FDA Investigator Inspection: India

ASIJIT SEN EMAIL: ASI.JIT.SEN@GMAIL.COM IN.LINKEDIN.COM/IN/ASIJITS

SOURCES: WWW.FDA.GOV

FDA Inspection

FDA inspects manufacturers or processors of FDA-regulated products to verify that they comply with relevant regulations. Those inspected include

Vaccine and drug manufacturers Blood banks Food processing facilities Dairy farms Animal feed processors Compounding pharmacies

FDA Inspection CONT

FDA also inspects

Facilities that conduct studies in people (clinical trials) Laboratories that conduct studies in animals or microorganisms when these studies are used to apply for FDA approval of a medical product Foreign manufacturing and processing sites for FDA-regulated products that are sold in the United States Imported products at the border

FDA conducts several types of inspections to help protect consumers from unsafe products
Pre-approval inspection after a company submits an application to FDA to market a new product Routine inspection of a regulated facility For-cause inspection to investigate a specific problem that has come to FDAs attention

FDA Inspection: India (2005 2012)

US FDA inspections started in India in 2005 A total of 40 site inspections conducted between 2005 2012 Inspections have been conducted for 11 therapeutic areas Maximum inspection in the field of Psychiatry 30% Maximum inspection in the city of Bangalore 23% All 40 inspections have been DA i.e. Data Audit. The focus in such audits is verification of study data Deficiency %
NAI (No Action Initiated) - 65% VAI (Voluntary Action Initiated) - 35% OAI (Official Action Initiated) 00%

Global Clinical Inspections by FDA: Year-wise & Action Taken

No Action Indicated Official Action Indicated Voluntary Action Indicated
# of Clinical Inspection by FDA

436 360 347

492

379

416

449

410

328

313

215

350

337 271

41 25 172 1996

56 145 1997

44 126 1998

41 161 1999

59 140 2000

52 25 116 2003 42 101 2004 155 2005

70 176

104

64

50 184

161 31 162 2010 13 138 2011

173 00 154 2012

108 1995

189

201

2006

2007

2008

2009

Year of inspection

Indian Clinical Inspections by FDA: Year-wise & Action Taken

No Action Indicated Voluntary Action Indicated Official Action Initiated
# of Clinical Inspection by FDA

4 2 0 2005 1 0 2006

5 1 1 3

6 4

2007

2008 2009 Year of inspection

2010

2011

2012

List of FDA Inspected Sites

No.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 Dr. M K Ramesh Dr. Sachidanand A Sarvajna Murthy Dr. Anil Abraham Dr. Sathianathan Ramanathan Dr. Nadukuru N Raju Dr. Prasad Rao Gundugurti Dr. Kenneth Tharayil Dr. Jitendra K Trivedi Dr. Sathianathan Ramanathan Dr. Sathianathan Ramanathan Dr. Ranjiv K Mahajan Dr. Chandrasekhar K Dr. Rupam Borgohain Dr. Mariappa Srinivasa Dr. Raghunadharao Digumarti Dr. Shamsher Dwivedee Dr. Yasmin R Bhagat Dr. Sripada Prasad V Dr. Nita Shanbhag Dr. Narayanan Pravda Dr. Bipin Kumar Sethi Dr. Anthony Mesquita Dr. K. T. Shenoy Dr. Matthew Thomas Dr. Sat Pal Garg Dr. Sanjay Reddy Dr. Anaita Udwadia Hegde Dr. Venu Gopal Jhanwar Dr. Srikanta Sathyanarayana Dr. Pradeep Sambarey Dr. Vyankatesh Shivane Krishnacharya Dr. Shalini Fusey Dr. Sreenivasa Murthy Dr. K Subramanian Krishna Kumar Dr. Bipin K Sethi Dr. Gulla Surya Prakash Dr. Bandgar Tushar Ramkrishna Dr. Sandeep K Gupta Dr. Anita Ramesh Dr. Umesh Jalihal

7
City
Bangalore Bangalore Bangalore Chennai Hyderabad Hyderabad Bangalore Lucknow Chennai Chennai Ludhiana Hyderabad Hyderabad Bangalore Hyderabad New Delhi Mumbai Hyderabad Mumbai Kerala Hyderabad Goa Trivandrum Kerala New Delhi Bangalore Mumbai Varanasi Bangalore Pune Mumbai Nagpur Bangalore Madurai Hyderabad Secundrabad Mumbai Lucknow Chennai Bangalore

Name

Therapeutic Area
Surgery Dermatology Dermatology Psychiatry Psychiatry Psychiatry Dermatology Psychiatry Psychiatry Psychiatry Psychiatry Psychiatry Neurology Psychiatry Oncology Psychiatry Ophthalmology Psychiatry Ophthalmology Ophthalmology Endocrinology TB & Chest Gastroenterology Dermatology Ophthalmology Endocrinology Neurology Psychiatry Endocrinology Obs & Gyn Diabetology Obs & Gyn Dermatology Oncology Endocrinology Obs & Gyn Diabetology Diabetology Oncology Gastroenterology Victoria Hospital Victoria Hospital St Johns Medical College Madras Medical College Government Hospital Mental Care Asha Hospital M S Ramaiah Medical College & Hospital

Location

Inspection Date
05-Sep-2005 05-Sep-2005 19-Jun-2006 16-Apr-2007 30-Apr-2007 05-Jul-2007 01-Aug-2007 04-Sep-2007 18-Feb-2008 29-Sep-2008 09-Jan-2009 19-Jan-2009 09-Jul-2009 09-Jul-2009 12-Aug-2009 31-Aug-2009 11-Sep-2009 12-Oct-2009 16-Nov-2009 14-Dec-2009 08-Feb-2010 04-May-2010 12-Jun-2010 12-Jun-2010 18-Oct-2010 29-Nov-2010 30-May-2011 02-Jul-2011 26-Aug-2011 29-Aug-2011 08-Sep-2011 09-Sep-2011 04-Feb-2012 04-Feb-2012 26-Mar-2012 21-May-2012 16-Jul-2012 01-Sep-2012 04-Sep-2012 09-Oct-2012

Classification
VAI2 VAI VAI NAI NAI NAI NAI VAI VAI NAI VAI NAI VAI VAI NAI VAI VAI NAI NAI NAI VAI NAI NAI VAI VAI NAI VAI NAI VAI NAI NAI NAI NAI NAI NAI NAI NAI VAI NAI VAI

Chhatrapati Shahuji Maharaj Medical University Madras Medical College Madras Medical College Dayanand Medical College & Hospital Asha Hospital Nizam's Institute Medical Sciences Spandana Nursing Home Nizam's Institute Medical Sciences VIMHANS St George Hospital Apollo Hospital Omkar Eye Care Centre Regional Institute of Ophthalmology Care Hospital TB & Chest Disease Hospital Sree Gokulam Medical College Kerala Institute of Medical Sciences R P Centre, AIIMS Bangalore Diabetes Hospital Jaslok Hospital & Research Centre Deva Mental Health Care Jnana Sanjeevini Medical Centre B. J. Medical College & Sassoon General Hospital Research Health Institute Government Medical College & Hospital Life Care Clinic & Research Centre Meenakshi Mission Hospital and Research Centre Care Hospital Care Hospital Research Health Institute in Diabetes M. V. Hospital & Research Centre Sri Ramachandra University M. S. Ramaiah Memorial Hospital

FDA Inspection in India: Year - Wise

10 8 6 6

2 1
2005 2006

2 1
2007 2008 2009 2010 2011 2012

FDA Inspection in India: Therapeutic - Wise

TB & Chest Surgery Neurology Gastroenterology Oncology Obs & Gyn Diabetology Ophthalmology Endocrinology Dermatology Psychiatry 1 1 2 2 3 3 3 4 4 5

12

FDA Inspection in India: Deficiency & Classification Codes - Wise

10

Clinical Investigator Inspection List (CIIL) Codes

Deficiency
No deficiencies noted Failure to obtain and/or document subject consent Inadequate drug accountability Failure to follow investigational plan Inadequate and inaccurate records Failure to notify IRB of changes, failure to submit progress reports Other n/a 21 CFR 312.60, 50.20, 50.27 21 CFR 312.60, 312.62 21 CFR 312.60 21 CFR 312.62 21 CFR 312.66 n/a

Code
00 02 04 05 06 15 18

CFR Reference

23

11 2
Code 00 Code 02

10 1 1
Code 18

5
Code 04 Code 05 Code 06

Code 15

Classification Codes:
NAI - No Action Indicated. VAI - Voluntary Action Indicated. VAI2 - No response requested. OAI - Official Action Indicated.

26

13 1 0

NAI

VAI

VAI2

OAI

FDA Inspections in India: City - wise

Trivnadrum Varanasi Goa Nagupur Ludhiana Secundrabad Pune Madurai Kerela New Delhi Lucknow Chennai Mumbai Hyderabad Bangalore
1 1 1 1 1 1 1 1 2 2 2 4 5 8

11