Inspection Observation FY18 (Final)

Number of 483 issued from the System*
Inspections ending between 10/1/2017 and 9/30/2018
Citation Program Area 483s Issued
Biologics 89
Bioresearch Monitoring 216
Devices 966
Drugs 716
Foods 2583
Human Tissue for Transplantation 97
Parts 1240 and 1250 70
Radiological Health 26
Veterinary Medicine 206
Sum Product Area 483s from System* 4969
Actual Total in System 483s** 4910
*This table does not represent the complete set of 483's issued
during the fiscal year as some 483's were manually prepared and
not available in this format. The sum of 483's for all Product Areas
will be greater than the actual Total 483's issued during the fiscal
year since a 483 may include citations related to multiple product
areas, and counted more than once, under each relevant product
center.
** This is the Actual Total number of 483's issued from this system,
and that are represented in this spreadsheet.
m*
of 483's issued
y prepared and
ll Product Areas
uring the fiscal
multiple product
elevant product
om this system,
heet.
Citation Program Area Cite Id Reference Number
Biologics 76 21 CFR 606.100(b)
Biologics 9225 21 CFR 606.171
Biologics 154 21 CFR 606.160(a)(1)
Biologics 9089 21 CFR 600.14(c)
Biologics 67 21 CFR 606.65(e)
Biologics 41 21 CFR 606.40(a)(1)
Biologics 18093 21 CFR 630.10(g)(1)
Biologics 114 21 CFR 606.121(c)(1)
Biologics 123 21 CFR 606.121(c)(4)(i)
Biologics 18134 21 CFR 640.21(g)
Biologics 57 21 CFR 606.60(a)
Biologics 160 21 CFR 606.160(a)(1)

Biologics 224 21 CFR 640.4(f)
Biologics 12202 21 CFR 606.170(a)

Biologics 12203 21 CFR 606.170(a)
Biologics 15079 21 CFR 606.121(c)(11)
Biologics 18038 21 CFR 606.100(b)
Biologics 18067 21 CFR 630.5(d)
Biologics 80 21 CFR 606.100(b)(1)
Biologics 84 21 CFR 606.100(b)(5)
Biologics 93 21 CFR 606.100(b)(14)
Biologics 94 21 CFR 606.100(b)(15)

Biologics 121 21 CFR 606.121(c)(2)
Biologics 158 21 CFR 606.160(e)(1)

Biologics 159 21 CFR 606.160(a)(1)
Biologics 161 21 CFR 606.160(a)(2)
Biologics 338 21 CFR 640.65(b)(2)(i)
Biologics 368 21 CFR 640.72(d)

Biologics 9086 21 CFR 600.14(a)(1)
Biologics 9270 21 CFR 610.40(h)(2)(ii)
Biologics 9315 21 CFR 640.65(b)(3)

Biologics 15080 21 CFR 606.121(c)(12)
Biologics 18039 21 CFR 606.100(b)(22)
Biologics 18040 21 CFR 606.160(e)(2)
Biologics 18044 21 CFR 610.40(a)(2)
Biologics 18049 21 CFR 606.145(b)
Biologics 18077 21 CFR 630.10(d)(2)
Biologics 18081 21 CFR 630.10(e)(1)
Biologics 18087 21 CFR 630.10(f)(3)(i)(B)
Biologics 18094 21 CFR 630.10(g)(2)
Biologics 18096 21 CFR 630.10(g)(2)(ii)
Biologics 18104 21 CFR 630.15(b)(1)(ii)
Biologics 18105 21 CFR 630.15(b)(2)
Biologics 18107 21 CFR 630.15(b)(2)(iii)

Short Description
Establish, maintain and follow manufacturing SOPs
Biological product deviation report
Concurrent documentation
When to report
Following manufacturer's instructions
Thorough investigations
Required records
Provide space for examination
Prevention of contamination
Proof Of Identity
Proper name of product
Expiration date
Blood & Blood Components
Informed consent
Maintain and clean equipment
Procedures to maintain records of emergency

transfusions
Person performing, test results, interpretation

Arm preparation
Quality control
Equipment observed, standardized, calibrated
Notification
Adverse Reaction - Investigations

Adverse Reaction- Reports of Investigations
Lookback System [Collecting Establishment]
Required labeling information - manufacturing use
SOPs for investigations, records
Emergency medical services
Educational Material
Provide space for storage of blood & blood products
Provide space for quarantine of unsuitable for use items
Provide proper equipment to meet requirements
Safe, sanitary, orderly storage
Record review prior to release
Donor criteria
Accurate measurement of quantity of blood
QC procedures for supplies and reagents
Schedules and procedures for equipment & calibration
Center approval for collection of rare antibodies

Name, address, unique facility identifier
Adequate identification and handling of test samples
Donor deferral record - each location

Legibility and indelibility
Determination of lot numbers and supplies
General requirements - storage
General requirements - inspection
Storage temps./agitation
Reporting of fatal donor reactions
Physician review of four month sample
Donor reaction
Notification to and approval from CBER
Maintenance - concurrence
Maintenance - tracing
Who must report - manufacturer
Review of Adverse Experiences - promptness
Review of Adverse Experiences - SOPs
Documentation
Donor Deferral
One or more approved screening tests
Labeling of reactive units, units from deferred donors
Donor identification
Package label - small containers

Equipment calibration frequency
Lookback System [Consignee]
Labeling; test results for rel transmitted infections
Control risk of bacterial contamination of platelets
Cumulative deferral record HIV, HBV, HCV
Test for HTLV, syphilis, West Nile, Chagas
Release of contaminated product
Donation interval
Medical Assessment Factors
Hemoglobin or Hematocrit for male allogeneic donor
Donor's Acknowledgment
Donor's Acknowledgment - Exculpatory language
Donor deferral if at risk from procedure
Informed consent
Donor consent clear

Long Description
Written standard operating procedures including all steps to be followed in the [collection] [processing]
[compatibility testing] [storage] [distribution] of blood and blood components for [allogeneic transfusion]
[autologous transfusion] [further manufacturing purposes] were not always [established] [maintained]
[followed] [available to personnel in the areas where procedures were performed]. Specifically, ***
Failure to submit a biological product deviation report [within 45 days from the date you acquired
information suggesting that a reportable event occurred]. Specifically, ***
Records are not concurrently maintained with the performance of each significant step in the [collection]
[processing] [compatibility testing] [storage] [distribution] of each unit of blood and blood components so
that all steps can be clearly traced. Specifically, ***
Biological product deviations [were] [are] not reported within the 45 calendar day timeframe. Specifically,
***
Failure to use supplies and reagents in a manner consistent with instructions provided by the
manufacturer. Specifically, ***
Failure to [perform a thorough investigation] [make a record of the conclusions and follow-up] of [an
unexplained discrepancy] [a failure of a lot or unit to meet any of its specifications].
Specifically,***_x000D_
_x000D_
Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control]
[general] records. Specifically, ***
Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their
eligibility as blood donors. Specifically, ***_x000D_
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
blood. Specifically, ***
Failure to obtain from the donor on the day of donation [proof of identity] [a postal address where the
donor may be contacted for 8 weeks after donation]. Specifically, ***
The container label fails to include the [proper name] [modifier(s)] [attribute(s)] of the product in a
prominent position. Specifically, ***
The container label fails to include the [expiration date, including the day, month, and year] [hour of
expiration, for product less than 72 hours expiration, including product prepared in a system that might
compromise sterility]. Specifically, ***
Failure to maintain temperatures during shipment of [Fresh Frozen Plasma at -18 ?C or colder]
[Cryoprecipitated AHF at -18 ?C or colder] [Liquid Plasma at 1 to 10 ?C] [Plasma at -18 ?C or colder]
[Platelets as close as possible to the labeled range] [Platelet Rich Plasma as close as possible to the
labeled range] [Red Blood Cells between 1 and 10 ?C] [Red Blood Cells, Frozen at -65 ?C or colder]
[Source Plasma at -5 ?C or colder] [Source Plasma Liquid at 10 ?C or colder] [Whole Blood as required].
Specifically, ***
Failure of the responsible physician to [obtain the informed consent of a plateletpheresis donor on the
first day of donation and at subsequent intervals of no longer than 1 year] [explain the risks and hazards
of the procedure to the donor] [explain the risks and hazards in a manner that the donor may give
consent and had a clear opportunity to refuse]. Specifically, ***
Failure to [maintain] [locate] equipment used in the [collection] [processing] [compatibility testing]
[storage] [distribution] of blood and blood products [in a clean and orderly manner] [so as to facilitate
cleaning and maintenance]. Specifically, ***
Records [including signature by the physician requesting the procedure] are not maintained of all
emergency transfusions [including complete documentation justifying the emergency action]. Specifically,
***
Records fail to [identify the person performing the work] [include dates of the various entries] [show test
results] [include interpretation of the results] [show the expiration date assigned to specific products] [be
as detailed as necessary] so as to provide a complete history of the work performed. Specifically, ***
The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of
Whole Blood. Specifically, ***
Failure to test each month (of manufacture) four units prepared from different donors at the end of the
storage period for [platelet count] [pH of not less than 6.0 measured at the storage temperature of the
unit] [actual plasma volume]. Specifically, ***
Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood
and blood components is not [observed] [standardized] [calibrated] on a regularly scheduled basis as
prescribed in the SOP Manual. Specifically, ***
Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of
tests for evidence of infection with a relevant transfusion-transmitted infection(s)] [deferred because their
donated platelets have been determined to be contaminated with an organism likely to be associated with
a bacterial infection that is endogenous to the bloodstream of the donor] [determined not be to eligible as
a donor based on eligibility criteria]. Specifically, ***
A thorough investigation of each reported adverse reaction was not made. Specifically,
Written reports of investigations of adverse reactions, including conclusions and follow up, are not
prepared and maintained. Specifically,
Failure to [establish] [maintain] [follow] an appropriate system for HCV "lookback." Specifically, ***
For products intended for further manufacturing use, the container label failed to contain a statement
listing the results of all tests for relevant transfusion-transmitted infections required under the regulations
found to be negative. Specifically, ***
Written standard operating procedures for all steps in [the investigation of product deviations under the
regulations] [recordkeeping related to current good manufacturing practice and other applicable
requirements and standards] were not [established] [maintained] [followed] [available to personnel in the
areas where procedures were performed]. Specifically, ***
Failure to [establish] [maintain] [follow] standard operating procedures for obtaining rapid emergency
medical services for donors when medically necessary. Specifically, ***
Failure to provide educational material concerning relevant transfusion-transmitted infections to the donor
before donation. Specifically, ***
Failure to provide adequate space for the storage of blood or blood components pending completion of
tests. Specifically, ***
Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and
[reagents] not suitable for use. Specifically, ***
Failure of equipment to perform in the manner for which it was designed so as to assure compliance with
the official requirements prescribed in 21 CFR 606. Specifically, ***
Failure to store all supplies and reagents used in the [collection] [processing] [compatibility testing]
[storage] [distribution] of blood and blood components in a safe, sanitary and orderly manner.
Specifically, ***
All records pertinent to a lot or unit were not reviewed before the release or distribution of a lot or unit of
final product. Specifically, ***
The standard operating procedures failed to include written descriptions of criteria used to determine
donor eligibility. Specifically, ***_x000D_
The standard operating procedure fails to include a written description of the blood collection procedure,
including in-process precautions taken to measure accurately the quantity of blood removed from the
donor. Specifically, ***
The standard operating procedure fails to include a written description of the quality control procedures
for supplies and reagents employed in [blood collection] [processing] [pretransfusion testing].
Specifically, ***
The standard operating procedure fails to include a written description of schedules and procedures for
equipment maintenance and calibration. Specifically, ***
The plasmapheresis of donor(s) whose blood contained rare antibodies but did not meet the donor
requirements for [donor eligibility] [collection] [plasmapheresis] was performed without the prior approval
of the Director, Center for Biologics Evaluation and Research. Specifically, ***
The container label fails to include the [name] [address] [unique facility identifier] [license number of each
manufacturer, for a licensed product]. Specifically, ***
Failure to adequately provide for identification and handling of all test samples so that they are accurately
related [to the specific unit of product being tested] [to its donor] [to the specific recipient]. Specifically, ***
Failure to maintain at each location a record of all donors found to be ineligible or deferred at that location
so that products from such donors are not collected and/or released. Specifically, ***
Records are [illegible] [not indelible]. Specifically, ***
Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for
specific [lots] [units] of the final product. Specifically, ***
Failure to [store] [maintain] the Red Blood Cells between 1 and 6 degrees Celsius immediately after
processing. Specifically, ***
Failure to [inspect Red Blood Cells immediately after separation of the plasma, periodically during
storage, and at the time of issue] [prevent issuance if Red Blood Cells are abnormal in color, physical
appearance, or indicative of microbial contamination]. Specifically, ***
Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous
gentle agitation] [at 1 to 6 degrees Celsius]. Specifically, ***
Failure to report as soon as possible a fatal donor reaction associated in any way with plasmapheresis to
the Center for Biologics Evaluation and Research. Specifically, ***
Failure of the responsible physician to [review] [sign] the [accumulated laboratory data, including plasma
or serum protein electrophoresis data] [collection records] within 14 days after the sample was drawn.
Specifically, ***
Failure of the donor record to contain a full explanation of a donor reaction, while on the plasmapheresis
premises or reported to the center after the donor has left the premises, including the measures taken to
assist the donor and the outcome of the incident. Specifically, ***
Failure to request from CBER and obtain approval for exceptions or alternatives to requirements in
subchapter F of chapter I of 21 CFR. Specifically, ***
Records are not made [concurrently with the performance] of each step in the [manufacture] [distribution]
of products. Specifically, ***
Records are not maintained in a manner which allows steps in the [manufacture] [distribution] of product
to be traced. Specifically, ***
Failure to submit [a] biological deviation [report] [reports]. Specifically, ***
Adverse experience information [is] [was] not [promptly] reviewed. Specifically, ***
There are no written procedures for the [surveillance] [receipt] [evaluation] [reporting] of post-marketing
adverse experiences to FDA. Specifically, ***
Failure to [document that you have successfully notified a deferred donor] [document that you have made
reasonable attempts to notify a deferred donor]. Specifically, ***
Failure to defer a donor who tested reactive by a screening test for evidence of infection due to a relevant
transfusion-transmitted infection from future donations of human blood and blood components.
Specifically, ***
Blood and blood components intended for transfusion or for use in manufacturing a product were not
tested for evidence of infection due to relevant transfusion-transmitted infections [using one or more
screening tests that the FDA has licensed, approved, or cleared for such use] [in accordance with the
manufacturer's instructions]. Specifically, ***
Human blood or blood components [collected from a deferred donor] [which had a reactive screening test
for a relevant transfusion-transmitted infection] were [shipped] [used], but the product labeling did not
include the appropriate elements. Specifically, ***
Failure to establish a system that positively identifies each donor and relates such donor directly to his
[blood] [accumulated records and laboratory data]. Specifically, ***
The container label is not capable of bearing a full label, but the package label does not include [the
address and license number of the manufacturer] [the expiration date] [the statement, "Caution: Federal
law prohibits dispensing without prescription"] [the instructions regarding inclusion of a Medication Guide].
Specifically, ***
Equipment used in the [collection] [processing] [compatibility testing] [storage and distribution] of blood
and blood components is not observed, standardized and calibrated with at least the frequency required.
Specifically, ***
Failure to [establish] [maintain] [follow] an appropriate system for HIV lookback. Specifically, ***
The container label of blood and blood components failed to list the results of tests demonstrating
evidence of infection due to relevant transfusion-transmitted infections as required under the regulations.
Specifically, ***
The standard operating procedures fail to include a written description of the procedures to control the
risks of bacterial contamination of platelets. Specifically, ***
Failure to maintain at all locations operating under the same license or under common management a
cumulative record of donors deferred from donation under the regulations based on reactive testing for
evidence of infection due to HIV, HBV, or HCV. Specifically, ***
Failure to test each donation of blood and blood components intended for transfusion or for use in
manufacturing a product for evidence of infection with [HTLV] [syphilis] [West Nile virus] [Chagas
disease]. Specifically, ***
Failure to prevent the release for transfusion of [a platelet product identified as bacterially contaminated]
[any other component prepared from the same collection as a platelet product identified as bacterially
contaminated]. Specifically, ***
Failure to determine the eligibility of a donor by assuring the interval since the donor's last donation was
appropriate before collection. Specifically, ***
Medical history assessment failed to include factors that make the donor ineligible to donate because of
an increased risk for, or evidence of, a relevant transfusion-transmitted infection such as [behaviors
associated with a relevant transfusion-transmitted infection] [receipt of blood or blood components or
other medical treatments and procedures associated with possible exposure to a relevant transfusion-
transmitted infection] [signs and/or symptoms of a relevant transfusion-transmitted infection]
[institutionalization for 72 hours or more consecutively in the past 12 months in a correctional institution]
[intimate contact with risk for a relevant transfusion-transmitted infection] [nonsterile percutaneous
inoculation]. Specifically, ***
Failure to assure the donor safety and product potency for blood collected from a male allogeneic donor
based on a [hemoglobin level that is less than 13.0 grams of hemoglobin per deciliter of blood]
[hematocrit value that is less than 39 percent]. Specifically, ***
Failure to [provide donor acknowledgment information to the donor] [obtain the donor's documented
acknowledgement that the donor has reviewed the donor acknowledgment information] prior to each
donation. Specifically, ***
The donor acknowledgment [contained exculpatory language through which the donor is made to waive
or appear to waive any of the donor's legal rights] [did not address the donor's review of educational
material regarding relevant transfusion-transmitted infections] [did not address the donor's agreement to
not donate if the donation could result in a potential risk to recipients] [did not address that a sample of
the donor's blood will be tested for specified relevant transfusion-transmitted infections] [did not address
donations determined to be not suitable] [did not address the deferral of donors from donation] [did not
address the donor's record with identification of the donor as ineligible to donate] [did not address donor
notification of the basis for deferral and the period of deferral] [did not address donors receipt and review
of information regarding risks and hazards of the specific donation procedure] [did not address an
opportunity for the donor to ask question and withdraw from the donation procedure]. Specifically, ***
Failure to defer a donor from donation when the responsible physician determined the donor had medical
conditions that would place the donor at risk from plasmapheresis. Specifically, ***
Failure of the responsible physician to obtain the informed consent of a plasma donor [on the day of the
first donation or no more than 1 week before the first donation] [at intervals of no longer than 1 year] [who
did not return within 6 months of the last donation] [when the donor was enrolled in a new collection
program]. Specifically, ***
Failure of the responsible physician to explain the risks and hazards of the plasmapheresis procedure in
a manner that the donor [gave their consent] [had a clear opportunity to refuse the procedure].
Specifically, ***
Frequency
28
12
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
Bioresearch Monitoring 7560 21 CFR 312.60
Bioresearch Monitoring 7530 21 CFR 312.62(b)
Bioresearch Monitoring 7318 21 CFR 56.115(a)(2)
Bioresearch Monitoring 7526 21 CFR 312.62(a)
Bioresearch Monitoring 7290 21 CFR 56.108(c)
Bioresearch Monitoring 7278 21 CFR 56.107(e)
Bioresearch Monitoring 3931 21 CFR 58.35(b)(5)

Bioresearch Monitoring 3914 21 CFR 58.31(f)
Bioresearch Monitoring 7277 21 CFR 56.107(d)
Bioresearch Monitoring 7293 21 CFR 56.109(f)
Bioresearch Monitoring 7411 21 CFR 312.53(c)(1)

Bioresearch Monitoring 3978 21 CFR 58.90(g)

Bioresearch Monitoring 7369 21 CFR 56.109(h)

Bioresearch Monitoring 7554 21 CFR 312.53(c)(4)

Short Description
FD-1572, protocol compliance
Case history records- inadequate or inadequate
Minutes of IRB meetings
Accountability records
Consent form not approved/signed/dated
List of members
General responsibilities of sponsors
Initial and continuing reviews
Members present for review
Conflict of interest
Unanticipated problems
QAU: monitor facilities, etc.
QAU: authorize deviations from protocols or SOPs
Equipment: calibration
Consent not obtained, exceptions do not apply
Written procedures per 56.108(a) and (b)
Safety reports
Informed consent
Final report: circumstances affecting data qual., integrity
Copies of all research proposals and related documents
Method to keep members advised
Prompt reporting of noncompliance
Confidentiality, FDA inspection of records
Investigator non-compliance
Initial and continuing review
Unused drug disposition (investigator)
Approval from a majority of members present
Personnel: education, training, experience
Management: personnel understand their functions
Study director: all data recorded and verified
Study director: follow GLP regulations
QAU: separate and independent
Conduct: in accordance with protocol
Conduct: changes not obscuring original entries
One non-affiliate member
Continuing review
Reasonably foreseeable risks or discomforts
Investigator statement (FDA 1572)
Ensuring compliance with plan and protocol
Transfer of obligations
Record retention
Changes in research
Research not eligible for expedited review
Personnel: summary of training, job description
QAU: maintain a master schedule
QAU: inspect study at adequate intervals
QAU: review final study report
QAU: signed statement in final report
QAU: SOPs and required records
Facility: suitable size and construction
Facility: supply storage areas
Facility: archives
Equipment: inspection, cleaning and maintenance
Equipment: maintenance SOPs
Animal care: disease free animals at study start
Animal care: animal identification
Animal care: feed and water analysis records
Test article: reserve sample retention
Conduct: changes in automated data entries
Final report: objectives, procedures, changes
Final report: data on test and control articles
Final report: description of methods

Final report: dosage, regimen, route of admin., duration
Final report: operations on data, analysis of data
Final report: reports of individual scientists
Final report: statement by QAU
Procedures, identification of those which were

experimental
Short form: Oral presentation/signing
Prompt reporting of unanticipated problems
Minor changes
Approval by institution in absence of IRB approval
Records of continuing review
Informed consent sought
Monitoring of data collected
Vulnerable subject safeguards
Retention of records
Reporting of suspension/termination
Children as subjects
Reporting findings and actions to investigator/institution
Copy of consent form not provided
Monitoring investigations
New observations, adverse effects and risks
Records of unused drug disposition
Financial info
Final study report
Financial information - sufficient and accurate
Record retention requirement
Required label statement
Reporting
Risks minimized by using procedures already being

performed
Circumstances of obtaining consent

Long Description
An investigation was not conducted in accordance with the [signed statement of investigator]
[investigational plan]. Specifically, ***
Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data
pertinent to the investigation] [informed consent]. Specifically, ***_x000D_
Minutes of IRB meetings have not been [prepared] [maintained] in sufficient detail to show [attendance at
the meetings] [actions taken by the IRB] [the vote on actions, including the number of members voting for,
against and abstaining] [the basis for requiring changes in or disapproving research] [a written summary
of the discussion of controverted issues and their resolution]. Specifically, ***
Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by
subjects]. Specifically, ***_x000D_
Informed consent was not properly documented in that the written informed consent used in the study
[was not approved by the IRB] [was not signed by the subject or the subject's legally authorized
representative at the time of consent ] [was not dated by the subject or the subject's legally authorized
representative at the time of consent]. Specifically, ***
A list of IRB members has not been [prepared] [maintained], identifying members by [name] [earned
degrees] [representative capacity] [indications of experience sufficient to describe each member's chief
anticipated contribution to IRB deliberations] [any employment or other relationship between each
member and the institution]. Specifically, ***
Failure to [select qualified investigators] [provide investigators with the information needed to conduct the
study properly] [ensure proper monitoring of the study] [ensure the study is conducted in accordance with
the protocol and/or investigational plan] [ensure that FDA and all investigators are promptly informed of
significant new adverse effects or risks]. Specifically, ***
The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of
research. Specifically, ***
For other than expedited reviews, the IRB does not always review proposed research at convened
meetings at which a majority of the members of the IRB are present, including at least one member
whose primary concerns are in nonscientific areas. Specifically, ***
The IRB allowed a member to participate in the IRB's [initial] [continuing review] of a project in which the
member had a conflicting interest. Specifically, ***
Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.
Specifically, ***_x000D_
_x000D_
The quality assurance unit did not monitor each study to assure management that the facilities,
equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP
regulations. Specifically, ***
The quality assurance unit failed to determine whether any deviations from approved protocols or
standard operating procedures had been made with proper authorization and documentation.
Specifically, ***
Not all equipment used for the generation, measurement, or assessment of data is adequately tested,
calibrated and/or standardized. Specifically, ***
Legally effective informed consent was not obtained from a subject or the subject's legally authorized
representative, and the situation did not meet the criteria in 21 CFR 50.23 - 50.24 for exception.
Specifically, ***
Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21
CFR 56.108(a) and (b). Specifically, ***
Failure to report [promptly] to the sponsor adverse effects that may reasonably be regarded as caused
by, or probably caused by, an investigational drug. Specifically, ***
Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to
[drug administration] [conducting study-related tests]. Specifically, ***
The final study report did not include a description of all circumstances that may have affected the quality
or integrity of the data. Specifically, ***
Copies have not been [prepared] [maintained] of all [research proposals reviewed] [scientific evaluations,
if any, accompanying research proposals] [approved sample consent documents] [progress reports
submitted by investigators] [reports of injuries to subjects]. Specifically, ***
The IRB uses an expedited review procedure, but [has not adopted] [is not following] a method for
keeping members advised of research proposals which have been approved under the procedure.
Specifically, ***
The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB]
[appropriate institutional officials] [the FDA] of any instance of serious or continuing noncompliance with
these regulations or the requirements or determinations of the IRB. Specifically, ***
There was no statement in the informed consent document that [described the extent, if any, to which
confidentiality of records identifying the subject would be maintained] [noted the possibility that the Food
and Drug Administration might inspect the records]. Specifically, ***
An investigator who did not comply with [the signed agreement] [the general investigational plan]
[applicable regulatory requirements] was not [promptly brought into compliance] [terminated].
Specifically, ***
Failure to assure that an IRB [complying with applicable regulatory requirements] was responsible for the
initial and continuing review and approval of a clinical study. Specifically, ***
Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance
with sponsor instructions]. Specifically, *** _x000D_
For other than expedited reviews, research approved by the IRB does not always receive the approval of
a majority of those IRB members present. Specifically, ***
Not all individuals engaged in the conduct of or responsible for the supervision of a nonclinical laboratory
study have education, training, and experience, or combination thereof, to enable that individual to
perform assigned functions. Specifically, ***
Testing facility management failed to assure that all personnel clearly understood the functions they were
to perform. Specifically, ***
The study director failed to assure that all experimental data, including observations of unanticipated
responses of the test system, were accurately recorded and verified. Specifically, ***
The study director failed to assure that all applicable GLP regulations were followed. Specifically, ***
The quality assurance unit, for any given study, was not entirely separate from and independent of the
personnel engaged in the direction and conduct of that study. Specifically, ***
Not all nonclinical laboratory studies were conducted in _x000D_
accordance with the protocol. Specifically, ***_x000D_
Not all changes in entries were made so as not to obscure the original entry, indicated the reason for
such change, and were dated and signed or identified at the time of the change. Specifically, ***
The IRB does not include at least one member who is not otherwise affiliated with the institution, and who
is not part of the immediate family of a person who is affiliated with the institution. Specifically, ***
The IRB does not conduct continuing review of research at intervals [appropriate to the degree of risk] [of
not less than once per year]. Specifically, ***
The informed consent document lacked a description of reasonably foreseeable risks or discomforts to
the subject. Specifically, ***
Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an
investigator to participate in an investigation. Specifically, ***
Failure to ensure that an investigation was conducted in accordance with the general investigational plan
and protocols as specified in the IND. Specifically, ***
Transfer of obligations to a contract research organization [was not described in writing] [did not describe
each of the obligations assumed by the contract research organization, where not all obligations were
assumed]. Specifically, ***
Investigational records were not retained for a period of two years following [approval of a drug's
marketing application] [discontinuance of the investigation and notification of FDA]. Specifically,
***_x000D_
Not all changes in research activity were approved by an Institutional Review Board prior to
implementation. Specifically, ***
The IRB used an expedited review procedure for research which did not appear in an FDA list of
categories eligible for expedited review, and which had not previously been approved by the IRB [within
one year]. Specifically, ***
The testing facility failed to maintain a current summary of training and experience and job description for
each individual engaged in or supervising the conduct of a nonclinical laboratory study. Specifically, ***
The quality assurance unit failed to maintain a copy of a master schedule sheet that contained all
required elements for all nonclinical laboratory studies conducted by the testing facility. Specifically, ***
The quality assurance unit failed to inspect each nonclinical laboratory study at intervals adequate to
assure the integrity of the study and maintain written and properly signed records of each periodic
inspection. Specifically, ***
The quality assurance unit failed to review the final study report to assure that such report accurately
described the methods and standard operating procedures, and that the reported results accurately
reflected the raw data of the study. Specifically, ***
The quality assurance unit failed to prepare and sign a statement to be included with the final study report
which specified the dates inspections were made and findings reported to management and to the study
director. Specifically, ***
The quality assurance unit failed to maintain and make available for inspection required records regarding
its responsibilities and procedures and the method of indexing such records. Specifically, ***
The testing facility is not of suitable size and construction to facilitate the proper conduct of nonclinical
laboratory studies. Specifically, ***
The testing facility does not provide storage areas, as needed, for feed, bedding, supplies, and
equipment. Specifically, ***
Space is not provided for archives, limited to access by authorized personnel only, for the storage and
retrieval of all raw data and specimens from completed studies. Specifically, ***
Not all equipment is adequately inspected, cleaned, and maintained. Specifically, ***
The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration,
and/or standardization of equipment are not adequate. Specifically, ***
At the initiation of a nonclinical laboratory study, not all animals were free of any disease or condition that
might interfere with the purpose or conduct of the study. Specifically, ***
Not all animals used in laboratory procedures that require manipulations and observations are
appropriately identified. Specifically, ***
Not all feed and water analyses for contaminants were maintained as raw data. Specifically, ***.
Not all reserve samples from each batch of test and control articles for studies of more than 4 weeks'
duration were retained for the required period of time. Specifically, ***
Not all changes in automated data entries were made so as [not to obscure the original entry] [to indicate
the reason for change] [to be dated] [to identify the responsible individual]. Specifically, ***
The final study report did not include the objectives and procedures stated in the approved protocol,
including any changes in the original protocol. Specifically, ***
The final study report did not include the test and control articles identified by name, chemical abstracts
number or code number, strength, purity, and composition or other appropriate characteristics.
Specifically, ***
The final study report did not include a description of the methods used. Specifically, ***
The final study report did not include a description of the dosage, dosage regimen, route of
administration, and duration. Specifically, ***
The final study report did not include [a description of the transformations, calculations, or operations
performed on the data] [a summary and analysis of the data] [a statement of the conclusions drawn from
the analysis]. Specifically, ***
The final study report did not include the signed and dated reports of each of the individual scientists or
other professionals involved in the study. Specifically, ***
The final study report did not include the statement prepared and signed by the quality assurance unit as
required by FDA Good Laboratory Practice regulations. Specifically, ***
The informed consent document did not contain [a description of the procedures to be followed]
[identification of any procedures which were experimental]. Specifically, ***
A short form informed consent document [did not state that the required elements of informed consent
had been presented orally to the subject or the subject's legally authorized representative] [was not
signed by the subject or the subject's legally authorized representative] [was not signed by the witness].
Specifically, ***
[appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human
subjects or others. Specifically, ***
The IRB used an expedited review procedure to review supposedly minor changes to previously-
approved research, but the changes were not minor in nature. Specifically, ***
The institution approved research which had not been approved by the IRB. Specifically, ***
Records have not been [prepared] [maintained] of all continuing review activities. Specifically, ***
The IRB approved the conduct of research, but did not determine that informed consent would be sought
from each prospective subject or the subject's legally authorized representative, to the extent required by
21 CFR 50. Specifically, ***
The IRB approved the conduct of research, but did not determine, where appropriate, that the research
plan made adequate provisions for monitoring the data collected to ensure the safety of subjects.
Specifically, ***
The IRB approved the conduct of research in a situation where some or all of the subjects were likely to
be vulnerable to coercion or undue influence, but did not determine that additional safeguards had been
included in the study to protect the rights and welfare of those subjects. Specifically, ***
Records required by 21 CFR 56 have not been maintained for three years following completion of the
research. Specifically, ***
[appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval .
Specifically, ***
The IRB did not determine [at the time of initial review] [at the time of continuing review for an on-going
study which was started on/before April 30, 2001] that a study was in compliance with 21 CFR Part 50
Subpart D, "Additional Safeguards for Children in Clinical Investigations." Specifically, ***
The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the
[investigator] [institution]. Specifically, ***
A copy of the written consent form which had been approved by the IRB and signed and dated by the
subject or the subject's legally authorized representative, was not provided to the subject or the subject's
legally authorized representative at the time of consent. Specifically, ***
Failure to monitor the progress of an investigation conducted under your IND. Specifically, ***
Not all participating investigators were [promptly] informed of new observations discovered by or reported
to the sponsor [with respect to adverse effects and safe use]. Specifically, ***
Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance
with 21 CFR Part 312.57. Specifically, ***
Information necessary for submission of required financial [certification] [disclosure] statements to FDA
was not provided to the sponsor. Specifically, ***_x000D_
An adequate final report was not provided to the sponsor shortly after completion of the investigator's
participation in the investigation. Specifically, ***
Failure to obtain from an investigator [sufficient] [accurate] financial information to allow complete and
accurate certification or disclosure statements. Specifically, ***
Records and reports were not retained for two years after [marketing application approval]
[discontinuance of the investigation and notification of FDA]. Specifically***
The immediate package of the investigational new drug does not bear a label with the statement
"Caution: New Drug- Limited by Federal (or United States) law to investigational use
The IRB's [suspension] [termination of approval] for research was not reported [promptly] to [the
investigator] [appropriate institutional officials] [the Food and Drug Administration]. Specifically, ***
The IRB approved the conduct of research, but did not determine that risks to subjects were minimized,
whenever appropriate, by using procedures already being performed on the subjects for diagnostic or
treatment purposes. Specifically, ***
The general requirements for informed consent were not met in that [you] [the investigator] did not seek
consent under circumstances that [provided the prospective subject or the subject's representative
sufficient opportunity to consider whether or not to participate] [minimized the possibility of coercion or
undue influence]. Specifically, ***
Frequency
118
69
14
13
10
4
3
2
2
1
1
1
1
1
Devices 3130 21 CFR 820.100(a)
Devices 14713 21 CFR 820.198(a)
Devices 479 21 CFR 820.50

Devices 546 21 CFR 820.75(a)
Devices 3282 21 CFR 820.90(a)
Devices 3696 21 CFR 820.100(b)

Devices 2327 21 CFR 820.22
Devices 3103 21 CFR 820.30(i)
Devices 3331 21 CFR 820.181
Devices 3233 21 CFR 820.72(a)
Devices 2371 21 CFR 820.30(a)
Devices 3159 21 CFR 820.184
Devices 541 21 CFR 820.70(c)
Devices 3172 21 CFR 820.198(c)
Devices 2350 21 CFR 820.25(b)
Devices 3678 21 CFR 820.30(g)
Devices 3680 21 CFR 820.70(a)

Devices 3160 21 CFR 820.184
Devices 3125 21 CFR 820.80(d)
Devices 3104 21 CFR 820.30(j)
Devices 3120 21 CFR 820.80(a)

Devices 3168 21 CFR 820.198(a)
Devices 14712 21 CFR 820.184
Devices 731 21 CFR 803.50(a)(1)
Devices 3101 21 CFR 820.30(g)

Devices 3121 21 CFR 820.80(b)
Devices 14722 21 CFR 820.40
Devices 732 21 CFR 803.50(a)(2)
Devices 3132 21 CFR 820.120
Devices 3127 21 CFR 820.80(e)
Devices 3119 21 CFR 820.75(b)
Devices 3666 21 CFR 820.20(c)

Devices 3128 21 CFR 820.90(a)
Devices 3117 21 CFR 820.70(i)
Devices 3118 21 CFR 820.75(a)
Devices 4059 21 CFR 820.22
Devices 486 21 CFR 820.50(a)
Devices 3226 21 CFR 820.70(g)(1)
Devices 3345 21 CFR 820.200(a)
Devices 3669 21 CFR 820.20(c)

Devices 3263 21 CFR 820.250(b)
Devices 3375 21 CFR 820.198(e)
Devices 631 21 CFR 803.17(a)(1)
Devices 2968 21 CFR 812.100
Devices 2974 21 CFR 812.110(b)
Devices 3123 21 CFR 820.80(c)
Devices 3235 21 CFR 820.72(a)
Devices 3285 21 CFR 820.90(b)(2)
Devices 3427 21 CFR 820.50(a)(2)

Devices 2604 21 CFR 820.30(e)
Devices 3286 21 CFR 820.90(b)(1)
Devices 3415 21 CFR 820.22
Devices 3426 21 CFR 820.50(a)(1)
Devices 3686 21 CFR 820.90(b)(2)

Devices 3837 21 CFR 820.25(b)
Devices 419 21 CFR 820.20(b)
Devices 2328 21 CFR 820.22
Devices 14716 21 CFR 820.30(f)
Devices 3264 21 CFR 820.250(b)

Devices 14720 21 CFR 820.50(a)(3)
Devices 537 21 CFR 820.70(a)
Devices 3425 21 CFR 820.50(a)(1)
Devices 539 21 CFR 820.70(b)
Devices 633 21 CFR 803.17(a)(3)

Devices 2650 21 CFR 820.30(f)
Devices 3207 21 CFR 820.50(b)
Devices 4070 21 CFR 820.30(g)
Devices 3192 21 CFR 820.30(g)
Devices 3676 21 CFR 820.30(f)
Devices 3677 21 CFR 820.30(g)

Devices 14714 21 CFR 820.30(c)
Devices 632 21 CFR 803.17(a)(2)
Devices 3108 21 CFR 820.70(e)

Devices 3193 21 CFR 820.30(g)
Devices 3266 21 CFR 820.86
Devices 2302 21 CFR 820.20(e)
Devices 2928 21 CFR 812.40

Devices 3170 21 CFR 820.198(b)
Devices 3236 21 CFR 820.72(b)
Devices 3262 21 CFR 820.250(a)
Devices 3409 21 CFR 820.200(d)

Devices 14718 21 CFR 820.30(g)
Devices 2557 21 CFR 820.30(c)
Devices 2630 21 CFR 820.30(e)
Devices 3173 21 CFR 820.198(d)
Devices 3203 21 CFR 820.40(b)

Devices 3310 21 CFR 820.120(b)
Devices 3433 21 CFR 820.75(c)
Devices 4191 21 CFR 806.10(a)(1)

Devices 3102 21 CFR 820.30(h)
Devices 3191 21 CFR 820.30(g)
Devices 3199 21 CFR 820.40(a)
Devices 3237 21 CFR 820.72(b)
Devices 3269 21 CFR 820.80(b)

Devices 3668 21 CFR 820.20(c)
Devices 3671 21 CFR 820.25(a)
Devices 3683 21 CFR 820.70(g)
Devices 14505 21 CFR 812.140(a)(3)
Devices 2430 21 CFR 820.30(b)
Devices 3313 21 CFR 820.120(d)

Devices 3674 21 CFR 820.30(d)
Devices 14710 21 CFR 820.150
Devices 454 21 CFR 820.40(a)

Devices 3149 21 CFR 820.180
Devices 3232 21 CFR 820.72(a)
Devices 3432 21 CFR 820.75(b)(2)
Devices 3434 21 CFR 820.75(c)
Devices 4212 21 CFR 806.20(b)(4)

Devices 14719 21 CFR 820.30(h)
Devices 2949 21 CFR 812.46(a)
Devices 3111 21 CFR 820.70(f)
Devices 3171 21 CFR 820.198(b)
Devices 3190 21 CFR 820.30(g)
Devices 3201 21 CFR 820.40(a)
Devices 3372 21 CFR 820.198(d)

Devices 14717 21 CFR 820.30(g)
Devices 2269 21 CFR 820.20(a)

Devices 2293 21 CFR 820.20(d)
Devices 2339 21 CFR 820.22
Devices 2973 21 CFR 812.110(a)
Devices 2981 21 CFR 812.140(a)(2)(i)
Devices 2984 21 CFR 812.140(a)(3)(i)
Devices 3200 21 CFR 820.40(a)
Devices 3204 21 CFR 820.40(b)
Devices 3224 21 CFR 820.70(g)(2)
Devices 3231 21 CFR 820.70(i)

Devices 3239 21 CFR 820.72(b)
Devices 3270 21 CFR 820.80(c)
Devices 3328 21 CFR 820.180(b)
Devices 3343 21 CFR 820.198(e)
Devices 3347 21 CFR 820.200(c)
Devices 14711 21 CFR 820.160(a)
Devices 2935 21 CFR 812.43(b)
Devices 2985 21 CFR 812.140(a)(3)(ii)
Devices 2991 21 CFR 812.140(b)(1)
Devices 2992 21 CFR 812.140(b)(2)
Devices 3007 21 CFR 812.140(d)
Devices 3009 21 CFR 812.140(e)
Devices 3063 21 CFR 812.140(a)(3)(iii)
Devices 3109 21 CFR 820.70(d)

Devices 3175 21 CFR 820.186
Devices 3206 21 CFR 820.50(b)
Devices 3219 21 CFR 820.70(d)

Devices 3346 21 CFR 820.200(b)
Devices 3665 21 CFR 820.20(b)(3)
Devices 3841 21 CFR 820.90(b)(2)
Devices 4192 21 CFR 806.10(a)(2)
Devices 4193 21 CFR 806.10(b)
Devices 4208 21 CFR 806.20(a)

Devices 14715 21 CFR 820.30(d)
Devices 635 21 CFR 803.17(b)(1)

Devices 636 21 CFR 803.17(b)(2)
Devices 642 21 CFR 803.18(b)(1)(i)
Devices 733 21 CFR 803.50(b)(1)
Devices 734 21 CFR 803.50(b)(2)
Devices 735 21 CFR 803.50(b)(2)
Devices 774 21 CFR 803.52(e)(4)

Devices 2602 21 CFR 820.30(d)
Devices 2916 21 CFR 812.7(d)
Devices 2920 21 CFR 812.18(b)
Devices 2930 21 CFR 812.42
Devices 2944 21 CFR 812.43(d)
Devices 2950 21 CFR 812.46(a)
Devices 2966 21 CFR 812.66
Devices 2969 21 CFR 812.100
Devices 2980 21 CFR 812.140(a)(1)
Devices 2982 21 CFR 812.140(a)(2)(ii)
Devices 2983 21 CFR 812.140(a)(2)(iii)
Devices 3002 21 CFR 812.140(b)(5)
Devices 3003 21 CFR 812.140(b)(6)
Devices 3038 21 CFR 812.150(b)(1)
Devices 3049 21 CFR 812.150(b)(5)

Devices 3064 21 CFR 812.140(a)(4)
Devices 3113 21 CFR 820.70(g)
Devices 3138 21 CFR 820.130
Devices 3139 21 CFR 820.140

Devices 3147 21 CFR 820.170(a)
Devices 3208 21 CFR 820.50(b)
Devices 3230 21 CFR 820.70(i)
Devices 3308 21 CFR 820.120(a)
Devices 3309 21 CFR 820.120(b)
Devices 3323 21 CFR 820.170(b)
Devices 3672 21 CFR 820.30(c)
Devices 3699 21 CFR 820.160(b)
Devices 3838 21 CFR 820.40(a)
Devices 4202 21 CFR 806.10(c)(9)
Devices 4211 21 CFR 806.20(b)(3)
Devices 4437 21 CFR 803.40(b)
Devices 6849 21 CFR 812.5(a)
Devices 14507 21 CFR 812.140(a)(3)(ii)
Devices 14508 21 CFR 812.140(a)(4)

Devices 14516 21 CFR 812.25(e)
Devices 14523 21 CFR 812.43(c)
Devices 21425 21 CFR 820.184(f)

Short Description
Lack of or inadequate procedures
Lack of or inadequate complaint procedures
Purchasing controls, Lack of or inadequate procedures

Lack of Written MDR Procedures
Lack of or inadequate process validation
Nonconforming product, Lack of or inadequate

procedures
Documentation
Quality audits - Lack of or inadequate procedures
Design changes - Lack of or Inadequate Procedures
DMR - not or inadequately maintained
Calibration, Inspection, etc. Procedures Lack of or
Inadequ
Design control - no procedures
DHR content
Environmental control Lack of or inadequate

procedures
Investigation of device failures
Training - Lack of or inadequate procedures
Design Validation - Risk analysis not

performed/inadequate
Process control procedures, Lack of or inadequate
procedures
Lack of or inadequate DHR procedures
Lack of or inadequate final acceptance procedures
Design history file
Lack of or inadequate procedures - Acceptance

activities
Complaints
DHR - not or inadequately maintained
Report of Death or Serious Injury
Design validation- Lack of or inadequate procedures

Lack of or inadequate receiving acceptance procedures
Procedures not adequately established or maintained
Report of Malfunction
Lack of or inadequate procedures for labeling
Documentation
Lack/Inad procedure-Monitoring/Control of Validated

Proces
Management review - Lack of or inadequate
procedures
Nonconforming product control
Software validation for automated processes
Documentation
Quality Audits - defined intervals
Evaluation of suppliers, contractors, etc., requirements
Maintenance schedule, Lack of or inadequate schedule
Servicing - Lack of or inadequate procedures
Management review - defined interval, sufficient

frequency
Sampling plans
Records of complaint investigation
Lack of System for Event Evaluations
Investigator non-compliance with

agreement/plan/regulations
Investigator non-compliance with

agreement/plan/regulations
Lack of or inadequate In-process acceptance

procedures
Equipment control activity documentation
Product rework procedures, Lack of or inadequate

procedures
Supplier oversight
Lack of procedures, or not maintained
Design review - Lack of or inadequate procedures
Procedures for product review,disposition lack
of/inadequate
Quality Audit/Reaudit - conducted
Documented evaluation
Product rework documentation, DHR {see also 820.184}

Training records
Lack of or inadequate organizational structure
Quality audits - auditor independence
Design verification - output does not meet input

requirement
Sampling methods - Lack of or inadequate procedures

Acceptable supplier records, inadequate records
Production processes
Evaluation and Selection, Suppliers, Contractors, etc.
Production and Process Change Procedures, lack of or

Inad.
Lack of System for Timely Submission of Reports

Design verification - Lack of or inadequate procedures
Supplier notification of changes
Design validation - documentation
Design validation - user needs and intended uses
Design verification - documentation
Design validation - software validation not performed

Design input - Lack of or inadequate procedures
Lack of System for Determining MDR Events
Contamination control, Lack of or inadequate

procedures
Design validation - simulated testing
Acceptance status
Quality System Procedures
Sponsors' general responsibilities

Review and evaluation for investigation
Calibration procedures - content
Statistical techniques - Lack of or inadequate

procedures
Service reports
Design validation - Risk analysis
Design input - documentation
Design review - documentation
Evaluation, timeliness, identification
Document change records, maintained.

DHR documentation of label release {see also 820.184}
Process changes - review, evaluation and revalidation
Report of risk to health

Design transfer - Lack of or inadequate procedures
Design validation - production units
Document review, approval documentation
Remedial action
Incoming acceptance records, documentation

Management review dates
Personnel
Equipment Installation, Placement, Specified

Requirements
Investigator's subject records inadequate
Identification procedures, Lack of or inadequate

procedures
Design plans - Lack of or inadequate
Records, DHR {see also 820.184(e)}

Design output - documentation
Lack of or inadequate procedures for storage.
Document review, approval by designated individual

Availability
Equipment suitability & capability
Documentation of validated process performance
Documentation - review in response to changes or

deviations
Justification for not reporting

Incorrect translation to production specifications
Sponsor securing investigator compliance
Buildings
Rationale documented for no investigation
Design validation acceptance criteria
Not approved or obsolete document retrieval
Records of MDR Investigation

Design validation - software validation documentation
Submission Within One Month
Quality policy and objectives

Quality plan
Quality Audit/Reaudit - documentation
Subject participation prior to study approval
Investigator device accountability inadequate
Investigator records of informed consent inadequate
Document locations, Dissemination, etc.
Change records, content
Periodic equipment inspection lack of or inadequate

procedu
Documentation of software validation

Remedial action - documentation
Documentation
Retention period
Maintained
Service reports/MDRs/complaints
Lack of or inadequate procedures for distribution
Sponsor shipped devices to unqualified person(s)
Investigator records of relevant observations

inadequate
Sponsor correspondence records inadequate
Sponsor device shipment records inadequate
Record retention inadequate
Notice of transfer of responsibility for records
Investigator records of exposure to device inadequate
Personnel requirements, Lack of or inadequate

requirements
QSR
Approval, inadequate purchasing data
Training temp work under special environmental

conditions
Analyzing service report
Management representative
Product rework adverse effects {see also 820.184}
Report of violation of the Act (see 803.52(e)(9))
Time to report - 10 days
Records not kept

Design output - Lack of or inadequate procedures
Traceability Lack of or inadequate {see also 820.120(e)}
Info evaluated to determine if event was reportable

Reports and information documentation
Adverse events--all info not in file
Reporting Information Reasonably Known
Providing Incomplete or Missing Information
Explanation of Incomplete Information
Date Received by Manufacturer

Design output - review and approval
Investigational device represented as safe and /or
effective
Exporter of investigational device
Sponsor began study before IRB/FDA approval
Monitors not qualified
Device return/disposal by non-compliant investigator
No IRB notification of significant risk determination
No investigator protection - subject rights, safety,

welfare
Investigator correspondence records inadequate
Investigator records of persons receiving devices

inadequate
Investigator records of disposition of devices
inadequate
Sponsor records of adverse device effects & complaints
Other sponsor records required by FDA inadequate
Sponsor evaluation rpt not timely, distributed
Sponsor progress reports for significant risk study

Investigator protocol records inadequate
Equipment design and installation
Packaging
Lack of or inadequate procedures for handling

Lack of or inadequate instructions
Approval of purchasing data {see also 820.40(a)}
Validation of changes to automated process software
Remain legible
Examination for accuracy
Installer records
Design input - review and approval
Distribution records
Document review procedures, designated individual
Device number, identification
Events
Report of malfunction likely to cause death or injury
Label does not contain required information
Investigator adverse effect records inadequate
Investigator record of protocol deviations inadequate

Sponsor's lack of written monitoring procedures
No investigator agreement
DHR - UDI not included

Long Description
Procedures for corrective and preventive action have not been [adequately] established. Specifically, ***
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not
been [adequately] established. Specifically,***
Procedures to ensure that all purchased or otherwise received product and services conform to specified
requirements have not been [adequately] established. Specifically, ***
Written MDR procedures have not been [developed] [maintained] [implemented]. Specifically, ***
A process whose results cannot be fully verified by subsequent inspection and test has not been
[adequately] validated according to established procedures. Specifically, ***
Procedures have not been [adequately] established to control product that does not conform to
specified requirements. Specifically, ***
Corrective and preventive action activities and/or results have not been [adequately] documented.
Specifically, ***
Procedures for quality audits have not been [adequately] established. Specifically, ***
Procedures for design change have not been [adequately] established. Specifically,***
A device master record has not been [adequately] maintained. Specifically, ***
Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not
been [adequately] established. Specifically, ***
Procedures for design control have not been established. Specifically,***
The device history record does not demonstrate that the device was manufactured in accordance with
[the device master record] [21 CFR 820]. _x000D_
_x000D_
Procedures to control environmental conditions have not been [adequately] established. Specifically,
***
Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its
specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***
Procedures for training and identifying training needs have not been [adequately] established.
Specifically, ***
Risk analysis [was not performed] [is inadequate] [is incomplete]. Specifically, ***
Process control procedures that describe any process controls necessary to ensure conformance to
specifications have not been [adequately] established. Specifically, ***
Procedures for device history records have not been [adequately] established. Specifically,***
Procedures for finished device acceptance have not been [adequately] established. Specifically, ***
The design history file [was not established] [does not demonstrate that the design was developed
following the approved design plan] [does not demonstrate that the design was developed following the
requirements of 21 CFR 820].
Procedures for acceptance activities have not been [adequately] established. Specifically,***
Complaint files are not [adequately] maintained. Specifically, ***
A device history record has not been [adequately] maintained. Specifically, ***
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death
or serious injury. Specifically, ***
Procedures for design validation have not been [adequately] established. Specifically,***
Procedures for acceptance of incoming product have not been [adequately] established. Specifically, ***
Document control procedures have not been adequately [established] [maintained]. Specifically,***
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device has malfunctioned and would be likely to
cause or contribute to a death or serious injury if the malfunction were to recur. Specifically, ***
Procedures to control labeling activities have not been [adequately] established. Specifically, ***
Acceptance activities were not [documented] [maintained as part of the device history record]
[adequately documented] [adequately maintained as part of the device history record]. Specifically, ***
Procedures for monitoring and control of process parameters for a validated process have not been
[adequately] established. Specifically, ***
Procedures for management review have not been [adequately] established. Specifically,***
Products that do not conform to specifications are not adequately controlled. Specifically, ***
Software used as part of [production] [the quality system] has not been [adequately] validated for its
intended use according to an established protocol. Specifically, ***
Process validation [activities] [results] have not been [documented] [approved] [adequately
documented] [adequately approved]. Specifically, ***
Quality audits were not performed [at defined intervals] [at sufficient frequency] to determine whether
the quality system activities and results comply with quality system procedures. Specifically, ***
Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately]
established. Specifically, ***
Schedules for the adjustment, cleaning, and other maintenance of equipment have not been
[adequately] established. Specifically, ***
Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified
requirements] have not been [adequately] established. Specifically, ***
Management with executive responsibility has not reviewed the suitability and effectiveness of the
quality system [at defined intervals] [with sufficient frequency]. Specifically, ***
Sampling plans are not [written] [based on valid statistical rationale]. Specifically, ***
Records of complaint investigations do not include required information. Specifically, ***
The written MDR Procedure does not include an internal system which provides for the timely and
effective [identification] [communication] [evaluation] of events that may be subject to medical device
reporting requirements. Specifically, ***
An investigation was not conducted according to the [signed agreement] [investigational plan]
[applicable FDA regulations]. Specifically, ***
An investigation was not conducted in accordance with [the signed agreement] [the investigational plan]
[applicable FDA regulations] [conditions of approval imposed by an IRB] [conditions of approval imposed
by FDA]. Specifically, ***
Procedures for the [acceptance] [control] of in-process product have not been [adequately] established.
Specifically, ***
Equipment [calibrations] [inspections] [checks] [maintenance activities] have not been documented.
Specifically, ***
Procedures for rework of nonconforming product have not been [adequately] established. Specifically,
***
The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors]
[consultants] was not clearly defined. Specifically, ***
Document control procedures have not been [established] [maintained]. Specifically,***
Procedures for design review have not been [adequately] established. Specifically,***
Procedures that define the responsibility for review and the authority for the disposition of
nonconforming product have not been [adequately] established. Specifically, ***
Quality [audits] [reaudits] have not been performed. Specifically, ***
The evaluation of potential [suppliers] [contractors] [consultants] was not documented. Specifically, ***
Rework and reevaluation activities have not been [fully] documented in the device history record.
Specifically, ***
Personnel training is not documented. Specifically, ***
The organizational structure has not been [adequately] established and maintained to ensure that
devices are [designed] [produced] in accordance with 21 CFR 820. Specifically, ***
Individuals who conduct quality audits have direct responsibility for the matters being audited.
Specifically, ***
Design verification does not confirm that design output meets design input requirements. Specifically,
***
Procedures to ensure sampling methods are adequate for their intended use have not been [adequately]
established. Specifically,***
Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.
Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device
conforms to its specifications. Specifically, ***
Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to
meet specified requirements. Specifically, ***
Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately]
established. Specifically, ***
The written MDR procedure does not include an internal system which provides for timely transmission
of complete medical device reports to [FDA] [manufacturers]. Specifically, ***
Procedures for design verification have not been [adequately] established. Specifically,***
There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product
or service. Specifically, ***
The results of design validation, including [identification of the design] [method(s)] [the date] [the
individual(s) performing validation], were not [adequately] documented in the design history file.
Specifically, ***
Design validation did not ensure the device conforms to defined user needs and intended uses.
Specifically, ***
The design verification results, including [identification of the design] [method(s)] [the date] [the
individual(s) performing the verification], were not [adequately] documented in the design history file.
Specifically, ***
Validation of device software [was not performed] [is inadequate] [is incomplete]. Specifically, ***
Procedures for design input have not been [adequately] established. Specifically,***
The written MDR procedure does not include an internal system which provides for a standardized
review process/procedure for determining when an event meets the criteria for reporting. Specifically,
***
Procedures to prevent contamination of equipment or product by substances that may have an adverse
effect on product quality have not been [adequately] established. Specifically, ***
The design was not validated under actual or simulated use conditions. Specifically, ***
The acceptance status of product was not [identified to indicate conformance or nonconformance with
acceptance criteria] [maintained]. Specifically, ***
Quality system procedures and instructions have not been established. Specifically,***
For an investigational study, [qualified investigators were not selected] [investigators were not provided
with the information they need to conduct an investigation properly] [proper monitoring was not
ensured] [IRB review and approval were not ensured] [an IDE application was not submitted to FDA for a
significant risk study] [reviewing IRBs were not promptly informed of significant new information about
an investigation] [FDA was not promptly informed of significant new information about an investigation].
Specifically, ***
Not all complaints have been [adequately] reviewed and evaluated to determine whether an
investigation is necessary. Specifically, ***
Calibration procedures do not include [specific directions and limits for accuracy and precision]
[provisions for remedial action]. Specifically, ***
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying
the acceptability of process capability and product characteristics have not been [adequately]
Service reports [are not documented] [do not include the required information]. Specifically, ***
Results of the design risk analysis were not [adequately] documented. Specifically, ***
Design input requirements were not [adequately] documented. Specifically, ***
The design review results, including [identification of the design] [the date] [the individual(s) performing
the review], were not documented in the design history file. Specifically, ***
Complaints representing events that are MDR reportable were not [promptly reviewed, evaluated, and
investigated by a designated individual] [maintained in a separate portion of the complaint files] [clearly
identified]. Specifically, ***
Records of changes to documents were not [adequately] maintained. Specifically, ***
The DHR does not include [complete] records of examination and release of device labeling, including
date and signature of the examiner. Specifically, ***
A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations
occurred. Specifically, ***
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in
writing to FDA. Specifically, ***
Procedures for design transfer have not been [adequately] established. Specifically,***
The design was not validated [under defined operating conditions] [using initial production units, lots or
batches or their equivalents]. Specifically, ***
The documentation of approval of documents does not include [the document approval date] [the
signature of the approving official]. Specifically, ***
When test/measurement equipment was found to not meet accuracy and precision limits, [no]
[inadequate] action was taken to [bring the equipment into calibration] [evaluate whether there was any
adverse effect on the device's quality]. Specifically, ***
Acceptance or rejection of incoming product was not documented. Specifically, ***
The results and/or dates of management reviews are not documented. Specifically, ***
Personnel do not have the necessary [education] [background] [training] [experience] to perform their
jobs. Specifically, ***
The [appropriate design, construction, placement, and installation of manufacturing equipment have not
been ensured] [equipment used in the manufacturing process does not meet specified requirements].
Specifically, ***
Records of each subject's [case history] [exposure to the investigational device] are not all [accurate]
[complete] [current]. Specifically, ***
Procedures for identifying product during all stages of receipt, production, distribution, and installation
have not been [adequately] established. Specifically, ***
Design plans that describe or reference the design and development activities and define responsibility
for implementation have not been [adequately] established. Specifically, ***
Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the
DHR. Specifically, ***
Design output was not [adequately] documented before release. Specifically, ***
Procedures for the control of storage areas and stock rooms have not been [adequately] established.
Specifically,***
Documents were [not reviewed] [not approved] by designated individual(s) prior to issuance .
Specifically, ***
Required records [are not maintained at a location that is reasonably accessible to responsible officials of
the manufacturer and to employees of the FDA] [were not made readily available for review and copying
by the FDA] [are not legible] [are not stored to minimize deterioration and prevent loss] [are not backed
up when stored in automated data processing systems]. Specifically, ***
Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of
producing valid results]. Specifically, ***
There is [no] [inadequate] documentation of [monitoring and control methods and data] [the date
performed] [the individual performing the process] [the major equipment used] for a validated process.
Specifically, ***
There is no documentation of the [review and evaluation of a process] [revalidation of a process]
performed in response to changes or process deviations. Specifically, ***
A justification for not reporting the correction or removal action to FDA that included [conclusions] [follow-
ups] [reviews] by a designated person was not included in the record. Specifically,***
The device design was not correctly translated into production specifications. Specifically, ***
An investigator was not complying with the [signed agreement] [investigational plan] [requirements of the
regulations] [conditions of approval imposed by the IRB or FDA] and [compliance of the investigator was
not promptly secured] [shipments of the investigational device to the investigator were not discontinued]
[the investigator's participation in the investigation was not terminated]. Specifically, ***
Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations]
[prevent mix-ups] [assure orderly handling of product]. Specifically, ***
Records for complaints where no investigation was made do not include required information.
Specifically, ***
Acceptance criteria were not established prior to the performance of validation activities. Specifically, ***
Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are
being] used. Specifically, ***_x000D_
_x000D_
Investigation records of MDR reportable complaints do not include required information. Specifically, ***
Results of the validation of the device software were not [adequately] documented. Specifically, ***
A supplemental report was not submitted to FDA within one month following receipt of information that
was not provided when the initial report was submitted. Specifically, ***
The [quality policy] [quality objectives] was/were not established by management with executive
responsibility. Specifically, ***
A quality plan has not been [adequately] established. Specifically, ***
The dates of quality [audits] [reaudits] have not been documented. Specifically, ***
Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct
the investigation. Specifically, ***
Records of [receipt] [use] [disposal] of a device that relate to the [type and quantity] [dates of receipt]
[batch number or code mark] of the device are not all [accurate] [complete] [current]. Specifically, ***
Records documenting that informed consent was obtained for each subject prior to participation in the
study are not all [accurate] [complete] [current]. Specifically, ***
Documents were not available at all locations for which they are designated, used, or otherwise
necessary. Specifically, ***
Records of changes did not include [a description of the change] [identification of the affected documents]
[the signature of the approving official(s)] [the approval date] [when the change became effective].
_x000D_
Procedures for conducting periodic inspections to ensure adherence to equipment maintenance

schedules have not been [adequately] established. Specifically, ***
Software validation activities and results for computers or automated data processing systems used as
part of [production] [the quality system] have not been [adequately] documented. Specifically, ***
Evaluations of out-of-calibration equipment and remedial actions taken were not documented.
Specifically, ***
In-process inspections, tests, or other verification activities and approvals were not documented.
Specifically, ***
Required records are not retained for [the design and expected life of the device] [at least 2 years from
the date of release of the device for commercial distribution]. Specifically, ***
Records of complaint investigations are not maintained by the formally designated unit. Specifically, ***
Service reports that represent MDR reportable events were not automatically considered complaints and
processed in accordance with the requirements of 21 CFR 820.198. Specifically, ***
Procedures for control and distribution of finished devices have not been [adequately] established.
Specifically,***
Investigational devices were shipped to individuals who were not qualified investigators participating in
the investigation. Specifically, ***
Records for each subject concerning [previous medical history] [condition upon entering the investigation]
[condition during the course of the investigation] [all diagnostic test results] are not all [accurate]
Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA],
including required reports are not all [accurate] [complete] [current]. Specifically, ***
Records of shipment of an investigational device that include the [name and address of the consignee]
[type and quantity of device] [date of shipment] [batch number or code mark] reports are not all [accurate]
Required records were not all maintained [during the investigation] [for a period of two years after the
date on which an investigation was terminated or completed] [for a period of two years after the date that
the records were no longer required for purposes of supporting a premarket approval application or a
notice of completion of a product development protocol]. Specifically, ***
A notice of transfer of responsibility for the maintenance of required records was not submitted [within 10
working days after the transfer occurred]. Specifically, ***
Records of each subject's exposure to the device, including [the date and time of each use] [the use of
any other therapy] are not all [accurate] [complete] [current]. Specifically, ***
Requirements have not been [adequately] established to address personnel [health] [cleanliness]
[personal practices] [clothing]. Specifically, ***
The quality system record has not been [adequately] maintained. Specifically, ***
Purchasing data that clearly describe or reference specified requirements for purchased or otherwise
received product and services have not been [approved] [established] [adequately approved] [adequately
established]. Specifically, ***
Maintenance and other personnel who are required to work temporarily under special environmental
conditions are not appropriately trained or supervised by a trained individual. Specifically, ***
Service reports were not analyzed following appropriate statistical methods. Specifically, ***
No management representative had been appointed to ensure that quality system requirements are met,
and to report to management on the performance of the quality system. Specifically, ***
Documentation of rework and reevaluation activities does not include a determination of whether there
has been any adverse effect from rework upon the product. Specifically, ***
A violation of the FD&C Act involving a device which might present a risk to health was not reported to
FDA. Specifically, ***
A report of the required information regarding device correction and removal actions was not sent to FDA
within 10 days of initiating the correction or removal. Specifically, ***
There is no record maintained of a correction or removal action that was not required to be reported to
FDA. Specifically,***
Procedures for design output have not been [adequately] established. Specifically,***
Procedures for identifying with a control number each unit, lot, or batch of implantable or life supporting,
life sustaining finished devices or appropriate components have not been [adequately] established.
Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for all
information that was evaluated to determine if an event was reportable. Specifically, ***
The written MDR procedure does not include documentation and recordkeeping requirements for all
Medical Device Reports and information submitted to [FDA] [device manufacturers]. Specifically, ***
MDR event files do not contain or reference all adverse event information in the possession of the
reporting entity, including documentation of the deliberations and decision making process used to
determine if an event was or was not reportable. Specifically, ***
An MDR report submitted to FDA did not include all information that was reasonably known to the
manufacturer. Specifically, ***
The firm did not obtain and provide FDA with information that is incomplete or missing from reports
submitted by user facilities, distributors, and other initial reporters. Specifically, ***
An MDR report with incomplete information was submitted to FDA without a statement explaining why
such information was incomplete and the steps taken to obtain the information. Specifically, ***
An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block
G the date received by the manufacturer. Specifically, ***
Design output was not [reviewed] [approved] before release. Specifically, ***
An investigational device was represented as being [safe] [effective] for the purposes for which it [is]
[was] being investigated. Specifically, ***
An investigational device was exported without obtaining FDA's approval prior to exportation and without
complying with the export requirements of Section 802 of the Food, Drug, and Cosmetic Act. Specifically,
***
[An investigation] [Part of an investigation] was initiated before [FDA approval] [IRB approval].
Specifically, ***
Monitors that are qualified by [training] [experience] were not chosen to monitor the investigational study.
Specifically, ***
An investigator was not required to [return] [dispose of] the investigational device(s) when the investigator
could not be brought into compliance with the [signed agreement] [investigational plan] [requirements of
the regulations] [conditions of approval imposed by the IRB or FDA] . Specifically, ***
The reviewing IRB did not notify [the investigator] [the sponsor] after determining that a device study,
presented for approval as a non-significant risk device study, was actually a significant risk device study.
Specifically, ***
The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.
Specifically, ***
Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA],
including required reports, are not all [accurate] [complete] [current]. Specifically, ***
Records of persons who [received] [used] [disposed] of each device are not all [accurate] [complete]
[current]. Specifically, ***
Records that relate to the [reason why devices] [quantity of devices that] were [returned to the sponsor]
[repaired] [disposed of] are not all [accurate] [complete] [current]. Specifically, ***
Records concerning [anticipated adverse device effects] [unanticipated adverse device effects]
[complaint] reports are not all [accurate] [complete] [current]. Specifically, ***
Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are
not all [accurate] [complete] [current]. Specifically, ***
Reports of the results of evaluation of unanticipated adverse device effects were not all submitted [within
10 working days of receiving notice of the effect] to [FDA] [all reviewing IRBs] [all participating
investigators]. Specifically, ***
Progress reports for a significant risk device study were not submitted [at required intervals] [at least
yearly] to [FDA] [all reviewing IRBs]. Specifically, ***
Copies maintained of the study protocol are not all [accurate] [complete] [current]. Specifically, ***
Equipment used in the manufacturing process has not been appropriately [designed] [constructed]
[placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***
Device packaging and/or shipping containers are not designed and constructed to protect the device from
alteration or damage during processing, storage, handling, and distribution. Specifically, ***
Procedures for product handling have not been [adequately] established. Specifically,***_x000D_
_x000D_
[Installation instructions] [inspection instructions] [test procedures] have not been [adequately]
The purchasing data were not approved. Specifically, ***
Changes to software used as part of [production] [the quality system] were not [adequately] validated
before approval and issuance. Specifically, ***
Labels were not [printed] [applied] [affixed] so as to remain [legible] [affixed] during processing, storage,
handling, distribution, and/or use. Specifically, ***
Labeling was not sufficiently examined by a designated individual for accuracy including [the correct
expiration date] [control numbers] [storage instructions] [handling instructions] [certain additional
processing instructions] before release. Specifically, ***
The person installing the device did not [adequately] document the inspection and test results to
demonstrate proper installation.
Design input requirements were not [reviewed] [approved] by designated individual(s). Specifically, ***
Distribution records [were not maintained] [do not include or refer to the location of required information].
Specifically, ***
The document control procedures do not designate an individual to review documents for adequacy and
approve them prior to issuance. Specifically, ***_x000D_
_x000D_
The [total number] [sub-lot identification] of devices subject to correction or removal actions was not
reported. Specifically,***
A description of the events that led to the correction or removal actions was not contained in the record.
Specifically,***
The importer failed to submit a report to the manufacturer on FDA Form 3500A within 30 days concerning
information that one of the devices marketed by the importer has malfunctioned and that such device or a
similar device marketed by the importer would be likely to cause or contribute to a death or serious injury
if the malfunction were to recur. Specifically, ***
The label for an investigational device does not include [the name and place of business of manufacturer,
packer, or distributor] [the quantity of contents] [the statement "CAUTION -- Investigational device.
Limited by Federal (or United States) law to investigational use."]. Specifically, ***
Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all
[accurate] [complete] [current]. Specifically, ***
Records showing [dates] [reasons for] each deviation from the protocol are not all [accurate] [complete]
[current]. Specifically,***
There are no written procedures for monitoring an investigational device study. Specifically,***
A signed investigator agreement was not obtained from each participating investigator . Specifically,***
The device history record does not include, or refer to the location of any unique device identifier (UDI) or
universal product code (UPC). Specifically, ***
Frequency
354
229
142
139
138
119
86
78
76
63
58
54
50
49
49
48
48
47
45
44
41
40
40
38
37
37
36
33
31
30
29
28
28
25
24
24
24
23
22
22
22
21
19
18
18
18
18
18
18
18
17
17
17
17
17
17
17
16
16
16
15
15
14
14
13
13
13
13
13
11
11
11
11
10
10
10
10
9
9
9
9
9
8
8
8
8
8
7
7
7
7
7
6
6
6
5
5
5
5
4
4
3
3
3
3
3
3
3
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Drugs 1105 21 CFR 211.22(d)
Drugs 3603 21 CFR 211.160(b)
Drugs 2027 21 CFR 211.192
Drugs 1361 21 CFR 211.100(a)
Drugs 1213 21 CFR 211.67(a)
Drugs 1263 21 CFR 211.68(b)
Drugs 1215 21 CFR 211.67(b)
Drugs 3585 21 CFR 211.110(a)
Drugs 1274 21 CFR 211.68(a)
Drugs 1883 21 CFR 211.165(a)
Drugs 1177 21 CFR 211.63
Drugs 1451 21 CFR 211.113(b)
Drugs 1111 21 CFR 211.25(a)
Drugs 1914 21 CFR 211.166(a)
Drugs 1112 21 CFR 211.25(a)
Drugs 4402 21 CFR 211.192

Drugs 1434 21 CFR 211.42(c)(10)(iv)
Drugs 9001 21 CFR 211.22(a)
Drugs 1358 21 CFR 211.100(b)
Drugs 1890 21 CFR 211.165(e)
Drugs 2031 21 CFR 211.194(a)
Drugs 1450 21 CFR 211.113(a)
Drugs 2419 21 CFR 211.198(a)
Drugs 3565 21 CFR 211.58
Drugs 1809 21 CFR 211.160(a)

Drugs 1912 21 CFR 211.166(a)
Drugs 2401 21 CFR 211.194(a)(4)
Drugs 4391 21 CFR 211.180(e)(2)
Drugs 3632 21 CFR 211.170(b)
Drugs 1767 21 CFR 211.137(a)
Drugs 2009 21 CFR 211.188
Drugs 1540 21 CFR 211.125(a)
Drugs 4342 21 CFR 211.142(b)
Drugs 1435 21 CFR 211.42(c)(10)(v)
Drugs 2026 21 CFR 211.192
Drugs 4389 21 CFR 211.198(a)
Drugs 1133 21 CFR 211.25(a)
Drugs 1452 21 CFR 211.113(b)
Drugs 3559 21 CFR 211.56(a)

Drugs 3572 21 CFR 211.100(b)
Drugs 1844 21 CFR 211.84(d)(2)
Drugs 4303 21 CFR 211.67(b)
Drugs 4352 21 CFR 211.160(b)(4)
Drugs 4576 21 CFR 211.192
Drugs 3613 21 CFR 211.160(b)(4)
Drugs 1049 21 CFR 211.22(a)
Drugs 1787 21 CFR 211.80(a)
Drugs 1810 21 CFR 211.160(a)
Drugs 4314 21 CFR 211.84(d)(2)
Drugs 1033 21 CFR 211.22(a)
Drugs 1943 21 CFR 211.180(e)(1)
Drugs 2012 21 CFR 211.188(b)
Drugs 1885 21 CFR 211.165(b)
Drugs 1975 21 CFR 211.182
Drugs 3602 21 CFR 211.160(a)
Drugs 1194 21 CFR 211.42(c)
Drugs 1891 21 CFR 211.165(f)
Drugs 1920 21 CFR 211.166(a)(3)

Drugs 2205 21 CFR 211.186(b)(9)
Drugs 3547 21 CFR 211.46(b)
Drugs 1220 21 CFR 211.67(b)(3)
Drugs 1448 21 CFR 211.111
Drugs 3583 21 CFR 211.110(a)
Drugs 6730 21 CFR 314.80(b)
Drugs 1842 21 CFR 211.84(d)(1)
Drugs 1942 21 CFR 211.180(e)
Drugs 2008 21 CFR 211.186(a)
Drugs 4340 21 CFR 211.142
Drugs 18970 FDCA 501(a)(2)(A)
Drugs 1086 21 CFR 211.22(b)
Drugs 1421 21 CFR 211.42(c)(10)
Drugs 1790 21 CFR 211.80(b)
Drugs 2028 21 CFR 211.192
Drugs 3616 21 CFR 211.165(d)
Drugs 4306 21 CFR 211.80(a)
Drugs 4357 21 CFR 211.166(a)
Drugs 1098 21 CFR 211.22(c)
Drugs 1801 21 CFR 211.84(a)

Drugs 4401 21 CFR 211.186(b)(9)
Drugs 4413 21 CFR 211.194(a)(8)
Drugs 18973 FDCA 501(a)(2)(A)
Drugs 1136 21 CFR 211.25(c)
Drugs 1169 21 CFR 211.42(a)
Drugs 1802 21 CFR 211.84(b)
Drugs 1926 21 CFR 211.166(b)
Drugs 2020 21 CFR 211.188(b)(8)
Drugs 3571 21 CFR 211.100(a)
Drugs 4315 21 CFR 211.84(d)(2)
Drugs 4353 21 CFR 211.160(b)(4)
Drugs 1159 21 CFR 211.28(a)
Drugs 1270 21 CFR 211.68(b)
Drugs 1388 21 CFR 211.101(d)
Drugs 1395 21 CFR 211.103
Drugs 1728 21 CFR 211.87
Drugs 3592 21 CFR 211.110(c)
Drugs 4336 21 CFR 211.150

Drugs 6732 21 CFR 314.80(c)(1)(i)
Drugs 8911 21 CFR 314.81(b)(1)(ii)
Drugs 17764 21 CFR 212.20(e)
Drugs 18937 FDCA 501(a)(2)(A)
Drugs 21377 FDCA 501(a)(2)(A)

Drugs 1134 21 CFR 211.25(b)
Drugs 1219 21 CFR 211.67(b)(2)

Drugs 1256 21 CFR 211.68(b)
Drugs 1436 21 CFR 211.42(c)(10)(vi)
Drugs 1833 21 CFR 211.84(d)(1)
Drugs 2011 21 CFR 211.188(a)
Drugs 3445 21 CFR 211.65(a)
Drugs 3561 21 CFR 211.56(b)
Drugs 3567 21 CFR 211.84(d)(2)
Drugs 3629 21 CFR 211.170(b)
Drugs 4305 21 CFR 211.68(b)

Drugs 4406 21 CFR 211.194(a)(2)
Drugs 18961 FDCA 501(a)(2)(A)
Drugs 1162 21 CFR 211.28(a)
Drugs 1227 21 CFR 211.67(c)
Drugs 1495 21 CFR 211.122(a)
Drugs 1851 21 CFR 211.84(e)
Drugs 1932 21 CFR 211.167(a)
Drugs 2033 21 CFR 211.194(c)
Drugs 2044 21 CFR 211.196
Drugs 2406 21 CFR 211.194(a)(8)
Drugs 2619 21 CFR 211.198(b)(2)
Drugs 3570 21 CFR 211.100(a)
Drugs 3582 21 CFR 211.105(a)

Drugs 3615 21 CFR 211.160(b)(4)
Drugs 3623 21 CFR 211.170(a)
Drugs 4368 21 CFR 211.188(b)(12)
Drugs 18939 FDCA 501(a)(2)(A)
Drugs 18941 FDCA 501(a)(2)(A)
Drugs 18944 FDCA 501(a)(2)(A)
Drugs 18956 FDCA 501(a)(2)(A)
Drugs 1413 21 CFR 211.42(c)(5)
Drugs 2567 21 CFR 211.198(a)
Drugs 3588 21 CFR 211.110(a)(3)
Drugs 3639 21 CFR 211.204
Drugs 4309 21 CFR 211.84(c)(2)
Drugs 4350 21 CFR 211.160(b)(3)
Drugs 4382 21 CFR 211.198(b)(2)
Drugs 4404 21 CFR 211.194(a)(1)
Drugs 4409 21 CFR 211.194(a)(4)
Drugs 8912 21 CFR 314.81(b)(2)
Drugs 18008 FDCA 503B(a)(10)
Drugs 18951 FDCA 501(a)(2)(A)
Drugs 18953 FDCA 501(a)(2)(A)
Drugs 1224 21 CFR 211.67(b)(6)
Drugs 1261 21 CFR 211.68(a)

Drugs 1454 21 CFR 211.115(a)
Drugs 1550 21 CFR 211.125(f)
Drugs 1626 21 CFR 211.130
Drugs 1823 21 CFR 211.84(c)(4)
Drugs 1879 21 CFR 211.180(c)
Drugs 1918 21 CFR 211.166(a)(2)
Drugs 1927 21 CFR 211.166(b)
Drugs 1928 21 CFR 211.166(c)(1)
Drugs 2034 21 CFR 211.194(d)
Drugs 2402 21 CFR 211.194(a)(5)
Drugs 3553 21 CFR 211.48(a)
Drugs 3581 21 CFR 211.101(d)
Drugs 3614 21 CFR 211.160(b)(4)
Drugs 4302 21 CFR 211.56(b)

Drugs 4307 21 CFR 211.80(d)
Drugs 4328 21 CFR 211.122(a)
Drugs 4338 21 CFR 211.150(b)
Drugs 4343 21 CFR 211.160(b)(1)
Drugs 4359 21 CFR 211.170(b)(1)
Drugs 4388 21 CFR 211.198(a)
Drugs 4418 21 CFR 211.42(b)
Drugs 6831 21 CFR 314.80(c)(2)

Drugs 17763 21 CFR 212.20(d)
Drugs 17853 21 CFR 212.60(d)
Drugs 18942 FDCA 501(a)(2)(A)

Drugs 18966 FDCA 501(a)(2)(A)
Drugs 21297 21 CFR 211.186(a)
Drugs 1411 21 CFR 211.105(b)
Drugs 1418 21 CFR 211.42(c)(7)
Drugs 1420 21 CFR 211.42(c)(9)
Drugs 1433 21 CFR 211.42(c)(10)(iii)
Drugs 1498 21 CFR 211.122(b)
Drugs 1505 21 CFR 211.122(d)
Drugs 1629 21 CFR 211.130(a)
Drugs 1630 21 CFR 211.130(b)
Drugs 1632 21 CFR 211.130(c)
Drugs 1725 21 CFR 211.134(c)
Drugs 1770 21 CFR 211.137(d)
Drugs 1777 21 CFR 211.150(b)
Drugs 1797 21 CFR 211.82(a)
Drugs 1846 21 CFR 211.84(d)(3)
Drugs 1917 21 CFR 211.166(a)(1)
Drugs 1922 21 CFR 211.166(a)(4)
Drugs 2004 21 CFR 211.184(d)
Drugs 2017 21 CFR 211.188(b)(5)
Drugs 2024 21 CFR 211.188(b)(12)
Drugs 2025 21 CFR 211.188(b)(13)

Drugs 2397 21 CFR 211.194(a)(1)
Drugs 2399 21 CFR 211.194(a)(2)
Drugs 3557 21 CFR 211.52
Drugs 4317 21 CFR 211.84(d)(3)
Drugs 4325 21 CFR 211.110(a)
Drugs 4345 21 CFR 211.160(b)(1)
Drugs 4349 21 CFR 211.160(b)(2)
Drugs 4351 21 CFR 211.160(b)(3)
Drugs 4360 21 CFR 211.170(b)
Drugs 4387 21 CFR 211.198(a)
Drugs 6832 21 CFR 314.80(c)(2)
Drugs 6833 21 CFR 314.80(c)(2)(ii)(A)
Drugs 17812 21 CFR 212.50
Drugs 17863 21 CFR 212.60(g)(3)
Drugs 17961 21 CFR 361.1(c)(2)

Drugs 17993 21 CFR 361.1(f)(1)
Drugs 17994 21 CFR 361.1(f)(2)
Drugs 18938 FDCA 501(a)(2)(A)
Drugs 18949 FDCA 501(a)(2)(A)
Drugs 18957 FDCA 501(a)(2)(A)
Drugs 18959 FDCA 501(a)(2)(A)

Drugs 18971 FDCA 501(a)(2)(A)
Drugs 18972 FDCA 501(a)(2)(A)
Drugs 21284 FDCA 501(a)(2)(A)
Drugs 21295 21 CFR 211.110(b)
Drugs 1079 21 CFR 211.22(a)

Drugs 1163 21 CFR 211.28(b)
Drugs 1174 21 CFR 211.42(b)
Drugs 1223 21 CFR 211.67(b)(5)
Drugs 1251 21 CFR 211.42(c)(1)
Drugs 1637 21 CFR 211.130(e)

Drugs 1774 21 CFR 211.142(a)
Drugs 1843 21 CFR 211.84(d)(2)
Drugs 1845 21 CFR 211.84(d)(3)
Drugs 1876 21 CFR 211.180(b)
Drugs 1886 21 CFR 211.165(c)
Drugs 1976 21 CFR 211.182
Drugs 1978 21 CFR 211.182
Drugs 2007 21 CFR 211.186(a)
Drugs 2014 21 CFR 211.188(b)(2)
Drugs 2019 21 CFR 211.188(b)(7)
Drugs 2023 21 CFR 211.188(b)(11)

Drugs 2035 21 CFR 211.194(e)
Drugs 2398 21 CFR 211.194(a)(2)
Drugs 2405 21 CFR 211.194(a)(7)
Drugs 2618 21 CFR 211.198(b)(1)
Drugs 2621 21 CFR 211.198(b)(3)

Drugs 3562 21 CFR 211.56(c)
Drugs 3611 21 CFR 211.160(b)(3)
Drugs 3612 21 CFR 211.160(b)(3)
Drugs 3641 21 CFR 211.204
Drugs 4320 21 CFR 211.84(d)(6)
Drugs 4322 21 CFR 211.101(d)
Drugs 4323 21 CFR 211.115(a)
Drugs 4330 21 CFR 211.130(e)
Drugs 4364 21 CFR 211.176
Drugs 4369 21 CFR 211.188(b)(11)
Drugs 4372 21 CFR 211.188(b)(8)
Drugs 4373 21 CFR 211.188(b)(7)
Drugs 4379 21 CFR 211.188(b)(1)
Drugs 4383 21 CFR 211.198(b)(1)
Drugs 4405 21 CFR 211.194(a)(2)
Drugs 4412 21 CFR 211.194(a)(7)
Drugs 6830 21 CFR 314.80(c)(2)
Drugs 6842 21 CFR 314.80(j)
Drugs 8907 21 CFR 314.81(b)(1)(ii)
Drugs 17723 21 CFR 212.10
Drugs 17743 21 CFR 212.30(b)
Drugs 17851 21 CFR 212.60(c)

Drugs 17958 21 CFR 361.1(c)(2)
Drugs 17959 21 CFR 361.1(c)(2)
Drugs 17962 21 CFR 361.1(c)(2)
Drugs 17965 21 CFR 361.1(c)(3)
Drugs 18001 21 CFR 361.1(f)(9)
Drugs 18003 21 CFR 361.1(f)(11)
Drugs 18024 21 CFR 314.80(c)(2)(ii)(B)

Drugs 18936 FDCA 501(a)(2)(A)
Drugs 18948 FDCA 501(a)(2)(A)
Drugs 18955 FDCA 501(a)(2)(A)

Drugs 18960 FDCA 501(a)(2)(A)
Drugs 18963 FDCA 501(a)(2)(A)
Drugs 21373 21 CFR 212.30(b)
Drugs 21376 21 CFR 212.30(a)
Drugs 1168 21 CFR 211.34
Drugs 1218 21 CFR 211.67(b)(1)
Drugs 1222 21 CFR 211.67(b)(4)
Drugs 1384 21 CFR 211.101(c)
Drugs 1393 21 CFR 211.103
Drugs 1396 21 CFR 211.42(c)(2)
Drugs 1419 21 CFR 211.42(c)(8)
Drugs 1430 21 CFR 211.42(c)(10)(i)
Drugs 1496 21 CFR 211.122(a)

Drugs 1506 21 CFR 211.122(e)
Drugs 1541 21 CFR 211.125(b)
Drugs 1545 21 CFR 211.125(c)
Drugs 1546 21 CFR 211.125(d)
Drugs 1633 21 CFR 211.130(d)
Drugs 1636 21 CFR 211.130(e)
Drugs 1722 21 CFR 211.134(a)
Drugs 1726 21 CFR 211.86
Drugs 1794 21 CFR 211.80(d)
Drugs 1796 21 CFR 211.80(d)
Drugs 1798 21 CFR 211.82(b)
Drugs 1803 21 CFR 211.84(b)
Drugs 1818 21 CFR 211.84(c)(2)
Drugs 1849 21 CFR 211.84(d)(6)
Drugs 1868 21 CFR 211.94(b)
Drugs 1870 21 CFR 211.94(d)
Drugs 1874 21 CFR 211.180(b)
Drugs 1941 21 CFR 211.180(d)
Drugs 1956 21 CFR 211.180(e)(1)
Drugs 1957 21 CFR 211.180(e)(2)
Drugs 1958 21 CFR 211.180(f)
Drugs 1977 21 CFR 211.182
Drugs 1999 21 CFR 211.184(a)
Drugs 2001 21 CFR 211.184(b)

Drugs 2003 21 CFR 211.184(c)
Drugs 2015 21 CFR 211.188(b)(3)
Drugs 2016 21 CFR 211.188(b)(4)
Drugs 2018 21 CFR 211.188(b)(6)
Drugs 2021 21 CFR 211.188(b)(9)
Drugs 2032 21 CFR 211.194(b)
Drugs 2086 21 CFR 211.208

Drugs 2089 21 CFR 211.208
Drugs 2400 21 CFR 211.194(a)(3)
Drugs 2569 21 CFR 211.198(b)
Drugs 2572 21 CFR 211.198(b)

Drugs 3545 21 CFR 211.44
Drugs 3548 21 CFR 211.46(c)
Drugs 3549 21 CFR 211.46(c)
Drugs 3554 21 CFR 211.48(a)
Drugs 3558 21 CFR 211.52
Drugs 3566 21 CFR 211.84(c)(4)
Drugs 3569 21 CFR 211.89
Drugs 3577 21 CFR 211.101(b)(4)
Drugs 3578 21 CFR 211.101(c)(1)
Drugs 3580 21 CFR 211.101(c)(3)
Drugs 3586 21 CFR 211.110(a)(1)
Drugs 3604 21 CFR 211.160(b)(1)
Drugs 3608 21 CFR 211.160(b)(2)
Drugs 3610 21 CFR 211.160(b)(3)
Drugs 3625 21 CFR 211.170(a)(1)

Drugs 3628 21 CFR 211.170(a)(3)
Drugs 3630 21 CFR 211.170(b)
Drugs 3631 21 CFR 211.170(b)
Drugs 3633 21 CFR 211.170(b)(1)
Drugs 3640 21 CFR 211.204

Drugs 4310 21 CFR 211.84(c)(3)
Drugs 4321 21 CFR 211.101(b)
Drugs 4344 21 CFR 211.160(b)(1)
Drugs 4354 21 CFR 211.165(d)
Drugs 4356 21 CFR 211.166(b)
Drugs 4375 21 CFR 211.188(b)(5)
Drugs 4378 21 CFR 211.188(b)(2)
Drugs 4380 21 CFR 211.198(b)(3)
Drugs 4399 21 CFR 211.186(b)(7)
Drugs 4410 21 CFR 211.194(a)(5)

Drugs 4414 21 CFR 211.204
Drugs 6706 21 CFR 310.305(c)(1)(i)
Drugs 6728 21 CFR 314.80(b)
Drugs 6736 21 CFR 314.80(c)(1)(ii)
Drugs 8906 21 CFR 314.81(b)(1)(i)

Drugs 8908 21 CFR 314.81(b)(2)(i)
Drugs 8935 FDCA 760(b)(1)
Drugs 10022 21 CFR 310.305(a)

Drugs 17741 21 CFR 212.30(b)
Drugs 17742 21 CFR 212.30(b)
Drugs 17749 21 CFR 212.30(a)
Drugs 17760 21 CFR 212.20(c)
Drugs 17761 21 CFR 212.20(c)
Drugs 17765 21 CFR 212.20(d)
Drugs 17787 21 CFR 212.40(d)
Drugs 17822 21 CFR 212.50(b)(7)
Drugs 17830 21 CFR 212.50(b)(5)
Drugs 17841 21 CFR 212.50(d)
Drugs 17855 21 CFR 212.60(e)
Drugs 17858 21 CFR 212.60(f)
Drugs 17913 21 CFR 212.100(a)
Drugs 17960 21 CFR 361.1(c)(2)
Drugs 17964 21 CFR 361.1(c)(2)
Drugs 17985 21 CFR 361.1(d)(7)
Drugs 17991 21 CFR 361.1(d)(9)
Drugs 17997 21 CFR 361.1(f)(5)
Drugs 18009 FDCA 503B(a)(10)

Drugs 18016 21 CFR 361.1(b)(3)(i)
Drugs 18025 21 CFR 314.80(c)(2)(ii)(B)

Drugs 18033 21 CFR 314.80(g)(1)
Drugs 18940 FDCA 501(a)(2)(A)
Drugs 18947 FDCA 501(a)(2)(A)

Drugs 18964 FDCA 501(a)(2)(A)
Drugs 18965 FDCA 501(a)(2)(A)
Drugs 21255 21 CFR 329.100(c)(1)
Drugs 21294 21 CFR 211.110(b)
Drugs 21296 21 CFR 211.186(a)
Drugs 21360 FDCA 505-1(f)(4)
Drugs 21422 FDCA 503B(b)(2)(A)

Short Description
Procedures not in writing, fully followed
Scientifically sound laboratory controls
Investigations of discrepancies, failures
Absence of Written Procedures
Cleaning / Sanitizing / Maintenance
Computer control of master formula records
Written procedures not established/followed
Control procedures to monitor and validate

performance
Calibration/Inspection/Checking not done
Testing and release for distribution
Equipment Design, Size and Location
Procedures for sterile drug products
Training , Education , Experience overall
Lack of written stability program
Training--operations, GMPs, written procedures
Written record of investigation incomplete

Environmental Monitoring System
Lack of quality control unit
SOPs not followed / documented
Test methods
Complete test data included in records
Procedures for non-sterile drug products
Complaint Handling Procedure
Buildings not maintained in good state of repair
Following/documenting laboratory controls

Written program not followed
Complete Test Data
Items to cover on annual reviews
Annual visual exams of drug products
Expiration date lacking
Prepared for each batch, include complete information
Strict control not exercised over labeling issued
Storage under appropriate conditions
Cleaning System
Quality control unit review of records
Procedures to be written and followed
GMP Training Frequency
Validation lacking for sterile drug products
Sanitation--buildings not clean, free of infestation

Procedure Deviations Recorded and Justified
Establish reliability of supplier's C of A
Written procedures fail to include
Calibration - at intervals, written program, remedial

action
No written record of investigation
Establishment of calibration procedures
Approve or reject components, products
Procedures To Be in Writing
Lab controls established, including changes
Reports of Analysis (Components)
Authority lacking to review records, investigate errors
Review of representative number of batches
Batch production and Batch Control Record

Requirements
Microbiological testing
Written records kept in individual logs
Deviations from laboratory control requirements
Defined areas of adequate size for operations
Failing drug products not rejected
Valid stability test methods

Manufacturing Instructions and Specifications
Equipment for Environmental Control
Cleaning SOPs/instructions
Establishment of time limitations
Written in-process control procedures
Failure to develop written procedures
Component identity verification
Records reviewed annually
Written procedures followed
Written warehousing procedures established/followed
Disinfecting and cleaning agents, ISO 5 area
Adequate lab facilities not available
Aseptic Processing Area
Handling and Storage to Prevent Contamination
Extent of discrepancy, failure investigations
Acceptance criteria for sampling & testing
Written Procedures Not Followed
Results not used for expiration dates, storage cond.
Approve or reject procedures or specs
Components withheld from use pending release

Complete instructions, procedures, specifications et. al.
Second person sign off
Disinfecting materials, aseptic processing area
Inadequate number of personnel
Buildings of Suitable Size, Construction, Location
Representative Samples
Adequate number of batches on stability
Labeling Control Records and Label Copies
Changes to Procedures Not Reviewed, Approved
Testing Each Component for Conformity with Specs
Instruments, apparatus, et. al. not meeting specs
Clothing appropriate for duties performed
input/output verification
Component addition checked by 2nd person
Actual vs. theoretical yields not determined
Retest of approved components/containers/closures
In-process materials characteristics testing
Written distribution procedure

Late submission of 15-day report
Failure to meet specifications
Written QA procedures established, followed
Beta-lactam drugs, inadequate sanitation
Use of non-pharmaceutical grade components

Supervisor Training/Education/Experience
Cleaning SOPs/schedules
Backup file not maintained
Equipment to control conditions
Identity Testing of Each Component
Accurate reproduction
Equipment construction - reactive surfaces
Written sanitation procedures lacking
Component identification test
Reserve samples identified, representative, stored
Backup data not assured as exact and complete

Suitability of testing methods verified
Air flow quality, higher classified area
Protective Apparel Not Worn
Cleaning/maintenance records not kept
Written procedures describing in detail
Rejecting When Specifications Not Met
Sterility/pyrogen-free testing
Testing and standardization of standards et. al.
Distribution Record Requirements
Identification of Person Performing Review of Lab

Records
Complaint Investigation/Follow-Up Findings
Approval and review of procedures
Identification of containers, lines, equipment

Test devices not meeting specifications
Active ingredient retained sample kept
Investigations made into any unexplained discrepancy
Highly potent drugs, prevention of cross-contamination
Improper gowning, contamination
Exposure of personnel in aspectic processing
Cleanliness, ISO-classified areas
Mfg / Processing Operations Area
Adverse Drug Experience
Mixing adequacy
Returned drug procedures in writing and followed
Containers sampled so as to prevent contamination
Drug products-sampling procedures/specifications
Written record of complaint to include findings, follow-up
Sample identification and other information
Data secured in course of each test
Timely submission
Drug product label, outsourcer facility
Personnel contact outside ISO 5 area
Actionable microbial contamination, ISO 5 area
Cleaning SOP/inspection
Written calibration / inspection records not kept

Reprocessing procedures not written or followed
Procedures Written and Followed
Procedures are written, and followed
Top/Middle/Bottom container sampling
Records not made readily available to FDA
Stability sample storage conditions described
Accelerated stability studies
Homeopathic drugs, assessment of stability
Laboratory equipment calibration records
Testing Calculations
Plumbing System Defects
Verification of component addition
Written calibration procedures
Written sanitation procedures not followed

Status of Each Lot Identified
Written procedures not followed
Recall facilitation
Incoming lots - conformance to written specs-
Retention time of reserve samples, in general
Complaints reviewed by Quality Control Unit
Adequate space lacking to prevent mix-ups and

contamination
Late submission of quarterly safety reports

Determination need for investigation
Supplies adequately controlled
Personnel habits, contamination

Non-sterilized and non-depyrogenated, sterile drug
Master production and control records, procedure
Distinctive ID or code not recorded in batch record
Quarantined Drug Products Area
Control / Lab Operations Area
Air Supply
Labeling and packaging improperly approved/released
Label storage access limited to authorized personnel
Prevention of cross contamination, mix-ups
Unlabeled filled containers controls
Lot or control number assigned
Examinations documented
Expiration date location on labeling
Distribution Recall System
Examination on receipt, before acceptance
Establish reliability of supplier's C of A
Sample size - test intervals
Testing in same container - closure system
Labeling: documentation of exam and review
In-Process and Laboratory Control Results
Documentation of Batch Investigations
Results of drug product inspections and examinations

Description and Identification of Samples
Laboratory Test Method Verification
Washing and toilet facilities are deficient
Certificates of Testing (Containers, Closures)
Control procedures fail to include the following
Samples (various types) representative, identified

properly
In-process samples representative, identified properly
Drug products - samples representative, identified

properly
Reserve drug product sample quantity - all tests
Reporting of adverse drug experience to FDA
Late submission of annual safety reports
Incomplete periodic safety report
Adequate controls (general)
Complete record of all laboratory test data
RDRC has not kept minutes of its meetings

Packaging, labeling - Rx only
Label - For research use
Hazardous drugs, prevention of cross-contamination
First pass air blockage, open unit with sterile product
Dust-collecting overhangs, surrounding area of ISO 5
Location, ISO 5 classified area

No sporicidal agents, cleanroom and ISO 5 area
Inadequate sporicidal agents, cleanroom and ISO 5

area
Disinfectant contact time
In-process conformity - examination, sample testing
Contract drug products--lack of responsibility

Habits of good sanitation & health
Product flow through building is inadequate
Cleaning SOPs/equipment protection
Incoming material area
Packaging line inspection after use

Quarantine - actual practice
Component written specification
Container/Closure Written Test Procedure
Record maintenance 1 year (except exempt OTC)
Sampling and testing plans not described
Specific information required in individual logs
Personnel dating/signing equipment log
Signature and checking of records -- 2 persons
Identification of Equipment and Lines
Documentation of Actual Yield and Theoretical Yield
Identification of Persons Performing Significant Steps

Stability testing records not included
Test methods ID and data location
Identification of Person Performing the Testing
Complaint Record required information
Reason for Not Conducting Complaint Investigation

Written procedures lacking for use of pesticides etc.
Acceptance of drug products
Sampling/testing of drug products
Record information inclusions
Microbiological Contamination Exam
Component release checked by 2nd person
Reprocessing procedures lack steps to be taken
Packaging line inspection documentation
Failing to test for penicillin cross-contamination
Identification of persons involved, each significant step
Labeling control records including specimens or copies
Actual yield, % of theoretical yield
Dates not included for each significant step
Written complaint record must include
Statement of methods and data
Signatures and dates--person who performs test
Interval
Failure to maintain records
Contamination, chemical or physical change,

deterioration
Personnel not qualified
Equipment procedures overall
Analytical methods
Signatures of RDRC Chairman
>50% of members not at RDRC meeting
Numerical votes not in the minutes of any RDRC
meetings
Annual reports not submitted to FDA
Label - Name, address manufacturer
Label - Parenteral drug, sterile
Periodic safety report missing ICSR

Non-microbial contamination, production area
Disruption of airflow from personnel movement
Ceiling tiles, cleanroom

Flow of personnel and materials, facility
Inadequate HEPA filter, sterile product area
Equipment procedures
Orderly handling, prevention of mix-ups, prevention of

contamination
Consultant Records
Cleaning SOP/responsibility
Cleaning SOPs/equipment identification
Weighing/measuring/subdividing supervision
Yield calculations not verified by 2nd person
Rejected Material Area
Released Drug Products Area
Floors, walls, ceiling surfaces
Sampling/testing of labeling/packaging materials

Destruction of obsolete labeling
Examination of issued labels
Label reconciliation discrepancies
evaluation/investigation
Destruction of excess labels with lot numbers
Examination of packaging and labeling
Packaging line inspection before use
Correct labels during finishing operations
Rotation of components/containers/closures
Disposition recorded by lot identification
Identification of Each Lot in Each Shipment
Quarantine Storage of Components
Representative Samples Criteria
Appropriate Opening of Component Containers
Objectionable microbiological contamination
Protection from external factors
Written Procedures to Remove Pyrogens
Record maintenance 3 years (exempt OTC drugs)
Reader/Photocopy equipment not made available
Representative Number of Batches for Annual Review
Review of problem drugs
Responsible firm officials notified in writing
Dedicated equipment: records part of batch record
Record information required
Component Test Records

Individual inventory record
Identification of Components and In-Process Materials
Weights and Measures of Components Used
Documentation of Packaging and Labeling Area

Inspections
Container/Closure Description
Test method modification records not maintained
Salvaging and return to marketplace

No records maintained
Statement of Sample Weights and Measures
Maintenance of Complaint File
Complaint File Location

Adequate lighting not provided
Air filtration system lacking in production area
Air recirculation of dust from production areas
Potable water standards not met
Washing and toilet facilities not provided and accessible
Composite sample top/middle/bottom
Quarantine of Rejected Components et. al.
Subdivided component/container/finished drug
Q.C. release check by second individual
Container ID checks by a second individual
Tablet or capsule weight variation
Determination of conformance
Sampling/testing of in-process materials
Drug product sample
Retention time for reserve samples of actives

Retention times for actives of OTC drugs
Drug product reserve containers
Investigation of reserve sample deterioration
Reserve sample retention time
Returned drug products identified and held

Sterile Equipment, Aseptic Techniques in sample
collecting
Identification of new containers
Sampling and testing procedures described
Acceptance/Rejection Levels
Tentative expiration date
In-process and laboratory control results
Identity of major equipment and lines used
Determination not to conduct investigation of complaint
Theoretical yield statement including percentages
Calculations performed are in the records

Record information maintained
Late submission
Failure to review ADE information
Submission of report follow-up
Mix-up
Summary
Failure of responsible person to report AE (non-RX

Drug)
Failure to develop written procedures

Equipment not clean
Equipment not suitable
Specifications and processes
Proposed changes to existing specs/methods
Review of records for errors
Contamination, mix-ups and deterioration
Complete instructions, procedures, specs
Weight or measurement of each component
Production area & equipment checks
Equipment
Documenting procedures
Written complaint procedures
Representation of the required fields of expertise
RDRC did not meet at least once each quarter
Scientific knowledge and benefit
Institutional Review Board (IRB) approved research
Label - radioactivity, amount
Container label, outsourcer facility

Limit of radiation dose
Late submission of an ICSR

Failure to submit electronic format safety report
Inadequate control, construction adjacent to drug
production
Personnel in aseptic processing, cleanroom gowning

Unsealed HEPA filter, perimeter
Sinks, drains in cleanroom of ISO 5 area
Failure to submit report in approved electronic format
In-process specification, invalid
Master production and control records, batch uniformity
Failure to comply with REMS Implementation System
Outsourcing facility, compounded drug report follow up

Long Description
The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully
followed]. Specifically, ***
Laboratory controls do not include the establishment of scientifically sound and appropriate
[specifications] [standards] [sampling plans] [test procedures] designed to assure that [components]
[drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to
appropriate standards of identity, strength, quality and purity. Specifically, ***
There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its
components to meet any of its specifications] whether or not the batch has been already distributed.
Specifically, ***
There are no written procedures for production and process controls designed to assure that the drug
products have the identity, strength, quality, and purity they purport or are represented to possess.
Specifically, ***
Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent
[malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the
drug product. Specifically, ***
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.
Specifically, ***
Written procedures are not [established] [followed] for the cleaning and maintenance of equipment,
including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically, *** _x000D_
Control procedures are not established which [monitor the output] [validate the performance] of those
manufacturing processes that may be responsible for causing variability in the characteristics of in-
process material and the drug product. Specifically, ***_x000D_
Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not

performed according to a written program designed to assure proper performance. Specifically, ***
Testing and release of drug product for distribution do not include appropriate laboratory determination
of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient]
prior to release. Specifically, ***
Equipment used in the manufacture, processing, packing or holding of drug products is not [of
appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use]
[cleaning and maintenance]. Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
are not [established] [written] [followed]. Specifically, ***
Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the
[education] [training] [experience] required to perform their assigned functions. Specifically, ***
There is no written testing program designed to assess the stability characteristics of drug products.
Specifically, ***
Employees are not given training in [the particular operations they perform as part of their function]
[current good manufacturing practices] [written procedures required by current good manufacturing
practice regulations]. Specifically, ***
Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its
components to meet specifications] do not [always] include the conclusions and follow-up. Specifically,
***
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically, ***
There is no quality control unit. Specifically, ***
Written production and process control procedures are not [followed in the execution of production and
process control functions] [documented at the time of performance]. Specifically, ***
The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established]
[documented]. Specifically, ***
Laboratory records do not include complete data derived from all tests, examinations and assay
necessary to assure compliance with established specifications and standards. Specifically, , ***
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile
are not [established] [written] [followed]. Specifically, ***
Procedures describing the handling of written and oral complaints related to drug products are [not
written or followed] [deficiently written or followed]. Specifically, ***
Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not
maintained in a good state of repair. Specifically, ***
Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control
mechanisms] are not [followed] [documented at the time of performance]. Specifically, ***
The written stability testing program is not followed. Specifically, ***
Laboratory records are deficient in that they do not include a complete record of all data obtained during
testing. Specifically, ***
Written procedures are not [established] [followed] for evaluations done at least annually and including
provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations
conducted for each drug product]. Specifically, ***
Reserve samples from representative sample lots or batches of drug products selected by acceptable
statistical procedures are not examined visually at least once a year for evidence of deterioration.
Specifically, ***
Drug products do not bear an expiration date determined by appropriate stability data to assure they
meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, ***
Batch production and control records [are not prepared for each batch of drug product produced] [do
not include complete information relating to the production and control of each batch]. Specifically, ***
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Specifically, ***
Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that
their identity, strength, quality, and purity are not affected. Specifically, ***
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room]
[equipment] to produce aseptic conditions. Specifically, ***
Drug product production and control records, are not [reviewed] [approved] by the quality control unit
to determine compliance with all established, approved written procedures before a batch is released or
distributed. Specifically, ***
Procedures describing the handling of all written and oral complaints regarding a drug product are not
[established] [written] [followed]. Specifically, ***
GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that
employees remain familiar with CGMP requirements applicable to them. Specifically, ***
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile
did not include [adequate] validation of the [aseptic] [sterilization] process. Specifically, ***
Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained
in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin].
Specifically, ***
Deviations from written production and process control procedures are not [recorded] [justified].
Specifically, ***
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test
results are not appropriately validated at appropriate intervals. Specifically, ***
Written procedures for cleaning and maintenance fail to include [assignment of responsibility]
[maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and
materials used] [description in sufficient detail of the methods of disassembling and reassembling
equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or
obliteration of previous batch identification] [instructions for protection of clean equipment from
contamination prior to use] [parameters relevant to the operation]. Specifically, ***
The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals
[in accordance with an established written program] [with provisions for remedial action in the event
accuracy and/or precision limits are not met]. Specifically, ***
Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a
batch or any of its components to meet specifications]. Specifically, ***
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not
written or followed] [deficiently written or followed]. Specifically, ***
The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug
product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].
Specifically, ***
Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers]
[closures]. Specifically, ***
The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control
mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit]
[reviewed and approved by the quality control unit]. Specifically, ***
Reports of analysis from component suppliers are accepted in lieu of testing each component for
conformity with all appropriate written specifications, without [performing at least one specific identity
test on each component] [establishing the reliability of the supplier's analyses through appropriate
validation of the supplier's test results at appropriate intervals]. Specifically, ***
The quality control unit lacks authority to [review production records to assure that no errors have
occurred] [fully investigate errors that have occurred]. Specifically, ***
Written procedures are not [established] [followed] for evaluations conducted at least annually to
review records associated with a representative number of batches, whether approved or rejected.
Specifically, ***
The batch production and control records are deficient in that they do not include documentation of the
accomplishment of each significant step in [manufacturing] [processing] [packing] [holding]. Specifically,
***
Each batch of drug product required to be free of objectionable microorganisms is not tested through
appropriate laboratory testing. Specifically, ***
Written records of major equipment [cleaning] [maintenance] [use] are not included in individual
equipment logs. Specifically, ***
Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory
mechanisms] are not [recorded] [justified]. Specifically, ***
The [separate or defined areas] [control systems] necessary to prevent contamination or mix-ups are
deficient. Specifically, ***
Drug products failing to meet established [standards] [specifications] [quality control criteria] are not
rejected. Specifically, ***
The written stability program for drug products does not include [reliable] [meaningful] [specific] test
methods. Specifically, ***
The master production and control records are deficient in that they do not include complete
[manufacturing] [control] [instructions] [sampling] [testing] [procedures] [specifications] [special
notations] [precautions]. Specifically, ***
Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is
not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of
the methods, equipment, and materials used in the cleaning and maintenance operation, and the
methods of disassembly and reassembling equipment as necessary to assure proper cleaning and
maintenance. Specifically, ***_x000D_
Time limits are not established when appropriate for the completion of each production phase to assure
the quality of the drug product. Specifically, ***
Written procedures are not [established] [followed] that describe the [in-process controls] [tests]
[examinations] to be conducted on appropriate samples of in-process materials of each batch.
Specifically, ***
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to
FDA] of post marketing adverse drug experiences. Specifically, ***
Drug product component testing is deficient in that at least one specific test to verify the identity of each
component is not performed. Specifically,***
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality
standards of each drug product to determine the need for changes in specifications or manufacturing or
control procedures. Specifically, ***
Procedures for the preparation of master production and control records are not [described in a written
procedure] [followed]. Specifically, ***
Procedures describing the warehousing of drug products are not [established] [followed]. Specifically,
***
Disinfecting agents and [cleaning pads] [cleaning wipes] used in the ISO 5 classified aseptic processing
areas were not sterile. Specifically, ***
Adequate lab facilities for testing and approval or rejection of [components] [drug product containers]
[closures] [packaging materials] [in-process materials] [drug products] are not available to the quality
control unit. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related
to aseptic processing of drug products. Specifically,***
There was a failure to handle and store [components] [drug product containers] [closures] at all times in
a manner to prevent contamination. Specifically, ***
Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any
of its specifications] did not extend to [other batches of the same drug product] [other drug products
that may have been associated with the specific failure or discrepancy]. Specifically, ***
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to
assure that batches of drug products meet [each appropriate specification] [appropriate statistical
quality control criteria] as a condition for their approval and release. Specifically, ***
Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling]
[testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, ***
Results of stability testing are not used in determining [appropriate storage conditions] [expiration
dates]. Specifically, ***
The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications
impacting on the [identity] [strength] [quality] [purity] of drug products. Specifically, ***
Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has
been sampled, tested, examined, and released by the quality control unit. Specifically, ***
Master production and control records lack [complete manufacturing and control instructions] [sampling
and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, ***
Laboratory records do not include the initials or signature of a second person showing that the original
records have been reviewed for [accuracy] [completeness] [compliance with established standards].
Specifically, ***
[Equipment was] [Materials or supplies were] not disinfected prior to entering the aseptic processing
areas. Specifically, ***
The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture]
[processing] [packing] [holding] of each drug product. Specifically, ***
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the
suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.
Specifically, ***
Representative samples are not taken of each shipment of each lot of [components] [drug product
containers] [closures] for testing or examination. Specifically, ***
An adequate number of batches of each drug product are not tested [nor are records of such data
maintained] to determine an appropriate expiration date. Specifically, ***
The batch production and control records are deficient in that they do not include [complete labeling
control records] [specimen] [copy] of labeling. Specifically, ***
Changes to written procedures are not [drafted, reviewed and approved by the appropriate
organizational unit] [reviewed and approved by the quality control unit]. Specifically, ***
Each component is not tested for conformity with all appropriate written specifications for purity,
strength, and quality. Specifically, ***
The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications
was observed. Specifically, ***
Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is
not appropriate for the duties they perform. Specifically, ***
Input to and output from [the computer] [related systems of formulas] [records or data] are not checked
for accuracy. Specifically, ***
Each component is not added to a batch by one person and verified by a second person. Specifically, ***
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate
phase of [manufacturing] [processing] [packaging] [holding] of the drug product. Specifically, ***
Approved [components] [drug product containers] [closures] are not retested or reexamined as
appropriate for identity, strength, quality and purity after [storage for long periods] [exposure to conditions
that might have an adverse effect] with subsequent approval or rejection by the quality control unit.
Specifically, ***
In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the
quality control unit [during the production process] [after storage for long periods]. Specifically, ***
Written distribution procedures are not [established] [followed]. Specifically, ***

Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within
15 calendar days of initial receipt of the information. Specifically, ***
An NDA-Field Alert Report was not submitted within three working days of receipt of information
concerning a failure of one or more distributed batches of a drug to meet the specifications established
for it in the application. Specifically, ***
You did not [establish] [follow] written quality assurance procedures. Specifically,***
You produced beta-lactam drugs without providing adequate [containment] [segregation] [cleaning of
work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically,
***
You used a non-pharmaceutical grade component in the formulation of a drug product. Specifically, ***
Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug
product lack the [education] [training] [experience] to perform their assigned functions in such a manner
as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is
represented to possess. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and
cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, ***
Failure to maintain a backup file of data entered into the computer or related system. Specifically, ***
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control
the aseptic conditions. Specifically, *** _x000D_
The identity of each component of a drug product is not verified by conducting at least one test to verify
the identity, using specific identity tests if they exist. Specifically, ***
The batch production and control records are deficient in that they are not [an accurate reproduction of
the appropriate master production or control record] [checked for accuracy, dated, and signed].
Specifically, ***
Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive,
additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product
beyond the official or other established requirements. Specifically, ***
There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing
in sufficient detail the methods, equipment and materials to be used] for sanitation. Specifically, ***
Specific identification tests are not conducted on components that have been accepted based on the
supplier's report of analysis. Specifically, ***
Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of
drug product] [retained and stored under conditions consistent with product labeling]. Specifically, ***
Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping
hard copy or alternate systems. Specifically, ***
The suitability of all testing methods is not verified under actual conditions of use. Specifically, ***
Your facility design allowed the influx of poor quality air into a higher classified area. Specifically, ***
Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, ***
Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically,
***
There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage]
[handling] [sampling] [examination] [testing] of labeling and packaging materials. Specifically, ***
Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the
appropriate written specifications for identity, strength, quality, and purity. Specifically, ***
Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine
conformance to such requirements. Specifically, ***
Laboratory records do not include complete records of any testing and standardization of laboratory
[reference standards] [reagents] [standard solutions]. Specifically, ***
Distribution records do not contain the [name and strength of the drug product] [description of dosage
form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug
product]. Specifically, ***
Laboratory records are deficient in that they do not include the [initials] [signature] of the second person
reviewing the record for accuracy. Specifically, ***
Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].
Specifically, ***
Written procedures are not [drafted, reviewed and approved by the appropriate organizational units]
[reviewed and approved by the quality control unit]. Specifically, ***
All [compounding and storage containers] [processing lines] [major equipment] used during the
production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase
of processing of the batch]. Specifically, ***
Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting
established specifications are used. Specifically, ***
A sample which is representative of each lot in each shipment of each active ingredient is not
[appropriately identified] [retained]. Specifically, ***
Batch production and control records do not include the results of any investigation made into any
unexplained discrepancy, whether or not the batch of drug product had already been distributed.
Specifically, ***
You produced highly potent drugs without providing adequate [containment] [segregation] [cleaning of
work surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically,
***
Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to
become contaminated. Specifically, ***
Personnel engaged in aseptic processing were observed with [exposed hands] [exposed wrists] [exposed
legs] [exposed hair] [exposed mouth]. Specifically, ***
The ISO 5 classified aseptic processing areas had [difficult to clean] [particle-generating] [visibly dirty]
equipment or surface. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing
and processing operations. Specifically, ***
Complaint procedures are deficient in that they do not include provisions that allow for the review to
determine if the complaints represent [serious] [unexpected adverse drug experiences] which are
required to be reported to FDA. Specifically, ***
The in process control procedures were deficient in that they did not include an examination of the
adequacy of mixing to assure uniformity and homogeneity. Specifically, ***
Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing]
[followed]. Specifically, ***
Containers are not [opened] [sampled] [resealed] in a manner designed to prevent contamination of [their
contents] [other components] [other drug product containers or closures]. Specifically, ***
Laboratory controls do not include a determination of conformance to [written descriptions of sampling
procedures] [appropriate specifications] for drug products. Specifically, ***
Written records of investigation of a drug complaint do not include [the findings of the investigation] [the
follow-up]. Specifically, ***
Laboratory records do not include [a description of the sample received for testing] [the source or location
from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code
of the sample] [the date the sample was taken] [the date the sample was received for testing].
Specifically, ***
Laboratory records do not include a complete record of all data secured in the course of each test,
including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the
[specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product
tested]. Specifically, ***
An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval
of the application] to the FDA division responsible for reviewing the application. Specifically, ***
The labels of your outsourcing facility's drug products are deficient. Specifically,***
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing
area with gloved hands and then engaged in aseptic processing without changing or sanitizing gloves.
Specifically, ***
You did not make adequate product evaluation and take remedial action where actionable microbial
contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic
production. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the
equipment for cleanliness immediately before use. Specifically, ***
Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment,
including computers or related systems are not maintained. Specifically, ***
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will
conform with all established standards, specifications, and characteristics are not [written] [followed].
Specifically, ***
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not
[written] [followed]. Specifically, ***
Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug
products are not [written] [followed]. Specifically, ***
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of
container. Specifically, ***_x000D_
Records associated with drug product [components] [containers] [closures] [labeling] [production] [control]
[distribution] and within the retention period for such records, were not made readily available for
authorized inspection. Specifically, ***
The written stability program for drug products does not describe the storage conditions for samples
retained for testing. Specifically, ***
Accelerated stability studies, combined with basic stability information, used to support tentative
expiration dates are not supported with ongoing full shelf life studies. Specifically, ***
There is no written assessment of stability of homeopathic drug products based at least on [testing or
examination of the drug product for compatibility of the ingredients] [marketing experience with the drug
product to indicate that there is no degradation of the product for the normal or expected period of use].
Specifically, ***
Laboratory records do not include complete records of the periodic calibration of laboratory [instruments]
[apparatus] [gauges] [recording devices]. Specifically, ***
Laboratory records are deficient in that they do not include all calculations performed during testing.
Specifically, ***
The plumbing system contains defects that could contribute to the contamination of drug products.
Specifically, ***
Each component is not added to the batch by one person and verified by a second person.. Specifically,
***
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in
that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for
remedial action if limits are not met]. Specifically, ***
Written procedures for sanitation are not followed. Specifically, ***
Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its
status in terms of being quarantined, approved or rejected. Specifically, ***
Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of
packaging and labeling materials are not followed. Specifically, ***
A system by which the distribution of each lot of drug product can be readily determined to facilitate its
recall if necessary, has not been established. Specifically, ***
Laboratory controls do not include determination of conformance to appropriate written specifications for
the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [in-
process materials] [labeling] [drug products] used in the manufacture, processing, packing, or holding of
drug products. Specifically, ***
You did not retain reserve samples for drug products for one year after the expiration dates of the drug
products. Specifically, ***
Written procedures describing the handling of complaints do not include provisions for [review by the
quality control unit of any complaint involving the possible failure of a drug product to meet any of its
specifications] [a determination as to the need for an investigation of any unexplained discrepancy]
[explaining the reasons for the failure of the batch or any of its components to meet specifications].
Specifically, ***
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-
ups between [different components] [drug product containers] [closures] [labeling] [in-process materials]
[drug products] and to prevent contamination. Specifically, ***
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the
close of the quarter. Specifically, ***
When errors occurred or a production batch or any component of the batch, failed to meet specifications,
you did not [determine the need for an investigation] [conduct an investigation] [take appropriate
corrective actions] when necessary. Specifically, ***
Your [identity] [purity] [quality] of [reagents] [solutions] [supplies] used in your testing procedures are not
adequately controlled. Specifically, ***
Personnel did not [disinfect] [change gloves frequently enough] to prevent contamination. Specifically, ***
[Non-sterilized] [Non-depyrogenated] equipment was used in sterile drug production. Specifically, ***
The preparation of your master production and control records was not [described in a written procedure]
[followed in accordance with your written procedure]. Specifically, ***
The batch records do not record the distinctive [identification number] [code] [name of equipment] to
identify major equipment to show the specific equipment used in the manufacture of a batch of a drug
product. Specifically, ***
to the quarantine storage of drug products prior to release. Specifically, ***
Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls
and operations. Specifically, ***
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency
particulate air filters under positive pressure. Specifically, ***
Labeling and packaging materials not meeting the appropriate written specifications were [approved]
[released for use]. Specifically, ***
Access to the storage area for labels and labeling materials is not limited to authorized personnel.
Specifically, ***
There is insufficient physical or spatial separation from operations and other drug products to prevent
mix-ups and cross-contamination. Specifically, ***
Filled drug product containers which are set aside and held in an unlabeled condition are not [identified]
[handled] to preclude mislabeling of individual containers, lots or portions of lots. Specifically, ***
The drug product is not identified with a lot or control number that permits the determination of the history
of the manufacture and control of the batch. Specifically, ***
The results of the examination of the packaged and labeled products were not documented in the batch
production or control records. Specifically, ***
Drug product expiration dates do not appear on the labeling in the manner prescribed by regulations.
Specifically, ***
The distribution system is deficient in that each lot of drug product cannot be readily determined to
facilitate its recall if necessary. Specifically, ***
Each container or grouping of containers of [components] [drug product containers] [closures] is not
examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container
damage] [broken seals] [contamination]. Specifically, ***
Establishment of the reliability of the [container] [closure] supplier's report of analyses is deficient in that
the test results are not appropriately validated at appropriate intervals. Specifically, ***
The written stability program for drug products does not include [sample size] [test intervals] based on
statistical criteria for each attribute examined to assure valid estimates of stability. Specifically, ***
The written stability program does not assure testing of the drug product in the same container-closure
system as that in which the drug product is marketed. Specifically, ***
There is no documentation of the examination and review of labels and labeling for conformity with
[established specifications] [the assigning of a lot or control number]. Specifically, ***
The batch production and control records are deficient in that they do not include [in-process] [laboratory]
control results. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of batch
investigations performed. Specifically, ***
The batch production and control records are deficient in that they do not include results of drug product
[examinations] [inspections]. Specifically, ***
Laboratory records are deficient in that they do not include a [description and identification of the sample
received] [quantity] [lot number] [date sample taken] [date sample received for testing]. Specifically, ***
Verification of the suitability of the testing methods is deficient in that they are not [performed under actual
conditions of use] [documented on the laboratory records]. Specifically, ***
Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service
towels] [cleanliness]. Specifically, ***
Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual
identification] [establishing the reliability of the supplier's test results through appropriate validation of the
test results at appropriate intervals]. Specifically, ***
Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of
mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of
solutions]. Specifically,***
Samples taken to determine conformance to appropriate written specifications for the acceptance of each
lot within each shipment of [components] [drug product containers] [closures] [labeling] are not
[representative] [adequately identified]. Specifically, ***
Samples taken of in-process materials for determination of conformance to specifications are not
[representative] [properly identified]. Specifically, ***
Samples taken of drug products for determination of conformance to written specifications are not
[representative] [properly identified]. Specifically, ***
The reserve sample of drug product does not consist of at least twice the quantity necessary to perform
all the required tests of drug product. Specifically, ***
Written procedures describing the handling of all written and oral complaints do not include provisions for
review to determine whether the complaint represents a serious and unexpected adverse drug
experience which is required to be reported to the Food and Drug Administration. Specifically, ***
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the
anniversary date of the approval of the application. Specifically, ***
You failed to submit a periodic report containing [a narrative summary and analysis of the ADE
information for the reporting interval in the report] [an analysis of the post marketing 15-day Alert reports
submitted during the reporting interval] [a history of actions taken since the last report because of adverse
drug experiences] [an index with a line listing of your patient identification code and adverse reaction
term(s) for all ICSRs you submitted for the reporting interval]. Specifically, ***
Your firm lacks adequate production and process controls to ensure the consistent production of a PET
drug that meets the applicable standards of identity, strength, quality and purity. Specifically,***
Laboratory test records did not contain a complete record of all data obtained in the course of each test,
including [the date and time the test was conducted] [all graphs, charts, and spectra from laboratory
instrumentation, properly identified to show the specific component, in-process material, or drug product
for each lot tested]. Specifically, ***
The RDRC did not keep minutes for each of its meetings. Specifically, ***
The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the
RDRC research project did not bear the statement "Rx only". Specifically, ***
RDRC research project did not bear a statement that the drug is to be administered in compliance with
radioactive drug research use. Specifically, ***
You produced hazardous drugs without providing adequate [containment] [segregation] [cleaning of work
surfaces] [cleaning of utensils] [cleaning of personnel] to prevent cross-contamination. Specifically, ***
Personnel [conducted aseptic manipulations] [placed equipment/supplies] in an area that blocked the
movement of first pass air around an open unit, either before or after it was filled with sterile product.
Specifically, ***
The [ISO 5 classified aseptic processing areas] [segregated production areas surrounding the ISO 5
classified aseptic processing area] contained dust-collecting overhangs without adequate and frequent
cleaning. Specifically, ***
The ISO 5 classified aseptic processing area was located within a non-classified room (segregated
production area). Specifically, ***
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing
area. Specifically, ***
The use of sporicidal agents in the [cleanrooms] [ISO 5 classified aseptic processing] area was
[inadequate] [infrequent]. Specifically, ***
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were
insufficient to achieve adequate levels of disinfection. Specifically, ***
Your examination and testing of samples did not assure that the drug product and in-process material
conformed to specifications. Specifically, ***
The quality control unit lacks responsibility for approving or rejecting drug products [manufactured]
[processed] [packed] [held] under contract by another company. Specifically, ***
Production personnel were not practicing good sanitation and health habits. Specifically, ***
The flow of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug
products] though the building is not designed to prevent contamination. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean
equipment from contamination prior to use. Specifically, ***
to the receipt, identification, storage, and withholding from use of [components] [drug product containers]
[closures] [labeling] pending sampling, testing, or examination by the quality control unit before release
for manufacturing or packaging. Specifically, ***
Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable
for subsequent operations have been removed. Specifically, ***
Drug products are not quarantined before being released by the quality control unit. Specifically, ***
Component testing is deficient in that each component is not tested for conformity with all appropriate
written specifications for purity, strength, and quality. Specifically, ***
Drug product container and closure test procedures are deficient in that [containers] [closures] are not
tested for conformance in accordance with appropriate written procedures. Specifically, ***
All records of [production] [control] [distribution] [components] [drug product containers] [closures]
[labeling] associated with a batch of drug product were not maintained at least one (1) year after the
expiration date. Specifically, ***
Sampling and testing plans for drug products are not described in written procedures which include the
[method of sampling] [number of units per batch to be tested]. Specifically, ***
Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].
Specifically, ***
The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or
initialing] the equipment cleaning and use log. Specifically, ***
The master production and control records for each batch size of drug product are not [prepared, dated,
and signed by one person with a full handwritten signature] [independently checked, dated, and signed
by a second person]. Specifically, ***
The batch production and control records are deficient in that they do not include the identity of major
[equipment] [lines] used. Specifically, ***
The batch production and control records are deficient in that they do not include a statement of the
[actual yield] [percentage of theoretical yield]. Specifically, ***
The batch production and control records are deficient in that they do not include identification of persons
[performing] [supervising] [checking] each significant step in the operation. Specifically, ***
Laboratory records do not include complete records of all stability testing performed. Specifically, ***
Laboratory records are deficient in that they do not include [a statement of the method used in testing the
sample] [the location of the data that assures the accuracy and reliability of the test method]. Specifically,
***
Laboratory records are deficient in that they do not include the [initials] [signature] of the person
performing the tests and the dates the tests were performed. Specifically, ***
Complaint records are deficient in that they do not include the known [name and strength of the drug
product] [lot number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
Complaint records are deficient in that they do not document the reason and the individual making the
decision not to conduct a complaint investigation. Specifically, ***
Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents]
[cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug
product containers] [closures] [packaging, labeling materials] [drug products]. Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are [not made]
[deficient] for drug products. Specifically, ***
The specifications for drug products are deficient in that they do not include a description of the [sampling
plan] [testing procedures] for drug products. Specifically, ***
Records of returned drug products do not include the [name] [labeled potency] [lot, control or batch
number] [reason for return] [quantity] [date of disposition] [ultimate disposition]. Specifically, ***
Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination
that is objectionable in view of its intended use is not subjected to microbiological tests before use.
Specifically, ***
Each container of component dispensed to manufacturing is not examined by a second person to assure
that [the component was released by the quality control unit] [the weight or measure is correct as stated
in the batch records] [the containers are properly identified]. Specifically, ***
Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with
all established standards, specifications, and characteristics. Specifically, ***
Results of inspection of packaging and labeling facilities are not documented in the batch production
records. Specifically, ***
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility
existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.
Specifically, ***
Batch production and control records do not include the identification of the persons [performing] [directly
supervising] [checking] each significant step in the operation, for each batch of drug product produced.
Specifically, ***
Batch production and control records do not include complete labeling control records, including
specimens or copies of all labeling used for each batch of drug product produced. Specifically, ***
The batch production and control records do not include a statement of the [actual yield] [percentage of
theoretical yield] at appropriate stages of processing for each batch of drug product produced.
Specifically, ***
Batch production and control records do not include dates of each significant step in the [manufacture]
[processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, ***
Written complaint records do not include, where known, [the name and strength of the drug product] [lot
number] [name of complainant] [nature of complaint] [reply to complainant]. Specifically, ***
Laboratory records do not include a statement of [each method used in the testing of a sample] [the
location of data that establish that the methods used in the testing of the sample meet proper standards
of accuracy and reliability as applied to the product tested]. Specifically, ***
Laboratory records do not include [the initials or signature of the person who performs each test] [the
date(s) the tests were performed]. Specifically, ***
Periodic reports of non-alert adverse drug experiences have not been submitted [quarterly for an
application which was approved less than three years ago] [yearly for an application which was approved
three or more years ago]. Specifically, ***
You failed to maintain for a period of 10 years records of all adverse drug experiences known to you,
including raw data and any correspondence. Specifically, ***
concerning [bacteriological contamination] [significant chemical, physical, or other change or
deterioration] in a distributed drug product. Specifically, ***
You lack [a sufficient number of] personnel with the necessary [education] [background] [training]
[experience] to perform their assigned functions. Specifically, ***
You did not implement procedures to ensure that all your equipment is [properly installed] [maintained]
[capable of repeatedly producing valid results]. Specifically,***
Your laboratory analytical methods are not [suitable for their intended use] [sufficiently sensitive]
[sufficiently specific] [sufficiently accurate] [sufficiently reproducible]. Specifically, ***
The RDRC Chairman did not sign all [applications] [minutes] [reports] of the committee. Specifically, ***
The RDRC met without having more than 50% of its membership present. Specifically, ***
The minutes of an RDRC meeting did not include the numerical results of votes on protocols involving
use in human subjects. Specifically, ***
The RDRC did not submit annual reports to FDA as required by regulations. Specifically, ***
RDRC research project did not bear the [name] [address] of the manufacturer, packer, or distributor.
Specifically, ***
The label of a radioactive parenteral drug prepared, packaged, distributed, and primarily intended for use
in the RDRC research project did not bear a statement as to whether the contents are sterile. Specifically,
***
You submitted a periodic report that failed to contain an ICSR for a serious, expected, or nonserious
adverse drug experience. Specifically, ***
Non-microbial contamination was observed in your production area. Specifically, ***
Personnel moved rapidly in the vicinity of [open sterile units] [instruments], which disrupted the airflow
and increased the risk of bringing lesser quality air into the ISO 5 classified aseptic processing area.
Specifically, ***
Unsealed, loose ceiling tiles were observed in your cleanroom. Specifically, ***
Your facility was designed and/or operated in a way that permits poor flow of [personnel] [materials].
Specifically, ***
You had inadequate HEPA filter [coverage] [airflow] over the area to which sterile product was exposed.
Specifically, ***
You did not [implement procedures] [document your activities in accordance with your procedures] to
ensure that all equipment is [cleaned] [suitable for its intended purposes] [properly installed, maintained,
and capable of repeatedly producing valid results] that could reasonably be expected to adversely affect
the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when
improperly used or maintained. Specifically, ***
Your facilities are not adequate to ensure [the orderly handling of materials and equipment] [the
prevention of mix-ups] [the prevention of contamination of equipment or product by substances,
personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on
product quality. Specifically, ***
Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service
provided]. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of
responsibility for cleaning and maintaining equipment. Specifically, ***
Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or
obliteration of the previous batch identification. Specifically, ***
Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically,
***
Yield calculations are not performed by one person and independently verified by a second person.
Specifically, ***
to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.
Specifically,***
to the storage of drug products after release. Specifically,***
Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard
surfaces that are easily cleanable. Specifically,***
Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt
and before use in packaging and labeling of a drug product. Specifically, ***
Obsolete or outdated labels, labeling and packaging materials are not destroyed. Specifically, ***
Labeling materials issued for a batch were not carefully examined for identity and conformity to the
labeling specified in the master or batch production records. Specifically, ***
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and
returned, were not [evaluated] [investigated]. Specifically, ***
Excess labeling bearing lot or control numbers is not destroyed. Specifically, ***
Examination of packaging and labeling materials for suitability and correctness before packaging
operations is [not performed] [not documented in the batch production records]. Specifically, ***
Inspection of the [packaging] [labeling] facilities immediately before use is not done to assure that all drug
products have been removed from previous operations. Specifically, ***
Packaged and labeled products are not examined during finishing operations to provide assurance that
containers and packages in the lot have the correct label. Specifically, ***
There is a lack of rotation so that the oldest approved stock of [components] [drug product containers]
[closures] is used first. Specifically, ***
The distinctive code for each lot of [components] [drug product containers] [closures] is not used in
recording the disposition of each lot. Specifically, ***
Each lot in each shipment received was not identified with a distinctive code for each container or
grouping of containers for [components] [drug product containers] [closures]. Specifically, ***
Incoming [components] [drug product containers] [closures] are not stored under quarantine until they
have been tested or examined, as appropriate, and released. Specifically, ***
The [number of containers to be sampled] [amount of material taken from each container] is not based
upon appropriate criteria. Specifically, ***
The containers of components, or drug product containers or closures which are sampled are not opened
in a manner to prevent [contamination of their contents] [contamination of other components]
[contamination of other drug product containers] [contamination of other closures]. Specifically, ***
Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological
contamination is deficiently subjected to microbiological tests before use. Specifically, ***
Container closure systems do not provide adequate protection against foreseeable external factors in
storage and use that can cause deterioration or contamination of the drug product. Specifically, ***
There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of
sterilization] [methods of processing] to remove pyrogenic properties. Specifically, ***_x000D_
Records for all [production] [control] [distribution] [components] [drug product containers] [closures]
[labeling] associated with a batch of OTC drug product exempt from expiration dating were not
maintained for 3 years after distribution of the last lot of drug product incorporating the component or
using the container, closure, or labeling. Specifically, ***
Suitable reader or photocopying equipment was not made readily available for [drug product]
[component] records maintained using reduction techniques. Specifically, ***
The procedures for the annual quality standards record evaluation are deficient in that they do not
address a review of a representative number of [approved] [rejected] batches. Specifically, ***
The procedures for the annual quality standards record evaluation are deficient in that they do not
address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation]
records for each drug product. Specifically, ***
Procedures are not established which are designed to assure that the responsible officials of the firm, if
they are not personally involved in or immediately aware of such actions, are notified in writing of
[investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory
actions brought by FDA relating to good manufacturing practices]. Specifically, ***
The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.
Specifically, ***
The records for [components] [drug product containers or closures] [labeling] do not include the [identity
and quantity of each shipment of each lot] [name of the supplier] [supplier's lot number] [receiving code]
[date of receipt] [name of the prime manufacturer if different from the supplier] [location of the prime
manufacturer]. Specifically, ***
The [component] [drug product container] [closure] [labeling] records do not include the [results of tests or
examinations performed] [the conclusions derived from tests or examinations performed]. Specifically, ***
Records fail to include an individual inventory record of each [component] [reconciliation of the use of
each component] [drug product container] [drug product closure] with sufficient information to allow
determination of any associated batch or lot of drug product. Specifically, ***
The batch production and control records are deficient in that they do not include specific identification of
each [batch of component] [in-process material] used. Specifically, ***
The batch production and control records are deficient in that they do not include [weights] [measures] of
components used in the process. Specifically, ***
The batch production and control records are deficient in that they do not include documentation of the
inspection of the [packaging] [labeling] area before and after use. Specifically, ***
The batch production and control records are deficient in that they do not include a description of drug
product containers and closures. Specifically, ***
Complete records are not maintained of any modification of an established method employed in testing.
Specifically, ***
Drug products that have been subjected to improper storage conditions were salvaged and returned to
the marketplace without further evidence or inspection. Specifically, ***
No records are maintained for salvaged drug products. Specifically, ***
Laboratory records are deficient in that they do not include a statement of the [weight] [measure] of the
sample used for testing. Specifically, ***
Complaint procedures are deficient in that written complaint records are not maintained in a file
designated for drug product complaints. Specifically, ***
Complaint procedures are deficient in that written complaint files are not maintained at the manufacturing
site nor were they readily available from their off-site location. Specifically, ***
Adequate lighting is not provided in all areas. Specifically, ***
The production area air supply lacks an appropriate air filtration system. Specifically, ***
Air is recirculated to production areas, without adequate measures to control recirculation of dust.
Specifically, ***
The potable water being permitted for use in the potable water system fails to meet standards prescribed
by the Environmental Protection Agency. Specifically, ***
Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, ***
Sampling procedures are deficient regarding compositing for testing of samples collected from the top,
middle, and bottom of the component container. Specifically, ***
Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system
designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Specifically, ***
Containers holding subdivided components for drug product manufacturing are deficiently identified in
that they lack the batch for which component was dispensed, including its name, strength, and lot
number. Specifically, ***
Component containers dispensed to manufacturing are deficiently examined by a second person in that
the component is not released by the quality control unit. Specifically, ***
Component containers dispensed to manufacturing are deficiently examined by a second person in that
the containers are improperly identified. Specifically, ***
The in-process control procedures were deficient in that it did not include an examination of [tablet]
[capsule] weight variation. Specifically, ***
Determinations of conformance to appropriate written specifications for acceptance are deficient in that
they are not made for each lot within each shipment of [components] [drug product containers] [closures]
[labeling] used in the manufacture, processing, packing or holding of drug products. Specifically, ***
The specifications for in-process materials are deficient in that they do not include a description of the
[sampling plan] [testing procedures] for in-process materials. Specifically, ***
Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, ***
Reserve samples of active drug ingredients are deficient in that they are not retained at least one year
after the expiration date of the last lot of the drug containing the active drug ingredient. Specifically, ***
Reserve samples of OTC drug ingredients are deficient in that they are not retained for at least three
years after the distribution of the last batch which contained the ingredient of OTC drugs exempt from
expiration dating. Specifically, ***
Drug product reserve samples are not stored in [the same immediate container-closure system as the
marketed product] [an immediate container-closure system that has essentially the same characteristics
as the marketed product]. Specifically, ***
Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained
with other stability data]. Specifically, ***_x000D_
The retention period for drug product reserve samples (except those described in 211.170(b)(2) and (3))
is deficient in that they are not retained for one year after the expiration date of the drug product.
Specifically, ***
Returned drug products are not [identified as such] [held]. Specifically, ***
Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample.
Specifically, ***
For components removed from the original containers, the new container fails to be identified with
[component name or item code] [receiving or control number] [weight or measure] [batch for which
component was dispensed including product name, strength and lot number]. Specifically, ***
Written specifications for laboratory controls do not include a description of the [sampling] [testing]
procedures used. Specifically, ***
The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].
Specifically, ***
Where data from accelerated studies was used to project a tentative expiration date beyond a date
supported by actual shelf life studies, there were no [stability studies] [drug product testing at appropriate
intervals] conducted until the tentative expiration date was verified or the appropriate expiration date
determined. Specifically, ***
Batch production and control records do not include [in-process] [laboratory control] results for each batch
of drug product produced. Specifically, ***
Batch production and control records do not include the identity of individual major [equipment] [lines]
used for each batch of drug product produced. Specifically, ***
The written record did not include the [reason an investigation was found not to be necessary] [name of
the responsible person making the determination not to conduct an investigation] when an investigation
into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications]
was not conducted. Specifically, ***
Master production and control records lack a statement of theoretical yield [including the maximum and
minimum percentages of theoretical yield beyond which investigation is required]. Specifically, ***
Laboratory records do not include a record of all calculations performed in connection with the test.
Specifically, ***
Records of returned drug products are not maintained. Specifically, ***
Each post marketing 15-day Alert report was not submitted to FDA within 15 calendar days of initial
receipt of the information. Specifically, ***
Adverse drug experience information obtained or otherwise received from any source was not [promptly]
reviewed, including information from [commercial marketing experience] [post marketing clinical
investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature]
[unpublished scientific papers]. Specifically, ***
Follow-up reports were not submitted [within 15 calendar days of receipt of new information] [as
requested by FDA] concerning post marketing 15-day reports. Specifically, ***
concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another
article. Specifically, ***
An annual report did not include [a brief summary of significant new information from the previous year
that might affect the safety, effectiveness, or labeling of the drug product] [a brief description of actions
the applicant has taken or intends to take as a result of this new information] [a brief description of
actions the applicant has taken or intends to take as a result of new information from the previous year
that might affect the safety, effectiveness, or labeling of the drug product] [a brief statement whether
labeling supplements for pediatric use have been submitted and whether new studies in the pediatric
population have been initiated]. Specifically, ***
Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to
the Secretary. Specifically, ***
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA]
of postmarketing adverse drug experiences. Specifically, ***
You did not implement procedures to ensure that all your equipment is clean. Specifically, ***
You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.
Specifically,***
Your facilities are not adequate to ensure the prevention of contamination of [equipment] [product] by
[substances] [personnel] [environmental conditions] that could reasonably be expected to have an
adverse effect on product quality. Specifically,***
You did not approve or reject, before implementation, [any initial] [any proposed changes to existing]
[specifications] [methods] [processes or procedures] to ensure that they maintain the identity, strength,
quality, and purity of a PET drug. Specifically, ***
You did not approve or reject, before implementation, proposed changes to existing [specifications]
[methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and
purity of a PET drug. Specifically,***
You did not review production records to determine whether errors had occurred. Specifically,***
You did not handle and store [components] [containers] [closures] in a manner that prevents
[contamination] [mix-ups] [deterioration] and ensures that they are and remain suitable for their intended
use. Specifically,***
Your master production and control records did not include complete [production and control instructions]
[sampling and testing procedures] [specifications] [special notations] [precautions to be followed].
Specifically,***
Your master production and control records did not include an accurate statement of the weight or
measurement of each component, using the same weight system (metric, avoirdupois, or apothecary) for
each component. Specifically, ***
Your [production area] [equipment in the production area] was not checked to ensure [cleanliness]
[suitability] immediately before use. Specifically,***
All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing
valid results]. Specifically,***
You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment.
Specifically,***
You have not [developed] [followed] written procedures for the receipt and handling of all complaints
concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,***
The RDRC met without having the appropriate representation of the required fields of expertise.
Specifically, ***
The RDRC did not meet at least once each quarter in which research activity was authorized or
conducted. Specifically, ***
The RDRC did not [consider] [assure] that scientific knowledge and benefit is likely to result from the
proposed research study. Specifically, ***
The RDRC did not assure that research was approved by an Institutional Review Board (IRB).
Specifically, ***
RDRC research project did not bear the [name and half-life of the radionuclide] [total quantity of
radioactivity in the drug product's immediate container] [amount of radioactivity per unit volume or unit
mass at a designated referenced time]. Specifically, ***
The container labels of your outsourcing facility's drug products are deficient. Specifically,***
The RDRC did not determine that the cumulative radiation dose to an adult research subject from a
number of studies conducted within one year did not exceed an annual and total dose commitment of 5
rems for the [whole body] [active blood-forming organs] [lens of the eye] [gonads]. Specifically, ***
You failed to submit an ICSR for the reporting period [within 30 days of the close of the quarter] [within 60
days of the anniversary date of the approval of the application]. Specifically, ***
Not all safety report submissions were made in an electronic format. Specifically, ***
Your firm produced drugs while construction was underway in an adjacent area without adequate controls
to prevent contamination of the production environment and product. Specifically, ***
Personnel engaged in aseptic processing were observed leaving and re-entering the cleanroom from
non-classified areas without first replacing gowning apparel. Specifically, ***
HEPA filters were not sealed around each perimeter to the support frame. Specifically, ***
Sinks or drains were present in the cleanroom where the ISO 5 classified aseptic processing area was
located. Specifically, ***
Not all safety report submissions, including ICSRs and any ICSR attachments, were made in an
electronic format that FDA can process, review, and archive. Specifically, ***
Your in-process specifications for sampling and testing of in-process materials and drug products [were
inconsistent with drug product final specifications] [were not derived from previous acceptable process
average and process variability estimates] [were not determined by the application of suitable statistical
procedures]. Specifically, ***
Your master production and control records for each drug product were not [prepared, dated, and signed
by one person] [independently checked, dated, and signed by a second person]. Specifically, ***
An application holder did not [ensure wholesalers / distributors who distribute the drug are authorized to
distribute the drug] [comply with the audit plan and schedule described in the REMS] [identify and
address non-compliant authorized wholesalers / distributors] [maintain a Support / Call Center or a REMS
Program website] [maintain the drug distribution and dispensing records to ensure restricted distribution],
as required by your approved REMS Implementation System. Specifically, ***
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the
previous six month period. Specifically, ***
Frequency
208
127
107
86
81
71
64
64
60
56
53
50
47
47
41
40
35
35
34
33
33
32
32
31
29
29
28
28
27
26
26
25
25
23
23
23
22
21
21
21
20
20
20
20
18
17
17
17
17
16
16
16
15
15
15
14
14
14
14
14
13
13
13
13
12
12
12
12
12
11
11
11
11
11
11
11
10
10
10
10
10
8
8
8
7
7
7
7
7
7
6
6
6
4
4
4
4
4
4
4
4
4
3
3
3
3
3
3
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Foods 18254 21 CFR 1.502(a)
Foods 1524 21 CFR 123.11(b)
Foods 18145 21 CFR 117.35(c)
Foods 18161 21 CFR 117.80(c)
Foods 18141 21 CFR 117.35(a)
Foods 18138 21 CFR 117.10
Foods 18149 21 CFR 117.40

Foods 18148 21 CFR 117.37
Foods 18140 21 CFR 117.20(b)
Foods 905 21 CFR 123.6(b)
Foods 959 21 CFR 123.6(c)(1)
Foods 1560 21 CFR 110.35(c)
Foods 960 21 CFR 123.6(c)(2)
Foods 18146 21 CFR 117.35(d)
Foods 18142 21 CFR 117.35(a)
Foods 961 21 CFR 123.6(c)(3)
Foods 15839 21 CFR 111.70(e)
Foods 908 21 CFR 123.6(d)

Foods 1306 21 CFR 110.20(b)(7)
Foods 6004 21 CFR 123.6(c)(4)
Foods 1525 21 CFR 123.11(c)
Foods 18165 21 CFR 117.93
Foods 963 21 CFR 123.6(c)(5)
Foods 1422 21 CFR 110.20(b)(4)
Foods 945 21 CFR 123.12(a)(2)
Foods 19030 21 CFR 117.130(a)(1)
Foods 904 21 CFR 123.6(b)
Foods 1695 21 CFR 110.80(b)(2)
Foods 1552 21 CFR 110.35(a)
Foods 6008 21 CFR 123.8(a)(3)
Foods 15927 21 CFR 111.103

Foods 18147 21 CFR 117.35(e)
Foods 4470 21 CFR 108.25(c)(2)
Foods 18398 21 CFR 117.4
Foods 1405 21 CFR 110.10(b)(6)
Foods 15858 21 CFR 111.75(a)(1)(i)
Foods 18153 21 CFR 117.80(a)
Foods 15641 21 CFR 111.453
Foods 1287 21 CFR 110.20(a)(1)

Foods 1554 21 CFR 110.35(a)
Foods 15532 21 CFR 111.255(b)
Foods 18139 21 CFR 117.20(a)
Foods 990 21 CFR 110.10(b)(3)
Foods 15797 21 CFR 111.553

Foods 15829 21 CFR 111.70(b)(1)
Foods 1562 21 CFR 110.35(d)
Foods 15869 21 CFR 111.75(c)
Foods 1553 21 CFR 110.35(a)
Foods 1689 21 CFR 110.80
Foods 1701 21 CFR 110.80(b)(7)
Foods 18143 21 CFR 117.35(b)(1)
Foods 6005 21 CFR 123.6(c)(6)
Foods 2386 21 CFR 110.80(a)(1)
Foods 15830 21 CFR 111.70(b)(2)
Foods 15897 21 CFR 111.83(a)
Foods 15861 21 CFR 111.75(a)(2)(ii)(A)
Foods 1125 21 CFR 110.40(a)
Foods 9931 21 CFR 120.6(b)
Foods 15531 21 CFR 111.255(a)
Foods 15762 21 CFR 111.205(a)

Foods 18144 21 CFR 117.35(b)(2)
Foods 6001 21 CFR 123.11(b)
Foods 18163 21 CFR 117.80(c)(8)
Foods 6020 21 CFR 123.9(a)
Foods 15825 21 CFR 111.65
Foods 16042 21 CFR 111.503
Foods 933 21 CFR 123.8(a)(2)(ii)
Foods 1292 21 CFR 110.20(b)(1)
Foods 3078 21 CFR 114.80(b)
Foods 15763 21 CFR 111.205(a)

Foods 19027 21 CFR 117.126(a)(1)
Foods 1005 21 CFR 110.10(b)(7)
Foods 2392 21 CFR 110.80(b)(1)
Foods 3086 21 CFR 114.100(b)
Foods 15659 21 CFR 111.475(b)(1)
Foods 6018 21 CFR 123.7(a)
Foods 19066 21 CFR 117.165(b)
Foods 1427 21 CFR 110.20(b)(5)

Foods 1581 21 CFR 110.37(e)
Foods 6021 21 CFR 123.10
Foods 1424 21 CFR 110.20(b)(4)
Foods 18151 21 CFR 117.40(f)
Foods 19049 21 CFR 117.145(a)
Foods 1006 21 CFR 110.10(b)(8)

Foods 1406 21 CFR 110.10(b)(6)
Foods 1597 21 CFR 110.37(b)(3)

Foods 19033 21 CFR 117.135(a)(1)
Foods 19058 21 CFR 117.135(c)(3)
Foods 3080 21 CFR 114.83
Foods 15838 21 CFR 111.70(d)
Foods 16057 21 CFR 111.535(b)(1)
Foods 18262 21 CFR 1.504(a)

Foods 3071 21 CFR 114.80(a)(1)
Foods 19048 21 CFR 117.135(c)(2)
Foods 1173 21 CFR 110.40(f)

Foods 1698 21 CFR 110.80(b)(5)
Foods 15809 21 CFR 111.570(b)(1)
Foods 1556 21 CFR 110.35(b)(2)
Foods 1615 21 CFR 110.93
Foods 6007 21 CFR 123.9(a)

Foods 21276 21 CFR 117.405(a)(1)
Foods 1007 21 CFR 110.10(b)(9)
Foods 6015 21 CFR 123.6(c)(6)
Foods 15453 21 CFR 111.16

Foods 1402 21 CFR 110.10(b)(4)
Foods 4511 21 CFR 108.25(f)
Foods 906 21 CFR 123.6(b)
Foods 1565 21 CFR 110.35(d)(3)
Foods 4519 21 CFR 108.35(c)(3)(i)
Foods 1126 21 CFR 110.40(a)

Foods 16122 21 CFR 118.4(a)(2)(i)
Foods 18160 21 CFR 117.80(b)(8)
Foods 19044 21 CFR 117.165(b)
Foods 901 21 CFR 123.6(a)
Foods 1316 21 CFR 113.87(c)
Foods 3062 21 CFR 114.10
Foods 3647 21 CFR 110.10(c)

Foods 3658 21 CFR 110.37(e)(2)
Foods 4464 21 CFR 108.25(c)(1)
Foods 18290 21 CFR 1.506(a)(1)
Foods 21098 21 CFR 112.123(a)
Foods 1702 21 CFR 110.80(b)(8)
Foods 3073 21 CFR 114.80(a)(2)
Foods 12755 21 CFR 120.11(a)(1)(iv)
Foods 15932 21 CFR 111.105(a)
Foods 18162 21 CFR 117.80(c)
Foods 19059 21 CFR 117.145(a)

Foods 932 21 CFR 123.7(d)
Foods 985 21 CFR 110.10(b)(1)
Foods 1066 21 CFR 110.40(b)
Foods 1571 21 CFR 110.35(d)(5)
Foods 3652 21 CFR 110.37(e)(1)
Foods 4515 21 CFR 108.35(c)(2)
Foods 12747 21 CFR 120.8(b)(3)

Foods 15494 21 CFR 111.25(c)
Foods 15790 21 CFR 111.403
Foods 15819 21 CFR 111.55
Foods 18154 21 CFR 117.80(a)(2)
Foods 19039 21 CFR 117.150(a)(1)
Foods 19062 21 CFR 117.150(a)(1)
Foods 1429 21 CFR 110.20(b)(6)
Foods 1696 21 CFR 110.80(b)(3)
Foods 3877 21 CFR 113.60(c)
Foods 4479 21 CFR 108.25(e)
Foods 6019 21 CFR 123.8(a)(2)
Foods 9961 21 CFR 120.24(a)
Foods 16138 21 CFR 118.4(c)(1)

Foods 18562 21 CFR 1.512(b)(2)
Foods 19036 21 CFR 117.145(a)
Foods 19084 21 CFR 117.305
Foods 21165 21 CFR 112.147(a)
Foods 1403 21 CFR 110.10(b)(4)
Foods 1426 21 CFR 110.20(b)(5)
Foods 1598 21 CFR 110.37(b)(4)
Foods 3085 21 CFR 114.100(a)
Foods 6016 21 CFR 123.6(c)(7)
Foods 9958 21 CFR 120.12(c)
Foods 12742 21 CFR 120.8(a)

Foods 12745 21 CFR 120.8(b)(1)
Foods 15409 21 CFR 111.14(b)(1)
Foods 15796 21 CFR 111.430(b)
Foods 15828 21 CFR 111.70(a)
Foods 15840 21 CFR 111.70(e)
Foods 15871 21 CFR 111.75(c)(2)
Foods 16152 21 CFR 118.5(a)

Foods 18283 21 CFR 1.505(b)
Foods 19031 21 CFR 117.130(a)(2)
Foods 19061 21 CFR 117.145(c)(1)
Foods 21148 21 CFR 112.144(b)(1)
Foods 1128 21 CFR 110.40(a)
Foods 1642 21 CFR 113.100(b)

Foods 3659 21 CFR 110.37(e)(3)
Foods 15454 21 CFR 111.16
Foods 15496 21 CFR 111.27(b)
Foods 15736 21 CFR 111.353

Foods 15747 21 CFR 111.210(g)
Foods 15759 21 CFR 111.205(b)(2)
Foods 15817 21 CFR 111.570(b)(2)(ii)(F)

Foods 18399 21 CFR 117.305
Foods 21147 21 CFR 112.144(a)
Foods 1172 21 CFR 110.40(e)
Foods 1293 21 CFR 110.20(b)(2)
Foods 1570 21 CFR 110.35(d)(5)

Foods 1763 21 CFR 110.35(b)(1)
Foods 2361 21 CFR 110.80
Foods 3661 21 CFR 110.37(e)(5)

Foods 6014 21 CFR 123.6(c)(2)
Foods 9930 21 CFR 120.6(c)
Foods 9941 21 CFR 120.8(a)

Foods 15410 21 CFR 111.14(b)(2)
Foods 15543 21 CFR 111.260(c)
Foods 15761 21 CFR 111.205(b)(1)
Foods 15831 21 CFR 111.70(b)(3)
Foods 15885 21 CFR 111.77(a)
Foods 15930 21 CFR 111.105
Foods 16058 21 CFR 111.535(b)(2)
Foods 16117 21 CFR 118.4

Foods 16120 21 CFR 118.4
Foods 18164 21 CFR 117.80(c)(9)
Foods 18281 21 CFR 1.505(a)(2)
Foods 19060 21 CFR 117.145(b)
Foods 21141 21 CFR 112.142(e)(1)
Foods 918 21 CFR 123.8(a)
Foods 1184 21 CFR 110.35(e)

Foods 1453 21 CFR 129.40(a)(1)
Foods 3072 21 CFR 114.80(a)(1)
Foods 4181 21 CFR 113.89
Foods 4475 21 CFR 108.25(c)(3)(i)
Foods 6010 21 CFR 123.8(a)(3)(i)
Foods 6017 21 CFR 123.7(c)

Foods 9928 21 CFR 120.12(b)
Foods 9936 21 CFR 120.7(a)
Foods 12734 21 CFR 120.12(a)
Foods 12748 21 CFR 120.8(b)(5)
Foods 15546 21 CFR 111.260(f)

Foods 15662 21 CFR 111.303
Foods 15843 21 CFR 111.70(g)
Foods 15862 21 CFR 111.75(a)(2)
Foods 15928 21 CFR 111.103
Foods 15986 21 CFR 111.123(b)(2)

Foods 16140 21 CFR 118.4(c)(2)
Foods 18156 21 CFR 117.80(b)(1)
Foods 18167 21 CFR 117.95(a)(3)
Foods 18293 21 CFR 1.506(b)
Foods 19035 21 CFR 117.135(c)(1)
Foods 21109 21 CFR 112.126(b)
Foods 913 21 CFR 123.8(a)(1)
Foods 929 21 CFR 123.8(b)
Foods 931 21 CFR 123.8(d)
Foods 986 21 CFR 110.10(b)(2)
Foods 1045 21 CFR 113.10
Foods 1067 21 CFR 110.40(c)
Foods 1289 21 CFR 110.20(a)(3)

Foods 1330 21 CFR 113.100(a)
Foods 1602 21 CFR 110.37(a)
Foods 3075 21 CFR 114.80(a)(4)
Foods 3082 21 CFR 114.89
Foods 3643 21 CFR 110.10(b)(5)
Foods 3657 21 CFR 110.37(d)(4)
Foods 6006 21 CFR 123.6(c)(7)
Foods 6009 21 CFR 123.8(a)(3)(iii)
Foods 9935 21 CFR 120.7(a)
Foods 9955 21 CFR 120.11(a)(1)
Foods 12743 21 CFR 120.8(b)(4)
Foods 12744 21 CFR 120.8(b)(4)
Foods 15404 21 CFR 111.12(c)
Foods 15505 21 CFR 111.27(a)(3)(v)
Foods 15743 21 CFR 111.210(h)(3)
Foods 15744 21 CFR 111.210(h)(2)
Foods 15832 21 CFR 111.70(c)(1)
Foods 15853 21 CFR 111.73
Foods 15882 21 CFR 111.75(h)(2)
Foods 15983 21 CFR 111.123(a)(7)

Foods 16013 21 CFR 111.140(b)(1)
Foods 16195 21 CFR 118.10(a)(3)(iv)
Foods 18256 21 CFR 1.502(b)(1)
Foods 19037 21 CFR 117.145(b)

Foods 19045 21 CFR 117.160(a)
Foods 19056 21 CFR 117.165(b)
Foods 19083 21 CFR 117.180(d)
Foods 21101 21 CFR 112.123(d)(1)
Foods 21151 21 CFR 112.145(a)
Foods 21166 21 CFR 112.147(a)
Foods 1040 21 CFR 113.10
Foods 1090 21 CFR 110.40(d)

Foods 1129 21 CFR 110.40(a)
Foods 1425 21 CFR 110.20(b)(4)
Foods 1578 21 CFR 110.37(f)
Foods 1599 21 CFR 110.37(b)(5)
Foods 1709 21 CFR 110.80(b)(13)
Foods 1766 21 CFR 110.35(b)(1)
Foods 2301 21 CFR 129.80(f)
Foods 2388 21 CFR 110.80(a)(5)
Foods 3067 21 CFR 114.80(a)

Foods 3654 21 CFR 110.37(d)(1)
Foods 9939 21 CFR 120.7(c)
Foods 9943 21 CFR 120.8(a)
Foods 9947 21 CFR 120.11(b)

Foods 9954 21 CFR 120.11(a)(1)(iv)
Foods 12746 21 CFR 120.8(b)(2)
Foods 12749 21 CFR 120.8(b)(6)
Foods 15388 21 CFR 111.10(b)
Foods 15401 21 CFR 111.12(b)

Foods 15442 21 CFR 111.15(b)(1)
Foods 15542 21 CFR 111.260(b)
Foods 15544 21 CFR 111.260(d)
Foods 15567 21 CFR 111.260(l)(4)
Foods 15582 21 CFR 111.155(e)
Foods 15607 21 CFR 111.165(c)(2)
Foods 15610 21 CFR 111.165(d)(1)
Foods 15642 21 CFR 111.455(a)
Foods 15774 21 CFR 111.415(f)(1)

Foods 15786 21 CFR 111.410(b)
Foods 15842 21 CFR 111.70(f)
Foods 15863 21 CFR 111.75(a)(2)(ii)(B)
Foods 15872 21 CFR 111.75(c)(3)
Foods 15963 21 CFR 111.113(b)(2)
Foods 16014 21 CFR 111.140(b)(1)
Foods 16040 21 CFR 111.610(a)
Foods 16045 21 CFR 111.503

Foods 16118 21 CFR 118.4
Foods 16142 21 CFR 118.4(c)(3)
Foods 16203 21 CFR 118.10(b)(1)

Foods 16494 FDCA 601(c)
Foods 18157 21 CFR 117.80(b)(2)
Foods 18296 21 CFR 1.506(d)(1)(i)
Foods 18559 21 CFR 1.512(b)(1)(i)(A)
Foods 19051 21 CFR 117.145(c)(1)

Foods 19052 21 CFR 117.150(a)(1)
Foods 21035 21 CFR 112.22(c)
Foods 21279 21 CFR 117.415(a)(2)
Foods 21280 21 CFR 117.420(b)
Foods 938 21 CFR 123.9(c)
Foods 975 21 CFR 123.9(b)(1)
Foods 1130 21 CFR 110.40(a)
Foods 1255 21 CFR 129.20(a)
Foods 1596 21 CFR 110.37(b)(2)
Foods 1640 21 CFR 113.100(b)
Foods 2274 21 CFR 129.80(g)(1)
Foods 3077 21 CFR 114.80(b)
Foods 3089 21 CFR 114.100(c)
Foods 3656 21 CFR 110.37(d)(3)

Foods 3874 21 CFR 113.60(b)
Foods 4421 21 CFR 110.20(a)
Foods 4514 21 CFR 108.35(c)(1)
Foods 4524 21 CFR 108.35(g)

Foods 4529 21 CFR 108.35(c)(2)(ii)
Foods 6022 21 CFR 123.12(c)
Foods 9917 21 CFR 120.10(c)
Foods 12732 21 CFR 120.10(a)
Foods 12751 21 CFR 120.8(b)(7)
Foods 15302 21 CFR 120.11(a)(2)
Foods 15425 21 CFR 111.15(i)
Foods 15434 21 CFR 111.15(d)(2)
Foods 15458 21 CFR 111.20(d)(1)(i)

Foods 15480 21 CFR 111.20(h)
Foods 15481 21 CFR 111.23(b)
Foods 15499 21 CFR 111.27(a)
Foods 15533 21 CFR 111.255(c)
Foods 15551 21 CFR 111.260(j)(1)
Foods 15566 21 CFR 111.260(l)(3)
Foods 15573 21 CFR 111.153
Foods 15578 21 CFR 111.155(c)
Foods 15645 21 CFR 111.455(c)

Foods 15652 21 CFR 111.465(b)
Foods 15737 21 CFR 111.210(h)(5)
Foods 15748 21 CFR 111.210(f)
Foods 15760 21 CFR 111.205(b)(1)
Foods 15783 21 CFR 111.410(d)

Foods 15791 21 CFR 111.403
Foods 15801 21 CFR 111.560(b)
Foods 15841 21 CFR 111.70(f)
Foods 15860 21 CFR 111.75(a)(2)

Foods 15901 21 CFR 111.83(b)(3)
Foods 15921 21 CFR 111.95(b)(2)
Foods 15951 21 CFR 111.110(c)
Foods 15977 21 CFR 111.123(a)(1)
Foods 16008 21 CFR 111.135
Foods 16017 21 CFR 111.140(b)(3)
Foods 16043 21 CFR 111.503
Foods 16134 21 CFR 118.4(b)(3)

Foods 16192 21 CFR 118.10(a)(3)(i)
Foods 16193 21 CFR 118.10(a)(3)(ii)
Foods 16204 21 CFR 118.10(b)(2)
Foods 18155 21 CFR 117.80(a)(5)
Foods 18263 21 CFR 1.504(b)(1)
Foods 18295 21 CFR 1.506(d)(1)(i)
Foods 18330 21 CFR 1.510(a)(1)

Foods 18397 21 CFR 117.4
Foods 19028 21 CFR 117.126(a)(2)
Foods 19034 21 CFR 117.135(b)
Foods 19038 21 CFR 117.145(c)(1)
Foods 19072 21 CFR 117.150(a)(1)
Foods 19078 21 CFR 117.139(a)
Foods 21054 21 CFR 112.42(a)
Foods 21091 21 CFR 112.113
Foods 1303 21 CFR 113.81(f)
Foods 1304 21 CFR 129.35(a)(1)

Foods 1483 21 CFR 113.87(a)
Foods 1487 21 CFR 113.87(b)
Foods 1561 21 CFR 110.35(c)
Foods 1641 21 CFR 113.100(b)
Foods 1691 21 CFR 113.40(a)(4)

Foods 1731 21 CFR 113.40(a)(2)
Foods 1734 21 CFR 113.40(a)(2)(iii)
Foods 1761 21 CFR 129.80(a)
Foods 1944 21 CFR 129.80(d)
Foods 2102 21 CFR 113.40(a)(13)(i)
Foods 2206 21 CFR 113.40(b)(15)
Foods 2271 21 CFR 129.80(e)
Foods 2272 21 CFR 129.80(e)
Foods 2275 21 CFR 129.80(g)(2)
Foods 3644 21 CFR 110.10(b)(5)

Foods 3650 21 CFR 110.35(d)(1)
Foods 3872 21 CFR 113.60(a)(3)
Foods 4067 21 CFR 113.40(a)(12)(iii)
Foods 9946 21 CFR 120.11(b)
Foods 9986 21 CFR 120.24(c)
Foods 15402 21 CFR 111.12

Foods 15403 21 CFR 111.12(b)
Foods 15443 21 CFR 111.15(b)(2)
Foods 15478 21 CFR 111.20(f)
Foods 15492 21 CFR 111.25(a)
Foods 15493 21 CFR 111.25(b)
Foods 15498 21 CFR 111.27(d)
Foods 15511 21 CFR 111.27(d)
Foods 15526 21 CFR 111.30(c)
Foods 15545 21 CFR 111.260(e)
Foods 15549 21 CFR 111.260(i)
Foods 15560 21 CFR 111.260(k)(2)
Foods 15579 21 CFR 111.155(c)(1)
Foods 15583 21 CFR 111.155(d)(1)
Foods 15599 21 CFR 111.160(d)(1)
Foods 15619 21 CFR 111.180(b)(1)
Foods 15620 21 CFR 111.180(b)(1)
Foods 15623 21 CFR 111.180(b)(2)
Foods 15649 21 CFR 111.465(a)(1)
Foods 15698 21 CFR 111.320(a)
Foods 15732 21 CFR 111.365(a)
Foods 15733 21 CFR 111.365
Foods 15771 21 CFR 111.415(h)
Foods 15784 21 CFR 111.410(c)

Foods 15800 21 CFR 111.560(a)(2)
Foods 15845 21 CFR 111.73
Foods 15849 21 CFR 111.73
Foods 15867 21 CFR 111.75(b)(1)
Foods 15891 21 CFR 111.80(a)
Foods 15920 21 CFR 111.95(b)(1)

Foods 15933 21 CFR 111.105(b)
Foods 15938 21 CFR 111.105(f)
Foods 15939 21 CFR 111.105(g)
Foods 15944 21 CFR 111.105(i)
Foods 15952 21 CFR 111.113
Foods 15978 21 CFR 111.123(a)(2)
Foods 15984 21 CFR 111.123(a)(8)
Foods 15995 21 CFR 111.127(d)
Foods 16004 21 CFR 111.130(b)
Foods 16070 21 CFR 111.35(b)(2)
Foods 16071 21 CFR 111.35(b)(3)
Foods 16206 21 CFR 118.10(b)(3)
Foods 16508 21 CFR 129.80(f)
Foods 18150 21 CFR 117.40(e)
Foods 18166 21 CFR 117.95(a)
Foods 18288 21 CFR 1.505(d)
Foods 18303 21 CFR 1.506(e)(1)
Foods 18401 21 CFR 117.320
Foods 18572 21 CFR 1.512(b)(3)(i)

Foods 19029 21 CFR 117.310
Foods 19050 21 CFR 117.145(b)
Foods 21029 21 CFR 112.21(a)
Foods 21033 21 CFR 112.22(a)
Foods 21037 21 CFR 112.30(b)
Foods 21049 21 CFR 112.32
Foods 21102 21 CFR 112.123(d)(2)
Foods 21108 21 CFR 112.126(a)(2)
Foods 21113 21 CFR 112.128(b)
Foods 21131 21 CFR 112.133
Foods 21154 21 CFR 112.145(c)(3)
Foods 21156 21 CFR 112.145(e)
Foods 21167 21 CFR 112.147(b)
Foods 21400 21 CFR 117.80(b)(4)
Foods 976 21 CFR 123.9(b)(2)
Foods 1329 21 CFR 113.100(a)
Foods 1331 21 CFR 113.100(a)(1)
Foods 1351 21 CFR 129.35(a)(3)(i)
Foods 1353 21 CFR 129.35(a)(3)(i)
Foods 1423 21 CFR 129.37(d)
Foods 1471 21 CFR 113.83
Foods 1529 21 CFR 113.89
Foods 1533 21 CFR 113.100(b)
Foods 1566 21 CFR 110.35(d)(4)
Foods 1577 21 CFR 110.37(f)

Foods 1595 21 CFR 110.37(b)(1)
Foods 1601 21 CFR 110.37(a)
Foods 1643 21 CFR 113.100(e)
Foods 1651 21 CFR 113.40(a)(1)
Foods 1669 21 CFR 110.80(a)(3)
Foods 1688 21 CFR 110.80
Foods 1711 21 CFR 110.80(b)(15)
Foods 1806 21 CFR 129.80(b)(1)
Foods 2142 21 CFR 113.40(b)(1)
Foods 2153 21 CFR 113.40(b)(2)(iii)
Foods 2273 21 CFR 129.80(g)(1)
Foods 2396 21 CFR 110.80(b)(6)
Foods 2837 21 CFR 113.40(g)(4)
Foods 3083 21 CFR 114.89
Foods 3653 21 CFR 110.37(d)

Foods 3655 21 CFR 110.37(d)(2)
Foods 3660 21 CFR 110.37(e)(4)
Foods 3663 21 CFR 110.40(e)
Foods 3712 21 CFR 110.93
Foods 3862 21 CFR 113.60(a)(1)
Foods 3881 21 CFR 113.60(d)
Foods 4062 21 CFR 113.100(a)
Foods 6002 21 CFR 123.11(b)

Foods 9919 21 CFR 120.10(a)
Foods 9932 21 CFR 120.6(a)

Foods 9981 21 CFR 120.12(b)(4)
Foods 12709 21 CFR 129.80(c)

Foods 12720 21 CFR 1.225
Foods 12733 21 CFR 120.11(a)(1)(iv)(C)
Foods 12750 21 CFR 120.8(b)(6)
Foods 15349 FDCA 761(d)

Foods 15381 21 CFR 111.8
Foods 15447 21 CFR 111.15(c)(3)
Foods 15455 21 CFR 111.20(a)
Foods 15491 21 CFR 111.25
Foods 15506 21 CFR 111.27(a)(4)
Foods 15521 21 CFR 111.27(d)(6)
Foods 15536 21 CFR 111.255(d)
Foods 15547 21 CFR 111.260(g)
Foods 15548 21 CFR 111.260(h)
Foods 15554 21 CFR 111.260(j)(2)(ii)
Foods 15557 21 CFR 111.260(k)
Foods 15563 21 CFR 111.260(l)(1)(i)
Foods 15564 21 CFR 111.260(l)(1)(ii)
Foods 15571 21 CFR 111.153
Foods 15589 21 CFR 111.160(c)

Foods 15613 21 CFR 111.165(e)
Foods 15630 21 CFR 111.180(b)(3)(i)
Foods 15647 21 CFR 111.460(b)
Foods 15648 21 CFR 111.465(a)(2)

Foods 15660 21 CFR 111.475(b)(2)
Foods 15702 21 CFR 111.320(b)
Foods 15706 21 CFR 111.325(a)

Foods 15709 21 CFR 111.325(b)(2)
Foods 15715 21 CFR 111.375(b)
Foods 15723 21 CFR 111.365(i)
Foods 15734 21 CFR 111.360
Foods 15745 21 CFR 111.210(h)(1)
Foods 15746 21 CFR 111.210(h)(1)
Foods 15755 21 CFR 111.205(c)
Foods 15778 21 CFR 111.415(b)
Foods 15799 21 CFR 111.560(a)(1)
Foods 15802 21 CFR 111.560(c)
Foods 15803 21 CFR 111.560(c)
Foods 15810 21 CFR 111.570(b)(2)
Foods 15855 21 CFR 111.73
Foods 15864 21 CFR 111.75(a)(2)(ii)(C)
Foods 15865 21 CFR 111.75(a)(2)(ii)(D)
Foods 15898 21 CFR 111.83(b)(1)
Foods 15903 21 CFR 111.87
Foods 15935 21 CFR 111.105(d)
Foods 15954 21 CFR 111.113(a)(2)
Foods 15972 21 CFR 111.120(b)
Foods 15973 21 CFR 111.120(c)
Foods 15985 21 CFR 111.123(b)(1)

Foods 15989 21 CFR 111.127
Foods 16016 21 CFR 111.140(b)(2)(ii)
Foods 16037 21 CFR 111.605
Foods 16066 21 CFR 111.35(b)(1)(i)
Foods 16074 21 CFR 111.35(b)(4)
Foods 16133 21 CFR 118.4(b)(2)

Foods 16171 21 CFR 118.7(a)
Foods 16172 21 CFR 118.7(a)
Foods 16190 21 CFR 118.10(a)(1)
Foods 16191 21 CFR 118.10(a)(2)
Foods 16205 21 CFR 118.10(b)(3)
Foods 16286 21 CFR 113.87(c)
Foods 16495 FDCA 601(c)
Foods 16500 21 CFR 129.35(a)(3)(i)
Foods 18152 21 CFR 117.40(g)

Foods 18158 21 CFR 117.80(b)(5)
Foods 18170 21 CFR 117.110(b)
Foods 18271 21 CFR 1.504(d)
Foods 18299 21 CFR 1.506(d)(1)(ii)
Foods 18333 21 CFR 1.510(b)(1)
Foods 18641 21 CFR 118.10(a)(4)
Foods 19041 21 CFR 117.150(b)(2)
Foods 19043 21 CFR 117.165(a)(4)
Foods 19046 21 CFR 117.160(b)
Foods 19065 21 CFR 117.165(a)(4)
Foods 19071 21 CFR 117.145(c)(1)

Foods 19079 21 CFR 117.139(b)
Foods 21026 21 CFR 112.11
Foods 21134 21 CFR 112.140(b)
Foods 21137 21 CFR 112.142(a)
Foods 21153 21 CFR 112.145(c)
Foods 21169 21 CFR 112.147(c)
Foods 21177 21 CFR 112.150(b)(1)
Foods 21187 21 CFR 112.161(b)

Foods 21256 21 CFR 1.502(a)
Foods 21273 21 CFR 117.206(a)
Foods 21275 21 CFR 117.206(a)(5)
Foods 939 21 CFR 123.9(f)
Foods 950 21 CFR 123.12(d)
Foods 1060 21 CFR 123.11(a)
Foods 1093 21 CFR 110.40(g)
Foods 1132 21 CFR 110.40(a)
Foods 1176 21 CFR 110.40(f)
Foods 1188 21 CFR 110.37(c)
Foods 1196 21 CFR 110.10(a)
Foods 1197 21 CFR 110.10(a)
Foods 1276 21 CFR 129.20(c)
Foods 1286 21 CFR 129.35(a)(1)
Foods 1300 21 CFR 113.81(c)
Foods 1348 21 CFR 129.35(a)(2)
Foods 1428 21 CFR 110.20(b)(6)
Foods 1472 21 CFR 113.83

Foods 1484 21 CFR 113.87(a)
Foods 1500 21 CFR 113.89
Foods 1600 21 CFR 110.37(a)
Foods 1644 21 CFR 113.100(e)
Foods 1660 21 CFR 113.40(a)(1)(v)
Foods 1665 21 CFR 110.80(a)(2)
Foods 1697 21 CFR 110.80(b)(4)
Foods 1706 21 CFR 110.80(b)(10)
Foods 1708 21 CFR 110.80(b)(12)
Foods 1757 21 CFR 113.40(a)(8)
Foods 1812 21 CFR 129.80(c)
Foods 1945 21 CFR 129.80(d)
Foods 2101 21 CFR 113.40(a)(13)
Foods 2104 21 CFR 113.40(a)(13)(iii)
Foods 2111 21 CFR 113.40(b)(4)
Foods 2143 21 CFR 113.40(b)(1)(iv)
Foods 2149 21 CFR 113.40(b)(1)(v)

Foods 2150 21 CFR 113.40(b)(2)
Foods 2151 21 CFR 113.40(b)(2)(i)
Foods 2154 21 CFR 113.40(b)(2)(iii)
Foods 2167 21 CFR 113.40(b)(10)
Foods 2169 21 CFR 113.40(b)(10)
Foods 2219 21 CFR 113.40(b)(9)
Foods 2284 21 CFR 129.80(f)
Foods 2384 21 CFR 110.80(a)(7)
Foods 2391 21 CFR 110.80(a)(6)

Foods 2394 21 CFR 110.80(b)(6)
Foods 2838 21 CFR 113.40(g)(1)(i)(A)
Foods 2840 21 CFR 113.40(g)(1)(i)(A)
Foods 2852 21 CFR 113.40(g)(1)(i)(C)
Foods 2885 21 CFR 113.40(i)
Foods 2888 21 CFR 113.40(j)
Foods 2898 21 CFR 113.40(g)(2)(ii)(C)
Foods 2901 21 CFR 113.40(i)
Foods 3088 21 CFR 114.100(b)
Foods 3090 21 CFR 114.100(d)

Foods 3645 21 CFR 110.10(d)
Foods 3662 21 CFR 110.37(e)(6)
Foods 3708 21 CFR 110.80(a)(1)
Foods 3709 21 CFR 110.80(a)(1)
Foods 3710 21 CFR 110.80(b)(16)
Foods 3818 21 CFR 113.40(f)(8)
Foods 3819 21 CFR 113.40(f)(9)(iii)

Foods 3822 21 CFR 113.40(a)(1)(ii)
Foods 3857 21 CFR 113.60(a)
Foods 3859 21 CFR 113.60(a)
Foods 3863 21 CFR 113.60(a)(1)
Foods 3866 21 CFR 113.60(a)(1)(i)(a)
Foods 3867 21 CFR 113.60(a)(1)(i)(b)
Foods 3876 21 CFR 113.60(c)
Foods 3886 21 CFR 113.87(e)

Foods 4069 21 CFR 113.40(b)(14)
Foods 4419 21 CFR 110.10(c)

Foods 4465 21 CFR 114.100(c)
Foods 4512 21 CFR 108.25(g)
Foods 4517 21 CFR 108.35(c)(2)(ii)
Foods 4518 21 CFR 108.35(c)(2)(ii)
Foods 4521 21 CFR 108.35(d)
Foods 4523 21 CFR 108.35(f)
Foods 6012 21 CFR 123.8(a)(3)(iii)
Foods 9929 21 CFR 120.12(b)(4)
Foods 9933 21 CFR 120.6(b)
Foods 9953 21 CFR 120.11(a)(1)(iv)(A)
Foods 9964 21 CFR 120.25
Foods 12701 21 CFR 129.35(a)(4)(iii)
Foods 12702 21 CFR 129.37(a)

Foods 12703 21 CFR 129.80(a)
Foods 12708 21 CFR 129.80(f)
Foods 12753 21 CFR 120.11(a)(1)(iv)(B)
Foods 12754 21 CFR 120.11(a)(1)(iv)(C)
Foods 15300 place holder

Foods 15305 21 CFR 120.14(a)(2)
Foods 15351 FDCA 761(b)(1)
Foods 15358 FDCA 761(c)(1)
Foods 15380 21 CFR 111.8

Foods 15391 21 CFR 111.10(b)(3)
Foods 15392 21 CFR 111.10(b)(4)
Foods 15400 21 CFR 111.12(a)

Foods 15429 21 CFR 111.15(k)
Foods 15431 21 CFR 111.15(e)(1)
Foods 15432 21 CFR 111.15(e)(2)

Foods 15433 21 CFR 111.15(d)(1)
Foods 15437 21 CFR 111.15(a)(1)
Foods 15450 21 CFR 111.15(f)(3)
Foods 15456 21 CFR 111.20(b)
Foods 15475 21 CFR 111.20(e)(1)
Foods 15482 21 CFR 111.23(c)
Foods 15501 21 CFR 111.27(a)(3)(i)
Foods 15507 21 CFR 111.27(a)(5)(i)
Foods 15524 21 CFR 111.30(a)
Foods 15525 21 CFR 111.30(b)
Foods 15527 21 CFR 111.30(c)
Foods 15534 21 CFR 111.255(c)
Foods 15535 21 CFR 111.255(d)
Foods 15539 21 CFR 111.260(a)(1)
Foods 15552 21 CFR 111.260(j)(2)
Foods 15558 21 CFR 111.260(k)(1)
Foods 15559 21 CFR 111.260(k)(1)

Foods 15572 21 CFR 111.153
Foods 15577 21 CFR 111.155(b)
Foods 15581 21 CFR 111.155(c)(3)
Foods 15584 21 CFR 111.155(d)(1)
Foods 15594 21 CFR 111.160(c)(2)

Foods 15602 21 CFR 111.160(e)
Foods 15604 21 CFR 111.165(b)
Foods 15605 21 CFR 111.165(c)

Foods 15606 21 CFR 111.165(c)(1)
Foods 15608 21 CFR 111.165(c)(3)
Foods 15609 21 CFR 111.165(c)(3)
Foods 15611 21 CFR 111.165(d)(2)
Foods 15614 21 CFR 111.170
Foods 15618 21 CFR 111.180(b)(1)
Foods 15624 21 CFR 111.180(b)(3)
Foods 15627 21 CFR 111.180(b)(3)
Foods 15634 21 CFR 111.180(b)(3)(ii)(D)
Foods 15650 21 CFR 111.465(a)
Foods 15653 21 CFR 111.470
Foods 15655 21 CFR 111.475(a)
Foods 15677 21 CFR 111.315(b)(1)
Foods 15710 21 CFR 111.325(b)(2)(i)
Foods 15712 21 CFR 111.325(b)(2)(ii)
Foods 15722 21 CFR 111.365(j)

Foods 15724 21 CFR 111.365(h)
Foods 15725 21 CFR 111.365(g)
Foods 15727 21 CFR 111.365(e)
Foods 15728 21 CFR 111.365(d)
Foods 15739 21 CFR 111.210(h)(3)(ii)(B)
Foods 15741 21 CFR 111.210(h)(3)(i)
Foods 15750 21 CFR 111.210(d)
Foods 15751 21 CFR 111.210(d)
Foods 15752 21 CFR 111.210(c)
Foods 15753 21 CFR 111.210(b)
Foods 15754 21 CFR 111.210(a)
Foods 15764 21 CFR 111.430(a)
Foods 15770 21 CFR 111.420(a)
Foods 15777 21 CFR 111.415(c)
Foods 15779 21 CFR 111.415(a)
Foods 15785 21 CFR 111.410(b)

Foods 15787 21 CFR 111.410(b)
Foods 15808 21 CFR 111.570(a)
Foods 15813 21 CFR 111.570(b)(2)(ii)(B)
Foods 15820 21 CFR 111.55
Foods 15821 21 CFR 111.60(a)
Foods 15834 21 CFR 111.70(c)(2)
Foods 15847 21 CFR 111.73
Foods 15848 21 CFR 111.73

Foods 15850 21 CFR 111.73
Foods 15866 21 CFR 111.75(a)(2)(ii)(E)
Foods 15870 21 CFR 111.75(c)(1)
Foods 15874 21 CFR 111.75(c)(4)
Foods 15878 21 CFR 111.75(e)
Foods 15879 21 CFR 111.75(f)(1)
Foods 15886 21 CFR 111.77(b)
Foods 15893 21 CFR 111.80(c)
Foods 15899 21 CFR 111.83(b)(1)
Foods 15900 21 CFR 111.83(b)(2)
Foods 15915 21 CFR 111.95(a)
Foods 15922 21 CFR 111.95(b)(3)
Foods 15941 21 CFR 111.105(i)
Foods 15943 21 CFR 111.105(i)
Foods 15946 21 CFR 111.105(i)
Foods 15953 21 CFR 111.113(a)(1)
Foods 15955 21 CFR 111.113(a)(3)
Foods 15958 21 CFR 111.113(a)(5)
Foods 15960 21 CFR 111.113(b)(1)
Foods 15975 21 CFR 111.120(e)

Foods 15997 21 CFR 111.127(f)
Foods 15999 21 CFR 111.127(h)
Foods 16000 21 CFR 111.130

Foods 16007 21 CFR 111.135
Foods 16038 21 CFR 111.605(b)
Foods 16044 21 CFR 111.503
Foods 16046 21 CFR 111.503
Foods 16047 21 CFR 111.510
Foods 16048 21 CFR 111.515
Foods 16050 21 CFR 111.525(a)
Foods 16052 21 CFR 111.530
Foods 16053 21 CFR 111.535(a)
Foods 16065 21 CFR 111.35(b)(1)
Foods 16067 21 CFR 111.35(b)(1)(ii)
Foods 16068 21 CFR 111.35(b)(1)(iii)
Foods 16069 21 CFR 111.35(b)(1)(iii)
Foods 16072 21 CFR 111.35(b)(3)
Foods 16084 21 CFR 111.140(b)(3)
Foods 16089 FDCA 417(d)(1)(A)
Foods 16119 21 CFR 118.4(a)(1)
Foods 16131 21 CFR 118.4(b)

Foods 16132 21 CFR 118.4(b)(1)
Foods 16135 21 CFR 118.4(b)(4)
Foods 16139 21 CFR 118.4(c)(1)
Foods 16147 21 CFR 118.4(d) (3)

Foods 16149 21 CFR 118.4(e)
Foods 16150 21 CFR 118.4(e)
Foods 16153 21 CFR 118.5(a)(1)
Foods 16164 21 CFR 118.6(c)
Foods 16179 21 CFR 118.8(a)
Foods 16185 21 CFR 118.9
Foods 16194 21 CFR 118.10(a)(3)(iii)
Foods 16201 21 CFR 118.10(d)
Foods 16207 21 CFR 118.10(b)(4)
Foods 16232 21 CFR 118.11(f)
Foods 16272 21 CFR 700.25(c)
Foods 16288 21 CFR 113.100(b)
Foods 16292 21 CFR 113.100(c)(3)
Foods 16313 21 CFR 113.40(a)(1)
Foods 16446 21 CFR 113.40(f)(8)
Foods 16488 21 CFR 113.40(i)
Foods 16501 21 CFR 129.35(a)(4)(i)
Foods 16504 21 CFR 129.35(b)
Foods 16509 21 CFR 129.20(a)
Foods 16511 21 CFR 129.35(a)(3)(i)
Foods 18159 21 CFR 117.80(b)(6)

Foods 18270 21 CFR 1.504(c)(3)
Foods 18272 21 CFR 1.504(d)
Foods 18282 21 CFR 1.505(b)
Foods 18284 21 CFR 1.505(c)(1)
Foods 18291 21 CFR 1.506(a)(1)
Foods 18292 21 CFR 1.506(a)(2)
Foods 18300 21 CFR 1.506(d)(2)
Foods 18306 21 CFR 1.506(e)(1)(i)(D)
Foods 18313 21 CFR 1.506(e)(3)
Foods 18324 21 CFR 1.508(a)
Foods 18331 21 CFR 1.510(a)(2)
Foods 18334 21 CFR 1.510(b)(1)
Foods 18349 21 CFR 1.511(b)

Foods 18400 21 CFR 117.315
Foods 18563 21 CFR 1.512(b)(2)
Foods 18690 21 CFR 106.30(b)
Foods 18701 21 CFR 106.30(e)(2)(ii)
Foods 18707 21 CFR 106.30(e)(3)(ii)(C)
Foods 18776 21 CFR 106.55(a)
Foods 19047 21 CFR 117.155(b)

Foods 19055 21 CFR 117.165(a)(4)
Foods 19064 21 CFR 117.150(d)

Foods 19067 21 CFR 117.155(b)
Foods 19068 21 CFR 117.135(c)(6)
Foods 19069 21 CFR 117.145(a)
Foods 19081 21 CFR 117.170(d)
Foods 21055 21 CFR 112.42(b)
Foods 21099 21 CFR 112.123(b)(1)
Foods 21100 21 CFR 112.123(b)(2)
Foods 21103 21 CFR 112.123(e)
Foods 21104 21 CFR 112.124
Foods 21105 21 CFR 112.125
Foods 21107 21 CFR 112.126(a)(1)
Foods 21112 21 CFR 112.128(a)
Foods 21118 21 CFR 112.130
Foods 21119 21 CFR 112.130(c)
Foods 21129 21 CFR 112.132(a)
Foods 21140 21 CFR 112.142(d)
Foods 21145 21 CFR 112.143(b)
Foods 21149 21 CFR 112.144(b)(2)
Foods 21170 21 CFR 112.147(c)

Foods 21180 21 CFR 112.150(b)(6)
Foods 21182 21 CFR 112.151
Foods 21184 21 CFR 112.153
Foods 21186 21 CFR 112.161(a)
Foods 21274 21 CFR 117.206(a)(1)
Foods 21283 21 CFR 117.475(c)

Short Description
Develop FSVP
Sanitation monitoring
Pest Control
Manufacturing, Processing, Packing, Holding - Controls
Sanitary Operations - Plant Maintenance
Personnel
Equipment and Utensils - Design and Maintenance

Sanitary Facilities and Control
Plant Construction and Design
HACCP plan implementation
Food safety hazards
Lack of effective pest exclusion
Critical control points
Sanitation of food contact surfaces - frequency
Sanitary Operations - Plant Sanitation
Critical limits
Specifications - identity, purity, strength, composition
Signed and dated

Screening
Monitoring - adequacy
Sanitation Records
Storage and Transportation
Corrective action plan
Floors, walls and ceilings
Importer verification
Hazard Analysis - Identification of Hazard
No HACCP plan
Manufacturing conditions
Buildings/sanitary
Verification - record review - frequency
Written procedures - quality control operations

Sanitation of non-food contact surfaces - frequency
Process filing
Training of employees and records
Failure to wear
Component - verify identity, dietary ingredient
Plant Operations - precautions
Written procedures - holding
Harborage areas
Cleaning and sanitizing operations
Batch record - complete
Grounds
Not washed/sanitized when appropriate
Written procedures - product complaint

Specifications - component identity
Failure to clean - general
Specifications met - verify; finished batch
Buildings/good repair
Reasonable precautions
Equipment, containers, utensils
Cleaning and sanitizing substances- safe and adequate
Verification procedures - adequacy
Storage
Specifications-component purity, strength, composition
Reserve sample - collect, hold
Component - qualify supplier
Materials and workmanship
Sanitation monitoring
Batch record - every batch
Master manufacturing record - each batch

Toxic Chemicals - identified, held, stored
Sanitation monitoring documentation
Process Control - Foreign Objects
Records - content
Quality control - quality, dietary supplement
Written procedures - returned dietary supplement
Calibration - adequacy
Sufficient space
Code - required elements
Master manufacturing record - unique formulation

Food Safety Plan
Storage of personal items
Maintenance of equip., utensils, and finished food

packaging
Maintenance of processing and production records
Written procedures - holding; distributing
Corrective action per predetermined plan
Sanitation Controls Verif Procedures: Establish

Implement
Safety lighting and glass

Running water at suitable temperature
HACCP training or qualification
Drip and condensate
Instruments and Controls
Allergen Controls Monitoring Proced: Establish

Implement
Personal food/drink/tobacco
Effective use of hair restraint
As source of contamination
Preventive Controls - Identify
Sanitation Controls Procedures
Scheduled process establishment
Specifications - labels, packaging
Records - returned dietary supplement: written

procedures
Hazard analysis written

Scheduled process
Allergen Controls Procedures
Q.C. instrument accuracy, maintenance

Work-in-progress
Written procedures - product complaint; review,
investigate
Storage requirements
Storage/transportation of finished goods

(contamination)
Records entries - timing

Supply-Chain Program Establish and Implement
Precautions against contamination--micro, foreign
substances
Verification procedures - none/frequency
Written procedures - cleaning

Unsecured jewelry
Approved school
HACCP plan location
Non-food-contact surfaces (S)
Process adherence
Precluding contaminants
Pullet environment testing
Raw Materials - Allergen Identification
Process Controls Verif Procedures: Establish Implement
Hazard analysis
Initial temperature of container contents
Personnel
Training of handlers and supervisors

Hand cleaning and sanitizing preparations
Registration
Procedures - establish, approve supplier
Equip & tools - cleanability
Metal / extraneous materials
pH testing
Records - not signed and dated by qualified individual
Processes, specifications, written procedures
Process Control Measures
Sanitation Controls Monitoring Proced: Establish

Implement
Corrective action documentation
Suitable outer garments
Seams on food contact surfaces
Shown to be effective
Suitable locations
Process filing
HACCP plan - critical limits not listed or not adequate

Procedures - equipment - cleaning, sanitizing
Written procedures - labeling operations
Production, process controls - implement
Appropriate quality control operations
Process Controls Corrective Action Proced: Estab

Implement
Sanitation Controls Corrective Action Proced: Estab
Implemnt
Fans/air blowing equipment
Holding foods - refrigerate/freeze/heat
Coding - required elements
Recall procedures
Ongoing verification - complaints, calibration records
Process controls - HACCP plan - 5 log reduction
Monitoring for rodents

Develop FSVP
Process Controls Monitoring Procedures: Establish
Implement
Preventive controls records - general requirements
Written sampling plan for spent irrigation water or
sprouts
Hand jewelry - remove/cover
Adequate lighting
Drainage
Raw materials, packaging, finished product
Records system
Records - signed/dated
HACCP plan not implemented

HACCP plan - food hazards not listed
Personnel - records - written procedures
Records - packaging, labeling operations
Specifications - manufacturing process
Specifications - contamination limits
Specifications met - test, examinations; compliance
Testing when laying hens 40 to 45 weeks

Supplier approval - document
Hazard Analysis - Written
Sanitation Controls - Monitoring Records
Testing spent irrigation water
Installation and maintenance of equipment (S)
Review not signed/dated

Hand drying
Written procedures - pest control
Instruments - calibration
Manufacturing operations - written procedures

Packaging description, representative label
Master manufacturing record - controls, procedures
Record - product complaint; findings

Training Records - general requirements
Environmental testing requirements
Lack of thermometer
Contamination with microorganisms, chemicals, filth,

etc.
Safe and adequate for use

Safe and adequate for use
Testing
Signs
Monitoring - none
SSOP records
No HACCP plan
Personnel - records - training
Batch record - date, time; maintenance
Master manufacturing record - specifications; quality
Specifications - contamination limits
Specifications not met - reject, quality control
Ensure quality; package, labeled, master record
Records - ret'nd dietary supplement: material review,

dispos
No written SE prevention plan

Written SE plan lacks required elements
Adulterated Food Disposition
Evaluation - performance, risk
Sanitation Controls - Monitoring Frequency
Treat seed with a scientifically valid method
Verification - reviewers qualifications
Storage of cleaned portable equipment (S)

Suitability - equipment, utensils
Thermal processing
Process deviation identification
Process adherence
Monitoring record review adequacy
Corrective action per regulation

Records - general - include name, date, time
Hazard analysis - written - elements
Records required - not maintained
HACCP plan - corrective action plan not included
Batch record - yield

Written procedures - laboratory operations
Specifications - finished packaging, labeling
Appropriate tests, examinations; certificate of analysis
Written procedure quality control operations material

review
Quality control - batch, product specifications

Monitoring for flies
Raw Material Control - Cleaning - Water Quality
Human Food By-Product: Identifying as Animal food
Supplier verification - establish written procedures
Process Controls Procedures - Adequate
Buildings - prevent contamination
Reassessment of HACCP plan
Verification - corrective action
Verification - recordkeeping
Personal cleanliness
Supervisors
Non food-contact equipment in processing area
Drainage
Process records - forms missing information
Suitable temp. and pressure
Container testing
Process deviation
Glove condition
Doors opening into processing areas
Records values/observations
Verification - record review - calibration
No hazard analysis
Verification activities - minimum
HACCP plan - monitoring procedures not adequate
HACCP plan - monitoring procedures - none listed
Personnel - education, training, experience
Equipment - protect from contamination
Master manufacturing record - specific actions; quality
Master manufacturing record - sampling, tests,

examinations
In-process identity, purity, strength, composition
Specifications met - identity, purity, strength,

composition
Tests, examinations - scientifically valid
Quality control operations - finished batch,

specifications
Records - quality control operations; responsibilities
Refrigeration requirements documentation
LACF compliance
Process Controls Monitoring Frequency

Process Controls Validation Not Performed
Allergen Controls Verif Procedures: Establish
Implement
PCQI Training Records
Food contact surface sanitary inspection and

maintenance
Written environmental monitoring plan
Representative samples
Operators
Holding, conveying, mfg systems - design &

construction
Food-contact - corrosion resistant
Spacing of equipment
Odor, attractant for pests, harborage
Backflow prevention
Filling, assembling, packing controls
Unacceptable toxic compounds
Bacteriological swab, rinse count - containers, closures

(S)
Holding in bulk or suitable containers
Quality control procedures

Maintained
All hazards not considered
HACCP plan - location and type of juice
HACCP plan - not validated

Verification - CCP, CA record review
HACCP plan - critical control points not listed
HACCP plan - verify procedures / frequency - none

listed
Personnel - hygienic practices
Personnel - quality control operations

Physical plant - clean and sanitary
Batch record - date, time; maintenance
Batch record - component; unique identifier
Batch record - approved, released, rejected
Components - contamination, deterioration, mix-ups
Product received - quality control; documentation;

specs
Product received - identify
Hold - temperature, humidity, light
Batch-lot,control number packaged, labeled dietary

supplemen
Labels - issuance, use
Specifications - product received for packaging, labeling
Component - certificate of analysis
Specifications met identity,purity, strength, comp,; basis
Quality control - reject; specification not met
QC ops; written procedures; material review, disposition
Records - available; FDA
Written procedures returned dietary supplement;

reprocessing
Written SE plan not implemented/followed
Removal of pest harborages
Name and location

Insanitary conditions; contaminated with filth
Raw Materials Control - Treatment for Microorganisms
Verification activity frequency
Definition very small importer
Allergen Controls - Monitoring Records

Allergen Controls Corrective Action Proced: Estab
Implement
Training for supervisors
Supply-Chain Appropriate Verification Activities
Supply-Chain Written Procedures for Receiving Raw

Materials
Official review
Record retention
Food-contact - withstand food & cleaning cmpds.
Bottling room separation, plant operations
Convey sewage
Record form not signed
Bacteriological test - bottled water
Visible code
Process deviations- identification and records
Self-closing doors
Cooling water - not chlorinated, sanitized
Maintenance of grounds
Registration
Approved school
Process change reporting to CFSAN
Lack of records
Corrective action documentation
Corrective action - predetermined plan
HACCP plan - recordkeeping system
Calibration, testing - no records
Hand-washing facilities
Pest control measures
Floors, walls, ceilings

Physical plant - screening against pests
Records - cleaning, pest control
Equipment - design - suitable
Batch record - follow master
Batch record - date, each step
Batch record - approved, released, rejected; batch
Written procedures - product received; packaging,

labeling
Components - quarantine
Hold - mix-up, contamination, deterioration

Retain reserve samples - 1 year, 2 years
Corrective action plans
Master manufacturing record theoretical and expected

yield
Master manufacturing record-specifications; packaged,

label
Manufacturing history
Written procedures -packaging operations
Quality control, review, approve; investigate, follow-up
Specifications - product received for packaging, labeling
Component - confirm identity; specifications met

Reserve sample - retained
Documentation - supplier qualification
Quality control operations - tests, examinations; results
QC operations - master manufacturing record,

modifications
Quality control operations - product complaints;

investigate
Records - material review, disposition
Written procedures - returned dietary supplement;

destroyed
Cross contamination from people

Biosecurity measures documentation
Rodent and pest control documentation
Date and time of activity
Use of testing procedures
Hazard analysis biological, chemical, physical
Verification activity assurance
Record - keep
Management responsibilities - qualified individuals
Food Safety Plan - Preparation
Preventive Controls - Written
Process Controls Monitoring Records
Other Controls Corrective Action Proced: Establish
Implement
Recall Plan - Written
Ag. water - annual inspection
Handling harvested produce
Critical Factors
Product water location, quality

Operating processes not posted
Visual indicators not used
Insecticides/rodenticides
Review not timely
Steam controller
Present each retort, accurate
Adjusted to agree with TID
Records - equipment inspection
Sanitizing operations inadequate
Fill-in weight, drained weight - recording frequency
Measured, recorded
Package identification
Records - product, volume, date, code, distribution
Chemical, physical, radiological tests - bottled water
Impermeable (S)
Wet cleaning
Closures other than double seams and glass
Venting, other installations
Validation - reviewer's qualifications
Process controls - not exempt, single facility
Personnel - quality control personnel - qualified

Personnel - quality control operations; responsibilities
Physical plant - repair
Physical plant - bulbs, fixtures, skylights
Procedures - calibrating instruments
Procedures - calibrating automated, mechanical equip
Equipment - maintain, clean, sanitize
Equipment - maintain - general
Equipment - automated - calibrate, inspect
Batch record - component; identity, weight
Batch record - specifications
Batch record - label
Components - representative samples
Components - identify lot received
Labels - identify
Written procedures - packaging, labeling received
Written procedures - product received
Records - receiving; components, packaging, labels,

products
Hold - reserve samples; ordinary storage
Examination, testing; appropriate
Conditions, controls -protect; microorganisms,

contamination
Manufacturing operations - prevent contamination
Obsolete labels, packaging - dispose
Packaging, labels - master manufacturing record

Product complaint - quality control investigate
Specifications met - quality
Specifications met - contamination limits
Specifications met, in-process - quality finished batch
Components packaging, labels received
Records - established specifications

Quality control - supplier qualification
Quality control - representative samples
Quality control - reserve samples
QC - required operations master manufacturing/batch

records
Quality control operations - material review, disposition
Quality control operations - batch production records
Quality control - finished batch, distribution
QC operations - packaged, labeled; specifications
Returned dietary supplement; salvage, redistribution
Document-equipment date of use, maintain, clean,

sanitize
Documentation - instruments, controls; calibrations
Signature and date on SE plans
Container sample results
Temperature Devices
Human Food By-Products
Evaluation, reevaluation - another entity
Verification activity before import, periodically
Record Availability
Very small importer assurances, supplier

Food Safety Plan - Signing
Allergen Controls - Monitoring Frequency
Personnel training
Training content requirements
Training records
Hygienic practices
Non-food-contact surface maintenance and cleaning
Buildings - drainage
Pest exclusion from fully-enclosed buildings
Plumbing size, design, installation, and maintenance
Sufficient sample collection sites
Corrective action components of an environmental

monitoring plan
Aseptic samples - sprouts and spent irrigation water
Raw materials and Rework Controls - Filth and

Contamination
Process adequacy records
Process records - not done; not timely
Still retorts
Sample frequency - product water
Sample - total coliforms
Containers kept sanitary
Scheduled processes not established
Process deviation log/file
Recording device records - dated; retort number
Single-service articles
Contamination of food, contact surfaces, water

supplies, etc
Sufficient quantities of water
Safe and adequate sanitary quality
Incomplete information
TID accuracy test frequency
Aflatoxin and other natural toxins
Supervisory competence
Proper pH controls
Mechanical washers - records
No accurate TID
Adjusted to agree with TID
Representative samples - bottled water
Conveyor transportation
Critical factors record - frequency
Process deviation evaluation
Readily accessible
Good repair
Devices and fixtures
Lack of automatic control / alarm (S)
Storage/transportation of finished goods (deterioration)
Teardown examinations - did not perform
Postprocess handling: equipment design, closure

integrity
Critical factors - no record
Sanitation corrections
Corrective action - predetermined plan inadequate
Sanitation SSOP - none or not implemented

Records - actual values
Records - cleaning, sanitizing solutions

Not registered
Calibration, testing - record review timeliness
HACCP plan - valid procedures / frequency - none listed
MedWatch form not used (dietary supplements)

Written procedures - hygienic practices
Cleaning compounds and toxic materials - holding
Physical plant - size, construction, design
Equipment - procedures
Equipment - bonded seams
Cleaning compounds - adequate, safe
Batch record - originals, copies, electronic
Batch record - results; monitoring
Batch record - results; testing, examination; batch
Batch record - initials; verifying weight
Batch record - packaging, labeling
Batch record - quality control review; monitoring
Batch record - quality control; tests, examinations
Written procedures - packaging
Packaging, labels - quarantine

Product received - mix-ups
Document - required operation
Hold - in-process material; temperature, humidity, light
Hold - reserve sample; closure system

Records - product distribution
Examination, testing; scientifically valid
Laboratory operations: electronic

Laboratory methodology followed
Records - manufacturing operations; written procedures
Metal, foreign material
Manufacturing operations - sanitation
Instructions; specifications; packaged, labeled
Instructions; specifications; quality
Master manufacturing record: readily available
Dietary supplement - protect, contamination
Product complaint - quality control review
Product complaint - review, investigation
Product complaint -investigate, findings, follow-up
Record - product complaint; good manufacturing

practice
Specifications met - received product identified
Documentation - qualify supplier
Re-confirm certificate of analysis
Reserve sample -container-closure system
Material review, disposition - quality control
Quality control - basis; tests, examinations
QC master manufacturing record; material review,

disposition
QC operations -specifications; components, packaging,
labels
QC operations - material review, disposition decision
Quality control - components, identity specifications

Quality control operations - packaging, labeling
Signature; review, approval, rejection; reprocessing
Records - keep: 1 year, 2 years
Written procedures - instruments, controls; calibrating
Records - equipment; calibrations, inspections, checks
Cross contamination from equipment

Environmental test
Plan appropriate to layout
Written SE prevention plan
Pullets records documentation
Signatures or initials on operational records
Temperature-indicating device accuracy - initial

temperature
Insanitary conditions; injurious to health
E. coli follow-up, eliminate, prevent reoccurrence
Compressed Gases
Identification Of Rework
Mixing of Adulterated Food
Review entity's hazard analysis
Verification activity - appropriate
Record - available
SE prevention plan corrective actions
Corrective Action for Unanticipated Food Safety

Problems
Process Controls Record Review
Process Controls Validation Requirements
Sanitation Controls Record Review
Other Controls - Monitoring Records

Recall Plan - Contents and Procedures
General requirement to prevent foreseeable food safety
hazards
Records - equipment cleaning and sanitizing
Prevent hazards on seed
Sampling plan
Corrective actions in the sampling plan
Record - treatment
Records - supervisory review

Maintain, follow FSVP
Modified Requirement Temp Control - Monitor,
Corrective Action, Verification
Modified Requirement Temp Control - Records
Computerized records
Determination of compliance
SSOP(S)
Compressed air/gases
Food-contact - unlawful indirect additives
Insufficient number of Q.C. instruments
Sewage disposal
Employees with illness, lesions, contamination source
Lack of instruction/reporting of health conditions
Ventilation - condensation
Approved source - product, operations water
Fill
Operations water location, quality
Adequate ventilation
Critical factors not stated

Vent not posted
Evaluation by process authority
General inadequacy
Not signed by closure inspector
TID not reference instrument
Pasteurization or other adequate treatment
Preventive control measures
Mechanical manufacturing control
Batters, breading, gravies, sauces, etc.
Observable
Sample, test - cleaning, sanitizing solutions
Records - sanitizing times, intensities (S)
Measured, recorded
15 minute interval (S)
Steam controller
MIG - range
TID not reference instrument

Present each retort, accurate
Range, chart graduations
Unauthorized adjustment
No indicator
Operator check, record, frequency
Air introduction
Inspection - filled containers
Receipt/storage - liquid and dry raw materials
Thawed appropriately
Contamination by raw materials, refuse, other
ingredients
No accurate TID
TID accuracy test frequency
Range
Thermal processing crit factors-methods, controls

adequate
Critical factors - frequency measured, recorded
Operating conditions observed, recorded - frequency
Critical factor - scheduled process
Processing and production - required information
Product distribution
Supervision
Refuse receptacles
Water quality -- wash, rinse, convey food
Inspection of containers and carriers upon receipt
Ice manufacturing
Automatic device to stop chain (S)
Recording interval 15 minutes or less (S)

TID record of accuracy
Record: visual closure examination, qualified person
Frequency: visual closure examinations, record
Teardown examinations - frequency (S)
Required can seam measurements (micrometer)
Required can seam measurements (seam scope)
Coding - no mark, permanently visible
Thermal processing - clock time agreement with time of

day
Heat distribution data, other retort installation
Level of competency (S)

Process deviations - action to rectify
Record retention
Process change substantiation
Process change - increase
Notify FDA - spoilage
Recall procedures
Calibration record review adequacy
Records - information not entered when observed
GMP correction - timely
CCP record review adequacy
Finished product not analyzed for E.coli
Testing for disinfectants & DBPs
Product water-contact surfaces - remedy unsanitary

condition
Product water samples after processing
Bacteriological tests - government standards (S)
CA record review adequacy
Calibration, testing - record review adequacy
place holder
Importer - implementation of affirmative steps
No AE report made (dietary supplement)
Timing of AE report submission (dietary supplement)
Written procedures - sick or infected personnel

Hand washing
Jewelry and objects - remove
Personnel - qualified - general

Sanitation supervisors - assigned
Water supply - not component - suitability
Water supply - may be component - suitability

Animals and pests in facility
Grounds - equipment, litter, weeds
Plumbing - source of contamination
Physical plant - space; equipment, materials
Adequate light - processing, holding
Records - water
Equipment - installed to facilitate cleaning
Refrigerator, freezer - temperature recording device
Equipment - automated - design, selection
Equipment - automated - suitability
Equipment - automated - QC check
Batch record - each step
Batch record - 1 year, 2 years
Batch record - control number, finished batch
Batch record - initials; each step
Batch record - identifier; packaging
Batch record - identifier; labels

Written procedures - labels
Visually examine - supplier's invoice
Quality control - components, approve, release
Components - identify lot produced
Packaging - quality control; tests, examination

Packaging, labels - mix-ups
Product received - visually examine invoice, guarantee,

cert
Product received - quarantine

Product received - quarantine; representative samples
Product received - quality control; approve
Product received - quality control; quarantine; release
Product received - unique identifier, disposition
Quarantine component, package, labels, rejected

product
Written procedures - components
Documentation - components
Documentation - product received; packaging, labeling
Documentation - required operation; material review,

disposi
Hold - reserve samples; contamination, deterioration
Distribute dietary supplement; contamination,

deterioration
Records - holding, distribution: 1 year, 2 years
Sampling plans; components
Document; laboratory methodology followed
Records - document; results
Containers - segregating, identifying

Mechanical steps - contamination
Identifying, holding - contamination, mix-ups
Microorganism, decomposition - remove, destroy,

prevent
Chemical,microbiological,other test-contaminated
components
Components; add, verify
Components, verify weight, measure
Master manufacturing record - ingredients list
Master manufacturing record - Supplemental Facts
Master manufacturing record - components; weight,

measure
Master manufacturing record - list components
Master manufacturing record - dietary ingredients
Records - packaging, labeling operations: electronic
Repackaging, relabeling - quality control, approve
Filling, assembling, packaging, labeling - sanitary

handling
Clean, sanitize - filling, packaging equipment
Label, packaging - discrepancies

Packaging - issuance, use
Records - product complaints: readily available
Record - product complaint; batch, lot, control number
Production, process controls - packaged, labeled
Production, in- process control system - design, quality
Specifications identity, purity strength, composition
Specifications met - component identity
Specifications met - component purity, strength,

composition
Specifications met in-process purity, strength,
composition
Documentation - quality control, review, approve
supplier
Specifications met - verify; production, process control
Documentation - specifications met; basis, quality

control
Product - visually examine, identified
Containers closures visual ID review suppliers

documentation
Specifications not met - identity; component, reject
Specifications - representative samples; finished batch
Reserve sample container-closure

contamination,deterioration
Reserve sample - batch, lot, control number
Records - production, process control: 1 year, 2 years
Documentation - ensure specifications met
QC required operations production and process control
QC required operations components packaging labels
QC - required operations returned dietary supplements
QC production, process control; material review,

disposition
Quality control - adulteration; material review,

disposition
QC returned dietary supplement; material review,

disposition
Quality control - dietary supplement; adulteration
Quality control operations - quarantine

Quality control operations - packaging; repackaging
QC operations - packaging, labeling; approving,

rejecting
Quality control operations - returned dietary supplement

Quality control operations - product complaints
Records - original, true copies
Written procedures - returned dietary supplement;
salvaged
Written procedures returned dietary supplement
investigation
Returned dietary supplement - material review,
disposition
Returned dietary supplement - destroyed
Returned dietary supplement - specifications
Returned dietary supplement - investigation
Records - returned dietary supplement: 1 year, 2 years
Written procedures - equipment, utensils; make, keep
Procedures - equipment; calibrating, inspecting,

checking
Equipment, utensils; maintaining, cleaning, sanitizing
Procedures contact surfaces; maintaining, cleaning,

sanitize
Instruments, controls; calibrate date, reference std,

method
Records - material review, follow-up
Reportable food report - submission
Procurement of chicks
Transfer or introduction of SE
Limiting visitors
Stray animals
Satisfactory rodent control methods
Disinfection methods, poultry house

Egg transport temperature/time
Eggs to be processed as table eggs
Poultry house has multiple groups of laying hens
Four egg tests, flock in positive poultry house
Method to be used, environmental samples
Supervisor duties
Depopulation cleaning and disinfection procedures
24 hour retrieval of offsite records
Data and information re: compliance activities
60 day updates
Tamper-resistant feature, vaginal product
Review of processing and production records
Accuracy record: accuracy test
RD accuracy test frequency
Hydrostatic retorts: conveyor chain speed record

intervals
Thermal processing:Instrument dependability - critical
facts
Public water system test results, certificates
Air - contact surface - oil, dust, rust, moisture
Bottling room separation, storage areas
Sample frequency - operations water
Raw Materials - Thawing

Evaluation impact of factors
Document review entity's hazard analysis
Supplier approval - evaluation
Revaluate - new information
Procedures - establish unapproved supplier
Supplier approval - another entity
Onsite audit
Audit - document
Verification activity review, assess
Corrective actions - take, document
Record - sign, date
Record - translate to English
Customer CGMPs - sign, date

Record Retention
Assurance, small supplier
Equipment, utensil - design: cleanable, intended use
Cold storage, in-process and final formula - 45 degrees

F
Cold storage - validated high temperature alarm
System of process controls to prevent adulteration
Process Controls Verification Records

Allergen Controls Record Review
Sanitation Controls Corrective Action Records

Sanitation Controls - Verification Records
Other Controls Procedures
Other Controls Monitoring Procedures - Establish

Implement
Reanalysis Revise Food Safety Plan After Reanalysis
Ag. water distribution system maintenance
Equipment installation, maintenance
Equip & tools - storage
Produce contact with equipment
Instrument accuracy, maintenance, and quantity
Transport equipment
Building size, construction, and design
Pest contamination in buildings
Hand-washing facilities
Waste from hand-washing facilities
Waste / trash disposal and storage
Requirement to inspect seed
Sanitary food contact surfaces
Testing when no irrigation water generated
Adequate corrective action plan

Documentation of corrective actions taken
Method - Water quality
Method - irrigation water - sprouts
Record requirements
Modified Requirement Temp Control - Establish

Implement
Supply-Chain Records
Long Description
You did not develop an FSVP. Specifically, ***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with Current Good Manufacturing Practices including [safety of water that comes into
contact with food or food contact surfaces, including water used to manufacture ice] [condition and
cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging
material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
You did not [exclude pests from your food plant] [use pesticides under precautions and restrictions] to
protect against contamination of food. Specifically, ***
You did not conduct operations under conditions and controls necessary to minimize the potential for
[growth of microorganisms] [allergen cross-contact] [contamination of food] [deterioration of food].
Specifically, ***
You did not [maintain your plant in a clean and sanitary condition] [keep your plant in repair].
Specifically, ***
You did not take a reasonable measure and precaution related to personnel practices. Specifically, ***
Your equipment and utensils were not designed and constructed to be adequately cleaned or maintained
to protect against [allergen cross-contact] [contamination]. Specifically, ***
Your plant did not have adequate sanitary facilities and accommodations. Specifically, ***
Your plant was not [constructed] [designed] to facilitate maintenance and sanitary operations.
Specifically, ***
You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP
plan. Specifically, ***
Your HACCP plan does not list the food safety hazards that are reasonably likely to occur. Specifically, ***
Effective measures are not being taken to [exclude pests from the processing areas] [protect against the
contamination of food on the premises by pests]. Specifically, ***
Your HACCP plan does not list one or more critical control points that are necessary for each of the
identified food safety hazards. Specifically, ***
You did not clean and sanitize your utensils or equipment as frequently as necessary to protect against
[allergen cross-contact] [contamination of food]. Specifically, ***
You did not clean and sanitize your utensils or equipment in a manner that protects against [allergen
cross-contact] [contamination]. Specifically, ***
Your HACCP plan [does not list a critical limit that ensures control of one or more hazards] [lists a critical
limit that does not ensure control of one or more hazards]. Specifically,
You did not establish product specifications for the [identity] [purity] [strength] [composition] of the
finished dietary supplement. Specifically, ***
Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least
annually]. Specifically, ***
Failure to provide adequate screening or other protection against pests. Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the
critical limit. Specifically***
You are not maintaining sanitation control records that document [monitoring] [corrections of sanitation
deficiencies] for [safety of water that comes into contact with food or food contact surfaces, including
water used to manufacture ice] [condition and cleanliness of food contact surfaces] [prevention of cross-
contamination from insanitary objects] [maintenance of hand washing, hand sanitizing, and toilet
facilities] [protection of food, food packaging material, and food contact surfaces from adulteration]
[proper labeling, storage and use of toxic chemicals] [control of employee health conditions] [exclusion
of pests]. Specifically, ***
You did not store or transport food, including ingredients, under conditions that protect against [allergen
cross-contact] [contamination] [deterioration] [adulteration]. Specifically, ***
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 123.7(b) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically***
The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately
cleaned and kept clean] [kept in good repair]. Specifically, ***
You do not have or have not implemented [written verification procedures] [product specifications] [an
affirmative step] for ensuring that [fish] [fishery products] you import are processed in compliance with
the Seafood HACCP regulation. Specifically, ***
Your hazard analysis did not identify a known or reasonably foreseeable hazard that required a
preventive control. Specifically, ***
You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably
likely to occur. Specifically, ***
Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize
[the potential for growth of microorganisms] [contamination]. Specifically, ***
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition. Specifically, ***
You did not review [some of] your [critical control point monitoring] [corrective action] [calibration] [in-
process testing] [end-product testing] records [within one week] [within a reasonable time] after the
records were made. Specifically, ***
You did not [establish] [follow] written procedures for quality control operations. Specifically, ***
You did not clean your non-food contact surface in a manner and as frequently as necessary to protect
against [allergen cross-contact] [contamination]. Specifically, ***
You did not provide FDA with information on the scheduled process for a new acidified food before
packing the food. Specifically, ***
You did not [train employees in the principles of food hygiene and food safety] [have records
documenting training of qualified individuals]. Specifically, ***
Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.
Specifically, ***
You did not conduct at least one appropriate test or examination to verify the identity of a dietary
ingredient, prior to its use. Specifically, ***
You did not [conduct operations in accordance with adequate sanitation principles] [have plant
sanitation under the supervision of a competent individual] [take adequate precautions to ensure that
production procedures did not contribute to allergen cross-contact and to contamination]. Specifically,
***
You did not [establish] [follow written] procedures for holding and distributing operations. Specifically,
***
Failure to [properly store equipment] [remove litter and waste] [cut weeds or grass] that may constitute
an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant
buildings or structures. Specifically, ***
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that
protects against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically,
***
Your batch production record did not include complete information relating to the production and
control of each batch. Specifically, ***
You did not keep the grounds around your plant in a condition that would protect against the
contamination of food. Specifically, ***
Employees did not [wash] [sanitize] hands thoroughly in an adequate hand-washing facility [before
starting work] [after each absence from the work station] [at any time their hands may have become
soiled or contaminated]. Specifically, ***
You did not [establish] [follow] written procedures for the requirements to review and investigate a
product complaint. Specifically, ***
You did not establish an identity specification for each component. Specifically, ***
Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against
You did not verify that your finished batch of dietary supplement meets product specifications for
[identity] [purity] [strength] [composition] [limits on contamination that may adulterate or that may lead
to adulteration of the dietary supplement]. Specifically, ***
Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from
becoming adulterated. Specifically, ***
All reasonable precautions are not taken to ensure that production procedures do not contribute
contamination from any source. Specifically, ***
Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold]
[store] food in a manner that protects against contamination. Specifically, ***
You did not ensure that your cleaning compounds and sanitizing agents are safe and adequate under the
conditions of use. Specifically, ***
Your HACCP plan lists verification [procedures] [frequencies] that have not been developed in
accordance with 21 CFR 123.8(a) to ensure that your HACCP plan is adequate to control food safety
hazards, and is being effectively implemented. Specifically, ***
Failure to store raw materials in a manner that [protects against contamination] [minimizes
deterioration]. Specifically, ***
You did not establish component specifications for [purity] [strength] [composition]. Specifically, ***
You did not collect and hold reserve samples of packaged and labeled dietary supplements that you
distributed. Specifically, ***
You did not qualify a supplier of a component by establishing the reliability of the supplier's certificate of
analysis through confirmation of the results of their tests or examinations. Specifically, ***
The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning]
[maintenance]. Specifically, ***
You are not monitoring the sanitation conditions and practices with sufficient frequency to assure
conformance with current good manufacturing practice including [safety of water that comes into
contact with food or food contact surfaces, including water used to manufacture ice] [condition and
cleanliness of food contact surfaces] [prevention of cross-contamination from insanitary objects]
[maintenance of hand washing, hand sanitizing, and toilet facilities] [protection of food, food packaging
material, and food contact surfaces from adulteration] [proper labeling, storage and use of toxic
chemicals] [control of employee health conditions] [exclusion of pests]. Specifically, ***
You did not prepare a batch production record every time you manufactured a batch of dietary
supplement. Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary
supplement that you manufactured. Specifically, ***
You did not [identify] [hold] [store] a toxic chemical in a manner that protects against contamination.
Specifically, ***
Your sanitation control records do not accurately document the conditions or practices observed at your
firm. Specifically***_x000D_
_x000D_
You did not take an adequate measure to protect against inclusion of metal or extraneous material in
food. Specifically, ***
Your records do not include the [name and location of the processor or importer] [date and time of the
activity the record reflects] [signature or initials of the person performing the operation] [identity of the
product and the production code, if any]. Specifically, ***
You did not implement quality control operations to ensure the quality of the dietary supplement.
Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement is received.
Specifically, ***
Your process monitoring equipment is not calibrated to ensure that it reads accurately. Specifically, ***
Failure to provide sufficient space for [placement of equipment] [storage of materials] as necessary for
the maintenance of sanitary operations and the production of safe food. Specifically, ***
Each container is not marked with an identifying code specifying the [establishment where the product
was packed] [product contained therein] [year] [date] [packing period]. Specifically, ***
You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a
dietary supplement that you manufactured. Specifically, ***
You did not have a written food safety plan. Specifically, ***
Personal [clothing] [belongings] were stored in an area where [food is exposed] [equipment or utensils
are washed]. Specifically, ***
Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through
appropriate cleaning and sanitizing. Specifically, ***
You did not maintain [processing] [production] records showing adherence to the scheduled process.
Specifically, ***
You did not make and keep written procedures for holding and distributing operations. Specifically, ***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically,***
You did not [establish] [implement] adequate written sanitation controls verification procedures for
[product testing] [environmental monitoring]. Specifically, ***
Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed
Hand-washing facilities lack running water of a suitable temperature. Specifically, ***
No one associated with your firm has completed the required HACCP training or is HACCP qualified
through job experience. Specifically, ***
The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating
[food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Your instruments and controls were not [accurate] [precise] [adequately maintained] [adequate in
number]. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring allergen controls.
Specifically, ***
Employees were observed to be [eating food] [chewing gum] [drinking beverages] [using tobacco] in
areas where [food is exposed] [equipment or utensils are washed]. Specifically, ***
Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective
manner. Specifically, ***
Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].
Specifically, ***
You did not identify a preventive control for a hazard when one was needed. Specifically, ***
Your sanitation controls procedures did not ensure [cleanliness of food-contact surfaces] [prevention of
allergen cross-contact] [prevention of cross-contamination]. Specifically, ***
A scheduled process was not established by a qualified person who has expert knowledge acquired
through appropriate training and experience in acidification and processing of acidified foods.
Specifically, ***
You did not establish [label] [packaging] specifications. Specifically, ***_x000D_
You did not make and keep records of written procedures for fulfilling requirements for returned dietary
supplements. Specifically, ***
You did not have a written hazard analysis to identify and evaluate known or reasonably foreseeable
hazards [to determine whether there are any hazards requiring a control]. Specifically, ***
Acidified food is not manufactured in accordance with the scheduled process. Specifically, ***
Your allergen controls procedures did not include appropriate controls for [protection of food from allergen
cross-contact] [labeling]. Specifically, ***
Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of
undesirable microorganisms are not [accurate] [adequately maintained]. Specifically,***
Failure to handle work-in-progress in a manner that protects against contamination. Specifically, ***
You did not make and keep written procedures to fulfill the requirements that apply to the review and
investigation of a product complaint. Specifically, ***
Failure to properly [identify] [hold] [store] toxic [cleaning compounds] [sanitizing agents] [pesticide
chemicals] in a manner that protects against contamination of [food] [food-contact surfaces] [food-
packaging materials]. Specifically, ***
Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical]
[microbial] contamination. Specifically, ***
Processing or other information was not [always] entered on your records at the time it was observed.
Specifically, ***
You did not [establish] [implement] a written supply-chain program. Specifically, ***
Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces]
[food packaging systems] with [microorganisms] [foreign substances]. Specifically, ***
Your HACCP plan does not list verification [procedures] [frequencies] that have been developed to ensure
that the HACCP plan is adequate to control food safety hazards, and is being effectively implemented.
Specifically, ***
You did not [establish] [follow] written procedures for cleaning the physical plant. Specifically, ***
Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment]
[containers]. Specifically, ***
Personnel involved in [acidification] [pH control] [heat treatment] [critical factors of the operation] were not
under the operating supervision of a person who attended and satisfactorily completed a school approved
by the FDA Commissioner. Specifically, ***
Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery
product processed]. Specifically, ***
Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against
contamination. Specifically, ***
You did not process each low-acid canned food in conformity with at least the filed scheduled processes
and modifications. Specifically, ***
The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with
[lubricants] [fuel] [metal fragments] [contaminated water] [contaminants]. Specifically, ***
Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age. Specifically,***
You did not [identify] [hold] raw materials and other ingredients that are food allergens, and rework that
contains food allergens, in a manner that protects against allergen cross-contact. Specifically, ***
You did not [establish] [implement] adequate written process controls verification procedures.
Specifically, ***
You did not conduct, or have conducted for you, a hazard analysis to determine whether there are food
safety hazards that are reasonably likely to occur for each kind of fish and fishery product you process.
Specifically, ***
The initial temperature of the contents of the containers to be processed was not [determined] [recorded]
with sufficient frequency to ensure the temperature of the product was no lower than the minimum initial
temperature specified in the scheduled process. Specifically, ***
Operators of processing and packaging systems are not under the operating supervision of a person who
has attended and satisfactorily completed a school approved by the Commissioner. Specifically, ***
Appropriate training in food handling techniques and food protection principles has not been provided to
[food handlers] [supervisors]. Specifically, ***
Lack of effective hand [cleaning] [sanitizing] preparations. Specifically, ***
You did not register and file Form FDA 2541 (food canning establishment registration) with FDA within 10
days after first engaging in the manufacture, processing and packaging of acidified foods. Specifically, ***
You did not establish written procedures to ensure that you import foods only from foreign suppliers you
have approved based on an evaluation of the foreign supplier's performance and the risk posed by the
You did not use equipment and tools that are of adequate design, construction, and workmanship to
enable them to be adequately cleaned and maintained. Specifically, ***
Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food.
Specifically, ***
You did not exercise sufficient control so that the finished equilibrium pH of an acidified food was not
higher than 4.6. Specifically, ***
Your review of [critical control point monitoring records] [corrective action records] [calibration records]
[periodic end-product or in-process testing records] are not [performed] [signed] [dated] by an individual
who is trained in the application of HACCP principles to juice processing or otherwise qualified through
job experience. Specifically, ***_x000D_
Your quality control personnel did not approve or reject [processes] [specifications] [written procedures]
[controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength,
or composition of a dietary supplement. Specifically, ***
You did not take an adequate measure to destroy or prevent the growth of undesirable microorganisms in
your food. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring sanitation controls.
Specifically, ***
You do not have records that document corrective actions that were taken. Specifically, ***
Suitable outer garments are not worn that protect against contamination of [food] [food contact surfaces]
[food packaging materials]. Specifically, ***
Failure to have smoothly bonded or well maintained seams on food contact surfaces, to minimize
accumulation of [food particles] [dirt] [organic matter] and the opportunity for growth of microorganisms.
Specifically, ***
The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been
shown to provide adequate [cleaning] [sanitizing treatment]. Specifically, ***
Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.
Specifically, ***
You did not provide FDA with information on the scheduled process for a new low-acid canned food prior
to packing the food. Specifically, ***
Your HACCP plan [does not list one or more of the critical limits that must be met at each critical control
point] [lists a critical limit that does not prevent, eliminate, or reduce to an acceptable level the occurrence
of an identified food hazard]. Specifically, ***
You did not [establish] [follow] written procedures for maintaining, cleaning, and sanitizing, equipment,
utensils, and any other contact surfaces that are used to manufacture, package, label, or hold
components or dietary supplements. Specifically, ***
You did not [establish] [follow] written procedures for labeling operations. Specifically, ***
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure the quality of the
dietary supplement. Specifically, ***
You did not have appropriate quality control operations to ensure that [food is suitable for human
consumption] [food packaging materials are safe and suitable]. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for process controls.
Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for sanitation controls.
Specifically, ***
Failure to [locate] [operate] fans and other air-blowing equipment in a manner that minimizes the potential
for contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature
that prevents the food from becoming adulterated. Specifically, ***
The identification code for hermetically sealed containers did not identify in code the [establishment
where packed] [product in the container] [year packed] [day packed] [period during which packed].
Specifically, ***
You did not prepare and maintain files on current procedures for [recalling products that may be injurious
to health] [identifying, collecting, warehousing, and controlling products] [determining the effectiveness of
recalls] [notifying FDA of recalls] [implementing recall programs]. Specifically, ***
Your verification procedures do not include, at a minimum, ongoing verification activities including [review
of consumer complaints] [calibration of process monitoring instruments] [review of monitoring, corrective
action, and calibration records]. Specifically, ***
Your HACCP plan does not include control measures that will consistently produce a 5 log reduction in
the most resistant microorganism of public health significance that is likely to occur in the juice, for a
period at least as long as the shelf life of the product. Specifically, ***
The presence of rodents is not monitored by appropriate monitoring methods. Specifically,***
You did not develop an FSVP. Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring process controls.
Specifically, ***
Your preventive controls records did not meet general records requirements. Specifically, ***
You did not [establish] [implement] a written sampling plan for each production batch of sprouts.
Specifically, ***
Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods
where food is being manipulated by hand. Specifically, ***
Failure to provide adequate lighting in [hand-washing areas] [dressing and locker rooms] [toilet rooms]
[areas where food is examined, stored, or processed] [areas where equipment and utensils are cleaned].
Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate
floor drainage. Specifically, ***
Records are not maintained of the examination of [raw materials] [packaging materials] [finished
products] [supplier's guarantees or certificates] to verify compliance with FDA regulations and guidelines
or action levels. Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the
critical control points. Specifically, ***
Your [written hazard analysis] [written HACCP plan], required by the juice HACCP regulation, [was] [were]
not signed and dated [upon initial acceptance] [upon modification] [upon verification] [upon validation] [by
the most responsible individual onsite at the processing facility or by a higher level official]. Specifically,
***
You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in
your HACCP plan. Specifically, ***
Your HACCP plan does not list all food hazards that are reasonably likely to occur. Specifically, ***
You did not make and keep written procedures for [preventing microbial contamination from sick or
infected personnel] [hygienic practices] [determining personnel qualification requirements]. Specifically,
***
You did not make and keep records of the written procedures for [packaging] [labeling] operations.
Specifically, ***
You did not establish a specification for a point, step, or stage in the manufacturing process where control
is necessary to ensure [the quality of the dietary supplement] [that the dietary supplement is packaged
and labeled as specified in the master manufacturing record]. Specifically, ***
You did not establish product specifications for limits on contamination that may adulterate, or that may
lead to adulteration of, the finished dietary supplement. Specifically, ***
You did not conduct appropriate tests or examinations to determine compliance with the specifications
established for [identity] [purity] [strength] [composition] [limits on contamination that may adulterate or
that may lead to adulteration of the dietary supplement]. Specifically, ***
Environmental testing for SE, using approved methods, was not done in a poultry house when any group
of laying hens constituting the flock was 40 to 45 weeks of age. Specifically,***
You did not document your approval of your foreign supplier. Specifically, ***
Your hazard analysis was not written. Specifically, ***
You did not have sanitation controls monitoring records. Specifically, ***
You did not test spent irrigation water from each production batch of sprouts for [E. coli O157:H7]
[Salmonella][pathogens reasonably necessary to minimize risk of serious adverse health consequences].
Specifically, ***
Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent
spaces]. Specifically, ***
A [processing] [production] record was not [signed or initialed] [dated] by the reviewer. Specifically, ***
Lack of a sanitary towel service or suitable hand drying devices. Specifically, ***
You did not [establish] [follow] written procedures for pest control. Specifically, ***
You did not calibrate instruments or controls used in manufacturing or testing a component or dietary
supplement [before the first use] [at the frequency specified in writing by the manufacturer or at routine
intervals or as necessary] to ensure the accuracy and precision of the instruments or controls.
Specifically, ***
You did not [establish] [follow] written procedures for manufacturing operations. Specifically, ***
Your master manufacturing record did not include [a description of the packaging] [a representative label,
or a cross-reference to the physical location of the actual or representative label]. Specifically,
Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met
specifications. Specifically, ***
The written record of a product complaint did not include the [findings of the investigation] [follow-up
action taken]. Specifically, ***
Your training records did not meet general record requirements. Specifically, ***
You did not test for Listeria spp. or Listeria monocytogenes in your [growing] [harvesting] [packing]
[holding] environment. Specifically, ***
Lack of an accurate indicating thermometer, temperature measuring device, or temperature recording
device in each freezer and cold storage compartment used to store food capable of supporting the growth
of microorganisms. Specifically, ***
Proper precautions to protect [food] [food-contact surfaces] [food-packaging materials] from
contamination with [microorganisms] [chemicals] [filth] [extraneous material] cannot be taken because of
deficiencies in plant [size] [construction] [design]. Specifically, ***
Sanitizing agents are [inadequate] [unsafe] under conditions of use. Specifically, ***
Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms]
[safe and adequate under the conditions of use]. Specifically, ***
Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify
[sanitation failures] [possible food contamination]. Specifically, ***
Lack of posted, readily understandable signs directing employees to wash and sanitize hands as
appropriate. Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limit. Specifically,
You do not [always] maintain sanitation standard operating procedure records that document [the
monitoring of conditions and practices during processing] [corrections to conditions and practices that
were not met]. Specifically, ***
You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are
reasonably likely to occur. Specifically, ***
You did not make and keep documentation of training. Specifically, ***
Your batch production records did not include the date and time of the maintenance, cleaning, and
sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to
records, such as individual equipment logs, where this information is retained. Specifically, ***
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure the quality of the dietary supplement.
Specifically, ***
You did not establish limits for contamination that may adulterate or may lead to adulteration of the
finished dietary supplement. Specifically, ***
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for
which a specification was not met. Specifically, ***
Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding]
operations ensure the quality of the dietary supplement. Specifically, ***
You did not make and keep records of a material review and disposition decision on a returned dietary
Your firm does not have a written SE prevention plan that is specific to [each farm] [the farm] where you
produce eggs. Specifically,***
Your written SE prevention plan lacks appropriate SE prevention measures. Specifically,***
You did not properly [dispose of] [recondition] adulterated food. Specifically, ***
You did not document the evaluation you conducted to determine [a foreign supplier's performance] [the
risk posed by a food]. Specifically, ***
Your sanitation controls monitoring frequency was not adequate. Specifically, ***
You did not treat your [seeds] [beans] for sprouting with a scientifically valid method to reduce
microorganisms of public health significance. Specifically, ***
The [reassessment of your HACCP plan] [monitoring, corrective action, or verification record review] was
not done by an individual who had successfully completed training in the application of HACCP principles
to fish and fishery product processing, or was otherwise qualified through job experience to perform these
functions. Specifically, ***
Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-
contact surfaces from contamination. Specifically, ***
Plant equipment or utensils were not suitable for their intended use. Specifically, ***
Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative cells of
microorganisms of public health significance and those of nonhealth significance capable of growing in
the food. Specifically, ***
When a process was less than the scheduled process or when critical factors were out of control you did
not either fully reprocess the portion of the production involved, keeping full records of the reprocessing
conditions, or set aside the portion of the product involved for further evaluation as to any potential public
health significance. Specifically, ***
You did not process a food in conformity with at least the scheduled process filed with FDA. Specifically,
***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
You did not take corrective action that ensured [the affected product was segregated] [a review of the
affected product was done to determine its acceptability] [affected product was not entered into
commerce] [the cause of the deviation was corrected] [the HACCP plan was reassessed in a timely
manner to determine if modifications were needed to reduce the risk of reoccurrence of the deviation and
modified as necessary]. Specifically, ***
Your required records do not [always] include [the name of the processor] [the name of the importer] [the
location of the processor] [the location of the importer] [the date and time of the activity] [the signature or
initials of the person performing the operation or creating the record] [the identity of the product] [the
production code]. Specifically, ***
Your written hazard analysis does not consist of [an identification of food hazards] [an evaluation of each
food hazard identified to determine if it must be addressed in the HACCP plan] [an identification of the
control measures that can be applied] [a review of your current process to determine whether
modifications are necessary] [an identification of critical control points]. Specifically, ***
You do not maintain [complete] records documenting [the implementation of your sanitation standard
operating procedure] [your written HACCP plan] [your written hazard analysis] [monitoring of critical
control points and their critical limits] [corrective actions taken in response to a deviation] [the verification
of your HACCP system] [the validation of your HACCP plan] [the validation of your hazard analysis].
Specifically, ***
Your HACCP plan includes a corrective action plan that is not in accordance with 21 CFR 120.10(a) to
ensure [affected product is not entered into commerce] [the cause of the deviation was corrected].
Specifically,***
Your batch production records did not include [a statement of the actual yield] [a statement of the
percentage of theoretical yield] at appropriate phases of processing. Specifically, ***
You did not [establish] [follow] written procedures for laboratory operations. Specifically, ***
You did not establish specifications [for the packaging and labeling of the finished dietary supplement] [to
ensure that you used the specified packaging] [to ensure that you applied the specified label].
Specifically, ***
You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine
whether components met established specifications. Specifically, ***
You did not [establish] [follow] written procedures for quality control operations for conducting a material
review and making a disposition decision. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement that
did not meet established product specifications. Specifically, ***
The presence of flies is not monitored by appropriate monitoring methods. Specifically,***
You did not inspect, segregate or otherwise handle raw materials and other ingredients to ensure they
were clean and suitable for processing. Specifically, ***
You did not accurately identify a human food by-product held for use as animal food. Specifically, ***
You did not establish [adequate] written procedures for ensuring that appropriate foreign supplier
verification activities are conducted with respect to a food you import. Specifically, ***
Your process controls procedures did not include appropriate [parameters] [maximum/minimum values].
Specifically, ***
You did not implement measures to prevent contamination of produce and food contact surfaces through
[floors] [walls] [ceilings] [fixtures] [ducts] [pipes] [drip] [condensate]. Specifically, ***
Your verification procedures do not include, at a minimum, reassessment of the HACCP plan [at least
annually] [whenever modifications to the process are made]. Specifically, ***
You did not take immediate corrective action to ensure that [no affected product entered into commerce]
[the cause of the deviation was corrected] [the HACCP plan was reassessed] when your verification
procedure revealed the need to take a corrective action. Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-
process testing]. Specifically, ***
Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining
adequate personal cleanliness. Specifically, ***
Supervisors have not satisfactorily completed training in a school approved by the Commissioner for
areas under their responsibility. Specifically, ***
Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be
kept in a clean condition. Specifically, ***
Lack of adequate drainage of areas which may contribute to contamination of food by [seepage] [foot-
borne filth] [providing a breeding place for pests]. Specifically, ***
Processing and production information forms did not include [the product] [the code number] [the date]
[the retort or processing system number] [the size of container] [the approximate number of containers
per coding interval] [the initial temperature] [the actual processing time] [the temperature-indicating device
readings] [temperature-recording device readings] [appropriate processing data]. Specifically, ***
Failure to provide running water [at a suitable temperature] [under suitable pressure] for [processing of
food] [cleaning of equipment, utensils and food-packaging materials] [employee sanitary facilities].
Specifically, ***
You did not [test] [examine] containers often enough to ensure that the containers suitably protected the
food from leakage and contamination. Specifically, ***
When a process operation deviated from the scheduled process or the equilibrium pH of the finished
product was higher than 4.6, you did not fully reprocess the food by a process established by a
competent processing authority as adequate to ensure a safe product; or thermally process the food as
required for low-acid food; or set aside the food for further evaluation as to any potential public health
significance. Specifically, ***
Gloves used in food handling are not maintained in an intact, clean, and sanitary condition. Specifically,
***
Toilet doors open into areas where food is exposed to airborne contamination, and there are no
alternative means taken to prevent such contamination. Specifically, ***
Your monitoring records do not contain the actual values and observations obtained during monitoring.
Specifically, ***
You did not review [some of] your calibration records within a reasonable time after the records were
made. Specifically, ***
You did not develop, or have developed for you, a written hazard analysis to determine whether there are
food hazards that are reasonably likely to occur for [each type of] juice you produce. Specifically, ***
_x000D_
. Specifically, ***
Your verification activities do not include, at a minimum, [review of consumer complaints to determine
whether they relate to the performance of the HACCP plan] [calibration of process monitoring
instruments] [end-product or in-product testing] [review of critical control point monitoring, corrective
action, and calibration records] to ensure that your HACCP system is being properly implemented.
Specifically, ***
Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure
compliance with the critical limits. Specifically, ***
Your HACCP plan does not list the [procedures for monitoring] [frequency of monitoring] at each critical
control point to ensure compliance with the critical limits. Specifically, ***
Personnel engaged in [manufacturing] [packaging] [labeling] [holding] dietary supplements do not have
the education, training, or experience to perform the person's assigned functions. Specifically, ***
Your equipment or utensils are not maintained to protect components and dietary supplements from
being contaminated. Specifically, ***
The written instructions in your master manufacturing record did not include specific actions necessary to
perform and verify points, steps, or stages in the manufacturing process where control is necessary to
ensure the quality of the dietary supplement. Specifically, ***
The written instructions in your master manufacturing record did not include [procedures for sampling] [a
cross-reference to procedures for tests or examinations]. Specifically, ***
You did not establish in-process specifications for a point, step, or stage in the master manufacturing
record where control is necessary to help ensure that specifications are met for [identity] [purity] [strength]
[composition]. Specifically, ***
You did not determine whether you met established product specifications for [identity] [purity] [strength]
[composition of the finished batch of the dietary supplement]. Specifically, ***
You did not ensure that the tests or examinations that you used to determine whether the specifications
are met are appropriate, scientifically valid methods. Specifically, ***
Your quality control operations did not include determining whether each finished batch conforms to
established product specifications. Specifically, ***
You did not make and keep written procedures for the responsibilities of the quality control operations.
Specifically, ***
You do not maintain records documenting compliance with refrigeration requirements. Specifically***
For a low-acid canned food, with respect to microbiological hazards that your supplier must control
according to the low-acid food regulations, you did not verify and document that the food was produced
according to the low-acid canned foods regulations. Specifically, ***
Your process controls monitoring frequency was not adequate. Specifically, ***
You did not validate that your process controls are adequate to control the hazard. Specifically, ***
You did not [establish] [implement] adequate written allergen controls verification procedures.
Specifically, ***
You did not have [complete] training records for your preventive controls qualified individual. Specifically,
***
You did not [inspect] [maintain] [clean] [sanitize] food contact surfaces as frequently as necessary to
protect against the contamination of produce. Specifically, ***
You did not [establish] [implement] a written environmental monitoring plan designed to identify L.
monocytogenes if it is present in the growing, harvesting, packing or holding environment. Specifically,
***
Your written sampling plan did not ensure that the collected samples are representative of the production
batch. Specifically, ***
Operators of [processing systems] [retorts] [aseptic processing systems] [product formulating systems]
are not under the operating supervision of a person that has attended and satisfactorily completed, a
school approved by the Commissioner. Specifically, ***
Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be
maintained in an appropriate sanitary condition. Specifically, ***
Lack of corrosion-resistant food contact surfaces. Specifically, ***
Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].
Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not minimize the [development of odor]
[potential for waste becoming an attractant and harborage or breeding place for pests]. Specifically, ***
Lack of backflow protection from piping systems that discharge [waste water] [sewage]. Specifically, ***
Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming
contaminated. Specifically, ***
Storage or use of toxic materials which are not required to maintain clean and sanitary conditions, are
unnecessary for use in laboratory testing procedures, are unnecessary for plant and equipment
maintenance, and are unnecessary for use in plant operations. Specifically, ***
You did not take a bacteriological swab or rinse count at least every three months from at least four
containers and closures selected just prior to filling and sealing. Specifically, ***
Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to
protect against contamination. Specifically, ***
Appropriate quality control procedures are not employed to ensure that finished foods do not present a
health hazard. Specifically, "***
Failure to maintain toilet facilities in a sanitary condition. Specifically, ***
In evaluating what food hazards are reasonably likely to occur, [you] [the person who performed the
evaluation for you] did not consider [microbiological contamination] [parasites] [chemical contamination]
[unlawful pesticide residues] [decomposition] [natural toxins] [use of unapproved color or food additives]
[presence of undeclared ingredients that may be allergens] [physical hazards]. Specifically, ***
Your HACCP plan is not specific to [each location where juice is processed] [each type of juice
processed]. Specifically, ***
You did not validate that your HACCP plan is adequate to control food hazards [at least once within 12
months after implementation] [at least annually] [when a change in the process occurred that could have
affected the hazard analysis or altered the HACCP plan in any way]. Specifically, ***
You did not review [all of] your [critical control point monitoring] [corrective action] records within one
week (7 days) of the day the records are made. Specifically, ***
Your HACCP plan does not list the critical control points for each of the identified food hazards.
Specifically, ***
Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is being implemented. Specifically, ***
Your personnel did not use hygienic practices to the extent necessary to protect against contamination of
components, dietary supplements, or contact surfaces. Specifically, ***
You have not identified personnel to be responsible for your quality control operations. Specifically, ***
You did not maintain your physical plant in a clean and sanitary condition. Specifically, ***
Your batch production records did not include the identity of equipment and processing lines used in
producing the batch. Specifically, ***
Your batch production records did not include the unique identifier that you assigned to [a component] [a
product that you received from a supplier for packaging or labeling as a dietary supplement] [the
packaging used] [the label used]. Specifically, ***
Your batch production records did not include documentation that quality control personnel approved and
released, or rejected, the packaged and labeled dietary supplement. Specifically, ***
You did not hold components under conditions that will [protect against contamination] [protect against
deterioration] [avoid mix-ups]. Specifically, ***
Your quality control personnel did not review and approve documentation to determine whether
quarantined received product meets established specifications. Specifically, ***
You did not identify each unique lot within each unique shipment of received product in a manner that
allows you to trace the lot to [the supplier] [the date received] [the name of the received product] [the
status of the received product] [the product that you packaged or labeled and distributed as a dietary
supplement]. Specifically, ***_x000D_
_x000D_
You did not hold [components] [dietary supplements] under appropriate conditions of temperature,
humidity, or light so that their identity, purity, strength, and composition are not affected. Specifically, ***
You did not assign a batch, lot, or control number to each lot of packaged and labeled dietary supplement
from a finished batch of dietary supplement. Specifically, ***
You did not control the [issuance] [use] of labels, Specifically, ***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically, ***
The certificate of analysis for a component does not include [a description of the test or examination
method(s) used] [limits of the test or examination] [actual results of the tests or examinations].
Specifically, ***
You did not provide adequate documentation of your basis for determining that compliance with the
specification[s] you selected for identity, purity, strength, and composition will ensure that the finished
batch of dietary supplement meets the specification[s]. Specifically, ***
Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an
established specification was not met. Specifically, ***
You did not make and keep [written procedures for the responsibilities of the quality control operations for
conducting a material review and making a disposition decision] [written procedures for approving or
rejecting any reprocessing]. Specifically, ***
You did not have required records, or copies of such records, readily available during the retention period
for inspection and copying by FDA when requested. Specifically, ***
You did not [establish] [follow] written procedures for quality control personnel to approve a returned
dietary supplement for reprocessing. Specifically, ***
Your written SE prevention plan is not [fully] implemented and followed. Specifically,***
Potential harborages for pests in and outside your poultry house have not been eliminated by [removing
debris within a poultry house] [removing debris and vegetation outside the poultry house]. Specifically,***
All required records do not include [your name] [the location of your farm]. Specifically,***
Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have become
contaminated with filth. Specifically, ***
You did not ensure that raw materials and other ingredients were not adulterated by pathogenic
microorganisms. Specifically, ***
You did not [determine] [document] the frequency of the verification activities that were needed to provide
adequate assurances that a food you obtain from a foreign supplier is produced in compliance with
processes and procedures that provide the required level of public health protection. Specifically, ***
You chose to comply with the requirements for a very small importer, but you did not document that you
meet the definition of a very small importer [before initially] [annually each year after] importing food as a
very small importer. Specifically, ***
You did not have allergen controls monitoring records. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for allergen controls.
Specifically, ***
You did not employ at least one supervisor or responsible party that has successfully completed
appropriate food safety training. Specifically, ***
You did not [determine] [conduct] [document] appropriate supplier verification activities. Specifically, ***
You did not [establish] [implement] [document the use of] written procedures for receiving raw materials
and other ingredients. Specifically, ***
You did not make available for official review and copying at reasonable times [all records] [all plans and
procedures] required by the regulations. Specifically, ***
Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the
required time period. Specifically, ***
Food contact surfaces are not designed to [withstand the environment of their intended use] [withstand
the action of food] [withstand cleaning compounds and sanitizing agents]. Specifically, ***
The bottling room was not separated from other plant operations by [tight walls] [ceilings] [self-closing
doors] to protect against contamination. Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey
sewage and liquid disposable waste from the plant. Specifically, ***
A [processing] [production] record form was not signed or initialed by a processing system operator or
other designated person. Specifically, ***
You did not take and analyze samples of bottled drinking water for bacteriological testing at least once a
week [for each type of bottled drinking water produced during a day's production run]. Specifically, ***
Each container is not marked with an identifying code permanently visible to the naked eye. Specifically,
***
Departures from a scheduled process having a possible bearing on public health or the safety of a food
are not [noted] [identified] [recorded] [made the subject of a separate file (or log identifying the
appropriate data) delineating them]. Specifically, ***
Toilet facilities lack self-closing doors. Specifically, ***
Container cooling water was not chlorinated or otherwise sanitized [for cooling canals] [for recirculated
water supplies]. Specifically, ***
Maintenance of the grounds is inadequate to protect against contamination of food. Specifically, ***
You did not register with FDA with required information on Form FDA 2541 (food canning establishment
registration) within 10 days after first engaging in the manufacture, processing, and packaging a low-acid
canned food. Specifically, ***
Operators of [retorts] [thermal processing systems] [aseptic processing and packaging systems]
[container closure inspections] were not under the operating supervision of a person who attended and
satisfactorily completed a school approved by the FDA Commissioner. Specifically, ***
For an intentional change in a previously filed scheduled process, you did not submit to FDA, within 30
days after first use, [a complete description of the modifications made and utilized] [a copy of the file
record showing prior substantiation by a qualified scientific authority as to the safety of the changed
process]. Specifically, ***
You do not have records to document the performance and results of the affirmative steps taken to
demonstrate that [fish] [fishery products] imported into the United States were processed in accordance
with the seafood HACCP regulation. Specifically, ***
You do not have records that [fully] document corrective actions that were taken. Specifically, ***
Your HACCP plan includes a corrective action plan. There was a deviation from a critical limit and you
did not take corrective action that ensured [product that was injurious to health or otherwise adulterated
did not enter commerce] [the cause of the deviation was corrected]. Specifically, ***
Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical
control points. Specifically, ***
You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-
process testing]. Specifically, ***
Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a
suitable temperature]. Specifically, ***
You did not take effective measures [to exclude pests from the physical plant] [to protect against
contamination of components, dietary supplements, and contact surfaces on the premises by pests].
Specifically, ***
Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and
kept clean and in good repair. Specifically, ***
Your physical plant did not use adequate screening or other protection against pests. Specifically, ***
You did not make and keep records of the written procedures for [cleaning the physical plant] [pest
control]. Specifically, ***
You did not use equipment or utensils of appropriate design, construction, and workmanship to enable
them to be [suitable for its intended use] [adequately cleaned] [properly maintained]. Specifically, ***
Your batch production record did not accurately follow the appropriate master manufacturing record.
Specifically, ***
Your batch production records did not include the date on which each step of the master manufacturing
record was performed. Specifically, ***
Your batch production records did not include documentation that quality control personnel approved and
released, or rejected, a batch for distribution. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for product received for packaging
or labeling as a dietary supplement. Specifically, ***
You did not quarantine components before you used them in the manufacture of a dietary supplement.
Specifically, ***
You held [components] [dietary supplements] [packaging] [labels] under conditions that lead to mix-up,
contamination, or deterioration. Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
The written instructions in your master manufacturing record did not include instructions for corrective
action plans to use when specifications are not met. Specifically, ***
Your master manufacturing record did not include a statement of [the theoretical yield for each point, step,
or stage of the manufacturing process to ensure quality control] [the expected yield of the finished dietary
supplement] [the maximum and minimum percentages of theoretical yield beyond which a deviation
investigation of a batch is necessary and material review is conducted and disposition decision is made].
Specifically, ***
Your master manufacturing record did not identify specifications for the points, steps, or stages in the
manufacturing process where control is necessary to ensure that the dietary supplement is packaged and
labeled as specified in the master manufacturing record. Specifically, ***
You were not able to determine the complete manufacturing history and control of a packaged and
labeled dietary supplement through distribution. Specifically, ***
You did not [establish] [follow] written procedures for packaging operations. Specifically, ***
Your quality control personnel did not [review and approve decisions about whether to investigate a
product complaint] [review and approve the findings and follow-up action of an investigation]. Specifically,
***
You did not establish specifications to [sufficiently] assure that the product you received for packaging or
labeling as a dietary supplement is adequately identified and is consistent with your purchase order.
Specifically,
You did not confirm the identity of components. Specifically, ***
You did not retain reserve samples for the required time. Specifically, ***
You did not make and keep documentation of your qualification of a supplier. Specifically, ***
Your quality control operations did not include reviewing and approving the results of required [tests]
[examinations]. Specifically, ***
Your quality control operations did not include reviewing and approving [master manufacturing records]
[modifications to the master manufacturing records]. Specifically, ***
Your quality control operations for product complaints did not include [reviewing and approving decisions
about whether to investigate a product complaint] [reviewing and approving the findings and follow-up
action of any investigation performed]. Specifically, ***
You did not make and keep documentation of your material review and disposition decision. Specifically,
***
You did not [establish] [follow] written procedures for when a returned dietary supplement must be
destroyed, or otherwise suitably disposed. Specifically, ***
You do not maintain practices that will protect against cross contamination when people move between
poultry houses. Specifically,***
You did not maintain records documenting compliance with biosecurity measures. Specifically, ***
You did not maintain records documenting compliance with rodent and other pest control measures.
Specifically,***
All your required records do not include the [date] [time] of the activity that the records reflect.
Specifically,***
You did not use testing procedures to identify [sanitation failures] [possible allergen cross-contact] [food
contamination]. Specifically, ***
Your hazard analysis did not include a known or reasonably foreseeable [biological] [chemical] [physical]
hazard that requires a control. Specifically, ***
You did not [determine] [document] which verification activity or activities were needed to provide
adequate assurances that a food you obtain from a foreign supplier is produced in compliance with
processes and procedures that provide the required level of public health protection. Specifically, ***
You did not keep a required FSVP record. Specifically, ***
You did not ensure that all individuals are qualified to perform their duties. Specifically, ***
Your food safety plan was not prepared or its preparation overseen by a preventive controls qualified
individual. Specifically, ***
You did not have written preventive controls. Specifically, ***
You did not have process controls monitoring records. Specifically, ***
You did not [establish] [implement] adequate written corrective action procedures for your controls.
Specifically, ***
You did not have a written recall plan. Specifically, ***
You have not inspected all of your agricultural water systems at the beginning of the growing season or
on a minimum annual basis to identify conditions that are reasonably likely to introduce hazards onto
produce or onto food contact surfaces. Specifically, ***
You did not handle harvested produce in a manner that protects against contamination with known or
reasonably foreseeable hazards. Specifically, ***
The critical factors identified in the schedule process for the prevention of the growth of microorganisms
not destroyed by the thermal process are not controlled in a manner to ensure the limits established are
not exceeded. Specifically, ***
The product water supply source was not [properly located, protected, and operated] [easily accessible]
[adequate] [of a safe, sanitary quality] [in conformance at all times with the applicable laws and
regulations]. Specifically, ***
Operating processes for each product and container size were not [posted in a conspicuous place near
the processing equipment] [readily available to the retort or processing system operator] [readily available
to FDA investigators]. Specifically, ***
Each retort [basket] [truck] [car] [crate] that contained retorted food product was not plainly and
conspicuously marked with a heat-sensitive indicator or by other effective means to visually indicate the
retorted units. Specifically, ***
Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect
against contamination of [food] [food-contact surfaces] [food-packaging materials]. Specifically, ***
A [processing] [production] record was not reviewed [within 1 working day after the actual process]
[before shipment or release for distribution] to determine completeness of the record and to ensure that
the product received the scheduled process. Specifically, ***
A retort was not equipped with an automatic steam controller to maintain the retort temperature.
Specifically, ***
Each retort did not have an accurate temperature-recording device. Specifically, ***
A temperature-recording device was not adjusted with sufficient frequency to ensure agreement as nearly
as possible with, but not higher than, the temperature-indicating device during processing. Specifically,
***
You did not maintain records at the plant pertaining to physical inspection of equipment used for
treatment of product water, including the [type and date of physical inspections of equipment] [conditions
found] [performance and effectiveness of equipment]. Specifically, ***
Sanitizing operations were not adequate to sanitize the intended [product water-contact surfaces] [critical
areas]. Specifically, ***
The [maximum fill-in weight] [drained weight] specified in the scheduled process was not [measured]
[recorded] at intervals of sufficient frequency to ensure that the weight of the product did not exceed the
maximum for the container size as specified in the scheduled process. Specifically, ***
A critical factor specified in the scheduled process was not [measured] [recorded] on the processing
record [at intervals of sufficient frequency to ensure that the factor was within the limits specified in the
scheduled process]. Specifically, ***
You did not identify each unit package from a [batch] [segment of a continuous production run] of bottled
drinking water with a production code which identifies [the particular batch] [the segment of production
run] [the day produced]. Specifically, ***
You did not record and maintain information as to the [kind of product] [volume produced] [date produced]
[lot code used] [distribution of finished product to wholesale and retail outlets]. Specifically, ***
You did not take and analyze samples of bottled drinking water for [chemical] [physical] [radiological]
testing at least annually [for each type of bottled drinking water produced during a day's production run].
Specifically, ***
Gloves used for food handling are not impermeable. Specifically, ***
Failure to sanitize and thoroughly dry, prior to use, food-contact surfaces which have been wet cleaned.
Specifically, ***
Appropriate detailed inspections and tests of containers were not conducted [by qualified personnel] [at
intervals of sufficient frequency to ensure proper closing machine performance and consistently reliable
hermetic seal production]. Specifically, ***
You did not have evidence in the form of heat distribution data that adequate venting of air is
accomplished for a retort installation that deviates from established air venting requirements for still
retorts. Specifically, ***
Your [validation of the HACCP plan] [validation of the hazard analysis] was not done by an individual who
had successfully completed training in the application of HACCP principles to juice processing or
otherwise qualified through job experience to perform these function. Specifically, ***
You do not conduct the 5-log reduction process and perform final packaging of your juice within a single
production facility operating under current good manufacturing practices. Specifically, ***
The personnel you identified to perform quality control operations [are not qualified to do so] [do not have
the education, training or experience to perform the assigned functions]. Specifically, ***
The personnel you identified to perform quality control operations do not have distinct and separate
responsibilities related to performing such operations from those responsibilities that the personnel
otherwise have when not performing such operations. Specifically, ***
You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements,
or contact surfaces from becoming contaminated. Specifically, ***
You did not use safety-type [light bulbs] [fixtures] [skylights] [glass] over exposed components or dietary
supplements. Specifically, ***
You did not [establish] [follow] written procedures for calibrating instruments and controls that you use in
manufacturing or testing a component or dietary supplement. Specifically, ***
You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated,
mechanical, and electronic equipment. Specifically, ***
You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or
hold components or dietary supplements. Specifically, ***
You did not [maintain] [clean] [sanitize] equipment, utensils, and contact surfaces used to manufacture,
package, label, or hold components or dietary supplements. Specifically, ***
You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to
ensure proper performance. Specifically, ***
Your batch production records did not include the [identity] [weight or measure] of each component used.
Specifically, ***
Your batch production records did not include documentation that the finished dietary supplement meets
established specifications. Specifically, ***
Your batch production records did not include an actual or representative label, or a cross-reference to
the physical location of the actual or representative label specified in the master manufacturing record.
Specifically, ***
You did not collect representative samples of components while the components were quarantined.
Specifically, ***
You did not identify each unique lot within each unique shipment of components that you received in a
manner that allows you to trace the lot to [the supplier] [the date received] [the name of the component]
[the status of the component] [the dietary supplement that you manufactured and distributed].
Specifically, ***
You did not identify each unique lot within each unique shipment of labels in a manner that allows you to
trace the lot to [the supplier] [the date received] [the name of the labels] [the status of the labels] [the
dietary supplement that you distributed]. Specifically, ***_x000D_
You did not make and keep written procedures for fulfilling the requirements that apply to packaging and
labeling received. Specifically, ***
You did not make and keep written procedures for fulfilling the requirements that apply to product
received for packaging or labeling as a dietary supplement and for distribution rather than for return to the
supplier. Specifically,
You did not make and keep receiving records for [components] [packaging] [labels] [products you
received for packaging or labeling as a dietary supplement]. Specifically, ***
You did not hold reserve samples [under conditions consistent with product labels] [under ordinary
storage conditions]. Specifically, ***
You did not verify that the laboratory examination and testing methodologies are appropriate for their
intended use. Specifically, ***
You did not perform manufacturing operations under conditions and controls that protect against [the
potential for growth of microorganisms] [the potential for contamination]. Specifically, ***
You did not take necessary precautions during the manufacture of a dietary supplement to prevent
contamination of [components] [dietary supplements]. Specifically, ***
You did not suitably dispose of labels and packaging for dietary supplements that are obsolete or
incorrect to ensure that they are not used in any future packaging and label operations. Specifically, ***
You did not examine, before [packaging] [labeling] operations, [packaging] [labels] for each batch of
dietary supplement to determine whether the [packaging] [labels] conformed to the master manufacturing
record. Specifically, ***
A qualified person did not investigate a product complaint that involved a possible failure of a dietary
supplement to meet a specification, or other requirement. Specifically, ***
You did not determine whether you met specifications established to ensure the quality of the dietary
You did not determine whether you met established limits on contamination that may adulterate or may
lead to adulteration of the finished batch of the dietary supplement. Specifically, ***
You did not monitor the in-process points, steps, or stages, where control is necessary to ensure that the
quality of the finished batch of dietary supplement, to determine whether the in-process specifications are
met. Specifically, ***
You did not collect representative samples of each unique lot of [components] [packaging] [labels] that
you received from a supplier to determine whether the [components] [packaging] [labels] meet[s]
established specifications. Specifically, ***
You did not make and keep records of established specifications. Specifically, ***
Your quality control personnel did not review and approve the documentation setting forth the basis for
qualification of suppliers. Specifically, ***
Your quality control personnel did not ensure that required representative samples are collected.
Specifically, ***
Your quality control personnel did not ensure that required reserve samples were collected and held.
Specifically, ***
Your quality control personnel did not perform required operations for the [master manufacturing record]
[batch record] [manufacturing operations]. Specifically, ***
You do not have quality control operations for a material review and disposition decision. Specifically, ***
Your quality control operations did not include reviewing and approving all batch production-related
records. Specifically, ***
Your quality control operations did not include approving and releasing, or rejecting, each finished batch
for distribution. Specifically, ***
Your quality control operations did not include determining whether the finished [packaged] [labeled]
dietary supplement conforms to established specifications. Specifically, ***
Your quality control operations for returned dietary supplements did not include approving or rejecting
salvage and redistribution of a returned dietary supplement. Specifically, ***
You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of
the equipment. Specifically, ***
You did not make and keep documentation of calibrations for instruments or controls that you use in
manufacturing or testing a component or dietary supplement. Specifically, ***
Your written SE plan does not [bear a date] [carry the signature(s) and not the initials of the person(s)
who administer the plan]. Specifically,***
Your container sample results indicated [that more than one sample exceeded more than one bacteria
per milliliter of capacity or one colony per square_x000D_
centimeter of surface area] [the presence of coliform organisms]. Specifically, ***
Your cold storage unit used to store and hold food did not have a temperature device [installed] [installed
to show temperature accurately]. Specifically, ***
You did not hold a human food by-product intended for distribution as animal food under conditions that
will protect against contamination. Specifically, ***
You did not document your review and assessment of [an evaluation] [a reevaluation] of a foreign
supplier's performance and the risk posed by a food that was performed by another entity. Specifically,
***
You did not conduct and document or obtain documentation of one or more supplier verification activities
[before importing the food into the United States] [periodically after importing the food into the United
States]. Specifically, ***
You did not [promptly] provide records for [review] [copying]. Specifically, ***
As a very small importer, you did not obtain written assurance, [before importing a food] [every 2 years
after initially importing a food], that your foreign supplier produced the food in compliance with process
and procedures that provide the required level of public health protection. Specifically, ***
Your food safety plan was not signed and dated [upon initial completion] [when modified]. Specifically, ***
Your allergen controls monitoring frequency was not adequate. Specifically, ***
You did not provide adequate training at sufficient frequency to [all personnel who handle covered
produce or food contact surfaces] [personnel who supervise personnel who handle covered produce or
food contact surfaces]. Specifically, ***
You did not provide employee training that includes [principles of food hygiene and food safety] [the
importance of health and personal hygiene for all personnel and visitors] [produce safety standards
applicable to the employee's job responsibilities]. Specifically, ***
You did not establish and keep records that document personnel training, including [the date of training]
[training topics] [persons trained]. Specifically, ***
You did not ensure that personnel who may contact produce or food contact surfaces use hygienic
practices to protect against produce contamination. Specifically, ***
You did not [maintain] [clean] non-food-contact surfaces of equipment and tools that you use during
harvesting, packing, and holding as frequently as necessary to protect against the contamination of
produce. Specifically, ***
You did not provide adequate drainage in all areas where normal operations release or discharge water
or other liquid waste to the ground or floor of buildings. Specifically, ***
You did not take adequate measures to exclude pests from your fully-enclosed buildings. Specifically, ***
Your plumbing [is not of adequate size and design] [is not adequately installed and maintained].
Specifically, ***
Your written environmental monitoring plan does not list a sufficient number of sampling sites to
determine whether measures are effective. Specifically, ***
Your environmental monitoring plan does not include an adequate written corrective action plan.
Specifically, ***
You did not aseptically collect samples of [spent irrigation water] [in-process sprouts]. Specifically, ***
You did not ensure that raw materials and other ingredients were not contaminated with [pests]
[undesirable microorganisms] [extraneous materials]. Specifically, ***
The records that relate to the general adequacy of your [processes] [equipment] were not maintained for
at least two years after their applicability to the product you produced. Specifically, ***
Processing and production information was not recorded [at the time it was observed] [by the retort or
processing system operator or other designated person]. Specifically, ***
For a still retort, records were not maintained for [the time that steam was turned on] [the time that the
retort reached processing temperature] [the time that steam was shut off] [the venting time] [the venting
temperature]. Specifically, ***
You did not take and analyze samples of product water [as often as necessary] [at least once every year
for chemical contamination] [at least once every four years for radiological contaminants]. Specifically, ***
The [product] [operations] source water that [was] [were] obtained from other than a public water system
[was] [were] not sampled and analyzed for total coliforms at least once each week. Specifically, ***
You did not [fill] [cap] [close] [seal] [package] containers in a sanitary manner so as to preclude
contamination of the bottled drinking water. Specifically, ***
Scheduled processes for low-acid foods have not been established by qualified persons having expert
knowledge of thermal processing. Specifically, ***
Process deviations were not recorded in a separate file or log that details both the deviations and the
actions taken. Specifically, ***
Temperature-recording device records were not identified by [date] [retort number] [data necessary to
correlate the temperature-recording device with the record of lots processed]. Specifically, ***
Failure to [store] [handle] [dispense] [use] [dispose of] single-service articles in a manner that protects
against the contamination of food and food-contact surfaces. Specifically, ***
The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food]
[food-contact surfaces] [water supplies] [ground surfaces]. Specifically, ***
Plumbing is not [of adequate size and design] [adequately installed and maintained] to carry sufficient
quantities of water to required locations throughout the plant. Specifically, ***
Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.
Specifically, ***
A record of a container closure examination did not specify [the product code] [the date of container
closure inspections] [the time of container closure inspections] [the measurements obtained] [all
corrective actions taken]. Specifically, ***
A temperature-indicating device was not tested for accuracy [upon installation] [at least once a year] [as
frequently as necessary to ensure accuracy during processing]. Specifically, ***
There is no assurance that [raw materials] [ingredients] which are susceptible to contamination with
aflatoxin or other natural toxins comply with current FDA standards before being incorporated into food.
Specifically, ***
The function of supervising overall sanitation of the plant has not been designated to the supervision of
one or more competent individuals assigned responsibility for this function. Specifically, ***
Failure to adequately [monitor pH] [maintain a pH of 4.6 or below] for foods that rely principally on the
control of pH to prevent the growth of undesirable microorganisms. Specifically, ***
You did not keep records of [inspections and conditions found] [physical maintenance] [performance] for
mechanical washers. Specifically, ***
Each retort did not have at least one temperature-indicating device that accurately indicated the
temperature during processing. Specifically, ***
A temperature-recording device was not adjusted with sufficient frequency to ensure agreement as nearly
as possible with, but not higher than, the temperature-indicating device during processing. Specifically,
***
Samples collected for [bacteriological] [chemical] [physical] [radiological] analysis were not primary
containers or unit packages from a batch or segment of a continuous production run for each type of
bottled drinking water. Specifically, ***
Failure to take effective measures to protect food transported by conveyor from contamination.
Specifically, ***
Process deviations are not evaluated by a competent processing authority in accordance with procedures
recognized by competent processing authorities as being adequate to detect any potential hazard to
public health. Specifically, ***
Failure to provide employees with [readily accessible] [adequate] toilet facilities. Specifically, ***
Failure to keep toilet facilities in good repair. Specifically, ***
Devices and fixtures are not designed and constructed to protect against recontamination of clean,
sanitized hands. Specifically, ***
Lack of [an automatic control for regulating temperature] [an automatic temperature alarm system] for
each freezer and cold storage compartment used to store food capable of supporting the growth of
microorganisms. Specifically, ***
Failure to [store] [transport] finished food under conditions that would protect against deterioration of the
food and its container. Specifically, ***
Teardown examinations for double-seam cans were not performed [by a qualified individual]. Specifically,
***
Container handling equipment used in handling filled containers was not [designed] [constructed]
[operated] to preserve the can seam or other container closure integrity. Specifically, ***
A record was not was not made of [the closing machine vacuum in vacuum-packed products] [the
maximum fill-in weight] [the drained weight] [a critical factor specified in the scheduled process].
Specifically, ***
You did not correct sanitation deficiencies in a timely manner. Specifically,***
You did not take corrective action that ensured [affected product was not entered into commerce] [the
cause of the deviation was corrected]. Specifically, ***
You do not [always] have or have not implemented a sanitation standard operating procedure that
addresses sanitation conditions and practices before, during and after processing. Specifically, ***
Your records do not [always] contain the actual values and observations obtained during monitoring.
Specifically, ***
You did not maintain records of [sampling] [testing] of cleaning and sanitizing solutions. Specifically, ***
Your food facility is not registered as required. Specifically, ***
You did not review [all of] your [calibration] [periodic end-product testing] [in-process testing] records
within a reasonable time after the records were made. Specifically, ***
Your HACCP plan does not list the validation [procedures] [frequencies] that have been developed to
ensure that the HACCP plan is adequate to control food hazards that are reasonably likely to occur.
Specifically, ***
A serious adverse event report for a dietary supplement was not submitted on a MedWatch form.
Specifically, ***
You did not [establish] [follow] written procedures for hygienic practices. Specifically, ***
You did not [identify] [hold] cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, or
other toxic materials in a manner that protects against contamination of components, dietary
supplements, or contact surfaces. Specifically, ***
Your physical plant was not suitable in size, construction, design to facilitate [maintenance] [cleaning]
[sanitizing] operations. Specifically, ***
You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and
utensils. Specifically, ***
You used equipment or utensils that do not have seams that are smoothly bonded or maintained to
minimize accumulation of extraneous materials or contaminants. Specifically, ***
Cleaning compounds or sanitizing agents were not [adequate for their intended use] [safe under their
conditions of use]. Specifically, ***
You did not keep batch production records as original records, true copies, or as electronic records.
Specifically, ***
Your batch production records did not include the actual results obtained during a monitoring operation.
Specifically, ***
Your batch production records did not include the results of testing or examination performed during
batch production, or a cross-reference to such results. Specifically, ***
Your batch production records did not include the initials of the person responsible for verifying the weight
or measure of each component used in the batch. Specifically, ***
Your batch production records did not include documentation, at the time of performance, of [packaging]
[labeling] operations. Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed
required monitoring operations. Specifically, ***
Your batch production records did not include documentation that quality control personnel reviewed the
results of tests and examinations. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for packaging received.
Specifically, ***
You did not quarantine [packaging] [labels] before you used them in the manufacture of a dietary
You did not hold received product under conditions that will avoid mix-ups. Specifically, ***
The person who performed a required operation did not document, at the time of performance, that the
required operation was performed. Specifically, ***
You did not hold in-process material under appropriate conditions of temperature, humidity, and light.
Specifically, ***
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
You did not make and keep records of product distribution. Specifically, ***
You did not identify and use an appropriate scientifically valid method for each established specification
for which testing or examination is required to determine whether the specification was met. Specifically,
***
Your electronic records for your laboratory operations do not comply with the electronic records
requirements. Specifically,
You did not make and keep documentation that established laboratory methodology was followed.
Specifically, ***
You did not make and keep records of the written procedures for manufacturing operations. Specifically,
***
You did not use effective measures to protect against the inclusion of metal or other foreign material in
[components] [dietary supplements]. Specifically, ***
You did not conduct manufacturing operations in accordance with adequate sanitation principles.
Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each point,
step, or stage in the manufacturing process where control is necessary to ensure that the dietary
supplement is packaged and labeled as specified in the master manufacturing record. Specifically, ***
The written instructions in your master manufacturing record did not include specifications for each point,
step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary
You did not have records or copies of records required for your master manufacturing records readily
available during the required retention period for inspection and copying by FDA when requested.
Specifically, ***
You did not protect manufactured dietary supplements from contamination during [filling] [assembling]
[packaging] [labeling] operations. Specifically, ***
A qualified person did not review a product complaint to determine whether the product complaint
involved a possible failure of a dietary supplement to meet specifications or any other requirements.
Specifically, ***
Your review and investigation of a product complaint did not extend to all relevant batches and records.
Specifically, ***
Your [review about whether to investigate a product complaint] [findings and follow-up action of an
investigation performed] did not extend to all relevant batches and records. Specifically, ***
You did not make and keep a written record of every product complaint that was related to good
manufacturing practice. Specifically, ***
You did not determine whether you met established specifications to provide sufficient assurance that
product you receive from a supplier is adequately identified and is consistent with your purchase order.
Specifically, ***
You did not maintain documentation of how you qualified the supplier of a component. Specifically, ***
You did not periodically re-confirm the supplier's certificate of analysis for a component. Specifically, ***
Your reserve sample of a dietary supplement was not held using the same container-closure system in
which the packaged and labeled dietary supplement was distributed. Specifically, ***
Your quality control personnel did not [conduct required material reviews] [make required disposition
decisions]. Specifically,
why the results of appropriate tests or examinations for each product specification will ensure that the
finished batch of the dietary supplement meets product specifications. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision when a
batch deviated from the master manufacturing record. Specifically, ***
Your quality control operations did not include determining whether [components] [packaging] [labels]
conform to established specifications. Specifically, ***
Your quality control operations did not include conducting a required material review and making a
required disposition decision for [components] [packaging] [labels] prior to [their] use. Specifically, ***
Your quality control personnel approved and released for distribution a batch of dietary supplement for
which one or more components did not meet identity specifications. Specifically, ***
You do not have quality control operations for [packaging] [labeling]. Specifically, ***
Your written documentation that quality control personnel reviewed, approved, or rejected for
reprocessing did not include the signature of the person performing the review, approval, or rejection.
Specifically, ***
You did not keep required written records for 1 year past the shelf life date or for 2 years beyond the date
of distribution of the last batch of dietary supplements associated with the records. Specifically, ***
You did not make and keep written procedures for calibrating instruments or controls that you use in
[manufacturing] [testing] a component or dietary supplement. Specifically, ***
You did not make and keep written records of calibrations, inspections, or checks of automated,
mechanical, or electronic equipment. Specifically, ***
You do not maintain practices that will protect against cross contamination when equipment is moved
among poultry houses. Specifically,***
An environmental test for SE was not done for each poultry house as required. Specifically,***
The poultry house environmental sampling plan was not appropriate to the poultry house layout.
Specifically,***
You do not have a written SE prevention plan. Specifically,***
You do not maintain documentation [that pullets were "SE monitored" or were raised under "SE
monitored" conditions] [that adequate environmental testing records for pullets were kept as required by
CFR regulations]. Specifically,***
All required records do not have the signature or initials of the person performing the operation or
creating the record. Specifically,***
The temperature-indicating device used to determine the initial temperature of the product was not tested
for accuracy [against a reference device for which the accuracy is traceable to a National Institute of
Standards and Technology (NIST), or other national metrology institute standard reference device, by
appropriate standard procedures] [with sufficient frequency to ensure that initial temperature
measurements are accurate]. Specifically, ***
Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have been
rendered injurious to health. Specifically, ***
You did not take appropriate measures to rectify or otherwise eliminate the cause of Escherichia coli
contamination of your [product] [operations] source water [in a manner sufficient to prevent its
reoccurrence]. Specifically, ***
You did not treat compressed air or other gases in such a way that food is not contaminated with unlawful
indirect food additives. Specifically, ***
You did not identify materials scheduled for rework. Specifically, ***
You mixed adulterated food with another lot of food. Specifically, ***
You did not [review] [assess] the hazard analysis conducted by another entity. Specifically, ***
You did not conduct an appropriate supplier verification activity. Specifically, ***
You did not make a required FSVP record available [promptly] to an authorized FDA representative upon
request. Specifically, ***
You did not maintain a record of the corrective actions taken under your SE prevention plan. Specifically,
***
You did not take an appropriate corrective action in response to an unanticipated food safety problem.
Specifically, ***
Your process controls records [were not reviewed by a preventive controls qualified individual or such
review was not overseen by a preventive controls qualified individual] [were not reviewed within specified
timeframes]. Specifically, ***
Your process controls validation [was not performed by or overseen by a preventive controls qualified
individual] [was not performed when necessary] [was not based on scientific evidence]. Specifically, ***
Your sanitation controls records [were not reviewed by a preventive controls qualified individual or such
You did not have controls monitoring records. Specifically, ***
Your written recall plan [did not include steps to be taken] [did not assign responsibility for taking steps] to
perform recall actions. Specifically, ***
You did not take appropriate measures to prevent the introduction of known or reasonably foreseeable
hazards into covered produce. Specifically, ***
You did not establish and keep documentation of the date and method of cleaning and sanitizing of
equipment. Specifically, ***
You did not take measures to prevent the introduction of hazards onto [seeds] [beans] used for sprouting.
Specifically, ***
Your environmental monitoring plan did not include a sampling plan that specifies [what you will test
collected sample for] [how often you will collect samples] [the point during production at which you will
collect samples] [sample collection sites]. Specifically, ***
Your written sampling does not include a corrective action plan if samples test positive for pathogens.
Specifically, ***
You did not establish documentation [of treatment of your seeds or beans] [from your seed supplier that
seeds or beans are treated and appropriately handled and packaged following treatment]. Specifically,
***
Your required records were not reviewed, dated, and signed by a supervisor or responsible party within a
reasonable time after the records are made. Specifically, ***
You did not [maintain] [follow] an FSVP. Specifically, ***
You did not [monitor temperature control with adequate frequency] [take corrective action when there was
a loss of temperature control] [verify implementation of temperature controls]. Specifically,***
You did not [establish] [maintain] records documenting temperature controls. Specifically, ***
Your computerized records do not provide that appropriate controls are implemented to ensure the
integrity of the electronic data and signatures. Specifically, ***
You have not provided evidence that the [fish] [fishery products] you import have been processed under
conditions that comply with the Seafood HACCP regulation. Specifically, ***
You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).
Specifically, ***
Failure to ensure that compressed air or other gases [mechanically introduced into food] [used to clean
food-contact surfaces or equipment] have been treated in such a way that foods are not contaminated
with unlawful indirect food additives. Specifically, ***
Failure to maintain food contact surfaces to protect food from contamination by any source, including
unlawful indirect food additives. Specifically, ***
An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control
or prevent the growth of undesirable microorganisms. Specifically,***
Failure to dispose of sewage into an adequate sewerage system or by other adequate means.
Specifically, ***
Employees who appear to have an [illness] [open lesion] [abnormal source of microbial contamination]
are not excluded from operations where there is a reasonable possibility of [food] [food contact surfaces]
[food packaging materials] becoming contaminated. Specifically, ***
Personnel with adverse health conditions are not instructed to report to their supervisors. Specifically, ***
The ventilation in the [processing room] [bottling room] [container washing and sanitizing area] was not
adequate to minimize condensation. Specifically, ***
The [product] [operations] water [supply was] [supplies were] not from an approved source. Specifically,
***
The filling of containers is not controlled to ensure that the filling requirements specified in the scheduled
process are met. Specifically, ***
The operations water supply was not [properly located, protected, and operated] [easily accessible]
[adequate] [of a safe, sanitary quality] [in conformance at all times with applicable laws and regulations].
Specifically, ***
Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where
they may contaminate food. Specifically, ***
A critical factor that may affect the scheduled process was not specified in the scheduled process.
Specifically, ***
Retort venting procedures for each product and container size were not [posted in a conspicuous place
near the processing equipment] [readily available to the retort or processing system operator] [readily
available to FDA investigators]. Specifically, ***
You did not have a deviation from the scheduled process evaluated for public health significance by a
competent processing authority. Specifically, ***
Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].
Specifically, ***
A record of a container closure examination was not signed or initialed by the container closure inspector.
Specifically, ***
The reference instrument for indicating the processing temperature was not a temperature-indicating
device. Specifically, ***
[Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or
other disease are not pasteurized or otherwise adequately treated. Specifically, ***
Failure to use adequate [sterilization] [irradiation] [pasteurization] [freezing] [refrigeration] [pH control]
[water activity control] to destroy or prevent the growth of undesirable microorganisms in food.
Specifically, ***
Failure to perform mechanical manufacturing steps so as to protect food against contamination.
Specifically, ***
Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in
a manner that protects against [contamination] [growth of microorganisms]. Specifically, ***
A bleeder was not arranged so that the operator could observe that it was functioning properly.
Specifically, ***
You did not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate
performance. Specifically, ***
You did not maintain [adequate] records regarding [the intensity of the sanitizing agent] [the time duration
that the sanitizing agent was in contact with the surface being sanitized]. Specifically, ***
Measurements and recordings of critical factors specified in the scheduled process were not made at
intervals of 15 minutes or less. Specifically, ***
A still retort was not equipped with an automatic steam controller to maintain the retort temperature.
Specifically, ***
The temperature range of a mercury-in-glass thermometer exceeded 17 ?F per inch (4 ?C per
centimeter) of graduated scale. Specifically, ***
The reference instrument for indicating the processing temperature was not a temperature-indicating
device. Specifically, ***
Each retort did not have an accurate temperature-recording device. Specifically, ***
Graduations on a temperature-recording device chart exceeded 2?F (1?C) within a range of 10?F (5?C)
of the process temperature. Specifically, ***
A means of preventing unauthorized adjustment to the temperature-recording device was not provided.
Specifically, ***
A retort did not have a means of determining the water level in the retort during operation. Specifically,
***
The operator did not [check] [record] the water level in the retort [at intervals sufficient to ensure its
adequacy]. Specifically, ***
A means for introducing compressed air at the proper pressure and rate was not provided for [a horizontal
retort] [a vertical still retort] for pressure processing in water. Specifically, ***
You did not visually or electronically inspect filled containers to assure they are [sound] [properly capped
or sealed] [properly coded and labeled]. Specifically, ***
Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against
Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming
adulterated. Specifically, ***
Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse]
[other ingredients] . Specifically, ***
Each product sterilizer did not have at least one temperature-indicating device that accurately indicated
the temperature during processing. Specifically, ***
A temperature-indicating device was not tested for accuracy [upon installation] [at least once a year] [as
frequently as necessary to ensure accuracy during processing]. Specifically, ***
Graduations on the temperature recorder-controller chart exceeded 2 degrees F within a range of 10
degrees F of the product sterilization temperature. Specifically, ***
The methods and controls used for the [manufacture] [processing] [packing] of a thermally processed
food were not operated or administered in a manner adequate to ensure that the product is safe.
Specifically, ***
A critical factor specified in the scheduled process for processing a low-acid food in hermetically sealed
containers was not [measured] [recorded] at intervals of sufficient frequency to ensure that the critical
factor was within the limits specified in the scheduled process. Specifically, ***
Observation and measurement of an operating condition was not [made] [recorded] at intervals of
sufficient frequency to ensure that commercial sterility of the food product was being achieved.
Specifically, ***
A critical factor was not [measured] [recorded] at intervals of sufficient frequency to ensure that the critical
factor was within the limits specified in the scheduled process. Specifically, ***
The [processing] [production] records do not contain sufficient additional information such as [product
code] [date] [container size] [product] to permit a public health hazard evaluation of the processes applied
to each [lot] [batch] [portion] of production. Specifically, ***
Records identifying initial distribution of finished product are not maintained. Specifically, ***
Responsibility for assuring compliance with current good manufacturing practices relating to personnel
has not been assigned to competent supervisory personnel. Specifically, ***
Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against
Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].
Specifically, ***
Failure to inspect [containers] [carriers] of raw materials upon receipt to ensure that their condition does
not contribute to the contamination or deterioration of food. Specifically, ***
Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality].
Specifically, ***
An automatic device was not used to stop the chain when the temperature dropped below that specified
in the scheduled process. Specifically, ***
Critical factors specified in the scheduled process were not [measured] [recorded] at intervals of 15
minutes or less. Specifically, ***
Records of the accuracy of a temperature-indicating device were not established. Specifically, ***
A qualified container closure inspection person did not record visual observations of gross closure
defects. Specifically, ***
A qualified container closure inspection person did not record the observations made of [the top seam of
a can randomly selected from each seaming head] [the container closures] at intervals of sufficient
frequency to ensure proper closure. Specifically, ***
Teardown examinations of double-seam cans [were not performed] [were not recorded] at sufficient
frequency. Specifically, ***
Measurements were not [taken] [recorded] for the can seam [cover hook] [body hook] [width (length,
height)] [tightness] [thickness]. Specifically, ***
Measurements were not [taken] [recorded] for the can seam [body hook] [overlap] [tightness] [thickness
by micrometer]. Specifically, ***
Hermetically sealed containers of low-acid processed food were not marked with an identifying code [that
was permanently visible to the naked eye]. Specifically, ***
Clock times on temperature-recording device records did not reasonably correspond to the time of day on
the processing records. Specifically, ***
No evidence in the form of heat distribution data or other suitable information was on file to demonstrate
that heat distribution was adequate for the [retort installation] [operating procedures]. Specifically, ***
Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of
education and experience to provide a needed level of competency. Specifically, ***
You did not record the action taken to rectify a departure from a scheduled process. Specifically, ***
You did not prepare, review, and retain required processing and production records [at the processing
plant or other reasonably accessible location] [for three years from the date of manufacture]. Specifically,
***
You did not obtain substantiation by a qualified scientific authority as to the adequacy of an intentional
change in a previously filed scheduled process, for which the change was basic to the adequacy of that
scheduled process, prior to using the changed process. Specifically, ***
You did not file with FDA an intentional change in a previously filed scheduled process in which the
change consisted solely of a higher initial temperature, a higher retort temperature, or a longer
processing time, and the modification was thereafter regularly scheduled. Specifically, ***
You did not [promptly] report to FDA an instance of [spoilage] [process deviation] of potential public health
significance when all or part of a lot was distributed. Specifically, ***
You did not prepare and maintain files on current procedures for [recalling products which may be
injurious to health] [identifying, collecting, warehousing and controlling products] [determining
effectiveness of recalls] [notifying FDA of recalls] [implementing recall programs]. Specifically, ***
Your review of [calibration] [in-process testing] [end-product testing] records does not ensure [that the
records are complete] [that the activities occurred in accordance with your written procedures] [occurred
within a reasonable time after the records were made]. Specifically, ***
Processing and other information is not [always] entered on your records at the time it is observed.
Specifically, ***
You do not [always] correct deficiencies from good manufacturing practice in a timely manner.
Specifically, ***
Your review of critical control point monitoring records does not [ensure that the records are complete]
[verify that they document values that are within critical limits]. Specifically, ***
You do not [always] analyze your finished juice product for biotype I Escherichia coli. Specifically, ***
Your [product] [operations] source water from a non-public source has been treated with a chlorine-based
disinfectant or ozone, but has not been tested for residual disinfectants and disinfection by-products that
are likely to result from such treatment. Specifically, ***
You did not [immediately] remedy the presence of unsanitary conditions, scale, residue, or oxidation on a
product water-contact surface by adequate cleaning and sanitizing prior to use. Specifically, ***
You did not take product water samples after processing and prior to bottling. Specifically, ***
The [procedures] [apparatus] for bacteriological tests were not in conformance with government-
recognized standards. Specifically, ***
Your review of corrective action records does not [ensure that the records are complete] [verify that the
appropriate corrective actions were taken]. Specifically, ***
Your review of [calibration of process monitoring instruments] [periodic end-product testing] [periodic in-
process testing] records does not ensure that [the records are complete] [the activities occurred in
accordance with your written procedures]. Specifically, ***
You have not implemented affirmative steps to ensure juice you receive for import into the United States
was processed in accordance with the juice HACCP regulation. Specifically, ***
No report was made of a serious adverse event associated with a dietary supplement marketed in the
United States. Specifically, ***
An adverse event report for a dietary supplement was not submitted to the Secretary of HHS within 15
business days of receipt of the report,. Specifically, ***
You did not [establish] [follow] written procedures for preventing microbial contamination from sick or
infected personnel. Specifically, ***
Your personnel did not thoroughly [wash] [wash and sanitize] their hands in an adequate hand-washing
facility [before starting work] [at any time when the hands may have become soiled or contaminated].
Specifically, ***
Your personnel did not remove unsecured [jewelry] [objects] that might fall into components, dietary
supplements, equipment, or packaging. Specifically, ***
Your personnel are not qualified to [manufacture] [package] [label] [hold] dietary supplements.
Specifically, ***
You did not assign one or more employees to supervise overall sanitation. Specifically, ***
Water that does not become a component of the dietary supplement was not [safe and sanitary] [at
suitable temperature] [under appropriate pressure] for all uses. Specifically, ***
Water that was used a manner such that the water may become a component of a dietary supplement did
not comply with applicable [Federal] [State] [local] requirements. Specifically, ***
You allowed [animals] [pests] in your physical plant. Specifically, ***
You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate
vicinity of the physical plant. Specifically, ***
The plumbing in your physical plant was not adequate to avoid being a source of contamination to
components, dietary supplements, water supplies, or any contact surface or creating an unsanitary
condition. Specifically, ***
Your physical plant did not have adequate space for the orderly placement of equipment and holding of
materials as necessary [for maintenance, cleaning, and sanitizing operations] [to prevent contamination
and mix-ups of components and dietary supplements]. Specifically, ***
Your physical plant did not provide adequate light in areas where components or dietary supplements are
[examined] [processed] [held]. Specifically, ***
You did not make and keep records that show that the water you use [complies with applicable Federal,
State, and local requirements] [does not contaminate the dietary supplement]. Specifically, ***
Your equipment or utensils were not [installed] [maintained] to facilitate cleaning of [the equipment] [the
utensils] [all adjacent spaces]. Specifically, ***
Your freezer, refrigerator, or other cold storage compartment that you use to hold components or dietary
supplements does not have an indicating thermometer, temperature-measuring device, or temperature-
recording device that indicates and records, or allows for recording by hand, the accurate temperature
within the compartment. Specifically, ***
You did not design or select automated, mechanical, or electronic equipment that you use to
[manufacture] [package] [label] [hold] a dietary supplement to ensure that the dietary supplement
specifications are consistently met. Specifically, ***
You did not determine the suitability of the automated, mechanical, or electronic equipment by ensuring
that the equipment is capable of operating satisfactorily within the operating limits required by the
process. Specifically, ***
Your quality control personnel did not periodically review routine [calibrations] [inspections] [checks] of
your automated, mechanical, or electronic equipment. Specifically, ***
You did not perform each step in the production of a batch, according to the master production record.
You did not keep batch production records for the required time period. Specifically, ***_x000D_
Your batch production records did not include the batch, lot, or control number of the finished batch of
dietary supplement. Specifically, ***
Your batch production records did not include initials of the persons performing each step. Specifically,
***
Your batch production records did not include [the unique identifier assigned to packaging used] [the
quantity of the packaging used]. Specifically, ***
Your batch production records did not include [the unique identifier assigned to labels used] [the quantity
of the labels used] [reconciliation of discrepancies between issuance and use of labels]. Specifically, ***
You did not [establish] [follow] written procedures for the requirements for labels received. Specifically,
***
You did not visually examine the supplier's invoice, guarantee, or certification in [a shipment] [shipments]
you received to ensure the components are consistent with your purchase order. Specifically, ***
Your quality control personnel did not [approve components while the components were quarantined]
[release components from quarantine] for use in the manufacture of a dietary supplement. Specifically,
***
You did not identify each lot of components that you produced in a manner that allows you to trace the lot
to [the supplier] [the date received] [the name of the component] [the status of the component] [the
dietary supplement that you manufactured and distributed]. Specifically, ***
Your quality control personnel did not review and approve the results of tests or examinations conducted
on the packaging while the packaging was quarantined. Specifically, ***
You did not hold [packaging] [labels] under conditions that will avoid mix-ups. Specifically, ***
You did not visually examine the supplier's invoice, guarantee, or certification in a shipment of received
product to ensure that the received product was consistent with your purchase order. Specifically, ***
You did not quarantine received product. Specifically, ***

You did not collect representative samples of received product while the received product was
quarantined. Specifically, ***
Your quality control personnel did not approve quarantined received product for [packaging] [labeling] as
a dietary supplement. Specifically, ***
Your quality control personnel did not release received product from quarantine for [packaging] [labeling]
as a dietary supplement. Specifically, ***
You did not use a unique identifier when you recorded the disposition of a unique lot within a unique
shipment of received product. Specifically, ***
You did not clearly identify, hold, and control under a quarantine system for appropriate disposition [a
component] [packaging] [labels] [product] that you received for packaging or labeling as a dietary
supplement that was rejected and unsuitable for use in manufacturing, packaging, or labeling operations.
Specifically, ***
You did not make and keep written procedures for fulfilling the requirements that apply to components of
dietary supplements. Specifically, ***
You did not make and keep documentation that the requirements that apply to production and process
control for components of dietary supplements were met. Specifically, ***
You did not make and keep documentation that the requirements that apply to production and process
control for product received for packaging or labeling as a dietary supplement were met. Specifically, ***
Your documentation of a required operation did not include a material review and disposition decision
conducted on components, packaging, labels, or products that you received for packaging or labeling as
a dietary supplement. Specifically, ***
You did not hold reserve samples of dietary supplements in a manner that protects against contamination
or deterioration. Specifically, ***
You did not distribute a dietary supplement under conditions that protect the dietary supplement against
contamination and deterioration. Specifically, ***
You did not keep the records required for your holding and distributing operations for the required time
period. Specifically, ***
You did not [establish] [follow] sampling plans for obtaining representative samples of components.
Specifically, ***
The person who conducted the testing and examination did not document [at the time of performance]
that established laboratory methodology was followed. Specifically, ***
The documentation for laboratory tests and examinations did not include the results of the testing and
examination. Specifically, ***
You did not segregate and identify containers for a specific batch of dietary supplements to identify their
contents and, when necessary, the phase of manufacturing. Specifically, ***
You did not perform mechanical manufacturing steps by effective means to protect the dietary
supplements against contamination. Specifically, ***
You did not identify and hold [components] [dietary supplements] for which a material review and
disposition decision is required in a manner that protects [components] [dietary supplements] that are not
under a material review against contamination and mix-ups with those that are under a material review.
Specifically, ***
You did not use effective means to [remove, destroy, or prevent the growth of microorganisms] [prevent
decomposition]. Specifically, ***
You did not perform chemical, microbiological, or other testing, as necessary to prevent the use of
contaminated components. Specifically, ***
The specific actions in your written instructions in your master manufacturing record for a manual
operation did not include one person to add and another person to verify the addition of the components.
Specifically, ***
The written instructions in your master manufacturing record did not include instructions to verify the
weight or measure and addition of components. Specifically, ***
Your master manufacturing record did not include the identity of each ingredient that will be declared on
the ingredients list of the dietary supplement. Specifically, ***
Your master manufacturing record did not include the [identity] [weight or measure] of each dietary
ingredient that will be declared on the Supplement Facts label. Specifically, ***
Your master manufacturing record did not include an accurate weight or measure of each component to
be used. Specifically, ***
Your master manufacturing record did not include a complete list of components to be used. Specifically,
***
Your master manufacturing record did not include the [name] [strength] [concentration] [weight] [measure]
of each dietary ingredient for each batch size. Specifically, ***
Your electronic records for your packaging and labeling operations do not comply with the electronic
records requirements. Specifically, ***
You [repackaged] [relabeled] a dietary supplement before approval by your quality control personnel
Specifically, ***
You did not use sanitary handling procedures during [filling] [assembling] [packaging] [labeling]
operations. Specifically, ***
You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement
packaging], as appropriate. Specifically, ***
You did not control the reconciliation of any issue and use [label discrepancies] [packaging
discrepancies]. Specifically, ***
You did not control the [issuance] [use] of packaging. Specifically, ***
You did not have records or copies of records required for product complaints readily available during the
required retention period for inspection and copying by FDA when requested. Specifically, ***
The written record of a product complaint did not include the batch, lot, or control number of the dietary
You did not implement a system of production and process controls that covers all stages of
manufacturing, packaging, labeling, and holding of dietary supplements to ensure that the dietary
supplement is [packaged] [labeled] as specified in the master manufacturing record. Specifically, ***
Your production and in-process control system is not designed to ensure that the dietary supplement is
manufactured, packaged, labeled, and held in a manner that will ensure the quality of the dietary
You did not provide adequate documentation of your basis for why meeting the in-process specifications,
in combination with meeting component specifications, will help ensure that the specifications are met for
[the identity] [purity] [strength] [composition]. Specifically, ***
You did not determine whether you met identity specifications established for components. Specifically,
***
You did not determine whether you met established component specifications established to ensure the
[purity] [strength] [composition] of dietary supplements manufactured using the components. Specifically,
***
You did not determine whether you met in-process specifications to ensure the [purity] [strength]
[composition] of the dietary supplements. Specifically, ***
[qualification] [re-qualification] of a supplier of a component. Specifically, ***
You did not select one or more established specifications for [identity] [purity] [strength] [composition]
[limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement]
that, if tested or examined on the finished batches of the dietary supplement, would verify that the
production and process control system is producing a dietary supplement that meets all product
Your quality control personnel did not review and approve your documentation of the basis for
determining compliance with [an] established specification[s] for [identity] [purity] [strength] [composition]
[limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement].
Specifically, ***
You did not [visually examine a product that you received for packaging or labeling] [have documentation
that the product you received for packaging or labeling is adequately identified and is consistent with your
purchase order]. Specifically, ***
You did not [conduct a visual identification of the containers and closures] [review the supplier's invoice,
guarantee, or certification] to determine whether packaging you received met the packaging
Your quality control personnel did not reject a component that did not meet an identity specification.
Specifically, ***
You did not collect representative samples [of a subset] of finished batches of dietary supplements that
you manufacture [before releasing for distribution] to verify that the finished batch of dietary supplement
meets established product specifications. Specifically, ***
Your reserve sample of a dietary supplement that was distributed to be packaged and labeled was not
held using a container-closure system that provides essentially the same characteristics to protect
against contamination or deterioration as the one in which it was distributed for packaging and labeling
elsewhere. Specifically, ***
Your reserve sample of dietary supplement was not identified with the batch, lot, or control number.
Specifically, ***
You did not keep the records required for your production and process control system for the required
time period. Specifically, ***
You did not make and keep documentation for why meeting in-process specifications, in combination with
meeting component specifications, helps ensure that the dietary supplement meets the specifications for
[identity] [purity] [strength] [composition] [limits on contamination that may adulterate or may lead to
adulteration of the finished batch of the dietary supplement]. Specifically, ***
Your quality control personnel did not perform required operations for the production and process control
system. Specifically, ***
Your quality control personnel did not perform required operations for [components] [packaging] [labels]
before use in the manufacture of a dietary supplement. Specifically, ***
Your quality control personnel did not perform required operations for returned dietary supplements.
Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision for a
specification established for the production and process control system that was not met. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision for an
unanticipated occurrence during the manufacturing operations that adulterated or may lead to
adulteration of the [component] [dietary supplement] [packaging]. Specifically, ***
Your quality control personnel did not conduct a material review and make a disposition decision when a
dietary supplement was returned. Specifically, ***
Your quality control personnel did not reject the dietary supplement when there was a deviation or
unanticipated occurrence during the production and in-process control system that [resulted in] [could
lead to] adulteration of the dietary supplement. Specifically, ***
Your quality control operations did not include approving, and releasing from quarantine, all [components]
[packaging] [labels] before they were used. Specifically, ***
Your quality control operations for packaging did not include approving or rejecting any repackaging of a
packaged dietary supplement. Specifically, ***
Your quality control operations for packaging and labeling did not include approving for release, or
rejecting, any packaged and labeled dietary supplement. Specifically, ***
You do not have quality control operations for returned dietary supplements. Specifically, ***
You do not have quality control operations for product complaints. Specifically, ***
You did not keep original records, true copies, or electronic records. Specifically, ***
You did not [establish] [follow] written procedures for when a returned dietary supplement may be
salvaged. Specifically, ***
You did not [establish] [follow] written procedures for conducting an investigation of your manufacturing
processes and other batches for a returned dietary supplement. Specifically, ***
You did not identify and quarantine returned dietary supplements until quality control personnel
conducted a material review and made a disposition decision. Specifically, ***
You did not destroy, or otherwise suitably dispose of, a returned dietary supplement not approved for
salvaging and redistribution or not approved for reprocessing. Specifically, ***
You did not ensure that a returned dietary supplement that was reprocessed met established product
You did not conduct an investigation of your manufacturing processes, and of each other batch implicated
when a dietary supplement was returned, to determine compliance with specifications. Specifically, ***
You did not keep the records required for returned dietary supplements for the required time period.
Specifically, ***
You did not make and keep written procedures for fulfilling the requirements for equipment and utensils.
Specifically, ***
You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated,
mechanical, or electronic equipment. Specifically, ***
You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] equipment and
utensils that are used to manufacture, package, label, or hold components or dietary supplements.
Specifically, ***
You did not make and keep written procedures for [maintaining] [cleaning] [sanitizing] contact surfaces
that are used to manufacture, package, label, or hold components or dietary supplements. Specifically,
***
Your calibration documentation did not [identify the instrument or control calibrated] [provide the date of
calibration] [identify the reference standard used] [include the certification of accuracy of the known
reference standard] [include a history of recertification of accuracy of a known reference standard]
[identify the calibration method used] [include appropriate limits for accuracy and precision] [provide the
calibration reading or readings found] [identify the recalibration method used] [identify the reading or
readings of recalibration found if the accuracy or precision limits were not met] [include the initials of the
person who performed the calibration or recalibration]. Specifically, ***
You did not make and keep documentation of the follow-up to your material review and disposition
decision. Specifically, ***
You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a
reportable food. Specifically, ***
You do not procure chicks from SE-monitored breeder flocks that meet the National Poultry Improvement
Plan's standards for "U.S. S. Enteritidis Clean" or equivalent status. Specifically,***
You have not taken [adequate] steps to assure that there is no introduction or transfer of SE into or
among poultry houses. Specifically,***
Visitors are not limited [on the farm] [in the poultry houses]. Specifically,***
Stray animals are not prevented from entering poultry houses. Specifically,***
When your monitoring indicated unacceptable rodent activity within a poultry house, appropriate methods
were not used to achieve satisfactory rodent control. Specifically,***
Following cleaning, disinfection of the poultry house was not done with spray, aerosol, fumigation or other
appropriate disinfection method. Specifically,***
Eggs were not [held ] [transported] at or below 45 deg. F beginning 36 hours after time of lay.
Specifically,***
Eggs intended to be processed as table eggs [were not held and transported as required at or below 45
deg. F] [were held at room temperature for more than 36 hours just prior to processing]. Specifically,***
Environmental testing for SE, using approved methods, was not done in a poultry house containing more
than one group of laying hens, when each group of laying hens was 40 to 45 weeks of age.
Specifically,***
You were required to perform egg testing, but you did not conducted egg testing on the eggs from a flock
in an SE positive poultry house [using egg sampling and testing methodology specified in the Code of
Federal Regulations] [at two week intervals]. Specifically,***
For testing to detect SE in environmental samples, you did not have the sample testing conducted by the
method entitled "Environmental Sampling and Detection of Salmonella in Poultry Houses." most current
edition, or an equivalent method in accuracy, precision and sensitivity in detecting SE. Specifically,***
You lack [qualified] supervisory personnel who are responsible for [development and implementation of
an SE plan that is appropriate for your farm and meets the regulatory requirement] [reassessing and
modifying the SE prevention plan as necessary] [reviewing records created to document the SE
prevention measures]. Specifically, ***
You did not maintain records documenting compliance with cleaning and disinfection procedures
performed at depopulation. Specifically,***
You are not able to retrieve and provide the records at your place of business within 24 hours of request
for official review. Specifically,***
Data and information reflecting compliance activities [is not entered on records at the time the activity is
performed or observed] [does not indicate the actual values]. Specifically***
You did not submit an update to a registration within 60 calendar days of a change to previously
submitted information. Specifically, ***
The identifying characteristic of the tamper-resistant feature of the retail package for a non-aerosol
cosmetic vaginal product is not referred to in the labeling statement of the package. Specifically,
***_x000D_
A [processing] [production] record was not reviewed by a representative of plant management [qualified
by suitable training or experience] to determine [completeness of the record] [whether the product
received the scheduled process]. Specifically, ***
A record of the accuracy of a temperature-indicating device did not include the identity of the [reference
device] [equipment] [procedures] used for the accuracy test. Specifically, ***
A reference device was not tested for accuracy once a year or more frequently when necessary to ensure
accuracy. Specifically, ***
The speed of the container-conveyor chain was not [determined] [recorded] at intervals of sufficient
frequency to ensure that the retort speed is maintained as specified. Specifically, ***
A critical factor was not measured with an instrument having the accuracy and dependability adequate to
ensure that the requirements of the scheduled process were met. Specifically, ***
For the public water system used as your source water and for which you did not conduct required
testing, you did not provide the public water system testing results, or certificates showing full compliance
with all provisions of EPA National Primary and Secondary Drinking Water Regulations pertaining to
chemical contaminants, for the source water testing requirements. Specifically, ***
Air under pressure that was directed at a product water-contact surface was not free of [oil] [dust] [rust]
[excessive moisture] [extraneous materials]. Specifically, ***
The bottling room was not separated from storage areas by [tight walls] [ceilings] [selfclosing doors] to
protect against contamination. Specifically, ***
You did not take and analyze samples of operations water [as often as necessary] [at least once every
year for chemical contamination] [at least once every four years for radiological contaminants].
Specifically, ***
You did not thaw your raw materials or other ingredients in a manner that prevented them from becoming
adulterated. Specifically, ***
Your hazard evaluation did not consider the impact of the [formulation of the food] [condition, function and
design of the nature of the establishment and equipment of a typical entity that manufactures/process,
grows, harvests, or raises this type of food] [raw materials and ingredients] [transportation practices]
[harvesting, raising, manufacturing, processing, and packing procedures] [storage and distribution]
[intended or reasonably foreseeable use] [sanitation conditions or practices] [temporal nature of a hazard
or other relevant factor] on the safety of the finished food for the intended customer. Specifically, ***
You did not document [your review and assessment of a hazard analysis conducted by another entity]
[that a hazard analysis conducted by another entity was conducted by a qualified individual]. Specifically,
***
You did not approve your foreign supplier on the basis of an evaluation that you conducted of the foreign
supplier's performance and the risk posed by a food or based on a review and assessment of another
entity's evaluation or reevaluation of a foreign supplier's performance the risk posed by a food.
Specifically, ***
You did not [promptly] reevaluate and document the concerns associated with a risk factor when you
became aware of new information about the factor. Specifically, ***
You did not establish written procedures for using an unapproved foreign supplier on a temporary basis.
Specifically, ***
You did not document your review and assessment of another entity's documentation of procedures and
activities established to ensure that you import food only from foreign suppliers approved based on an
evaluation of the risk posed by a food and foreign supplier's performance. Specifically, ***
For a food that may contain a hazard that will be controlled by the foreign supplier and is one for which
there is a reasonable probability that exposure to the hazard will result in serious adverse health
consequences or death to humans or animals, you did not conduct and document or obtain
documentation of an onsite audit of the foreign supplier [before initially importing the food into the United
States] [at least annually after importing the food into the United States]. Specifically, ***
For an onsite audit, you did not retain documentation [of the audit procedures] [of the dates the audit was
conducted] [of any corrective actions taken in response to significant deficiencies identified during the
audit] [that the audit was conducted by a qualified auditor]. Specifically, ***
You did not promptly [review and assess] [document your review and assessment of] the results of a
verification activity that you conducted or obtained documentation of or that was conducted by another
entity. Specifically, ***
You did not [take corrective actions] [document corrective actions you took] after you determined that
your foreign supplier was not in compliance with the applicable food safety requirements. Specifically, ***
You did not [sign] [date] an FSVP record [upon initial completion] [upon modification]. Specifically, ***
You did not provide an English translation of an FSVP record that you maintained in a language other
than English. Specifically, ***
You did not [sign] [date] an FSVP record [upon initial completion] [upon modification]. Specifically, ***
You did not retain records as required. Specifically, ***
Your FSVP did not provide [adequate] assurances that your foreign supplier is producing the food in
compliance with processes and procedures that provide the required level of public health protection.
Specifically, ***
You did not ensure that an equipment or utensil was designed [to be easily cleanable] [to withstand the
environment of the intended use]. Specifically, ***
You did not maintain a cold storage area for [an in-process infant formula] [a final infant formula] at a
temperature not to exceed 45 ?F (7.2 ?C) for a defined period of time. Specifically, ***
You did not equip a cold storage compartment with a validated high temperature alarm. Specifically, ***
You did not establish a system of process controls covering all stages of processing that was designed to
ensure that infant formula does not become adulterated due to the presence of microorganisms in the
formula or in the processing environment. Specifically, ***
You did not have process controls verification records. Specifically, ***
Your allergen controls records [were not reviewed by a preventive controls qualified individual or such
You did not have sanitation controls corrective action records. Specifically, ***
You did not have sanitation controls verification records. Specifically, ***
Your controls procedures did not ensure that hazards are significantly minimized or prevented.
Specifically, ***
You did not [establish] [implement] adequate written procedures for monitoring your controls. Specifically,
***
You [did not revise your written food safety plan as necessary] [did not document the basis for your
conclusion that no revisions to your food safety plan were necessary]. Specifically, ***
You did not adequately maintain agricultural water distribution systems to prevent water distribution
systems from being a source of contamination. Specifically, ***
You did not [install] [maintain] equipment to facilitate cleaning of the equipment and adjacent area.
Specifically, ***
You did not store and maintain equipment and tools [to protect covered produce from being contaminated
with foreseeable hazards] [to prevent the equipment and tools from attracting and harboring pests].
Specifically, ***
You did not ensure that equipment that is likely to come into contact with produce does so in a manner
that minimizes the potential for the contamination of produce or food contact surfaces with known or
reasonably foreseeable hazards. Specifically, ***
You did not ensure that instruments you use are [accurate and precise] [adequately maintained]
[adequate in number]. Specifically, ***
You did not ensure that equipment that is used to transport produce is [adequately clean before use in
transporting produce] [adequate for use in transporting produce].
Your buildings are not suitable in [size] [construction] [design] to maintain and clean to reduce the
potential for contamination. Specifically, ***
You did not take necessary measures to protect against contamination by pests in buildings. Specifically,
***
You did not provide personnel with adequate, readily accessible hand-washing facilities. Specifically, ***
You [did not provide for the appropriate disposal of waste associated with a hand-washing facility] [did not
take appropriate measures to prevent contamination from waste water]. Specifically, ***
You did not convey, store, and dispose of trash, litter and waste to [minimize the potential to attract or
harbor pests] [protect against contamination]. Specifically, ***
You did not visually examine [seeds] [beans] [packaging used to ship seeds] [packaging used to ship
beans] for signs of potential contamination with known or foreseeable hazards. Specifically, ***
Surfaces used to grow, harvest, pack, or hold sprouts were not cleaned and sanitized before they came in
contact with [sprouts] [seeds] [beans]. Specifically, ***
You did not test sprouts from each production batch of sprouts at the in-process stage for [E. coli
O157:H7] [Salmonella][pathogens reasonably necessary to minimize risk of serious adverse health
consequences]. Specifically, ***
Your written sampling plan does not include an adequate corrective action plan. Specifically, ***
You have not established records for corrective actions related to [environmental testing results] [spent
irrigation water testing results] [sprout testing results]. Specifically, ***
You did not test the quality of water using a scientifically valid method. Specifically, ***
You did not test the spent sprout irrigation water or sprouts from each production batch of sprouts for
pathogens using a scientifically valid method. Specifically, ***
You did not establish and keep required records that [include all necessary information] [were created at
the time the activity was performed or observed] [were dated and signed by the person who performed
the activity]. Specifically, ***
You did not [establish] [implement] temperature controls. Specifically, ***
You did not have the required [documentation] [components in the documentation] for the supply-chain
program. Specifically, ***
Frequency
278
188
183
175
167
161
158
143
140
136
117
112
111
93
86
79
79
77
77
77
76
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73
70
68
68
64
58
57
57
57
56
55
55
54
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52
47
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3
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3
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2
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1
1
1
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1
1
1
Human Tissue for 12277 21 CFR 1271.75(a)(1)

Transplantation
Human Tissue for 12213 21 CFR 1271.47(a)

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Human Tissue for 12231 21 CFR 1271.50(b)(1)

Transplantation

Transplantation

Transplantation

Transplantation
Human Tissue for 12247 21 CFR 1271.55(d)(2)

Transplantation
Human Tissue for 12286 21 CFR 1271.80(b)
Transplantation
Transplantation
Human Tissue for 12246 21 CFR 1271.55(d)(1)(iii)

Transplantation
Human Tissue for 12493 21 CFR 1271.90(c)

Transplantation

Transplantation

Transplantation

Transplantation
Human Tissue for 12282 21 CFR 1271.75(d)

Transplantation
Transplantation
Transplantation
Human Tissue for 12416 21 CFR 1271.260(e)
Transplantation
Transplantation
Transplantation

Transplantation

Transplantation
Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Transplantation
Transplantation
Transplantation
Human Tissue for 12257 21 CFR 1271.60(c)(2)

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Transplantation
Transplantation
Transplantation

Transplantation

Transplantation
Transplantation
Transplantation
Transplantation
Human Tissue for

12387 21 CFR 1271.220(a)
Transplantation

Transplantation
Human Tissue for 12395 21 CFR 1271.225
Transplantation
Transplantation
Transplantation
Transplantation
Transplantation

Transplantation
Transplantation
Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation

Transplantation
Short Description
Risk factors, clinical evidence
Donor eligibility procedures
Determination based on screening and testing
Procedures for all steps
Infection with communicable disease agents
Responsible person to determine, document
Donor screening standards
Procedures to meet core CTGP
Listing and interpretation of CD tests performed
Reasons for ineligibility on summary
Accurate, indelible, legible
Specimen collections not timely
Design of procedures to ensure compliance
Documentation--determination, by whom, date
Eligibility not required--warning labels
Eligibility statement--basis of determination
Summary--records used to make determination
Statement re: certified testing lab
Donors with risks not determined ineligible

Cleaned, sanitized per established schedules
Validation & approval--established procedures
Storage temperatures recorded, maintained
Records maintained concurrently
Accurate, indelible, legible
Deviations not reported to FDA
Name and address on summary
Name and personal info on accompanying records
Reproductive cells/ tissues- general
Kits not FDA approved, specifically labeled
Corrective actions
Inspected routinely
Periodic review of temperatures
Records incomplete
Establishing a system
SOP for release; reactive for CMV
Review and approval of procedures
Availability of procedures
Donor testing not negative for CD agents
Personal information included in I.D. code

Identified as quarantined, distinguishable
Records stating determination not completed
Statement of restrictions
Labeled re: biohazard, risks, test results
All core requirements covered in program
Deviations--evaluation, cause, corrective action
State of repair
Procedures for cleaning, sanitation
Documentation of activities
Temperature and humidity controls
Monitoring--cross contamination, exposure to CD
Monitoring-microorganisms where appropriate
Procedures inadequate
Calibrated per established schedules
Use prior to verification
Causing contamination, increasing risks
Sampling representative (in-process HCT/Ps)
Verification/validation
Documented, dated, signed
Changes to validated process
Change activities documented

Contamination, mix ups, improper release
Corrective actions
Evaluation--microorganisms, damage
Acceptance criteria designed to prevent CD
Release criteria verified, documented
Shipping conditions appropriate
Documentation elements for activities
Procedures re complaints
Adverse reaction reporting to FDA
Reproductive cells or tissues
Cytomegalovirus (CMV)
Long Description
Donors were not screened by a review of relevant medical records for [risk factors] [clinical evidence] of
communicable disease agents and diseases. Specifically, ***
Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps
were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[revised]. Specifically, ***
HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
Specifically, ***
Procedures for all steps performed in the [testing] [screening] [determining] of donor eligibility of HCT/Ps
were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed]
[revised]. Specifically, ***
Donors were not tested for evidence of infection with relevant communicable disease agents.
Specifically, ***
The eligibility of an HCT/P donor was not [determined] [documented] by a responsible person, based on
results of donor screening and donor testing. Specifically, ***
Donor screening of HCT/P donors considered eligible indicated that the donor was not free of [risk
factors for infection due to communicable disease agents] [clinical evidence of infection due to
communicable disease agents] [risk factors associated with xenotransplantation]. Specifically, ***
Procedures appropriate to meet core CGTP requirements for all steps that you perform in the
manufacture of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented]
[followed] [reviewed] [revised]. Specifically, ***
The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all
communicable disease tests performed. Specifically, ***
The summary of records for HCT/Ps from donors determined to be ineligible based on screening and
released for limited use did not contain a statement noting the reasons(s) for the ineligibility.
Specifically, ***
Donor eligibility records are not [accurate] [indelible] [legible]. Specifically, ***
Donor specimens used for testing of communicable disease agents were not collected at the appropriate
time. Specifically, ***
Procedures were not designed to ensure compliance with the donor eligibility requirements. Specifically,
***
Documentation of [the donor-eligibility determination] [the responsible person who made the donor-
eligibility determination] [the date of the donor-eligibility determination] was not maintained.
Specifically, ***
HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled
with the appropriate warning statements. Specifically, ***
After the completion of the donor-eligibility determination, HCT/Ps were not accompanied with a
statement whether the donor has been determined to be eligible or ineligible, based on the results of
screening and testing. Specifically, ***
After completion of the donor-eligibility determination, HCT/Ps were not accompanied with the
summary of the records used to make the donor-eligibility determination. Specifically, ***
The summary of records for HCT/Ps did not contain a statement that the communicable disease testing
was performed by a laboratory certified to perform such testing on human specimens under the Clinical
Laboratory Improvement Act of 1988 or has met equivalent requirements determined by the Centers for
Medicare and Medicaid Services. Specifically, ***
Donors were not determined to be ineligible that had [risk factors or clinical evidence of communicable
disease agents] [communicable disease risks associated with xenotransplantation]. Specifically, ***
Equipment used for manufacturing HCT/Ps was not [cleaned] [sanitized] [maintained] according to
established schedules. Specifically, ***
Processes with results which could not be fully verified by inspection and tests, were not validated and
approved according to established procedures. Specifically, ***
Storage temperatures of HCT/Ps were not [recorded] [maintained]. Specifically, ***
Records were not maintained concurrently with the performance of each step. Specifically, ***
Records were not [accurate] [indelible] [legible]. Specifically, ***
HCT/P deviations relating to core CGTP requirements that occurred [in your establishment] [at an
establishment under contract, agreement, or arrangement with your establishment] were not reported
to FDA. Specifically, ***
The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made
the donor-eligibility determination. Specifically, ***
The accompanying records for HCT/Ps included [the donor's name] [personal information that might
identify the donor]. Specifically, ***
Donors of reproductive cells or tissues not recovered by a method that ensures freedom from
contamination were not screened by a review of relevant medical records for [risk factors] [clinical
evidence] of communicable diseases of the genitourinary tract. Specifically, ***
Communicable disease agent tests [were not FDA-licensed, approved or cleared donor screening tests]
[were not specifically labeled for cadaveric specimens when such a test was available and cadaveric
specimens were used] [were not FDA-licensed, approved or cleared Chlamydia trachomatis or Neisseria
gonorrhea tests labeled for detection of these organisms in an asymptomatic, low-prevalence
population]. Specifically, ***
Appropriate corrective actions were not taken related to the inspections of environmental control
systems. Specifically, ***
Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to
maintenance schedules]. Specifically, ***
Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been
within acceptable limits. Specifically, ***
Records [did not identify the person performing the work] [did not show the dates of entries] [were not
detailed as necessary to provide a complete history of work performed] [did not relate to the HCT/P
involved]. Specifically, ***
A tracking system that enables the tracking of HCT/Ps back and forth from the donor to the consignee or
final disposition was not [established] [maintained] [defined] [documented] [implemented] [followed]
[reviewed] [revised]. Specifically, ****
A standard operating procedure for the release of HCT/Ps from donors that test reactive for
cytomegalovirus (CMV) was not [established] [maintained] [defined] [documented] [implemented]
Donor eligibility procedures were not [reviewed] [approved] by a responsible person before
implementation. Specifically, ***
Donor eligibility procedures were not available to personnel in the area where operations are performed,
or in a nearby area when such availability is impractical. Specifically, ***
Donor testing of HCT/P donors considered eligible was not negative or nonreactive for relevant
communicable disease agents. Specifically, ***
The distinct identification code affixed to the HCT/P container included an individual's [name] [social
security number] [medical record number]. Specifically, ***
HCT/Ps in quarantine pending completion of the donor eligibility determination were [not clearly
identified as quarantined] [not easily distinguishable from HCT/Ps available for release and distribution].
Specifically, ***
HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not
accompanied by records that stated the donor-eligibility determination had not been completed.
Specifically, ***
HCT/Ps shipped in quarantine prior to the completion of the donor-eligibility determination were not
accompanied by records that stated the product must not be implanted, transplanted, infused or
transferred until completion of the donor-eligibility determination. Specifically, ***
HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled
with [the Biohazard legend] [a statement warning of communicable disease risks] [a statement warning
of the reactive test results]. Specifically, ***
A quality program which addresses all of the core CGTP requirements, appropriate for the HCT/Ps
manufactured and the manufacturing steps performed, has not been [established] [maintained]
[defined] [documented] [implemented] [followed] [reviewed] [revised]. Specifically, ***
Investigation of deviations related to core CGTP requirements did not include [a review and evaluation
of the deviation] [efforts to determine the cause of the deviation] [corrective action(s) to address the
deviation and prevent recurrence]. Specifically, ***
Facilities were not maintained in a good state of repair. Specifically, ***
Procedures for facility cleaning and sanitation were not [established] [maintained] [defined]
[documented] [implemented] [followed] [revised]. Specifically, ***
Documentation of facility cleaning and sanitation activities was not maintained. Specifically, ***
Environmental controls do not provide for adequate control of [temperature] [humidity]. Specifically,
***
Environmental conditions are not monitored when such conditions could cause [contamination or cross
contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease
agents]. Specifically, ***
Environmental conditions were not monitored for microorganisms. Specifically, ***
Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established]
[maintained] [defined] [documented] [implemented] [followed] [revised]. Specifically, ***
Equipment used for [inspection] [measuring] [testing] was not calibrated according to established
schedules. Specifically, ***
Supplies and reagents were used before they were verified to meet specifications designed to prevent
the introduction, transmission, or spread of communicable disease. Specifically, ***
HCT/Ps were not processed in a way [that does not cause contamination or cross contamination during
processing] [that does not increase the risk of introduction, transmission, or spread of communicable
disease]. Specifically, ***
Sampling of in-process HCT/Ps was not representative of the material to be evaluated. Specifically, ***
Process changes were not [validated] [verified] to ensure the change does not cause an adverse impact
elsewhere in operations. Specifically, ***
The validation [activities] [results] were not [documented] [dated and signed by the individual(s)
approving the validation]. Specifically, ***
A validated process that was changed was not [reviewed] [evaluated] [revalidated]. Specifically, **
Activities related to a change to a validated process were not documented. Specifically, ***
Storage areas and stock rooms were not controlled [to prevent mix-ups, contamination and cross
contamination of HCT/Ps, supplies and reagents] [to prevent HCT/Ps from improperly being made
available for distribution]. Specifically, ***
Corrective actions were not [performed] [documented] when proper storage conditions were not met.
Specifically, ***
Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not
inspected for damage and contamination]. Specifically, ***
Incoming HCT/Ps were not [accepted] [rejected] [placed in quarantine] based on pre-established criteria
designed to prevent communicable disease transmission. Specifically, ***
Release criteria were not [verified] [documented] to have been met through a review of manufacturing
and tracking records before HCT/Ps were made available for distribution. Specifically, ***_x000D_
_x000D_
Appropriate shipping conditions were not [established] [maintained] [defined] [documented]

[implemented] [followed] [reviewed] [revised] for each type of HCT/P. Specifically, ***
Documentation for activities related to the [receipt] [shipment] [distribution] of HCT/Ps did not include
[identification of the HCT/P and the establishment that supplied the HCT/P] [activities performed and the
results of each activity] [date(s) of activity] [quantity of HCT/P subject to the activity] [disposition of the
HCT/P (identity of consignee)]. Specifically, ***
Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core
CGTP requirements were not [established] [maintained] [defined] [documented] [implemented]
Adverse reactions which involved a communicable disease related to an HCT/P made available for
distribution and were fatal or life threatening, resulted in permanent impairment or damage to the body,
or necessitated medical or surgical intervention, were not reported to FDA. Specifically, ***
Donors of reproductive cells or tissues not recovered by a method that ensures freedom from
contamination were not tested for communicable diseases of the genitourinary tract. Specifically, ***
Donors of viable, leukocyte-rich cells or tissue were not tested for evidence of infection due to
cytomegalovirus (CMV). Specifically, ***
Frequency
38
26
15
14
12
3
3
1
1
1
1
1
Parts 1240 and 1250 7036 21 CFR 1250.67
Parts 1240 and 1250 7032 21 CFR 1250.63
Parts 1240 and 1250 6564 21 CFR 1250.33(a)
Parts 1240 and 1250 7053 21 CFR 1250.75(b)
Parts 1240 and 1250 6558 21 CFR 1250.30(d)
Parts 1240 and 1250 7041 21 CFR 1250.70(a)
Parts 1240 and 1250 7055 21 CFR 1250.75(b)
Parts 1240 and 1250 6552 21 CFR 1250.28
Parts 1240 and 1250 6561 21 CFR 1250.32(b)

Parts 1240 and 1250 6591 21 CFR 1250.42(a)
Parts 1240 and 1250 7042 21 CFR 1250.70(a)
Parts 1240 and 1250 6525 21 CFR 1240.86
Parts 1240 and 1250 6554 21 CFR 1250.30(a)
Parts 1240 and 1250 6555 21 CFR 1250.30(a)
Parts 1240 and 1250 6560 21 CFR 1250.32(a)
Parts 1240 and 1250 6565 21 CFR 1250.33(a)
Parts 1240 and 1250 6572 21 CFR 1250.34

Parts 1240 and 1250 7089 21 CFR 1250.82(d)
Parts 1240 and 1250 7090 21 CFR 1250.82(e)
Parts 1240 and 1250 6549 21 CFR 1250.27
Parts 1240 and 1250 6563 21 CFR 1250.33(a)
Parts 1240 and 1250 6567 21 CFR 1250.33(b)

Parts 1240 and 1250 6569 21 CFR 1250.33(b)
Parts 1240 and 1250 6570 21 CFR 1250.33(c)
Parts 1240 and 1250 6580 21 CFR 1250.38(b)
Parts 1240 and 1250 6581 21 CFR 1250.38(b)
Parts 1240 and 1250 6593 21 CFR 1250.42(b)
Parts 1240 and 1250 7027 21 CFR 1250.53
Parts 1240 and 1250 7038 21 CFR 1250.67
Parts 1240 and 1250 7039 21 CFR 1250.67
Parts 1240 and 1250 7051 21 CFR 1250.75(a)
Parts 1240 and 1250 7058 21 CFR 1250.79(a)

Parts 1240 and 1250 7059 21 CFR 1250.79(b)
Parts 1240 and 1250 7060 21 CFR 1250.79(c)
Parts 1240 and 1250 7087 21 CFR 1250.82(c)
Parts 1240 and 1250 7092 21 CFR 1250.82(f)

Parts 1240 and 1250 7118 21 CFR 1250.90
Short Description
Prevention of the spread of communicable diseases
Maintained in good repair
Sanitary sewers or alternative methods
Plumbing design, installation, maintenance
Adequate and readily accessible
Equipment for cleaning and flushing
Handling to avoid contamination
Clean hands
Backflow protection
Clean and sanitary
Lack of backflow prevention
Ventilation and lighting
Clean and free from flies, rodents, and other vermin
Contamination
Adequate facilities for cleaning, bactericidal treatment
Thermometers
Identification marks on tanks and piping
Backflow prevention - general
Storage of perishables
Easily cleaned, self-draining
Cleaning of multiuse eating and drinking utensils

Equipment kept clean
Storage and handling after bactericidal treatment
Signs
Soap, sanitary towels, water
Connections easily cleanable, located and protected
Discharge not at approved servicing area
Signs for non-potable water
Bulk ice
Contamination of passenger stations
Container construction
Can washing and draining facilities
Daily emptying and cleaning
Potable water tanks -- openings
Cleaning, disinfecting, flushing

Clean condition
Long Description
Failure to [design] [construct] [maintain] [operate] servicing area [piping systems] [hydrants] [taps]
[faucets] [hoses] [buckets] [equipment] in such a manner as to prevent contamination of [drinking]
[culinary] water. Specifically, ***
Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to
prevent the spread of communicable diseases. Specifically, ***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are maintained in good repair. Specifically, ***
Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].
Specifically, ***
Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply]
[food] [food utensils]. Specifically, ***
Adequate [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees are not readily
accessible adjacent to [places] [areas] where [land] [air] conveyances are [serviced] [maintained]
[cleaned]. Specifically, ***
Equipment for [cleaning soil cans and removable containers] [flushing nonremovable containers and
waste carts] is [not designed so as to prevent backflow into the water line] [used for a purpose
connected with the handling of food, water, or ice]. Specifically, ***
Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid
Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment]. Specifically,
***
A water system not protected against backflow. Specifically, ***
Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a
clean and sanitary condition. Specifically, ***
A connection exists between a nonpotable water system on [a vessel] [your vessel] and a potable water
system on [a] [your] pier; there are no provisions to prevent backflow from the vessel to the pier.
Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately
[lighted] [ventilated]. Specifically, ***
Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free
from flies, rodents, and other vermin]. Specifically, ***
Not all food-handling operations are accomplished so as to minimize the possibility of contaminating
[food] [drink] [utensils]. Specifically, ***
Adequate facilities are not provided for the [cleaning] [bactericidal treatment] of [multiuse eating and
drinking utensils] [equipment used in the preparation of food and beverages]. Specifically, ***
Failure to equip each refrigerator with a thermometer located in the warmest region thereof.
Specifically, ***
Not all [tanks] [piping] bear clear marks of identification. Specifically, ***
Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures]
[apparatus] [equipment]. Specifically, ***
Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared
or kept hot for serving. Specifically, ***
Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food]
[beverages] are constructed so as to be [easily cleaned] [self-draining]. Specifically, ***
Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse
eating and drinking utensils after each use. Specifically, ***
Failure to keep all equipment clean. Specifically, ***
Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent
contamination before reuse. Specifically, ***
Signs directing food-handling employees to wash their hands after each use of toilet facilities are not
[posted] [readily observable by such employees]. Specifically, ***
Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold
running water]. Specifically, ***
Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of
contamination of the water supply. Specifically, ***
Discharge of [excrement] [garbage] from an air conveyance not at an approved servicing area.
Specifically, ***
Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for
drinking. Specifically, ***
Equipment used to [store] [wash] [handle] [deliver] bulk ice intended for [the cooling of drinking water
or other beverages] [food preservation purposes] is not [constructed so as not to become a factor in the
transmission of communicable diseases] [used for no other purposes]. Specifically, ***
Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas]
[stations]. Specifically, ***
Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent]
[equipped with close-fitting covers]. Specifically, ***
Failure to provide [adequate] can washing and draining facilities. Specifically, ***
Garbage cans are not [emptied daily] [thoroughly washed before being returned for use]. Specifically,
***
A potable water tank is equipped with a [manhole] [overflow] [vent] [device for measuring depth of
water] and [no] [inadequate] provision is made to prevent entrance into the tank of contaminating
substances. Specifically, ***
Failure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the
introduction, transmission, or spread of communicable diseases. Specifically, ***
Toilet and lavatory [equipment] [spaces] not maintained in a clean condition. Specifically, ***
Frequency
31
15
13
12
3
3
3
2
2
2
1
1
1
1
1
1
1
1
Radiological Health 5007 21 CFR 1002.13
Radiological Health 5700 21 CFR 1002.10
Radiological Health 5032 21 CFR 1010.2(b)
Radiological Health 5171 21 CFR 1040.10(g)(3)
Radiological Health 5940 21 CFR 1030.10(c)(3)(i)
Radiological Health 5008 21 CFR 1002.20(a)
Radiological Health 5034 21 CFR 1010.2(c)
Radiological Health 5213 21 CFR 1040.11(c)
Radiological Health 5811 21 CFR 1002.30(a)(1)
Radiological Health 5048 21 CFR 1010.4(d)
Radiological Health 5117 21 CFR 1030.10(c)(2)(vi)

Radiological Health 5122 21 CFR 1030.10(c)(3)(iii)
Radiological Health 5123 21 CFR 1030.10(c)(3)(iv)
Radiological Health 5173 21 CFR 1040.10(g)(5)(i)

Radiological Health 5197 21 CFR 1040.10(h)(1)(i)
Radiological Health 5198 21 CFR 1040.10(h)(1)(ii)
Radiological Health 5200 21 CFR 1040.10(h)(1)(iv)
Radiological Health 5203 21 CFR 1040.10(h)(2)(i)
Radiological Health 5204 21 CFR 1040.10(h)(2)(ii)
Radiological Health 5244 21 CFR 1040.20(f)
Radiological Health 5694 21 CFR 1002.10(d)

Short Description
Failure to submit
Failure to submit, distinct marking
Certification label or tag
Class IV "Danger" label
tests--errors and uncertainties accounted for
Failure to report
Certification not based on adequate test/testing

program
Demonstration laser products
Quality control procedures
Variances - Improper certification
Means to monitor interlocks
Methods, devices, procedures for testing
ID label lacks name and address

ID label lacks place, month & year of manufacture
Measurements with tap water container
Door position
Aperture label - laser radiation

User information, adequate instructions
User information, radiation output information
User info - list controls, etc.
Reproduction of affixed information
Controls, maintenance
Calibration of measurement system
Test deficiencies
Description of function, op. characteristics, uses
Five year requirement
Results of tests
Basis for selecting methods, devices, procedures
Obtaining info on first purchasers

Long Description
You did not submit an annual report [by the September 1 deadline] for products requiring one.
Specifically, ***
You did not submit a required product report [distinctly marked "Radiation Safety Product Report of
(your name)"] prior to the introduction of the product into commerce. Specifically, ***
A certification label or tag is not [in the English language] [permanently affixed or inscribed] [legible]
[readily accessible to view when the product is fully assembled for use]. Specifically, ***
Each Class IV laser product does not have affixed a label [bearing the DANGER logotype specified in the
regulation] [bearing the wording "LASER RADIATION--AVOID EYE OR SKIN EXPOSURE TO DIRECT OR
SCATTERED RADIATION" in the position specified in the regulation] [bearing the wording "CLASS IV LASER
PRODUCT" in the position specified in the regulation]. Specifically, ***
Tests for microwave oven compliance failed to account for all measurement errors and uncertainties to
ensure that the equivalent plane-wave power density did not exceed the required limit. Specifically, ***
You did not immediately report to the Director, CDRH, FDA, an accidental radiation occurrence reported
to or otherwise known to you. involving a product introduced or intended to be introduced into
commerce by you. Specifically, ***
Certification was not based upon [a test, in accordance with the standard] [a testing program in
accordance with good manufacturing practices]. Specifically, ***
Each demonstration laser product [does not comply with all of the applicable requirements for a Class I,
IIa, II, or IIIa laser product] [does not prevent human access to laser radiation in excess of the accessible
emission limits of Class I, IIa, II or IIIa]. Specifically, ***
You have not [established] [maintained] records containing a description of quality control procedures
with respect to electronic product radiation safety. Specifically, ***
Failure to modify the [tag] [label] [certification] of a product for which a variance has been granted to
state [that the product conforms to the applicable standard, except with respect to those characteristics
covered by the variance] [that the product conforms with the provisions of the variance] [the assigned
number and effective date of the variance]. Specifically, ***
A means of monitoring one or both of the required safety interlocks [was not provided] [did not cause
the_x000D_
oven to become inoperable and remain so until repaired when the required interlocks failed to perform
required functions]. Specifically, ***
You have not [established] [maintained] records of the [methods] [devices] [procedures] used in tests for
electronic product radiation safety. Specifically, ***
An identification label failed to provide the name and address of the [manufacturer] [individual or
company under whose name the product was sold]. Specifically, ***
An identification label fails to provide the [place] [month] [year] of manufacture. Specifically, ***
Microwave oven measurements were not made with the microwave oven [operating at maximum
output] [containing a load of 275 ? 15 milliliters of tap water initially at 20 ? 5 degrees centigrade placed
within the cavity at the center of the load-carrying surface provided by the manufacturer]. Specifically,
***
Measurements were not performed with the door of the microwave oven [fully closed] [with the door
fixed in any position that allowed the oven to operate]. Specifically, ***
The warning statement "AVOID EXPOSURE---Laser radiation is emitted from this aperture" was not
affixed in close proximity to each aperture through which is emitted accessible laser or collateral
radiation in excess of the accessible emission limits of Class I and table VI of Section 1040.10(d).
Specifically, ***
Adequate instructions for each laser product were not provided or caused to be provided for [assembly]
[operation] [maintenance] [clear warnings concerning precautions to avoid possible exposure to laser
and collateral radiation in excess of the accessible emission limits specified in the regulations] [a
maintenance schedule necessary to keep the product in compliance with the standard]. Specifically,
***
A statement [in appropriate units] of the magnitude of the [pulse durations] [maximum radiant power]
[maximum radiant energy per pulse of the accessible laser radiation detectable in each direction in
excess of the accessible emission limits in the standard] was not provided or caused to be provided for
each laser product. Specifically, ***
The manufacturer did not provide or cause to be provided a listing of [all controls] [all adjustments] [all
procedures for operation and maintenance] [the warning: "Caution --- use of controls or adjustments or
performance of procedures other than those specified herein may result in hazardous radiation
exposure."]. Specifically, ***
The manufacturer did not provide or cause to be provided in all [catalogs] [specification sheets]
[descriptive brochures] pertaining to each laser product, a legible reproduction of [the class designation]
[the warning] [the information required for positions 1, 2, and 3 of the applicable logotype] required b to
be affixed to the product. Specifically, ***
Adequate instructions for service adjustments and service procedures were not provided or caused to
be provided for each laser model, including [a listing of those controls and procedures that could be
utilized by persons other than the manufacturer or manufacturer's agent to increase accessible emission
levels of radiation] [a clear description of the location of displaceable portions of the protective housing
that could allow human access to laser or collateral radiation in excess of the accessible emission limits]
[a schedule of maintenance necessary to keep the product in compliance]. Specifically, ***
The Class [III] [IV] medical laser product is not supplied with instructions specifying a procedure and
schedule for calibration of the measurement system. Specifically, ***
The certification tests [did not account for all errors and statistical uncertainties in the process] [did not
account for changes in radiation emission or degradation in radiation safety with the age of the product].
[Failure to make measurements for certification purposes under those operational conditions, lamp
voltage, current, and position as recommended by the manufacturer.] [Failure to position the measuring
instrument at the recommended exposure position and so oriented as to result in the maximum
detection of the radiation by the instrument.] Specifically, ***
A product report did not describe the [function] [operational characteristics affecting radiation emission]
[intended and known uses of each model] of the listed product. Specifically, ***
You have not preserved your required record(s) for a period of five years from the date of the record.
Specifically, ***
You have not [established] [maintained] records of the results of tests for electronic product radiation
safety, including the control of unnecessary, secondary or leakage electronic product radiation.
Specifically, ***
You have not [established] [maintained] records of the basis for selecting the [methods] [devices]
[procedures] used in tests for electronic product radiation safety. Specifically, ***
For a product for which distribution records are required, you have not obtained such information as is
necessary to identify and locate first purchasers. Specifically, ***
Frequency
11
1
1
1
1
1
Veterinary Medicine 4185 FDCA 402(a)(4)

Veterinary Medicine 4093 21 CFR 530.11(d)
Veterinary Medicine 4097 21 CFR 530.20(a)(2)(iv)
Veterinary Medicine 13521 21 CFR 530.41(a)


Veterinary Medicine 18206 21 CFR 507.19(e)
Veterinary Medicine 1493 21 CFR 225.30(b)(4)

Veterinary Medicine 4560 21 CFR 225.165
Veterinary Medicine 18202 21 CFR 507.19(b)




Veterinary Medicine 4111 21 CFR 530.12(c)


Veterinary Medicine 13534 21 CFR 511.1(b)(7)(ii)
Veterinary Medicine 13571 21 CFR 589.2001(c)(3)(i)
Veterinary Medicine 18204 21 CFR 507.19(d)(2)
Veterinary Medicine 18209 21 CFR 507.22(a)(1)

Veterinary Medicine 21232 21 CFR 558.6(c)(8)

Short Description
Record keeping
Tissue residue
Tissue residue
Drugs prohibited for extralabel use in food producing

animal
Drug inventory
Records review prior to slaughter
Identity of animals
Expired drugs
System for administration of drugs
Rx not followed
Withdrawal period
Hospital pen
Dosage level
Extra label use w/o veterinary client-patient

relationship
Plant Operations
Pest Control
Medication status of animals
Calibration of scales and metering devices

Establishment and use of adequate procedures
Grounds
Sanitation
Raw Material Controls
Vermin and pest infestation
Bulk Type A and Type B storage
Record Requirements
Plant Maintenance
Species or class
Route of administration
Maintained in clean and orderly condition

Pest access minimized
Capability to produce a medicated feed
Integrity and identity
Daily inventory record kept
Information required
Discrepancies
Reasonable and effective procedures followed
Discrepancies investigated, reported

Facilities features
Adequate procedures established
Adequate procedures for Type A and Type B articles
Investigation and corrective action
Bagged or bulk deliveries
Individual/Employee Qualifications
Plant Construction and Design
Contamination with Mycotoxins/Natural Toxins
Frozen Raw Materials/Ingredients
Feeding areas
Feeding colostrum
Adequate drainage
Maintenance reasonably clean & orderly
Designed for inspection and use of cleanout
Lot number or shipment I.D. number
Daily comparison, actual vs theoretical
Three assays per year
First batch assay
Assay results out of specification
Maintaining proofread label

Preparation of MRF
Production records kept one year
Directions for use
Detention of feeds with yield discrepancies
Label stock review

Conditions of use
Properly installed
Cleanliness, inspection, cleanout
Use in accord with directions
Elements of records
Records: Maintenance
Records:establish, maintain, make available
Toxic Substances
Equipment and Utensils - cleaned
Equipment and Utensils - avoid adulteration
Animal Food Contact Surfaces

Identification of Rework
Holding and Distribution
Labeling of Stored/Distributed Animal Food
Record Requirements
Acknowledgement letter
Caution statement missing for VFD feeds

Long Description
Treatment records were not [maintained] [complete]. Specifically,***

Causing a residue of an approved human or animal drug above an established safe level, safe
concentration, or tolerance, through use of the drug contrary to its labeling. Specifically, ***
Causing an illegal residue in a food-producing animal of an approved human or animal drug through
[prescribing the use of] [using] the drug contrary to its labeling, and failing to take appropriate measures
to assure that [assigned timeframes for withdrawal were met] [no illegal residue would occur].
Specifically, ***
A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing

animal(s). Specifically, ***_x000D_
_x000D_
_x000D_
You lack an adequate inventory system for determining the quantities of drugs used to medicate your
[cows] [calves] [livestock]. Specifically, ***
Failure to systematically review treatment records prior to offering an animal for slaughter for human
food, to assure that drugs have been used only as directed and that appropriate withdrawal times have
been observed. Specifically, ***
Failure to [identify] [maintain records regarding the identity of] [record the existing identification of] the
animal(s) that you [purchased] [transported] and delivered for [sale] [consignment] at [an auction yard]
[a slaughter plant]. Specifically, ***
Expired drug(s) were observed in the drug storage area. Specifically, ***
Failure to have a system to control administration of drug treatments to your animals. Specifically, ***
Failure to follow your veterinarian's prescription for [dosage] [frequency and duration of treatment]
[route of administration] [species or class of animal] [pre-slaughter withdrawal time] [special cautionary
directions]. Specifically, ***
Administration of an approved animal drug contrary to the labeling, without benefit of a valid
veterinarian-client-patient relationship, in that pre-slaughter withdrawal time was not observed.
Specifically, ***
Failure to [identify] [segregate] [quarantine] treated animals. Specifically, ***
Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid
veterinarian-client-patient relationship. Specifically, ***
Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid
veterinary client-patient relationship. Specifically, ***
You did not [conduct operations in accordance with current good manufacturing practices] [ensure the
safety and suitability of the food-packaging materials] [assign supervision of overall plant cleanliness]
[take adequate precautions to prevent contamination of animal food] [use testing procedures to identify
sanitation failures] [reject, treat or process to eliminate contaminated food] [conduct all animal food
manufacturing under such conditions and controls to protect against contamination of animal food].
Specifically, ***
You did not take effective measures to [exclude pests from your plant] [protect against contamination of
animal food by pests]. Specifically, ***
Failure to inquire about the medication status of the animal(s) that you [transported] [purchased] and
delivered for [sale] [consignment] at [an auction yard] [a slaughter plant]. Specifically, ***
Failure to calibrate scales and metering devices [upon installation] [at least once a year after installation]
[as frequently as necessary] to insure their accuracy. Specifically, ***
Adequate procedures are not [established] [used] for all equipment used in the production and
distribution of medicated feeds to avoid unsafe contamination of medicated [and nonmedicated] feeds.
Specifically, ***
You did not keep the grounds around your animal food plant in a condition that would protect against
the contamination of animal food. Specifically, ***
You did not [clean] [maintain] [store] utensils and equipment in a manner that protects against
You did not inspect, segregate, or otherwise handle [shipping containers] [raw materials] [ingredients]
used in manufacturing [to ensure they were clean and suitable for processing] [under conditions that will
protect the animal food against contamination and minimize deterioration]. Specifically, ***
Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest
infestation. Specifically, ***
Bulk [Type A medicated articles] [Type B medicated feeds] are not identified and stored in a manner such
that their identity, strength, quality and purity will be maintained. Specifically, ***
You did not establish records documenting the training of principles of animal food hygiene and animal
food safety for individuals engaged in the manufacturing, processing, packing or holding of animal food.
Specifically, ***
You did not maintain your plant [in a clean manner] [in good repair] to prevent animal food from
becoming adulterated. Specifically, ***
Administration of an approved human or animal drug to a [species of animal] [class of animal] for which
the drug was not labeled, without benefit of a valid veterinarian-client-patient relationship. Specifically,
***
Administration of an approved animal drug via a route, [oral] [intramuscular] [intravenous]
[subcutaneous] [topical] [intramammary] [intrauterine], which was not indicated in the labeling, without
benefit of a valid veterinarian-client-patient relationship. Specifically, ***
Buildings are not maintained in a reasonably clean and orderly manner. Specifically, ***
The building is not constructed to minimize access by [rodents] [birds] [insects] [pests]. Specifically, ***
Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety]
[purity]. Specifically, ***
Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their
integrity and identity. Specifically, ***
Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.
Specifically, ***
Daily Inventory records for each drug used do not include [the quantity of drug on hand at the beginning
and end of the work day][the amount of each drug used, sold, or otherwise disposed of][the batches or
production runs of medicated feed in which each drug was used][information concerning any
semiprocessed intermediate mix to be used in a medicated feed][the action taken to reconcile any
discrepancies in the inventory record]. Specifically, ***
Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage
and theoretical drug usage. Specifically, ***
All equipment that comes in contact with [active drug components] [feeds in process] [finished
medicated feed] is not subject to all reasonable and effective procedures to prevent unsafe
contamination of manufactured feed. Specifically, ***
When significant discrepancies were noted on the batch production records, there was a failure to
[institute an investigation immediately] [describe the corrective action taken on the production record].
Specifically, *** _x000D_
_x000D_
The features of the facility necessary for the proper manufacture of medicated feeds fail to provide for
[ease of access to structures and equipment for routine maintenance] [ease of cleaning of equipment
and work areas] [facilities to promote personal hygiene] [structural conditions for control of vermin and
pests] [adequate space for the orderly receipt and storage of drugs and feed ingredients] [adequate
space for the controlled flow of materials through the processing and manufacturing operations]
[equipment necessary for the accurate packaging and delivery of a medicated feed of specified labeling
and composition]. Specifically, ***
Adequate procedures are not established for the [receipt] [storage] [inventory control] of all drugs to aid
in assuring their identity, strength, quality and purity when incorporated into products. Specifically, ***
Adequate procedures are not [established] [maintained] for the [identification] [storage] [inventory
control (receipt and use)] of all Type A medicated articles and Type B medicated feeds intended for use in
the manufacture of medicated feeds. Specifically, ***
Results of laboratory assays of drug components indicated that medicated feed was not in accord with
the permissible limits, and no [investigation] [corrective action] was implemented immediately.
Specifically, ***
All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that
the feed can be properly used. Specifically, ***
You did not ensure that all individuals who manufacture, process, pack, or hold animal food are qualified
to perform their assigned duties. Specifically, ***
Your plant is not constructed or designed to facilitate cleaning, maintenance and pest control to reduce
the potential for contamination. Specifically, ***
You did not [evaluate] [use] the [raw materials] [ingredients] susceptible to contamination with
mycotoxins or other natural toxins in a manner that does not result in animal food that can cause injury
or illness to animals or humans. Specifically, ***
You did not thaw your raw materials or ingredients in a manner that minimizes the potential for the
growth of undesirable microorganisms. Specifically, ***
Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and
non-medicated feeds and liquids. Specifically, ***
Feeding colostrum or milk from treated cows to calves intended for slaughter. Specifically, ***
The building grounds are not adequately drained so that they are free from standing water. Specifically,
***
Equipment is not maintained in a reasonably clean and orderly manner. Specifically, ***
Equipment is not [designed] [constructed] [installed] [maintained] so as to facilitate inspection and use
of cleanout procedures. Specifically, ***
The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed
manufacturer's shipment identification number]. Specifically, ***
A daily comparison is not made between the actual amount of drug used and the theoretical amount of
drug to be used in terms of the [semiprocessed] [intermediate] [finished] medicated feeds
manufactured. Specifically, ***
Periodic assays are not performed during the calendar year on at least three representative samples of
medicated feeds requiring a medicated feed mill license, for each drug or drug combination used.
Specifically, ***
No assay was performed on the first ever produced medicated feed batch of a medicated feed requiring a
medicated feed license. Specifically, ***
Failure to [investigate] [implement corrective action] [maintain a record on the premises of corrective
action] when assay results show medicated feeds [not in accord with label specifications] [not within
permissible assay limits]. Specifically,***
Proofread labels are not [initialed and dated by a responsible individual] [kept for one year after all the
labels from that batch have been used]. Specifically, ***
A Master Record File providing the complete procedure for manufacturing a specific product is not
[prepared] [checked] [dated] [signed or initialed] by a qualified person. Specifically, ***_x000D_
Production record(s), for each batch or run of medicated feed produced are not kept on the premises for
at least one year. Specifically, ***_x000D_
Failure to provide labeling containing directions for use as specified by the veterinarian for a human or
animal drug prescribed for use in an animal contrary to the drug's labeling. Specifically, ***
Medicated feeds implicated in drug inventory discrepancies based on a comparison of actual vs.
theoretical usage are not detained until the discrepancies have been reconciled. Specifically, ***
Label stock is not [reviewed periodically] [discarded when discontinued labels are found]. Specifically,
***
Administration of a drug for conditions not [specified in its labeling] [prescribed]. Specifically, ***
Equipment is not properly installed so as to [permit production of feeds of uniform quality] [facilitate
cleaning] [minimize spillage of drug components and finished product]. Specifically, ***
Equipment for producing medicated feeds of intended potency and purity is not [maintained in a
reasonably clean and orderly manner] [designed, constructed, installed and maintained so as to facilitate
inspection and use of cleanout procedures]. Specifically, ***
All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled
mixing directions. Specifically, ***
Formula, production and distribution records are not maintained identifying the [formulation] [date of
mixing] [date of shipment (if not for own use)]. Specifically, ***
Complete records of the investigation were not maintained. Specifically, ***
Failure to [establish] [maintain] [make available to FDA for inspection and copying] records that are
sufficient to demonstrate that material rendered for use in animal feed was not manufactured from,
processed with, or does not otherwise contain, cattle materials prohibited in animal feed.
Specifically,***
You did not [identify] [use] [store] toxic chemicals in a manner that protects against contamination.
Specifically, ***
Your equipment and utensils are not [designed] [constructed] to be adequately cleaned and maintained.
Specifically, ***
Your equipment and utensils are not [designed] [constructed] [used] appropriately to avoid the
adulteration of animal food with contaminants. Specifically, ***
Animal food contact surfaces are not [made of appropriate materials] [maintained] to protect animal
food from being contaminated. Specifically, ***
You did not accurately identify [raw materials] [other ingredients] [rework]. Specifically, ***
You did not hold animal food for distribution under conditions that protect against contamination and
minimize deterioration. Specifically, ***
You did not label the animal food ready for distribution with [information] [instructions] for safely using
the animal food for the intended animal species. Specifically, ***
Your records are not [original] [actual values and observations obtained during monitoring and
verification activities] [accurate, indelible and legible] [created concurrently with performance of the
activity documented] [detailed to provide history of work performed]. Specifically, ***
You distributed VFD feed to another distributor without first obtaining a written (nonverbal)
acknowledgement letter from the receiving distributor (consignee) before the feed was shipped.
Specifically, ***
Feeds containing VFD drugs or combination VFD drugs did not prominently and conspicuously display the
caution statement: "Caution: Federal law restricts medicated feed containing this veterinary feed
directive (VFD) drug to use by or on the order of a licensed veterinarian." Specifically, ***
Frequency
118
84
28
25
21
20
18
17
17
14
13
10
9
4
4
2
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1

Inspection Observation FY18 (Final)

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Inspection Observation FY18 (Final)

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Number of 483 issued from the System*

Inspections ending between 10/1/2017 and 9/30/2018

Citation Program Area 483s Issued

Bioresearch Monitoring 216

Human Tissue for Transplantation 97

Parts 1240 and 1250 70

Veterinary Medicine 206

Sum Product Area 483s from System* 4969

Actual Total in System 483s** 4910

Biologics 76 21 CFR 606.100(b)

Biologics 9225 21 CFR 606.171

Biologics 154 21 CFR 606.160(a)(1)

Biologics 9089 21 CFR 600.14(c)

Biologics 67 21 CFR 606.65(e)

Biologics 98 21 CFR 606.100(c)

Biologics 155 21 CFR 606.160(b)

Biologics 41 21 CFR 606.40(a)(1)

Biologics 333 21 CFR 640.64(e)

Biologics 18093 21 CFR 630.10(g)(1)

Biologics 114 21 CFR 606.121(c)(1)

Biologics 123 21 CFR 606.121(c)(4)(i)

Biologics 9097 21 CFR 600.15

Biologics 18134 21 CFR 640.21(g)

Biologics 57 21 CFR 606.60(a)

Biologics 150 21 CFR 606.151(e)

Biologics 160 21 CFR 606.160(a)(1)

Biologics 251 21 CFR 640.25(b)

Biologics 4425 21 CFR 606.60(a)

Biologics 9243 21 CFR 630.40(a)

Biologics 12202 21 CFR 606.170(a)

Biologics 15079 21 CFR 606.121(c)(11)

Biologics 18038 21 CFR 606.100(b)

Biologics 18067 21 CFR 630.5(d)

Biologics 18071 21 CFR 630.10(b)

Biologics 43 21 CFR 606.40(a)(3)

Biologics 46 21 CFR 606.40(a)(6)

Biologics 61 21 CFR 606.60(a)

Biologics 63 21 CFR 606.65

Biologics 78 21 CFR 606.100(c)

Biologics 80 21 CFR 606.100(b)(1)

Biologics 84 21 CFR 606.100(b)(5)

Biologics 93 21 CFR 606.100(b)(14)

Biologics 94 21 CFR 606.100(b)(15)

Biologics 100 21 CFR 606.110(b)

Biologics 144 21 CFR 606.140(c)

Biologics 158 21 CFR 606.160(e)(1)

Biologics 238 21 CFR 640.11(a)

Biologics 241 21 CFR 640.11(b)

Biologics 246 21 CFR 640.25(a)

Biologics 306 21 CFR 640.73

Biologics 338 21 CFR 640.65(b)(2)(i)

Biologics 368 21 CFR 640.72(d)

Biologics 377 21 CFR 640.120(a)

Biologics 9076 21 CFR 600.12(a)

Biologics 9078 21 CFR 600.12(a)

Biologics 9235 21 CFR 630.40(c)

Biologics 9256 21 CFR 610.41

Biologics 9262 21 CFR 610.40(b)

Biologics 9270 21 CFR 610.40(h)(2)(ii)

Biologics 9315 21 CFR 640.65(b)(3)

Biologics 9461 21 CFR 610.60

Biologics 15072 21 CFR 610.46(b)

Biologics 15080 21 CFR 606.121(c)(12)