/ INC REGULATORY CONSULTING & SUBMISSIONS FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS ROGER DONALDSON ALLSTATE INSURANCE CO ROGER DONALDSON ALLSTATE INSURANCE CO MARK FRANZEN PRECISION DOSE INC INDUSTRIAL PHARMACY MANAGEMENT - EIRS, AUDITS POLICES, ETC RISPERIDONE ORAL SOL 1 MG/ML ANDA 76-797 ELECTONIC SEQUENCES SN000 TO SN0015 PRESCRIPTION PARTNERS - EIRS, AUDITS, POLICES, ETC FOI DAILY LOG 3/19-23/12 FOI DAILY LOG 3/26-30/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 3/26-30/12 Signature/ Requester WASHINGTON INFORMATION SOURCE KEN REID WASHINGTON INFORMATION SOURCE GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 3/19-23/12 FOI DAILY LOG 3/19-23/12 FOI DAILY LOG 3/26-30/12 FOI DAILY LOG 3/19-23/12 FOI DAILY LOG 3/26-30/12 FOI DAILY LOG 3/19-23/12 FOI DAILY LOG 3/26-30/12 FOI DAILY LOG 3/19-23/12 Subject
Page 1001 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-2862 2012-2863 04/20/2012 05/18/2012 04/20/2012 05/18/2012 2012-2864 2012-2865 04/20/2012 05/18/2012 04/20/2012 05/18/2012 FDA/OF/CFSAN/OCD/EOS/ OC/OCC/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FATIMA ASLAM Keller and Heckman LLP BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC PAULINA DO EXPONENT JOY J LIU ROPES GRAY LLP FRENCH BRONZE TABLETS, NEW YORK, NY - DKT 88CB1936 VERIFIED CMPLNT 6/20/88, AMENDED & SUPPL VERIFIED CMPLNT 9/30/88 , NOTICE OF MOTION FOR SUMMARY JUDGMENT 12/19/88, ETC DOXYCYCLINE HYCLATE ANDA 91-052 - APRVL LTR 2/8/12 CYTOSPORT INC - CORR, MINS REGARDING WARNING LTR 6/29/11 AMERICAN BOTTLED WATER ASSN - GRAS 4G0043 MARS INC - CAP 2C0293 SPIRYCINA BLUE Signature/ Requester Subject
2012-2866
04/20/2012 05/18/2012
DUSTIN BLOCK IPD ANALYTICS LLC
2012-2867 2012-2868
04/20/2012 05/18/2012 04/20/2012 05/18/2012
ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
DANA THOMPSON FULBRIGHT & JAWORSKI LLP R IAN KLUGE Hyman Phelps and McNamara PC
ARIZONA NUTRITIONAL SUPPLEMENTS INC, CHANDLER, AZ - EIRS, 483S, WARNING LTRS, ETC 1/10 TO PRESENT AZTREONAM ANDA 65-439, ANDA 65-286 - APRVL RECS
2012-2869
04/20/2012 05/18/2012
BARBARA MORRISON BIOMARIN PHARMACEUTICAL INC
ALDURAZYME BLA 125058 - STATISTICAL RVWS, CORR
2012-2870 2012-2871 2012-2872
04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012
ORA/SE-FO/FLA-DO/FCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
ANDREW M PARISH ESQ ANDREW M PARISH PA CHRISTOPHER HANDEL CONSUMER REPORTS KATHLEEN G ENGER HOSPIRA INC
ENTRY #86201240565 - RECS DIETARY SUPPLEMENTS - CAERS 2008 TO PRESENT AMIDATE (ETOMIDATE INJ) NDA 18-227 - MEDICAL RVW
Page 1002 of 1132

Total Records: 12455 Control # 2012-2873 Recd Date / Due Date 04/20/2012 05/18/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2874 04/20/2012 05/18/2012 2012-2875 2012-2876 04/20/2012 05/18/2012 04/20/2012 05/18/2012 2012-2877 04/20/2012 05/18/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2878 04/20/2012 05/18/2012 2012-2879 2012-2880 2012-2881 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2882 2012-2883 2012-2884 2012-2885 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) 2012-731 ORIGINAL REQUEST LETTER 2012-1777 ORIGINAL REQUEST LETTER 2012-1812 ORIGINAL REQUEST LETTER 2012-2336 ORA/P-FO/LOS-DO/LACB/ MSNBC.COM Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. ATUL KHARE PHD AKORN INC BAXTER HEALTHCARE CORP - NEXTERONE (AMIODARONE HCL) NDA 22-325 ORIGINAL REQUEST LETTER 2012-2333 Date Range: 08/27/2003 - 10/24/2011; FDA Form 483 inspection records for Diamond Wipes International Inc. of Chino, Calif. Specific dates from August 2003 through October 2011. ORIGINAL REQUEST LETTER 2012-2279 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ GILI FALBISH NAVOTEK MEDICAL LTD JoNel Aleccia MSNBC.COM ATUL KHARE PHD AKORN INC INTUITIVE SURGICAL INC - DA VINCI SURGICAL SYS K101581 Date Range: 01/01/2012 - 04/13/2012; Any and all FDA Inspection records of plants in China that produce chicken jerky pet treats. ALCON LABORATORIES INC - TOBRADEX (TOBRAMYCIN & DEXAMETHASONE OPHTHALMIC OINTMENT) NDA 50-616 KRETZ, MICHAEL AMERIGEL OINTMENT K970133 - INDICATIONS, LIMITATIONS Signature/ Requester STEVE ROOSE MD Columbia Univ. College of Physicians and Surgeons Subject CELEXA (CITALOPRAM HYDROBROMIDE) - POST MARKETING RPTS, QT STUDY RECS, BLACK BOX WARNING, ETC
Page 1003 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/18/2012 2012-2886 2012-2887 2012-2888 2012-2889 2012-2890 2012-2891 2012-2892 2012-2893 2012-2894 2012-2895 2012-2896 2012-2897 2012-2898 2012-2899 2012-2900 2012-2901 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. DAVID SZYDLOSKI KEITH L DAVIDSON LAW OFC Joan Stitt (UG2CD-16) MERCK & CO., INC. DAVID SZYDLOSKI KEITH L DAVIDSON LAW OFC Joan Stitt (UG2CD-16) MERCK & CO., INC. DAVID SZYDLOSKI KEITH L DAVIDSON LAW OFC DONALD GRIGGS CONVAID MEDTRONIC - KAPPA 700/600 SERIES PULSE GENERATORS & MODEL 9953 SOFTWARE P980035 K082314 MEDTRONIC - CAPSURE PACING LEAD MODEL 4695 P950024 ORIGINAL REQUEST 2012-2091 MEDTRONIC - CAPSURE PACING LEAD MODEL 4695 P950024S001-S041 2012-805 ORIGINAL REQUEST LETTER 2012-1890 ORIGINAL REQUEST LETTER 2012-2080 ORIGINAL REQUEST LETTER 2012-1965 ORIGINAL REQUEST LETTER 2012-2072 2012-2045 2012-2053 2012-794 2012-2050 ORIGINAL REQUEST LETTER 2012-2203 2012-2199 Subject
Page 1004 of 1132

Total Records: 12455 Control # 2012-2902 2012-2903 2012-2904 2012-2905 Recd Date / Due Date 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 2012-2906 2012-2907 2012-2908 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2909 2012-2910 2012-2911 2012-2912 2012-2913 2012-2914 2012-2915 2012-2916 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NWE-DO/NWECB/ JAMIE L. WILHITE STURGILL TURNER ET AL Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. 2012-915 2012-916 2012-864 ORIGINAL REQUEST LETTER 2012-1567 COMPLETE RESPONSE 2012-600 COMPLETE RESPONSE 2012-589 CYNOSURE INC, WESTFORD, MA - SMART LIPO 483, EIR 2006 TO 4/16/12 ORIGINAL REQUEST LETTER 2012-1694 BLOOM, DIANE L LUKE, DANIEL FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DONALD GRIGGS CONVAID DONALD GRIGGS CONVAID DEAN GRESHAM PAYNE MITCHELL LAW GROUP ELLOIT FAVUS, MD FAVUS INSTITUTIONAL RESEARCH LLC DAVID SZYDLOSKI KEITH L DAVIDSON LAW OFC MEDTRONIC - KAPPA 70/600 SERIES PULSE GENERATORS & MODEL 9953 SOFTWARE P980035/S001-S265 PHARMACEUTICAL COMPANIES CONSUMER REWARDS PROGRAMS - REGULATIONS MERCK PHARMS - PROPECIA MALE FERTILITY CMPLNTS, SYMPTOMS AFTER STOPING THE DRUG, AGE OF PATIENTS, ETC WARNING LETTERS SINCE 2009 REGARDING ALL NATURAL LABELS ABIOMED - MTG RECS 2/24/12 K111739 Subject K111045
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Total Records: 12455 Control # 2012-2917 2012-2918 Recd Date / Due Date 04/20/2012 05/18/2012 04/20/2012 05/18/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-2919 2012-2920 04/20/2012 05/18/2012 04/20/2012 05/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2921 04/20/2012 05/18/2012 2012-2922 2012-2923 04/20/2012 05/18/2012 04/20/2012 05/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2924 04/20/2012 05/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2925 04/20/2012 05/18/2012 CBER/OCTMA/DDOM/ALFB/ SYDNEY A. HALPERN, Ph.D. UNIVERSITY OF ILLINOIS AT CHICAGO COLLEGE OF LIBERAL ARTS AND SCIENCES FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2927 04/20/2012 FDA/OMPT/CDER/ORP/DIDP/ ABDUR RASHID, Ph.D. ZOVIRAX (ACYCLOVIR) - CMC INFO YASINOW, STEPHEN MTG OF 12/6/50 COMMITTEE ON STERILIZATION OF THE BLOOD & BLOOD DERIVATIVES OF THE HEMOTOLOGY STUDY; MTG OF 3/28/51 LAB OF BIOLOGICS CONTROL & ARMED FORCES EPIDEMIOLOGY BOARD ETC TEVA - OLANZAPINE AER KATHERINE STETSON GLAXO SMITH KLINE TEVA PHARMS - PROAIR HFA INHALATION AEROSOL (ALBUTEROL SULFATE) FIELD ALERT RPTS 2011 TO PRESENT COLAS, BRIAN . ORA/ORM/ ORA/ORM/ ORA/CE-FO/CHI-DO/CCB/ GAIL LESSICK LACHMAN CONSULTANT SERVICES INC PAM ZEKMAN CBS 2 NEWS CHICAGO ABBOTT LABS - BIAXIN AND CLARITHROMYCIN AER DOMESTIC & FOREIGN INSP FOR DRUG COMPANIES, MEDICAL DEVICE MANUFACTURERS, BIORESEARCH MONITORING 2/1-29/12 SUPERMAX HEALTHCARE, AURORA, IL - EIRS LAST 5 YRS Joan Stitt (UG2CD-16) MERCK & CO., INC. MICHELE SINOWAY, PhD. LACHMAN CONSULTANT SERVICES INC ASTRA ZENECA - NEXIUM (ESOMEPRAZOLE MAGNESIUM) NDA 21-153/S008 RVW, APRVL 2012-730 Signature/ Requester Joan Stitt (UG2CD-16) MERCK & CO., INC. PAM ZEKMAN CBS 2 NEWS CHICAGO SUPERMAX HEALTHCARE, SUPERMAX INC - IMPORT REFUSAL RPTS SINCE 2008 Subject 2012-304
2012-2926
04/20/2012 05/18/2012
Page 1006 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/18/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2928 04/20/2012 05/18/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2929 04/20/2012 05/18/2012 2012-2930 04/20/2012 05/18/2012 2012-2931 2012-2932 2012-2933 2012-2934 2012-2935 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/20/2012 05/18/2012 2012-2936 2012-2937 2012-2938 04/20/2012 05/18/2012 04/20/2012 05/18/2012 04/23/2012 05/21/2012 2012-2939 2012-2940 04/23/2012 05/21/2012 04/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ HOFFSTADTER, LYNN RICHARD LARDNER ASSOCIATED PRESS LAURA LUSTER-SANTANGELO HERZFELD RUBIN NU SKIN, PROVO, UT; PHARMANEX, PROVO, UT; HERBALIFE, LOS ANGELES, CA, ETC - DIETARY SUPPLEMENTS CAERS 1/1/08 TO 4/15/12 ALLERGAN - LAP BAND SYS STUDIES, REGISTRATION, MDRS, ETC MERIT MEDICAL, GALWAY, IRELAND - EIRS, 483S CO RESP, FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ JEFFREY G THOMAS ATTY KEVIN S. FRIES COSMETIC INGEDIENT REVIEW VBEC PATCHES - RECS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ FOI SERVICES INC DAVID SELL PHILADELPHIA INQUIRER MTG BETWEEN HANSJORG WYSS, NORIAN, INC, WEST CHESTER, PA & FDA - RPTS, CORR DURASEAL EXACT SPINE SEALANT SYS P80013/S007, DURASEAL DURAL SEALANT SYS P40034/S019, ETC - TEXT OF SUPPLS, CORR, REVISIONS, ETC VCRP DATA LAUREN S. BARR INC RESEARCH CONSULTING & SUBMISSIONS LARUREN S. BARR INC RESEARCH CONSULTING & SUBMISSIONS LISA TARRISON-SCHRAMP CanReg, Inc. DAVID McFARLAND FDA WEBVIEW/FERDIC INC DAILY LOG 4/9-13/12 DAILY LOG 4/9-13/12 DAILY LOG 4/9-13/12 DAILY LOG 3/9-13/12 DAILY LOG 3/9-13/12 BAMBANG S. ADIWIJAYA, Ph.D. MERRIMACK PHARMACEUTICALS INC TARCEVA (ERLOTINIB HYDROCHLORIDE) - SBA Signature/ Requester BIOQ IRB INC Subject
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Total Records: 12455 Control # Recd Date / Due Date 05/21/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-2941 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2942 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2943 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2944 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2945 04/23/2012 05/23/2012 2012-2946 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2947 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2948 04/23/2012 05/21/2012 FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FOI SERVICES INC YANTAI CHINA PET FOODS, SHANDONG PROVINCE, CHINA - EIRS, 483S, CO RESP, ETC 2012 FOI SERVICES INC SHIRE ORPHAN THERAP - FIRAZYR (ICATIBANT INJ) NDA 22-150 AERS, NON-CLNCL SAFETY RECS FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ ANGELA D COBLE KENNEDY BERKLEY YARNEVICH & WILLIAMSON CHTD LEV PHARMS - CINRYZE (C1 ESTERASE INHIBITOR HUMAN) BLA 12-567 AERS, NON-CLNCL SAFETY RECS INDIVIDUAL RECS - VAERS FOI SERVICES INC LUNDBECK - WINSTROL (STANOZOLOL) NDA 12-885 AERS, NON-CLNCL SAFETY RECS FOI SERVICES INC SANOFI AVENTIS - DANOCRINE (DANAZOL) NDA 17-557 AERS, NON-CLNCL SAFETY RECS JAY H HENDERSON JAY HENDERSON PLLC BAXTER HEALTHCARE - VANCOCIN, VANCOCIN HCL (VANCOMYCIN HCL) NDA 50-871 RECS FOI SERVICES INC CSL BEHRING - BERINERT (C1 ESTERASE INHIBITOR HUMAN) BLA 12-587 AERS NON-CLNCL SAFETY RECS Signature/ Requester FOI SERVICES INC Subject ETC 9/11 TO 12/11
Page 1008 of 1132

Total Records: 12455 Control # 2012-2949 2012-2950 2012-2951 Recd Date / Due Date 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 2012-2952 04/23/2012 05/21/2012 2012-2953 04/23/2012 05/21/2012 2012-2954 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2955 2012-2956 04/23/2012 05/21/2012 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2957 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2958 04/23/2012 05/21/2012 2012-2959 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2960 04/23/2012 OC/OCC/ LANCE ROBINSON NATIONAL WHISTLEBLOWER CENTER ET AL V DEPT OF DUFFEY, ALEX FDA/OO/OFBA/OAGS/ PHILIP SONSON WALTERS KLUWER PHARMA SOLUTIONS THOMSON REUTERS - DERWANT WORLD DRUG INDEX HHSF22301110176C-178C LARIAM - AERS ALEX GURIEV CPMG INC HP ACTHAR GEL (REPOSITORY CORTICOTROPIN INJ) AERS GOURAB DE FDA/OMPT/CDRH/OCER/DFOI/ ANDREW HACK MD PHD MILLENNIUM MANAGEMENT LLC ABIOMED, MIKE MINOGUE, DAVID WEBER, KARIM BENALI, ETC - MINS, AGENDA, TRANS, ETC 2/24/12 ELI LILLY & CO - STRATTERA (ATOMOXETINE HCL ATX) ADHD-RS-IV SCORES FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OF/CFSAN/OCD/EOS/ Signature/ Requester THOMAS E SOULE EDELMAN COMBS ET AL MAX H BURNELL KIKO FOODS INC DAVID SHELTON DAVID SHELTON ATTY DAVID SHELTON DAVID SHELTON ATTY TONY BARTISH PARK WEST ASSET MANAGEMENT LLC ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS APP PHARMS - OXYTOCIN NDA 18-248 NON-CLNCL SAFETY RECS Subject IMPORTED CHICKEN JERKY USED AS PET FOOD TESTING, RESEARCH, INVESTIGATION, ETC KIKO FOODS INC, KENNER, LA - CERTIFICATE OF FREE TRADE ALEXIA FOODS INC, CONAGRA FOODS INC - RESP TO WARNING LTR 11/16/11; CONAGRA FOOD INC MISBRANDING OF FOOD PRODS RECS NESTLE USA INC, NESTLE HOLDINGS INC, GERBER PRODUCTS CO - RESP TO WARING LTR 2/22/10, MISBRANDING OF FOOD PRODS RECS MEETING 2/24/12 - RECS
Page 1009 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/21/2012 2012-2961 2012-2962 2012-2963 2012-2964 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 2012-2965 2012-2966 2012-2967 2012-2968 2012-2969 2012-2970 2012-2971 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-2972 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2973 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ KATHRYN D MATHEWS INTERMOUNTAIN MEDICAKL BIVALIRUDIN - AERS GARY L VERON SIDLEY AUSTIN LLP GENERIC SODIUM FERRIC GLUCONATE COMPLEX PROD ANDA 78-215 - APRVL RECS 3/31/11 TAMMARA, RANDOLPH GARY L VERON SIDLEY AUSTIN LLP FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ HONG SAJONZ Bayer HealthCare Pharmaceuticals MICHAEL TREAS HOLLYWOG, llc MICHAEL TREAS HOLLYWOG, llc BAYER - MARGARET HECKLER HOLDING ASPRIN BOTTLE PHOTO 10/85 BIO PROTECH INC, GANWON-DO, REPUBLIC OF KOREA EIR MOST RECENT APEX MEDICAL CORP, TUCHENG, TAWAIN, CHINA - EIR MOST RECENT TEI BIOSCIENCES INC - PROMATRIX DERMAL REPAIR SCAFFOLD K083440 TEI BIOSCIENCES INC - PROMATRIX DERMAL REPAIR SCAFFOLD K061407 PHARMACEUTICAL FACILITIES AND SUPPLIERS IN CHINA & INDIA - INSPS, ACTIVE INDREDIENT RECS GENERIC IRON SUCROSE INJ PRODS - SCIENTIFIC TESTS AND STANDARDS, DRAFT GUIDANCE FOR INDUSTRY ON BIOEQV RECOMMENDATION FDA/OO/OFBA/OAGS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ BRETT, MURDOCK BEN F PIERCE GORE BEN F PIERCE GORE ATTY MIRANDA HOOKER WILMER HALE EDWARD R BLUMBERG DEUTSCH & BLUMBERG PA Action Office Signature/ Requester LONDON AND MEAD Subject HEALTH AND HUMAN SERVICES ET AL - RECS HUGE DENTAL MATERIAL CO LTD - SYNTHERIC POLYMER TEETH K101029 UNILEVER AMERICAS, UNILEVER INC - RESP TO WARNING LTR, MISBRANDING OF FOOD PRODS 8/23/10 DELTA HEALTH ALLIANCE - DELTA HEALTH INITIATIVE COOPERATIVE AGREEMENT AWARD NUMBER U1FRH07411 INFUPHARMA LLC - INVESTIGATION RECS, MEMOS, STATEMENTS, ETC
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2974 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2975 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ 2012-2976 2012-2977 2012-2978 2012-2979 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 04/23/2012 05/21/2012 2012-2980 2012-2981 04/23/2012 05/21/2012 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2982 2012-2983 04/23/2012 05/21/2012 04/23/2012 05/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-2984 04/23/2012 ORA/OCI/ JULIA HARUMI MASS INVESTIGATION AND SURVEILLANCE OF MUSLIM Doe J OC/OM/OMP/DDM/ KIRSTEIN LUSTILA KIRSTEIN LUSTILA AUXILIUM PHARMACEUTICALS INC, MALVERN, PA XIAFLEX AERS, RPTS 2/2/10 TO PRESENT DKT 1978N-0023 ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ DIANA-LYNNE HSU SADAKA ASSOCIATES LLC PRICE CLARK COOK MOTLEY RICE LLC VALEANT PHARMS/GLAXOSMITHKNINE - WELLBLUTRIN, SNDA 344, NDA 18-644 GARDASIL - VAERS ORA/CE-FO/PHI-DO/PCB/ GERHARDT, NATHAN ROBERT STEELE STRYKER MEDICAL HILL-ROM INC, BATESVILLE IN - 483, 9/20/11-10/11/11 ORA/P-FO/LOS-DO/LACB/ GERHARDT, NATHAN ORA/CE-FO/DET-DO/DCB/ BECKY COOSEMAN BROWN & CROUPPEN PC MEAD JOHNSON - ENVIRONMENTAL SPLS, RESULTS, OBSERVATIONS, ETC HEALTH ONE PHARMACEUTICALS INC, EL MONTE, CA 483S 9/14/11 - 10/5//11 PROTICA INC, WHITEHALL, PA - 483S, 9/29/11 - 10/6/11 R. IAN KLUGE Hyman Phelps and McNamara PC RUIBANG (ZHEJIANG RUIBANG LABS), ZLHEJIANG PROVIDENCE, CHINA - EIRS, 483S, CO RESPS ETC GERALD J OREHOSTKY ANTARES PHARMA INC SANDOZ, INC, EBEWE PHARMA GESMBH MFG KG, ATTERSEE, AUSTRIA - EIRS, 483S, RPTS ETC Signature/ Requester CTR Subject
Page 1011 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/21/2012 Action Office ORA/OCI/ Signature/ Requester AMERICAN CIVIL LIBERTIES UNION OF NORTHERN CALIFORNIA CRAWFORD, WANDA Subject COMMUNITIES IN NORTHEN CALIFORNIA - FBI RECS 12/17/09 TO PRESENT ONGLYZA - MEDWATCH RPT
2012-2985
04/24/2012 05/22/2012
2012-2986
04/24/2012 05/22/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/
BRENDA M. GARTZ ELI LILLY & CO
CATALENT PHARMA SOLUTIONS, BRUSSELS, BELGIUM 483 7/09
2012-2987
04/24/2012 05/22/2012
FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/
SYMONE J. REDWINE KELLEY WITHERSPOON LLP
LOREAL COSMETICS - GARNIER FRUCTIS SLEEK & SHINE CMPLNTS
2012-2988 2012-2989
04/24/2012 05/22/2012 04/24/2012 05/22/2012
FDA/OMPT/CDRH/OCER/DFOI/ RUBLEIN, TOM FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ RAJAN S. EMBRAN JUBILANT CADISTA PHARMACEUTICALS INC
UNSAFE AND INEFFECTIVE DEVCS IN THE EU THAT WERE NOT APRVD IN THE US - CPRT ACTONEL NDA 20-835 - LBLG, APRVL
2012-2990
04/24/2012 05/22/2012
CHARLES CELESTE EAS Consulting Group, LLC
ALDARA CREAM NDA 20-723 - APRVL, LBLG, CHEMISTRY RVW 2/27/97
2012-2991 2012-2992
04/24/2012 05/22/2012 04/24/2012 05/22/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
Joan Stitt (UG2CD-16) MERCK & CO., INC. BRENT M. ARDAUGH NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE FERNAND TERRADAS, Ph.D. MEDTRONIC INTERNATIONAL TRADING SARL
FOI DAILY LOG 4/2-20/2012; K022236, K031328
2012-2993
04/24/2012 05/22/2012
SI-LOK SACROILIAC JOINT FIXATION SYS K112028
Page 1012 of 1132

Total Records: 12455 Control # 2012-2994 Recd Date / Due Date 04/24/2012 05/22/2012 2012-2995 04/24/2012 05/22/2012 2012-2996 04/24/2012 05/22/2012 2012-2997 2012-2998 2012-2999 2012-3000 2012-3001 2012-3002 04/24/2012 05/22/2012 04/24/2012 05/22/2012 04/24/2012 05/22/2012 04/24/2012 05/22/2012 04/24/2012 05/22/2012 04/24/2012 05/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3003 2012-3004 2012-3005 2012-3006 04/24/2012 05/22/2012 04/24/2012 05/22/2012 04/25/2012 05/23/2012 04/25/2012 05/23/2012 FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L ORA/ORO/DIOP/ ORA/ORO/DIOP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BRIAN HARTMAN ABC NEWS BRIAN F. TODT CARE FUSION CORP SERA LAM FILIGENT (HK) LTD INSTRUCTIONS PROVIDED TO OFFICIAL CORRESPONDENTS OF MEDICAL DVC COMPANIES CONCERNING THEIR DUTIES TO PROVIDE INFO FOR CDRH ONLINE REGISTRATION & LISTING DATABASE ALLERGAN - BOTOX & BOTOX COSMETIC AERS HELTON, SHARLA BIOFRIEND, BIOMASK SURGICAL FACEMASK - K101128 4 FOI REQUESTS - DELETED RECS SEAFOOD IMPORT REFUSALS 2011 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ GAYLORD, BRAIN JEFF SPEDDING Additives for Paper Industry GmbH MARK PIKKO BARON & BUDD PC RENAE N. FEO INTEGRA LIMIT UNCERTAINTY G. SRINIVAS ZYDUS PHARMACEUTICALS USA INC INTELGENX CORP - FORFIVO XL (BUPROPION HYDROCHLORIDE) NDA 22-497 SBA CYTOSPORT INC - MEMOS, TRANS, LTRS, ETC 9/11 TO PRESENT INSTRUMED FORCEPS OBSTETRICAL K092840 APIGARD 01 - FCN 959 ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester FERNAND TERRADAS, Ph.D. MEDTRONIC INTERNATIONAL TRADING SARL FERNAND TERRADAS, Ph.D. MEDTRONIC INTERNATIONAL TRADING SARL FERNAND TERRADAS, Ph.D. MEDTRONIC INTERNATIONAL TRADING SARL STEVEN SCHUSTER McLAUGHLIN & STERN LLP SHISHI HUABAO MINGXIANG FOODSTUFF CO LTD - ENTRY NO 224-3078522-4/5/1, IMPORT REFUSAL RECS INDIVIDUAL RECS 1965 TO PRESENT SYNTHES 6.5MM CANNULATED SCREW K021932 SIJF CANNULATED SCREW SYS K051296 Subject SIMMERTRY SACROILIAC JOINT FUSION SYS K102907
2012-3007
04/25/2012 05/23/2012
Page 1013 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3008 2012-3009 04/25/2012 05/23/2012 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3010 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3011 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3012 04/25/2012 05/23/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ MARK PIFKO BARON & BUDD PC CYTOSPORT INC - VANILLA CREME MUSCLE MILK LIGHT NUTRITIONAL SHAKES, CHOCOLATE MUSCLE MILK PREOTEIN NUTRITION SHAKE, ETC MEMOS, TRANS, INVESTIGATION, ETC SHIPLEY GROUP, FARMINGTON, UT - REQUESTS FOR PROPOSALS, CURRENT AND PAST CONTRACTS, SUBMITTED BIDS, ETC LOVASTATIN, SIMVASTATIN, PRAVASTATIN, ETC - AERS Doe J MAXALT - AERS CRAIG KRUMAN VPCI INC SODIUM FERRIC GLUCONATE - LIST OF COMPANIES WHO HAVE FIELD DRUG APPLS FDA/OMPT/CDRH/OCER/DFOI/ GOLDSTEIN, KEITH KEELEY ZECCA SUPERIOR RESEARCH & SUBMISSIONS LIST OF ALL WITHDRAWN, ADANDONED OR INACTIVE NDA'S DOCUMENT NUMBER GEN 1001245 Signature/ Requester Subject
2012-3013
04/25/2012 05/23/2012
FDA/OO/OFBA/OAGS/ TITUS, DAVID M FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ EMIL M DEGOMA MD PENN MEDICINE
2012-3014
04/25/2012 05/23/2012
2012-3015 2012-3016
04/25/2012 05/23/2012 04/25/2012 05/23/2012
ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
REMA C BHAMRE SELF & BHAMRE ATTY SHERI BUTLER SHEPPARD MULLIN RICHTER & HAMPTON, LLP
ADYA INC - ADYA CLARITY TEST RECS LUITPOLD PHARMACEUTICALS INC - VENOFER (IRON SUCROSE INJ) NDA 21-135 AERS
Page 1014 of 1132

Total Records: 12455 Control # 2012-3017 2012-3018 Recd Date / Due Date 04/25/2012 05/23/2012 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ 2012-3019 2012-3020 04/25/2012 05/23/2012 04/25/2012 05/23/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-3021 04/25/2012 05/23/2012 2012-3022 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3023 04/25/2012 05/23/2012 2012-3024 04/25/2012 05/23/2012 2012-3025 2012-3026 2012-3027 04/25/2012 05/23/2012 04/25/2012 05/23/2012 04/25/2012 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC MITCHELL A GOLDSTEIN BABENER & ASSOCS ARUN K CHOPRA TISHCON CORP SEPHY PHILIP RPH PHARM D SCIENTIFIC EXCHANGE LLC GARDEN STATE NUTRITIONALS, WEST CALDWELL, NJ EIR, 483 MOST RECENT BOCA PHARMA - HYDROCORTISONE ACETATE, PRAMOXINE HCL ANDA 89-440 SBA MAX INTERNATIONAL - MAXGXL CAERS CAERS 141371 - ADDITIONAL RECS CARES 135811 - ADDITIONAL RECS FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC SHERI BUTLER SHEPPARD MULLIN RICHTER & HAMPTON, LLP LUITPOLD PAHRMACEUTICALS INC - DEXFERRUM (IRON DEXTRAN INJ) NDA 40-024 AERS 4/1/11 TO PRESENT CAERS 150444 - ADDITIONAL RECS JOHN F COSTELLO JR TROUTMAN SANDERS LLP MORGAN LAMARE BECK & AMSDEN PLLC NEW CHAPTER INC - CMPLNTS, CORR, INVESTIGATION, ETC BRISTOL-MYERS SQUIBB CO - ABILIFY CORR Action Office ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester VY TRAN VARIAN MEDICAL SYSTEMS INC CHRISTOPHER MARLBOROUGH FARUQI & FARUQI LLP Subject VARIAN MEDICAL SYSTEMS INC, PALO ALTO, CA - EIRS 10/5-18/10 GSC PRODUCTS LLC, CLIFTON PARK, NY, SICAP INDUSTRIES LLC, ALBANY, NY - SINUS BUSTER, COLD BUSTER, ALLERGY BUSTER, ETC EIRS, MISBRANDING, AERS, ETC
Page 1015 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3028 2012-3029 2012-3030 2012-3031 04/25/2012 05/23/2012 04/25/2012 05/23/2012 04/25/2012 05/23/2012 04/25/2012 05/23/2012 2012-3032 2012-3033 2012-3034 2012-3035 2012-3036 04/25/2012 05/23/2012 04/25/2012 05/23/2012 04/26/2012 05/24/2012 04/26/2012 05/24/2012 04/26/2012 05/24/2012 2012-3037 04/26/2012 05/24/2012 2012-3038 04/26/2012 05/24/2012 2012-3039 04/26/2012 05/24/2012 2012-3040 04/26/2012 05/24/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/PHI-DO/PCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ SPEARS 297965, PHILLIP LEE OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ O'LEARY, KEVIN H. CARL JENKINS WOOD BURDITT GROUP MARILYNN WHITNEY COVINGTON & BURLING LLP AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC AMY ERIKSON HAGEN CRYOGENIC LABORATORIES INC AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC AMY ERICKSON HAGEN CRYOGENIC LABORATORIES INC CRYOBANK, PITTSBURGH, PA - EIR, WARNING LTR, CO RESP 5/05 TO PRESENT DKT FDA-2010-P-0491 DKT 1981N-0033P FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ O'LEARY, KEVIN CONFIRMA - CADSTREAM 5 K081556 SENTINELLE MEDICAL INC - AEGIS NAVIGATION K093672 O'LEARY, KEVIN ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ ROGER DONALDSON ALLSTATE INSURANCE CO MICHAEL E ATWATER ESQ ATWATER AND DAVIS LLC ALEX GURIEV CPMG INC INVIVO - DYNACAD 1.0 K041286 UNIT DOSE SERVICE LLC - INSPS, POLICIES, PROGRAMS, ETC PICTSWEET CO - FROZEN PEAS RECALL, NOTES, RPTS, DATA COMPILATIONS, ETC 2010 ABIOMED MANAGEMENT TEAM MTG - RECS 2/24/12 Signature/ Requester Subject
CRYOBIOLOGY INC, LA CROSSE, WI - EIR, WARNING LTR, CO RESP 5/05 TO PRESENT
CRYOBIOLOGY INC, COLUMBUS, OH - EIR, WARNING LTR, CO RESP 5/05 TO PRESENT
REPRODUCTIVE DIAGNOSTICS INC, COLUMBUS, OH - EIR, WARNING LTR, CO RESP 5/05 TO PRESENT
GEODONE, TRAZADONE, DIPHENHYDRAMINE, REMAZON, BENZTROPINE, NEPROXEN - AER
Page 1016 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3041 04/26/2012 05/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3042 2012-3043 04/26/2012 05/24/2012 04/26/2012 05/24/2012 2012-3044 2012-3045 2012-3046 2012-3047 04/26/2012 05/24/2012 04/26/2012 05/24/2012 04/26/2012 05/24/2012 04/26/2012 05/24/2012 ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/ATL-DO/ACB/ ORA/ ORA/ 2012-3048 04/26/2012 05/24/2012 2012-3049 04/26/2012 05/24/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3050 04/26/2012 05/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ AARON M. TEJANI, BSc, PHARMD, ACPR FRASER HEALTH AUTHORITY ANGLOTENSIN RECEPTOR BLOCKERS - AER NED FEDER, M.D. PROJECT ON GOVERNMENT OVERSIGHT ADVISORY COMMITTEE MTG 2/22/12 ENDOCRINOLOGIC & METABOLIC DRUGS ADVISORY COMMITTEE DOUGLAS N. BLUE ZETETIC GLOBAL MED LTD, ESSEX, UK - GLUCOSE TEST STRIP ENTRY NO F23-9050001- 5/1/1 OC/COS/OES/ OC/COS/OES/ CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ALICE MOORE HARVEST SELECT CATFISH LAUREN S. BARR INC RESEARCH CONSULTING & SUBMISSIONS TANYA RHODES MANUKA MEDICAL ANTHONY W. LEE NTEU CHAPTER 282 SHAMEEN AFIF-RIDER MEDIMMUNE INC BRANDON BROWN MACUGA LIDDLE & DUBIN PC DIAMOND NATURALS LAMB & RICE - CMPLNTS 1/12 TO PRESENT VAERS 362911 FDA DIVERSITY COUNCIL - RPT 1/12 - 3/7/12 MANUKA TEX K110042, MANUKA HD K102659 2012-2756 HARVEST SELECT CATFISH, UNIONTOWN, AL - 483 7/25/11 COOPER 328257, JACK BENADRYL, ULTRAM, KLONOPIN - AER Signature/ Requester Subject
Page 1017 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3051 04/26/2012 05/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ 2012-3052 04/26/2012 05/24/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-3053 04/26/2012 05/24/2012 2012-3054 04/26/2012 05/24/2012 2012-3055 2012-3056 2012-3057 2012-3058 2012-3059 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3060 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ YELENA PIMENOV LANDON-IP INC ARAVA NDA 20-905 - FORM FDA 3242 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ CVM/OCD/ JENNIFER SORENSON NATURAL RESOURCES DEFENSE COUNCIL JACK MEYERSON MEYERSON & O'NEILL ATTY JACK MEYERSON MEYERSON & O'NEILL ATTY PETE KILPATRICK ORTHOSCAN INC LINDA KARIYA NIHON KOHDEN AMERICA WARREN WILLIAMS FOREST RESEARCH INSTITUTE SERQUEL XR (QUETIAIPINE FUMARATE) ER TABS NDA 22047/S011 - APRVL RECS INSIGHT - FD MINI C-ARM FLUOROSCOPIC IMAGING SYS K120388 K080546, K050833, K022121 OXYELITE - CAERS QUALITATIVE MICROBIAL FOOD SAFETY RISK ASSESSMENTS OF ANIMAL DRUG PRODS - RESULTS, ANALYSIS, CORR, ETC MELTDOWN - CAERS DANIEL r. LEATHERS LIEFF CABRASER ET AL SIMPLY TICK GEL; XANTHAN GUM POWDER INVESTIGATIONS GERBER, LUCIE PARKE-DAVIS, WARNER-LAMBERT, COGNEX (TACRINE) CORR, HISTORY, CLNCL TRIALS, ETC DR. NIR SHTAYER OMRIX PHARMACEUTICALS LTD BAXTER - TISSEEL (FIBREN SEALANT) CMC DATA, LBLG Signature/ Requester Subject
Page 1018 of 1132

Total Records: 12455 Control # 2012-3061 Recd Date / Due Date 04/27/2012 05/25/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3062 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3063 2012-3064 04/27/2012 05/25/2012 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3065 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-3066 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3067 2012-3068 04/27/2012 05/25/2012 04/27/2012 05/25/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ WILLIAM KONSTAND TAG HEALTHCARE DAWN HAAKE NUVASIVE INC THE ARESON GROUP INC, TAG HEALTHCARE, TAG MEDICAL, ETC - EIRS 2001 NUVASIVE INC, MEMPHIS, TN - EIR NON-REDACTED 9/09, 11/11 BRAYDON BURGESS LYPRO BIOSCIENCES INC AMPHOTEC NDA 50-729/000 - APRVL PKG PHARMACOLOGY, MICROBIOLOGY RVWS SHAWN FOX TRACEY LAW FIRM LUNDBECK - CELEXA (CIPRAMIL, CITALOPRAM) ANIMAL STUDIES, CORR, MINS, ETC ORA/CE-FO/NJ-DO/NJCB/ SRINIVASA R PARUCHURI CISPHARMA OMC BRAYDON BURGESS LYPRO BIOSCIENCES INC ABELCET NDA 50-724/S000 - APRVL PKG PHARMACOLOGY, MICROBIOLOGY RVWS CISPHARMA INC, CRANBURY, NJ - EIR 12/16/10 TO 1/24/11 LORRAINE J PUGNI AARONSON RAPPAPORT ET AL MARC STRAUS MD - CONSENT AGREMENT 5/18/82 (CERTIFIED) Signature/ Requester BRAD E COOPER HAMOT MEDICAL CENTER Subject PRECEDEX (DEXEMEDETOMIDINE) - AERS
Page 1019 of 1132

Total Records: 12455 Control # 2012-3069 2012-3070 Recd Date / Due Date 04/27/2012 05/25/2012 04/27/2012 05/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3071 04/27/2012 05/25/2012 2012-3072 2012-3073 2012-3074 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 06/29/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ ORA/ ORA/ 2012-3075 2012-3076 2012-3077 2012-3078 2012-3079 2012-3080 2012-3081 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ PATRICK SCHREXNAILDER AMIPURDUE MELISSA EGAN WATERS CORP AMY FOWLER Ecolab AMY FOWLER Ecolab KORINA AKHONDZADEH KARA & ASSOCIATES INC KORINA AKHONDZADEH KARA & ASSOCIATES INC KORINA AKHONDZADEH KARA & ASSOCIATES INC NANOFUSE K120279 DYNAGRAFT II K040419 BACTERIN K091321 STRYKER - STRI-SHIELD FLYTE TOGAS K073017 CASA FUTURA TECHNOLOGIES - BIOFEEDBACK SYS FOR SPEECH DISORDERS K942651 THERMO SCIENTIFIC - QMS EVEROLIMUS REAGENTS, QMS CALIBRATORS, QMS CONTROLS K100144 STRYKER - T6 HOODS AND TOGAS K063005 BARRETT LAW GROUP PA OC/COS/OL/ WADMAN, MEREDITH DEL MONTE - FOOD PRODS MISBRANDING CORR, RECS ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/PHI-DO/PCB/ RUCHIKA CHANDRAN REGULATORY COMPLIANCE ASSOCIATES INC KIM NGUYEN AP PHARMA INC REP HENRY WAXMAN - RESP TO CONGRESSIONAL CORR LIFECORE BIIOMEDICAL LLC - EIRS, 483S LAST 3 YRS MEDRAD INC, INDIANOLA, PA - EIRS 8/11, 1/11, 2/11 Doe J Action Office ORA/P-FO/LOS-DO/LACB/ Signature/ Requester DAWN HAAKE NUVASIVE INC Subject NUVASIVE INC, SAN DIEGO, CA - EIRS NON-REDACTED DVC INSP 4/04, TISSUE INSP 8/03 BURZYNSKI RESEARCH INSTITUTE IRB - NOTIFICATION LTR
Page 1020 of 1132

Total Records: 12455 Control # 2012-3082 2012-3083 2012-3084 2012-3085 2012-3086 Recd Date / Due Date 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/27/2012 05/25/2012 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3087 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3088 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3089 2012-3090 2012-3091 2012-3092 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3093 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JODY L GREEN PHD ROCKY MOUNTAIN POISON AND DRUG CENTER COUGH AND COLD PREPARATIONS - ISRS 7912526-4, 7919138-4, 7919802-X, ETC Doe J CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ RICHARD O WOOD WOOD BURDITT GROUP KATE B WILSON CENTER FOR PUBLIC INTEGRITY DAVID E LINDEN MD LINDEN & ASSOCIATES LINDEN RESEARCH CONSULTANTS LLC - 483S, CO RESP 2006, 2007 BEDFORD LABS - COSMEGEN (DACTINOMYCIN) ANDA 90304 RECS UCSF MEDICAL CENTER, SAN FRANCISCO, CA MEDWATCH 3500A, FORM FDA 3419 ALLOGRAFT TISSUE DATABASE JODY L GREEN PHD ROCKY MOUNTAIN POISON AND DRUG CENTER COUGH AND COLD PREPARATIONS - ISRS 7591076-1, 7597960-7, 7598122-X, ETC CANDICE DURRENCE OPTIMER PHARMACEUTICALS INC DIFICID (FIDAXOMICIN TABS) NDA 201-699 AERS 7/18/11 TO 4/26/12 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC IVAN KORENDOVYCH SYRACUSE UNIV CENTER FOR SCIENCE AND TECHNOLOGY BYDUREON NDA 22-200 - APRVL LTR, LBLG, RVWS, ETC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester KORINA AKHONDZADEH KARA & ASSOCIATES INC MESYNTHES LTD - ENDOFORM DENTAL TEMPLATE K101546 MESYNTHES LTD - ENDOFORM DENTAL TEMPLATE K092096 COOK BIOTECH INC - OASIS WOUND MATRIX K061711 Subject OSTEOTECH K043048
Page 1021 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3094 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3095 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3096 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3097 04/30/2012 05/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3098 04/30/2012 05/29/2012 2012-3099 04/30/2012 05/29/2012 2012-3100 04/30/2012 05/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3101 2012-3102 2012-3103 2012-3104 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ LORI A COLVIN CYBERSONICS INC SERA LAM FILLIGENT (HK) LTD ROBERTA LEE ACUEITY HEALTHCARE INC BARD - HERNIA MESH RECALL,CMPLNTS VIADUCT MINISCOPE AND ACCESSORIES K040949 MED-SONICS CORP - URETRON MULTI PROBE LITHOTRIPTER K111058 BIOFRIEND, BIOMASK SURGICAL FACEMASK K101128 KENNETH REID WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE JORGE L CARDENAS UNILEVER DISCOVER RIMANTADINE, AMANTADINE, ADOPALENE - APRVL RECS FOI DAILY LOG 4/9-13/12 FOI DAILY LOGS 4/2-6/12 JOSEPH MUSTO METHYLGENE INC PFIZER - DIFLUCAN (FLUCONAZOLE) NDA 19-949 CMC RVW SECTION SUSANNA GREENBERG ESQ BALLARD SPAHR LLP WOCKHARDT - ANDA 78-492 APRVL RECS JODY L GREEN PHD ROCKY MOUNTAIN POISON AND DRUG CENTER COUGH AND COLD PREPARATIONS - ISRS 7652851-8, 7652852-X, 7655799-8, ETC JODY L GREEN PHD ROCKY MOUNTAIN POISON AND DRUG CENTER COUGH AND COLD PREPARATIONS - ISRS 7802323-9, 7821102-3, 7823760-6, ETC Signature/ Requester Subject
Page 1022 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/29/2012 2012-3105 04/30/2012 05/29/2012 2012-3106 2012-3107 2012-3108 2012-3109 2012-3110 2012-3111 2012-3112 2012-3113 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 2012-3114 04/30/2012 05/29/2012 2012-3115 2012-3116 2012-3117 2012-3118 2012-3119 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INC REGULATORY CONSULTING FOI SERVICES INC BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC FOI DAILY LOG 4/2-6/12 FOI DAILY LOG 4/9-13/12 FOI DAILY LOG 4/2-9/12 FOI SERVICES INC FOI DAILY LOG 4/9-13/12 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ Signature/ Requester Doe J TRAVIS SCHAFTENAAR UBS GLOBAL ASSET MANAGEMENT MELISSA EGAN WATERS CORP MELISSA EGAN WATERS CORP MEGAN B PICKEL BEVERIDGE & DIAMOND PC GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 4/2-6/12 FOI DAILY LOG 4/9-13/12 FOI DAILY LOG 4/2-6/12 FOI DAILY LOG 4/9-13/12 FOI DAILY LOG 4/2-6/12 FOI DAILY LOG 4/2-6/12 FOI DAILY LOGS 4/9-13/12 NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U K093916 THERMO SCIENTIFIC - QMS EVEROLIMUS REAGENTS, QMS CALIBRATORS, QMS CONTROLS K100144 CFSAN FOIA REQUESTS 3/16/12-4/26/12 HILL-ROM, BATESVILLE, IN - 483S 1/10 TO PRESENT Subject
Page 1023 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester & SUBMISSIONS 2012-3120 04/30/2012 05/29/2012 2012-3121 04/30/2012 05/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3122 04/30/2012 05/29/2012 2012-3123 04/30/2012 05/29/2012 2012-3124 2012-3125 04/30/2012 05/29/2012 04/30/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OGROP/OIP/ 2012-3126 2012-3127 2012-3128 2012-3129 2012-3130 2012-3131 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NYK-DO/NYDCB/ KATE KIADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC ULTRA-SEAL CORP, NEW PALTZ, NY - EIRS, 483S CO RESPS ETC LAST 5 YRS ULTRA -TAB LABS INC, HIGHLAND, NY - EIRS, 483S CO RESPS ETC LAST 5 YRS ASPIRE PHARMS, SOMERSET, NJ - EIRS, 483S CO RESPS ETC LAST 5 YRS US PHARMA LAB INC, NORTH BRUNSWICK, NJ - EIRS, 483S CO RESPS ETC LAST 5 YRS GARDEN STATE NUTRITIONALS (VITAQUEST), WEST CALDWELL, NJ - EIRS, 483S CO RESPS ETC LAST 5 YRS AMNEAL PHARMACEUTICALS, LLC, PATERSON, NJ - EIRS, 483S CO RESPS ETC LAST 5 YRS ORA/P-FO/LOS-DO/LACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/CIN-DO/CCB/ TRAVIS SCHAFTENAAR UBS GLOBAL ASSET MANAGEMENT ANGELA MITCHELL VIACORD CORD BLOOD BANKING RESEARCH MELISSA EGAN WATERS CORP KATE WILLSON ICIJ STEMCYTE INC, COVINA, CA - EIR, 483, CO RESP ETC 2/311/10 INVACARE, ELYRIA, OH - EIRS 2010. 2011 Doe J INC REGULATORY CONSULTING & SUBMISSIONS AMIODARONE - AERS FOI DAILY LOGS 4/9-13/12 Subject
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040 K083130 NIKOLAEV REGIONAL BUREAU OF FORENSIC MEDICAL EXAMINATION (NIK1) - DATE OF FDA INACTIVE CHANGE, COMM, RECS ETC
Page 1024 of 1132

Total Records: 12455 Control # 2012-3132 2012-3133 2012-3134 2012-3135 2012-3136 2012-3137 2012-3138 Recd Date / Due Date 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 04/30/2012 05/29/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3139 2012-3140 05/01/2012 05/30/2012 05/01/2012 05/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3141 2012-3142 2012-3143 2012-3144 2012-3145 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OSHC/OPD/ LOAR, S B MARGARET GROEL LACHMAN CONSULTANT SERVICES INC EFAVIRENZ, LAMIVUDINE, TENOFOVIR DISOPROXIL FUMARATE NDA 22-142 APRVL FDA/OMPT/CDRH/OCER/DFOI/ PEERY, JAAMES ARSENIC TRIOXIDE (TRISENOX) - APRVL, CO RESP FDA/OMPT/CDRH/OCER/DFOI/ PEERY, JAAMES LIGHT FOR WRINKLES K101190 ORA/CE-FO/CHI-DO/CCB/ AMY ERICKSON HAGEN MOTLEY RICE LLC MIDWEST SPERM BANK LLC, DOWNERS GROVE, IL - EIR, 483, CO RESP 5/1/05 TO PRESENT SILK N FX K110301 ORA/SE-FO/ATL-DO/ACB/ TAMISHA RAQIB FACET TECHNOLOGIES LLC KIMBERLY D. BARONE BADEN MOTLEY RICE LLC FACET TECHNOLOGIES LLC, KENNESAW, GA - EIR 2005 TO 2006 WELLBUTRIN NDA 18-644 - LBLG, CO RESP 9/8/83 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/CE-FO/NJ-DO/NJCB/ Action Office ORA/CE-FO/NJ-DO/NJCB/ Signature/ Requester KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC KATE CADDY DSM I-HEALTH INC FRAN KOCH INFORMATION ACCESS FRAN KOCH INFORMATION ACCESS TZU-HSUAN YANG PRO PHARMA TAIWAN INC JIM FAUCETT NORTHWEST CLINICAL RESEARCH CTR ASPEN SURGICAL PRODUCTS, CAREDONIA, MI CLEARANCE LTR 2/17/10 COREG NDA 20-297 - SBA FOI DAILY LOG 4/9-13/12 Subject NUTRI-SPORT PHARMACAL, FRANKLIN, NJ - EIRS, 483S CO RESPS ETC LAST 5 YRS MULTI-PAK PACKAGING, FAIRFIELD, NJ - EIRS, 483S, CO RESPS ETC LAST 5 YRS CONTRACT PHARMACAL CORP, HAUPPAUGE, NY - EIRS, 483S CO RESPS ETC LAST 5 YRS FOI DAILY LOGS 4/2-6/12
Page 1025 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3146 2012-3147 2012-3148 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3149 05/01/2012 05/30/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ 2012-3150 05/01/2012 05/30/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SWFO/SWID/COMPLIANCE/ 2012-3151 05/01/2012 05/30/2012 2012-3152 2012-3153 2012-3154 2012-3155 2012-3156 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/01/2012 05/30/2012 05/02/2012 05/31/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OC/OM/OMP/DDM/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ THOMPSON, CLARENCE LD STEVE WALDMAN MILLER WEISBROD LLP Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. ROSS RENDELMAN HOGAN LOVELLS LLP DKT 2000P-1471, 1998P-0821, 200P-1621, ETC. FOI DAILY LOG 4/23-27/2012 MEDTRONIC - SPECIFY 2X8 MODEL 39286 LEAD KIT APRVL, "A list of all FOIA requests closed 4/1-30/2012" on CD; FDA/OMPT/CDRH/OCER/DFOI/ HONHART, TRACY MAKO SURGICAL CORP - VOYAGER LINUX K050973, VOYAGER LINUX W/TACTILE GUIDANCE SYS K052851, UNICONDYLAR KNEE SYS K060017 CASH AWARDS GIVEN TO CFSAN EMPLOYEES IN 2011 ANN M. BEGLEY K & L GATES VINCEEL THROAT SPRAY, NECTADYN COUGH SYRUP ENTRY NO 328-7206489-7 CHRIS HAWLEY ASSOCIATED PRESS 7/28/04 LTR FROM KAREN TANDY OF DEA TO CRISTINA BEATO OF HHS REGARDING PETITION FROM RONALD DOUGHERTY - ALL FOLLOW UP DEBORAH L GETZ ATTORNEY AT LAW ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ DENA WHITE BOEHRINGER INGELHEIM NICHOLE ROFFI FRONTIER ADJUSTER ISOTRETINOIN - AER INDIVIDUAL RECS EQUIPOISE NDA 34-705 SUMMARY Signature/ Requester Subject
Page 1026 of 1132

Total Records: 12455 Control # 2012-3157 2012-3158 Recd Date / Due Date 05/02/2012 05/31/2012 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3159 2012-3160 2012-3161 2012-3162 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ 2012-3163 2012-3164 2012-3165 2012-3166 2012-3167 2012-3168 2012-3169 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 2012-3170 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DE WALT-BARNER, DENISE FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ HENSON SR, DONALD SCOTT E SPELL MICHAEL ALDER PC ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JOHN DAVID HART JOHN DAVID HART LAW OFC JOHN DAVID HART JOHN DAVID HART LAW OFC DONALD S SOLOMON PHD CATHETER CONNECTIONS BEADLE RETNARAJAN BIND BIOSCIENCES INC KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. MEDTRONIC INC - INSULIN PUMP P890022 SSED'S APRVL PKG ST JUDE MEDICAL - RIATE ENDOCARDIAL DEFIBRILLATION LEAD PRE-MARKET APRVL APPL, APPL FOR MODIFICATIONS, MDRS, ETC RISPERDAL (RISPERDONE) - AERS OSO BIOPHARMACEUTICALS MANUFACTURING LLC, ALBUQUERQUE, NM - EIR 8/9-16/11 HYDROPHOBIC SILICA GRAS 2419 - RVW MEMO, CORR BIOMET - M2A MAGNUM HIP IMPLANT SYS 510K, PMA SUBMISSIONS,, MDRS, ETC STELKAST - PROVIDENT HIP IMPLANT SYS 510K, PREMARKET APRVL NOTICES , MDRS, ETC IVERA MEDICAL INC - CUROS PORT PROTECTOR K111992 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ HENSON SR, DONALD FATIMA ASLAM Keller and Heckman LLP JAMES E WALKER III ESQ TUCKER & ASSOCIATES RECYCLED PLASTICS - FOOD CONTACT SUBSTANCES NO OBJECTION LTRS MULTISTATE SALMONELLA ENTERIDITIS OUTBREAK - LAB RESULTS, INVOICES, HARVEST RECS, ETC 10/11 TO 1/12 FDA/OMPT/CDRH/OCER/DFOI/ HENSON SR, DONALD P980022/S010 - SSED CRITERIA P980022/S010 - SSED'S APRVL PKG Action Office OC/OM/OMP/DDM/ Signature/ Requester VIVIAN BROWN WESTLAW COURT EXPRESS AMAURY SANCHEZ NOVEN PHARMACEUTICALS INC NEUPRO (ROTIGOTINE TRANSDERMAL SYS) NDA 21829/S001/S002 - RVWS Subject APPROVED DRUG PRODUCT 16TH EDITION 1996
Page 1027 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3171 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3172 2012-3173 2012-3174 05/02/2012 05/31/2012 05/02/2012 05/31/2012 05/02/2012 05/31/2012 2012-3175 2012-3176 05/02/2012 05/31/2012 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3177 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3178 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3179 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3180 05/02/2012 05/31/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ JENNIFER L REDIEHS WIEDNER & MCAULIFFE LTD PARI NEBULIZERS - RPTS, CLAIMS, INVESTIGATIONS, ETC 1/90 TO PRESENT BRODY MULLINS WALL STREET JOURNAL STEVE WILLIAMS, MARWOOD GROUP - DUREON RECS, CORR 9/15/10-10/30/10 IRINA RIVKIND CANTOR FITZGERALD HOVIONE FARMACIENCIA SA - RESP TO 483S 9/25/09, 1/27/11 Doe J LIVALO - AERS CROSS, AMY OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ NEUHAUS, NICOLE ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/KAN-DO/COMP/ JENNIFER WILEY ALDER BIOPHAMACEUTICALS SRINIVASA R PARUCHURI CISPHARMA OMC JAMES E WALKER III TUCKER & ASSOCIATES RESTAURANT CHAIN A MULTI-STATE OUTBREAK OF SALMONELLA ENTERIDITIS - FOI REQUESTS THAT HAVE REQUESTED FOI REQUEST INSECT-BASED FOOD COLORING IN STARBUCKS STORES - REGULATIONS TYSABRI - AERS DR VIJ, WASHINGTON UNIV SCHOOL OF MEDICINE - 483 12/12 CISPHARMA INC, CRANBURY, NJ - EIR 12/1610 TO 1/24/11 NANCY BAKER MD SMILEYS CLINIC TAMIFLU (OSELTAMIVIR) - AERS Signature/ Requester Subject
Page 1028 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/CE-FO/BLT-DO/CB/ 2012-3181 2012-3182 05/02/2012 05/31/2012 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3183 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3184 05/02/2012 05/31/2012 2012-3185 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3186 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3187 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3188 05/02/2012 05/31/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3189 2012-3190 05/02/2012 05/31/2012 05/02/2012 OM/OSS/OAGS/ OC/OM/OMP/DDM/ CECEILE RICHTER CECEILE RICHTER EDDIE W LACKEY JEFFERSON LABORATORES COMPLEX - CURRENT MAINTENANCE CONTRACT 11/1/11 TO 11/1/12 DKT 1980N-0140 PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP SANOFI-AVENTIS - FERRLECIT (SODIUM FERRIC GLUCONATE) NDA 17-44 AERS 10/09 TO PRESENT PETER S REICHERTZ SHEPPARD MULLIN RICHTER & HAMPTON, LLP GENERAMEDIX - NULECIT (SODIUM FERRIC GLUCONATE) ANDA 78-215 AERS 10/09 TO PRESENT JACQUELYN A CANNATA MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. TYSABRI (NATALIZUMAB) - LTR 11/18/05 (CERTIFIED) FDA/OMPT/CDRH/OCER/DFOI/ JACQUELYN A CANNATA MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. JACQUELYN A CANNATA MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. TYSABRI (NATALIZUMAB) - EMAIL 4/3/06 (CERTIFIED) TYSABRI (NATALIZUMAB) MTG 11/18/10 - RECS (CERTIFIED) JACQUELYN A CANNATA MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. GASTROINTESTINAL DRUGS A/C AND DRUG SAFETY AND RISK MANAGEMENT A/C JOINT MTG - TYSABRI (NATALIZUMAB) MEMO 7/20/07 (CERTIFIED) ORA/P-FO/SAN-DO/SFCB/ CRAWFORD, IAN JACQUELYN A CANNATA MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO, P.C. VITAGANIC - VITAMINS TESTING, VIOLATIONS, CONSUMER RECOMMENATIONS, ETC TYSABRI (NATALIZUMAB) - MEMO OF MTG MINS 9/8/10 LTR (CERTIFIED) Signature/ Requester Subject
Page 1029 of 1132

Total Records: 12455 Control # Recd Date / Due Date 05/31/2012 2012-3191 2012-3192 2012-3193 05/03/2012 06/01/2012 05/03/2012 06/25/2012 05/03/2012 06/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3194 05/03/2012 06/01/2012 2012-3195 05/03/2012 06/01/2012 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3196 2012-3197 05/03/2012 06/01/2012 05/03/2012 06/01/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CVM/OCD/ CVM/OCD/ 2012-3198 2012-3199 2012-3200 05/03/2012 06/01/2012 05/03/2012 06/01/2012 05/03/2012 06/01/2012 2012-3201 05/03/2012 06/01/2012 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CORRIE GOODING BOSTON SCIENTIFIC CORRIE GOODING BOSTON SCIENTIFIC NINOS SAROUKHANIOFF MARANGA MORGENSTERN LAW CORP RYAN WILDER SAC CAPITAL ADVISORS LP WINDSOR QUALITY FOOD CO - FEI 2022675 8/25/11, 2022675 9/13/10, 2022675 5/27/09 - EIR, 483, CO RESP, SAMPLE RPT IMPAX LABS INC, HAYWARD CA - 483 1/12 TO 5/1/12 AERO DV TRACHEOBRONCHIAL STENT SYS K083625 AERO TRACHEOBRONCHIAL STENT SYS K062511 CVM/OCD/ KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. BRENDA M. GARTZ ELI LILLY & CO BIOVET JOINT STOCK CO, PESHTERA, BULGARIA - EIR 4/1/10 CALCIUM FORMATE - CORR SINCE 9/1/11 MARY ANDERSON SHIRE INC PROZAC S18-936/S-065, 20-101/S-027, 20-974/S-001 - SBA SCOTT BRADLEY FLOUR CONFECTIONS INC. FLOUR CONFECTIONS INC, ONTARIO - DOCS OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ SIEGEL, JONATHAN B KATHLEEN G. ENGER HOSPIRA INC Action Office Signature/ Requester JEFFERSON FACILITIES MAINTENANCE UNION KRISTI O. SMEDLEY, Ph.D. Center for Regulatory Services, Inc. BLOEDVOORICNING, AMSTERDAM, NETHERLANDS, BRUSSELS - STICHTING SANQUIN - 483, EIR AMIDATE (ETOMIDATE INJECTION) NDA 18-227 CLNCL RVW 2012-854 Subject
Page 1030 of 1132

Total Records: 12455 Control # 2012-3202 2012-3203 Recd Date / Due Date 05/03/2012 06/01/2012 05/03/2012 06/01/2012 2012-3204 05/03/2012 06/01/2012 2012-3205 2012-3206 05/03/2012 06/01/2012 05/03/2012 06/01/2012 CTP/OD/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-3207 05/03/2012 06/01/2012 2012-3208 05/03/2012 06/01/2012 ORA/ ORA/ ORA/P-FO/SEA-DO/SCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3209 05/03/2012 06/01/2012 2012-3210 05/03/2012 06/01/2012 2012-3211 05/03/2012 06/01/2012 ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-3212 05/03/2012 06/01/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ CHRISTOPHER SHAKIB TERRELL HOGAN ELLIS YEGELWEL PA MEDTRONIC - CONCERTO MODEL C154DWK ICD APRVL FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ANGELIA D. SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS KATHRYN A. LACHOWSKY LAW OFFICE OF DAVID H WILLIAMS PLLC ERIK P. CREP WICKER SMITH ET AL AVASTIN - GENENTECH 483, SMPLS, 2011 TO 2012 SANT CHAWLA MD, SARCOMA ONCOLOGY CENTER, SANTA MONICA, CA - 483, CO RESP 8/5/09 HOSPIRA INC - INFUSION PUMP CORR CERTIFIED GAVIN JOHNSON WECT-TV VYVANSE - AER CASEY R. MARION BEAVER STEET FISHERIES INC SEA BEST AHI TUNA TEAK SPL 733497 Action Office FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester STEPHEN ALLEN ATKINSON WILLIAMSON PETTY LC GRAHAM MARTIN BENJAMIN L ENGLAND & ASSOCIATES LLC RICHARD KELLER BRUNO INDEPENDENT LIVING AIDS INC AZIM CHOWDHURY Keller and Heckman LLP JAY L. BREAKSTONE PARKER & WAICHMAN ATTYS MEDTRONIC - INFUSE BONE GRAFT RHBMP 2 LT CAGE; INFUSE BONE GRAFT LT CAGE LUMBAR TAPERED FUSION DEVICE - AER, CORR, MRTP SINCE 6/12/09 CMPLNT CPT1100211 Subject BIONICS HIRES 90K COCHLEAR IMPLANTS - AER, 1/08 TO PRESENT ALERT 53-06
Page 1031 of 1132

Total Records: 12455 Control # 2012-3213 Recd Date / Due Date 05/03/2012 06/01/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3214 05/04/2012 06/04/2012 2012-3215 05/04/2012 06/04/2012 2012-3216 05/04/2012 06/04/2012 ORA/CE-FO/NJ-DO/NJCB/ THOMPSON, RAY ORA/NE-FO/NWE-DO/NWECB/ THOMPSON, RAY ORA/NE-FO/NWE-DO/NWECB/ THOMPSON, RAY AMERICAN DIAGNOSTICA INC, STANFORD, CT 6/20-22/11; CARDIOPULMONARY CORP, MILFORD CT 6/13-16/11; COVIDIEN LP, 6/1-16/11, ETC 483S FORMATECH INC, ANDOVER, MA 7/15/11-08/31/11; GENZYME CORP, WALTHAM, MA 10/08-27/11; HAEMONETICS CORP, BRAINTREE, MA 08/24/11-09/19/11, ETC 483S ACCESS BIO INC, SOMERSET, NJ 6/22/11-08/29/11; AUROLIFE PHARMA LLC, DAYTON, NJ 10/25/11-11/02/11; BUXTON BIOMEDICAL INC, EAST HANOVER, NJ 12/19-22/11, ETC 483S A & Z PHARMACEUTICAL INC, DEER PARK, NY 11/03-05/11; ADVION BIOSCIENCES INC, ITHACA, NY 09/06-14/11; APP PHARMACEUTICALS LLC, GRAND ISLAND, NY 06/13/1107/08/11, ETC SANDOZ CANADA INC, BOUCHERVILLE, CANADA 07/26/1108-04/11; TEVA CZECH INDUSTRIES SPO, OPAVA, CZECH REPUBLIC 09/19-22/11; NOVARTIS PHARMA PRODUKTIONS GMBH, WEHR, GERMANY 09/12-15/11, ETC 483S APEX MEDICAL TECHNOLOGIES INC, SAN DIEGO, CA 11/2930/11; CARDIONET INC, SAN DIEGO, CA 12/14-20/11; GENENTECH INC, SOUTH SAN FRANCISCO, CA 06/14-23/11, ETC 483S GOLD STANDARD ORTHOPAEDICS LLC, LOUISVILLE, KY 11/16-18/11; ISOPURE CORP, SIMPSONVILLE, KY 08/2325/11; ACCUPACK MIDWEST INC, CINCINNATI, OH 07/18/1109/16/11, ETC 483S AIG TECHNOLOGIES INC, DEERFIELD BEACH, FL 06-27/1107-01/11; ADVANCED ORTHOGONAL EQUIPMENT INC, SAINT PETERSBURG, FL 08/18/11; AVEVA DRUG DELIVERY SYSTEMS INC, MIRAMAR, FL 08/24/11-09/28/11, ETC 483S ALPHAPROTECH INC, NOGALES, AZ 09/12-14/11; ABCO LABORATORIES INC, FAIRFIELD, CA 08/26/11-09/09/11; ADVANCED MEDICAL INNOVATIONS, CHATSWORTH, CA 09/28/11-10/06/11, ETC 483S WYETH PHARMS INC - EFFEXOR XR (VENLAFAXINE HCL) NDA 20-699/S054/S057 APRVL LTR, LBLG, MEDICAL RVWS, Signature/ Requester AMAURY SANCHEZ NOVEN PHARMACEUTICALS INC Subject DURAGESIC (FENTANYL TRANSDERMAN SYS) NDA 19813/S044,S033 RVW
2012-3217
05/04/2012 06/04/2012
ORA/NE-FO/NYK-DO/NYDCB/ THOMPSON, RAY
2012-3218
05/04/2012 06/04/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ THOMPSON, RAY
2012-3219
05/04/2012 06/04/2012
ORA/P-FO/SAN-DO/SFCB/ THOMPSON, RAY
2012-3220
05/04/2012 06/04/2012
ORA/CE-FO/CIN-DO/CCB/ THOMPSON, RAY
2012-3221
05/04/2012 06/04/2012
ORA/SE-FO/FLA-DO/FCB/ THOMPSON, RAY
2012-3222
05/04/2012 06/04/2012
ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ THOMPSON, RAY
2012-3223
05/04/2012 06/04/2012
ANGELIA D SLAYTON INC REGULATORY CONSULTING
Page 1032 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3224 05/04/2012 06/04/2012 2012-3225 2012-3226 2012-3227 2012-3228 2012-3229 2012-3230 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3231 05/04/2012 06/04/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3232 05/04/2012 06/04/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-3233 05/04/2012 06/04/2012 2012-3234 05/04/2012 06/04/2012 2012-3235 05/04/2012 ORA/ OC/COS/OL/ FDA/OF/CFSAN/OCD/EOS/ MAE WU NATURAL RESOURCES DEFENSE COUNCIL ROBERT A PAARLBERG PAARLBERRG & ASSOCIATES LLC PESTICIDE RESIDUE MONITORING OF FOOD - RESULTS 1/08 TO PRESENT, RPT1/05 TO PRESENT, TESTING 12/31/05 TO PRESENT, ETC REP WAXMAN, REP MARKEY, REP DEGETTE RESP TO CONGRESSIONAL LTR 02/14/12 - CLNCL DRUG TRIAL RESULTS LIST OF FIRMS THAT COMPRISE OFFICIAL ESTABISHMENT MARY ROBERTS BUZZ MONKEYS INC ROCKLINE INDUSTRIES, SHEBOYGAN, WI - EIRS 2012 LAUREN PEARLE ABC, INC. TAMIFLU - AERS 01/02 TO 12/12 FIX, MELALNIE FDA/OMPT/CDRH/OCER/DFOI/ HUNTLEIGH HEALTHCARE LTD FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NYK-DO/NYDCB/ ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS VIK BAJNATH ARTHREX INC VIK BAJNATH ARTHREX INC VIK BAJNATH ARTHREX INC DAVID MOYNHAM HUNTLEIGH HEALTHCARE LTD PHILLIPS - AVALON CTS CORDLESS FETAL TRANSDUCER SYS K023931 MERCK - SINGULAIR AERS SONICAID - K912639 2506865 - RPT MW#5024874 - RPT BARTOR PHARMACAL RYE, NY - EIRS, 483S 01/01/07 TO 12/31/10 MW#5024558 - RPT Signature/ Requester & SUBMISSIONS Subject ETC
Page 1033 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/04/2012 Action Office ORA/ ORA/ORM/ ORA/ORM/ 2012-3236 2012-3237 2012-3238 2012-3239 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 05/04/2012 06/04/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3240 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3241 05/07/2012 06/05/2012 2012-3242 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3243 05/07/2012 06/05/2012 2012-3244 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3245 05/07/2012 06/05/2012 ORA/P-FO/SAN-DO/SFCB/ RYAN WILDER SAC CAPITAL ADVISORS LP IMPAX LABORATORIES INC, HAYWARD, CA - 483S 1/1/125/1/12 FDA/OF/CFSAN/OCD/EOS/ ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC MICHAEL P MANAPOL ESQ BRIAN D WITZER INC MEDICIS PHARMACEUTICAL CORP - SOLODYN ER TABS NDA 50-808 AERS 1/1/06 TO 12/3/09 HYDROXYCUT, SMARTBURN, RAPID SLIM, ETC ORA/NE-FO/NYK-DO/NYDCB/ JAMES R SCHIFFER ALLEGAERT BERGER & VOGEL LLP CHANDRAN TIRUVATTAR DR REDDY'S LABORITORIES INC PADDOCK LLC - CLOBETASOL PROPIONATE ANDA 90-898 SBA REGIONCARE INC, GREAT NECK, NY - EIRS 2008 TO 2011 HARTWELL P MORSE III HUSCH BLACKWELL LLP DR REDDY'S LABS LTD - IBANDRONATE SODIUM ANDA 78997 APRVL LTR 4/30/12 CVM/OCD/ ORA/ORM/ ORA/ORM/ OC/OSHC/OPD/ SHUKLA, JAY DIANE SCHULMAN THE INDAGO GROUP KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. ELISE C BIGLEY KELLER ROHRBACK LLP QUESTCOR PHARMACEUTICALS INC - HP ACTHAR GEL ORPAH DRUG DESIGNATION DEGUSSAL/EVONIK - HYDROPHOBIC SILLCA REQUEST & RESP SUAVE - PROFESSIONAL KERATIN INFUSION HAIR TREATMENT CMPLNTS, COMMENTS, ADVERTSING, ETC LIST OF FACILITIES INSPECTED 01/01/10-05/02/12 Signature/ Requester FASS, THOMAS Subject INVENTORY
Page 1034 of 1132

Total Records: 12455 Control # 2012-3246 Recd Date / Due Date 05/07/2012 06/05/2012 2012-3247 2012-3248 2012-3249 05/07/2012 06/05/2012 05/07/2012 06/05/2012 05/07/2012 06/05/2012 2012-3250 05/07/2012 06/05/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3251 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3252 05/07/2012 06/05/2012 2012-3253 05/07/2012 06/05/2012 FDA/OF/CFSAN/OCD/EOS/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ 2012-3254 2012-3255 2012-3256 2012-3257 05/07/2012 06/05/2012 05/07/2012 06/05/2012 05/07/2012 06/05/2012 05/07/2012 06/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ FOI SERVICES INC LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS CVM/OCD/ FOI SERVICES INC DAVID MCFARLAND FDA WEBVIEW/FERDIC INC QUARANTINE SERVICES, CHINA - MTG SUMMARY RPTS 2012 FOI CLOSED REQUESTS 4/16-20/12 SHANDONG PETSWELL FOOD CO LTD, SHANDONG PROVINCE, CHINA - EIRS, 483S, CO RESP, ETC 2010 FOI CLOSED REQUESTS 4/16-20/12 FOI SERVICES INC CVM/OCD/ FOI SERVICES INC GAMBOL PET PRODUCTS (LIAOCHENG) CO LTD, SHANDONG PROVINCE, CHINA - EIRS, 483S, CO RESP, ETC 2012 JINAN WELCOME FOOD CO LTD, SHANDONG PROVINCE, CHINA - EIRS, 483S, CO RESP, ETC 2012 LAWLER, JOSEPH F AMIDATE (ETOMIDATE) NDA 18-227 APRVL LTRS, LBLG, RVWS, ETC PEDRICK, RUSSELL METOPROLOL - AERS Brown, Sanders E Signature/ Requester AMANDA ORLANDO AVALON RISK MANAGEMENT INC AUSTIN NELSON RBC CAPITAL MARKETS AUSTIN NELSON RBC CAPITAL MARKETS MICROCHIP IMPLANTS - CMPLNTS Subject EG PIAZZA INTERNATIONAL - ENTRY #80501222261 NOTICE OF ACTION #1 HOSPIRA INC, AUSTIN, TX - UNTITLED LTR 1/1/12 TO PRESENT HOSPIRA INC, CLAYTON, NC - 483S 1/1/12 TO PRESENT
Page 1035 of 1132

Total Records: 12455 Control # 2012-3258 Recd Date / Due Date 05/07/2012 06/05/2012 2012-3259 2012-3260 05/07/2012 06/05/2012 05/07/2012 06/05/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3261 2012-3262 05/07/2012 06/05/2012 05/07/2012 06/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3263 2012-3264 05/07/2012 06/05/2012 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3265 05/07/2012 06/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3266 2012-3267 2012-3268 05/07/2012 06/05/2012 05/07/2012 06/05/2012 05/07/2012 06/05/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC LAUREN S BARR JH BARR & ASSOCIATES LLC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC MARS INC - SPIRULINA (ANTHROSPIRA PLATENSIS) COLOR ADDITIVE PETITION CAREFUSION 303 INC - ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION K110535 FOI DAILY LOG 4/16-20/12 FOI SERVICES INC ALLERGAN INC - BOTOX BLA 103000 PROMOTION & MARKETING CMPLNTS, CORR FOI SERVICES INC ORA/NE-FO/NYK-DO/NYDCB/ FOI SERVICES INC LUITPOLD PHARMS, SHIRLEY, NY - EIRS, 483S, CO RESP, ETC 2/8/12-3/28/12 MERCK SHARP DOHME - JUVISYNC (SIMVASTATIN, SITAGLIPTIN PHOSPHATE) NDA 202-343 APRVL RECS FOI SERVICES INC LISA TARRISON-SCHRAMP CanReg, Inc. BRISTOL MYERS SQUIBB - ORENCIA (ABATACEPT) BLA 125118 APRVL RECS FOI CLOSED REQUESTS 4/16-20/12 FOI SERVICES INC FOI SERVICES INC SHANDONG HONVA FOOD CO LTD, SHANDONG PROVINCE, CHINA - EIRS, 483S, CO RESP, ETC 2012 Signature/ Requester LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS FOI CLOSED REQUESTS 4/16-20/12 Subject FOI CLOSED REQUESTS 4/23-27/12
Page 1036 of 1132

Total Records: 12455 Control # 2012-3269 2012-3270 2012-3271 Recd Date / Due Date 05/07/2012 06/05/2012 05/08/2012 06/06/2012 05/08/2012 06/06/2012 2012-3272 2012-3273 05/08/2012 06/06/2012 05/08/2012 06/06/2012 ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3274 2012-3275 05/08/2012 06/06/2012 05/08/2012 06/06/2012 2012-3276 05/08/2012 07/06/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ KEEL D-12127, KENNETH G ELYSSA M FRIED Finkelstein and Partners GARY LEHNUS Lehnus & Associates LACTULOSE SOL, MARIJUANA, AMITRIPTLINE ETC INFORMATION, RECS, ETC NY GOURMET SALADS INC; CRYSTAL SALADS; FARM FRESH GOURMET SALADS LLC ETC - CUSTOMERS, GROCERS, ETC 1/10 - 4/10 BRAHMS DIAGNOSTICA, LLC PCT LIA - ENDOTOXIN ACTIVITY ASSAY, K040887; BIOMERIEUX INC, - VIDAS BRAHMS PCT ASSAY, K071146; BRAHMS AKTIENGESELLSCHAFT - BRAHMS PCT SENSITIVE KRYPTOR TEST SYS, K070310 OLYMPUS XCHF-T160 VIDEOSCOPE K082576 OLYMPUS ENDOSCOPIC C02 REGULATION UNIT K081173 NATURE'S WAY & SCHWABE NORTH AMERICA INC, GREEB BAY, WI - UMCKA PRODS, PELARGONIUIM SIDOIDES, EIRS, CAERS, MISLABELING ETC RANBAXY, DEWAS, INDIA - 483 1/28-2/12/08 ORA/P-FO/SAN-DO/SFCB/ LOPER, MATTHEW WHITNEY DOCKEN TARGET CUSTONS BROKERS INC TARGET CORP - IRS #41-0215170TS, ENTRIES, RECS, NOTES, ETC, 2011 FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/DET-DO/DCB/ Signature/ Requester AUSTIN NELSON RBC CAPITAL MARKETS TYLER KENYON NORTHCOAST RESEARCH RANDY BYRD BIONOSTICS INC Subject IMPAX LABORATORIES INC, HAYWARD, CA - 483 1/12 TO PRESENT ZIMMER HOLDINGS INC - CO RESP 12/11 T0 PRESENT; 483, CO RESP ETC 4/12 EUROTROL INC, BURLINGTON, MA & EUROTROL BV, EDE, NETHERLANDS - DVCS SOLD W/O 510K CLEARANCE, COMM, RECS ETC IMPAX LABORATORIES - 483S, CO RESPS 2012
2012-3277 2012-3278 2012-3279
05/08/2012 06/06/2012 05/08/2012 06/06/2012 05/08/2012 06/06/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CHRISTOPHER MARLBOROUGH FARUQI & FARUQI LLP BRENDA M. GARTZ ELI LILLY & CO
2012-3280
05/08/2012 06/06/2012
2012-3281
05/08/2012 06/06/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/
TOM JEFFERSON, MD COCHRANE ACUTE
HOFFMAN-LA ROCHE - OSELTAMIVIR, CLNCL STUDY RPTS 2000 TO PRESENT
Page 1037 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3282 05/08/2012 06/06/2012 OM/OMP/DODM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3283 05/08/2012 06/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3284 05/08/2012 06/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3285 2012-3286 2012-3287 2012-3288 05/08/2012 06/06/2012 05/08/2012 06/06/2012 05/08/2012 06/06/2012 05/08/2012 06/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3289 2012-3290 2012-3291 05/08/2012 06/06/2012 05/08/2012 06/06/2012 05/08/2012 06/06/2012 CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ J. PRICE COLEMAN COLEMAN LAWFIRM DEWITT M. LOVELACE LOVELACE LAW FIRM PA MARTINA BERNSTEIN PETA BIGELOW TEA COMPANY - CORR, COMMENTS, PETITIONS, HEALTH CLAIMS, ETC BUMBLE BEE FOODS LLC - FOOD PROD MISBRANDING, COMPLIANCE RECS ANIMAL FEED SAFEGUARDS DESIGNED TO PREVENT BSE - RPTS, ETC CHARLES J. LANDY PILLSBURY WINTHROP ET AL CHARLES J. LANDY PILLSBURY WINTHROP ET AL CHARLES J. LANDY PILLSBURY WINTHROP ET AL SEAN CAHILL MEDICURE SANOFI AVENTIS - ACTHAR GEL SYNTHETIC REQUESTS 12/31/07 TO PRESENT AMPHASTAR PHARMS INC - CORTROSYN (COSYNTROPIN) REQUESTS 12/31/07 TO PRESENT QUESTCOR PHARMS INC - ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) 12/31/07 TO PRESENT INTEGRILIN RENAL STUDY NDA 20-718/S17 - CLNCL STUDY PARAKKAL DEEPAK CTR FOR STUDY OF COMPLEX DISEASES RESEARCH INSTITUTE AER #'S 3806336, 3888821, 3961282 ETC KEVIN XIE ACCORDA HEALTHCARE LLC SEPRACOR (SUNOVION PHARMACEUTICALS INC) LUNESTA (ESZOPICLONE), SBA, PRODUCT QUALITY STANDARDS DAN BURNS INFACARE PHARMACEUTICAL CORP GASTROINTESTINAL DRUG AC - TRANS 3/13/12 Signature/ Requester RESPIRATORY INFECTIONS GROUP Subject
Page 1038 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ ORA/P-FO/SAN-DO/SFCB/ 2012-3292 05/08/2012 06/06/2012 2012-3293 05/09/2012 06/07/2012 2012-3294 2012-3295 2012-3296 2012-3297 2012-3298 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3299 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3300 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3301 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ MICHAEL R COHEN INSTITUTE FOR SAFE MEDICATION PRACTICES MEDWATCH RPTS CODED AS MEDICATION ERRORS 3/01/12-04/30/12 JOHN F THOMPSON ROBINSON & THOMPSON CITALOPRAM, CELXA - AERS JOHN F THOMPSON ROBINSON & THOMPSON CYCLOSPORIN A, NEORAL - AERS FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN JOHN F THOMPSON ROBINSON & THOMPSON OLYMPUS - SINGLE USE ELECTROSURGICAL KNIFE SERIES K092309 ESICITALOPRAM, LEXAPRO - AERS OLYMPUS - SINGLE USE 3-LUMEN EXTRACTION BALLOON V K091495 OLYMPUS - TRACHEAL INTUBATION FIBER VIDEOSCOPE K082720 OLYMPUS - EVIS EXERA 160A SYS K051645 JOHN F. JOHNSON III, Esq. BENJAMIN L ENGLAND & ASSOCIATES LLC CURTIS RAYMOND ORCHID DESIGN LONGHAI GELEN FOODS CO - IMPORT ALERT 16-81, 16119, 16-127, 99-08 OLYMPUS - EVIS 180 SYS K061313 Signature/ Requester Subject
Page 1039 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3302 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3303 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3304 2012-3305 05/09/2012 06/07/2012 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3306 2012-3307 2012-3308 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 2012-3309 2012-3310 2012-3311 2012-3312 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 CTP/OD/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ PAULINE DO EXPONENT TANI MOK COTRONIC TECHNOLOGY LTD PAULINE DO COTRONIC TECHNOLOGY LTD JOSEPH ZALESKI CAPSTONE LLC CTP'S DRAFT RPT SBMTD TO EXTERNAL PEER REVIEW PANEL 7/11 COTRONIC TECHNOLOGY LTD, CHINA - K032434 DANONE TRADING BV, 1118BG SCHIPHOL AIRPORT, THE NETHERLANDS - GRN 425 COTRONIC TECHNOLOGY LTD, CHINA - K103407 GERHARDT, NATHAN ORA/CE-FO/CIN-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ J PRICE COLEMAN COLEMAN LAW FIRM DIANA L GESEKING SEDWICK LLP WM WRIGLEY JR CO - DKT 200N-0463 CORR , EMAILS, NOTES, ETC ABBOTT LABS, COLUMBUS, OH - EIRS, 483S, WARNING LTRS ETC 1/00 TO PRESENT SEI PHARMACEUTICALS INC, MIAMI, FL - 483 9/19-29/11 ORA/CE-FO/MIN-DO/MCB/ RICARDO RONQUILLO NEUROGESX INC BOB LUND BECKMAN COULTER INC FONTAROME CHEMICAL INC, ST FRANCIS, WI - EIRS, 483S, WARNING LTRS, ETC 01/07 TO PRESENT BECKMAN COULTER INC - DMF 1325 (TENITE POLYALLOMER CIEFINS) RECS 1970 TO 1980 PAUL J ROSCH MD AMERICAN INSTITUTE OF STRESS LIPITOR - AERS FRANCIS J MARTIN DELPOR INC JANSEN PHARMS - INVEGA SUSTENNA (PALIPERIDONE PALMITE) RX INJ SUSPENSION NDA 22-264 SBA Signature/ Requester Subject
Page 1040 of 1132

Total Records: 12455 Control # 2012-3313 2012-3314 2012-3315 Recd Date / Due Date 05/09/2012 06/07/2012 05/09/2012 06/07/2012 05/09/2012 06/07/2012 Action Office CTP/OD/ CTP/OD/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3316 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3317 05/09/2012 06/07/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3318 2012-3319 05/09/2012 06/07/2012 05/10/2012 06/08/2012 2012-3320 05/10/2012 06/08/2012 2012-3321 2012-3322 05/10/2012 06/08/2012 05/10/2012 06/08/2012 2012-3323 05/10/2012 06/08/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3324 05/10/2012 FDA/OMPT/CDER/ORP/DIDP/ MARILYNN WHITNEY CIMZIA - SUMMARY, MEDICAL, STATISTICAL RVWS, ETC FELDMAN, DAVID I HOOTNICK, ALEXANDRA CYNDY BURINDA PHOENIX REGULATORY ASSOCIATES LTD ASTRA ZENECA - ZOLADEX (GOSERELIN DEPOT) AERS TOTAL DIET SURVEY AND ARSENIC IN RICE BRIEFING MINS, CORR, MEMOS, ETC 3/23/12 L-PHENYLALANINE - CMPLNTS OC/OM/OMP/DDM/ VON LINDSEY FAEGRE DB CONSULTING CHRISTINE R THOMPSON TODD & WELD LLP SUZETTE BINNIE BLUE RIDGE HONEY CO UNAPPROVED INTRAUTERINE DVCS (IUD) AND INTRAUTERINE SYSTEMS (IUS) - PURCHASE, USE, DISTRIBUTION BY MEDICAL PROVIDERS IN MA SPL #461789 - ANALYSIS RESULTS DKT 1977N-0143 KUMAR, ROGER BYDUREON (EXENATIDE) - AERS KUMAR, ROGER BYETTA (EXENATIDE) - AERS KUMAR, ROGER Signature/ Requester JOSEPH ZALESKI CAPSTONE LLC DIANA L GESEKING SEDWICK LLP Subject CTP'S DRAFT RPT SBMTD TO EXTERNAL PEER REVIEW PANEL 7/11 - ROSTER OR LIST OF NAMES & AFFILIATIONS NESTLE USA, ANDERSON, IN - EIRS, 483S, WARNING LTRS 1/00 TO PRESENT VICTOZA (LIRAGLUTIDE) - AERS
Page 1041 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/08/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3325 2012-3326 2012-3327 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3328 2012-3329 2012-3330 2012-3331 2012-3332 2012-3333 2012-3334 2012-3335 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 2012-3336 05/10/2012 06/08/2012 2012-3337 05/10/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OL/ HAMILTON, LEROY L DAVID C FURR FDC SERVICES LLC DAVID C FURR FDC SERVICES LLC DAVID C FURR FDC SERVICES LLC DAVID C FURR FDC SERVICES LLC DAVID C FURR FDC SERVICES LLC ARLENE MORALES BURDOCK GROUP DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DORA GAUL BUTYRIC ACID IN ANIMAL FEED - REGULATORY STATUS, CONSUMPTION, SAFETY RECS, ETC UPSTATE NEW YORK TRANSPLANT SERVICES, BUFFALO, NY 2/17/02; GRAMERCY FERTILITY SERVICES, NEW YORK, NY 3/22/12 - 483S ST JUDE CHILDREN'S RESEARCH HOSPITAL, MEMPHIS, TN 1/11/12; DCI DONOR SERVICES (TENNESSEE DONOR SERVICES), NASHVILLE, TN 1/27/12 - 483S FIDP LIST NOMED - MANDIBULAR FIXATION SYS K010118 NOMED - BONE TRANSPORT SYS K021341 NOMED - TITANIUM RONDO FIX SYS K022323 NOMED - MINI-EXTERNAL FIXATORS K022230 COMMISSIONER HAMBURG, REP THORNBERYY, REP BARTON - LTR 3/7/12 NOMED - TITANIUM CALCANEUS PLATES K022324 FDA/OMPT/CDRH/OCER/DFOI/ PAUL HEYWOOD ALTRAN PRAXIS LTD RICARDO RONQUILLO NEUROGESX INC LEIGHANN STAHLI BLUE RIDGE CAPITAL VALERITAS LLC - V-GO DISPOSABLE INSULIN DELIVERY DVC K100504 DPT LABORATORIES LTD, SAN ANTONIO, TX - EIRS, 483S, WARNING LTRS, ETC 1/07 TO PRESENT PARKEDALE - CORTICOTROPIN NDA 08-317; ORGANICS LAGRANGE - CORTICOTROPIN NDA 10-831; WATSON LABS - CORTICOTROPIN NDA 88-772, ETC RECS Signature/ Requester COVINGTON & BURLING LLP Subject
Page 1042 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/08/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3338 05/10/2012 06/08/2012 2012-3339 05/10/2012 06/08/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/MIN-DO/MCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC ORA/P-FO/SAN-DO/SFCB/ DENISE HAMMANG BIOPHARMA COMPLIANCE SERVICES LLC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3343 05/10/2012 06/08/2012 ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ 2012-3344 2012-3345 2012-3346 2012-3347 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 2012-3348 2012-3349 05/10/2012 06/08/2012 05/10/2012 06/08/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY L DAVID C. FURR FDC SERVICES LLC DAVID C. FURR FDC SERVICES LLC NORMED - TITANIUM OSTEOTOMY SYS K022325 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON, LEROY ELECTROMEDICAL PRODUCTSINTL - CRANIAL ELECTROTHERAPY STIMULATOR DEVICE PETITION AUG, SEPT 2011 NORMED - BI MULTIDIRECTIONAL DISTRACTION K021342 JAMES GOODWIN JD MPP CENTER FOR PROGRESSIVE REFORM DAVID MCFARLAND FDA WEBVIEW/FERDIC INC LISA TARRISON-SCHRMAP CanReg, Inc. AUDIO RE RADIOLOGICAL DEVICES PANEL MTG 4/12/12 CLOSED FOI REQUESTS 4/23-27/12 INFANT FORMULA CURRENT GOOD MANUFACTURING PRACTICES, QUALITY CONTROL PROCEDURES, NOTIFICATION REQUIREMENTS, ETC - BRIEFING DATE, NAMES OF ATTENDEES, TITLES, ETC CLOSED FOI REQUESTS 4/23-27/12 FOI SERVICES INC RICARDO RONQUILLO NEUROGESX INC SCM PHARMA LTD UK, NORTH THUMBERLAND - EIR, 483, WARNING LTR 1/07 TO PRESENT ADVANCED REPRODUCTIVE LABS, IRVING, TX; SAN ANTONIO EYE BANK, SAN ANTONIO, TX - 483 FROEDTART HOSPITAL REPRODUCTIVE MIDICINE CLINIC, WILWAUKEE, WI; LIFE SOURCE UPPER MIDWEST OPO, SAINT PAUL, MN; REPRODUCTIVE SPECIALTY CTR, MILWAUKEE, WI - 483 TISSUE BANKS INTERNATIONAL-NATIONAL, SAN RAFAEL, CA 2/17/12; TISSUE LINK INC, WALNUT CREEK, CA 3/15/12 483S CLOSD FOI REQUESTS 4/23-27/12 Signature/ Requester MEDISCA INC Subject
2012-3340
05/10/2012 06/08/2012
2012-3341 2012-3342
05/10/2012 06/08/2012 05/10/2012 06/08/2012
Page 1043 of 1132

Total Records: 12455 Control # 2012-3350 2012-3351 2012-3352 2012-3353 2012-3354 Recd Date / Due Date 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-3355 05/10/2012 06/08/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3356 2012-3357 2012-3358 2012-3359 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 05/10/2012 06/08/2012 2012-3360 05/10/2012 06/08/2012 2012-3361 2012-3362 05/10/2012 06/08/2012 05/10/2012 06/08/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OGROP/OIP/ HOOTNICK, ALEXANDRA. HOOTNICK, ALEXANDRA. ARSENIC IN RICE, RICE PRODUCTS, JUICE - FOI REQUESTS FDA ARSENIC IN RICE STUDY - CONTRACT, SUMMARIES, CORR, ETC ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ OC/OM/OMP/DDM/ PROPUBLICA REEVES, MICHAEL . MARIA JOSE FLORES FAMILY FOODS DISTRIBUTORS INC STEVE ELLENBECKER GLOOR LAW GROUP LLC DOCTORS HOSPITAL, DALLAS, TX - WARNING LTRS, CMPLNTS 2008-2009, AER INDUSTRIAS LACTEAS TONI SA - MILK-BASED PRODS SID 2011-05-25/001, 2011-06-01/001, 2011-05-31/001 APRVL RAM MEDICAL INC - COUNTERFEIT POLYPROPYLENE SURGICAL MESH INVESTIGATION RECS, CMPLNTS, LAB ANALYSES, ETC OC/OM/OMP/DDM/ JEFF GERTH PROPUBLICA DKT 1977N-0094W DKT 1977N-0094W ZYMO INFACARE PHARMACEUTICAL CORP BOVINE THROMBIN - ISR 7930300 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester DAVID C. FURR FDC SERVICES LLC DAVID C. FURR FDC SERVICES LLC DAVID C. FURR FDC SERVICES LLC DAVID C. FURR FDC SERVICES LLC DAN BURNS INFACARE PHARMACEUTICAL CORP GASTROINTESTINAL DRUG A/C MTG TRANS 3/13/12 NORMED - EXTREMITY TITANIUM SYS K011118 NORMED - TITANIUM MINIPLATE SYS K931539 NORMED - CBS SYS K032634 Subject NORMED - DISTAL RADIUS SYS K022231
Page 1044 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OO/OFBA/OAGS/ 2012-3363 05/11/2012 06/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3364 05/11/2012 06/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3365 2012-3366 2012-3367 2012-3368 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3369 2012-3370 2012-3371 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 2012-3372 05/11/2012 06/11/2012 2012-3373 2012-3374 2012-3375 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ SELINGER, MARC J PRICE COLEMAN COLEMAN LAW FIRM J PRICE COLEMAN COLEMAN LAW FIRM JJ PRICE COLEMAN COLEMAN LAW FIRM MELANIE USSYK EXCITON TECHNOLOGIES INC J PRICE COLEMAN HAIN CELESTIAL GROUP, CELESTIAL SEASONINGS HEALTH CLAIMS FOR TEA PRODS CORR, EMAILS, FDA/OF/CFSAN/OCD/EOS/ J PRICE COLEMAN COLEMAN LAW FIRM BROMLEY TEA CO - HEALTH CLAIMS FOR TEA PRODS, COMM, EMAILS, MEETINGS , ETC DIAMOND PET FOODS, GASTON, SC - EIRS LAST 6 MONTHS TATA GLOBAL BEVERAGES LTD, TETLEY USA INC HEALTH CLAIMS FOR TEA PRODS CORR, EMAILS, MEETINGS, ETC ASSOCIATED BRITISH FOODS, TWININGS NORTH AMERICA INC - HEALTH CLAIMS FOR TEA PRODS, CORR, EMAILS, MEETINGS, ETC HONEST TEA INC - HEALTH CLAIMS FOR TEA PRODS CORR, EMAILS, MEETINGS, ETC THERABOND ANTIMICROBIAL BARRIER SYS K073213 SHAPIRO, STUART FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/BLT-DO/CB/ STEPHANIE B JOHNSON REDING & PILNEY STEPHANIE B JOHNSON REDING & PILNEY STEPHANIE B JOHNSON REDING & PILNEY ADVANCED COSMETIC RESEARCH LABS, CHATSWORTH, CA - TCA HAIR COLOR ACCELERATOR CMPLNTS, CAERS KPSS INC, LINTHICUM HEIGHTS, MD - TOPCHIC HAIR COLOR 250 ML CMPLNTS, CAERS KPSS INC, LINTHICUM HEIGHTS, MD - GOLDWELL TOPCHIC LOTION 6% CMPLNTS, CAERS WYETH/PFIZER - ZOSYN (TAZOBACTAM) NDA RVW WENDY B ACCARDI WICKER, SMITH, O'HARA, MCCOY, GRAHAM & FORD, PA METOPROLOL TARTRATE 100 MG - AERS 2008, 2009 WENDY B ACCARDI WICKER, SMITH, O'HARA, MCCOY, GRAHAM & FORD, PA GLIPIZIDE 10 MG - AERS 2008, 2009 Signature/ Requester Subject
Page 1045 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/11/2012 2012-3376 05/11/2012 06/11/2012 2012-3377 2012-3378 2012-3379 2012-3380 2012-3381 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3382 2012-3383 2012-3384 2012-3385 2012-3386 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 2012-3387 05/11/2012 06/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3388 05/11/2012 06/11/2012 CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANDREW M GREEN HALSCION HALSCION INC - HYDROGEL SCAFFOLD REQUEST FOR DESIGNATION LTR RVW MEMOS, EMAILS FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ MURDOCK, BRETT DR LAURENS HAVENGA MULTIMIN USA INC VERONICA KNAPP HOGAN LOVELLS US LLP AVINASH HASAMNIS HEMMO PHARMACEUTICALS PRIVATE LTD SAVORY SNACKS - TRANS FAT INTAKE BY US POPULATION BRAND NAME, PRODUCT CODE, PKG SIZE, ETC HEMMO PHARMACEUTICALS PRIVATE LTD, INDIA - EIR 3/11 BOVI-CU NADA 140-904 - LBLG, PI ORA/CE-FO/NJ-DO/NJCB/ LUCAS, STEVE K060507 ORA/P-FO/LOS-DO/LACB/ LAURA TANK CBR SYSTEMS INC CBR SYSTEMS INC - UMBILICAL CORD BLOOD STEM CELLS EIRS, 483S 2008 TO 2010 DPT LAKEWOOD INC, LAKEWOOD, NJ - EIRS 02/12 TO 03/12 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DAVID MOYNHAM HUNTLEIGH HEALTHCARE LTD CAROL NAKAGAWA MERGE HEALTHCARE STEPHANIE BERGERON IMPLANT DIRECT AUTUMN L BORTON PFIZER SANJAY H SHARMA PHD HETERO USA INC COVIDIEN - KENDALL - SCD SEQUENTIAL COMPRESSION COMFORT SLEEVE K100306 CALGARY SCIENTIFIC INC - RESOLUTION MD MOBILE K111346 NOBEL BIOCARE - MEDICAL DVC PACKAGING ISSUES MDRS WEST AGRO, HAMILTON, NY - EIRS, 483S 2/27/12 TO PRESENT PROMACTA (ELTROMBOPAG OLAMINE) TABS CHEMISTRY, BIOEQV RVWS, CORR, ETC Action Office Signature/ Requester COLEMAN LAW FIRM JAE H KIM GENORAY AMERICA INC Subject MEETINGS, ETC ZEN-7000 - K103425 ACCESSION NUMBER
Page 1046 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ OC/OIASI/OCP/ 2012-3389 05/11/2012 06/11/2012 2012-3390 05/11/2012 06/11/2012 2012-3391 2012-3392 05/11/2012 06/11/2012 05/11/2012 06/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3393 05/11/2012 06/11/2012 FDA/OMPT/CDRH/OCER/DFOI/ KAROL RODRIGUEZ MEDICAL EQUIPMENT OF FLORIDA ORA/SE-FO/FLA-DO/FCB/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DEN-DO/COMP/ ORA/SW-FO/KAN-DO/COMP/ 2012-3396 05/11/2012 06/11/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CLARK G SULLIVAN ARNALL GOLDEN GREGORY LLP FOLIC ACID DRUG EFFICACY STUDY - DESI 5897, FDC-D265 PROCEEDINGS, NATIONAL ACADEMY OF SCIENCES PRTS WILLIAM KONSTAND TAG HEALTHCARE MICHAEL BOOTH DENVER POST TINGLE X-RAY INC - 13-FBT STATIONARY X-RAY MEDICAL TABLE, 13-BF-7E DLOOR-WALL WALL STAND; SEDECAL G310R.1LO.APM02 32KW X-RAY HIGH FREQUENCY GENERATOR, ETC FDA APRVD CERTIFICATE LTR THE ARENSON GROUP INC, TAG HEALTHCARE, TAG MEDICAL, ETC - EIRS 2001 TO PRESENT MULTISTATE E COLI OUTBREAK IN THE MIDWEST & WEST 9/09 - STAFF RPTS, MEMOS, SUMMARIES, ETC ORA/SE-FO/FLA-DO/FCB/ FDA/OO/OFBA/OAGS/ OM/OMP/DODM/ JENNIFER BROWN INFOTRIEVE INC JOHN DAVIS PROCUREMENT REVIEW COUNCIL DOUGLAS N BLUE II ZETETIC INC CATHERINE SAINT LOUIS NEW YORK TIMES ANTIVIRAL DRUGS A/C - MITOCHODRIAL DAMAGE ASSOCIATED WITH NUCLEOSIDE ANALOGUES, ROCKVILLE,MD, 9/20-21/93 COUNTY OF SAN DIEGO FEDERAL GRANTS - FINANCIAL STATUS RPTS SF 269A/SF 425 2004 TO 2012 LIFESCAN - ONE TOUCH ULTRA BLOOD GLUCOSE TEST STRIPS ENTRY #FY620082153 RECS MIRALAX (POLYETHYLENE GLYCOL) - AERS LAST TEN YRS Signature/ Requester Subject
2012-3394 2012-3395
05/11/2012 06/11/2012 05/11/2012 06/11/2012
Page 1047 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3397 2012-3398 2012-3399 2012-3400 2012-3401 2012-3402 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/11/2012 06/11/2012 05/14/2012 06/12/2012 2012-3403 05/14/2012 06/12/2012 2012-3404 05/14/2012 06/12/2012 2012-3405 05/14/2012 06/12/2012 2012-3406 05/14/2012 06/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3407 05/14/2012 06/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3408 05/14/2012 06/12/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ CHARLES BARRETT CHARLES F BARRETT ATTORNEY AT LAW DOLE - MISBRANDING FOOD PRODS CORR DAVID B RHEINGOLD RHEINGOLD, VALET, ET AL INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS JENNIFER K REGISTER BLASINGAME BURCH ET AL ATTYS JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JERRY L. CHAPMAN INTERNATIONAL PHARMACEUTICAL QUALITY MUSTAFA NEVZAT ILAC SANAYII AS, YENIBOSNA, TURKEY - EIR 4/20/12-5/3/12 POST MARKET SURVEILLANCE STUDIES - PS120002, PS120003, PS120004, ETC, RECS INSTRUMED - RONGEUR K081651 FOI REQUESTS 4/30/12 TO 5/4/12 FOI REQUESTS 4/23-27/12 OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ ANNA WOLONCIEJ SIDLEY AUSTIN LLP JEFF GERTH PROPUBLICA DAVID MCFARLAND FDA WEBVIEW/FERDIC INC LISA TARRISON-SCHRAMP CanReg, Inc. CLOSED LOG REQUESTS 4/30/12 TO 5/4/12 CLOSED LOG REQUESTS 4/30-12 TO 5/4/12 CLOSED DAILY LOG 4/30/12 TO 5/4/12 DKT 1977N-0094 DKT 2003P-0110, 2006P-0533, 2006P-0534, ETC. Signature/ Requester Subject
Page 1048 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/KAN-DO/COMP/ 2012-3409 2012-3410 2012-3411 2012-3412 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 2012-3413 2012-3414 05/14/2012 06/12/2012 05/14/2012 06/12/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3415 05/14/2012 06/12/2012 ORA/SE-FO/ATL-DO/ACB/ GISSENDANNER, ROBIN CMPLNT 120110 - RPT ANNA DEMKOVIC ABBOTT LABORATORIES, INC. ANGELIA D. SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS A TAKEDA CO, BADEN-WUERTTEMBERG, GERMANY - 483 4/19/11 ABBOTT LABS, FAIRFIELD, CA - EIR 6/18-7/6/09, 4/13-15/11 CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ JONATHAN BERMAN JONES DAY ROBERTA LEE ACUEITY HEALTHCARE INC KRISTI O. SMEDLEY Center for Regulatory Services, Inc. SEAN DUNAGAN JUDICIAL WATCH ASPARTAME - CAERS 1/1/11-5/1/12 CENTER FOR SCIENCE IN THE PUBLIC INTEREST (CSPI) RESP TO 3/14/06 ACUEITY - MEDICAL LIGHT SOURCE K032430; VIADUCT MICROENDOSCOPE & ACCESSORIES K011189 NADA 55-099, 55-101, 139-941 FOI SUMMARIES Signature/ Requester Subject
Page 1049 of 1132

Total Records: 12455 Control # 2012-3416 Recd Date / Due Date 05/14/2012 06/12/2012 2012-3417 05/14/2012 06/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3418 2012-3419 05/14/2012 06/12/2012 05/14/2012 06/12/2012 2012-3420 05/14/2012 06/12/2012 2012-3421 05/14/2012 06/12/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/FLA-DO/FCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-3422 2012-3423 2012-3424 2012-3425 2012-3426 2012-3427 2012-3428 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ KRISTI O SMEDLEY Center for Regulatory Services, Inc. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) ORIGINAL REQUEST LETTER 2012-2908 ORIGINAL REQUEST LETTER 2012-2833 ORIGINAL REQUEST LETTER 2012-2829 ORIGINAL REQUEST LETTER 2012-2757 2012-1100 HYDROLYZED YEAST (AAFCO DEFINITION 96.12) SUBMISSIONS, CORR, MEMO RECS ETC ORIGINAL REQUEST LETTER 2012-2676 STRULOVIC, SOLOMAN CIBA VISION INC - CLEAR CARE SOL, LBLG INFO RECS, DOC CPT1200070 ERIK P. CREP WICKER SMITH ET AL INFUPHARMA - RPTS ORA/CE-FO/NJ-DO/NJCB/ BRENDA M GARTZ ELI LILLY & CO JOHN R. McLEOD BROWN & JAMES PC SYNTRAX INNOVATIONS - LIPOKINETIX RPTS CERTIFIED BIOCHEM LABS, LYNDHURST, NJ - 483 5/18/11 Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester WYNN STOCKING CAROLINA LIQUID CHEMISTRIES CORP BRENDA M GARTZ ELI LILLY & CO Subject ALBUMIN REAGENT K021636; CK NAC REAGENT K974833; DIRECT BILIRUBIN REAGENT K011972 SHLONOGI, OSAKA, JAPAN - 483 7/31/09
Page 1050 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/12/2012 2012-3429 2012-3430 2012-3431 2012-3432 2012-3433 2012-3434 2012-3435 2012-3436 2012-3437 2012-3438 2012-3439 2012-3440 2012-3441 2012-3442 2012-3443 2012-3444 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Signature/ Requester MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. 2010-5894 2012-835 FOI DAILY LOG 4/30/2012 - 5/4/2012 ORIGINAL REQUEST LETTER 2012-2504 ORIGINAL REQUEST LETTER 2012-3014 ORIGINAL REQUEST LETTER 2012-3040 ORIGINAL REQUEST LETTER 2012-2414 ORIGINAL REQUEST LETTER 2012-3050 ORIGINAL REQUEST LETTER 2012-2583 FOI DAILY LOG 5/7-11/12 ORIGINAL REQUEST LETTER 2012-3046 ORIGINAL REQUEST LETTER 2012-3011 ORIGINAL REQUEST LETTER 2012-2546 2012-1132 ORIGINAL REQUEST LETTER 2012-2980 ORIGINAL REQUEST LETTER 2012-2945 Subject
Page 1051 of 1132

Total Records: 12455 Control # 2012-3445 2012-3446 Recd Date / Due Date 05/14/2012 06/12/2012 05/14/2012 06/12/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ Signature/ Requester Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. VAERS DIRECT REPORTS, MEDWATCH REPORTS and ANY SOURCE DOCUMENTS for THE FOLLOWING TWO (2) CASES, VAERS IDs # 433364-1 # 434427-1 for Gardasil (HPV VACCINE, MERCK & CO, INC.) DIRECT REPORTS, MEDWATCH REPORTS and ANY SOURCE DOCUMENTS for THE FOLLOWING FOUR (4) CASES, ISR NUMBERS: 8180426 8190044 8217210 8255342 for JANUVIA, (SITAGLIPTIN PHOSPHATE, MERCK) 2012-1530 COMPLETE RESPONSE FOR Log Request # 2012-1532 LANCASTER LABS, LANCASTER, PA - EIRS, 483S, CO RESP 8/1/11 TO 1/31/12; 2012-1532 2012-1372 2012-1389 2012-945 2012-1390 2012-1441 2012-1468 2012-1469 2012-1472 2012-1526 Subject 2011-6176
2012-3447
05/14/2012 06/12/2012
2012-3448 2012-3449
05/14/2012 06/12/2012 05/14/2012 06/12/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/
Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC.
2012-3450 2012-3451 2012-3452 2012-3453 2012-3454 2012-3455 2012-3456 2012-3457 2012-3458 2012-3459
05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012
Page 1052 of 1132

Total Records: 12455 Control # 2012-3460 2012-3461 2012-3462 2012-3463 2012-3464 2012-3465 2012-3466 2012-3467 2012-3468 2012-3469 2012-3470 2012-3471 2012-3472 2012-3473 2012-3474 2012-3475 2012-3476 Recd Date / Due Date 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ Signature/ Requester Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) 2012-2419 2012-1942 2012-2054 2012-1032 2012-1774 2012-1650 2012-1649 2012-1636 2012-1615 2012-1613 2012-1640 2012-1565 2012-1564 2012-1544 2012-1543 2012-1537 Subject 2012-984
Page 1053 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/12/2012 2012-3477 2012-3478 2012-3479 2012-3480 2012-3481 2012-3482 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/14/2012 06/12/2012 05/15/2012 06/13/2012 2012-3483 2012-3484 05/15/2012 06/13/2012 05/15/2012 06/13/2012 2012-3485 05/15/2012 06/13/2012 OC/OCC/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-3486 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3487 2012-3488 05/15/2012 06/13/2012 05/15/2012 06/13/2012 ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ LACY L KOLO PHD Patton Boggs LLP ALAN BECKMAN MOBIUS THERAPEUTICS LLC MITOMYCIN - ISRS 7556657, 7556658, 7964160, ETC BETA-ALANINE - BILL OF LADING, WEIGHT, SHIPPER, ETC DANIEL KOCH WALKER SMITH CAPITAL LP WATSON LABS - CORTICOTROPIN ANDA 88-772 EQUIVALENT GENERIC RECS ANGELIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS HOSPIRA, LA AURORA DE HEREDIA, COSTA RICA - 483S 1/11 TO PRESENT Doe J Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CVM/OCD/ CHRISTOPHER HATTON CIRCA HEALTHCARE LLC ANIKA THERAPEUTICS INC - HYVISC STERILE INJ NADA 122-578 FOI SUMMARY SEC CMPLNT TCR 1309184950901 Signature/ Requester MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. MICHAEL W CZACK CZACK, MICHAEL INDIVIDUAL RECS 2012-1229 2012-1287 2012-1211 2012-1182 2012-2422 Subject
Page 1054 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3489 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3490 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3491 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3492 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3493 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3494 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3495 2012-3496 05/15/2012 06/13/2012 05/15/2012 06/13/2012 2012-3497 2012-3498 05/15/2012 06/13/2012 05/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ BARBARA JONES DOMINION GROUP INC ANN E CRUM SENSIENT IMAGING TECHNOLOGIES BARBARA JONES DOMINION GROUP INC KENNETH REID FOI DAILY LOG 4/16-20/12 FOI DAILY LOG 4/23-27/12 EDTA USE IN FOODS, DRUGS, COSMETICS - CAP 9C0218 FOI DAILY LOG 4/16-20/12 KAREN SCHULTZ DOMINION GROUP INC GALDERMA LABS - METROGEL (METRONIDAZOLE) 1% PUMP SBA, NDA 021789/S-004 KAREN SCHULTZ DOMINION GROUP INC GALDERMA LABS - METROGEL (METRONIDAZOLE) 1% PUMP ACTION LTR, NDA 021789/S-004 SKALIOTIS, ROSS NDA 17-078/S000,S030,036; ANDA 76-137/S000,S001 APRVL RECS BEAUDOIN, DERIC J KENALOG TOPICAL SPRAY - TESTING, SUPPLIERS, RAW MATERIALS, ETC DUSTIN BLOCK IPD ANALYTICS LLC CORTICOTROPIN ANDA 88-772 - PI, APRVL LTR DINA ONISHI JAZZ PHARMS ELESTRIN (ESTRADIOL) NDA 21-813 - ECTD SEQUENCE SUBMISSIONS 0000 TO 0007 Signature/ Requester Subject
Page 1055 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/13/2012 2012-3499 05/15/2012 06/13/2012 2012-3500 05/15/2012 06/13/2012 2012-3501 05/15/2012 06/13/2012 2012-3502 2012-3503 2012-3504 2012-3505 2012-3506 2012-3507 2012-3508 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 2012-3509 05/15/2012 06/13/2012 2012-3510 05/15/2012 06/13/2012 2012-3511 05/15/2012 06/13/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ ORA/ORM/ ORA/ORM/ MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION LIST OF DOMESTIC & FOREIGN GOOD MANUFACTURING PRACTICES (GMP) INPS 1/10 TO 4/12 Doe J OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/NE-FO/NYK-DO/NYDCB/ INC REGULATORY CONSULTING & SUBMISSIONS PETER MALONE BRISTOL MYERS SQUIBB CO LISA TARRISON-SCHRAMP CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. PETER MALONE BRISTOL MYERS SQUIBB CO GLADYS TONKIN Center for Regulatory Services, Inc. GLADYS TONKIN Center for Regulatory Services, Inc. DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CMPLNT FOI DAILY LOG 4/23-27/12 FOI DAILY LOG 4/16-20/12 FOI DAILY LOG 4/23-27/12 BRISTOL MYERS SQUIBB CO INC, SYRACUSE, NY - EIR 4/118/08 FOI DAILY LOG 4/16-20/12 FOI DAILY LOG 4/23-27/12 BRISTOL MYERS SQUIBB CO INC, EAST SYRACUSE, NY EIR 8/16- 20/10 FOI DAILY LOG 4/16-20/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 4/23-27/12 Signature/ Requester WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE FOI DAILY LOG 4/16-20/12 FOI DAILY LOG 4/23-27/12 Subject
Page 1056 of 1132

Total Records: 12455 Control # 2012-3512 2012-3513 2012-3514 2012-3515 2012-3516 2012-3517 2012-3518 2012-3519 2012-3520 2012-3521 2012-3522 2012-3523 2012-3524 2012-3525 2012-3526 2012-3527 2012-3528 Recd Date / Due Date 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SW-FO/DALFOI SERVICES INC Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. PSUEDOMONAS AERUGINOSA OUTBREAK AT METHODIST 2011-9635 2011-9534 2012-182 2011-9374 2011-9361 2011-9241 2011-9004 2011-8805 2011-8719 2011-8479 2011-7187 2011-5613 2009-8380 2009-7997 FOI SERVICES INC FOI DAILY LOG 4/23-27/12 Signature/ Requester Subject FOI DAILY LOG 4/16-20/12
Page 1057 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/13/2012 2012-3529 2012-3530 05/15/2012 06/13/2012 05/15/2012 06/13/2012 Action Office DO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3531 2012-3532 05/15/2012 06/13/2012 05/15/2012 06/13/2012 CVM/OCD/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3533 05/15/2012 06/13/2012 2012-3534 05/15/2012 06/13/2012 ORA/ ORA/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3535 05/15/2012 06/13/2012 2012-3536 2012-3537 05/15/2012 06/13/2012 05/15/2012 06/13/2012 2012-3538 2012-3539 2012-3540 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OM/OMP/DODM/ FDA/OMPT/CDRH/OCER/DFOI/ ROBIN FELDMAN LSRO SOLUTIONS APRIL LEE KODENT INC APRIL LEE CURASAN AG, FRANKFURT, GERMANY - CERASORB DENTAL, CERASORB M DENTAL, CERASORB PERIO K01443 BIOMATLANTE - MBCP K051885 DCK 1984F-0050 FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ ORA/SE-FO/ATL-DO/ACB/ MEG KINNARD ASSOCIATED PRESS APRIL HARRY INTEGRA LIMIT UNCERTAINTY DIAMOND PET FOODS, GASTON, SC - SALMONELLA RPTS, INSP, DATE PHYSICIAN INDUSTRIES - RADIO ABLATION NEEDLE K040565 DAVID FISCHER BLUNT WRAP USA BLUNT WRAP INC - KS SLIM GOLD US NON FOILED, KSS GREEN UNBLEACHED/EXECUTIVE BRANCH UNBLEACHED, KSS SNOOP DOGG - EQUIVALENCE RPT MORGAN LAMARE BECK & AMSDEN PLLC ABILIFY - AERS 2002 TO 2007 Doe J CMPLNT JAMES ANDREWS FOOD SAFETY NEWS MORGAN LAMARE BECK & AMSDEN PLLC ABILIFY - PROMOTIONAL RECS DIAMOND PET FOOD, GASTON, SC - 483, CMPLNTS Signature/ Requester MUSCARELLA, LAWRENCE . Joan Stitt (UG2CD-16) MERCK & CO., INC. ERIC WALTER CAMIL SR CAMIL CONSULTING CORP WATSON LABS - CORTICOTROPIN NDA 88-772; QUESTCOR PHARMA - HP ACTHAR GEL NDA 22-432; ORGANIVS LAGRANGE - CORTICOTROPIN NDA 10-831, ETEC RECS Subject HOSPITAL, HOUSTON, TX 2009 RECS 2011-9562
Page 1058 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/13/2012 2012-3541 2012-3542 05/15/2012 06/13/2012 05/15/2012 06/13/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ OM/OMP/DODM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ 2012-3543 2012-3544 2012-3545 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/15/2012 06/13/2012 2012-3546 2012-3547 2012-3548 2012-3549 2012-3550 05/15/2012 06/13/2012 05/15/2012 06/13/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ SCHAFER, DEBOARAH TISCHER LOCKHART HOLLINGSWORTH LLP ORA/SW-FO/DALDO/COMPLIANCE/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ SCHAFER, DEBORAH CHRISTOPHER SHAKIB TERRELL HOGAN ELLIS YEGELWEL PA AUDREY E. VARWIG DICKIE MCCAMEY & CHILCOTE PAIGE SAVITZ BEAVER STEET FISHERIES INC DEANNA R SWITS NIXON PEABODY LLP ISP TECHNOLOGIES INC, TEXAS CITY, TX - RECALL, FINES, CITATIONS MAOMING XINZHOU SEAFOOD CO LTD - FROZEN TILAPIA FILLETS ENTRY #002-8139311-6 ANALYTICAL RESULTS MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYS K120593 OB/GYN CONCEPTS LTD - OVU-TRAC OVULATION TIMING KIT K870528 IONTOPHERETIC DRUG DELIVERY SYS - SS&E, LBLG, PI, ETC 1991 TO 1995 MEDTRONIC - CONCERTO MODEL C154DWK ICD RECS FDA/OMPT/CDRH/OCER/DFOI/ DEANNA R. SWITS NIXON PEABODY LLP MYOSURE - HYSTEROSCOPIC TISSUE REMOVAL SYS K120593 ZETEK - OVACUE CUE FERTILITY MONITOR K850579 CVM/OCD/ Action Office Signature/ Requester KODENT INC PAUL MARTIN, Ph.D. PJM SCIENTIFIC PTY LTD WILLIAM WILSON AMERICANS FORLIMITED GOVERNMENT ESTRUMATE (CLOPROSTENOL SODIUM) NADA 113-645 FOI SUMMARY PUBLIC CITIZEN, ALLIANCE FOR JUSTICE, CENTER FOR PROGRESSIVE REFORM, ETC - FDA CHANGES-BEINGEFFECTED PROCESS MTGS, EMAILS, LTRS, ETC Subject
Page 1059 of 1132

Total Records: 12455 Control # 2012-3551 Recd Date / Due Date 05/16/2012 06/14/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3552 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3553 2012-3554 2012-3555 05/16/2012 06/14/2012 05/16/2012 06/29/2012 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3556 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3557 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3558 05/16/2012 06/14/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3559 05/16/2012 06/14/2012 CVM/OCD/ KRISTI O SMEDLEY PHD Center for Regulatory Services, Inc. PFIZER - ORBESEAL (BISMUTH SUBNITRATE) WARNING LTRS, LBLG, RVWS, ETC WASHBURN, KIMBERLEE STRYKER - HIP MODULE NAVIGATION SYS K022365, CT BASED HIP MODULE NAVIGATION SYS K050615; MAKO SURGICAL CORP - ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYS K093425, ETC MICHELE SINOWAY PHD LACHMAN CONSULTANT SERVICES INC BOEHRINGER INGELHEIM - VIRAMUNE XR NDA 201-152 APRVL SUMMARY, RVWS NORBERT GOTTESMAN AVET CAPITAL MANAGEMENT LLC AVANIR PHARMS - NUEDEXTA (DEXTROMETHORPHAN HYDROBROMIDE, QUINIDINE SULFATE) AERS, CORR ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ TISCHER LOCKHART HOLLINGSWORTH LLP MARTHA SLOBODA ADHESIVES RESEARCH INC TISCHER LOCKHART HOLLINGSWORTH LLP ALBUNEX - SS&E, LBLG, PI, ETC 1991 TO 1995 SPINAL CATHETERS ASSOCIATED WITH CAUDA EQUINA SYNDROME SS&E, LBLG, PI, ETC 1991 TO 1995 MONOSOL RX LLC, PORTAGE, IN - EIRS 2006-2012 MARK K REMUS STEPTOE & JOHNSON APP PHARMACEUTICALS LLC - NAROPIN (ROPIVACAINE HCL) NDA 20-533 FOI REQUESTS, LTRS, EMAILS, ETC Signature/ Requester TISCHER LOCKHART HOLLINGSWORTH LLP Subject ANGIOTENSIN-VONVERTING-ENZXYME INIBITORS (ACE INHIBITORS) SS&E, LBLG, PI, ETC 1991 TO 1995
Page 1060 of 1132

Total Records: 12455 Control # 2012-3560 Recd Date / Due Date 05/16/2012 06/14/2012 2012-3561 2012-3562 2012-3563 2012-3564 2012-3565 05/16/2012 06/14/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3566 05/16/2012 06/14/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3567 05/16/2012 06/14/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3568 2012-3569 2012-3570 05/16/2012 06/14/2012 05/16/2012 06/14/2012 05/16/2012 06/14/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3571 05/16/2012 FDA/OMPT/CDRH/OCER/DFOI/ BRENT M ARDAUGH MPH MS K050558, K944353, K901659 ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/CHI-DO/CCB/ ELIZABERH J MAHONEY BAXTER HEALTHCARE CORP MEG KINNARD AP ASSOCIATED PRESS BRENT M ARDAUGH MPH MS NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE BAXTER HEALTHCARE CORP, DEERFIELD, IL - EIRS 03/05/08-06/06/08 DIAMOND PET FOOD, GASTON, SC - EIRS, RECALLS 2005 TO PRESENT K001122, K984220, K972412, ETC WARREN WILLIAMS FOREST RESEARCH INSTITUTE ABILIFY (ARIPIPARAZOLE NDA 21-336/S002 - APRVL RECS JESSIE L JANDOVITZ MORELLI RATNER PC RISPERIDONE (RISPERIDAL) - AERS FDA/OMPT/CDRH/OCER/DFOI/ OC/OOPD/ FDA/OMPT/CDRH/OCER/DFOI/ GLOSSOP, NATASHA BRIAN WALTER ACORDA THEMAPEUTICS SUSAN D GOLDSTEIN-FALK MDI CONSULTANTS INC LYNDSY HASSETT STASON PHARMACEUTICALS INC CLOBAZAM, FELBAMATE, LAMOTRIGINE, ETC - ORPHAN DRUG DESIGNATION DENTSPLY INTERNATIONAL - QMIX ENDODONTIC IRRIGATIING SOL K103244 ZYRTEC ORAL TABS NDA 19-835 - APRVL RECS Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ GLOSSOP, NATASHA KOELIS - UROSTATION 3D PROSTATE SUITE K100793 EIGEN LLC - 3-D IMAGING WORKSTATION K081093 GLOSSOP, NATASHA Signature/ Requester Subject TRAXTAL TECHNOLOGIES INC - ABARIS K053610
Page 1061 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/14/2012 Action Office Signature/ Requester NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OC/OCM/EMOPS/ ORA/ ORA/ FOI SERVICES INC LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS LAUREN S BARR INC RESEARCH CONSULTING & SUBMISSIONS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS NICHOLAS J PAROLISI LITCHFIELD CAVO LLP 10 ALLEGED E COLI ILLNESSES ASSOCIATED WITH CLUSTER NO 0910MLEXH-1 - RPTS, MEMOS, ANALYTICAL STUDIES, ETC FOI CLOSED REQUESTS 5/7-11/12 FOI CLOSED REQUESTS 4/30 12 TO 5/4/12 FOI CLOSED REQUESTS 4/23-27/12 FOI CLOSED REQUESTS 4/16-2012 FOI CLOSED REQUESTS 4/0-13/12 FOI CLOSED REQUESTS 4/2-6/12 FOI CLOSED REQUESTS 3/26-30/12 FOI CLOSED REQUESTS 5/7-11/12 FOI CLOSED REQUESTS 4/30 12 TO 5/4/12 FOI CLOSES REQUESTS 5/7-11/12 Subject
2012-3572 2012-3573
05/16/2012 06/14/2012 05/16/2012 06/14/2012
2012-3574
05/16/2012 06/14/2012
2012-3575
05/16/2012 06/14/2012
2012-3576
05/16/2012 06/14/2012
2012-3577
05/16/2012 06/14/2012
2012-3578
05/16/2012 06/14/2012
2012-3579
05/16/2012 06/14/2012
2012-3580
05/16/2012 06/14/2012
2012-3581
05/16/2012 06/14/2012
2012-3582
05/16/2012 06/14/2012
Page 1062 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SW-FO/KAN-DO/COMP/ 2012-3583 05/16/2012 06/14/2012 CBER/OCTMA/DDOM/ALFB/ CTP/OD/ CTP/OD/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ NCTR/OD/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ ORA/ORM/ ORA/ORM/ ORA/ ORA/ 2012-3584 2012-3585 05/16/2012 06/14/2012 05/16/2012 06/14/2012 2012-3586 2012-3587 2012-3588 05/16/2012 06/14/2012 05/17/2012 06/15/2012 05/17/2012 06/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ JORDAN, DAVID P ROMAR RORENFELD POINTSTATE CAPITALL LP IVAN CABEZUELA NOMURA INTERNATIONAL PLC LISA TARRISON-SCHRAMP CanReg, Inc. JOHN F. THOMPSON ROBINSON & THOMPSON CITALOPRAM; CELEXA - AER LIST OF FORIEGN & DOMESTIC DRUG INSPS; 10/11 TO PRESENT EXCLUSIVE SUPPLEMENTS, FAHRENHEIT, GASPARI NUTRITION, ETC - DMAA (DIMETHYLAMYLAMINE) RESP TO WARNING LTRS NYCOMED US, MELLVILLE, NY - 483, WARNING LTRS, EIRS 2007 TO PRESENT FOI CLOSED REQUESTS 5/7-12/12 LEXIA B KROWN O'DONNELL & WILLIAMS PC CBER, CDER, CDRH, ETC - ORGANIZATIONAL CHARTS, NAMES, TITLES, ETC Signature/ Requester Subject
Page 1063 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3589 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3590 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3591 2012-3592 05/17/2012 06/15/2012 05/17/2012 06/15/2012 2012-3593 05/17/2012 06/15/2012 2012-3594 2012-3595 2012-3596 2012-3597 2012-3598 05/17/2012 06/15/2012 05/17/2012 06/15/2012 05/17/2012 06/15/2012 05/17/2012 06/15/2012 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3599 05/17/2012 06/15/2012 OC/OM/OMP/DDM/ SETH A. MAILHOT SHEPPARD MULLIN RICHTER & HAMPTON, LLP DKT 1978N-0021D ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/FLA-DO/FCB/ SCOTT ANTONIA, MD, Ph.D. MOFFITT CANCER CENTER RON JEFFREY CASMED MEDICAL SYSTEMS INC RON JEFFREY CASMED MEDICAL SYSTEMS INC WILLIAM A. OLSON, Ph.D. Center for Regulatory Services, Inc. WILLIAM A. OLSON, Ph.D. Center for Regulatory Services, Inc. AILEEN M. GARIEPY, MD, MPH YALE UNIVERSITY KARINA CASTILLO INTERFARMA CORP ANNE E. HANCOCK MCINTOSH LAW FIRM PC WATSON PHARMS - PREDNISOLONE NDC 0591-5059 PACKAGE INSERT INTERFARMA CORP, MIAMI, FL - EIR 1/10 ESSURE - RPTS FCN 1091 FAP 6B4495 SOMANETICS K082327 SOMANETICS CORP K080769 DR. ANTONIA - 483 8/15/02 BB-IND-7952 JOHN F. THOMPSON ROBINSON & THOMPSON ESICITALOPRAM; LEXAPRO - AER JOHN F. THOMPSON ROBINSON & THOMPSON CYCLOSPORIN A; NEORAL - AER Signature/ Requester Subject
Page 1064 of 1132

Total Records: 12455 Control # 2012-3600 Recd Date / Due Date 05/17/2012 06/15/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3601 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3602 05/17/2012 06/15/2012 2012-3603 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3604 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3605 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3606 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3607 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3608 05/17/2012 06/15/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ F. DOUGLAS HARTNETT ELITOK & HARTNETT AT LAW PLLC INDIVIDUAL RECS ANNE E. HANCOCK MCINTOSH LAW FIRM PC WATSON PHARMS - PREDNISONE NDC 0951-5442 PACKAGE INSERT CERTIFIED ANNE E. HANCOCK MCINTOSH LAW FIRM PC TEVA PARENTAL MEDICINES - METHYLPREDNISOLONE ACETATE PACKAGE INSERT CERTIFIED ANNE E. HANCOCK MCINTOSH LAW FIRM PC WATSON PHARMS - PREDNISONE NDC 0591-5442 PACKAGE INSERT CERTIFIED ANNE E. HANCOCK MCINTOSH LAW FIRM PC PHARMACIA & UPJOHN CO - DEPO MEDROL NDC 00090306 PACKAGE INSERT CERTIFIED OC/OM/OMP/DDM/ SETH MAILHOT SHEPPARD MULLIN RICHTER & HAMPTON, LLP ANNE E. HANCOCK MCINTOSH LAW FIRM PC GREENSTONE LLC - METHYLPREDNISOLONE NDC 597623327 PACKAGE INSERT CERTIFIED DKT FDA-2012-P-0317 ANNE E. HANCOCK MCINTOSH LAW FIRM PC BEDFORD LABS - METHYLPREDNISOLONE SODIUM SUCCINATE PACKAGE INSERT CERTIFIED Signature/ Requester ANNE E. HANCOCK MCINTOSH LAW FIRM PC Subject PHARMACIA & UPJOHN CO - SOLU MEDROL PACKAGE INSERT CERTIFIED
Page 1065 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3609 05/17/2012 06/15/2012 2012-3610 2012-3611 2012-3612 2012-3613 2012-3614 2012-3615 2012-3616 2012-3617 2012-3618 2012-3619 2012-3620 2012-3621 2012-3622 05/17/2012 06/15/2012 05/17/2012 06/15/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ WAFF 48 Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. ISR 8199431-6 2012-2402 2012-1739 2012-2535 2012-1201 2012-364 2012-986 2012-790 2012-2533 2012-478 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ JOAN SYLVAIN BAUGHAN Keller and Heckman LLP NANCY E ECKERT, LIFESOUTH COMMUNITY BLOOD CTR WARNING LTR 2012-601 WR GRACE & CO - FAP OB4231 TRAN, DUONG RIMED LTD - DIGI LITE TCD DVC K062578 Signature/ Requester Subject
Page 1066 of 1132

Total Records: 12455 Control # 2012-3623 Recd Date / Due Date 05/18/2012 06/18/2012 Action Office FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3624 05/18/2012 06/18/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3625 2012-3626 2012-3627 2012-3628 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 05/18/2012 06/18/2012 2012-3629 2012-3630 05/18/2012 06/18/2012 05/18/2012 06/18/2012 2012-3631 05/18/2012 06/18/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3632 2012-3633 05/18/2012 06/18/2012 05/18/2012 06/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3634 05/18/2012 CTP/OD/ MARLBORO SELECT - CORR 06/22/09 TO PRESENT FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ KATE WILLSON CENTER FOR PUBLIC INTEGRITY HUMAN CELL & TISSUE ESTABLISHMENTS OUTSIDE THE US 2001 TO PRESENT MERCK - ISRS 5792504, 587293, 6228059, ETC OC/OOPD/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ANN WATERHOUSE HILL-ROM PETER A TAKES KYPHA INC VALERIE SCHEIDT PF CHANG'S NORBERT GOTTESMAN AVET CAPITAL MANAGEMENT LLC AMY KINCANON LEXIS NEXIS COURTLINK INC GAIL LESSICK LACHMAN CONSULTANT SERVICES INC SEAN HIGGINS ANDREWS THORNTON FOREIGN & DOMESTIC DRUG COMPANIES, MEDICAL DVC MFRS, BIORESEARCH MONITORING (BIMO), ETC - INSPS 3/1-31/12 JACK3d, OXYELITE PRO, NUTREX LIPO-6 BLACK ETC ( DMAA) - AERS DADE BEHRING MARBUG GMBH (DADE BEHRING INC) DIMENSION VISTA C3 & C4 COMPLEMENT FLEX K061852 HUY FONG FOODS, ROSEMEAD,CA - EIRS, 483S MOST RECENT ABBOTT, DEPOMED - GRALISE (GABEPENTIN) 300 MG, 600 MG TABS NDA 22-544 ORPHAN DRUG DESIGNATION 2012-2423 K972111, K970636, K964873, ETC STEPHANIE ARMOUR BLOOMBERG NEWS PAUHLER FRESH, NOGALES, AZ, CULIACAN, MEXICO, AGRICOLA, SAN JUAN - EIR, ENFORCEMENT ACTIONS 2009 TO PRESENT Signature/ Requester STEPHANIE ARMOUR BLOOMBERG NEWS Subject LUCKY STAR MARKETING LLC, SAN BERNARDINO, CA EIRS, ENFORCEMENT ACTIONS 2009 TO PRESENT
Page 1067 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/18/2012 2012-3635 05/18/2012 06/18/2012 2012-3636 05/18/2012 06/18/2012 2012-3637 05/18/2012 06/18/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/P-FO/LOS-DO/LACB/ CBER/OCTMA/DDOM/ALFB/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3638 2012-3639 05/18/2012 06/18/2012 05/18/2012 06/18/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/OCI/ Doe J FDA/OMPT/CDRH/OCER/DFOI/ PETER A TAKES KYPHA INC INDIVIDUAL RECS IBL GMBH - C3D-CIC EIA TEST K032796 KATE WILLSON ICIJ INTERPORT CROSS INTERNATIONAL LLC 04/09/03; MUSCULOSKELETAL TRANSPLANT FOUNDATION 11/25/03, 08/09/06, 07/31/06, NUVASIVE INC 08/14/03, ETC - 483S Action Office CTP/OD/ ORA/SE-FO/ATL-DO/ACB/ Signature/ Requester FOI SERVICES INC MATTHEW ROMAN MACUGA LIDDLE & DUBIN PC BLAKE A EUDY MORRIS POLICH & PURDY LLP KIRKLAND - SIGNATURE SUPER PREMIUM ADULT DOG LAMB & CHICKEN, RICE & VEGETABLE FORMULA, ETC CMPLNTS AIRCAST INC - DJO AIRCAST ACCESSORY KIT K925677 Subject
Page 1068 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/OCI/ ORA/P-FO/LOS-DO/LACB/ 2012-3640 05/18/2012 06/18/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3641 05/18/2012 06/18/2012 2012-3642 2012-3643 2012-3644 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 2012-3645 2012-3646 05/21/2012 06/19/2012 05/21/2012 06/19/2012 2012-3647 05/21/2012 06/19/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/DEN-DO/COMP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC MARILYNN WHITNEY COVINGTON & BURLING LLP EILEEN BOYLE HOLOGIC INC BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC KIM CHRISTIAN TELEFLEX MEDICAL FABRICE VINCENT ESQ LIEFF, CABRASER, HEIMANN & BERNSTEIN, LLP BRENT M ARDAUGH MPH MS NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE FDA/OMPT/CDRH/OCER/DFOI/ BRENT M ARDAUGH MPH MS NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ KIM CHRISTIAN TELEFLEX MEDICAL ANGELA BOUSE TELEFLEX MEDICAL DAVID MCFARLAND FDA WEBVIEW/FERDIC INC GUIDANT CORP - ACS HI-TORQUE CROSS-IT 100XT GUIDE CLOSED FOI REQUESTS 5/7-11/12 TELEFLED MEDICAL RESPIRATORY CARE INC - AQUAPAK K811073 AIRLIFE NEBULIZER CAP K072119 K001122, K984220, K972412, ETC GE - LUNAR DXA BONE DENSITOMETER ENCORE 14 SOFTWARE RELEASE K113286 FUNFRESH FOODS INC, SAN CLEMENTE, CA - WORLD BERRIES ORGAN CACAO NIBS RECALL CORR, RPTS, MINS, ETC TELEFLEX MEDICAL - AQUAPAK PREFILLED HUMIDIFIER K780562 ST JUDE MEDICAL INC - RIATA, RIATA ST SILICONE ENDOCARDIAL DEFIBRILLATION LEADS MDRS, CMPLNTS, WARRANTY OBLIGATIONS, ETC K050558, K944353, K901659 SAVORY SNACKS - TRANS FAT INTAKE BY US POPULATION BRAND NAME, PRODUCT CODE, PKG SIZE, ETC DKT FDA-2006-P-0007, FDA-2008-D-0626 STEPHANIE ARMOUR BLOOMBERG NEWS RODRIGUEZ FRUIT, SAN DIEGO, CA; EMPAQUE PARRA, TECOMAN, MEXICO - EIRS, ENFORCEMENT ACTIONS 2009 TO PRESENT Signature/ Requester Subject
2012-3648
05/21/2012 06/19/2012
2012-3649 2012-3650 2012-3651 2012-3652
05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012
Page 1069 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/19/2012 2012-3653 2012-3654 2012-3655 2012-3656 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3657 2012-3658 2012-3659 2012-3660 2012-3661 2012-3662 2012-3663 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 2012-3664 2012-3665 2012-3666 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC HOLLY IMES MOOG MEDICAL DEVICES GROUP VILTECHMEDA, VILNIUS, LITHUANIA - EIR 1/19-23/12 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ MARC SELINGER EXAMINER.COM MEDTRONIC INC - GT2 FUSION GUIDE WIRE K001969 DIAMOND PET FOODS - CMPLNTS LAST 12 MTHS CHAMNESS, ERIC FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC ASAHI INTECC CO LTD - ASAHI WIRE ASAHI PTCA GUIDE WIRE CONFIANZA PRO K041531 FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC ORA/SW-FO/KAN-DO/COMP/ ORA/SE-FO/ATL-DO/ACB/ CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC BILL THOMSON WALL STREET JOURNAL CHARLES CELESTE EAS Consulting Group, LLC MARC SELINGER EXAMINER.COM BRIDGEPOINT MEDICAL - ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE K081187 OVALUM LTD - CITOP 0.014" GUIDEWIRE K070212 DRUG SAFETY ALLIANCE INC, DURHAM, NC - EIR 8/2325/11 PURINA VETERINARY DIETS - CMPLNTS LAST 6 MTHS NEOMETRICS INC - NEO WIRE PTA/PTCA GUIDEWIRE K101729 BOVINE SPONGIFORM ENCEPHALOPATHY - RESEARCH GETZ, DEBORAH FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC FDA/OMPT/CDRH/OCER/DFOI/ CHAMNESS, ERIC Action Office Signature/ Requester CHAMNESS, ERIC Subject WIRE WITH HYDROCOAT HYDROPHILIC COATING K990639 GUIDANT CORP - HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING K981381 GUIDANT CORP - HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING K973494 ASAHI INTECC CO LTD - ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE K101986 NUTRISYSTEM - AER
Page 1070 of 1132

Total Records: 12455 Control # 2012-3667 2012-3668 2012-3669 Recd Date / Due Date 05/21/2012 06/19/2012 05/21/2012 06/19/2012 05/21/2012 06/19/2012 ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/CE-FO/PHI-DO/PCB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-3670 05/21/2012 06/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3671 05/21/2012 06/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3672 05/21/2012 06/19/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3673 2012-3674 05/21/2012 06/19/2012 05/21/2012 06/19/2012 ORA/ORO/DIOP/ ORA/ORO/DIOP/ ORA/SE-FO/FLA-DO/FCB/ FOI SERVICES INC KATE WILSON ICIJ RUNAWAY COUNTRY EVENT, MELBORNE, JAMBOREE 5/4/12 TOBACCO INSP, CORR, SUMMARIES 2011-8978 TISSUE IMPORTED FOR RE-EXPORT RECS DRRICK STOBAUGH CENTER FOR THE STUDY OF COMPLEX DISEASES ISRS 6570960, 6570960, 6629342 PAMELA VENTURA APTALIS PHARMA SRL FEI 1000573478 NIKOLAS BURLEW REGULUS PHARMACEUTICAL CONSULTING REGULUS PHARMS CONSULTING INC, BOULDER, CO - 483, EIR 2/7-8/11, 10/31/11-11/8/11 CHRISTINO, NICOLE ORA/SE-FO/SJN-DO/SJCB/ Action Office ORA/P-FO/LOS-DO/LACB/ Signature/ Requester KATHLEEN BIEDERWOLF ALLSTATE INSURANCE CO IRINA RIVKIND CANTOR FITZGERALD Subject ELECTRONIC WAVEFORM LAB INC, HUNTINGTON BEACH, CA - ALL INSPS, POLICIES, PROGRAMS, ETC. WARNER CHILCOTT, FAJARDO, PUERTO RICO - 483, WARNING LTR 3/12 RECALLED TUNA PRODUCTS - RPTS, CMPLNTS 1/11 TO 1/12
Page 1071 of 1132

Total Records: 12455 Control # 2012-3675 Recd Date / Due Date 05/21/2012 06/19/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3676 05/21/2012 06/19/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-3677 2012-3678 2012-3679 05/21/2012 06/19/2012 05/22/2012 06/20/2012 05/22/2012 06/20/2012 2012-3680 05/22/2012 06/20/2012 2012-3681 05/22/2012 06/20/2012 ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3682 05/22/2012 06/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3683 2012-3684 05/22/2012 06/20/2012 05/22/2012 06/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Doe J ORA/P-FO/SEA-DO/SCB/ DOUGLAS J LAPOINTE CAMERON HODGE ET AL ENDOGASTRIC SOLUTIONS INC, REDMOND, WA CLEARANCE LTRS, INSPS, WARNINGS, ETC AMPHETAMINES - AERS (PERIPHERAL NERVE DISEASE OR NERVE CONDUCTION BLOCKS) MIDOLO, JOE APOTEX INC, ONTARIO, CANADA - EIRS, 483S, CO RESPS ETC WENDY FONG GRIFOLS BIOLOGICALS INC EXPEDITORS INTERNATIONAL OF WASHINGTON INC, NIPPON EXPRESS USA INC - ENTRY NUMBERS, NOTATIONS OF ERRORS, CORRECTIONS, ETC Doe J FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Doe J DAVID J ETTINGER Keller and Heckman LLP PHILIP BENZ ADVANCED VASCULAR DYNAMICS VASCULAR SOLUTIONS - K061219; HEMOSTASIS LLC K072900; HEMCON - K080818 ETC CMPLNT 125934 - RECS & RESULTS LYONDELL CHEMICAL - FAMF 000341 INDIVIDUAL RECS NELSON, AUSTIN IMPAX LABS INC, HAYWARD, CA; HOSPIRA INC, CLAYTON, NC; HOSPIRA INC, AUSTIN, TX - 483 SINCE 1/12 TO PRESENT Signature/ Requester AMY KINCANON LEXIS NEXIS COURTLINK INC Subject 2012-2981
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Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3685 05/22/2012 06/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3686 05/22/2012 06/20/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3687 05/22/2012 06/20/2012 2012-3688 2012-3689 2012-3690 05/22/2012 06/20/2012 05/22/2012 06/20/2012 05/22/2012 06/20/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3691 05/22/2012 06/20/2012 2012-3692 2012-3693 05/22/2012 06/20/2012 05/22/2012 06/20/2012 2012-3694 05/22/2012 06/20/2012 2012-3695 05/22/2012 06/20/2012 ORA/P-FO/LOS-DO/LACB/ GARY C COOPER LAW OFC FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/LOS-DO/LACB/ SPILLER JR, ROBERT M CHARLES J LANDY PILLSBURY WINTHROP SHAW PTTMAN LLP ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ JOHN GRAY OHIO STATE UNIV, FISHER COLLEGE OF BUSINESS ROBERT D PELTZ LEESFIELD & PARTNERS HUMAN DRUG MFG FIRMS LIST - NAMES, ADDRESSES, PRODS, ETC DIMETHYLAMYLAMINE, DMAA, METHYLHEXANAMINE ETC CAERS, STUDIES, RECS ETC MEHERRIN AGRICULTURAL & CHEMICAL CO, SEVERN, N CAROLINA - EIRS, RECS (PICTURESOF SAWS), RECS 12//6/11 TO PRESENT TEVA PHARMACEUTICALS, IRVINE, CA - TEVA PARENTAL MEDICINES, IRVINE, CA - COMM, 483S ANHING CORP - CUSTOMS & BORDER PROTECTION LIQUIDATED DAMAGE CASE 2012-2704-200865-01, DESTRUCTION, INVESTIGATION RPTS, RECS ETC Doe J FDA/OMPT/CDRH/OCER/DFOI/ Doe J GAIL H JAVITT SIDLEY AUSTIN LLP ISRS 3786570, 3898207, 3910895 ETC LIFECELL CORP - EIRS, 483S, CO RESPS ETC 11/2/10 ORA/CE-FO/NJ-DO/NJCB/ MICHAEL P HICKEY TESCHON RICCOBENE & SISS PA MAPLEWOOD BEVERAGES, MAPLEWOOD, NJ - INDIVIDUAL RECS; INSPS, HEALTH VIOLATIONS, TEST RESULTS, ETC 1/08 TO 12/11 INDIVIDUAL RECS Doe J ADDERALL - AERS (PERIPHERAL NERVE DISEASE OR NERVE CONDUCTION BLOCKS) Doe J RETALIN - AERS (PERIPHERAL NERVE DISEASE OR NERVE CONDUCTION BLOCKS) Signature/ Requester Subject
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Total Records: 12455 Control # 2012-3696 Recd Date / Due Date 05/22/2012 06/20/2012 Action Office FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3697 05/23/2012 06/21/2012 2012-3698 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3699 2012-3700 05/23/2012 06/21/2012 05/23/2012 06/21/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ BRANT WIGGER TRANSPHOTON CORP BRENT M ARDAUGH MPH MS NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3703 05/23/2012 06/21/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3704 2012-3705 05/23/2012 06/21/2012 05/23/2012 06/21/2012 ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ TYLER KENYON NORTHCOAST RESEARCH STEVE ELLMAN UGOPRINT HOSPIRA INC, ROCKY MOUNT, NJ - 483S 8/21/09, 1/9/10 NOVARTIS AG, LINCOLN, NE - 483 7/8/11 CORR MARIA MATTERN GLAXO SMITH KLINE ISRS M00959230, M00959259, M01345239, ETC ONA SCANDURRA MS RD COUNTRY LIFE LLC DUSTIN BLOCK IPD ANALYTICS LLC M & L PHARMS, SAN BERNADINO, CA - EIRS, 483S 6/10 TO PRESENT ROPINIROLE HCL ANDA 99-869 - EFFECTIVE APRVL LTR 5/17/12 K823145, K844050, K851421, ETC C! SYS K070589 FDA/OF/CFSAN/OCD/EOS/ BOBBY SCHOCHET OLSSON FRANK WEEDA TERMAN MATZ PC LOUIS D LETO ESQ PHD WILSON SOSINI GOODRICH & ROSATI Signature/ Requester AKIO KUBO SRD CO LTD Subject ORAL ICEBERG SL, SPAIN - CERAROOT IMPLANT SYS K093595; NOBEL BIOCARE USA LLC - ZIRCONIA IMPLANT SYS K061971; Z-SYS AG SWITZERLAND - Z-LOOK3 DENTAL IMPLANT K062542, ETC REPORTABLE FOOD REGISTRY - FOREIGN OBJECT SUBMISSIONS RECS FUJIFILM PHARMACEUTICALS USA INC - FAVIPIRAVIR CLNCL TRIALS SUBMISSIONS, PROTOCOLS, RESULTS, ETC
2012-3701 2012-3702
05/23/2012 06/21/2012 05/23/2012 06/21/2012
Page 1074 of 1132

Total Records: 12455 Control # 2012-3706 2012-3707 2012-3708 2012-3709 2012-3710 Recd Date / Due Date 05/23/2012 06/21/2012 05/23/2012 06/21/2012 05/23/2012 06/21/2012 05/23/2012 06/21/2012 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3711 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3712 2012-3713 05/23/2012 06/21/2012 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3714 2012-3715 05/23/2012 06/21/2012 05/23/2012 06/21/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BRODY MULLINS WALL STREET JOURNAL JEFF GERTH PROPUBLICA COMM BETWEEN FDA & STEVE WILLIAMS AT MARWOOD GROUP 1/10 TO 12/31/10 TYLENOL NDA 17-756, NDA 19-872; MUCOMYST NDA 13601/S029 - APRVL RECS CBER/OCTMA/DDOM/ALFB/ HUBER, MARIE BRODY MULLINS WALL STREET JOURNAL SIPULEUCEL-T PHASE III TRIAL - STATISTICAL ANALYSIS PLAN (SAP) COMM BETWEEN FDA & MICHAEL SULLIVAN OF SAC CAPITOL 1/05 TO 12/31/08 BRODY MULLINS WALL STREET JOURNAL COMM BETWEEN FDA & SHELDON BRADSHAW OF HUNTON & WILLIAMS 1/10 TO 1/31/10 FDA/OMPT/CDRH/OCER/DFOI/ FRISBIE, JEFFREY. MARY K. OLSON TULANE UNIVERSITY DEPT OF ECONOMICS FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/SEA-DO/SCB/ Action Office CBER/OCTMA/DDOM/ALFB/ HUBER, MARIE TRINE TSOUDEROS CHICAGO TRIBUNE JONATHAN A. KNOLL, Esq. COHEN & MALAD LLP TIMOTHY A ULATOWSKI - TRANSCRIPTS, SPEECHES, COMM MICRO THERAPEUTICS - SOLITAIRE FR REVASCULARIZATION DEVICE SAFETY NEVANAC 21-862; HYDASE 21-716; HYLENEX RECOMBIANT 21-859 KIRKMAN GROUP - 483 4/9/08, 9/1809 Signature/ Requester Subject PROVENGE - STATISTICAL ANALYSIS PLAN
Page 1075 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3716 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3717 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3718 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3719 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3720 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3721 05/23/2012 06/21/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3722 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/OCC/ OM/OMP/DODM/ THOMAS CLUDERAY ENVIRONMENTAL WORKING GROUP COMM BETWEEN FDA & PERSONAL CARE PRODUCTS COUNCIL SINCE 6/17/11 LAUREN S BARR JH BARR & ASSOCIATES LLC FOI DAILY LOG 5/7-11/12 WILSON JIAO SANTEC CHEMICALS CORP SICHUAN LONG MARCH PHARMACEUTICAL CO LTD NEOMYCIN SULFATE NDC NUMBER JOHN L. VILLANO, Ph.D. UNIVERSITY OF KENTUCKY CANCER CENTER TEMOZOLOMIDE - AER 9/08 TO PRESENT RAENEL GIBSON MYLAN INSTITUTIONAL KINEVAC (SINCALIDE) NDA 17-697 WILSON JIAO SANTEC CHEMICALS CORP MINSHENG GROUP SHAOXINHG PHARMACEUTICAL CO LTD - PRAZIQUANTEL NDC NUMBER MALIK M. ADIL, MD UNIVERSITY OF MINNESOTA DEPT OF NEUROLOGY ALTEPLASE, RETEPLASE, UROKINASE - AER Signature/ Requester Subject
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Total Records: 12455 Control # 2012-3723 Recd Date / Due Date 05/23/2012 06/21/2012 2012-3724 05/23/2012 06/21/2012 2012-3725 2012-3726 2012-3727 2012-3728 05/23/2012 06/21/2012 05/23/2012 06/21/2012 05/23/2012 06/21/2012 05/23/2012 06/21/2012 2012-3729 05/23/2012 06/21/2012 2012-3730 2012-3731 05/23/2012 06/21/2012 05/23/2012 06/21/2012 2012-3732 2012-3733 05/23/2012 06/21/2012 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3734 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3735 05/23/2012 FDA/OMPT/CDER/ORP/DIDP/ TISCHER LOCKHART PERSONNEL FILES OF FDA STAFF INSTRUCTORS FROM TAMI T. MARTIN SUPERNUS PHARMACEUTICALS INC BOEHRINGER INGELHEIM - VIRAMUNE XR NDA 01-152 RVW ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ WALCKER, CURTIS LAUREN M. BROCK LANGLEY & LEE LLC TORODAL (KETOROLAC) - APRVL, PKG, LBLG 1/89 TO PRESENT ABCO LABS, FAIRFIELD, CA - 483, CO RESP LOVELACE, RUTH ORA/SW-FO/DEN-DO/COMP/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ Action Office CTP/OD/ CTP/OD/ OC/COS/OL/ OM/OMP/DODM/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OF/CFSAN/OCD/EOS/ EDWYN POON TG MEDICAL (USA) INC ELENA HOWELL HOGAN LOVELLS LLP CYNTHIA M. INCORVATI NCA TECHNOLOGIES INC GARY C. COOPER LAW OFFICES OF GARY C COOPER SHAWN H. HUBER PROFESSIONAL HOSPITAL SUPPLY INC JOAN M. BECHTOLD SWEENEY & BECHTOLD LLC RITE AID, FLAX SEED OIL - CMPLNT ANDERSEN STERILIZERS INC , HAW RIVER, NC - EIR 11/11/11 TO 5/16/12 INDIVIDUAL RECS ENTRY NO W33-0779436-0 DSM PHARMS, GREENVILLE, NC - EIR, 483 FOOD FACILITY INSP - ALL CORR ENTRY NO W69-3236857-5 Signature/ Requester GREGORY N. CONNOLLY HARVARD SCHOOL OF PUBLIC HEALTH CHRIS KNIGHT Agra Informa Group CORR TO REP ED MARKEY 3/16/12 Subject LIST OF INGREDIENTS
Page 1077 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/21/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-3736 05/23/2012 06/21/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3737 2012-3738 2012-3739 2012-3740 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 2012-3741 05/24/2012 06/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ ORA/OCI/ ORA/OCI/ 2012-3742 2012-3743 05/24/2012 06/22/2012 05/24/2012 06/22/2012 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ 2012-3744 05/24/2012 06/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ BRIAN EDWARDS CUSTARD INSURANCE ADJUSTERS INC WELLSPRING PHARMACEUTICAL CANADA CORP, OAKVILLE, CANADA - COLACE RECALL EIRS, 483S MICHAEL KOSNAR NBC NEWS PATRICK F LINEHAN STEPTOE & JOHNSON FDA INVESTIGATOR JEFF NOVITSKY - TRAVEL EXPENSES, SALARY 1/09 TO 2/12 KV PHARMACEUTICAL CO - MAKENA (HYDROXYPROGESTERONE CAPROATE) EMAILS, MTG MINS, DISCUSSIONS, ETC ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OM/OMP/DDM/ MARILYNN WHITNEY COVINGTON & BURLING LLP TINA MAYER LUMENIS INC CAROLYN L WAGNER CARESTREAM HEALTH INC NANCY DUENSKIE ZURICH AMERICAN INSURANCE CO KAREN PAULS CBC RADIO-CANADA NIDEK - MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI K111493 RIVERAIN MEDICAL GROUP - SOFTVIEW MODEL 2.01 SYS K092363 MIKE GARCIA, CHICKEN BARN/EGG COLLECTION FACILITY, DANVILLE, PA - INSPS COUNTERFEIT AVASTIN & ALTUZAN - HIPAA SUBPEONA, RECS DKT FDA-2010-P-0491, FDA-2010-P-0196 BIJAN ESFANDIARI, Esq. BAUM HEDLUND ET AL DR THOMAS LAUGHREN - LEXAPRO DOCS Signature/ Requester HOLLINGSWORTH LLP Subject 1991-1995
Page 1078 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3745 2012-3746 2012-3747 2012-3748 2012-3749 2012-3750 2012-3751 2012-3752 2012-3753 2012-3754 2012-3755 2012-3756 2012-3757 2012-3758 2012-3759 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/OCI/ ORA/OCI/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN CURTIS RAYMOND ORCHID DESIGN TOSHIO MURATA NIDEK INC TOSHIO MURATA NIDEK INC TOSHIO MURATA NIDEK INC TOSHIO MURATA NIDEK INC MICHAEL S LABSON COVINGTON & BURLING LLP EXHALED NITRIC OXIDE (ENO) DOSE-RESPONSE STUDY FINAL RPT CARL ZEISS MEDITEC INC - CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER K111157 OPTOVUE - RT-VUE XR OCT K120238 OLYMPUS - VI SYS ENDOSCOPIC VIDEO IMAGING SYS K111756 TOPCON CORP - OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 K092470 OPTOVUE - IVUE MODEL 100 K091404 OLYMPUS - EVIS EXERA III VIDEO SYS K112680 OLYMPUS - UHI-4 HIGH FLOW INSUFFLATION UNIT K110294 OLYMPUS - LTF-S190-10, OTV-S190, CLV-S190 ENDOSCOPES K111425 OLYMPUS - CF-Y0023-L/I COLONOVIDEOSCOPE K101053 ORA/SW-FO/DEN-DO/COMP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ SPRUTH 08569-097, MICHAEL JOAN M BECHTOLD SWEENY & BECHTOLD LLC INDIVIDUAL RECS ORA/P-FO/SEA-DO/SCB/ JOHNSON, JILL ROCKNEY S TAVEAU BUTLER SNOW ET AL CAFFEINE - LBLG REQUIREMENTS, POLICIES, MARKETING, ETC CONMED ELECTROSURGERY - 483 TYLENOL - FOIA REQUESTS 1/10 TO PRESENT LABELLE'S, BELLINGHAM, WA - INSPS LAST 18 MONTHS Signature/ Requester Subject
Page 1079 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3760 2012-3761 2012-3762 2012-3763 2012-3764 2012-3765 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 05/24/2012 06/22/2012 2012-3766 2012-3767 2012-3768 2012-3769 05/24/2012 06/22/2012 05/25/2012 06/25/2012 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3770 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3771 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3772 05/25/2012 06/25/2012 FDA/OMPT/CDRH/OCER/DFOI/ HEATHER MUNDAY-MCGINLEY BENNETT BIGELOW & LEEDOM XOMED (MEDTRONIC) - LASER SHIELD II ENDOTRACHEAL TUBE, MDRS 1815162, 1079060, 694643, ETC REBECCA MOCK GILEAD SCIENCES INC HOLOPACK-VERPACKUNGSTECHNIK-GMBH, ABTSGMUND-UNTERGRONINGEN, GERMANY - EIR MOST RECENT SARAH SORSCHER JD MPH PUBLIC CITIZEN NICARDIPINE HCI NDA 78-405; ALBUTEROL SULFATE, IPUTROPIUM BROMIDE NDA 21-747; BUPROPION HYDROBROMIDE, AZILSARTAN KAMEDOXOMIL NDA 22-497, ETC - ARPVL RECS OC/OM/OMP/DDM/ OC/OM/OMP/DDM/ CBER/OCTMA/DDOM/ALFB/ GEISE, RUSSELL CHRIS CELESTE EAS Consulting Group, LLC CHRIS CELESTE EAS Consulting Group, LLC DENNIS W RAISCH PHD MS RPH UNIV OF NEW MEXICO COLLEGE OF PHARMACY ROMIPLOSTIM - ISRS 6119047, 6134011, 6149668, ETC DKT 1998P-0683 CBER/OCTMA/DDOM/ALFB/ GEISE, RUSSELL ORA/SW-FO/DALDO/COMPLIANCE/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/FLA-DO/FCB/ ORA/NE-FO/NWE-DO/NWECB/ STEPHANIE ELSBERRY BIODEN INC STEPHANIE ELSBERRY BIODEN INC STEPHANIE ELSBERRY BIODEN INC STEPHANIE ELSBERRY BIODEN INC STEPHANIE ELSBERRY BIODEN INC PROVIA LABORATORIES LLC, LEXINGTON, MA - EIRS 483S, CO RESP 2010 TO PRESENT GENECELL INTERNATIONAL LLC, KENDALL, FL - EIRS, 483S, CO RESP 2010 TO PRESENT NEW ENGLAND CRYOGENIC CENTER INC, NEWTON, MA EIRS, 483S, CO RESP 2010 TO PRESENT AMERISTEM INC, HOUSTON, TX - EIRS, 483S, CO RESP 2010 TO PRESENT STEMSAVE INC, NEW YORK, NY - EIRS, 483S, CO RESP 2010 TO PRESENT FENWAL INC - BONE MARROW COLLECTION KIT WITH FLEXIBLE PRE-FILTER & INLINE FILTERS, BONE MARROW COLLECTION STAND BK940005 FENWAL INC - BONE MARROW COLLECTION/TRANSFUSION KIT BK090031 DKT 2003N-0539 Signature/ Requester Subject
Page 1080 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester PS 2012-3773 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3774 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3775 2012-3776 2012-3777 05/25/2012 06/25/2012 05/25/2012 06/25/2012 05/25/2012 06/25/2012 2012-3778 2012-3779 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3780 2012-3781 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3782 2012-3783 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ PETER A TAKES KYPHA INC CARLOTA O ANDREWS WEGMANS SCHOOL OF PHARMACY QUIDEL CORP - SOFIA ANALYZER & INFLUENZA A+B FIA K112177 FIRST APRVD PI TO 1975 FDA/OMPT/CDRH/OCER/DFOI/ MICHAEL R HAMRELL MORIAH CONSULTANTS TIMOTHY P WALBERT HORIZON PHARMA INC DR PAUL OVERLIE - NIDPOE LTR 7/31/07, RESP, HEARING, PROCEEDING, ETC DUEXIS (FAMOTIDINE, IBUPROFEN) NDA 22-519 - APRVL RECS FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ASSAF LIVNE LAP-SPACE MEDICAL LTD JILL FRANKS MARS PETCARE US HEATHER MUNDAY-MCGINLEY BENNETT BIGELOW & LEEDOM PS LORI J BARR KIMBERLY-CLARK CORP ROBERT N TAUB MD PHD COLUMBIA UNIV MEDICAL CENTER LASER ENGINEERING INC - CO2 SURGICAL LASERS, 832525, MDRS PERSONAL PRODUCTS CO - UNSCENTED MENSTRUAL TAMPONS APPLICATOR K974629 IND 056350 - APPL, CORR ADVANCED SURGICAL INC - LAPAROSCOPIC CURVED TRIANGLE RETRACTOR K922435 DOG FOOD JERKY PRODS - CMPLNTS 2007 TO 2011 PAMELA SHEPPARD TARO PHARMACEUTICALS U.S.A., INC MERZ PHARMS - NAFTIN (NAFTFINE HCL) NDA 19-599 SBA PAMELA SHEPPARD TARO PHARMACEUTICALS U.S.A., INC VALEANT INTL - ZOVIRAX (ACYCLOVIR) NDA 20-478 SBA Subject
Page 1081 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3784 2012-3785 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3786 2012-3787 05/25/2012 06/25/2012 05/25/2012 06/25/2012 2012-3788 2012-3789 2012-3790 05/25/2012 06/25/2012 05/25/2012 06/25/2012 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3791 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3792 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3793 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3794 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DENNIS W RAISCH UNIV OF NEW MEXICO COLLEGE DARBEPOETIN - VENOUS THROMBOEMBOLISM ISRS 4041629, 4041639, 4042226 ETC DENNIS W RAISCH UNIV OF NEW MEXICO COLLEGE OF PHARMACY ELTROMBOPAG - VENOUS THROMBOEMBOLISM, ISRS 6207294, 6283119, 6311598 ETC DENNIS W RAISCH UNIV OF NEW MEXICO COLLEGE OF PHARMACY THALIDOMIDE - VENOUS THROMBOEMBOLISM ISRS, 4034563, 4039930, 4040990, ETC DENNIS W RAISCH UNIV OF NEW MEXICO COLLEGE OF PHARMACY EPOETIN - VENOUS THROMBOEMBOLISM AERS 4041629, 4041639, 4042246 ETC FDA/OMPT/CDRH/OCER/DFOI/ CTP/OD/ CTP/OD/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ ROBERT S MCQUATE PHD GRAS ASSOCIATES LLC MARILYNN WHITNEY COVINGTON & BURLING LLP PETER A TAKES KYPHA INC VIK BAJNATH ARTHREX INC RAENEL GIBSON MYLAN INSTITUTIONAL BRACCO DIAGNOSTICS - KINEVAC (SINCALIDE) INJ NDA 17-697/S012-S015 APRVL RECS FAMILY SMOKING PREVENTION & TOBACCO CONTROL ACT - NEW TOBACCO PROD RVW SOPS; NEW PROD SUBMISSIONS 2/23/11 TO PRESENT ETC DADE BEHRING INC - N ATISERA TO HUMAN COMPLEMENT FACTORS (C3C,C4), K050665, RECS MW #5024673 GRAS 000403 - MEMOS, CORR BLUMHARDT CONSULTING FDA/OMPT/CDRH/OCER/DFOI/ NEIL R ARMSTRONG MEDDIQUEST LTD CHROMOGENEX TECHNOLOGIES LTD - I-LIPO SYS, K111501 ATIVAN (LORAZEPAM) NDA 17-794 - TOXICOLOGY, PHARMACOLOGY, STATISTICS, ETC Signature/ Requester Subject
Page 1082 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3795 05/25/2012 06/25/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3796 2012-3797 05/25/2012 06/25/2012 05/29/2012 06/26/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3798 2012-3799 2012-3800 2012-3801 2012-3802 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 2012-3803 05/29/2012 06/26/2012 2012-3804 05/29/2012 06/26/2012 2012-3805 05/29/2012 06/26/2012 2012-3806 05/29/2012 06/26/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CVM/OCD/ KRISTI O SMEDLEY Center for Regulatory Services, Inc. RICK CONFER BLUE BELT TECHNOLOGIES INC RICK CONFER BLUE BELT TECHNOLOGIES INC RICK CONFER BLUE BELT TECHNOLOGIES INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANGELA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC CAERS 151213 - ADDITIONAL RECS CAERS 151881 - ADDITONAL RECS CARERS 151217 - ADDITIONAL RECS CARES 151607 - ADDITIONAL RECS MAKO SURGICAL CORP - RESTORIS MCK UNI IMPLANT K090763 CAERS 151606 - ADDITIONAL RECS LALLEMAND - PENICILLIN G POTASSIUM IN DISTILLERS GRAINS GRAS NOTIFICATION 11 ZIMMER - UNICOMPARTMENTAL KNEE SYS IMPLANT K033363 INSTRUMENT MAKAR INC - BONE SCREW K923841 BATTS, SHERREEN ALICE MEIKLE VPX/REDLINE CYTOSPORT INC - INVESTIGATION, PROD RVWS, 8/1/11 TO PRESENT PERCOCET - AERS DENNIS W RAISCH UNIV OF NEW MEXICO COLLEGE OF PHARMACY LENALIDOMIDE - VENOUS THROMBOEMBOLISM ISRS 4958393, 4991573, 4991588 ETC Signature/ Requester OF PHARMACY Subject
Page 1083 of 1132

Total Records: 12455 Control # 2012-3807 Recd Date / Due Date 05/29/2012 06/26/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3808 05/29/2012 06/26/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3809 05/29/2012 06/26/2012 2012-3810 05/29/2012 06/26/2012 2012-3811 05/29/2012 06/26/2012 2012-3812 05/29/2012 06/26/2012 2012-3813 2012-3814 2012-3815 2012-3816 2012-3817 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 2012-3818 05/29/2012 06/26/2012 2012-3819 05/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ INC REGULATORY CONSULTING & SUBMISSIONS GLADYS B TONKIN Center for Regulatory Services, Inc. GLADYS B TONKIN Center for Regulatory Services, Inc. BARBARA JONES DOMINION GROUP INC BARBARA JONES DOMINION GROUP INC CEBI COHEN WOLTERS KLUWER LAW & BUSINESS DEBI COHEN WOLTERS KLUWER LAW & BUSINESS LISA TARRISON-SCHRAMP FOI DAILY LOG 4/30/12 TO 5/4/12 FOI DAILY 5/7-11/12 FOI DAILY LOG 4/30/12 TO 5/4/12 FOI DAILY LOG 5/7-11/12 FOI DAILY LOG 4/30/12 TO 5/4/12 FOI DAILY LOG 5/7-11/12 FOI DAILY LOG 4/30/12 TO 5/4/12 INC REGULATORY CONSULTING & SUBMISSIONS FOI DAILY LOG 4/30/12 TO 5/4/12 KENNETH REID WASHINGTON INFORMATION SOURCE KENNETH REID WASHINGTON INFORMATION SOURCE FOI DAILY 5/7 - 11/12 FOI DAILY LOG 4/30/12 TO 5/4/12 FOI DAILY LOGS 5/7-11/12 MALIK M ADIL MD UNIV OF MINNESOTA - ZEENAT QURESHI STROKE RESEARCH CTR ALTEPLASE - ISR 5634726, RETEPLASE - ISR 4418122, UROKINASE - ISR 4341451, ETC Signature/ Requester ANIL HITESHI SPECTRUM PHARMACEUTICALS INC Subject ZEVALIN (IBRITUMOMAB TIUXETAN) IND 4850 - RECS
Page 1084 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/26/2012 2012-3820 2012-3821 2012-3822 2012-3823 2012-3824 2012-3825 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/29/2012 06/26/2012 05/30/2012 06/27/2012 2012-3826 05/30/2012 06/27/2012 2012-3827 2012-3828 2012-3829 05/30/2012 06/27/2012 05/30/2012 06/27/2012 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3830 2012-3831 05/30/2012 06/27/2012 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3832 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ PAMELA SHEPPARD TARO PHARMACEUTICALS USA INC VALEANT INTL - ZOVIRAX (ACYCLOVIR) NDA 21-478 SBA CVM/OCD/ GUYLANDO A M MORENO FROST BROWN TODD LLC PAMELA SHEPPARD TARO PHARMACEUTICALS USA INC MASCOMA CORP - MASCOMA GRAIN TECHNOLOGY YEAST ESTABLISHMENT OF AN INGREDIENT DEFINITION MERZ PHARMS - NAFTIN (NAFTIFINE HCL) NDA 19-599 SBA CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/SJN-DO/SJCB/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. JOSHUA KINCANNON ESQ KEEFE BARTELS CLARK ATTY AT LAW SEAN HIGGINS ESQ ANDREWS & THORNTON BRIAN R BOWMAN AMERIWATER BRIAN COBERTT ARK SCIENCES INC ANDREW P ZAPPIA LECLAIR RYAN NADA 141-217 - CMC SECTION, BATCH RECS FOR PRODUCTION EPIC PHARMA LLC - MECLIZINE HCL ANDA 200-294 APRVL LTR 4/13/12, FILING DATE, RECS MEDTRONIC - QUICK-SET INFUSION SETS MDRS, COMM, RECALL RECS EXCLUSIVE SUPPLEMENTS INC, FAHRENHEIT NUTRITION, GASPARI NUTRITION INC, ETC - RESP TO DMAA WARNING LTR 4/24/12 MAR COR MILLENIUM HX K110578 FOI DAILY LOG 5/14-18/2012 FOI DAILY LOG 5/21-25/2012 FOI SERVICES INC FOI DAILY LOG 5/7-11/12 Signature/ Requester CanReg, Inc. LISA TARRISON-SCHRAMP CanReg, Inc. FOI DAILY LOG 4/30/12 TO 5/4/12 5/7-11/12 Subject
Page 1085 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ 2012-3833 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3834 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/KAN-DO/COMP/ 2012-3835 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3836 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3837 05/30/2012 06/27/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3838 05/30/2012 06/27/2012 2012-3839 2012-3840 05/30/2012 06/27/2012 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3841 2012-3842 05/30/2012 06/27/2012 05/30/2012 ORA/NE-FO/NYK-DO/NYDCB/ FDA/OMPT/CDRH/OCER/DFOI/ GAIL RICHARDS WHIZBANG! CREATIVE MEHUL GOVANI PL DEVELOPMENTS, WESTBURY, NY - EIR 8/9/11 VESTICON - EPLEY OMNIIAX K071973 Doe J ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ STUART, DARLA JOHN LIPPOTH ALEXION PHARMACEUTICALS CHILDREN'S HOSPITAL COLORADO, AURORA, CO MEDICAL DVC REPORTING ANNUAL USER FACILITY RPT 2008, 2009 ALEXION PHARMS, SMITHFIELD, RI - EIR 1/25,26,28/11,2/4/11, 2/16-18/11 REMICADE - AERS YANNA LAMBRINIDOU PHD Parents for Nontoxic Alternatives ENVIRONMENTAL HEALTH PESPECTIVES (EHP), DR TEE L GUIDOTTI - EMAILS, LTRS, RPTS AARON S KESSELHEIM MD JD MPH BRIGHAM & WOMEN'S HOSPITAL TRUTHFUL PRESCRIPTION DRUG ADVERTISING AND PROMOTION (BAD AD) PROGRAM - RECS 2010 TO PRESENT JOHN L VILLANO MD PHD UNIV OF KENTUCKY MAKRKEY CANCER CENTER ISRS 3615969, 3625646, 3667776, ETC LISA HANSEN AM LEGAL SERVICES INC KV PHARMS - MAKENA (HYDROXYPROGESTERONE CAPROATE) TEST RESULTS, SLIDES, COMM, ETC SAVID S BLOCH WINSTON & STRAWN LLP MALATHION ANDA 78-743, ANDA 91-559 - RECS Signature/ Requester Subject
Page 1086 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/27/2012 2012-3843 2012-3844 05/30/2012 06/27/2012 05/30/2012 06/27/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OMP/DODM/ 2012-3845 2012-3846 2012-3847 2012-3848 2012-3849 2012-3850 05/31/2012 06/28/2012 05/31/2012 06/28/2012 05/31/2012 06/28/2012 05/31/2012 06/28/2012 05/31/2012 06/28/2012 05/31/2012 06/28/2012 2012-3851 05/31/2012 06/28/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-3852 05/31/2012 06/28/2012 2012-3853 05/31/2012 06/28/2012 FDA/OO/OFBA/OAGS/ ORA/OCI/ ORA/OCI/ DUFFIELD, WILL FDA/OMPT/CDRH/OCER/DFOI/ ROBERT PINTO SPARTECH POLYCAST CELL CAST ACRYLIC SPARTECH POLYCAST CELL CAST ACRYLIC - MAF-300 MASTER FILE FIREARMS, DESTRUCTIVE DVCS - ACQUISITION, MAINTENANCE, DEPLOYMENT, ETC OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OMP/DODM/ HELLEN A OKTECH USP PHARMACOPEIA BURT GOODSON APTUS ENDOSYSTEMS INC HELLEN A OKETCH USP PHARMACOPEIA HELLEN A OKETCH USP PHARMACOPEIA HELLEN A IKETCH USP PHARMACOPEIA BRENDA BATTAT HEARING LOSS ASSOC OF AMERICA JOSEPH MUENCH ST PETER'S HOSPITAL DR LISA TSENG, HI HEALTHINNOVATIONS - ONLINE HEARING TEST LTR 3/28/12 HOLY BASIL (OCIMUN SANCTUM OR OCIMUM OCIMUM TENUIFLORUM) - CAERS 1/05 TO 5/12 GINKGO (GINKGO BILOBA) - CAERS 1/05 TO 5/12 ASTAXANTHIN - CAERS 1/05 TO 5/12 DKT 2012N-0091 VINPOCETINE - CAERS 1/05 TO 5/12 ORA/CE-FO/NJ-DO/NJCB/ Doe J TERRY G MAHN FISH & RICHARDSON PC Action Office Signature/ Requester PL DEVELOPMENTS ULTIMATE POWER MEAL - MEDICAL ANALYSIS, RECALL RECS, CORR, ETC SUN PHARMACEUTICAL INDUSTRIES - XEROSTOMIA ANDA 77-126 INDICATION CARVE-OUT RECS, CORR; DKT 2006P0410 Subject
CLEVIDIPINE - ISRS 7327914, 7332187, 7352457, ETC
Page 1087 of 1132

Total Records: 12455 Control # 2012-3854 2012-3855 Recd Date / Due Date 05/31/2012 06/28/2012 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3856 2012-3857 2012-3858 05/31/2012 06/28/2012 05/31/2012 06/28/2012 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3859 2012-3860 05/31/2012 06/28/2012 05/31/2012 06/28/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3861 05/31/2012 06/28/2012 2012-3862 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3863 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3864 05/31/2012 FDA/OMPT/CDRH/OCER/DFOI/ TASER MODEL X-26 ELECTRIC CONTROL DVC (ECD) RECS FOI SERVICES INC ANDA 202-194 FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ ANGELIA SMYTH IOVATE HEALTH SCIENCES INTERNATIONAL INC ANDA 202-727 CAERS 151890 FOI SERVICES INC CBER/OCTMA/DDOM/ALFB/ FOI SERVICES INC SANQUIN PLASMA PRODUCTS, AMSTERDAM, NETHERLANDS - EIR, 483, CO RESP 9/19-28/11, ETC EXENATIDE SYNTECH NDA 22-220 FOI SERVICES INC ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/MIN-DO/MCB/ CAROLINA M HEAVNER K & L GATES PAULA EICHMAN APTALIS PHARMATECH INC NDA 202-107 TAPEMARK CO, ST PAUL, MN - EIRS, 483S, WARNING LTRS, ETC 5/07 TO 5/12 APTALIS PHARMATECH - EIR 11/11 Action Office CBER/OCTMA/DDOM/ALFB/ Signature/ Requester ROGER KUMAR GOLDMAN SACHS & CO ARTHUR P BEDROSIAN LANNETT CO INC SIMVASTATIN TABS ANDA 78-735 - SBA Subject VIROPHARMA - (SANQUIN) 483S
Page 1088 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/28/2012 2012-3865 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3866 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3867 05/31/2012 06/28/2012 2012-3868 05/31/2012 06/28/2012 2012-3869 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3870 05/31/2012 06/28/2012 2012-3871 2012-3872 05/31/2012 06/28/2012 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/ ORA/ ORA/CE-FO/BLT-DO/CB/ 2012-3873 05/31/2012 06/28/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ BRUCE D GOODMAN STEINBERG GOODMAN & KALISH BLACKSTONE MEDICAL INC - ICON MODULAR SPINAL FIXATION SYS MDRS, EIRS, CORR, ETC ORA/ ORA/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ HENRY D ACCIANI O'CONNOR ACCIANI ET AL MARCUS PETOYAN GIANNI PETOYAN ATTY MEDTRONIC - STIMULATION SYS MODEL #37711 CMPLNTS, RPTS BY DOCTORS, CO RESP NEXIUM (ESOMEEPRAZOLE) - AERS, EIRS, CORR, ETC Doe J INDIVIDUAL RECS CVM/OCD/ Doe J MICHAEL GRAY PHARMASHIELD LLC FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC BISPHENOL A RESEARCH FUNDED BY THE NATIONAL INSTITUTE OF ENVIRONMENT HEALTH SCEINCES (NIEHS) MEMOS, EMAILS, RECS, ETC VIOLATIONS OF REGULATIONS PROHIBITING THE USE OF MAMMALIAN PROTEIN IN THE MANUFACTURE OF ANIMAL FEED - FINAL RULE 1997 ELECTRONIC ORANGE BOOK, 2000 TO 20010 LISA HERNANDEZ PHD ZOSANO PHARMA EPIPEN NDA 19-430 - SBA FOI SERVICES INC Action Office Signature/ Requester INGRAM #AE6335, CURTIS US-MERCK-0612USA01635 - ISR 5245743; US-MERCK0701USA01851 - ISR 5245747; US-MERCK-0711USA04183 ISR 5542962 ETC Subject
Page 1089 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/NE-FO/NWE-DO/NWECB/ 2012-3874 2012-3875 05/31/2012 06/28/2012 05/31/2012 06/28/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3876 05/31/2012 06/28/2012 2012-3877 05/31/2012 06/28/2012 2012-3878 05/31/2012 06/28/2012 2012-3879 2012-3880 05/31/2012 06/28/2012 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3881 2012-3882 06/01/2012 06/29/2012 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3883 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3884 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ JULIA W MONACK COLLORA LLP APPENDIX B-PROD NAME SORTED BY APPLICANT; BARBARA GOULDING LTR 4/12/10 - CERTIFIED MARY LYONS ALEXION PHARMACEUTICALS ALEXION PHARMACEUTICALS INC - SOLIRIS (ECULIZUMAB), MEDICAL RVWS CAPOLONGO, DENNIS J CBER/OCTMA/DDOM/ALFB/ CHARLES H KYPER KYPER & ASSOCIATES PHARMACIA/UPJOHN-PFIZER - DEPODROL/METHYLPREDNISOLONE ACETATE, 40 & 80 MG INJ, AERS, CORR, RECS ETC 2000 TO PRESENT REGENLAB SARL - REGEN-BC FAMILY KITS BK110061 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/LOS-DO/LACB/ ORA/CE-FO/MIN-DO/MCB/ PATRICK C MORROW MORROW MORROW RYAN & BASSETT STEPHEN E ABRAHAM LAW OFFICES OF STEPHEN ABRAHAM STEPHEN E ABRAHAM LAW OFFICES OF STEPHEN ABRAHAM CRAIG ROUSH ROCKLINE INDUSTRIES MICHELE SINOWAY LACHMAN CONSULTANT SERVICES INC DEUTREL INDUSTRIES INC, LANCASTER, CA - EIRS, 483S, RECS GUY & O'NEILL INC, FREDONIA WI - EIRS, 483S, COMM 3/4/05, 7/13/09 TO PRESENT TEVA PHARMACEUTICALS - ANDA 78-730 APRVL SUMMARY NU SCIENCE CORP, LANCASTER, CA - EIRS, 483S, RECS FAROUK SYSTEMS INC - RECS, 2000 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ DR DEBORAH COHEN BMJ GROUP TIM BENNETT SUNSHINE HOSPITAL ST JUDE MEDICAL - MECHANICAL HEART VALVE SJM MASTERS SERIES WITH SILIZONE COATING P810002/S046 PROLIA (DENOSUMAB) - AERS Signature/ Requester Subject
Page 1090 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3885 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3886 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3887 2012-3888 2012-3889 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3890 2012-3891 2012-3892 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 2012-3893 06/01/2012 06/29/2012 2012-3894 06/01/2012 06/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3895 06/01/2012 06/29/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA WEBVIEW/FERDIC INC FOI DAILY REQUESTS CLOSED 5/21-25/12 WOLTERS KLUWER LAW & BUSINESS ALISON M. AGNEW PILLSBURY PARKEDALE PHARMACEUTICALS - CORTICOTROPIN NDA 08-317 WOLTERS KLUWER LAW & BUSINESS FOI DAILY REQUESTS CLOSED 5/14-18/12 FOI SERVICES INC FOI DAILY REQUESTS CLOSED 5/21-25/12 FOI SERVICES INC FOI DAILY REQUESTS CLOSED 5/14-18/12 FOI DAILY REQUESTS CLOSED 5/21-25/12 CanReg, Inc. ALISON M. AGNEW PILLSBURY ORGANON USA INC - CORTROPHIN ZINC NDA 09-854 LISA TARRISON-SCHRAMP CanReg, Inc. FOI DAILY REQUESTS CLOSED 5/21-25/12 DAILY LOG CLOSED 5/14-18/12 ALISON M. AGNEW PILLSBURY ORGANON USA INC - PURIFIED CORTROPHIN GEL NDA 08975 ALISON M. AGNEW PILLSBURY ORGANICS LAGRANGE - CORTICOTROPIN NDA 10-831 Signature/ Requester Subject
Page 1091 of 1132

Total Records: 12455 Control # 2012-3896 2012-3897 Recd Date / Due Date 06/01/2012 06/29/2012 06/01/2012 06/29/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3898 06/01/2012 06/29/2012 FDA/OF/CFSAN/OCD/EOS/ THOMPSON, CLARENCE LD CALL FOR APPLICATIONS FOR 2012 STUDENT LOAN REPAYMENT PROGRAM - E-MAIL, LINKS, JUSTIFAICATION MEMO TEMPLATE, CFSAN-ALLHANDS E-MAIL, 4/17/12 (2:25 PM) WATSON LABS - CORTICOTROPIN NDA 88-772 FDA WEBVIEW/FERDIC INC ALISON M. AGNEW PILLSBURY SANOFI AVENTIS - ACTHAR NDA 07-504 Signature/ Requester Subject FOI DAILY REQUESTS CLOSED 5/14-18/12
2012-3899
06/01/2012 06/29/2012
ALISON M. AGNEW PILLSBURY
2012-3900 2012-3901 2012-3902
06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012
FDA/OF/CFSAN/OCD/EOS/ MOTEN, LEVEETA OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/MIN-DO/MCB/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ALSION M. AGNEW PILLSBURY DAVID J GRYCZ SEDGWICK LLP
2012 STUDENT LOAN REPAYMENT PKG - APPLICATION PKG 2009-4213, 2009-5482 INDIVIDUAL RECS - 2011-5406 ATTACHMENT & ADDITIONAL LAB RESULTS, RECS ETC
2012-3903 2012-3904 2012-3905
06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012
OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
ALISON M. AGNEW PILLSBURY ALISON M. AGNEW PILLSBURY PAMELA VENTURA APTALIS PHARMA SRL
2011-326, 2011-327 TEVA PHARMS, IRVINE, CA - 483 APTALIS PHARMA CANADA INC, CANADA - QAP
2012-3906
06/01/2012 06/29/2012
PAMELA VENURA APTALIS PHARMA SRL
APTALIS PHARMATECH INC, VANDALIA, OH - QAP
Page 1092 of 1132

Total Records: 12455 Control # 2012-3907 Recd Date / Due Date 06/01/2012 06/29/2012 2012-3908 06/01/2012 06/29/2012 Action Office ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2012-3909 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ 2012-3910 2012-3911 2012-3912 2012-3913 2012-3914 2012-3915 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 06/01/2012 06/29/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3916 06/01/2012 OC/OM/OMP/DDM/ ANGELIA SLAYTON DKT 1998C-0431 STAIGER, LUANA ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ OC/OM/OMP/DDM/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SEA-DO/SCB/ LOLI, GENE TIFFANY E. TIBBETTS GRIMM VRANJES ET AL ANNA WOLONCIEJ SIDLEY AUSTIN LLP MUSCARELLA, LAWRENCE. KERI VAN BECELAERE CLINICAL SITE MONITOR URACIL MUSTARD NDA 12-892 - MED RVW, CHEMISTRY RVW, TOXICOLOGY RVW PSEUDOMONAS AERUGINOSA OUTBREAK - METHODIST HOSP, HOUSTON, TX DR RAM PATAK, WEST HILLS, CA - 483 DKT 1988G-0288 INDIVIDUAL RECS MIRGEN PHARMS, BIOSE, ID - 483 1/12/12-2/17/12 KIRSTY BARNES BIOPHARM INSIGHT BRILINTA (TICAGRELOR) - COMM, CLNCL DATA, AERS, ETC ABIGAIL MOSS BIOPHARM INSIGHT DENDREON - PROVENGE (SIPULEUCEL-T), IMPACT STUDY SAFETY & EFFICACY RECS BREININGER, JASON Signature/ Requester Subject MEAD JOHNSON NUTRITIONALS, EVANSVILLE, IN - 483
Page 1093 of 1132

Total Records: 12455 Control # Recd Date / Due Date 06/29/2012 2012-3917 2012-3918 06/01/2012 06/29/2012 06/04/2012 07/02/2012 2012-3919 06/04/2012 07/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ 2012-3920 06/04/2012 07/02/2012 2012-3921 2012-3922 06/04/2012 07/02/2012 06/04/2012 07/02/2012 2012-3923 2012-3924 06/04/2012 07/02/2012 06/04/2012 07/02/2012 2012-3925 06/04/2012 07/02/2012 2012-3926 2012-3927 06/04/2012 07/02/2012 06/04/2012 07/02/2012 OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ DEWITT M LOVELACE LOVELACE LAW FIRM PA ALISON M AGNEW PILLSBURY WINTHROP SHAW PTTMAN LLP MICAHEL A LOCKE IMMUNOSTICS INC CHRISTOPHER SHAKIB TERRELL HOGAN ELLIS YEGELWEL PA BETHANY J HILLS TRACHTENBERG HODGSON RUSS LLP ALEX WAYNE BLOOMBERG NEWS BRENT M ARDAUGH NORTHWESTERN UNIV FEINBERG SCHOOL OF MEDICINE FDA/OMPT/CDRH/OCER/DFOI/ BRENT M ARDAUGH NORTHWESTERN UNIV K852097, K870729, K874096 K893626, K894703, K912144, ETC TRAVEL RECS FOR THE HEAD OF FDA 10/10 TO 9/11 LIFE-TECH INC - ULTRASONIC PULSED DOPPLER IMAGING SYS K120234 SYNTHES (USA) - PLATE FEMORAL LCP PLATE MDRS MEDTEK LLC - LIFEGUARD 510K SUBMISSION ABIOMED INC - FOI REQUESTS 12/05 TO PRESENT BLUE DIAMOND GROWERS - PROD MISBRANDING RECS WILLIAMS, VINCENT M SUPERVISORY CONSUMER SAFETY OFFICER GS-696-14 POSTITION DESCRIPTION, DATE OF HIRING, JOB ANNOUNCEMENT, ETC STEVE MILLOY JUNKSCIENCE.COM SAM KASS (WHITE HOUSE CHEF) - FOOD/NUTRITION RECS, EMAILS, MINS, MEMOS, ETC OC/OM/OMP/DDM/ Action Office Signature/ Requester INC RESEARCH CARLA SCARMAZZI KING & SPALDING EILEEN BOYLE HOLOGIC INC ORTHOSCAN-HD K051754 DKT 1978N-1241 Subject
2012-3928
06/04/2012 07/02/2012
Page 1094 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester FEINBERG SCHOOL OF MEDICINE 2012-3929 06/04/2012 07/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3930 06/04/2012 07/02/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3931 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3932 06/04/2012 07/02/2012 2012-3933 06/04/2012 07/02/2012 2012-3934 06/04/2012 07/02/2012 ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3935 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/OCI/ ORA/OCI/ KAREN PAULS CBC RADIO-CANADA MEDIPLAN, RXNORTH - COUNTERFEIT LIPITOR, CRESTOR, CELEBREX INVESTIGATION RECS ELIF A ORAL UNIV OF MICHIGAN DEPT OF INTERNAL MEDICINE CHEMX PHARMS - APHTHALSOL NDA 20-511/S000 PI WILLIAM THYMIUS CHRISTOPHER P DI GIULIO PC CONAGRA FOODS INC - PAM NON-STICK COOKING SPRAY CMPLNTS GEORGIA L MCGOWAN EVERAGE LAW FIRM PLLC INDIVIDUAL RECS Doe J BOTOX - AERS A LUKE SMITH FARUQI & FARUQI LLP TEVA PHARMS - LIPTOR (ATORVASTATIN) NDA 78-773; MYLAN LABS - NDA 91-226; APOTEC INC - NDA 90-548, ETC SBA PETER T MURPHY DC SAFETY CO INC MEDICAL DRESSING CO, JINTAN CITY, JIANGSU, CHINA 483 9/19/11 Subject
Page 1095 of 1132

Total Records: 12455 Control # 2012-3936 Recd Date / Due Date 06/04/2012 07/02/2012 2012-3937 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3938 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3939 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3940 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3941 2012-3942 06/04/2012 07/02/2012 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3943 2012-3944 2012-3945 2012-3946 06/04/2012 07/02/2012 06/04/2012 07/05/2012 06/04/2012 07/05/2012 06/04/2012 07/02/2012 CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ TRISH LANDRY BEAUFORT LLC ELIZABETH MASON MEDSEP CORP ELIZABETH MASON MEDSEP CORP ELIZABETH MASON MEDSEP CORP MEDTRONIC - TYMPANOCENTESIS COLLECTOR OPERATOR'S MANUAL, CORR REGADRING EXEMPTION CELL PRO - CEPRATE SC STEM CELL CONCENTRATION SYS BP940001 NEXELL THERAPEUTICS INC - ISOLEX 300 MAGNETIC CELL SELECTION SYS BP970001 COBE LABORATORIES INC - COBE 2991 CELL PROCESSOR BK840009 FDA/OMPT/CDRH/OCER/DFOI/ TRISH LANDRY BEAUFORT LLC NANCY YUEN GlaxoSmithKline CDT SPECULUM - OPERATOR'S MANUAL, CORR REGARDING EXEMPTION FINASTERIDE - ISRS M00959230, M00959259, MO1345239, ETC MORRIS, LARRY THALLIUM CHLORIDE T201, THALLIUM T201 FRATTI, JOHN LEVAQUIN, CIPRO & AVELOX - AERS MARY F MORRISON TEMPLE UNIVERSITY SCHOOL OF MEDICINE MINOCYCLINE - NDA PHASE I & PHASE II CLNCL TRIAL RECS Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester BETHANY J HILLS TRACHTENBERG HODGSON RUSS LLP ANGELLIA D SLAYTON INC REGULATORY CONSULTING & SUBMISSIONS CENTOCOR - REMICADE (INFLIXIMAB) BLA 10-3772/S5012 APRVL LTR, LBLG, MEDICAL RVWS, ETC Subject LIFE-TECH INC - ULTRASONIC PULSED DOPPLER IMAGING SYS K102813
Page 1096 of 1132

Total Records: 12455 Control # 2012-3947 2012-3948 Recd Date / Due Date 06/04/2012 07/02/2012 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3949 2012-3950 2012-3951 06/04/2012 07/02/2012 06/04/2012 07/02/2012 06/04/2012 07/02/2012 2012-3952 06/04/2012 07/02/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3953 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3954 06/04/2012 07/02/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-3955 2012-3956 06/04/2012 07/02/2012 06/04/2012 07/02/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/FLA-DO/FCB/ R IAN KLUGE Hyman Phelps and McNamara PC ANNA KIEBURTZ Hyman Phelps and McNamara PC NETWORK INC (VAXA INTERNATIONAL & WESTERN HEALTH PRODS), TAMPA, FL - EIRS, 483S, CO RESP CMPLNT 32782 KIM NGUYEN AP PHARMA INC DOW CHEMICAL CO, PLAQUEMINE, LA; HUBEI HASUN PHARMACEUTICALS CO LTD - EIRS, 483S LAST 3 YRS MANON VRANDERICK DUCHESNAY MANNITOL - AERS LAST 5 YRS ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ CBER/OCTMA/DDOM/ALFB/ CBER/OCTMA/DDOM/ALFB/ ELIZABETH MASON MEDSEP CORP R IAN KLUGE Hyman Phelps and McNamara PC DR MICHAEL DESBOROUGH OXFORD UNIV HOSPITALS DEPT OF HEMATOLOGY JESSIE L JANDOVITZ MORELLI RATNER PC IMMUNOGLOBULIN - NUMBER OF HEMOLYSIS CASES, AERS, BRANDS, ETC RISPERIDAL (RISPERIDONE) - AERS FENWAL INC - BONE MARROW COLLECTION KIT WITH FLEXIBLE PRE-FILTER & INLINE FILTERS BK0900031 CMPLNT 32782 Action Office CBER/OCTMA/DDOM/ALFB/ Signature/ Requester ELIZABETH MASON MEDSEP CORP MAURA M NORDEN SIDLEY AUSTIN LLP Subject BIOMET BIOLOGICS INC - BIOCUE MINI PLATELET CONCENTRATION KIT BK100027 CLAIRE M DEMATTEIS LTR - CONSUMER DIRECTED RX DRUG PROMOTIONAL LBLG, MINS10/21-22/08
Page 1097 of 1132

Total Records: 12455 Control # 2012-3957 2012-3958 2012-3959 Recd Date / Due Date 06/04/2012 07/02/2012 06/04/2012 07/02/2012 06/05/2012 07/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3960 2012-3961 2012-3962 06/05/2012 07/03/2012 06/05/2012 07/03/2012 06/05/2012 07/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/FLA-DO/FCB/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/P-FO/LOS-DO/LACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3963 2012-3964 06/05/2012 07/03/2012 06/05/2012 07/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3965 06/05/2012 07/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3966 06/05/2012 07/03/2012 2012-3967 06/05/2012 07/03/2012 2012-3968 06/05/2012 07/03/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ ELINOR E BAXTER BRENNAN MANNA & DIAMOND PL KAREEM KHAIRAT EMCCO FOR OILS AND FOOD INDUSTRIES SAE PETER WHORISKEY WASHINGTON POST AMGEN INC - EPO-8903 CLNCL TRIAL RPT ENTRY #605-1576021-7 - RECS KELLY MILLER, 580 SERVICES LLC - 510K SUBMISSIONS MICHELE SINOWAY PHD LACHMAN CONSULTANT SERVICES INC SNBL LTR 4/13/12 PRENDERGAST, JOYCE E ANTHONY J D'AMICO ESQ SAVINIS D'AMICO & KANE LLC STELKAST PROVEN KNEE MEDICAL DVC - WARNINGS, COMM, QUALITY SYS AUDITS, ETC CHANTIX (VERENICLINE) - AERS 5/16/09 TO 5/26/12 STEPHEN J CARR AKERMAN SENTERFITT ATTYS BIJAN ESFANDIARI ESQ BAUM HEDLUND ET AL DIANE MARKS TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D INC ELECTROSTIM MEDICAL SUPPLIES INC, TAMPA,FL WARNING LTRS, 510K APPL, COMM, ETC POMONA VALLEY HOSPITAL MEDCIAL CENTER - IRB PROCEDURES, MEMBERSHIP LISTS 1/1/08 TO 10/1/08 ADDERALL TABS NDA 11-522 - SBA MUN, HEE JIN ORA/CE-FO/DET-DO/DCB/ Action Office ORA/CE-FO/CHI-DO/CCB/ MELSSIA WILSON rOBERT SZWAJKOS CURTIN & HEEFNER LLP TRUCKERS WORLD ADULT NOVELTY, GARY, TN - NOTICE OF INVESTIGATION NAME & CONTACT RECS LIST OF EXPIRED DRUG PATENTS 1989 TO 1/10 Signature/ Requester Subject J.R. CARLSON LABS, ARLINGTON HEIGHTS, IL - EIRS, 483S
Page 1098 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3969 2012-3970 06/05/2012 07/03/2012 06/05/2012 07/03/2012 2012-3971 06/05/2012 07/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-3972 06/05/2012 07/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-3973 06/05/2012 07/03/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/NJ-DO/NJCB/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-3974 2012-3975 06/05/2012 07/03/2012 06/05/2012 07/03/2012 2012-3976 2012-3977 2012-3978 06/05/2012 07/03/2012 06/05/2012 07/03/2012 06/05/2012 07/03/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3979 2012-3980 06/05/2012 07/03/2012 06/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ BEVERIDGE & DIAMOND PC Joan Stitt (UG2CD-16) FOI DAILY LOG 5/28/2012- 6/1/2012 CFSAN REQUESTS 4/26/12-5/23/12 FOI SERVICES INC LISA TARRISON-SCHRAMP CanReg, Inc. FRANCISCO JOSE dos SANTOS MARTINS DYNATECH BENZENESULFONIC ACID - TOXICOLGY STUDY CLOSED FOI REQUESTS 5/28/12-6/1/12 JULIA G YOUNG STRICK LAW FIRM PLLC PAM ZAKMAN CBS 2 NEWS CHICAGO BRUCE D GOODMAN STEINBERG GOODMAN & KALISH BRUCE D GOODMAN STEINBERG GOODMAN & KALISH BRUCE D GOODMAN STEINBERG GOODMAN & KALISH DAVID MCFARLAND FDA WEBVIEW/FERDIC INC DEBI COHEN WOLTERS KLUWER LAW & BUSINESS CLOSED FOI REQUESTS 5/28/12-6/1/12 CLOSED FOI REQUESTS 5/28/12-6/1/12 SUPERMAX HEALTH CARE, SUPERMAX INC - INSPS, INVESTIGATIONS OF GLOVES; IMPORT REFUSALS 2011, 2012 BLACKSTONE MEDICAL INC, ORTHOFIX INC - PHOENIX MINIMALLY INVASIVE SPINAL FIXATION SYS EIRS, APRVLS, MDRS, ETC 2000 TO PRESENT LSG SKY CHEFS INC - RECS Signature/ Requester Subject
BLACKSTONE MEDICAL INC, ORTHOFIX INC - SFS SPINAL FIXATION SYS EIRS, APRVLS, MDRS, ETC 2000 TO PRESENT
BLACKSTONE MEDICAL INC, ORTHOFIX INC - FIREBIRD SPINAL FIXATION SYS EIRS, APRVLS, MDRS, ETC 2000 TO PRESENT
CLOSED FOI REQUESTS 5/28/12-6/1/12
Page 1099 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/05/2012 2012-3981 2012-3982 06/06/2012 07/05/2012 06/06/2012 07/05/2012 2012-3983 2012-3984 2012-3985 2012-3986 06/06/2012 07/05/2012 06/06/2012 07/05/2012 06/06/2012 07/05/2012 06/06/2012 07/05/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3987 2012-3988 06/06/2012 07/05/2012 06/06/2012 07/05/2012 FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/ ORA/ ORA/ORO/DIOP/ ORA/ORO/DIOP/ 2012-3989 06/06/2012 07/05/2012 2012-3990 06/06/2012 07/05/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3991 06/06/2012 FDA/OMPT/CDRH/OCER/DFOI/ LEX J PEARCE NEUTRAL LUER ACTIVATED DEVICE & EXTESION SETS LYNCH, REAGAN MARTINA BERNSTEIN PETA FEED MFG ESTABLISHMENTS, CA - EIRS, RECS 1/1/08 TO PRES; FDA VIOLATIONS OF FDA ON PROHIBITIED ANIMAL PROTEINS WARNER CHILCOTT - ASACOL 400 MG, AERS CBER/OCTMA/DDOM/ALFB/ SHIN KANG WELLS FARGO JACK KASKEY BLOOMBERG NEWS SANQUIN/VIROPHARMA - CINRYZE, EUROPE (BELGIUM & HOLLAND), EIRS, 483S, CORR FOOD IMPORT ACTION PLANS - CORR 1/1/08 TO PRESENT; EUROPEAN UNION RECS MEROLA, ERIC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OF/CFSAN/OCD/EOS/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ CBER/OCTMA/DDOM/ALFB/ OC/COS/OES/ OC/COS/OES/ FDA/OMPT/CDRH/OCER/DFOI/ Kay Taylor PERKINELMER INC ROBIN FELDMAN LSRO SOLUTIONS MICHELLE SCHILTZ-TAING BISCO INC MEMORIAL SLOAN KETTERING CANCER CTR, FDA & NCI MTG, BELTSVILLE, MD - MINS, 7/2/74 POLYSORBATE 60 (POLYOXYETHYLENE (20) SORBITAN MONOSTERATE) - FAP 4A3775 & FAP 4A3824 SEPTODONT - BIODENTINE K092251 K091283 Doe J Signature/ Requester MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Corr re: Wyeth/Pfizer's Prevnar 13 vaccine (04/22/2012 06/06/2012) A list of all FOIA requests closed 5/1-31/2012 Subject
Page 1100 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/05/2012 2012-3992 2012-3993 06/06/2012 07/05/2012 06/06/2012 07/05/2012 2012-3994 2012-3995 2012-3996 2012-3997 06/06/2012 07/05/2012 06/06/2012 07/05/2012 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3998 06/07/2012 07/06/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-3999 2012-4000 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ 2012-4001 2012-4002 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ MEADY AMORY LD AMORY CO INC MICHAEL R COHEN RPH MS SCD INSTITUTE FOR SAFE MEDICATION PRACTICES FDA EVALUATION OF THE KOREAN SHELLFISH SANITATION PROGRAM 2008, 2012 MEDWATCH RPTS CODED AS MEDICATION ERRORS 5/130/12 Brown, Sanders E FDA/OMPT/CDRH/OCER/DFOI/ LEX PEARCE ICU MEDICAL INC NEUTRAL LUER ACTIVATED DVC AND EXTENSION SETS K120443 GPS TRACKING IMPLANT - MDRS Gordon, Ian SHELLFISH, KRILL OIL IN RX DRUGS & SUPPLEMENTS MFRS, DISTRIBUTORS OC/OM/OMP/DDM/ CVM/OCD/ ROBERT H SINDT ATTY JOYCE RIDLEY WOLTER KLOWER ELIZABETH BARBEHENN PHD PUBLIC CITIZEN TRADJENTA (LINAGLIPTIN) NDA 201-281/S002 - MEDICAL, STATISTICAL RVWS DKT FDA-1995-S-0039, FDA-1997-S-0039 CVM/OCD/ ROBERT H SINDT ATTY GEVO - ANIMAL GRAS NOTICE 10 ORA/P-FO/SAN-DO/SFCB/ ORA/NE-FO/NWE-DO/NWECB/ Action Office Signature/ Requester ICU MEDICAL INC ANITA FENTY Covance Inc. MARK B FREDKIN MORGAN, FRANICH, FREDKIN & MARSH GEVO - ANIMAL FOOD GRAS NOTICE 13 WHITTLESTONE INC, CASTLE ROCK, CO - EIR, 2007 Subject K120443, SUMMARY, SUBSANTIAL EQUIVALENCE DECISION LTR, INDICATIONS FOR USE STATEMENT PHT CORP, CHARLESTOWN, MA - EIR 9/6-15/11
Page 1101 of 1132

Total Records: 12455 Control # 2012-4003 Recd Date / Due Date 06/07/2012 07/06/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4004 2012-4005 2012-4006 06/07/2012 07/06/2012 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4007 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4008 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4009 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4010 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4011 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4012 06/07/2012 FDA/OMPT/CDRH/OCER/DFOI/ MICAEL JOHANSSON SYNOVIS MICRO COMPANIES ALLIANCE INC ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP CORTICOTROPIN NDA 10-831 - ANNUAL RPT ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP CORTICOTROPIN NDA 07-504 - ANNUAL RPT ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP CORTICOTROPIN NDA 88-772 - ANNUAL RPT ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP CORTICOTROPIN NDA 08-317 - ANNUAL RPT ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP ORGANICS LAGRANGE - CORTICOTROPIN NDA 10-831; ORGANON USA INC - PURIFIED CORTROPHIN GEL NDA 08975; SANOFI AVENTIS - ACTHAR (CORTICOTROPIN) NDA 07-504, ETC LBLG ORA/OCI/ ORA/OCI/ CVM/OCD/ Doe J GREGORY P BERGT PENNFIELD OIL CO ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP PUCHENG LIFECOME BIOCHEMISTRY CO LTD - LASALOCID NADA 096-298 FERMENTATION PROCEDURES RECS HP ACTHAR NDA 08-372 - ANNUAL RPT INDIVIDUAL RECS Signature/ Requester ERIC H WEINBERG ERIC H WEINBERG ESQ Subject PRADAXA (DABIGATRAN ETEXILATE MESYLATE) - IND SUBMISSIONS, CLNCL TRIAL PROTOCOLS, SAFETY MONITORING, ETC
Page 1102 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/06/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-4013 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4014 2012-4015 06/07/2012 07/06/2012 06/07/2012 07/06/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4016 06/07/2012 07/06/2012 2012-4017 06/07/2012 07/06/2012 ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/ATL-DO/ACB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4018 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4019 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4020 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4021 06/07/2012 07/06/2012 FDA/OMPT/CDRH/OCER/DFOI/ BARD PERIPHERAL VASCULAR INC K034021 Allison Olenginski Larson & Anderson LLC IND 7656 PEGylated Recombinant Methionyl Human Soluble Tumor Necrosis Factor Type I Receptor (PEG sTNF- RI) (03/30/1998 - 06/06/2012) Deborah Eickhoff LEO Pharma Inc. NDA 202-833: PICATO (ingenol mebutate) gel - Unredacted Reviewer/Evaluation Reports (03/01/2011 - 02/02/2012) ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP NDA 17-861 - ANNUAL RPT David G. Perkins Abbott Laboratories, Inc Peter Gerold Gerold, Peter J Cook Endoscopy's (FEI 1037905) response to the April 19, 2011 FDA 483 and any response to any Untitled Letter associated with this inspection (04/14/2011 - 06/06/2012) Lexiscan - AERS William Hu Philips Healthcare Informatics ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP Philips Healthcare Informatics, Foster City, CA (04/13/2012 04/18/2012) - EIR CORTICOTROPIN-ZINC HYDROXIDE NDA 09-854 - ANNUAL RPT ALISON M AGNEW PILLSBURY WINTHROP SHAW PITTMAN LLP Signature/ Requester ETTEPLAN Subject MICROVASCULAR ANASTOMOTIC COUPLER K040162; VIOPTIX INC - VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYS K090679 CORTICOTROPIN NDA 08-975 - ANNUAL RPT
Page 1103 of 1132

Total Records: 12455 Control # 2012-4022 Recd Date / Due Date 06/07/2012 07/06/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4023 2012-4024 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4025 2012-4026 06/07/2012 07/06/2012 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4027 06/07/2012 07/06/2012 2012-4028 2012-4029 06/07/2012 07/06/2012 06/07/2012 07/06/2012 2012-4030 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-4031 06/07/2012 07/06/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ANNE E. HEROLD JONES WARD PLC REGLAN - PKG, RVW, LBLG FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ CALLIE G. MOORE ACERTARA ACOUSTIC LABORATORIES Rodolfo J Ricart Ricart, Rodolfo J MICHELE LEE BUENAFE ACERTARA ACOUSTIC LABORATORIES IRINA RIVKIND CANTOR FITZGERALD RIFAXIMIN - 483 6/08 TO 9/09 INTRAOPERATIVE DOPPLER SYS - FLOWMETER BLOOD CARDIOVASCULAR VTI K082870 Vortech Pharmaceuticals LTD, Dearborn, MI - EIRs, 483s (01/01/2000 - 06/01/2012) ULTHERA SYS K072505 FDA/OF/CFSAN/OCD/EOS/ Scott Gould scott gould Dan Moellentin, PharmD, Associate Professor EASTERN MAINE MEDICAL CENTER Voluntary Cosmetic Registration Program - List of Labelers and contact information Exanatide associated nephrotic syndrome (04/01/2005 03/01/2012) ORA/NE-FO/NWE-DO/NWECB/ TERI G. POON REED SMITH LLP Tina Babos IPD ANALYTICS LLC NDA No. 202343 - Summary Review and Medical Review DAVOL INC, WARWICK, RI - EIR 3/10 Signature/ Requester Tracy White White, Tracy M Subject Ambien - AERS
Page 1104 of 1132

Total Records: 12455 Control # 2012-4032 2012-4033 2012-4034 2012-4035 2012-4036 Recd Date / Due Date 06/07/2012 07/06/2012 06/07/2012 07/06/2012 06/07/2012 07/06/2012 06/07/2012 07/06/2012 06/07/2012 07/06/2012 CVM/OCD/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J Melinda Culver Culver, Melinda Submission to the FDA Center for Veterinary Medicine by Nestle Purina regarding the use of medium chain triglycerides (MCTs) in animal food or feed and the response(s), if any, by the agency (01/01/2008 - 06/07/2012) Reumofan Plus - Recall Recs Doe J FDA/OMPT/CDRH/OCER/DFOI/ HENSON, JOHN. D STATUS OF CMPLNT 1100031 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester Vijay Hingorani Vanguard Healthsciences, Inc. HAROLD T. DODGE, Jr. RUSH HANNULA ET AL NAME OF INDIVIDUAL WHO PREPARED PMA 980022/S010 SYNTHES INC - NORIAN CRS, SRS, R, XR DOCS Subject PRADAXA - clinical review documents
2012-4037
06/07/2012 07/06/2012
FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/MIN-DO/MCB/
2012-4038
06/07/2012 07/06/2012
Kim Wagner BIOPHARM DEVELOPMENT ASSOCIATES, LLC
Remicade BLA 103772
2012-4039
06/08/2012 07/09/2012
Loretta Szczotka-Flynn OD, PhD CWRU Dept of Ophthalmology
Silicone Hydrogel Contact Lenses; 510K applications which lead to the approval of several silicone hydrogel contact lenses for either daily or extended wear. Representative materials (and companies) are: lotrafilcon A, lotrafilcon B, balafilcon A, comfilcon A, narafilcon B, efrofilcon A, galyfilcon A, silficon A, enfilcon A, senofilcon A. (companies: CibaVision, Bausch&Lomb, CooperVision, Vistakon, Contemac) (01/01/1998 - 06/07/2012) Complete copy of page 6 of the Clinical Review for BLA 98-0369 for Herceptin, approved on 09/25/1998
2012-4040
06/08/2012 07/09/2012
2012-4041 2012-4042
06/08/2012 07/09/2012 06/08/2012
FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/
Steven Walsh Plasma Surgical, Inc. Kelly Marie Sohn
Rhytec Portrait PSR 510(k) submission - K071786 FDA Staff Manual Guide 4850.7 The recommended contents of
Page 1105 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/09/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Signature/ Requester Kelly M. Sohn Subject such a submission are described more fully in FDA Staff Manual Guide 4850.7 that is publicly available under FDA's public information regulations in part 20. TITLE 21--FOOD AND DRUGS PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION Subpart C--Administrative Actions Sec. 312.47 Meetings. Wichita Fusion Nail -- approval, reports, or complaints
2012-4043
06/08/2012 07/09/2012
Caroline McKenna Law Offices of G. Oliver Koppell & Assoc
2012-4044
06/08/2012 07/09/2012
CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ OC/COS/OES/ OC/COS/OES/ OC/OCC/
TIM SCHWAB Food & Water Watch
AQUABOUNTY TECHNOLOGIES - AQUADVANTAGE SALMON SHAREHOLDER DISCLOSURE RECS 8/15/08
2012-4045 2012-4046 2012-4047
06/08/2012 07/17/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012
FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/DET-DO/DCB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/FLA-DO/FCB/ CBER/OCTMA/DDOM/ALFB/ CTP/OD/ CTP/OD/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ OC/COS/OL/ ORA/
DEWITT M LOVELACE LOVELACE LAW FIRM PA MARIANNA CARUSO CHARLES RIVER LABS DEWIT M LOVELACE LOVELACE LAW FIRM PA ANN L WEISMANN CITIZENS FOR RESPONSIBILITY & ETHICS IN WASHINGTON
KELLOGG CO - PROD MISBRANDING RECS ISIS SERVICES LLC, SAN CARLOS, CA -EIR 3/22/11-4/7/11 PEPISCO INC - PROD MISBRANDING RECS
2012-4048
06/08/2012 07/09/2012
REP JIM RENACCI - COMM 1/11 TO PRESENT; SUAREZ CORPORATION INDUSTRIES (SCI) - RECS 1/05 TO PRESENT
Page 1106 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office ORA/ ORA/CE-FO/CIN-DO/CCB/ 2012-4049 06/08/2012 07/09/2012 CTP/OD/ CTP/OD/ GREGORY N CONNOLLY DMD MPH HARVARD SCHOOL OF PUBLICH HEALTH 2012-4050 06/08/2012 07/09/2012 ORA/ ORA/ ORA/SW-FO/DALDO/COMPLIANCE/ 2012-4051 06/08/2012 07/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4052 06/08/2012 07/09/2012 ORA/ ORA/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ 2012-4053 06/08/2012 07/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4054 06/08/2012 07/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4055 2012-4056 2012-4057 2012-4058 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 ORA/CE-FO/NJ-DO/NJCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ RITU BARAL COLLINS STEWART LLC RITU BARAL COLLINS STEWART LLC RITU BARAL COLLINS STEWART LLC RITU BARAL COLLINS STEWART LLC CATALENT PHARMA SOLUTIONS, SOMERSET,NJ - 483 3/12 BANNER PHARMACAPS, HIGH POINT, NC - 483 5/12 BANNER PHARMACAPS, HIGH POINT, NC - 483 4/12 BANNER PHARMACAPS, HIGH POINT, NC - 483 3/12 BRYAN SAYLER HOUNDS PARTNERS DMAA (DIMETHYLAMYLAMINE) - AERS DR K C JINDAL FDC LTD PREDNISONE ACETATE OPHTHALMIC SUSPENSION NDA17-011, TOBRAMYCIN OPHTHALMIC SOL NDA 50-541, TRIFLURIDINE OPHTHALMIC SOL NDA 18-299 - SBA DAMARYS DEL CASTILLO GOYA DE PUERTO RICO INC CMPLNT Doe J AMGEN - PROLIA AERS Doe J UNILEVER - SOFT AND BEAUTIFUL CMPLNT PHILIP MORRIS, ALTRIA GROUP INC - MARLBORO LIGHTS CIGARETTES RECS, RESP TO LTR 6/17/11 Signature/ Requester Subject
Page 1107 of 1132

Total Records: 12455 Control # 2012-4059 2012-4060 2012-4061 2012-4062 Recd Date / Due Date 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4063 2012-4064 06/08/2012 07/09/2012 06/08/2012 07/09/2012 2012-4065 2012-4066 06/08/2012 07/09/2012 06/08/2012 07/09/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4067 06/08/2012 07/09/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4068 2012-4069 06/08/2012 07/09/2012 06/08/2012 07/09/2012 2012-4070 06/08/2012 07/09/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Nicole Dove SUMMIT MEDICAL LTD Francis G. Gleason, Jr. Gleason & Gleason Attorneys at Law Francis G. Gleason, Jr. Gleason & Gleason Attorneys at Law Records regarding 510K application(s) for market approval of a medical device submitted by Medelle Corporation beginning in the first quarter of 2004 through the end of 2008. Correspondence between FDA and Invo Bioscience and of any 510K application for market approval on a medical device known as the "Invo cell" which may have been submitted by Invo Bioscience. Invo Bioscience has been and may still be located in Beverly, Massachusetts. K102148 ANDREW D. ASHE, Esq. DYAX CORP KALBITOR (ECALLANTIDE) - APRVL REID, JUSTUS ELAINE S. WALLER SEATTLE GENETICS INC ORA/NE-FO/NYK-DO/NYDCB/ CBER/OCTMA/DDOM/ALFB/ JANE BROWN MD NEEDHAM PEDIATRICS PC JAMES McCREADY LONG ISLAND JEWISH MEDICAL CENTER CIRCULATORY TECHNOLOGY INC - BIGGER BETTER BLADDER WARNING LTR ERADICATION OF THE FOX POPULATION AT THE TOWN OF PALM BEACH ADCETRIS (BRENTUXIMAB VEDOTIN) AER 9/11 TO 5/31/12 INDIVIDUAL RECS FDA/OMPT/CDRH/OCER/DFOI/ HAMILTON PHD, LEROY L JONATHAN B. NACE PAULSON & NACE HUMIRA - CLNCL TRIAL ORA/CE-FO/NJ-DO/NJCB/ Action Office ORA/CE-FO/NJ-DO/NJCB/ Signature/ Requester RITU BARAL COLLINS STEWART LLC RITU BARAL COLLINS STEWART LLC FORM 3429 & RELATED DOCS SINCE 1/12 CATALENT PHARMA SOLUTIONS, SOMERSET, NJ - 483 5/12 Subject CATALENT PHARMA SOLUTIONS, SOMERSET, NJ - 483 4/12
Page 1108 of 1132

Total Records: 12455 Control # 2012-4071 Recd Date / Due Date 06/08/2012 07/09/2012 2012-4072 2012-4073 2012-4074 2012-4075 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ 2012-4076 2012-4077 06/08/2012 07/09/2012 06/08/2012 07/09/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/BLT-DO/CB/ FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/SE-FO/ATL-DO/ACB/ 2012-4078 06/08/2012 07/09/2012 FDA/OF/CFSAN/OCD/EOS/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ 2012-4079 2012-4080 2012-4081 2012-4082 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/08/2012 07/09/2012 06/11/2012 07/10/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/CE-FO/CIN-DO/CCB/ LONERY 0849065, JOHN LAUREN S BARR JH BARR & ASSOCIATES LLC LAUREN S BARR JH BARR & ASSOCIATES LLC Mary E. Lynn The Windward Company North American Science Assiciates, Inc., Northwood Ohio - EIR (04/10/2005 - 05/10/2005) FOI CLOSED REQUESTS 5/21-25/12 FOI CLOSED REQUESTS 5/14-18/12 FOOD & NUTRITION MGMT POLICY MANUAL J. PRICE COLEMAN COLEMAN LAW FIRM CORR BETWEEN FDA & CHICKEN OF THE SEA J. PRICE COLEMAN COLEMAN LAW FIRM J. PRICE COLEMAN COLEMAN LAW FIRM CORR BETWEEN FDA & APPLE & EVE LLC FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Summit Medical Semi Condoianis Dentistry360 Mihir Shah UE LifeSciences Inc Nancy Burton Nancy Burton All records of fish caught in Pacific Ocean waters and inspected by the Food and Drug Administration and found to contain radioisotopes released in the Fukushima triple nuclear reactor meltdown since March 11, 2011. CORR BETWEEN FDA & MCCORMICK & CO K113259 K02836 Action Office OM/OMP/DODM/ Signature/ Requester ANGELIA D. SLAYTON INC RESEARCH CONSULTING & SUBMISSIONS K112535 Subject DCK FDA-2012-N-0171
Page 1109 of 1132

Total Records: 12455 Control # 2012-4083 Recd Date / Due Date 06/11/2012 07/10/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4084 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4085 2012-4086 06/11/2012 07/10/2012 06/11/2012 07/10/2012 2012-4087 06/11/2012 07/10/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/NE-FO/NWE-DO/NWECB/ FDA/OF/CFSAN/OCD/EOS/ ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/KAN-DO/COMP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4088 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4089 2012-4090 06/11/2012 07/10/2012 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4091 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDER/ORP/DIDP/ Diane Nelms ALCON LABORATORIES Urokinase - testing requirements for release of FDA approved product (06/02/1997 - 06/08/2012) ORA/NE-FO/NWE-DO/NWECB/ Eric Hall Hall, Eric Eric Hall Hall, Eric Flovent HFA S-004 sNDA approval package Exemplar Pharmaceuticals, LLC- EIRs, 483s (2011-2012) Eric Hall Hall, Eric The Asmanex full pediatric program Marian S. Rosen & Association ISR Number 4755457-3 ISR Number 6436946-2 ISR Number 6259539-9 ISR Number 6436946-2 Raphael Lewis North Run Capital, LP Maggie Palmisano Hallberg & McClain, P.A. All correspondence, including but not limited to emails, in relation to Abiomed Inc.'s Impella products. Investigation of the relationship between Simply Thick and the development of NEC in infants including, including lab results (05/01/2011 - 06/08/2012) Eric Hall Hall, Eric Ciclesonide pediatric studies Signature/ Requester Eric Hall Hall, Eric Subject Teva budesonide inhalation aerosol ANDA approval package
Page 1110 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4092 2012-4093 2012-4094 2012-4095 2012-4096 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4097 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4098 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4099 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-4100 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ RITU BARAL CHEMPORT INC, DONGSU-DONG NAJU-SI JEOLLANAMDO, SOUTH KOREA - 483S 4/12 RITU BARAL CHEMPORT LAB, FONHDU-FONH NSJU-DI JROLLANAMDO, SOUTH KOREA - 483S 3/12 RITU BARAL EQUATEQ LTD, LEWIS, SCOTLAND - 483S 3/12 RITU BARRAL EQUATEQ LTD, LEWIS, SCOTLAND - 483S 4/12 RITU BARRAL ORA/SE-FO/ATL-DO/ACB/ HART, TARA ORA/SE-FO/ATL-DO/ACB/ HART, TARA ORA/SE-FO/ATL-DO/ACB/ HART, TARA ORA/SE-FO/ATL-DO/ACB/ HART, TARA DIAMOND PET FOODS - DRY PET FOOD RECALL CMPLNTS 05/05/12 DIAMOND PET FOODS - PUPPY FORMULA RECALL COMPLNTS 4/30/12 DIAMOND PET FOODS - ONE PRODUCTION RUN DRY DOG FOOD RECALL CMPLNTS 4/26/12 DIAMOND PET FOODS - DRY DOG FOOD BAGS CMPLNTS 04/06/12 EQUATEQ LTD, LEIWIS, SCOTLAND - 483S 5/12 Signature/ Requester Subject
Page 1111 of 1132

Total Records: 12455 Control # 2012-4101 Recd Date / Due Date 06/11/2012 07/10/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4102 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4103 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4104 2012-4105 2012-4106 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4107 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4108 06/11/2012 07/10/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4109 2012-4110 2012-4111 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ TARA HART WOODRUFF SWEITZER TARA HART WOODRUFF SWEITZER TARA HART WELLPET LLC - PET FOOD RECALL 5/7/12 CANIDAE - PET FOOD RECALL 5/5/12 APEX - PET FOOD RECALL 5/4/12 RITU BARAL COLLINS STEWART LLC NISSHIN PHARMA, JAPAN - 483 3/12 RITU BARAL COLLINS STEWART LLC NISSHAN PHARMA, JAPAN - 483 4/12 CBER/OCTMA/DDOM/ALFB/ FDA/OF/CFSAN/OCD/EOS/ NATHAN A BEAVER FOLEY & LARDNER LLP SHAMEEN AFIF-RIDER MEDIMMUNE INC RITU BARAL COLLINS STEWART LLC NISSHIN PHARMA, JAPAN - 483 5/12 NUTRASWEET CO - MICROPARTICULATED PROTEIN PROD FAP VAERS 397055, 417991, 422860, ETC ELIZABETH BARBEHENN PUBLIC CITIZEN LIRAGLUTIDE - ISRS 7792076, 7793173, 7798076, ETC CINDY HSU TRAVERT NDA 16-717- CLNCL PHARMACOLOGY, BIOPHARMACEUTICS, CHEMISTRY REVWS, ETC RITU BARAL Signature/ Requester Subject CHEMPORT INC, DONGSU-DONG NAJU-SI JEOLLANAMDO, SOUTH KOREA - 483S 5/12
Page 1112 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/10/2012 2012-4112 2012-4113 2012-4114 2012-4115 2012-4116 2012-4117 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 2012-4118 2012-4119 06/11/2012 07/10/2012 06/11/2012 07/10/2012 OC/OOPD/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/ ORA/ ORA/SE-FO/ATL-DO/ACB/ Vick, Linda PHIL SHUGART CAROLINA LIQUID CHEMISTRIES CORP semi condoianis Dentistry360 Yamil Hernandez Yamil Hernandez Orphan Drug Designation Application Package for the drug H.P. Acthar Gel (Repository Corticotropin Or Adrenocorticotropic Hormone) in the treatment of Infantile Spasms (IS) submitted by Questcor Pharmaceuticals Dried Pasta Products - Complaints (01/01/2002 - 06/10/2012) DIERCT BILIRUBIN REAGENT K011972; CK-NAC REAGENT K974833; TOTAL BILIRUBIN REAGENT K003892 K070700 CBER/OCTMA/DDOM/ALFB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/SE-FO/ATL-DO/ACB/ Action Office Signature/ Requester WOODRUFF SWEITZER TARA HART WOODRUFF SWEITZER TARA HART WOODRUFF SWEITZER TARA HART WOODRUFF SWEITZER SHAMEEN AFIF-RIDER MEDIMMUNE LLC CHICKEN JERKY - PET TREATS ANALYSIS, RESULTS VAERS 295697, 331721, 362590 DIAMOND - PET FOOD RECALL 5/21/12 SOLID GOLD HEALTH PRODUCTS FOR PETS INC - PET FOOD RECALL 5/8/12 NATURAL BALANCE - PET FOOD RECALL 5/4/12 Subject
2012-4120
06/11/2012 07/10/2012
ORA/ ORA/ FDA/OMPT/CDRH/OCER/DFOI/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/
Sue Longacre SAFETY RESEARCH & STRATEGIES INC N. KIRKLAND POPE POPE MCGLAMRY ET AL ATTYS
2012-4121
06/11/2012 07/10/2012
WRIGHT MEDICAL TECHNOLOGY INC - CONSERVE PLUS HIP REPLACEMENT SYS; CONSERVE PLUS TOTAL RESURFACING SYS; CONSERVE TOTAL HIP SYS W/BFH TECH - ADRS, CLNCL STUDIES, 510K FCN 1125 PAPERPAK INDUSTRIES
2012-4122 2012-4123 2012-4124 2012-4125 2012-4126
06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/11/2012 07/10/2012 06/12/2012
FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/KAN-DO/COMP/
ALICIA B. RICHARDS AQUASOL CORP KATE WILLSON PAUL BARBER BARBER, PAUL LYNN REICHHELM PESSIN KATZ LAW PA AUSTIN NELSON
HUMAN CELL & TISSUE ESTABLISMENT REGISTRATION CENTER FOR PUBLIC INTEGRITY DATABASE HEARTLAND TAN SYSTEMS - ALPHA SOLAR SYS TANNING BED K943656 INDIVIDUAL RECS HOSPIRA INC, MCPHERSON, KS - 483 2/1/12
Page 1113 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/11/2012 2012-4127 06/12/2012 07/11/2012 2012-4128 06/12/2012 07/11/2012 2012-4129 06/12/2012 07/11/2012 2012-4130 06/12/2012 07/11/2012 2012-4131 2012-4132 06/12/2012 07/11/2012 06/12/2012 07/11/2012 2012-4133 2012-4134 06/12/2012 07/11/2012 06/12/2012 07/11/2012 2012-4135 06/12/2012 07/11/2012 2012-4136 06/12/2012 07/11/2012 2012-4137 06/12/2012 07/11/2012 2012-4138 06/12/2012 07/11/2012 2012-4139 06/12/2012 07/11/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/NE-FO/NWE-DO/NWECB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/SAN-DO/SFCB/ ORA/SE-FO/SJN-DO/SJCB/ ORA/CE-FO/CHI-DO/CCB/ ORA/ ORA/ ORA/NE-FO/NYK-DO/NYDCB/ ORA/ ORA/ ORA/CE-FO/CHI-DO/CCB/ ORA/ORM/ ORA/ORM/ ORA/CE-FO/BLT-DO/CB/ DANNY ROBBINS ASSOCIATED PRESS DALLAS BUREAU JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS DIETARY SUPPLEMENT COMPANIES - NUMBER OF INSPS, CGMP REGULATIONS 2011 CARDINAL HEALTH 414 LLC, BELTSVILLE, MD - 483S 3/131/12 DENTAL TECHNOLOGIES INC, LINCOLNWOOD, IL; CPC LABORATORIES INC, CHICAGO, IL; BIOSYNERGY INC, ELK GROVE VILLAGE, IL, ETC - 483S 3/1-31/12 PFIZER PHARMACEUTICALS LLC, CAROLINA, PR; FENWAL INTL INC, MARICAO, PR - 483S, 2/1-29/12 DOW PHARMACEUTICAL SCIENCES, PETALUMA, CA; ANGIODYNAMICS INC, FREMONT, CA; ASPINE USA INC, SAN FRANCISCO, CA - 483S 2/1-29/12 FOUGERA PHARMACEUTICALS INC, HICKSVILLE, NY; TOPIDERM INC, NORTH AMITYVILLE, NY; ANGIODYNAMICS INC, QUEENSBURY, NY, ETC - 483S, 2/1-29/12 ONYX MEDICAL CORP, MEMPHIS, TN; INTEC INDUSTRIES INC, BIRMINGHAM, AL; PERMOBIL INC, LEBANON, TN ETC 483S 2/1-29/1/2 BIOGENESIS INC, HACKENSACK, NJ; UNETTE CORP, RANDOLPH, NJ; DAVAGEN PHARMACEUTICALS LLC, SOMERSET, NJ ETC - 483S 2/1-29/12 QUARTET TECHNOLOGY INC, DRACUT, MA; MICROSPECIALITIES INC, MIDDLETOWN, CT; ADVANCED INSTRUMENTS INC, NORWOOD, MA ETC - 483S, 2/1-29/12 SCHWABE NORTH AMERICA INC, GREEN BAY, WI; DIVERSIFIED MANUFACTURING CORP, NEWPORT, MN; BRENNTAG GREAT LAKES LLC, MENOMONEE FALLS, WI ETC - 483S, 2/1-29/12 Doe J INDIVIDUAL RECS ORA/SE-FO/FLA-DO/FCB/ Action Office Signature/ Requester RBC CAPITAL MARKETS JOHN A CHIOCCA CHIOCCA & CHIOCCA AILEEN CHOH GREAT GLOVE USA INC ANITA A DONSKY, MAURICE E DONSKY, BLUE WATER CONNECTION SEAFOOD CORP - INVESTIGATION RECS 7/15/11 TG MEDICAL SDN BHD - ENTRY #112-7161512-7 FDA NOTICE OF ACT, TESTING RPT, PACKING LIST, ETC Subject
Page 1114 of 1132

Total Records: 12455 Control # 2012-4140 Recd Date / Due Date 06/12/2012 07/11/2012 2012-4141 06/12/2012 07/11/2012 2012-4142 06/12/2012 07/11/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/P-FO/LOS-DO/LACB/ Action Office ORA/CE-FO/CIN-DO/CCB/ Signature/ Requester JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDA NEWS Subject OGENIX CORP, BEACHWOOD, OH; AFASSCO INC, ORRVILLE, OH; GRIMM SCIENTIFIC INDUSTRIES, MARIETTA, OH, ETC - 483S 3/1-31/12 PROPORTIONAL TECHNOLOGIES INC, HOUSTON, TX; ALOESCIENCE LABS INC, GARLAND, TX; ALCON RESEARCH LTD, FT WORTH, TX, ETC - 483S 3/1-31/12 INTRACEUTICALS LLC, LONG BEACH, CA; PACIFIC CONSOLIDATED INDUSTRIES LLC, RIVERSIDE, CA; AMERICAN OPTISURGICAL INC, LAKE FOREST, CA, ETC 483S, 2/1-29/12 B&G LABS INC, ST LOUIS, MO; MERIDIAN MEDICAL TECHNOLOGIES, ST LOUIS, MO & BRENTWOOD, MO - 483S, 2/1-29/12 Inova Blood Donor Services, Sterling, VA - 483s, EIRs (1/23/2012- 2/13/2012) and EIRs (2009-2011) BAITELLA AG, ZURICH, SWITZERLAND; GE HEALTHCARE FINLAND OY, HELSINKI, FINLAND; BTS SPA, PADOVA, ITALY ETC - 483S, 2/1-29/12 Protica, Inc., Whitehall, PA - Corr, 483s (01/01/2011 06/11/2012) FROSST IBERICA SA, ALCALA DE HENARES, SPAIN; WATSON PHARMA PRIVATE LTD, VERNA, GOA, INDIA; PETRA HYGIENIC SYS INTL, CONCORD, CANADA ETC 483S, 2/1-29/12 LASERSIGHT TECHNOLOGIES INC, WINTER PARK, FL; GULF FIBEROPTICS INC, OLDSMAR, FL; CLOROX HEALTHCARE HOLDINGS LLC (DBA HEALTHLINK), JACKSONVILLE, FL ETC - 483S, 2/1-29/12 BIOPRO INC, PORT HURON, MI; 3T MEDICAL SYStems LLC, LIVONIA, MI; LEBANON CORP, LEBANON, IN - 483S, 2/129/12 FLAEM NUOVA SPA, DELLA BATTAGLIA, ITALY; ALBERT BROWNE LTD, LEISTER, UK; HAAG STREIT UK LTD, HARLOW, UK ETC - 483S, 3/1-31/12 Recall Records dated September 30, 2011 involving Velveeta shells and Cheese and Velveeta Rotini and Cheese manufactured by Kraft Foods Global, Inc. SIEMENS HEALTHCARE DIAGNOSTICS INC, NEWARK, DE 483S, 2/1-29/12
2012-4143
06/12/2012 07/11/2012
2012-4144 2012-4145
06/12/2012 07/11/2012 06/12/2012 07/11/2012
ORA/CE-FO/BLT-DO/CB/ Riemer, Todd FDA/OMPT/CDRH/OCER/DFOI/ JOHNATHAN RICKMAN FDA NEWS ORA/CE-FO/PHI-DO/PCB/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ Aaron M. White Stern & Goldberg JOHNATHAN RICKMAN FDA NEWS
2012-4146 2012-4147
06/12/2012 07/11/2012 06/12/2012 07/11/2012
2012-4148
06/12/2012 07/11/2012
2012-4149
06/12/2012 07/11/2012
2012-4150
06/12/2012 07/11/2012
2012-4151
06/12/2012 07/11/2012
FDA/OF/CFSAN/OCD/EOS/ ORA/CE-FO/CHI-DO/CCB/ ORA/CE-FO/PHI-DO/PCB/
Sue Longacre SAFETY RESEARCH & STRATEGIES INC JOHNATHAN RICKMAN FDA NEWS
2012-4152
06/12/2012 07/11/2012
Page 1115 of 1132

Total Records: 12455 Control # 2012-4153 2012-4154 Recd Date / Due Date 06/12/2012 07/11/2012 06/12/2012 07/11/2012 2012-4155 06/12/2012 07/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4156 06/12/2012 07/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4157 06/12/2012 07/11/2012 2012-4158 06/12/2012 07/11/2012 2012-4159 06/12/2012 07/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4160 2012-4161 06/12/2012 07/11/2012 06/12/2012 07/11/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4162 06/12/2012 07/11/2012 2012-4163 06/12/2012 07/11/2012 ORA/CE-FO/DET-DO/DCB/ ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SW-FO/DEN-DO/COMP/ RENEERS, PATRICK ORA/SE-FO/FLA-DO/FCB/ JOHNATHAN RICKMAN FDA NEWS PRODUCT QUEST MANUFACTURING LLC, HOLLY HILL, FL; BAUSCH & LOMB INC, TAMPA, FL; HILL DERMACEUTICALS INC, SANFORD, FL, ETC - 483S, 3/1-31/12 FLUORIDE (HYDROFLUOSILICIC ACID) IN WATER WARNINGS, GOAL BLOOD LEVELS ORA/P-FO/LOS-DO/LACB/ ONA SCANDURRA COUNTRY LIFE LLC JOHNATHAN RICKMAN FDA NEWS M & L PHARMS, SAN BERNADINO, CA - EIRS, 483S 6/05 TO PRESENT SIGMA-ALDRICH CO LTD, GILLINGHAM, UK; KINGKEY GROUP KINGKEY DAILY CHEMICAL CO LTD, SHANTOU CITY, CHINA; ZHEJIANG XINHUA PHARMACEUTICAL CO LTD, LINHAI, ZHEJIANG, CHINA, ETC - 483S, 3/1-31/12 ORA/SE-FO/ATL-DO/ACB/ ORA/SW-FO/DEN-DO/COMP/ JOHNATHAN RICKMAN FDANEWS JOHNATHAN RICKMAN FDA NEWS Francois Ravenelle oncozyme pharma inc. DYNASTHETICS, SALT LAKE CITY, UT; FRESENIUS MEDICAL CARE NORTH AMERICA, OGDEN, UT - 483S 3/131/12 HOSPIRA INC, CLAYTON, NC; DERMATREATE LLC, MONCKS CORNER, SC; COOK ENDOSCOPY, WINSTON-SALEM, NC ETC - 483S, 3/1-31/12 Pentamidine Isethionate toxicology review r.p.shah memorial trust for children with disabilities r.p.shah memorial trust for children Steroids - AERs ORA/P-FO/SEA-DO/SCB/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester Eli Bental, Eliyahu JOHNATHAN RICKMAN FDA NEWS Bhupesh ASTRON RESEARCH LTD NATUS MEDICAL INC, SEATTLE, WA; GLOBAL PATHOGEN SOLUTIONS INC, CAMAS, WA; PETNET SOLUTIONS INC, KENT, WA - 483S, 2/1-29/12 ANDA A078179 - Clinical pharmacology and bio pharmaceutics review Subject K110565
Page 1116 of 1132

Total Records: 12455 Control # 2012-4164 Recd Date / Due Date 06/12/2012 07/11/2012 Action Office ORA/CE-FO/DET-DO/DCB/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS Subject INTEGRATED BIOMEDICAL TECHNOLOGY INC, ELKHART, IN; CARDINAL HEALTH MSU PET SITE, EAST LANSING, MI; TOWER LABORATORIES LTD, MONTAGUE, MI, ETC - 483S, 3/1-31/12 FORTEO - AERS KOBER, MARY JANE
2012-4165
06/12/2012 07/11/2012
2012-4166
06/12/2012 07/11/2012
FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ DEABOLD, GEORGE DEBORAH ARTHUR COCHLEAR AMERICAS BRENDA M GARTZ ELI LILLY & CO
GED-1, GED-4 SKIN SHOCK DVCS - APRVL RECS
2012-4167 2012-4168
06/12/2012 07/11/2012 06/12/2012 07/11/2012
COCHLEAR BONE-ANCHORED SOLUTIONS AB, MOLNLYYCKE, SWEDEN - EIR 5/14-17/07 TORRENT PHARMACEUTICALS LTD, GUJARAT STATE, INDIA - EIR 3/8/11
2012-4169
06/12/2012 07/11/2012
BRENDA M GARTZ ELI LILLY & CO
STRIDES ARCOLAB LTD, KAMATAKA, INDIA - EIR 3/17/09, 2/3/11
2012-4170
06/12/2012 07/11/2012
ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SE-FO/FLA-DO/FCB/
DANNY ROBBINS ASSOCIATED PRESS DALLAS BUREAU DANNY ROBBINS ASSOCIATED PRESS DALLAS BUREAU
ADVOCARE INTERNATIONAL - 483S, WARNING LTRS, CO RESP, ETC NUTRITION SCIENCE LABORATORIES LLC - 483S, WARNING LTRS, CO RESP, ETC CUSTOM NUTRITION LABORATORIES LLC - 483S, WARNING LTRS, CO RESP, ETC FDA TELEPHONE DIRECTORIES - NUMBERS, POSITION, OFFICES ALIGN & ALIGN TO URETHRAL SUPPORT SYS - K093747
2012-4171
06/12/2012 07/11/2012
2012-4172
06/12/2012 07/11/2012
ORA/SW-FO/DALDO/COMPLIANCE/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/
DANNY ROBBINS ASSOCIATED PRESS DALLAS BUREAU JONATHAN BERMAN JONES DAY JENNIFER K REGISTER BLASINGAME BURCH ET AL ATTYS
2012-4173 2012-4174
06/13/2012 07/12/2012 06/13/2012 07/12/2012
Page 1117 of 1132

Total Records: 12455 Control # 2012-4175 Recd Date / Due Date 06/13/2012 07/12/2012 2012-4176 06/13/2012 07/12/2012 2012-4177 06/13/2012 07/12/2012 2012-4178 06/13/2012 07/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-4179 06/13/2012 07/12/2012 2012-4180 2012-4181 06/13/2012 07/12/2012 06/13/2012 07/12/2012 2012-4182 06/13/2012 07/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4183 2012-4184 2012-4185 06/13/2012 07/12/2012 06/13/2012 07/12/2012 06/13/2012 07/12/2012 ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ ORA/CE-FO/CHI-DO/CCB/ TINA LIVESAY HEARTLAND LIONS EYE BANKS JOHN WALSH JAMES ALEXANDER CORP ADRIANNA IWASINSKI KWTV NEWS 9 HEARTLAND LIONS EYE BANKS, SPRINGFIELD, IL - EIRS 2010 UNIVAR USA INC, STRONGSVILLE, OH - EIRS, 483S, RECALLS 6/09 TO PRESENT CHAD KERKSICK,, UNIV OF OKLAHOMA - INVESTIGATION FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ANNE L WEISMANN CITIZENS FOR RESPONSIBILITY & ETHICS IN WASHINGTON ANNE SAVAS MAGSTIM COMPANY US LLC GREGORY H ARABIAN GREGORY H ARABIAN & ASSOC PC TIM BOYD AIDS HEALTHCARE FOUNDATIONS GILEAD SCIENCES INC - APPL FEES, PROD FEES, ESTABLISHMENT FEES 1/10 TO PRESENT ENDO GIA STAPLING DVC - RECS NEURONETICS - K061053 FOIA REQUESTS 3/11 TO PRESENT FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester JENNIFER K REGISTER BLASINGAME BURCH ET AL ATTYS JENNIFER K REGISTER BLASINGAME BURCH ET AL ATTYS JENNIFER K REGISTER BLASINGAME BURCH ET AL ATTYS ANNE L WEISMANN CITIZENS FOR RESPONSIBILITY & ETHICS IN WASHINGTON JEFFERIES & CO, QVT FINANCIAL, NEW YORK, NY, JAFFRAY OF MINNEAPOLIS, MN, ETC - HEDGE FUNDS, FINANCIAL FIRMS OR TRADERS TRANS, MINS, TELEPHONE CONVERSATIONS, ETC 1/10 TO PRESENT ALIGN URETHRAL SUPPORT SYS - K070073 Subject URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYS - K041176 URETEX SUP PUBOURETHRAL SLING - K012949
Page 1118 of 1132

Total Records: 12455 Control # 2012-4186 Recd Date / Due Date 06/13/2012 07/12/2012 2012-4187 2012-4188 06/13/2012 07/12/2012 06/13/2012 07/12/2012 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4189 06/13/2012 07/12/2012 2012-4190 06/13/2012 07/12/2012 2012-4191 06/13/2012 07/12/2012 2012-4192 06/13/2012 07/12/2012 2012-4193 06/13/2012 07/12/2012 2012-4194 06/13/2012 07/12/2012 2012-4195 06/13/2012 07/12/2012 2012-4196 06/13/2012 07/12/2012 2012-4197 06/13/2012 FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC SAMANTHA GAN CSL RESEARCH AND DEVELOPMENT JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC JENNIFER STAUNTON INSTRUMED INTERNATIONAL INC DAMON J WHITAKER 2010-2889 - UNREDACTED RECS INSTRUMED LAPAROSCOPES & ACCESSORIES K040855 INSTRUMED RETRACTORS K071771 INSTRUMED VASCULAR CLAMPS K092544 INSTRUMED FORCEPS GYNAECOLOGICAL K092840 ISTRUMED OBSTETRICAL FORCEPS K100517 H1N1 - RECS DENTAL MEDICAL INSTRUMENT CASE & CASSETTE K962545 INSTRUMED VESSEL DILATORS K100518 Doe J FDA/OF/CFSAN/OCD/EOS/ Action Office ORA/P-FO/SAN-DO/SFCB/ THOMAS A LUCAS LIISA RAPELI-LIKTALO CHEMIGATE OY INDIVIDUAL RECS Signature/ Requester Subject GIUSTO'S SPECIALTY FOODS, SOUTH SAN FRANCISCO, CA - SOY BREAD CONTAMINATION WARNING LTR, INSP SCHEDULE & RESULTS 1978 WESTERN POLYMER CORP - CATIONIC STARCH FCN 964
Page 1119 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/12/2012 2012-4198 2012-4199 06/13/2012 07/12/2012 06/13/2012 07/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4200 06/13/2012 07/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4201 06/13/2012 07/12/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4202 06/13/2012 07/12/2012 CBER/OCTMA/DDOM/ALFB/ CTP/OD/ CTP/OD/ CVM/OCD/ FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDRH/OCER/DFOI/ OC/COS/OES/ OC/COS/OES/ ORA/ ORA/ 2012-4203 2012-4204 06/13/2012 07/12/2012 06/13/2012 07/12/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ ZHANG JI RUI AA USA TRADING INC RAMONA KULIK STRYKER SUSTAINABILITY VENOUS HEALTH SYS INC, SUNNYVALE, CA - VASCULAIRE COMPRESSION SYS K103113 CASE 297037 DALE WILCOX CAUSE OF ACTION DOCS REFERRING TO EXPENDITURES OR DIRECT PYMTS MADE TO NON GVT ENTITIES FOR GIFT PURCHASE Doe J ALELVIA - AER FRANK, RENEE BARR LABS - JOLESSA AER SCHOENTHAL, FRANK FDA/OMPT/CDRH/OCER/DFOI/ BURGESS, CLAY PRADAXA - AER Action Office Signature/ Requester BRYAN CAVE LLP FRESENIUS USA - K991459, K922005 RECS, LBLG, PKG Subject
Page 1120 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office Signature/ Requester SOLUTIONS 2012-4205 06/13/2012 07/12/2012 FDA/OMPT/CDRH/OCER/DFOI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ 2012-4206 2012-4207 2012-4208 2012-4209 06/13/2012 07/12/2012 06/13/2012 07/12/2012 06/13/2012 07/12/2012 06/13/2012 07/12/2012 ORA/ ORA/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4210 2012-4211 2012-4212 06/13/2012 07/12/2012 06/13/2012 07/12/2012 06/14/2012 07/13/2012 2012-4213 2012-4214 06/14/2012 07/13/2012 06/14/2012 07/13/2012 2012-4215 2012-4216 06/14/2012 07/13/2012 06/14/2012 07/13/2012 2012-4217 2012-4218 06/14/2012 07/13/2012 06/14/2012 07/13/2012 ORA/SE-FO/SJN-DO/SJCB/ ORA/P-FO/SEA-DO/SCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/BLT-DO/CB/ ORA/CE-FO/CHI-DO/CCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ FDA/OMPT/CDRH/OCER/DFOI/ Doe J JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS CYPRESS MEDICAL PRODUCTS LLC, ELWOOD, IL; COVIDIEN, CRYSTAL LAKE, IL; SYSMEX AMERICA INC, MUNDELEIN, IL, ETC - 483S 2/1-29/12 PETNET SOLUTIONS, CHARLOTTESVILLE, VA; MEDICAL SUPPLIES CORP, BALTIMORE, MD - 483S 2/1-29/12 SHIONOGI INC, ALPHARETTA, GA; PETNET SOLUTIONS INC, DURHAM, NC; KALE RESEARCH & TECHNOLOGY, MOUNT PLEASANT, NC, ETC - 483S 2/1-29/12 JAMES G COLE INC (ASN/MAXAM NEUTRACEUTICS, HOOD RIVER, OR - 483S 3/1-31/12 ABBOTT PHARMACEUTICALS PR LTD, BARCELONETA, PR 483S 3/1-31/12 SOVEREIGN PHARMACEUTICALS LLC, FORT WORTH, TX; MILLAR INSTRUMENTS INC, HOUSTON, TX; JK PRODUCTS & SERVICES INC, JONESBORO, AR, ETC - 483S 2/1-29/12 TANGO3 LLC, SIMPSONVILLE, KY - 483 2/1-29/12 FDA/OMPT/CDRH/OCER/DFOI/ KIM CHRISTIAN KMGH-TV TELEFLEX MEDICAL RESPIRATORY INC - HUDSON RCI CONCHA COLUMN & CIRCUIT K993355 ALLERGAN BREAST IMPLANTS CVM/OCD/ CVM/OCD/ ELISABETH HOLMES CENTER FOR FOOD SAFETY ELISABETH HOLMES CENTER FOR FOOD SAFETY PAMELA PICIRILLO HOSPIRA INC THERESA MARCHETTA KMGH-TV NUMBER OF RX WRITTEN FOR FLUOROQUINOLONES RPT 4/12 BY MARLA LUTHER PhD OF FDA REGARDING ANTIMICROBIALS ENTRY NO WIG-2062122-1 MONIKA BHATT HODGSON RUSS LLP CARDINAL HEALTH INC - NICOLET CORTICAL STIMULATOR K072964; RADIONICS INC - OJEMANN CORTICAL STIMULATOR K924226; DELSYS INC - BAGNOLI 8 EMG SYS K990356 ETHOXYQUIN - AER Subject
Page 1121 of 1132

Total Records: 12455 Control # 2012-4219 Recd Date / Due Date 06/14/2012 07/13/2012 2012-4220 06/14/2012 07/13/2012 ORA/CE-FO/PHI-DO/PCB/ Action Office ORA/P-FO/SAN-DO/SFCB/ Signature/ Requester JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS Subject FORCES OF NATURE INC, SONOMA, CA; IMPAX LABORATORIES INC, HAYWARD, CA; NIDEK INC, FREMONT, CA, ETC - 483S 3/1-31/12 DIGESTIVE CARE INC, BETHLEHEM, PA; ABBEY COLOR INC, PHILADELPHIA, PA; MEDISURG RESEARCH & MANAGEMENT CORP, NORRISTOWN, PA, ETC - 483S 3/131/12 GLARGINE, DETEMIR, DEGLUDEC ETC - RECS OF DELIBERATIONS RE POSSIBLE CANCER RISK
2012-4221
06/14/2012 07/13/2012
MARC RENDELL CREIGHTON DIABETES CENTER
2012-4222
06/14/2012 07/13/2012
INVAGEN PHARMACEUTICALS INC, HAUPPAUGE, NY; ALTAIRE PHARMACUETICALS INC, AQUEBOGUE, NY; ANSEN CORP, OGDENSBURG, NY, ETC - 483S 3/1-31/12 GUARDIAN DRUG CO INC, DAYTON, NJ; DPT LAKEWOOD LLC, LAKEWOOD, NJ - 483S 3/1-31/12 TORBOT GROUP INC, CRANSTON, RI; CORREX INC, WALTHAM, MA; ATC TECHNOLOGIES INC, WILMINGTON, MA, ETC - 483S 3/1-31/12 ALTHEA LABORATORIES INC, MILWAUKEE, WI; FONTAROME CHEMICAL INC, ST FRANCIS, WI; SMT HEALTH SYSTEMS INC, DETROIT LAKES, MN, ETC - 483S 3/1-31/12 HEALING WAYS, DESERT HOT SPRINGS, CA; BLUEFIELD ASSOCIATES INC, ONTARIO, CA; GINGI-PAK, CAMARILLO, CA, ETC - 483S 3/1-31/12 SIMMLER INC, HIGH RIDGE, MO; PERIO PROTECT LLC, ST LOUIS, MO - 483S 3/1-31/12 CSL BEHRING, BERN, SWITZERLAND - 483S 2/1-29/12 U.S. INFANT FORMULA FACTORIES - LIST, ADDRESSES, PHONE #S, 483S, CO RESPS 2008 TO PRESENT, ELIZABETH H DICKINSON, ESQ, CHIEF COUNSEL - NEW DRUG APRVL APPLICATION MTG, 5/18/12 MINS, RECS ETC
2012-4223 2012-4224
06/14/2012 07/13/2012 06/14/2012 07/13/2012
ORA/CE-FO/NJ-DO/NJCB/ ORA/NE-FO/NWE-DO/NWECB/
2012-4225
06/14/2012 07/13/2012
2012-4226
06/14/2012 07/13/2012
2012-4227 2012-4228 2012-4229 2012-4230
06/14/2012 07/13/2012 06/14/2012 07/13/2012 06/14/2012 07/13/2012 06/14/2012 07/13/2012
ORA/SW-FO/KAN-DO/COMP/ CBER/OCTMA/DDOM/ALFB/ ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/COS/OES/ OC/COS/OES/
JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS SHRITEH, HAITHAM DAVID LOHMAN SANESA PARTNERS
Page 1122 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office OC/OCC/ 2012-4231 06/14/2012 07/13/2012 2012-4232 06/14/2012 07/13/2012 2012-4233 2012-4234 2012-4235 06/14/2012 07/13/2012 06/14/2012 07/13/2012 06/14/2012 07/13/2012 ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/ATL-DO/ACB/ ORA/CE-FO/BLT-DO/CB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/CE-FO/CIN-DO/CCB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS QUADRANT CHEMICAL CORP, GARLAND TX; NEURO RESOURCE GROUP INC, PLANO, TX; ORTHOFIX INC, LEWISVILLE, TX, ETC - 483S, 1/1-31/12 FERRO CORPORATION, SCOTTCARE CORPORATION, CLEVELAND HEARTLAB INC ETC CLEVELAND, OH - 483S, 1/1-31/12 H&H ASSOCIATES, ORDINARY, VA; CREATIVE TECHNOLOGIES INC, CHESAPEAKE, VA - 483S, 1/1-31/12 MONITOR INSTRUMENTS INC, HILLSBOROUTH, NC; UNISPLINT CORP, BUFORD, GA - 483S, 1/1-31/12 MELALEUCA INC, KNOXVILLE, TN; CROWN LAVORATORIES INC (DBA DEL-RAY DERMATOLOGICALS), JOHNSON CITY, TN; NIDEK MEDICAL PORDUCTS INC, BIRMINGHAM, AL 483S, 3/1-31/12 CAS NO. 58-08-2, CAFFEINE FOOD ADDITIVES, DIETARY SUPPLEMENTS ETC - REGULATORY STATUS, USES, SAFETY RECS ETC MERCK & CO INC - GARDASIL BLA #125126, HUMAN PAPILLOMAVIRUS QUADRIVALENT (TYPES 6M 11M 16, 18), VAERS REQUIREMENTS & REPORTS, ETC ALLURE COSMETICS, HAYWARD, CA - CAERS, CMPLNTS, RESPS 1/1/12 TO 4/1/12 DERMAQUEST INC, HAYWARD, CA - AERS, CMPLNTS, RESPS, 1/1/12 TO 4/1/12 Signature/ Requester Subject
2012-4236
06/14/2012 07/13/2012
ANEET PANESAR BURDOCK GROUP
2012-4237
06/14/2012 07/13/2012
CHRISTINA CIAMPOLILLO CONWAY, HOMER ET AL
2012-4238 2012-4239
06/14/2012 07/13/2012 06/14/2012 07/13/2012
FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OF/CFSAN/OCD/EOS/ ORA/P-FO/SAN-DO/SFCB/
LEIANN LAIKS FUSION LAW GROUP LEIANN LAIKS FUSION LAW GROUP
2012-4240
06/14/2012 07/13/2012
ELIZABETH BARBEHENN PUBLIC CITIZEN
ISRS #'S 7793203, 7793223, 782229 ETC
2012-4241
06/14/2012 07/13/2012
CVM/OCD/
KRISTI O SMEDLEY Center for Regulatory Services, Inc.
RICHMOND CHEMICAL COMPANY - BIOENGINEERED YEAST-WITH GLUCOAMYLASE SUBMISSIONS, CORR, RESPS ETC PETA & INGRID NEWKIRK - RECS, RPTS, CORR ETC
2012-4242
06/14/2012
JEFFREY S KERR
Page 1123 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/13/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4243 2012-4244 06/14/2012 07/13/2012 06/15/2012 07/16/2012 2012-4245 2012-4246 2012-4247 2012-4248 06/15/2012 07/16/2012 06/15/2012 07/16/2012 06/15/2012 07/16/2012 06/15/2012 07/16/2012 2012-4249 06/15/2012 07/16/2012 2012-4250 2012-4251 2012-4252 2012-4253 2012-4254 06/15/2012 07/16/2012 06/15/2012 07/16/2012 06/15/2012 07/16/2012 06/15/2012 07/16/2012 06/15/2012 07/16/2012 2012-4255 06/15/2012 07/16/2012 2012-4256 06/15/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FOI SERVICES INC LISA TARRISON-SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC WILLIAM A OLSON Center for Regulatory Services, Inc. KEN REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/14-5/18/12 FOI DAILY LOG 5/14-18/12 FOI DAILY LOG 5/14-18/12 FOI DAILY LOG 5/14-18/12 FOI DAILY LOG 5/14-18/12 FOI DAILY LOG 5/14-18/12 ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ OC/OM/OMP/DDM/ PAUL B CALLAHAN CHARLES RIVER LABS MERLE ZIMMERMANN AMERICAN HERBAL PRODUCTS ASSOCIATION TISA TARRISON-SCHRAMP CanReg, Inc. BARBARA JONES DOMINION GROUP INC WILLIAM A OLSON Center for Regulatory Services, Inc. KEN REID WASHINGTON INFORMATION SOURCE DEBI COHEN WOLTERS KLUWER LAW & BUSINESS FOI DAILY LOG 5/21-25/12 FOI DAILY LOG 5/21-25/12 FOI DAILY LOG 5/21-25/12 FOI DAILY LOG 5/21-25/12 FOI DAILY LOG 5/21-25/12 FOI DAILY LOG 5/21-25/12 ISIC SERVICES LLC, SAN CARLOS, CA - EIR, 3-22-11 TO 47-11 DKT FDA-1995-S-0039 Signature/ Requester FEDERAL BUREAU OF INVESTIGATION, DEPARTMENT OF JUSTICE Subject
Page 1124 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/16/2012 2012-4257 06/15/2012 07/16/2012 2012-4258 2012-4259 06/15/2012 07/16/2012 06/15/2012 07/16/2012 2012-4260 06/15/2012 07/16/2012 ORA/CE-FO/MIN-DO/MCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SW-FO/KAN-DO/COMP/ Action Office OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ Signature/ Requester FOI SERVICES INC JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS MEDIAGNOST GMBH, REUTLINGEN, GERMANY; ITEM INDUSTRIES LTD, SHENZHEN, GUANGDONG, CHINA; COPAN ITALIA, BRESCIA, ITALY, ETC - 483S 1/1-31/12 HOSPIRA INC, MEPHERSON, KS; NOVARTIS CONSUMER HEALTH, LINCOLN, NE - 483S 1/1-31/12 3M DRUG DELIVERY SYSTEMS, NORTHRIDGE, CA; LEE PHARMACEUTICALS INC, SOUTH EL MONTE, CA; NUTRI GRANULATIONS, LA MIRADA, CA, ETC - 483S 1/1-31/12 ROCKLINE INUDSTRIES INC, SHEBOYGAN, WI; NATIONAL CREATIVE ENTERPRISE INC, BURNSVILLE, MN; AD-TECH MEDICAL INSTRUMENT CORP, RACINE, WI, ETC - 483S 1/131/12 SHIRE HUMAN GENETICS THERAPIES INC, CAMBRIDGE, MA; EXEMPLAR PHARMACEUTICALS LLC, FALL RIVER, MA; IMMUNEX RHODE ISLAND CORP, WEST GREENWICH, RI, ETC - 483S 1/1-31/12 MYCONE DENTAL SUPPLY CO INC, CHERRY HILL, NJ; CASE MEDICAL, SOUTH HACKENSACK, NJ; GLAXOSMITHKLLINE CONSUMER HEALTHCARE LP, CLIFTON, NJ, ETC - 483S 1/1-31/112 AMCOL HEALTH & BEAUTY SOLUTIONS INC, LAFAYETTE, LA; TITERTEK INSTRUMENTS INC, HUNTSVILLE, AL; LEISURE PRODUCTS INC, KINGSPORT, TN, ETC INVAGEN PHARMACEUTICALS INC, HAUPPAUGE, NY; ARCH CHEMICALS, ROCHESRER, NY; CONTRACT PHARMACAL CORP, HAUPPAGE, NY, ETC - 483S 1/1-31/12 BIO DATA CORP, HORSHAM, PA; ZOLL LIFECOR CORP, PITTSBURGH, PA; CUSTOM ULTRASONICS INC, IVYLAND, PA - 483S 1/1-31/12 LIBBY LABORATORIES INC, BERKELEY, CA; CELERA CORP, ALAMEDA, CA; CEPHEID, SUNNYVALE, CA, ETC - 483S 1/131/12 483S ISSUES FROM 1/12 TO 6/12/12 EUROGENTEC SA, SERAING, BELGIUM - EIR Subject
2012-4261
06/15/2012 07/16/2012
2012-4262
06/15/2012 07/16/2012
2012-4263
06/15/2012 07/16/2012
ORA/SE-FO/NOL-DO/NOCB/ ORA/SE-FO/NOL-DO/NOCB/ ORA/NE-FO/NYK-DO/NYDCB/
2012-4264
06/15/2012 07/16/2012
2012-4265
06/15/2012 07/16/2012
2012-4266
06/15/2012 07/16/2012
2012-4267 2012-4268
06/15/2012 07/16/2012 06/15/2012 07/16/2012
ORA/ORM/ ORA/ORM/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/
TONY CHEN FDAZILLA PAUL B. CALLAHAN CHARLES RIVER LABS
Page 1125 of 1132

Total Records: 12455 Control # 2012-4269 Recd Date / Due Date 06/15/2012 07/16/2012 2012-4270 06/15/2012 07/16/2012 2012-4271 06/15/2012 07/16/2012 2012-4272 2012-4273 06/15/2012 07/16/2012 06/15/2012 07/16/2012 2012-4274 06/15/2012 07/16/2012 2012-4275 2012-4276 06/15/2012 07/16/2012 06/15/2012 07/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4277 2012-4278 06/15/2012 07/16/2012 06/15/2012 07/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4279 06/15/2012 07/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4280 06/15/2012 07/16/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ PAMELA SHEPPARD TARO PHARMACEUTICALS USA INC ALLERGAN - TAZAROTENE (TAZORAC) MEDICAL RVW, CHEMISTRY RVW, LBLG PAMELA SHEPPARD TARO PHARMACEUTICALS USA INC ALLERGAN - TAZAROTENE (TAZORAC) MEDICAL RVW, CHEMISTRY RVW, LBLG ORA/P-FO/SEA-DO/SCB/ JOHNATHAN RICKMAN FDA NEWS PAMELA SHEPPARD TARO PHARMACEUTICALS USA INC ALLERGAN - TAZAROTENE (TAZORAC) MEDICAL RVW, CHEMISTRY RVW, LBLG SAGEMAX BIOCERAMICS INC, AUBURN, WA - 483 1/1-31/12 ORA/SW-FO/DEN-DO/COMP/ ORA/CE-FO/DET-DO/DCB/ ORA/SE-FO/FLA-DO/FCB/ CBER/OCTMA/DDOM/ALFB/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ Action Office ORA/ORM/ ORA/ORM/ FDA/OF/CFSAN/OCD/EOS/ IOVATE HEALTH SCIENCES INTERNATIONAL INC BARRETT W. STETSON LAW FIRM OF BARRETT W STETSON AMIR PELED ALPHA BIO TEC LTD JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS BIOMATERIALS COMPANIES THAT PRODUCE DENTAL PRODUCTS APRVD BY FDA MEDOP INC, OLDSMAR, FL; CERAGROUP INDUSTRIES INC, FORT LAUDERDALE, FL; CHAMCO INC, COCOA, FL - 483 1/1-31/12 APPLIED LABS INC, COLUMBUS, IN; ROYAL OAK MEDICAL DEVICES LLC, OXFORD, MI; ACUMEDIA MANUFACTURERS INC, LANSING, MI - 483 1/1-31/12 AMGEN INC, LONGMONT, CO; AMGEN INC, BOULDER, CO; FMC CORP, GREEN RIVER, WY - 483 1/1-31/12 ESTEVE HUAYI PHARMS CO LTD, SHAOXING, CHINA; SANDOZ PRIVATE LTD, NAVI MUMBAI, INDIA; SA AJINOMOTO OMNICHEN NV, LOUVAIN LA NEUVE, BELGIUM - 483 1/1-31/12 INDIVIDUAL RECS Signature/ Requester GAIL LESSICK LACHMAN CONSULTANT SERVICES INC CAERS 150166, 150606 Subject ALL DOMESTIC & FOREIGN INSP 4/1-30/12
Page 1126 of 1132

Total Records: 12455 Control # Recd Date / Due Date Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4281 2012-4282 2012-4283 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 2012-4284 2012-4285 2012-4286 2012-4287 2012-4288 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 2012-4289 2012-4290 2012-4291 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 ORA/OCI/ ORA/OCI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4292 2012-4293 06/18/2012 07/17/2012 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ ORA/P-FO/LOS-DO/LACB/ Jonathan Siegel Kingdon Capital Management Angelia Slayton INC RESEARCH McGuff Pharmaceuticals, Inc., Santa Ana, CA - 483s, EIRs, Pre-approval inspections (08/01/2011 - 06/15/2012) Remicade (infliximab) - BLA 103772 S 5129 Doe J Francis Ginah GILEAD SCIENCES INC LETAIRIS (ambrisentan) - Approval letter (certified) FDA/OF/CFSAN/OCD/EOS/ CBER/OCTMA/DDOM/ALFB/ MYER Services d/b/a MSI Detective Servic Richard M. Niles MARSHALL UNIVERSITY Investigatory Records FAP4A4754 FDA/OF/CFSAN/OCD/EOS/ ORA/SW-FO/DALDO/COMPLIANCE/ FDA/OMPT/CDRH/OCER/DFOI/ CBER/OCTMA/DDOM/ALFB/ Ogden & Sulllivan, P.A. Leigh Turner Leigh Turner Erich J Weidenbener, MD Erich J. Weidenbener, MD Richard Hudson Baerlocher USA LLC Dr. Alan Buchman, Chicago, IL - Reports FCN 204 InVivo Therapeutics - Meeting Minutes, etc. FDA/OO/OFBA/OAGS/ FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDRH/OCER/DFOI/ Bret Andre EyeReg Consulting Inc. Noe M. Rivera Covidien- Product Monitorig Veronica Jenkins Healthy And Happy America (HAHA) Corpora Equetro - AERs; Influenza Vaccines and Stephens Johnson Syndrome - AERs Celltex Therapeutics - 483 (04/01/2011 - 06/13/2012) FDA-SOL-12-1104293 MW5024199, MW5024200 K050157 Signature/ Requester Subject
Page 1127 of 1132

Total Records: 12455 Control # 2012-4294 Recd Date / Due Date 06/18/2012 07/17/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4295 2012-4296 2012-4297 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4298 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4299 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4300 2012-4301 2012-4302 2012-4303 2012-4304 2012-4305 2012-4306 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 FDA/OMPT/CDRH/OCER/DFOI/ ORA/CE-FO/DET-DO/DCB/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/SE-FO/ATL-DO/ACB/ Jeanne Hathaway Jeanne Hathaway Leslie S. Harris, Paralegal Campiche Blue Arnold PLLC Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) 2012-3502 2012-3263 2012-1269 2012-2213 Trident Hemispherical Acebutular Shell 54 MM E - Corr, Warnings, Recalls, etc. 2012-987 Burt's Bees - 483 (2012) Angelia Slayton INC RESEARCH A copy or list of all approved products that went through the 505 b2 application process from 2005 to the present. Dr. Johan Haggblad Pharmalink AB NDA 20-954 (Busulfex) - Toxicology Study dinicola, victor j Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Cellcept - AERs FOI DAILY LOG 6/11-15/2012 FOI DAILY LOG 6/4-8/2012 JEFFERIES & CO Signature/ Requester Subject Coritcotropin (ANDA 088772)- Labeling, etc.
Page 1128 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/17/2012 2012-4307 2012-4308 2012-4309 2012-4310 2012-4311 2012-4312 2012-4313 2012-4314 2012-4315 2012-4316 2012-4317 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4318 2012-4319 06/18/2012 07/17/2012 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ OC/OCC/ 2012-4320 06/18/2012 ORA/CE-FO/PHI-DO/PCB/ SEAN HIGGINS ESQ EXCLUSIVE SUPPLEMENTS INC, FAHRENHEIT NUTRITION, FDA/OMPT/CDRH/OCER/DFOI/ Joe Landolina Joseph Landolina LISA HANSEN AM LEGAL SERVICES INC KV PHARMS MTG - RECS 5/18/12 K112215, K010933, K072681 etc. CAPSUGEL Signature/ Requester MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. Joan Stitt (UG2CD-16) MERCK & CO., INC. C.I. Farmacapsulas S.A. - Response to WL issued 5/15/12 2012-2986 2012-733 2012-2813 2012-3217 2012-968 2012-3630 2012-2670 2012-2674 2011-9353 2012-3063 Subject
Page 1129 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/17/2012 Action Office ORA/SE-FO/FLA-DO/FCB/ ORA/SW-FO/DALDO/COMPLIANCE/ ORA/SW-FO/DEN-DO/COMP/ 2012-4321 2012-4322 06/18/2012 07/17/2012 06/18/2012 07/17/2012 CVM/OCD/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4323 2012-4324 2012-4325 2012-4326 2012-4327 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4328 06/18/2012 07/17/2012 2012-4329 2012-4330 2012-4331 2012-4332 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ DEBI COHEN WOLTERS KLUWER LAW & BUSINESS ALVIN J LORMAN ALVIN J LORMAN LAW OFC LISA TARRISON-SCHRAMP CanReg, Inc. DAVID MCFARLAND FDA WEBVIEW/FERDIC INC LAUREN S BARR JH BARR & ASSOCIATES LLC CLOSED FOIA REQUESTS 6/4-8/12 CLOSED FOIA REQUESTS 6/4-8/12 CLOSED FOIA REQUESTS 6/4-8/12 2,2-DIMETHYLOLPROPIOIC ACID - FCN 1061 CLOSED FOIA REQUESTS 6/4-8/12 FRATTI, JOHN ORA/ORM/ ORA/ORM/ ORA/ORM/ ORA/ORM/ OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ ORA/P-FO/LOS-DO/LACB/ JOHNATHAN RICKMAN FDA NEWS JOHNATHAN RICKMAN FDA NEWS LAUREN S BARR JH BARR & ASSOCIATES LLC BRENDA M GARTZ ELI LILLY & CO DR KAREN WEISS, JOHNSON & JOHNSON - EMAILS, LTRS, CONFLICT OF INTEREST STATEMENTS, ETC BACHEM INC, TORRANCE, CA - EIR 6/1411 PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFRS, ETC IN & OUTSIDE THE US - 483S 5/1-31/12 PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFRS, ETC IN & OUTSIDE THE US - 483S 4/1-30/12 CLOSED FOIA REQUESTS 5/28/12-6/1/12 ORA/NE-FO/NWE-DO/NWECB/ DAVID LOHMAN SANESA PARTNERS JIM FAUCETT NORTHWEST CLINICAL RESEARCH CTR EXAMPLAR PHARMS, FALL RIVER, MA - 483S, WARNING LTRS. UNTITLED LTRS, ETC 1/11 TO PRESENT KETASET VERTIRNARY FORMULATIONS NADA 043-304, VETALAR 045-290,; KETALAR FOR HUMANS NDA 16-812, ETC - SUMMARY RPTS Signature/ Requester ANDREWS & THORNTON Subject MUSCLE WARFARE INC, ETC - RESP TO DMAA WARNING LTR 2/24/12
Page 1130 of 1132

Total Records: 12455 Control # 2012-4333 2012-4334 2012-4335 2012-4336 Recd Date / Due Date 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4337 2012-4338 2012-4339 2012-4340 2012-4341 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC Lisa Erwin OFFICE OF THE ATTORNEY GENERAL FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ORA/NE-FO/NWE-DO/NWECB/ Yale New Haven Hospital ACON LABORATORIES INC - CALL VIVID BLOOD GLUCOSE MONITORING SYS K112653 BIONIME CORP - RIGHTEST BLOOD GLUCOSE MONITORING SYS GM700 K110737 Date Range: 07/01/2011 - 09/30/2011; All records, especially transcripts and notes, from and pertaining to the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting that took place on September 8-9, 2011. See: https://www.federalregister.gov/articles/2011/07/14/201117695/obstetrics-and-gynecology-devices-panel-of-themedical-devices-advisory-committee-notice-of-meeting; HEMORRHOLD LIGATOR K963166 - CLNCL RECS FREUND MEDICAL PRODUCTS, DAYTON, OH - K863427 FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC ANDON MEDICAL CO - AG-608N SINGLE & MULTI BLOOD GLUCOSE MONITORING SYS K110017 Individual Records FOI SERVICES INC FDA/OF/CFSAN/OCD/EOS/ Action Office OM/OSS/OPILS/DFI/ OM/OSS/OPILS/DFI/ FDA/OF/CFSAN/OCD/EOS/ FOI SERVICES INC ALVIN J LORMAN ALVIN J LORMAN LAW OFC ALVIN J LORMAN ALVIN J LORMAN LAW OFC UCB INC - NEUPRO (ROTIGOTINE) NDA 21-829/S2 APRVL RECS ISOPHORONE DISOCYANATE - FCN 1060 ACRYLIC RESINS - FCN 1130 Signature/ Requester Subject CLOSED FOIA REQUESTS 6/4-8/12
2012-4342 2012-4343
06/18/2012 07/17/2012 06/18/2012 07/17/2012
DAVID CHOTENOVSKY CRH MEDICAL CORP BETH HAMLETT ADVANCED VASCULAR DYNAMICS
2012-4344
06/18/2012 07/17/2012
RITU BARAL CANACCORDGENUITY
NISSHIN PHARMA PRODUCTION PLANT, JAPAN - 483S 2/12
2012-4345
06/18/2012
CANCICE DURRENCE
OPTIMER PHARMACEUTICALS INC - DIFICID (FIDAXOMICIN) TABS NDA 20-1699 ISRS 7985701
Page 1131 of 1132

Total Records: 12455 Control # Recd Date / Due Date 07/17/2012 Action Office FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4346 06/18/2012 07/17/2012 FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ 2012-4347 06/18/2012 07/17/2012 2012-4348 2012-4349 06/18/2012 07/17/2012 06/18/2012 07/17/2012 2012-4350 06/18/2012 07/17/2012 FDA/OF/CFSAN/OCD/EOS/ FDA/OMPT/CDRH/OCER/DFOI/ OC/OCC/ ORA/NE-FO/NWE-DO/NWECB/ 2012-4351 06/18/2012 07/17/2012 2012-4352 2012-4353 2012-4354 06/18/2012 07/17/2012 06/18/2012 07/17/2012 06/18/2012 07/17/2012 OM/OMP/DODM/ JENNIFER HSIEH OM/OMP/DODM/ ORA/CE-FO/DET-DO/DCB/ FDA/OMPT/CDRH/OCER/DFOI/ FOI SERVICES INC BRENDA M GARTZ ELI LILLY & CO MAHMOUD AYESH Zx Pharma, LLC DRUG APRVLS & CLNCL TRIALS - TRANS 5/22/12 DKT 1995S-0039 TIANJIN EMPECS MEDICAL DEVICE CO - MEDISIGN BLOOD GLUCOSE MONITORING SYS, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYS K111456 JHP PHARMS, ROCHESTER, MI - EIRS 6/8/11 North Run Capital, LP ORA/NE-FO/NYK-DO/NYDCB/ ORA/P-FO/LOS-DO/LACB/ ORA/SE-FO/ATL-DO/ACB/ ORA/P-FO/LOS-DO/LACB/ ORA/P-FO/SAN-DO/SFCB/ FDA/OF/CFSAN/OCD/EOS/ GENEVIERVE P RUPELLL CSK Labs ROBIN FELDMAN LSRO SOLUTIONS ATLAS POWDER CO - POLYSORBATE 60 (POLYOXYETHYLENE 20 SORBITAN MONOSTEARATE) FAP OAOO29 Abiomed Inc. Impella - Internal FDA emails GENENTECH INC, CA - 483S 3/1/07, 9/21/07, 10/29/07, ETC BRAD SCHONOHOFT GRIFOL, LOS ANGELES, CA, CLAYTON, NC, MELVILLE, NY EIRS, 483S 1/11 TO PRESENT RICHARD O WOOD WOOD BURDITT GROUP TOPICAL ANTISEPTIC SKIN PREPARATION PROD - COMM Signature/ Requester OPTIMER PHARMACEUTICALS INC Subject
Page 1132 of 1132

Responsive Documents - CREW: FDA: Regarding FOIA Logs: 6/19/2012 - CREWLog Response

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03/01/2011 03/29/2011 03/01/2011 03/29/2011

FDA/OMPT/CDRH/OCER/DFOI/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/ FDA/OMPT/CDER/ORP/DIDP/

03/01/2011 03/29/2011 03/01/2011 03/29/2011

FDA/OF/CFSAN/OCD/EOS/ CVM/OCD/ ORA/CE-FO/MIN-DO/MCB/ ORA/SW-FO/KAN-DO/COMP/ ORA/P-FO/LOS-DO/LACB/

2011-1577 2011-1578 2011-1579

03/01/2011 03/29/2011 03/01/2011 03/29/2011 03/01/2011 03/29/2011

TAMARA STIER ICON DEVELOPMENT SOLUTIONS

ALAN S MARION MD - EIRS LAST 5 YRS

03/01/2011 03/29/2011 03/01/2011

FDA/OF/CFSAN/OCD/EOS/ SMITH, WINFIELD E FDA/OMPT/CDER/ORP/DIDP/ GABRIEL B SHERMAN

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

K914972, K926138, K923367 ETC - APRVLS

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

2011-1696 2011-1697 2011-1698

03/04/2011 04/01/2011 03/04/2011 04/01/2011 03/04/2011 04/01/2011

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report

Monday June 18 2012 10:41 AM

Disclosure FOI Request Log Range from 03/01/2011 Report