Inspections, Compliance, Enforcement, and Criminal Investigations

FY 2015 Inspectional Observation Summaries

Number of 483s Issued from the System*

Inspections ending between 10/1/2014 12:00:00 AM and 9/30/2015 12:00:00 AM

 
Center Name 483s Issued
Biologics 123
Bioresearch Monitoring 283
Devices 1008
Drugs 678
Foods 2300
Human Tissue for Transplantation 81
Parts 1240 and 1250 66
Radiological Health 17
Veterinary Medicine 294
Sum Product Area 483s from System* 4850
Actual Total in System 483s** 4751
 
 

* 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.

Back to Inspectional Observation Summaries


Select a link below to expand/collapse the view for the Inspectional Observational Summaries

Expand All

Cite Id Reference Number Short Description Long Description Frequency
76 21 CFR 606.100(b) Maintained and followed Written standard operating procedures including all steps to be followed in the [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components for [homologous transfusion] [autologous transfusion] [further manufac 59
98 21 CFR 606.100(c) Thorough investigations 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,*** 24
155 21 CFR 606.160(b) Required records Failure to maintain [donor] [processing] [storage and distribution] [compatibility testing] [quality control] [general] records.  Specifically, *** 16
160 21 CFR 606.160(a)(1) Person performing, test results, interpretation 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 pr 16
154 21 CFR 606.160(a)(1) Concurrent documentation 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.  Sp 13
159 21 CFR 606.160(a)(1) Legibility and indelibility Records are [illegible] [not indelible].  Specifically, *** 12
9225 21 CFR 606.171 Biological product deviation report Failure to submit a biological product deviation report [within 45 days from the date you acquired information suggesting that a reportable event occurred].  Specifically, *** 10
4425 21 CFR 606.60(a) Equipment observed, standardized, calibrated 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, * 9
41 21 CFR 606.40(a)(1) Provide space for examination Failure to provide adequate space for [private] [accurate] examinations of individuals to determine their suitability as blood donors.  Specifically, *** 8
77 21 CFR 606.100(b) Written SOPs available for use by personnel Failure to make available written procedures for use by personnel in the areas where the procedures are performed.  Specifically, *** 5
78 21 CFR 606.100(c) Record review prior to release 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, *** 5
150 21 CFR 606.151(e) Procedures to maintain records of emergency transfusions Records [including signature by the physician requesting the procedure] are not maintained of all emergency transfusions [including complete documentation justifying the emergency action].  Specifically, *** 5
12203 21 CFR 606.170(a) Adverse Reaction- Reports of Investigations Written reports of investigations of adverse reactions, including conclusions and follow up, are not prepared and maintained.  Specifically,  5
35 21 CFR 606.40 Clean & orderly Failure to maintain facilities in a clean and orderly manner.  Specifically, *** 4
67 21 CFR 606.65(e) Following manufacturer's instructions Failure to use supplies and reagents in a manner consistent with instructions provided by the manufacturer.  Specifically, *** 4
94 21 CFR 606.100(b)(15) Schedules and procedures for equipment & calibration The standard operating procedure fails to include a written description of schedules and procedures for equipment maintenance and calibration.  Specifically, *** 4
143 21 CFR 606.140(b) Provisions to monitor lab test procedures & instruments Failure to establish  adequate provisions for monitoring the [reliability] [accuracy] [precision] [performance] of laboratory test procedures and instruments.  Specifically, *** 4
246 21 CFR 640.25(a) Storage temps./agitation Failure to store platelets immediately after resuspension [at 20 to 24 degrees Celsius with continuous gentle agitation] [at 1 to 6 degrees Celsius].  Specifically, *** 4
9243 21 CFR 630.6(a) Notification Failure to make reasonable attempts to notify a donor who has been [deferred based on the results of tests for evidence of communicable disease agent(s)] [determined not be to suitable as a donor based on suitability criteria].  Specifically, *** 4
12202 21 CFR 606.170(a) Adverse Reaction - Investigations A thorough investigation of each reported adverse reaction was not made.  Specifically, 4
31 21 CFR 606.20(b) Qualifications of responsible personnel The personnel responsible for the [collection] [processing] [compatibility testing] [storage] [distribution] of blood or blood components are not adequate in [number] [educational background] [training and experience, including professional training as ne 3
9234 21 CFR 630.6(c) Notification w/in 8 weeks Failure to make reasonable attempts to notify the donor within 8 weeks after determining that the donor is deferred or determined not to be suitable for donation.  Specifically, *** 3
61 21 CFR 606.60(a) Provide proper equipment to meet requirements 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, *** 2
75 21 CFR 606.100(a) SOP compliance Failure of the Standard Operating Procedure to comply with additional standards in 21 CFR 640.  Specifically, *** 2
117 21 CFR 606.121(f) Labeling of blood products unsuitable for transfusion Failure to prominently label blood and blood components determined to be unsuitable for transfusion with ["NOT FOR TRANSFUSION"] [the reason the unit is considered unsuitable].  Specifically, *** 2
158 21 CFR 606.160(e) Unsuitable donors A record is not available from which unsuitable (deferred) donors may be identified so that products from such individuals will not be distributed.  Specifically, *** 2
161 21 CFR 606.160(a)(2) Determination of lot numbers and supplies Appropriate records are not available to determine the lot numbers of [supplies] [reagents] used for specific [lots] [units] of the final product.  Specifically, *** 2
224 21 CFR 640.4(f) Arm preparation The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.  Specifically, *** 2
3245 21 CFR 640.61 Explanation of hazards Failure to explain to the prospective Source Plasma donor [by a qualified physician] the [hazards of the plasmapheresis procedure] [risks of a hemolytic transfusion reaction] [hazards involved if the donor is hyperimmunized].  Specifically, *** 2
9044 21 CFR 600.10(b) Personnel capabilities Failure to assure that personnel have [capabilities commensurate with] [the necessary training in] [necessary experience in] [a thorough understanding of] the operations which they perform.  Specifically, *** 2
9086 21 CFR 600.14(a)(1) Who must report - manufacturer Failure to submit [a] biological deviation [report] [reports].  Specifically, *** 2
9089 21 CFR 600.14(c) When to report Biological product deviations [were] [are] not reported within the 45 calendar day timeframe.  Specifically, ***  2
9236 21 CFR 630.6(b)(1) Deferred or not suitable Failure to notify the donor [that the donor is deferred or determined not to be suitable] [of the reason for deferral].  Specifically, *** 2
9238 21 CFR 630.6(b)(3) Results of testing Failure to notify the donor of the results of [tests for evidence of infection due to communicable disease agents that were a basis for deferral] [supplemental tests].   Specifically, *** 2
36 21 CFR 606.40 Suitable size, construction, etc. Failure to provide facilities of  suitable [size] [construction] [location] so as to facilitate adequate cleaning, maintenance and proper operations.  Specifically, *** 1
43 21 CFR 606.40(a)(3) Provide space for storage of blood & blood products Failure to provide adequate space for the storage of blood or blood components pending completion of tests.  Specifically, *** 1
46 21 CFR 606.40(a)(6) Provide space for quarantine of unsuitable for use items Failure to provide adequate space for the [quarantine] [storage] [handling] [disposition] of [products] and [reagents] not suitable for use.  Specifically, *** 1
47 21 CFR 606.40(a)(7) Provide space for collection, processing, testing, dist, etc Failure to provide adequate space for the orderly [collection] [processing] [compatibility testing] [storage] [distribution] of blood and blood components to prevent contamination.  Specifically, *** 1
51 21 CFR 606.40(c) Provide adequate toilet facilities Failure to provide [adequate] [clean] [convenient] toilet facilities for donors and personnel.   Specifically, *** 1
54 21 CFR 606.40(d)(2) Provide adequate disposal of blood & blood components Failure to provide for safe and sanitary disposal for blood and blood components not suitable for use or distribution.  Specifically, *** 1
57 21 CFR 606.60(a) Maintain and clean equipment 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, *** 1
65 21 CFR 606.65(c) Testing of representative samples of reagent lots Representative samples of each lot of [Anti-human globulin] [Blood grouping reagents] [Lectins] [Antibody screening and reverse grouping cells] [Hepatitis test reagents] [Syphilis serology reagents] [Enzymes] are not tested on a regularly scheduled basis  1
80 21 CFR 606.100(b)(1) Donor criteria The standard operating procedure fails to include written descriptions of criteria used to determine donor suitability, including acceptable medical history criteria.  Specifically, *** 1
81 21 CFR 606.100(b)(2) Donor qualifying tests & measurements The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests and measurements, including minimum and maximum values for a test or procedure when a factor in determining acceptability.  Specificall 1
85 21 CFR 606.100(b)(6) Methods of component preparation The standard operating procedure fails to include written descriptions of the methods for component preparation, including any time restrictions for specific steps in processing.  Specifically, *** 1
89 21 CFR 606.100(b)(10) Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents  Specifically, *** 1
95 21 CFR 606.100(b)(16) Labeling procedures to avoid labeling mix-ups The standard operating procedure fails to [include a written description of the labeling procedures] [include safeguards to avoid labeling mix-ups].  Specifically, *** 1
114 21 CFR 606.121(c)(1) Proper name of product The container label fails to include the [proper name] [modifier(s)] [attribute(s)] of the product in a prominent position. Specifically, *** 1
142 21 CFR 606.140(a) Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective.  Specifically, *** 1
162 21 CFR 606.165(a) Distribution and receipt - recalls Failure of distribution and receipt procedures to include a system by which the distribution or receipt of each unit can be readily determined to facilitate its recall.  Specifically, *** 1
181 21 CFR 610.53(c) Dating periods for licensed biological products Failure to assign dating periods in accordance with 21 CFR 610.53 or as approved by CBER.  Specifically, *** 1
208 21 CFR 640.3(a)(1) Donor suitability procedures not followed  Failure to [follow] [maintain] [maintain on the premises] standard procedures and methods for determining the suitability of a donor as a source of blood.  Specifically, *** 1
231 21 CFR 640.4(g)(3) Identification Containers for samples fail to bear the donor's identification before collection of the samples.  Specifically, *** 1
280 21 CFR 640.34(g)(1) Final product - inspection Failure to [inspect the final product immediately after separation of the plasma for] [prevent issue for transfusion when there is] abnormality in color, physical appearance, indications of contamination.  Specifically, *** 1
281 21 CFR 640.34(g)(2) Final product - evidence of thawing Failure to [inspect the final plasma product for evidence of thawing or breakage at the time of issuance] [store the final plasma product in a manner to show evidence of thawing] [prevent issue of Plasma or Fresh Frozen Plasma where there is evidence of t 1
318 21 CFR 640.63(c)(3) Blood hemoglobin Each donor was not in good health on the day of donation, as indicated in part by a blood hemoglobin level of less than 12.5 grams per 100 milliliters of blood or 38% hematocrit.  Specifically, *** 1
320 21 CFR 640.63(c)(5) Serum protein Each donor was not in good health on the day of donation, as indicated in part by a total [serum] [plasma] protein of less than 6.0 grams per 100 milliliters of blood.  Specifically, *** 1
333 21 CFR 640.64(e) Prevention of contamination The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of blood.  Specifically, *** 1
3246 21 CFR 640.61 Obtaining consent in an appropriate manner Failure to present the hazards and risks of plasmapheresis in such a manner that intelligent and informed consent can be given by the prospective Source Plasma donor.  Specifically, *** 1
3258 21 CFR 640.63(d) Unreliable answers Failure to consider as unsuitable any donor who does not appear to be providing reliable answers to medical history questions.  Specifically, *** 1
9076 21 CFR 600.12(a) Maintenance  - concurrence Records are not made [concurrently with the performance] of each step in the [manufacture] [distribution] of products.  Specifically, *** 1
9087 21 CFR 600.14(a)(1) Who must report - receiving information Failure to [establish] [maintain] [follow] procedures for obtaining information on all [deviations] [complaints] [adverse events] for a distributed biological product subject to biological product deviation reporting.  Specifically, *** 1
9095 21 CFR 600.80(c)(1)(i) Reporting Requirements - 15-day alert All [serious] [unexpected] adverse experiences were not reported within 15 calendar day of initial receipt of the information.  Specifically, *** 1
9097 21 CFR 600.15 Blood & Blood Components 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] [Plat 1
9100 21 CFR 600.80(c)(2)(i) Reporting Requirements - Periodic adverse experience reports Periodic adverse experience reports are not reported at [quarterly] [annual] intervals as required.  Specifically, *** 1
9106 21 CFR 600.81 Distribution Reports Product distribution reports [are not submitted] [do not contain complete information] [are not filed at the appropriate intervals].  Specifically, *** 1
9220 21 CFR 606.100(b)(20) Donor notification The standard operating procedure fails to include a written description of the [donor notification process] [process for follow-up if the initial attempt at donor notification fails].  Specifically, *** 1
9223 21 CFR 606.160(b)(6) Required records - transfusion reaction and complaints Failure to maintain records of transfusion reaction reports and complaints, including investigation and follow up.  Specifically, *** 1
9227 21 CFR 606.171(a) BPDR - procedures Failure to establish a procedure to obtain information about [deviations] [complaints] [adverse events] from your contractor.  Specifically, *** 1
9239 21 CFR 630.6(b)(4) Follow up and counseling Failure to provide appropriate information concerning medical follow-up and counseling.  Specifically, *** 1
9266 21 CFR 610.40(e) Further testing Failure to further test each donation found to be reactive to a screening test.  Specifically, *** 1
9269 21 CFR 610.40(h) Shipment/use of reactive units, units from deferred donors Human blood or blood components that were [reactive by a screening test] [collected from a donor with a previous record of a reactive screening test] for evidence of a communicable disease agent were [shipped] [used] without meeting the exceptions set for 1
9270 21 CFR 610.40(h)(2)(ii) Labeling of reactive units, units from deferred donors Human blood or blood components [collected from a deferred donor] [which had a reactive screening test for a communicable disease agent] were [shipped] [used], but the product labeling did not include the appropriate elements.  Specifically, *** 1
9328 21 CFR 610.1 Consideration of all results Failure to consider all test results in determining whether the test results meet the test objectives.  Specifically, *** 1
15030 21 CFR 606.60(b) Equipment calibration frequency 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, *** 1
15041 21 CFR 610.47(b) Lookback System [Consignee] Failure to [establish] [maintain] [follow] an appropriate system for HCV lookback.  Specifically, *** 1
Cite Id Ref No Short Description Long Description Frequency
7560 21 CFR 312.60 FD-1572, protocol compliance An investigation was not conducted in accordance with the [signed statement of investigator] [investigational plan].  Specifically, *** 171
7530 21 CFR 312.62(b) Case history records- inadequate or inadequate Failure to prepare or maintain [adequate] [accurate] case histories with respect to [observations and data pertinent to the investigation] [informed consent].   Specifically, *** 92
7318 21 CFR 56.115(a)(2) Minutes of IRB meetings 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 req 29
7526 21 CFR 312.62(a) Accountability records Investigational drug disposition records are not adequate with respect to [dates] [quantity] [use by subjects].  Specifically, *** 24
7281 21 CFR 56.108(a)(1) Initial and continuing reviews The IRB [has no] [did not follow its] written procedure for conducting its [initial] [continuing] review of research. Specifically, *** 22
7227 21 CFR 50.27(a) Consent form not approved/signed/dated 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  15
7334 21 CFR 56.115(a)(5) List of members 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 14
7562 21 CFR 312.60 Informed consent 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, *** 14
7290 21 CFR 56.108(c) Members present for review 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.  Specifical 13
7520 21 CFR 312.64(b) Safety reports 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, *** 13
7482 21 CFR 312.50 General responsibilities of sponsors 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 pl 10
7391 21 CFR 50.25(a)(5) Confidentiality, FDA inspection of records 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 rec 9
7209 21 CFR 50.25(a)(1) Procedures, identification of those which were experimental The informed consent document did not contain [a description of the procedures to be followed] [identification of any procedures which were experimental].  Specifically, *** 8
7498 21 CFR 312.66 Unanticipated problems Failure to report promptly to the IRB all unanticipated problems involving risk to human subjects or others.  Specifically, *** 8
7335 21 CFR 56.115(a)(6) Written procedures per 56.108(a) and (b) Documentation has not been [prepared] [maintained] of written procedures for the IRB, as required by 21 CFR 56.108(a) and (b).  Specifically, *** 7
7231 21 CFR 50.20 Consent not obtained, exceptions do not apply 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, *** 6
7278 21 CFR 56.107(e) Conflict of interest 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, *** 6
7293 21 CFR 56.109(f) Continuing review 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, *** 6
7342 21 CFR 56.108(b)(2) Prompt reporting of noncompliance 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 determina 6
7390 21 CFR 50.25(a)(4) Alternate procedures, courses of treatment There was [no] [an incomplete] disclosure in the informed consent document of appropriate alternate procedures or courses of treatment, if any, that might be advantageous to the subject.  Specifically, *** 6
7480 21 CFR 312.50 Ensuring compliance with plan and protocol Failure to ensure that an investigation was conducted in accordance with the general investigational plan and protocols as specified in the IND.  Specifically, *** 6
7527 21 CFR 312.62(a) Unused drug disposition (investigator) Unused supplies of an investigational drug were not [returned to the sponsor] [disposed of in accordance with sponsor instructions].  Specifically, ***  6
7531 21 CFR 312.62(c) Record retention 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, *** 6
7319 21 CFR 56.115(a)(3) Records of continuing review Records have not been [prepared] [maintained] of all continuing review activities.  Specifically, *** 5
7343 21 CFR 56.108(b)(3) Reporting  of suspension/termination The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any suspension or termination of IRB approval.  Specifically, *** 5
7552 21 CFR 312.66 Changes in research Not all changes in research activity were approved by an Institutional Review Board prior to implementation.  Specifically, *** 5
7666 21 CFR 50.20 Understandable language The general requirements for informed consent were not met in that the information given was not in language understandable to the subject or the subject's representative.  Specifically, *** 5
7695 21 CFR 50.25(c) ClincialTrials.gov statement The informed consent document does not include the [complete] required statement:  "A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law.  This Web site will not include information that can iden 5
7286 21 CFR 56.108(b)(1) Prompt reporting of unanticipated problems The IRB [has no] [did not follow] written procedures for ensuring prompt reporting to [the IRB] [appropriate institutional officials] [the FDA] of any unanticipated problems involving risks to human subjects or others.  Specifically, *** 4
7321 21 CFR 56.110(c) Method to keep members advised 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, ***  4
7371 21 CFR 56.108(a)(1) Reporting findings and actions to investigator/institution The IRB [has no] [did not follow its] written procedure for reporting its [findings] [actions] to the [investigator] [institution].  Specifically, *** 4
7388 21 CFR 50.25(a)(2) Reasonably foreseeable risks or discomforts  The informed consent document lacked a description of reasonably foreseeable risks or discomforts to the subject.  Specifically, *** 4
7392 21 CFR 50.25(a)(7) Whom to contact The informed consent document lacked an explanation of whom to contact [for answers to pertinent questions about the research and research subjects' rights] [in the event of a research-related injury to the subject].  Specifically, *** 4
7411 21 CFR 312.53(c)(1) Investigator statement (FDA 1572) Failure to obtain [an] [a complete] investigator statement, form FDA-1572, before permitting an investigator to participate in an investigation.  Specifically, *** 4
7517 21 CFR 312.66 Initial and continuing review 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, *** 4
3914 21 CFR 58.31(f) Management: personnel understand their functions Testing facility management failed to assure that all personnel clearly understood the functions they were to perform.  Specifically, *** 3
4026 21 CFR 58.185(a)(10) Final report: names of those involved The final study report did not include [the name of the study director] [the names of other scientists or professionals] [the names of all supervisory personnel] involved in the study.  Specifically, *** 3
7277 21 CFR 56.107(d) One non-affiliate member 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, *** 3
7316 21 CFR 56.115(a)(4) Copies of IRB/CI correspondence Copies have not been maintained of all correspondence between the IRB and the investigators.  Specifically, *** 3
7320 21 CFR 56.109(e) IRB approvals/disapprovals - general The IRB has not promptly notified in writing [the investigator] [the institution] when the IRB has [approved] [disapproved] [required modifications to secure IRB approval of] proposed research activity.   Specifically, *** 3
7340 21 CFR 56.108(a)(3) Prompt reporting of changes The IRB [has no] [did not follow its] written procedure for ensuring prompt reporting to the IRB of changes in research activity.  Specifically, *** 3
7368 21 CFR 56.108(a)(2) More frequent reviews, verification of no changes The IRB [has no] [did not follow its] written procedure for determining which projects [require review more often than annually] [need verification from sources other than the investigator that no material changes have occurred since previous IRB review]  3
7384 21 CFR 50.25(b)(1) Statement of risks The informed consent document did not contain a statement that the test article or procedure might involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable.  Specifically, *** 3
7393 21 CFR 50.25(a)(8) Participation; refusal and discontinuance The informed consent document did not contain a statement that [participation was voluntary] [refusal to participate would involve no penalty or loss of benefits to which the subject was otherwise entitled] [the subject might discontinue participation at  3
7453 21 CFR 312.56(b) Investigator non-compliance 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, *** 3
7638 21 CFR 312.20(a) Failure to submit an IND The sponsor failed to submit an IND to the FDA prior to conducting a clinical investigation with an investigational new drug. Specifically,*** 3
7654 21 CFR 56.110(b) Research not eligible for expedited review 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, ***   3
7664 21 CFR 50.20 Circumstances of obtaining consent 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 t 3
3902 21 CFR 58.29(a) Personnel: education, training, experience 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, ** 2
3919 21 CFR 58.33(b) Study director: all data recorded and verified 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, *** 2
3931 21 CFR 58.35(b)(5) QAU: authorize deviations from protocols or SOPs 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, *** 2
3932 21 CFR 58.35(b)(6) QAU: review final study report 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,  2
7276 21 CFR 56.107(c) One scientific and one non-scientific member The IRB does not include [at least one member whose primary concerns are in the scientific area] [at least one member whose primary concerns are in nonscientific areas].  Specifically, *** 2
7297 21 CFR 56.109(b) Information given to subjects The IRB does not require that information given to subjects as part of informed consent contain all necessary elements of informed consent.  Specifically, ***: 2
7317 21 CFR 56.115(a)(1) Copies of all research proposals and related documents 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 s 2
7337 21 CFR 56.115(b) Retention of records Records required by 21 CFR 56 have not been maintained for three years following completion of the research.  Specifically, *** 2
7370 21 CFR 56.111(c) Children as subjects The IRB approved the conduct of research involving children as subjects, but did not determine that the research was in compliance with 21 CFR 50 Subpart D.  Specifically, *** 2
7387 21 CFR 50.25(a)(1) Statement of research, purpose, duration of participation The informed consent document did not contain [a statement that the study involved research] [an explanation of the purposes of the research, and the expected duration of the subject's participation].  Specifically, *** 2
7389 21 CFR 50.25(a)(3) Benefits to the subject A description of any benefits [to the subject] [to others] which might reasonably be expected from the research was not included in the informed consent document.  Specifically, *** 2
7534 21 CFR 312.68 FDA access to clinical investigator records Failure to permit an authorized officer or employee of FDA to [have access to] [copy] [verify] records or reports.  Specifically, *** 2
7543 21 CFR 312.61 Unauthorized recipients (investigator) A study drug was [administered to subjects] [provided to persons] not under the investigator's personal supervision or under the supervision of a subinvestigator responsible to the investigator.   Specifically, *** 2
7629 21 CFR 312.56(c) Annual report Failure to submit to FDA [within 60 days of the anniversary date that the IND went into effect] an annual report of the investigation.  Specifically, *** 2
7652 21 CFR 56.113 Reporting 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, *** 2
7656 21 CFR 56.108(c) Approval from a majority of members present 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, *** 2
7658 21 CFR 50.25(b)(2) Termination by investigator The informed consent document did not include a statement of anticipated circumstances under which the subject's participation might be terminated by the investigator, without regard to the subject's consent.  Specifically, *** 2
7659 21 CFR 50.25(a)(6) Compensation, medical treatment in event of injury For research involving more than minimal risk, the informed consent document lacked an explanation as to whether any [compensation] [medical treatments] were available if injury occurred, and, if so, [of what they consisted] [where further information mig 2
7692 21 CFR 56.106(e) Changes in contact or chairperson information The IRB did not revise its registration information with respect to changes in [the contact person] [the chairperson] within 90 days of the change.  Specifically, *** 2
3903 21 CFR 58.29(b) Personnel: summary of training, job description 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, *** 1
3917 21 CFR 58.33 study director: overall study responsibility The study director did not have overall responsibility for the technical conduct of the study as well as for the interpretation, analysis, documentation and reporting of results, and does not represent the single point of study control.  Specifically, *** 1
3918 21 CFR 58.33(a) Study director: follow study protocol The study director failed to assure that the protocol, including any change, was approved and was followed.  Specifically, *** 1
3920 21 CFR 58.33(c) Study director: unforeseen circumstances The study director failed to assure that unforeseen circumstances that might affect the quality and integrity of the nonclinical laboratory study were noted when they occurred and corrective action was taken and documented.  Specifically, *** 1
3923 21 CFR 58.33(f) Study director: transfer of data to archives The study director failed to assure that all raw data, documentation, protocols, specimens, and final reports were transferred to the archives during or at the close of the study.  Specifically, *** 1
3924 21 CFR 58.35(a) QAU: monitor facilities, etc. 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, *** 1
3925 21 CFR 58.35(a) QAU: separate and independent 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, *** 1
3926 21 CFR 58.35(b)(1) QAU: maintain a master schedule 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, *** 1
3928 21 CFR 58.35(b)(3) QAU: inspect study at adequate intervals 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, *** 1
3934 21 CFR 58.35(c) QAU: SOPs and required records 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, *** 1
3955 21 CFR 58.63(b) Equipment: maintenance SOPs The standard operating procedures for routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment are not adequate.  Specifically, *** 1
3983 21 CFR 58.105(a) Test article: characterization The identity, strength, purity, composition, or other characteristics of each batch of test and control article have not been appropriately defined and documented.  Specifically, *** 1
3985 21 CFR 58.105(b) Test article: stability The stability of each test or control article was not determined by the testing facility or by the sponsor before study initiation, or concomitantly according to written standard operating procedures which provide for periodic analysis of each batch.  Spe 1
4010 21 CFR 58.130(d) Conduct: gross findings available to pathologist Not all records of gross findings for a specimen from postmortem observations were available to a pathologist when examining that specimen histopathologically.  Specifically, *** 1
4025 21 CFR 58.185(a)(9) Final report: circumstances affecting data qual., integrity The final study report did not include a description of all circumstances that may have affected the quality or integrity of the data.  Specifically, *** 1
4028 21 CFR 58.185(a)(12) Final report: reports of individual scientists 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, *** 1
4029 21 CFR 58.185(a)(13) Final report: storage locations The final study report did not include the locations where all [specimens] [raw data] [the final report] are to be stored.  Specifically, *** 1
7230 21 CFR 50.27(b)(2) Short form: Oral presentation/signing 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 autho 1
7274 21 CFR 56.107(a) At least five members with varying backgrounds The IRB is not composed of at least five members [with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution].   Specifically, *** 1
7304 21 CFR 56.110(b)(1) No more than minimal risk The IRB used an expedited review procedure for research appearing in an FDA list of categories eligible for expedited review, but the reviewer did not find the research involved no more than minimal risk to the subjects.  Specifically, ***   1
7309 21 CFR 56.111(a)(1) Risks minimized by sound research design The IRB approved the conduct of research, but did not determine that risks to subjects were minimized by using procedures which were consistent with sound research design and which did not unnecessarily expose subjects to risk.  Specifically, *** 1
7326 21 CFR 56.111(a)(6) Monitoring of data collected 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, *** 1
7328 21 CFR 56.111(b) Vulnerable subject safeguards 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 an 1
7333 21 CFR 56.104(c) Emergency use and IRB approval A clinical investigator did not report to the IRB [, within five days of use,] the emergency use of a test article for which the IRB had not reviewed the research proposal.  Specifically, *** 1
7336 21 CFR 56.115(a)(7) Statements of significant new findings Documentation has not been [prepared] [maintained] of all statements of significant new findings provided to subjects, as required by 21 CFR 50.25.  Specifically, *** 1
7339 21 CFR 56.108(a)(4) Changes in approved research The IRB [has no] [did not follow its] written procedure for ensuring that changes in approved research, during the periods for which IRB approval had already been given, would not be initiated without IRB review and approval (except where necessary to eli 1
7353 21 CFR 50.52 Factors required for approval The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was  1
7358 21 CFR 50.55(a) Adequate provisions for assent of children For a clinical investigation involving children, the IRB did not determine that adequate provisions had been made for soliciting the assent of the children when, in the judgment of the IRB, the children were capable of providing assent.  Specifically, *** 1
7363 21 CFR 50.55(f)  Documentation of permission by parents or guardian Permission by parents or guardians for the participation of children as subjects in a clinical investigation was not documented in accordance with and to the extent required by 21 CFR 50.27.  Specifically, *** 1
7378 21 CFR 50.27(a) Copy of consent form not provided 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 1
7380 21 CFR 50.27(b)(2) Short form: IRB approval of oral presentation The IRB did not approve a written summary of what was to be said to the subject or the subject's legally authorized representative, in a situation where a short form written consent document was prepared.  Specifically, ***  1
7381 21 CFR 50.27(b)(2) Short form: Summary copy not signed/given In a situation where a short form written consent document was prepared, a copy of the summary of what was to be said to the subject or the subject's legally authorized representative [was not signed by the witness] [was not signed by the person actually  1
7399 21 CFR 50.24(a)(7) Additional protections of rights and welfare In approving an investigation without requiring informed consent, the IRB did not [find] [document] that additional protections of the rights and welfare of the subjects would be provided, including [consultation with, and public disclosure to, the commun 1
7406 21 CFR 56.109(a) Scope of reviews The IRB does not review all research activities covered by the regulations.  Specifically, *** 1
7461 21 CFR 312.58(a) FDA access to sponsor records Failure to permit FDA to [have access to] [review] [copy] records or reports related to a clinical investigation.  Specifically, *** 1
7479 21 CFR 312.56(a) Monitoring investigations Failure to monitor the progress of an investigation conducted under your IND.  Specifically, *** 1
7488 21 CFR 312.59 Records of unused drug disposition Failure to maintain [adequate] written records of the disposition of an investigational drug in accordance with 21 CFR Part 312.57.  Specifically, *** 1
7518 21 CFR 312.64(d) Financial info Information necessary for submission of required financial [certification] [disclosure] statements to FDA was not provided to the sponsor.  Specifically, *** 1
7519 21 CFR 312.64(c) Final study report An adequate final report was not provided to the sponsor shortly after completion of the investigator's participation in the investigation.   Specifically, *** 1
7558 21 CFR 312.57(c) Record retention requirement Records and reports were not retained for two years after [marketing application approval] [discontinuance of the investigation and notification of FDA]. Specifically*** 1
7632 21 CFR 312.6(a) Required label statement 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 1
7634 21 CFR 312.7(a) Promotion of Investigational Drug Representations were made in a promotional context that the investigational drug is [safe] [effective] for the purposes for which it is under investigation. Specifically, *** 1
7639 21 CFR 312.20(b) Starting a study before IND is in effect The sponsor began a clinical investigation subject to IND requirements before an IND was in effect.  Specifically,*** 1
7683 21 CFR 56.106(b)(2) IRB registration information Registration information does not include the IRB [name] [mailing address] [street address different from the mailing address] [phone number] [facsimilie number] [electronic mail address].  Specifically, ** 1
7690 21 CFR 56.106(c) Renewal every 3 years The IRB failed to renew its registration every 3 years.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
3130 21 CFR 820.100(a) Lack of or inadequate procedures Procedures for corrective and preventive action have not been [adequately] established. Specifically, *** 377
14713 21 CFR 820.198(a) Lack of or inadequate complaint procedures  Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been [adequately] established.  Specifically,***  294
479 21 CFR 820.50 Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established.  Specifically, *** 139
546 21 CFR 820.75(a) Lack of or inadequate process validation  A process whose results cannot be fully verified by subsequent inspection and test has not been [adequately] validated according to established procedures.  Specifically, *** 134
630 21 CFR 803.17 Lack of Written MDR Procedures Written MDR procedures have not been [developed] [maintained] [implemented].  Specifically, *** 129
3282 21 CFR 820.90(a) Nonconforming product,  Lack of or inadequate procedures  Procedures have not been [adequately] established to control product that does not conform to specified requirements.  Specifically, ***  114
3696 21 CFR 820.100(b) Documentation Corrective and preventive action activities and/or results have not been [adequately] documented.  Specifically, ***   97
2327 21 CFR 820.22 Quality audits - Lack of or inadequate procedures  Procedures for quality audits have not been [adequately] established. Specifically, ***  95
3103 21 CFR 820.30(i) Design changes - Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,*** 89
3331 21 CFR 820.181 DMR - not or inadequately maintained  A device master record has not been [adequately] maintained.  Specifically, *** 77
2350 21 CFR 820.25(b) Training - Lack of or inadequate procedures Procedures for training and identifying training needs have not been [adequately] established. Specifically, ***  72
3125 21 CFR 820.80(d) Lack of or inadequate final acceptance procedures  Procedures for finished device acceptance have not been [adequately] established. Specifically, ***  62
3121 21 CFR 820.80(b) Lack of or inadequate receiving acceptance procedures  Procedures for acceptance of incoming product have not been [adequately] established. Specifically, *** 56
3680 21 CFR 820.70(a) Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been [adequately] established.   Specifically, ***  56
14712 21 CFR 820.184 DHR - not or inadequately maintained  A device history record has not been [adequately] maintained.  Specifically, *** 55
14722 21 CFR 820.40 Procedures not adequately established or maintained Document control procedures have not been adequately [established] [maintained].  Specifically,***  55
3118 21 CFR 820.75(a) Documentation Process validation [activities] [results] have not been  [documented] [approved] [adequately documented] [adequately approved].  Specifically, *** 54
541 21 CFR 820.70(c) Environmental control  Lack of or inadequate procedures  Procedures to control environmental conditions have not been [adequately] established.  Specifically, *** 51
3101 21 CFR 820.30(g) Design validation- Lack of or inadequate procedures  Procedures for design validation have not been [adequately] established.  Specifically,***  51
3160 21 CFR 820.184 Lack of or inadequate DHR procedures  Procedures for device history records have not been [adequately] established.  Specifically,***  51
3172 21 CFR 820.198(c) Investigation of device failures  Complaints involving the possible failure of [a device] [labeling] [packaging] to meet any of its specifications were not [reviewed] [evaluated] [investigated] where necessary. Specifically, ***  51
3233 21 CFR 820.72(a) Calibration, Inspection, etc. Procedures Lack of or Inadequ Procedures to ensure equipment is routinely [calibrated] [inspected] [checked] [maintained] have not been [adequately] established.  Specifically, *** 50
3666 21 CFR 820.20(c) Management review - Lack of or inadequate procedures  Procedures for management review have not been [adequately] established.  Specifically,***  50
732 21 CFR 803.50(a)(2) Report of Malfunction 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 malfunc 48
3168 21 CFR 820.198(a) Complaints  Complaint files are not [adequately] maintained.  Specifically ***  48
3159 21 CFR 820.184 DHR content  The device history record does not demonstrate that the device was manufactured in accordance with [the device master record] [21 CFR 820]. 47
731 21 CFR 803.50(a)(1) Report of Death or Serious Injury 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, *** 44
3678 21 CFR 820.30(g) Design Validation - Risk analysis not performed/inadequate  Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***  44
2650 21 CFR 820.30(f) Design verification - Lack of or inadequate procedures  Procedures for design verification have not been [adequately] established.  Specifically,***  39
3120 21 CFR 820.80(a) Lack of or inadequate procedures - Acceptance activities Procedures for acceptance activities have not been [adequately] established.  Specifically,*** 39
3415 21 CFR 820.22 Quality Audit/Reaudit - conducted  Quality [audits][reaudits] have not been performed.  Specifically, ***  38
2371 21 CFR 820.30(a) Design control - no procedures  Procedures for design control have not been established.  Specifically,***  37
2604 21 CFR 820.30(e) Design review - Lack of or inadequate procedures  Procedures for design review have not been [adequately] established.  Specifically,***  35
3127 21 CFR 820.80(e) Documentation 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, *** 33
631 21 CFR 803.17(a)(1) Lack of System for Event Evaluations 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, *** 32
419 21 CFR 820.20(b) Lack of or inadequate organizational structure  The organizational structure has not been [adequately] established and maintained to ensure that devices are [designed] [produced] in accordance with 21 CFR 820.  Specifically, ***  29
3104 21 CFR 820.30(j) Design history file 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].   29
3286 21 CFR 820.90(b)(1) Procedures for product review,disposition lack of/inadequate Procedures that define the responsibility for review and the authority for the disposition of nonconforming product have not been [adequately] established.  Specifically, *** 29
3128 21 CFR 820.90(a) Nonconforming product control Products that do not conform to specifications are not adequately controlled. Specifically, *** 27
486 21 CFR 820.50(a) Evaluation of suppliers, contractors, etc., requirements Requirements that must be met by [suppliers] [contractors] [consultants] have not been [adequately] established.   Specifically, *** 26
3263 21 CFR 820.250(b) Sampling plans  Sampling plans are not [written][based on valid statistical rationale].  Specifically, ***  25
3375 21 CFR 820.198(e) Records of complaint investigation  Records of complaint investigations do not include required information.  Specifically, ***  25
3669 21 CFR 820.20(c) Management review - defined interval, sufficient frequency  Management with executive responsibility has not reviewed the suitability and effectiveness of the quality system [at defined intervals] [with sufficient frequency].  Specifically, ***  25
3117 21 CFR 820.70(i) Software validation for automated processes Software used as part of [production] [the quality system] has not been [adequately] validated for its intended use according to an established protocol.  Specifically, *** 24
3837 21 CFR 820.25(b) Training records  Personnel training is not documented. Specifically, *** 24
3192 21 CFR 820.30(g) Design validation - user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, *** 23
3285 21 CFR 820.90(b)(2) Product rework procedures, Lack of or inadequate procedures  Procedures for rework of nonconforming product have not been [adequately] established.  Specifically, ***  22
14716 21 CFR 820.30(f) Design verification - output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, ***  22
539 21 CFR 820.70(b) Production and Process Change Procedures, lack of or Inad. Procedures for changes to a [specification] [method] [process] [procedure] have not been [adequately] established.  Specifically, ***  21
2974 21 CFR 812.110(b) Investigator non-compliance with agreement/plan/regulations 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, *** 21
2557 21 CFR 820.30(c) Design input - documentation  Design input requirements were not [adequately] documented.   Specifically, *** 20
14720 21 CFR 820.50(a)(3) Acceptable supplier records, inadequate records  Records of acceptable [suppliers] [contractors] [consultants] have not been [adequately] established.  20
4059 21 CFR 820.22 Quality Audits - defined intervals  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, ***  19
3132 21 CFR 820.120 Lack of or inadequate procedures for labeling  Procedures to control labeling activities have not been [adequately] established. Specifically, ***  18
4191 21 CFR 806.10(a)(1) Report of risk to health A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA.  Specifically, *** 18
447 21 CFR 820.40 Lack of procedures, or not maintained   Document control procedures have not been [established] [maintained].  Specifically,***  17
2302 21 CFR 820.20(e) Quality System Procedures Quality system procedures and instructions have not been established.  Specifically,***  17
537 21 CFR 820.70(a) Production processes Production processes were not [developed] [conducted] [controlled] [monitored] to ensure that a device conforms to its specifications.  Specifically, ***  16
2328 21 CFR 820.22 Quality audits - auditor independence  Individuals who conduct quality audits have direct responsibility for the matters being audited. Specifically, ***  16
3102 21 CFR 820.30(h) Design transfer - Lack of or inadequate procedures   Procedures for design transfer have not been [adequately] established.  Specifically,*** 16
3235 21 CFR 820.72(a) Equipment control activity documentation Equipment [calibrations] [inspections] [checks][maintenance activities] have not been documented.  Specifically, *** 16
3426 21 CFR 820.50(a)(1) Documented evaluation  The evaluation of potential [suppliers] [contractors] [consultants] was not documented.  Specifically, ***  16
3207 21 CFR 820.50(b) Supplier notification of changes There is no agreement with [suppliers] [contractors] [consultants] to notify you of changes in the product or service.  Specifically, *** 15
3226 21 CFR 820.70(g)(1) Maintenance schedule, Lack of or inadequate schedule  Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.  Specifically, ***  15
3262 21 CFR 820.250(a) Statistical techniques - Lack of or inadequate procedures  Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics have not been [adequately] established.  Specifically,***  15
3427 21 CFR 820.50(a)(2) Supplier oversight The type and extent of control to be exercised over [the product] [services] [suppliers] [contractors] [consultants] was not clearly defined. Specifically, *** 15
3433 21 CFR 820.75(c) Process changes - review, evaluation and revalidation A validated process was not [reviewed and evaluated] [revalidated] when changes or process deviations occurred. Specifically, *** 15
14505 21 CFR 812.140(a)(3) Investigator's subject records inadequate Records of each subject's [case history] [exposure to the investigational device] are not all [accurate] [complete] [current].  Specifically, *** 15
14714 21 CFR 820.30(c)  Design input - Lack of or inadequate procedures Procedures for design input have not been [adequately] established.  Specifically,***  15
454 21 CFR 820.40(a) Document review, approval by designated individual Documents were  [not reviewed] [not approved] by designated individual(s) prior to issuance .  Specifically, *** 13
3677 21 CFR 820.30(g) Design validation - software validation not performed  Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***  13
2630 21 CFR 820.30(e) Design review - documentation  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, ***  12
3119 21 CFR 820.75(b) Lack/Inad procedure-Monitoring/Control of Validated Proces   Procedures for monitoring and control of process parameters for a validated process have not been [adequately] established. Specifically, *** 12
3191 21 CFR 820.30(g) Design validation - production units  The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***  12
3671 21 CFR 820.25(a) Personnel  Personnel do not have the necessary [education] [background] [training] [experience] to perform their jobs. Specifically, ***  12
3676 21 CFR 820.30(f) Design verification - documentation  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, ***  12
3686 21 CFR 820.90(b)(2) Product rework documentation, DHR {see also 820.184} Rework and reevaluation activities have not been [fully] documented in the device history record.  Specifically, *** 12
632 21 CFR 803.17(a)(2) Lack of System for Determining MDR Events 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, *** 11
633 21 CFR 803.17(a)(3) Lack of  System for Timely Submission of Reports The written MDR procedure does not include an internal system which provides for timely transmission of complete medical device reports to [FDA] [manufacturers].  Specifically, *** 11
2968 21 CFR 812.100 Investigator non-compliance with agreement/plan/regulations An investigation was not conducted according to the [signed agreement] [investigational plan] [applicable FDA regulations].  Specifically, *** 11
3108 21 CFR 820.70(e) Contamination control, Lack of or inadequate procedures  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, ***  11
3123 21 CFR 820.80(c) Lack of or inadequate In-process acceptance procedures  Procedures for the [acceptance] [control] of in-process product have not been [adequately] established. Specifically, ***  11
3170 21 CFR 820.198(b) Review and evaluation for investigation Not all complaints have been [adequately] reviewed and evaluated to determine whether an investigation is necessary. Specifically, *** 11
3425 21 CFR 820.50(a)(1) Evaluation and Selection, Suppliers, Contractors, etc. Potential [suppliers] [contractors] [consultants] were not [evaluated] [selected] based on their ability to meet specified requirements.  Specifically, ***  11
3201 21 CFR 820.40(a) Not approved or obsolete document retrieval Documents that were [not approved] [obsolete] were observed at a location where they [could be] [are being] used. Specifically, *** 10
3231 21 CFR 820.70(i) Documentation of software validation 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, ***  10
3236 21 CFR 820.72(b) Calibration procedures - content  Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action].  Specifically, *** 10
4070 21 CFR 820.30(g) Design validation - documentation  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, ***  10
14710 21 CFR 820.150 Lack of or inadequate procedures for storage.  Procedures for the control of storage areas and stock rooms have not been [adequately] established.  Specifically,***  10
14718 21 CFR 820.30(g) Design validation - Risk analysis  Results of the design risk analysis were not [adequately] documented.  Specifically, *** 10
502 21 CFR 820.60 Identification procedures, Lack of or inadequate procedures  Procedures for identifying product during all stages of receipt, production, distribution, and installation have not been [adequately] established.  Specifically, ***  9
2430 21 CFR 820.30(b) Design plans - Lack of or  inadequate  Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, *** 9
3175 21 CFR 820.186 QSR  The quality system record has not been [adequately] maintained   Specifically ***  9
3264 21 CFR 820.250(b) Sampling methods - Lack of or inadequate procedures  Procedures to ensure sampling methods are adequate for their intended use have not been [adequately] established.  Specifically,*** 9
4192 21 CFR 806.10(a)(2) Report of violation of the Act (see 803.52(e)(9)) A violation of the FD&C Act involving a device which might present a risk to health was not reported to FDA.  Specifically, *** 9
2269 21 CFR 820.20(a) Quality policy and objectives  The [quality policy] [quality objectives] was/were not established by management with executive responsibility.  Specifically, *** 8
3232 21 CFR 820.72(a) Equipment suitability & capability Certain [inspection] [measuring] [test] equipment is not [suitable for its intended purposes] [capable of producing valid results].  Specifically, *** 8
3345 21 CFR 820.200(a) Servicing - Lack of or inadequate procedures  Procedures or instructions for [performing servicing activities] [verifying that servicing meets specified requirements] have not been [adequately] established. Specifically, *** 8
3432 21 CFR 820.75(b)(2) Documentation of validated process performance 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, *** 8
3674 21 CFR 820.30(d) Design output - documentation  Design output was not [adequately] documented before release.  Specifically, *** 8
4208 21 CFR 806.20(a) Records not kept There is no record maintained of a correction or removal action that was not required to be reported to FDA.   Specifically,*** 8
14711 21 CFR 820.160(a) Lack of or inadequate procedures for distribution Procedures for control and distribution of finished devices have not been [adequately] established.  Specifically,*** 8
2981 21 CFR 812.140(a)(2)(i) Investigator device accountability inadequate 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, *** 7
4212 21 CFR 806.20(b)(4) Justification for not reporting 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,*** 7
14719 21 CFR 820.30(h) Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***  7
2928 21 CFR 812.40 Sponsors' general responsibilities 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]  6
3149 21 CFR 820.180 Availability 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 store 6
3193 21 CFR 820.30(g) Design validation - simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***  6
3204 21 CFR 820.40(b) Change records, content 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].  Specifically, *** 6
3206 21 CFR 820.50(b) Approval, inadequate purchasing data 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, ***  6
3266 21 CFR 820.86 Acceptance status   The acceptance status of product was not [identified to indicate conformance or nonconformance with acceptance criteria] [maintained].  Specifically, ***  6
3683 21 CFR 820.70(g) Equipment Installation, Placement, Specified Requirements 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, ***  6
6803 21 CFR 807.20(a) Devices not listed Devices for which listing is required have not been listed.  Specifically, *** 6
2985 21 CFR 812.140(a)(3)(ii) Investigator records of relevant observations inadequate 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] [complete] [current].  Specifically, *** 5
3113 21 CFR 820.70(g) Equipment design and installation  Equipment used in the manufacturing process has not been appropriately [designed] [constructed] [placed] [installed] to facilitate maintenance, adjustment, cleaning, and use. Specifically, ***  5
3171 21 CFR 820.198(b) Rationale documented for no investigation  Records for complaints where no investigation was made do not include required information.  Specifically ***  5
3173 21 CFR 820.198(d) Evaluation, timeliness, identification 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, *** 5
3190 21 CFR 820.30(g) Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, *** 5
3372 21 CFR 820.198(d) Records of MDR Investigation  Investigation records of MDR reportable complaints do not include required information.  Specifically ***  5
6800 21 CFR 807.20 Establishment not registered An establishment for which registration is required has not been registered.  Specifically, *** 5
14717 21 CFR 820.30(g) Design validation - software validation documentation  Results of the validation of the device software were not [adequately] documented.  Specifically, *** 5
812 21 CFR 803.56 Submission Within One Month 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, *** 4
2293 21 CFR 820.20(d) Quality plan A quality plan has not been [adequately] established.  Specifically, *** 4
3269 21 CFR 820.80(b) Incoming acceptance records, documentation  Acceptance or rejection of incoming product was not documented. Specifically, *** 4
3270 21 CFR 820.80(c) Documentation In-process inspections, tests, or other verification activities and approvals were not documented. Specifically, *** 4
3313 21 CFR 820.120(d) Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.  Specifically, *** 4
3409 21 CFR 820.200(d) Service reports   Service reports [are not documented] [do not include the required information].  Specifically, ***  4
4057 21 CFR 820.20(a) Management ensuring quality policy is understood Management with executive responsibility has not ensured that the quality policy is understood, implemented and maintained at all levels of the organization.  Specifically, ***  4
7013 21 CFR 812.110(d) Inadequate financial disclosure by investigator The sponsor was not supplied [sufficient financial information to allow submission of complete and accurate certification or disclosure statements] [financial disclosure updates when a relevant change occurred during the course of the study or within one  4
14715 21 CFR 820.30(d) Design output - Lack of or inadequate procedures  Procedures for design output have not been [adequately] established.  Specifically,*** 4
635 21 CFR 803.17(b)(1) Info evaluated to determine if event was reportable 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, *** 3
2338 21 CFR 820.22 Quality audit - audit report review  Reports of results of quality [audits] [reaudits] are not reviewed by management having responsibility for the matters audited.   Specifically, ***  3
2949 21 CFR 812.46(a) Sponsor securing investigator compliance 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 inves 3
2970 21 CFR 812.100 Investigator lack of informed consent Informed consent was not obtained in accordance with the regulations regarding the protection of human subjects. Specifically, *** 3
2980 21 CFR 812.140(a)(1) Investigator correspondence records inadequate Records relating to correspondence with [another investigator] [an IRB] [the sponsor] [a monitor] [FDA], including required reports, are not all [accurate] [complete] [current].  Specifically, *** 3
2984 21 CFR 812.140(a)(3)(i) Investigator records of informed consent inadequate Records documenting that informed consent was obtained for each subject prior to participation in the study are not all [accurate] [complete] [current].  Specifically, *** 3
2991 21 CFR 812.140(b)(1) Sponsor correspondence records inadequate Records relating to correspondence with [another sponsor] [a monitor] [an investigator] [an IRB] [FDA], including required reports are not all [accurate] [complete] [current].  Specifically, *** 3
3007 21 CFR 812.140(d) Record retention inadequate 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 pur 3
3109 21 CFR 820.70(d) Personnel requirements, Lack of or inadequate requirements  Requirements have not been [adequately] established to address personnel [health] [cleanliness] [personal practices] [clothing].  Specifically, ***  3
3111 21 CFR 820.70(f) Buildings Buildings [are not of suitable design] [do not contain sufficient space] to [perform necessary operations] [prevent mix-ups] [assure orderly handling of product].  Specifically, ***  3
3138 21 CFR 820.130 Packaging 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, ***  3
3139 21 CFR 820.140 Lack of or inadequate procedures for handling Procedures for product handling have not been [adequately] established.  Specifically,*** 3
3203 21 CFR 820.40(b) Document change records, maintained. Records of changes to documents were not [adequately] maintained.  Specifically, *** 3
3237 21 CFR 820.72(b) Remedial action 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, *** 3
3309 21 CFR 820.120(b) Examination for accuracy 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.  Specifica 3
3310 21 CFR 820.120(b) DHR documentation of label release {see also 820.184} The DHR does not include [complete] records of examination and release of device labeling, including date and signature of the examiner.  Specifically, *** 3
3434 21 CFR 820.75(c) Documentation - review in response to changes or deviations 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, *** 3
3668 21 CFR 820.20(c) Management review dates The results and/or dates of management reviews are not documented. Specifically, *** 3
3699 21 CFR 820.160(b) Distribution records  Distribution records [were not maintained] [do not include or refer to the location of required information].  Specifically, *** 3
4189 21 CFR 820.198(a) General Complaint handling procedures for [receiving] [reviewing] [evaluating] complaints have not been [established] [defined] [documented] [completed] [implemented].  Specifically, *** 3
6802 21 CFR 807.21(a) Annual registration Your annual registration [is not current] [was not updated within 30 days of receipt of form FDA 2891a from FDA].   Specifically, *** 3
6847 21 CFR 807.30(b) Listing not updated or update not timely Device listing information was not updated [in a timely manner].  Specifically, *** 3
14507 21 CFR 812.140(a)(3)(ii) Investigator adverse effect records inadequate Records for each subject concerning [anticipated] [unanticipated] adverse device effects are not all [accurate] [complete] [current].  Specifically, *** 3
512 21 CFR 820.65 Traceability Lack of or inadequate {see also 820.120(e)}  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, *** 2
733 21 CFR 803.50(b)(1) Reporting Information Reasonably Known An MDR report submitted to FDA did not include all information that was reasonably known to the manufacturer.  Specifically, *** 2
735 21 CFR 803.50(b)(2) Explanation of Incomplete Information 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, *** 2
750 21 CFR 803.52(b)(4) Date of Report by the Initial Reporter An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of report by the initial reporter.  Specifically, *** 2
2431 21 CFR 820.30(b) Design plans- updated  Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***  2
2602 21 CFR 820.30(d) Design output - review and approval  Design output was not [reviewed] [approved] before release.  Specifically, ***  2
2969 21 CFR 812.100 No investigator protection - subject rights, safety, welfare The rights, safety, and welfare of subjects in an investigational study were not [adequately] protected.  Specifically, *** 2
2993 21 CFR 812.140(b)(2) Sponsor device disposition records inadequate Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [acc 2
3003 21 CFR 812.140(b)(6) Other sponsor records required by FDA inadequate Records that FDA requires to be maintained for [a category of investigation] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, *** 2
3057 21 CFR 812.150(b)(8) Sponsor report of use without informed consent A copy of a report from an investigator regarding use of an investigational device without obtaining informed consent was not submitted to FDA [within five working days of receipt].  Specifically, *** 2
3141 21 CFR 820.150(a) Storage procedures to prevent mix-ups Procedures for controlling the storage of product in storage areas and stock rooms were not [established] [defined] [documented] [complete] [implemented] to prevent mix-ups, damage, other adverse effects.  Specifically, *** 2
3147 21 CFR 820.170(a) Lack of or inadequate instructions [Installation instructions] [inspection instructions] [test procedures] have not been [adequately] established.  Specifically,*** 2
3164 21 CFR 820.184(d) Acceptance records The device history record does not include [complete] acceptance records that demonstrate the device is manufactured in accordance with the device master record.  Specifically, *** 2
3199 21 CFR 820.40(a) Document review, approval documentation  The documentation of approval of documents does not include [the document approval date] [the signature of the approving official].  Specifically, *** 2
3224 21 CFR 820.70(g)(2) Periodic equipment inspection lack of or inadequate procedu  Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules have not been [adequately] established.  Specifically, ***  2
3288 21 CFR 820.90(b)(1) Documentation of disposition, justification, signature There is [no] [incomplete] documentation of the [disposition of nonconforming product] [justification for use of nonconforming product] [the signature of the individual authorizing the use of nonconforming product].  Specifically, *** 2
3312 21 CFR 820.120(d) Mixups Labeling and packaging operations were not controlled to prevent labeling mix-ups.  Specifically, *** 2
3323 21 CFR 820.170(b) Installer records  The person installing the device did not [adequately] document the inspection and test results to demonstrate proper installation.  2
3332 21 CFR 820.184(e) ID label, labeling The device history record does not include the primary identification label and labeling for each device.  Specifically, *** 2
3665 21 CFR 820.20(b)(3) Management representative 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, *** 2
3841 21 CFR 820.90(b)(2) Product rework adverse effects {see also 820.184} 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, *** 2
4058 21 CFR 820.20 Management responsibility Management with executive responsibility has not ensured that an adequate and effective quality system has been fully implemented and maintained at all levels of the organization.  Specifically, *** 2
4193 21 CFR 806.10(b) Time to report - 10 days 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, *** 2
4213 21 CFR 806.20(b)(5) Records of communications A copy of all communications regarding the correction or removal action was not contained in the record.  Specifically,*** 2
14516 21 CFR 812.25(e) Sponsor's lack of written monitoring procedures There are no written procedures for monitoring an investigational device study.  Specifically,*** 2
14721 21 CFR 820.70(g)(2) Periodic equipment inspections  Periodic inspections of equipment [were not] conducted to ensure adherence to applicable maintenance schedules [were not documented].  Specifically, ***  2
745 21 CFR 803.52(b)(2) Death An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block B that the outcome attributed to the adverse event was death.  Specifically, *** 1
749 21 CFR 803.52(b)(3) Date of Event An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block B the date of the event.  Specifically, *** 1
760 21 CFR 803.52(c)(6) Model, Catalog, Serial and Lot Numbers An individual medical device manufacturer report submitted per FDA Form 3500A did not contain in Block D the device [model] [catalog] [serial] [lot] number.  Specifically, *** 1
774 21 CFR 803.52(e)(4) Date Received by Manufacturer An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block G the date received by the manufacturer.  Specifically, *** 1
2351 21 CFR 820.25(b) Training Employees have not been adequately trained.  Specifically, *** 1
2649 21 CFR 820.30(f) Design verification acceptance criteria Acceptance criteria were not [established] [defined] [documented] [complete] [implemented] prior to the performance of verification activities.  Specifically, *** 1
2933 21 CFR 812.43(a) Investigator(s) not qualified One or more investigators were selected who were not qualified by [training] [experience] to investigate a device.  Specifically, *** 1
2944 21 CFR 812.43(d) Monitors not qualified Monitors that are qualified by [training] [experience] were not chosen to monitor the investigational study.  Specifically, *** 1
2973 21 CFR 812.110(a) Subject participation prior to study approval Subjects were allowed to participate in an investigation prior to obtaining [IRB] [FDA] approval to conduct the investigation. Specifically, *** 1
2983 21 CFR 812.140(a)(2)(iii) Investigator records of disposition of devices inadequate 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, *** 1
2992 21 CFR 812.140(b)(2) Sponsor device shipment records inadequate 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] [complete] [current]. Specifically, *** 1
2994 21 CFR 812.140(b)(3) Sponsor records of investigator agreements inadequate Signed investigator agreements that include the required financial disclosure information are not all [accurate] [complete] [current]. Specifically, *** 1
2995 21 CFR 812.140(b)(4) Availability of records of non-significant risk studies For an investigation subject to the abbreviated requirements, records are not [consolidated in one location] [available for FDA inspection and copying].  Specifically, *** 1
2997 21 CFR 812.140(b)(4)(ii) Sponsor records re non-significant risk status inadequate For an investigation subject to the abbreviated requirements, records that include a brief explanation of why the device is not a significant risk device are not all [accurate] [complete] [current].  Specifically, *** 1
3021 21 CFR 812.150(a)(1) Investigator report of unanticipated adverse effects A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB].  Specifically, *** 1
3025 21 CFR 812.150(a)(3) No investigator progress reports Progress reports on the investigation were not submitted [at the required intervals] [at least yearly] to the [sponsor] [monitor] [reviewing IRB]. Specifically, *** 1
3028 21 CFR 812.150(a)(4) No approval for investigator change in non-emergency Prior approval was not obtained from the sponsor for [changes in] [deviations from] an investigational plan in a non-emergency situation.  Specifically, *** 1
3035 21 CFR 812.150(a)(7) Investigator report in response to a request Information about a device investigation that was [accurate] [complete] [current] was not provided upon request by [a reviewing IRB] [FDA].  Specifically, *** 1
3038 21 CFR 812.150(b)(1) Sponsor evaluation rpt not timely, distributed 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, *** 1
3055 21 CFR 812.150(b)(7) Sponsor final report for significant risk study A final report to [FDA] [all reviewing IRBs] [all participating investigators] was not submitted [within six months] after [completion] [termination] of a significant risk device study.  Specifically, *** 1
3065 21 CFR 812.140(a)(5) Additional investigator records FDA requires Records that FDA requires by [regulation] [specific requirement] to be maintained for [a category of investigations] [a particular investigation] are not all [accurate] [complete] [current].  Specifically, *** 1
3115 21 CFR 820.70(h) Use and removal, Lack of or inadequate procedures  Procedures for the use and removal of manufacturing material have not been [adequately] established.  Specifically, ***  1
3155 21 CFR 820.181(a) DMR device specifications The device master record does not include or refer to the location of  device software specifications.  Specifically, *** 1
3198 21 CFR 820.40(b) Document changes, review and approval, communication  Changes to documents were not [reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval] [communicated to appropriate personnel in a timely manner].  Specifically, ***  1
3200 21 CFR 820.40(a) Document locations, Dissemination, etc. Documents were not available at all locations for which they are designated, used, or otherwise necessary.  Specifically, *** 1
3218 21 CFR 820.70(c) Environmental control system-documentation/review inspection Inspections of environmental control system were not [documented] [reviewed]. Specifically, *** 1
3227 21 CFR 820.70(g)(1) Activity documentation Maintenance activities, including the [date] [individuals performing those activities], have not been documented.  Specifically, *** 1
3250 21 CFR 820.72(b)(2) Calibration documentation There is [no] [incomplete] documentation of [the equipment identification] [calibration dates] [the individual performing each calibration] [the next calibration date] for [inspection] [measurement] [test] equipment .  Specifically, *** 1
3283 21 CFR 820.90(a) Specific non-conforming product procedures Procedures for addressing the [identification] [documentation] [evaluation] [segregation] [disposition] [investigation] of nonconforming product were not [defined] [documented] [complete].  Specifically, *** 1
3302 21 CFR 820.100(a)(3) Identifying corrective & preventive actions The procedures addressing identification of corrective and preventive actions were not [established] [defined] [documented] [complete] [implemented].  Specifically, *** 1
3304 21 CFR 820.100(a)(5) Changes to correct/prevent quality problems Changes in methods and procedures needed to correct and prevent identified quality problems are not [implemented] [recorded] [effective].  Specifically, *** 1
3308 21 CFR 820.120(a) Remain legible Labels were not [printed] [applied] [affixed] so as to remain [legible] [affixed] during processing, storage, handling, distribution, and/or use.  Specifically, *** 1
3346 21 CFR 820.200(b) Analyzing service report Service reports were not analyzed following appropriate statistical methods. Specifically, *** 1
3398 21 CFR 820.80(d)(3) No release signature Finished devices were released for distribution without signature of the individual designated to authorize such release.  Specifically, *** 1
3670 21 CFR 820.20(c) Management review participants Documentation does not show that management with executive responsibility participated in  management reviews. Specifically, *** 1
3682 21 CFR 820.70(d) Implementing Personnel Procedures, Health, Cleanliness.  Requirements addressing the [health] [cleanliness] [personal practices] [clothing] of employees have not been implemented.  Specifically, *** 1
3690 21 CFR 820.100(a)(3) Identification of actions needed Not all of the actions needed to correct and prevent the recurrence of nonconforming product and other quality problems have been identified.  Specifically, *** 1
3698 21 CFR 820.150(b) Procedures - receipt and dispatch Procedures were not established for authorizing receipt from and dispatch to storage areas and stock rooms. Specifically, *** 1
4202 21 CFR 806.10(c)(9) Device number, identification The [total number] [sub-lot identification] of devices subject to correction or removal actions was not reported.  Specifically,*** 1
4204 21 CFR 806.10(c)(11) Domestic & foreign consignees The [names] [addresses] [telephone numbers] of all domestic and foreign consignees of devices subject to correction or removal actions and number of devices distributed to each consignee were not reported.  Specifically,*** 1
4211 21 CFR 806.20(b)(3) Events A description of the events that led to the correction or removal actions was not contained in the record.  Specifically,*** 1
4252 21 CFR 821.25(c)(3) Quality assurance procedures: 6-month & annual audits A quality assurance program that includes audit procedures for each device subject to tracking and audits performed at 6-month intervals for the first 3 years of distribution and annual audits thereafter using a statistically relevant sampling [has not be 1
4254 21 CFR 821.30(a) Failure to report A distributor of a tracked device failed to provide required tracking information promptly.  Specifically,*** 1
4430 21 CFR 803.18(d)(1) Distributor responsibilities for records Device complaint records are not [established] [maintained] by the device distributor, including any relevant [incident information] [information regarding the evaluation of the allegations].  Specifically, *** 1
4431 21 CFR 803.18(d)(1) Distributor's device incident records Device incident records kept by device distributors are not [prominently identified as such] [filed by device] [maintained in written form] [maintained in electronic form which is backed up].  Specifically, *** 1
6805 21 CFR 807.25(b) Device activities not reported Device activities have not been reported to FDA.  Specifically, *** 1
7012 21 CFR 812.100 Investigator lack of control of investigational devices Devices under investigation were not properly controlled.  Specifically, *** 1
9115 21 CFR 809.10(a)(8) Name of Manufacturer/Packer/Distributor  An in vitro diagnostic [product label] [outside container] [wrapper] does not include the [name] [place of business] of the manufacturer, packer or distributor.  Specifically, *** 1
9674 21 CFR 809.10(c)(2)(ii) Not exempt--lacks For Investigational Use statement  A [shipment] [delivery for product testing] of an in vitro diagnostic product prior to full commercial marketing, is  not exempt from the requirements for labels and accompanying labeling because all labeling does not bear a prominently placed statement  1
14506 21 CFR 812.140(a)(3)(i) Investigator documentation for lack of informed consent Records of [written concurrence of a licensed physician for] [the circumstances justifying] the absence of informed consent for a study subject are not all [accurate] [complete] [current].  Specifically,*** 1
14523 21 CFR 812.43(c) No investigator agreement A signed investigator agreement was not obtained from each participating investigator .  Specifically,*** 1
14724 21 CFR 809.10(c)(2)(i) Not properly labeled for research use The labeling for a product in the laboratory research phase of development [represents the product as an effective in vitro diagnostic product][does not prominently state "For Research Use Only. Not for use in diagnostic procedures."], Specifically*** 1
14732 21 CFR 860.7(g)(1)  Responsibility to provide valid scientific evidence  The [manufacturer][importer] failed to [assure that adequate, valid scientific evidence exists][present to the FDA adequate, valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended uses and conditio 1
Cite Id Reference Number Short Description Long Description Frequency
1105 21 CFR 211.22(d) Procedures not  in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].  Specifically, *** 160
3603 21 CFR 211.160(b) Scientifically sound laboratory controls 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] [ 130
2027 21 CFR 211.192 Investigations of discrepancies, failures 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, *** 124
1451 21 CFR 211.113(b) Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].  Specifically, *** 104
1361 21 CFR 211.100(a) Absence of Written Procedures  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, *** 95
1434 21 CFR 211.42(c)(10)(iv) Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.  Specifically, *** 83
1883 21 CFR 211.165(a) Testing and release for distribution 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, *** 80
3585 21 CFR 211.110(a) Control procedures to monitor and validate performance 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 69
1213 21 CFR 211.67(a) Cleaning / Sanitizing / Maintenance 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, *** 68
1274 21 CFR 211.68(a) Calibration/Inspection/Checking not done Routine [calibration] [inspection] [checking] of  [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.  Specifically, *** 64
1914 21 CFR 211.166(a) Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.  Specifically, *** 63
1435 21 CFR 211.42(c)(10)(v) Cleaning System Aseptic processing areas are deficient regarding the system for cleaning  and disinfecting the [room] [equipment] to produce aseptic conditions.  Specifically, *** 60
1177 21 CFR 211.63 Equipment Design, Size and Location 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, *** 56
2009 21 CFR 211.188 Prepared for each batch, include complete information 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, *** 56
1215 21 CFR 211.67(b) Written procedures not established/followed 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, *** 53
1452 21 CFR 211.113(b) Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include [adequate] validation of the sterilization process.  Specifically, *** 53
1358 21 CFR 211.100(b) SOPs not followed / documented 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, *** 52
1112 21 CFR 211.25(a) Training--operations, GMPs, written procedures 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, *** 50
4402 21 CFR 211.192 Written record of investigation incomplete 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, *** 47
1809 21 CFR 211.160(a) Following/documenting laboratory controls Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].  Specifically, *** 40
2419 21 CFR 211.198(a) Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].  Specifically, *** 40
2031 21 CFR 211.194(a) Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.  Specifically, , *** 39
1111 21 CFR 211.25(a) Training , Education , Experience overall Employees  engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.  Specifically, *** 37
4391 21 CFR 211.180(e)(2) Items to cover on annual reviews 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 37
1263 21 CFR 211.68(b) Computer control of master formula records 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, *** 35
1159 21 CFR 211.28(a) Clothing appropriate for duties performed Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not  appropriate for the duties they perform.  Specifically, *** 33
1890 21 CFR 211.165(e) Test methods  The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].  Specifically, *** 33
1932 21 CFR 211.167(a) Sterility/pyrogen-free testing  Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.  Specifically, *** 33
4314 21 CFR 211.84(d)(2) Reports of Analysis (Components) 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 reliabilit 33
4352 21 CFR 211.160(b)(4) Calibration - at intervals, written program, remedial action 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] 30
4576 21 CFR 211.192 No written record of investigation 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, *** 30
1448 21 CFR 211.111 Establishment of time limitations Time limits are not established when appropriate  for the completion of each production phase to assure the quality of the drug product.  Specifically, *** 27
1810 21 CFR 211.160(a) Lab controls established, including changes 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 27
2026 21 CFR 211.192 Quality control unit review of records 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, *** 27
9001 21 CFR 211.22(a) Lack of quality control unit There is no quality control unit.  Specifically, *** 27
1194 21 CFR 211.42(c) Defined areas of adequate size for operations The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, *** 26
1767 21 CFR 211.137(a) Expiration date lacking 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, *** 26
1162 21 CFR 211.28(a) Protective Apparel Not Worn Protective apparel is not worn as necessary to protect drug products from contamination.  Specifically, *** 25
1833 21 CFR 211.84(d)(1) Identity Testing of Each Component 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, *** 25
3565 21 CFR 211.58 Buildings not maintained in good state of repair Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.  Specifically, *** 25
4303 21 CFR 211.67(b) Written procedures fail to include 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 method 25
2028 21 CFR 211.192 Extent of discrepancy, failure  investigations 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 specif 22
1433 21 CFR 211.42(c)(10)(iii) Air Supply Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.  Specifically, *** 21
1436 21 CFR 211.42(c)(10)(vi) Equipment to control conditions Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.  Specifically, *** 21
1450 21 CFR 211.113(a) Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].  Specifically, *** 21
4342 21 CFR 211.142(b) Storage under appropriate conditions Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.  Specifically, *** 21
1912 21 CFR 211.166(a) Written program not followed The written stability testing program is not followed.  Specifically, *** 20
1920 21 CFR 211.166(a)(3) Valid stability test methods The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.  Specifically, *** 20
3572 21 CFR 211.100(b) Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not [recorded] [justified].  Specifically, *** 20
4389 21 CFR 211.198(a) Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].  Specifically, *** 20
1098 21 CFR 211.22(c) Approve or reject procedures or specs The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.  Specifically, *** 19
1133 21 CFR 211.25(a) GMP Training Frequency 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, *** 19
1943 21 CFR 211.180(e)(1) Review of representative number of batches 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, *** 19
3571 21 CFR 211.100(a) Changes to Procedures Not Reviewed, Approved Changes to written procedures are  not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].  Specifically, *** 19
3559 21 CFR 211.56(a) Sanitation--buildings not clean, free of infestation 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, *** 18
3632 21 CFR 211.170(b) Annual visual exams of drug products 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, *** 17
1885 21 CFR 211.165(b) Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.  Specifically, *** 16
4306 21 CFR 211.80(a) Written Procedures Not Followed Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].  Specifically, *** 16
1227 21 CFR 211.67(c) Cleaning/maintenance records not kept Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.  Specifically, *** 15
1787 21 CFR 211.80(a) Procedures To Be in Writing 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, *** 15
1891 21 CFR 211.165(f) Failing drug products not rejected Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.  Specifically, *** 15
1975 21 CFR 211.182 Written records kept in individual logs Written records of major equipment [cleaning] [maintenance] [use]  are not included in individual equipment logs.  Specifically, *** 15
4340 21 CFR 211.142 Written warehousing procedures established/followed Procedures describing the warehousing of drug products are not [established] [followed].  Specifically, *** 15
1801 21 CFR 211.84(a) Components withheld from use pending release 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, *** 14
3547 21 CFR 211.46(b) Equipment for Environmental Control 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, *** 14
1033 21 CFR 211.22(a) Authority lacking to review records, investigate errors The quality control unit lacks authority  to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].  Specifically, *** 13
1169 21 CFR 211.42(a) Buildings of Suitable Size, Construction, Location 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, *** 13
1395 21 CFR 211.103 Actual vs. theoretical yields not determined 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, *** 13
1540 21 CFR 211.125(a) Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.  Specifically, *** 13
1790 21 CFR 211.80(b) Handling and Storage to Prevent Contamination There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.  Specifically, *** 13
2205 21 CFR 211.186(b)(9) Manufacturing Instructions and Specifications 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, *** 13
4315 21 CFR 211.84(d)(2) Testing Each Component for Conformity with Specs Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically, *** 13
4401 21 CFR 211.186(b)(9) Complete instructions, procedures, specifications et. al. Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].  Specifically, *** 13
6730 21 CFR 314.80(b) Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences. Specifically, *** 13
1933 21 CFR 211.167(a) Sterility/pyrogens - test methods written, followed Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed].  Specifically, *** 12
1942 21 CFR 211.180(e) Records reviewed annually  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, *** 12
2619 21 CFR 211.198(b)(2) Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].  Specifically, *** 12
4372 21 CFR 211.188(b)(8) Labeling control records including specimens or copies 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, *** 12
4413 21 CFR 211.194(a)(8) Second person sign off 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, *** 12
6732 21 CFR 314.80(c)(1)(i) Late submission of 15-day report 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, *** 12
1550 21 CFR 211.125(f) Procedures Written and Followed Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, *** 11
3583 21 CFR 211.110(a) Written in-process control procedures 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, *** 11
3602 21 CFR 211.160(a) Deviations from laboratory control requirements Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].  Specifically, *** 11
1174 21 CFR 211.42(b) Product flow through building is inadequate The flow  of [components] [drug product containers] [closures] [labeling] [in-process materials ] [drug products] though the building is not designed to prevent contamination.  Specifically, *** 10
1421 21 CFR 211.42(c)(10) Aseptic Processing Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.  Specifically,*** 10
2008 21 CFR 211.186(a) Written procedures followed Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].  Specifically, ***  10
8907 21 CFR 314.81(b)(1)(ii) Contamination, chemical or physical change, deterioration An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product.   Specifically, ** 10
1049 21 CFR 211.22(a) Approve or reject components, products  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, *** 9
1270 21 CFR 211.68(b) input/output verification Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.  Specifically, ***  9
1626 21 CFR 211.130 Procedures are written, and followed Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].  Specifically, *** 9
1728 21 CFR 211.87 Retest of approved components/containers/closures 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 subsequen 9
1802 21 CFR 211.84(b) Representative Samples Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.  Specifically, *** 9
3570 21 CFR 211.100(a) Approval and review of procedures Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].  Specifically, *** 9
3613 21 CFR 211.160(b)(4) Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].  Specifically, *** 9
3616 21 CFR 211.165(d) Acceptance criteria for sampling & testing 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 thei 9
4357 21 CFR 211.166(a) Results not used for expiration dates, storage cond. Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].  Specifically, *** 9
4409 21 CFR 211.194(a)(4) Data secured in course of each test 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] [c 9
8911 21 CFR 314.81(b)(1)(ii) Failure to meet specifications 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, *** 9
1261 21 CFR 211.68(a) Written calibration / inspection records not  kept Records of the [calibration checks] [inspections] of  automatic, mechanical or electronic equipment, including computers or related systems are not maintained.  Specifically, *** 8
1495 21 CFR 211.122(a) Written procedures describing in detail 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, *** 8
1777 21 CFR 211.150(b) Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.  Specifically,  *** 8
1868 21 CFR 211.94(b) Protection from external factors 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, *** 8
1926 21 CFR 211.166(b) Adequate number of batches on stability 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, *** 8
3561 21 CFR 211.56(b) Written sanitation procedures lacking 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, ***    8
4351 21 CFR 211.160(b)(3) Drug products - samples representative, identified properly Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].  Specifically, *** 8
2012 21 CFR 211.188(b) Batch production and Batch Control Record Requirements 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, *** 7
2020 21 CFR 211.188(b)(8) Labeling Control Records and Label Copies The batch production and control records are deficient in that they do not  include [complete labeling control records] [specimen] [copy] of labeling.  Specifically, *** 7
3639 21 CFR 211.204 Returned drug procedures in writing and followed Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed].  Specifically, *** 7
4353 21 CFR 211.160(b)(4) Instruments, apparatus, et. al. not meeting specs The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.   Specifically, *** 7
4406 21 CFR 211.194(a)(2) Suitability of testing methods verified The suitability of all testing methods is not verified under actual conditions of use.  Specifically, *** 7
1086 21 CFR 211.22(b) Adequate lab facilities not available  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, *** 6
1136 21 CFR 211.25(c) Inadequate number of  personnel The number of qualified  personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, *** 6
1844 21 CFR 211.84(d)(2) Establish reliability of supplier's C of A 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, *** 6
1869 21 CFR 211.94(c) Containers & Closures Clean, Sterilized, Pyrogen-free Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use.  Specifically, *** 6
2034 21 CFR 211.194(d) Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].  Specifically, *** 6
3557 21 CFR 211.52 Washing and toilet facilities are deficient Washing and toilet facilities lack [hot and cold water] [soap or detergent] [air driers or single-service towels] [cleanliness].  Specifically, *** 6
3629 21 CFR 211.170(b) Reserve samples identified, representative, stored 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, *** 6
4320 21 CFR 211.84(d)(6) Microbiological Contamination Exam 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, *** 6
4343 21 CFR 211.160(b)(1) Incoming lots - conformance to written specs- 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 6
4344 21 CFR 211.160(b)(1) Sampling and testing procedures described Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used.  Specifically, *** 6
6831 21 CFR 314.80(c)(2) Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.  Specifically, *** 6
1134 21 CFR 211.25(b) Supervisor Training/Education/Experience 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, i 5
1505 21 CFR 211.122(d) Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.  Specifically, *** 5
1851 21 CFR 211.84(e) Rejecting  When Specifications Not Met 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, *** 5
1852 21 CFR 211.94(a) Reactive/Additive/Absorptive Containers/Closures Drug product containers or closures are [reactive] [additive] [absorptive] so as to alter the safety, identity, strength, quality, and purity of the drug beyond the official or established requirements.  Specifically, *** 5
1922 21 CFR 211.166(a)(4) Testing in same container - closure system 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, ***  5
2033 21 CFR 211.194(c) Testing and standardization of standards et. al. Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].  Specifically, *** 5
2567 21 CFR 211.198(a) Adverse Drug Experience 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, *** 5
2569 21 CFR 211.198(b) Maintenance of Complaint File Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.  Specifically, *** 5
2618 21 CFR 211.198(b)(1) Complaint Record required information 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, *** 5
3592 21 CFR 211.110(c) In-process materials characteristics testing 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, *** 5
3614 21 CFR 211.160(b)(4) Written calibration procedures 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] 5
4302 21 CFR 211.56(b) Written sanitation procedures not followed Written procedures for sanitation are not followed.  Specifically, *** 5
4349 21 CFR 211.160(b)(2) In-process samples representative, identified properly Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].  Specifically, *** 5
4387 21 CFR 211.198(a) Reporting of adverse drug experience to FDA 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  5
4388 21 CFR 211.198(a) Complaints reviewed by Quality Control Unit 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 5
4418 21 CFR 211.42(b) Adequate space lacking  to prevent mix-ups and contamination 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.   5
8912 21 CFR 314.81(b)(2) Timely submission 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, *** 5
17763 21 CFR 212.20(d) Determination need for investigation When errors occurred or a production batch failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary. Specifically,*** 5
1163 21 CFR 211.28(b) Habits of good sanitation & health  Production personnel were not practicing good sanitation and health habits.  Specifically, *** 4
1388 21 CFR 211.101(d) Component addition checked by 2nd person Each component is not added to a batch by one person and verified by a second person.  Specifically, *** 4
1411 21 CFR 211.105(b) Distinctive ID or code not recorded in batch record 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, *** 4
1449 21 CFR 211.111 Deviations of production time limits Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product].  Specifically, *** 4
1636 21 CFR 211.130(e) Packaging line inspection before use 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, *** 4
1724 21 CFR 211.134(b) Representative samples after completion Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations.  Specifically, *** 4
1774 21 CFR 211.142(a) Quarantine - actual practice Drug products are not quarantined before being released by the quality control unit.  Specifically, *** 4
1842 21 CFR 211.84(d)(1) Component identity verification Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.  Specifically,*** 4
1849 21 CFR 211.84(d)(6) Objectionable microbiological contamination Each lot of a [component] [drug product containers] [closures] liable to objectionable  microbiological contamination is deficiently subjected to microbiological tests before use.  Specifically,  *** 4
1876 21 CFR 211.180(b) Record maintenance 1 year (except exempt OTC) All records of  [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product are not maintained at least one (1) year after the expiration date.  Specifically, *** 4
1918 21 CFR 211.166(a)(2) Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.  Specifically, *** 4
1927 21 CFR 211.166(b) Accelerated stability studies Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not  supported with ongoing full shelf life studies.  Specifically, *** 4
1957 21 CFR 211.180(e)(2) Review of problem drugs 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, *** 4
2007 21 CFR 211.186(a) Signature and checking of records -- 2 persons 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, *** 4
2401 21 CFR 211.194(a)(4) Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.  Specifically, *** 4
3567 21 CFR 211.84(d)(2) Component identification test Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.  Specifically, *** 4
3569 21 CFR 211.89 Quarantine of Rejected Components et. al. 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, *** 4
3582 21 CFR 211.105(a) Identification of containers, lines, equipment 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, ***  4
3591 21 CFR 211.110(b) In-process materials specifications In-process specifications are not [consistent with drug product final specifications] [derived from previous acceptable process average and process variability estimates where possible] [determined by the application of suitable statistical procedures whe 4
3630 21 CFR 211.170(b) Drug product reserve containers 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, *** 4
4305 21 CFR 211.68(b) Backup data not assured as exact and complete Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.  Specifically, *** 4
4307 21 CFR 211.80(d) Status of Each Lot Identified 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, *** 4
4316 21 CFR 211.84(d)(3) Testing Containers & Closures Conformity with Specs Containers and closures are not tested for conformance with all appropriate written procedures.  Specifically, *** 4
4336 21 CFR 211.150 Written distribution procedure Written distribution procedures are not [established] [followed].  Specifically, *** 4
4338 21 CFR 211.150(b) Recall facilitation 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, *** 4
4355 21 CFR 211.165(c) Sampling and testing plans not followed Written procedures for sampling and testing plans are not followed for each drug product.  Specifically, ***   4
4382 21 CFR 211.198(b)(2) Written record of complaint to include findings, follow-up Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].  Specifically, *** 4
4386 21 CFR 211.198(b) Written complaint record  to be maintained at facility A written record of each complaint is not maintained in a file designated for drug product complaints [at the facility where the drug product was manufactured, processed or packed] [at a facility other than the facility in which the drug product was manuf 4
4404 21 CFR 211.194(a)(1) Sample identification and other information 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 4
4410 21 CFR 211.194(a)(5) Calculations performed are in the records Laboratory records do not include a record of all calculations performed in connection with the test.  Specifically, ***  4
4411 21 CFR 211.194(a)(6) Test results, comparison with standards not included Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug prod 4
8906 21 CFR 314.81(b)(1)(i) Mix-up An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be [mistaken for] [applied to] another article.   Specifically, *** 4
17749 21 CFR 212.30(a) Prevention of contamination 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,*** 4
17764 21 CFR 212.20(e) Written QA procedures established, followed You did not [establish] [follow] written quality assurance procedures. Specifically,*** 4
1079 21 CFR 211.22(a) Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.  Specifically, *** 3
1219 21 CFR 211.67(b)(2) Cleaning SOPs/schedules Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.  Specifically, *** 3
1220 21 CFR 211.67(b)(3) Cleaning SOPs/instructions 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 necess 3
1371 21 CFR 211.101(a) Batches Formulated to less than 100% Written production and control procedures  include batches formulated with the intent to provide less than  100 percent of the labeled or established amount of active ingredient.  Specifically, *** 3
1430 21 CFR 211.42(c)(10)(i) Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,*** 3
1454 21 CFR 211.115(a) Reprocessing procedures not written or followed 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, *** 3
1632 21 CFR 211.130(c) Lot or control number assigned 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, *** 3
1798 21 CFR 211.82(b) Quarantine Storage of Components Incoming [components] [drug product containers] [closures] are not stored under quarantine until they have been tested or examined, as appropriate, and released.  Specifically, *** 3
1803 21 CFR 211.84(b) Representative Samples Criteria The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.  Specifically, *** 3
1843 21 CFR 211.84(d)(2) Component written specification Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.  Specifically,  *** 3
1870 21 CFR 211.94(d) Written Procedures to Remove Pyrogens There are no written [standards or specifications] [methods of testing] [methods of cleaning] [methods of sterilization] [methods of processing] to remove pyrogenic properties.  Specifically, *** 3
1917 21 CFR 211.166(a)(1) Sample size - test intervals 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, *** 3
1928 21 CFR 211.166(c)(1) Homeopathic drugs, assessment of stability 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 degradati 3
1978 21 CFR 211.182 Personnel  dating/signing equipment log The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.  Specifically, *** 3
2019 21 CFR 211.188(b)(7) Documentation of Actual Yield and Theoretical Yield 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, *** 3
2032 21 CFR 211.194(b) Test method modification records not maintained Complete records are not maintained of any modification of an established method employed in testing.  Specifically, *** 3
2044 21 CFR 211.196 Distribution Record Requirements 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, *** 3
2203 21 CFR 211.186(b)(7) Theoretical Yield and Percentages The master production and control records are deficient in that they do not include a statement of theoretical yield and [minimum] [maximum] [yield percentages].  Specifically, *** 3
2420 21 CFR 211.198(a) Quality Control Review Complaint procedures are deficient in that they do not include provisions that allow for the review and determination of an investigation by the quality control unit.  Specifically, *** 3
3562 21 CFR 211.56(c) Written procedures lacking for use of pesticides etc. 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] [packagin 3
4321 21 CFR 211.101(b) Identification of new containers 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 an 3
4323 21 CFR 211.115(a) Reprocessing procedures lack steps to be taken Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.  Specifically, *** 3
4324 21 CFR 211.110(b) In-process materials specifications testing Examination and testing of samples is not done to assure that in-process materials conform to specifications.  Specifically, *** 3
4350 21 CFR 211.160(b)(3) Drug products-sampling procedures/specifications Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.  Specifically, *** 3
4364 21 CFR 211.176 Failing to test for penicillin cross-contamination 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, *** 3
4366 21 CFR 211.188(a) Accurate reproduction included Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was  checked for accuracy, dated and signed.  Specifically, *** 3
4368 21 CFR 211.188(b)(12) Investigations made into any unexplained discrepancy 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, *** 3
4371 21 CFR 211.188(b)(9) Description of containers and closures Batch production and control records do not include a description of drug product [containers] [closures] used for each batch of drug product produced.  Specifically, *** 3
4377 21 CFR 211.188(b(3) Identification of each  component or in-process material Batch production and control records do not include the specific identification of each batch of [component] [in-process material] used for each batch of drug product produced.  Specifically, *** 3
4380 21 CFR 211.198(b)(3) Determination not to conduct investigation of complaint 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 3
4405 21 CFR 211.194(a)(2) Statement of methods and data 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 prod 3
6735 21 CFR 314.80(c)(1)(ii) Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated.  Specifically, *** 3
10021 21 CFR 314.98(a) (Flag to indicate ANDA applicant) (DO NOT PRINT ON FDA 483.  This cite is to be used as a flag to indicate that the recipient of an FDA 483 involving ADE reporting is the applicant for one or more approved ANDAs, as opposed to approved NDAs.  No specifics text is required for this cite.) 3
17812 21 CFR 212.50 Adequate controls (general) 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,*** 3
17851 21 CFR 212.60(c) Analytical methods Your laboratory analytical methods [are not suitable for their intended use] [are not sufficiently sensitive] [are not sufficiently specific] [are not accurate] [are not reproducible].  Specifically,*** 3
1164 21 CFR 211.28(c) Unauthorized Personnel in Limited Access Areas Unauthorized personnel have access to enter areas of the buildings and facilities designated as limited access areas.  Specifically, *** 2
1168 21 CFR 211.34 Consultant Records Records are not maintained stating the consultant's [name] [address] [qualifications] [type of service provided].  Specifically, *** 2
1218 21 CFR 211.67(b)(1) Cleaning SOP/responsibility Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.  Specifically, *** 2
1224 21 CFR 211.67(b)(6) Cleaning SOP/inspection Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.  Specifically, *** 2
1266 21 CFR 211.42(d) Penicillin processing area not  kept separate The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use.  Specifically,  *** 2
1396 21 CFR 211.42(c)(2) Rejected Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.  Specifically,*** 2
1409 21 CFR 211.42(c)(4) In-Process Material Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.  Specifically, *** 2
1413 21 CFR 211.42(c)(5) Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.  Specifically, *** 2
1431 21 CFR 211.42(c)(10)(ii) Temperature / Humidity Controls Aseptic processing areas are deficient regarding [temperature] [humidity]  controls.  Specifically, *** 2
1496 21 CFR 211.122(a) Sampling/testing of labeling/packaging materials Labeling and packaging materials are not  [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.  Specifically, *** 2
1545 21 CFR 211.125(c) Label reconciliation discrepancies evaluation/investigation Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not [evaluated] [investigated].  Specifically, *** 2
1629 21 CFR 211.130(a) Prevention of cross contamination, mix-ups There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.  Specifically, ***  2
1630 21 CFR 211.130(b) Unlabeled filled containers controls 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, *** 2
1722 21 CFR 211.134(a) Correct labels during finishing operations 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, *** 2
1776 21 CFR 211.150(a) Distribution of oldest approved drugs The oldest approved stock of drug products are not distributed first and there is no justification for this practice.  Specifically,  *** 2
1796 21 CFR 211.80(d) Identification of Each Lot in Each Shipment 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, ***  2
1879 21 CFR 211.180(c) Records not made readily available to FDA 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, *** 2
1886 21 CFR 211.165(c) Sampling and testing plans not described 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, *** 2
1924 21 CFR 211.166(a)(5) Testing of reconstituted drugs The written stability program does not include testing  of  drug products for reconstitution [at time of dispensing - as directed in the labeling] [after they are reconstituted].  Specifically, *** 2
1976 21 CFR 211.182 Specific information required in individual logs Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].  Specifically, *** 2
2001 21 CFR 211.184(b) Component Test Records 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, *** 2
2004 21 CFR 211.184(d) Labeling: documentation of exam and review 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, *** 2
2023 21 CFR 211.188(b)(11) Identification of Persons Performing Significant Steps 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, *** 2
3550 21 CFR 211.46(c) Exhaust systems inadequate to control air contamination Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.  Specifically, *** 2
3590 21 CFR 211.110(a)(5) Solution clarity, completeness, pH The in-process control procedures were deficient in that they did not include an examination of the [clarity] [completeness] [pH] of solutions.  Specifically, *** 2
3611 21 CFR 211.160(b)(3) Acceptance of drug products Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.  Specifically, *** 2
3623 21 CFR 211.170(a) Active ingredient retained sample kept A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].   Specifically, *** 2
3640 21 CFR 211.204 Returned drug products identified and held Returned drug products are not [identified as such] [held].  Specifically, *** 2
4322 21 CFR 211.101(d) Component release checked by 2nd person 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 properl 2
4325 21 CFR 211.110(a) Control procedures fail to include the following 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,*** 2
4328 21 CFR 211.122(a) Written procedures not followed Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.  Specifically, *** 2
4330 21 CFR 211.130(e) Packaging line inspection documentation Results of inspection of packaging and labeling facilities are not documented in the batch production records.  Specifically, *** 2
4345 21 CFR 211.160(b)(1) Samples (various types) representative, identified properly 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].  Specificall 2
4369 21 CFR 211.188(b)(11) Identification of persons involved, each significant step 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, *** 2
4375 21 CFR 211.188(b)(5) In-process and laboratory control results  Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.  Specifically, *** 2
4376 21 CFR 211.188(b)(4) Weights and measures of components used Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.  Specifically, *** 2
4383 21 CFR 211.198(b)(1) Written complaint record must include 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, *** 2
4399 21 CFR 211.186(b)(7) Theoretical yield statement including percentages 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, *** 2
4403 21 CFR 211.194(b) Test method modification records do not  include Records maintained of any modification of an established method employed in testing do not include [the reason for the modification] [the data to verify that the modification produced results that are at least as accurate and reliable for the material bei 2
4412 21 CFR 211.194(a)(7) Signatures and dates--person who performs test Laboratory records do not include [the initials or signature of the person who performs each test] [the date(s) the tests were performed].  Specifically, *** 2
6829 21 CFR 314.80(c)(2) Failure to report non-alert ADEs Individual ADEs which were not reported to FDA in a post marketing 15-day alert have not been included in a periodic safety report.  Specifically, *** 2
6830 21 CFR 314.80(c)(2) Interval 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, *** 2
6832 21 CFR 314.80(c)(2) Late submission of annual safety reports 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, *** 2
8914 21 CFR 314.81(b)(2)(iv)(b) Mfg and control changes not requiring a supplemental app. An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.   Specifically, *** 2
8935 FDCA 760(b)(1) Failure of responsible person to report AE (non-RX Drug)   Serious adverse event(s) for a non-prescription drug used in the United States has not been reported to the Secretary. Specifically, *** 2
18008 FDCA 503B(a)(10) Drug product label, outsourcer facility The labels of your outsourcing facility?s drug products are deficient.  Specifically,*** 2
1165 21 CFR 211.28(d) Excluding Employees with Illness, Lesions Employees with [apparent illness] [open lesions] are not excluded from direct contact with [components] [drug product containers] [closures] [in-process materials] [drug products] until the condition is [corrected] [determined by competent medical personn 1
1207 21 CFR 211.65(b) Substances That Come in Contact Substances required for equipment operations such as lubricants and coolants come in contact with [components] [drug product containers] [closures] [in-process materials] [drug product] so as to alter the safety, identity, strength, quality or purity of t 1
1222 21 CFR 211.67(b)(4) Cleaning SOPs/equipment identification Procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification.  Specifically, *** 1
1251 21 CFR 211.42(c)(1) Incoming material area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, te 1
1384 21 CFR 211.101(c) Weighing/measuring/subdividing supervision Component [weighing] [measuring] [subdividing] operations are not adequately supervised.  Specifically, *** 1
1393 21 CFR 211.103 Yield calculations not verified by 2nd person Yield calculations are not performed by one person and independently verified by a second person.  Specifically, *** 1
1416 21 CFR 211.42(c)(6) Pkg / Labeling Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the packaging and labeling operations. Specifically, *** 1
1418 21 CFR 211.42(c)(7) Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.  Specifically, *** 1
1456 21 CFR 211.115(b) Reprocessing/quality control unit Reprocessing  was  performed without the [review] [approval] of the quality control unit.  Specifically, *** 1
1498 21 CFR 211.122(b) Labeling and packaging improperly approved/released Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use].  Specifically, ***  1
1549 21 CFR 211.125(e) Return of  labeling Returned labeling is not maintained and stored in a manner to [prevent mix-ups] [provide proper identification].  Specifically, *** 1
1633 21 CFR 211.130(d) Examination of packaging and labeling Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].  Specifically, *** 1
1646 21 CFR 211.132(b)(2) Gelatin capsules requiring tamper-evident technology Two-piece, hard gelatin capsules (OTC) are not sealed using an acceptable tamper-evident technology.  Specifically, *** 1
1650 21 CFR 211.132(b) Tamper-evident feature to remain intact The tamper-evident feature [is not designed to] [does not] remain intact when  handled in a reasonable manner during [manufacture] [distribution] [retail display].  Specifically, *** 1
1725 21 CFR 211.134(c) Examinations documented The results of the examination of the packaged and labeled products were not documented in the batch production or control records.  Specifically, *** 1
1791 21 CFR 211.80(c) Storage off Floor, Spaced Suitably Bagged or boxed components of drug product [containers] [closures] are not [stored off the floor] [suitably spaced to allow cleaning and inspection].  Specifically, *** 1
1935 21 CFR 211.167(b) Ophthalmic ointments - testing for foreign particles Each batch of ophthalmic ointment is not appropriately  tested to determine conformance to specifications regarding the presence of [foreign particles] [harsh or abrasive substances].  Specifically, *** 1
1936 21 CFR 211.167(b) Ophthalmic ointments -test methods written, followed Test procedures for ophthalmic ointments are not [written] [followed].  Specifically, *** 1
1938 21 CFR 211.167(c) Controlled release dosage form testing Each batch  of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.  Specifically, *** 1
1939 21 CFR 211.167(c) Controlled release test methods written, followed Test procedures describing the testing of controlled release dosage form drug product are not [written] [followed].  Specifically, *** 1
1956 21 CFR 211.180(e)(1) Representative Number of Batches for Annual Review 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, *** 1
1977 21 CFR 211.182 Dedicated equipment: records part of batch record The records of [cleaning] [maintenance] [use] for dedicated equipment are not part of the batch record.  Specifically, *** 1
1979 21 CFR 211.182 Chronological Order of Equipment Log Entries The entries in the equipment cleaning and use logs are not in chronological order.  Specifically, *** 1
1999 21 CFR 211.184(a) Record information required 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 ma 1
2003 21 CFR 211.184(c) Individual inventory record 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  1
2005 21 CFR 211.184(e) Records of disposition of rejected material Records do not include the disposition of rejected [components] [drug product containers] [closures] [labeling].  Specifically, *** 1
2011 21 CFR 211.188(a) Accurate reproduction 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, *** 1
2015 21 CFR 211.188(b)(3) Identification of Components and In-Process Materials 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, *** 1
2018 21 CFR 211.188(b)(6) Documentation of Packaging and Labeling Area Inspections 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, *** 1
2025 21 CFR 211.188(b)(13) Results of drug product inspections and examinations The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections].  Specifically, *** 1
2087 21 CFR 211.208 Salvaging performed without evidence Salvaging operations  on drug products which may have been subjected to improper storage conditions proceeded  in the absence of evidence from [laboratory tests and assays to establish that the drug products meet all applicable standards of identity, stre 1
2200 21 CFR 211.186(b)(4) Variation in the Amount of Components Used The master production and control records are deficient in that they lack a justification for the variation in the amount of components used in the preparation of a dosage form.  Specifically, *** 1
2398 21 CFR 211.194(a)(2) Test methods ID and data location 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, *** 1
2399 21 CFR 211.194(a)(2) Laboratory Test Method Verification 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, *** 1
2405 21 CFR 211.194(a)(7) Identification of Person Performing the Testing 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, *** 1
2406 21 CFR 211.194(a)(8) Identification of Person Performing Review of Lab Records Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.  Specifically, *** 1
2572 21 CFR 211.198(b) Complaint File Location 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, *** 1
2587 21 CFR 211.198(b) Retention time of complaints Complaint procedures are deficient in that written complaint records are not maintained for [at least one (1) year after the expiration date of the drug product] [at least one (1) year after the date that the complaint was received].  Specifically, *** 1
2606 21 CFR 211.198(b) Retention time of OTC drug complaints Complaint procedures are deficient in that complaint records are not maintained for OTC drugs, without an expiration date, for at least three (3) years after distribution of the drug product.  Specifically, *** 1
2620 21 CFR 211.198(b)(2) Complaint Record at Location of Investigation Complaint records are deficient in that they are not maintained at the establishment where the investigation occurred.  Specifically, *** 1
2621 21 CFR 211.198(b)(3) Reason for Not Conducting Complaint Investigation 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, *** 1
3445 21 CFR 211.65(a) Equipment construction - reactive surfaces 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 require 1
3548 21 CFR 211.46(c) Air filtration system lacking in production area The production area air supply lacks an appropriate air filtration system.  Specifically, *** 1
3551 21 CFR 211.46(d) Penicillin air handling systems not kept separate Air-handling systems for the [manufacture] [processing] [packing] of penicillin are not completely separate  from those for other drug products for human use.  Specifically, *** 1
3553 21 CFR 211.48(a) Plumbing System Defects The plumbing system contains defects that could contribute to the  contamination of drug products.  Specifically, *** 1
3555 21 CFR 211.48(b) Drains--Size, Back-siphonage Prevention Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer].  Specifically, *** 1
3573 21 CFR 211.101(b) Measured components for manufacturing Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate].  Specifically, *** 1
3581 21 CFR 211.101(d) Verification of component addition Each component is not added to the batch by one person and verified by a second person..  Specifically, *** 1
3588 21 CFR 211.110(a)(3) Mixing adequacy 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, *** 1
3594 21 CFR 211.110(d) Rejected in-process materials not quarantined Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.  Specifically, *** 1
3596 21 CFR 211.122(g) Failure to include one of special control procedures Packaging and labeling operations involving the use of cut labels fail to include one of the three special control procedures provided for in the regulations ( e.g., dedicated lines, automated equipment for 100% exam, visual inspection for 100% exam).  Sp 1
3597 21 CFR 211.122(g)(3) Visual inspection The packaging and labeling operation involving cut labels and relying on visual inspection does not provide for [100-percent examination for correct labeling during or after completion of finishing operations for hand-applied labeling] [examination to be  1
3598 21 CFR 211.132(b)(1) OTC products requiring tamper-evident packaging OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging are not sold in tamper-evident packages.  Specifically, *** 1
3599 21 CFR 211.132(b)(1) Hard gelatin capsules The packaging of hard gelatin capsules which are not sealed by tamper resistant technology does not include two tamper resistant packaging features.  Specifically, *** 1
3600 21 CFR 211.132(c) Tamper evident-labeling requirement OTC products packaged for retail sale which are not specifically excluded from the requirement for tamper-evident packaging do not bear a prominently-placed statement on the package which [identifies all tamper-evident features] [identifies capsule sealin 1
3607 21 CFR 211.160(b)(2) Acceptance of in-process materials Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials.  Specifically, *** 1
3610 21 CFR 211.160(b)(3) Drug product sample Drug product samples are not [representative of the entire batch] [properly identified].  Specifically, *** 1
3615 21 CFR 211.160(b)(4) Test devices not meeting specifications Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.  Specifically, *** 1
3633 21 CFR 211.170(b)(1) Reserve sample retention time 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, *** 1
3641 21 CFR 211.204 Record information inclusions 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, *** 1
4304 21 CFR 211.68(b) Written record not kept of program and validation data A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.  Specifically, *** 1
4309 21 CFR 211.84(c)(2) Containers sampled so as to prevent contamination 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, *** 1
4311 21 CFR 211.84(c)(4) Compositing of Sub Samples Components which must be sampled from top, middle and bottom of the container are not kept separate, but instead are composited for testing.  Specifically, *** 1
4326 21 CFR 211.122(g)(2) Electronic or electromechanical equipment The packaging and labeling operation for cut labels which relies on the use of electronic or electromechanical equipment does not provide for 100-percent examination for correct labeling [during] [after completion of] finishing operations.  Specifically,  1
4337 21 CFR 211.150(a) Distribution of oldest stock first Distribution procedures do not include a procedure whereby the oldest approved stock of a drug product is distributed first.  Specifically, *** 1
4341 21 CFR 211.142(a) Quarantine - written procedures Written procedures for the warehousing of drug products do not include quarantine of drug products before release by the quality control unit.  Specifically, *** 1
4354 21 CFR 211.165(d) Acceptance/Rejection Levels The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].  Specifically, *** 1
4356 21 CFR 211.166(b) Tentative expiration date  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 expir 1
4359 21 CFR 211.170(b)(1) Retention time of reserve samples, in general Reserve samples for drug products are not retained for one year after the expiration date of the drug product.  Specifically, *** 1
4360 21 CFR 211.170(b) Reserve drug product sample quantity - all tests 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, *** 1
4365 21 CFR 211.176 Marketing of drug products with penicillin levels Marketing of drug products which contain detectable levels of penicillin occurred, when tested according to FDA-approved procedures for detecting and measuring penicillin contamination in drugs.  Specifically, *** 1
4370 21 CFR 211.188(b)(10) Records of any sampling performed Batch production and control records do not include a record of any sampling performed, for each batch of drug product produced.  Specifically, *** 1
4373 21 CFR 211.188(b)(7) Actual yield, % of theoretical yield 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, *** 1
4378 21 CFR 211.188(b)(2) Identity of major equipment and lines used Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.  Specifically, *** 1
4381 21 CFR 211.198(b)(2) Written investigation record or copy kept at establishment The written record or copy of the record of an investigation of a complaint conducted in relation to [any unexplained discrepancy] [ the failure of a batch or any of its components to meet any of its specifications]  is not maintained at the establishment 1
4384 21 CFR 211.198(b) Records maintained for 3 years (exempt OTC drugs) Written complaint file records for OTC drugs lacking expiration dating because they meet the criteria for exemption, are not maintained for 3 years after distribution of the drug product.  Specifically, *** 1
4385 21 CFR 211.198(b) Records maintained for 1 year (except certain  OTC drugs) Written complaint file records involving a drug product are not maintained until at least 1 year after the expiration date of the drug product, or 1 year after the date the complaint was received, whichever is longer.  Specifically, *** 1
4400 21 CFR 211.186(b)(8) Description of containers, labels, et. al. Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible fo 1
4407 21 CFR 211.194(a)(2) Reference and method not stated Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].  Specifically, *** 1
4408 21 CFR 211.194(a)(3) Weight or measure of sample Laboratory records do not include a statement of the weight or measure of sample used for each test, where appropriate.  Specifically, *** 1
4415 21 CFR 211.204 Returned drug products with doubt cast as to safety et. al. Returned drug products held, stored or shipped before or during their return under conditions which cast doubt on their safety, identity, strength, quality or purity are not [destroyed] [subjected to examination, testing or other investigation to prove th 1
4416 21 CFR 211.204 Reprocessed returned drug products Returned drug products were reprocessed without assuring that the subsequent drug product met the appropriate standards of safety, identity, strength, quality and purity.  Specifically, *** 1
6705 21 CFR 310.305(c) Failure to report Adverse drug experience information has not been reported to FDA.  Specifically, *** 1
6736 21 CFR 314.80(c)(1)(ii) Submission of report follow-up 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, *** 1
6833 21 CFR 314.80(c)(2)(ii) Incomplete periodic safety report Not all periodic reports contained [a narrative summary and analysis of the information in the report] [an analysis of the post marketing 15-day Alert reports submitted during the reporting interval] [an FDA Form 3500A for each adverse drug experience not 1
8938 FDCA 760(c)(1) Timing of AE report submission (non-RX drugs) An adverse event report for a nonprescription drug was not submitted to the Secretary of HHS within 15 business days of receipt of the report.  1
10022 21 CFR 310.305(a) Failure to develop written procedures Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of postmarketing adverse drug experiences. Specifically, *** 1
17723 21 CFR 212.10 Personnel not qualified Your personnel lack the [necessary education] [background] [training] [experience] to perform their assigned functions.  Specifically,*** 1
17741 21 CFR 212.30(b) Equipment not clean You did not implement procedures to ensure that all your equipment is clean.  Specifically, *** 1
17742 21 CFR 212.30(b) Equipment not suitable You did not implement procedures to ensure that all your equipment is suitable for its intended purposes.  Specifically,*** 1
17744 21 CFR 212.30(b) Equipment not properly installed You did not document your activities in accordance with your procedures for cleaning all of your equipment.  Specifically,*** 1
17755 21 CFR 212.20(a) Oversight of production operations You did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is s 1
17787 21 CFR 212.40(d) Contamination, mix-ups and deterioration 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,*** 1
17822 21 CFR 212.50(b)(7) Complete instructions, procedures, specs Your master production and control records did not contain [complete production and control instructions] [complete sampling and testing procedures] [complete specifications] [special notations] [precautions to be followed].  Specifically,*** 1
17859 21 CFR 212.60(g) Test records complete (general) Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,*** 1
17863 21 CFR 212.60(g)(3) Record of all test data Laboratory records did not contain a complete record of all data obtained in the course of each test.  Specifically,*** 1
17881 21 CFR 212.70(d)(1) Laboratory determination completed You did not [establish] [follow] procedures to ensure that each batch of a PET drug product was given final release before an appropriate laboratory determination was completed.  Specifically,*** 1
17882 21 CFR 212.70(d)(2) Data and documentation review You did not [establish] [follow] procedures to ensure that each batch of a PET drug product was given final release before associated laboratory data and documentation were reviewed and they demonstrate that the PET drug product met specifications.  Speci 1
17898 21 CFR 212.71(c) Correction of problems You did not take [appropriate] action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.  Specifically,*** 1
17939 21 CFR 212.71(a) Procedures to Investigate Cause of Non-Conforming Product You did not [establish] [follow] procedures to investigate the cause(s) of the nonconforming batch(s) of a PET drug product. Specifically, *** 1
17962 21 CFR 361.1(c)(2) Numerical votes not in the minutes of any RDRC meetings The minutes of an RDRC meeting did not include the numerical results of votes on protocols involving use in human subjects.  Specifically, *** 1
17968 21 CFR 361.1(c)(3) FDA research proposals not reported +30 subjects The RDRC did not [immediately] report to FDA a research proposal that involves exposure of more than thirty (30) subjects.  Specifically, *** 1
17983 21 CFR 361.1(d)(6) Radioactive drug - chemical standard The RDRC did not [consider][assure] that the radioactive drug used in a research study met the appropriate chemical standard of [identity][strength][quality][purity] as needed for safety and to be of such uniform and reproducible quality as to give signif 1
17984 21 CFR 361.1(d)(6) Radioactive materials for parenteral use - preparation The RDRC did not determine that radioactive materials for parenteral use were prepared in [sterile][pyrogen-free] form.  Specifically, *** 1
17993 21 CFR 361.1(f)(1) Packaging, labeling - Rx only 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, *** 1
18009 FDCA 503B(a)(10) Container label, outsourcer facility The container labels of your outsourcing facility?s drug products are deficient.  Specifically,*** 1
Cite Id Reference Number Short Description Long Description Frequency
1560 21 CFR 110.35(c) Lack of effective pest exclusion 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, *** 320
1524 21 CFR 123.11(b) Sanitation monitoring 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 279
1306 21 CFR 110.20(b)(7) Screening Failure to provide adequate screening or other protection against pests.  Specifically, *** 202
905 21 CFR 123.6(b) HACCP plan implementation You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan.  Specifically, *** 190
1422 21 CFR 110.20(b)(4) Floors, walls and ceilings 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, *** 167
945 21 CFR 123.12(a)(2) Importer verification 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, * 163
1552 21 CFR 110.35(a) Buildings/sanitary Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.  Specifically, *** 162
1581 21 CFR 110.37(e) Running water at suitable temperature Hand-washing facilities lack running water of a suitable temperature.  Specifically, *** 160
961 21 CFR 123.6(c)(3) Critical limits 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, 157
959 21 CFR 123.6(c)(1) Food safety hazards Your HACCP plan does not list the food safety hazards that are reasonably likely to occur.  Specifically, *** 153
1695 21 CFR 110.80(b)(2) Manufacturing conditions Failure to [manufacture] [package] [store] foods under conditions and controls necessary to minimize [the potential for growth of microorganisms] [contamination].  Specifically, *** 147
960 21 CFR 123.6(c)(2) Critical control points Your HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards.  Specifically, *** 141
1553 21 CFR 110.35(a) Buildings/good repair Failure to maintain [buildings] [fixtures] [physical facilities] in repair sufficient to prevent food from becoming adulterated.  Specifically, *** 139
1689 21 CFR 110.80 Reasonable precautions All reasonable precautions are not taken to ensure that production procedures do not contribute contamination from any source. Specifically, *** 137
6004 21 CFR 123.6(c)(4) Monitoring - adequacy Your HACCP plan lists monitoring [procedures] [frequencies] that do not ensure compliance with the critical limit.  Specifically*** 127
963 21 CFR 123.6(c)(5) Corrective action plan 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*** 124
1701 21 CFR 110.80(b)(7) Equipment, containers, utensils Failure to [construct] [handle] [maintain] equipment, containers and utensils used to [convey] [hold] [store] food in a manner that protects against contamination.  Specifically, *** 121
1554 21 CFR 110.35(a) Cleaning and sanitizing operations 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, *** 119
990 21 CFR 110.10(b)(3) Not washed/sanitized when appropriate 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, *** 115
1287 21 CFR 110.20(a)(1) Harborage areas 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, *** 114
1597 21 CFR 110.37(b)(3) As source of contamination Plumbing constitutes a source of contamination to [food] [water supplies] [equipment] [utensils].  Specifically, *** 109
1427 21 CFR 110.20(b)(5) Safety lighting and glass Failure to provide safety-type [light bulbs] [lighting fixtures] [skylights] [glass] suspended over exposed food.  Specifically, *** 107
904 21 CFR 123.6(b) No HACCP plan You do not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur.  Specifically, *** 100
1405 21 CFR 110.10(b)(6) Failure to wear Failure to wear [hair nets] [head bands] [caps] [beard covers] [hair restraints] where appropriate.  Specifically, *** 93
1525 21 CFR 123.11(c) Sanitation Records 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 93
2392 21 CFR 110.80(b)(1) Maintenance of equip., utensils, and finished food packaging Failure to maintain [equipment] [utensils] [finished food containers] in an acceptable condition through appropriate cleaning and sanitizing.  Specifically, *** 90
1424 21 CFR 110.20(b)(4) Drip and condensate The plant is not constructed in such a manner as to prevent [drip] [condensate] from contaminating [food] [food-contact surfaces] [food-packaging materials]. Specifically, *** 87
2386 21 CFR 110.80(a)(1) Storage Failure to store raw materials in a manner that [protects against contamination] [minimizes deterioration].  Specifically, *** 84
1007 21 CFR 110.10(b)(9) Precautions against contamination--micro, foreign substances Failure to take necessary precautions to protect against contamination of [food] [food contact surfaces] [food packaging systems] with [microorganisms] [foreign substances].  Specifically, *** 83
1292 21 CFR 110.20(b)(1) Sufficient space 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, *** 83
1562 21 CFR 110.35(d) Failure to clean - general Failure to clean [food-contact surfaces] [utensils] as frequently as necessary to protect against contamination of food.  Specifically, *** 83
908 21 CFR 123.6(d) Signed and dated Your HACCP plan was not signed and dated [upon initial acceptance] [upon modification] [at least annually].  Specifically, *** 82
6008 21 CFR 123.8(a)(3) Verification - record review - frequency 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, *** 82
1125 21 CFR 110.40(a) Materials and workmanship The [design] [materials] [workmanship] of [equipment] [utensils] does not allow proper [cleaning] [maintenance].  Specifically, *** 72
1556 21 CFR 110.35(b)(2) Storage requirements 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, *** 68
6005 21 CFR 123.6(c)(6) Verification procedures - adequacy 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, * 68
1173 21 CFR 110.40(f) Q.C. instrument accuracy, maintenance Instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms are not [accurate] [adequately maintained].  Specifically,*** 67
1599 21 CFR 110.37(b)(5) Backflow prevention Lack of backflow protection from piping systems that discharge [waste water] [sewage].  Specifically, *** 67
3652 21 CFR 110.37(e)(1) Suitable locations Failure to provide [hand washing] [hand sanitizing] facilities at each location in the plant where needed.  Specifically, *** 63
6020 21 CFR 123.9(a) Records - content 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].  63
3658 21 CFR 110.37(e)(2) Hand cleaning and sanitizing preparations Lack of effective hand [cleaning] [sanitizing] preparations.  Specifically, *** 62
3659 21 CFR 110.37(e)(3) Hand drying Lack of a sanitary towel service or suitable hand drying devices.  Specifically, *** 62
1066 21 CFR 110.40(b) Seams on food contact surfaces 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, *** 61
1005 21 CFR 110.10(b)(7) Storage of personal items Personal [clothing] [belongings] were stored  in an area where [food is exposed] [equipment or utensils are washed].  Specifically, *** 60
4470 21 CFR 108.25(c)(2) Process filing Failure to provide the FDA, before packing any new product, information on the scheduled processes for each acidified food in each container size. Specifically, *** 56
1698 21 CFR 110.80(b)(5) Work-in-progress Failure to handle work-in-progress in a manner that protects against contamination.  Specifically, *** 55
6018 21 CFR 123.7(a) Corrective action per predetermined plan You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected].  Specifically,*** 55
1406 21 CFR 110.10(b)(6) Effective use of hair restraint Failure to wear [hair nets] [head bands] [caps] [beard covers] [appropriate hair restraints] in an effective manner.  Specifically, *** 54
985 21 CFR 110.10(b)(1) Suitable outer garments Suitable outer garments are not worn  that protect against contamination of [food] [food contact surfaces] [food packaging materials]. Specifically, *** 52
15839 21 CFR 111.70(e)  Specifications - identity, purity, strength, composition  You did not establish product specifications for the [identity] [purity] [strength] [composition] of the finished dietary supplement.  Specifically, *** 52
1702 21 CFR 110.80(b)(8) Metal / extraneous materials Failure to take effective measures to protect against the inclusion of [metal] [extraneous material] in food.  Specifically, *** 48
1126 21 CFR 110.40(a) Precluding contaminants The [design] [construction] [use] of equipment and utensils fails to preclude the adulteration of food with [lubricants] [fuel] [metal fragments] [contaminated water] [contaminants].  Specifically, *** 47
1615 21 CFR 110.93 Storage/transportation of finished goods (contamination) Failure to [store] [transport] finished food under conditions that would protect against [physical] [chemical] [microbial] contamination.  Specifically, *** 47
15858 21 CFR 111.75(a)(1)(i) Component -  verify identity, dietary ingredient  You did not conduct at least one appropriate test or examination to verify the identity of a dietary ingredient, prior to its use.  Specifically, *** 46
1402 21 CFR 110.10(b)(4) Unsecured jewelry Employees failed to remove unsecured jewelry or other objects which might fall into [food] [equipment] [containers].  Specifically, *** 45
1571 21 CFR 110.35(d)(5) Shown to be effective The [facility] [procedure] [machine] used for [cleaning] [sanitizing] of [equipment] [utensils] has not been shown to provide adequate [cleaning] [sanitizing treatment].  Specifically, *** 44
1709 21 CFR 110.80(b)(13) Filling, assembling, packing controls Failure to perform [filling] [assembling] [packaging] in a manner that protects food from becoming contaminated.  Specifically, *** 44
6021 21 CFR 123.10 HACCP training or qualification No one associated with your firm has completed the required HACCP training or is HACCP qualified through job experience.  Specifically, *** 43
9931 21 CFR 120.6(b) Sanitation monitoring 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  43
15532 21 CFR 111.255(b)   Batch record - complete Your batch production record did not include complete information relating to the production and control of each batch.  Specifically, *** 43
3661 21 CFR 110.37(e)(5) Signs Lack of posted, readily understandable signs directing employees to wash and sanitize hands as appropriate.  Specifically, *** 42
933 21 CFR 123.8(a)(2)(ii) Calibration - adequacy Your process monitoring equipment is not calibrated to ensure that it reads accurately.  Specifically, *** 41
1006 21 CFR 110.10(b)(8) Personal food/drink/tobacco 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, *** 39
1429 21 CFR 110.20(b)(6) Fans/air blowing equipment 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, *** 39
3086 21 CFR 114.100(b) Maintenance of processing and production records Failure to maintain [processing] [production] records showing adherence to the scheduled processes, including records of [pH measurement] [critical factors] intended to ensure a safe product.  Specifically, *** 39
6001 21 CFR 123.11(b) Sanitation monitoring documentation Your sanitation control records do not accurately document the conditions or practices observed at your firm.  Specifically*** 39
12720 21 CFR 1.225 Not registered Your food facility is not registered as required.  Specifically, *** 39
15927 21 CFR 111.103 Written procedures - quality control operations You did not [establish] [follow] written procedures for quality control operations.  Specifically, *** 39
6015 21 CFR 123.6(c)(6) Verification procedures - none/frequency  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, *** 37
3078 21 CFR 114.80(b) Code - required elements 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, *** 36
3643 21 CFR 110.10(b)(5) Glove condition Gloves used in food handling are not maintained in an intact, clean, and sanitary condition.  Specifically, *** 36
1293 21 CFR 110.20(b)(2) Contamination with microorganisms, chemicals, filth, etc. 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].  Sp 34
3654 21 CFR 110.37(d)(1) Maintained Failure to maintain toilet facilities in a sanitary condition.  Specifically, *** 34
913 21 CFR 123.8(a)(1) Reassessment of HACCP plan 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, *** 31
3062 21 CFR 114.10 Personnel 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, *** 31
15762 21 CFR 111.205(a) Master manufacturing record - each batch  You did not [prepare] [follow] a written master manufacturing record for each batch size of a dietary supplement that you manufactured.  Specifically, *** 31
15829 21 CFR 111.70(b)(1) Specifications - component identity  You did not establish an identity specification for each component.  Specifically, *** 31
906 21 CFR 123.6(b) HACCP plan location Your HACCP plan is not specific to [the location where the fish are processed] [the kind of fish or fishery product processed].  Specifically, *** 30
3080 21 CFR 114.83 Scheduled process establishment 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, *** 30
1561 21 CFR 110.35(c) Insecticides/rodenticides Use of [insecticides] [rodenticides] without observing necessary precautions and restrictions to protect against contamination of [food] [food-contact surfaces] [food-packaging materials].  Specifically, *** 29
3071 21 CFR 114.80(a)(1) Scheduled process Acidified food is not manufactured in accordance with the scheduled process.  Specifically, *** 29
15869 21 CFR 111.75(c) Specifications met - verify; finished batch  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].  Spec 29
1598 21 CFR 110.37(b)(4) Drainage Plumbing is not [of adequate size and design] [adequately installed and maintained] to provide adequate floor drainage.  Specifically, *** 28
15797 21 CFR 111.553 Written procedures - product complaint  You did not [establish] [follow] written procedures for the requirements to review and investigate a product complaint.  Specifically, *** 28
901 21 CFR 123.6(a) Hazard analysis 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, *** 27
1696 21 CFR 110.80(b)(3) Holding foods - refrigerate/freeze/heat Failure to hold foods which can support the rapid growth of undesirable microorganisms at a temperature that prevents the food from becoming adulterated.  Specifically, *** 27
15641 21 CFR 111.453  Written procedures - holding  You did not [establish] [follow written] procedures for holding and distributing operations.  Specifically, *** 27
6010 21 CFR 123.8(a)(3)(i) Monitoring record review adequacy 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, *** 25
15830 21 CFR 111.70(b)(2) Specifications-component purity, strength, composition  You did not establish component specifications for [purity] [strength] [composition].  Specifically, *** 25
1426 21 CFR 110.20(b)(5) Adequate lighting 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, *** 24
1565 21 CFR 110.35(d)(3) Non-food-contact surfaces (S) Failure to clean non-food-contact surfaces of equipment as frequently as necessary to protect against contamination.  Specifically, *** 24
1578 21 CFR 110.37(f) Odor, attractant for pests, harborage 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, *** 24
15861 21 CFR 111.75(a)(2)(ii)(A)   Component - qualify supplier  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, *** 23
1067 21 CFR 110.40(c) Non food-contact equipment in processing area Non food-contact equipment in [manufacturing] [food handling] areas is not constructed so that it can be kept in a clean condition.  Specifically, *** 22
1570 21 CFR 110.35(d)(5) Safe and adequate for use Sanitizing agents are [inadequate] [unsafe] under conditions of use.  Specifically, *** 22
1602 21 CFR 110.37(a) Suitable temp. and pressure 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, *** 22
3656 21 CFR 110.37(d)(3) Self-closing doors Toilet facilities lack self-closing doors.  Specifically, *** 22
15897 21 CFR 111.83(a) Reserve sample - collect, hold  You did not collect and hold reserve samples of packaged and labeled dietary supplements that you distributed.  Specifically, *** 22
1132 21 CFR 110.40(a) Food-contact - unlawful indirect additives Failure to maintain food contact surfaces to protect food from contamination by any source, including unlawful indirect food additives.  Specifically, *** 21
2388 21 CFR 110.80(a)(5) Holding in bulk or suitable containers Failure to hold [raw materials] [rework materials] [ingredients] in bulk or in suitable containers so as to protect against contamination.  Specifically, *** 21
6022 21 CFR 123.12(c) Lack of records 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, *** 21
15763 21 CFR 111.205(a)  Master manufacturing record - unique formulation  You did not [prepare] [follow] a written master manufacturing record for each unique formulation of a dietary supplement that you manufactured.  Specifically, *** 21
3073 21 CFR 114.80(a)(2) pH testing Failure to exercise sufficient control including [frequent testing] [recording of results] so that the finished equilibrium pH values are not higher than 4.6.  Specifically, *** 20
3085 21 CFR 114.100(a) Raw materials, packaging, finished product 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, *** 20
4464 21 CFR 108.25(c)(1) Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of acidified foods. Specifically, *** 20
6019 21 CFR 123.8(a)(2) Ongoing verification - complaints, calibration records 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].  Speci 20
9955 21 CFR 120.11(a)(1) Verification activities - minimum 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 20
2361 21 CFR 110.80 Testing Failure to perform [chemical] [microbial] [extraneous material] testing where necessary to identify [sanitation failures] [possible food contamination]. Specifically, *** 19
6006 21 CFR 123.6(c)(7) Records values/observations Your monitoring records do not contain the actual values and observations obtained during monitoring.  Specifically, *** 19
16042 21 CFR 111.503 Written procedures - returned dietary supplement  You did not [establish] [follow] written procedures for when a returned dietary supplement is received.  Specifically, *** 19
1184 21 CFR 110.35(e) Storage of cleaned portable equipment (S) Failure to store cleaned and sanitized portable equipment in a [location] [manner] which protects food-contact surfaces from contamination.  Specifically, *** 18
1289 21 CFR 110.20(a)(3) Drainage 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, *** 18
2384 21 CFR 110.80(a)(7) Receipt/storage - liquid and dry raw materials Failure to receive and store [liquid] [dry] raw materials in bulk form in a manner which protects against contamination.  Specifically, *** 18
12742 21 CFR 120.8(a) HACCP plan not implemented You did not [fully] implement the [monitoring] [validation] [verification] [recordkeeping] procedures listed in your HACCP plan.  Specifically, *** 18
932 21 CFR 123.7(d) Corrective action documentation You do not have records that document corrective actions that were taken.  Specifically, *** 17
9930 21 CFR 120.6(c) SSOP records 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, *** 17
15531 21 CFR 111.255(a) Batch record - every batch You did not prepare a batch production record every time you manufactured a batch of dietary supplement.  Specifically, *** 17
15809 21 CFR 111.570(b)(1)   Written procedures - product complaint; review, investigate  You did not make and keep written procedures to fulfill the requirements that apply to the review and investigation of a product complaint.  Specifically, *** 17
931 21 CFR 123.8(d) Verification - recordkeeping You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, *** 16
1128 21 CFR 110.40(a) Installation and maintenance of equipment (S) Failure to [install] [maintain] equipment so as to facilitate cleaning of [the equipment] [all adjacent spaces].  Specifically, *** 16
1129 21 CFR 110.40(a) Food-contact - corrosion resistant Lack of corrosion-resistant food contact surfaces.  Specifically, *** 16
3655 21 CFR 110.37(d)(2) Good repair Failure to keep toilet facilities in good repair.  Specifically, *** 16
3877 21 CFR 113.60(c) Coding - required elements 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, *** 16
6007 21 CFR 123.9(a) Records entries - timing Processing or other information was not [always] entered on your records at the time it was observed.  Specifically, *** 16
6016 21 CFR 123.6(c)(7) Records system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of the critical control points.  Specifically, *** 16
9941 21 CFR 120.8(a) No HACCP plan 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, *** 16
9947 21 CFR 120.11(b) HACCP plan - not validated 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 HACC 16
1130 21 CFR 110.40(a) Food-contact - withstand food & cleaning cmpds. 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, *** 15
1172 21 CFR 110.40(e) Lack of thermometer 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, *** 15
4475 21 CFR 108.25(c)(3)(i) Process adherence Failure to process each food in conformity with at least the scheduled process filed with FDA. Specifically, *** 15
12747 21 CFR 120.8(b)(3) HACCP plan - critical limits not listed or not adequate 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].  Sp 15
15744 21 CFR 111.210(h)(2)   Master manufacturing record - sampling, tests, examinations  The written instructions in your master manufacturing record did not include [procedures for sampling] [a cross-reference to procedures for tests or examinations]. Specifically, *** 15
1425 21 CFR 110.20(b)(4) Spacing of equipment Aisles or working spaces between equipment and walls are [obstructed] [of inadequate width].  Specifically, *** 14
3712 21 CFR 110.93 Storage/transportation of finished goods (deterioration) Failure to [store] [transport] finished food under conditions that would protect against deterioration of the food and its container.  Specifically, *** 14
9928 21 CFR 120.12(b) Records - general - include name, date, time 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 14
12746 21 CFR 120.8(b)(2) HACCP plan - critical control points not listed Your HACCP plan does not list the critical control points for each of the identified food hazards.  Specifically, *** 14
15747 21 CFR 111.210(g)  Packaging description, representative label  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,  14
918 21 CFR 123.8(a) Verification - reviewers qualifications 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 wa 13
1403 21 CFR 110.10(b)(4) Hand jewelry - remove/cover Failure to [remove] [adequately cover] hand jewelry which cannot be adequately sanitized during periods where food is being manipulated by hand.  Specifically, *** 13
12734 21 CFR 120.12(a) Records required - not maintained 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  13
12748 21 CFR 120.8(b)(5) HACCP plan - corrective action plan not included  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,*** 13
15453 21 CFR 111.16 Written procedures - cleaning You did not [establish] [follow] written procedures for cleaning the physical plant.  Specifically, *** 13
1090 21 CFR 110.40(d) Holding, conveying, mfg systems - design & construction Lack of appropriate [design] [construction] to enable [holding] [conveying] [manufacturing] systems to be maintained in an appropriate sanitary condition.  Specifically, *** 12
3662 21 CFR 110.37(e)(6) Refuse receptacles Refuse receptacles for hand washing facilities are not [constructed] [maintained] to protect against contamination of food.  Specifically, *** 12
4511 21 CFR 108.25(f) Approved school Failure to have personnel involved in [acidification] [pH control] [heat treatment] [critical factors] under the operating supervision of a person who has attended and satisfactorily completed a school approved by the Commissioner. Specifically, *** 12
4515 21 CFR 108.35(c)(2) Process filing Failure to provide FDA, before packing any new product, information as to the scheduled process for each low-acid canned food in each container.  Specifically, *** 12
9936 21 CFR 120.7(a) Hazard analysis - written - elements 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 r 12
12749 21 CFR 120.8(b)(6) HACCP plan - verify procedures / frequency - none listed Your HACCP plan does not list the verification [procedures] [frequencies] that have been developed to ensure that the HACCP plan is being implemented.  Specifically, *** 12
15425 21 CFR 111.15(i) Hand-washing facilities Your hand-washing facilities [are not adequate] [are not convenient] [do not furnish running water at a suitable temperature].  Specifically, ***  12
15737 21 CFR 111.210(h)(5) Corrective action plans The written instructions in your  master manufacturing did not include instructions for corrective action plans to use when specifications are not met.  Specifically, *** 12
15819 21 CFR 111.55 Production, process controls - implement  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, *** 12
1763 21 CFR 110.35(b)(1) Safe and adequate for use Use of cleaning compounds and sanitizing agents which are not [free from undesirable microorganisms] [safe and adequate under the conditions of use].  Specifically, *** 11
2385 21 CFR 110.80(a)(1) Inspection, segregation, handling of raw materials Failure to [inspect] [segregate] [handle] raw materials to ascertain that they are clean and suitable for processing into food.  Specifically, *** 11
2394 21 CFR 110.80(b)(6) Contamination by raw materials, refuse, other ingredients Failure to take effective measures to protect finished food from contamination by [raw materials] [refuse] [other ingredients] .  Specifically, *** 11
3075 21 CFR 114.80(a)(4) Container testing Failure to [test] [examine] containers often enough to ensure that containers suitably protect the food from leakage and contamination.  Specifically, *** 11
4519 21 CFR 108.35(c)(3)(i) Process adherence Failure to process each low-acid canned food in conformity with at least the scheduled process. Specifically, *** 11
9954 21 CFR 120.11(a)(1)(iv) Verification - CCP, CA record review 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, *** 11
12745 21 CFR 120.8(b)(1) HACCP plan - food hazards not listed Your HACCP plan does not list all food hazards that are reasonably likely to occur.  Specifically, *** 11
12755 21 CFR 120.11(a)(1)(iv)  Records - not signed and dated by qualified individual 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 HA 11
15659 21 CFR 111.475(b)(1) Written procedures - holding; distributing  You did not make and keep written procedures for holding and distributing operations.  Specifically, *** 11
938 21 CFR 123.9(c) Official review You did not make available for official review and copying at reasonable times [all records] [all plans and procedures] required by the regulations.  Specifically, *** 10
1697 21 CFR 110.80(b)(4) Preventive control measures 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, *** 10
3647 21 CFR 110.10(c) Training of handlers and supervisors Appropriate training in food handling techniques and food protection principles has not been provided to [food handlers] [supervisors].  Specifically, *** 10
6014 21 CFR 123.6(c)(2) Monitoring - none 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, 10
12743 21 CFR 120.8(b)(4) HACCP plan - monitoring procedures not adequate Your HACCP plan lists monitoring [procedures] [frequencies of performing procedures] that do not ensure compliance with the critical limits.  Specifically, *** 10
15825 21 CFR 111.65 Quality control - quality, dietary supplement  You did not implement quality control operations to ensure the quality of the dietary supplement.  Specifically,  *** 10
15828 21 CFR 111.70(a)  Specifications - manufacturing process  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 man 10
16089 FDCA 417(d)(1)(A) Reportable food report - submission You did not submit a reportable food report to FDA within 24 hours after you determined that a food was a reportable food.  Specifically, *** 10
986 21 CFR 110.10(b)(2) Personal cleanliness Employees in contact with [food] [food-contact surfaces] [food-packaging materials] were not maintaining adequate personal cleanliness.  Specifically, *** 9
1566 21 CFR 110.35(d)(4) Single-service articles 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, *** 9
1596 21 CFR 110.37(b)(2) Convey sewage Plumbing is not [of adequate size and design] [adequately installed and maintained] to properly convey sewage and liquid disposable waste from the plant.  Specifically, *** 9
1600 21 CFR 110.37(a) General inadequacy Failure to use a water supply that is [sufficient for the operations] [derived from an adequate source].  Specifically, *** 9
1601 21 CFR 110.37(a) Safe and adequate sanitary quality Failure to use water which is [safe] [of adequate sanitary quality] in food and on food-contact surfaces.  Specifically, *** 9
1642 21 CFR 113.100(b) Review not signed/dated A [processing] [production] record was not [signed or initialed] [dated] by the reviewer.  Specifically, *** 9
2393 21 CFR 110.80(b)(1) Teardown equipment/thorough cleaning Failure to take apart equipment as necessary to ensure thorough cleaning.  Specifically, *** 9
3067 21 CFR 114.80(a) Quality control procedures Appropriate quality control procedures are not employed to ensure that finished foods do not present a health hazard.  Specifically, "*** 9
3088 21 CFR 114.100(b) Processing and production - required information 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 product 9
3651 21 CFR 110.37(b)(5) Cross contamination Systems that discharge waste water or sewage are cross-connected to systems that carry water for food or food manufacturing.  Specifically, *** 9
3657 21 CFR 110.37(d)(4) Doors opening into processing areas Toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination.  Specifically, *** 9
4479 21 CFR 108.25(e) Recall procedures Failure to prepare and maintain in files current procedures for [recalling products that may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining the effectiveness of recalls] [notifying FDA] [implementing r 9
9935 21 CFR 120.7(a) No hazard analysis 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, ***  .  Specifically, *** 9
9961 21 CFR 120.24(a) Process controls - HACCP plan - 5 log reduction 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 t 9
15454 21 CFR 111.16 Written procedures - pest control You did not [establish] [follow] written procedures for pest control.  Specifically, *** 9
15543 21 CFR 111.260(c)  Batch record - date, time; maintenance 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  9
15748 21 CFR 111.210(f) Master manufacturing record theoretical and expected yield 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  9
15838 21 CFR 111.70(d) Specifications - labels, packaging  You did not establish [label] [packaging] specifications.  Specifically, *** 9
15932 21 CFR 111.105(a)   Processes, specifications, written procedures 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 suppleme 9
16057 21 CFR 111.535(b)(1) Records - returned dietary supplement: written procedures  You did not make and keep records of written procedures for fulfilling requirements for returned dietary supplements.  Specifically, *** 9
3082 21 CFR 114.89 Process deviation Failure to fully reprocess, thermally process as a low-acid food under 21 CFR 113, or set aside for further evaluation as to any potential public health significance, a portion of food which [deviated from a scheduled process] [had an equilibrium pH of th 8
3089 21 CFR 114.100(c) Process deviations- identification and records 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, 8
9958 21 CFR 120.12(c) Records - signed/dated 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 a 8
15442 21 CFR 111.15(b)(1) Physical plant - clean and sanitary You did not maintain your physical plant in a clean and sanitary condition.  Specifically, *** 8
15533 21 CFR 111.255(c)   Batch record - follow master Your batch production record did not accurately follow the appropriate master manufacturing record.  Specifically, *** 8
15862 21 CFR 111.75(a)(2) Appropriate tests, examinations; certificate of analysis You did not conduct appropriate tests or examinations or rely on a certificate of analysis to determine whether components met established specifications.  Specifically, *** 8
16118 21 CFR 118.4 Written SE plan not implemented/followed Your written SE prevention plan is not [fully] implemented and followed. Specifically,*** 8
16135 21 CFR 118.4(b)(4) Stray animals Stray animals are not prevented from entering poultry houses.  Specifically,*** 8
950 21 CFR 123.12(d) Determination of compliance 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, *** 7
975 21 CFR 123.9(b)(1) Record retention Your [monitoring] [corrective action] [verification] records are not maintained at your facility for at least the required time period.  Specifically, *** 7
1330 21 CFR 113.100(a) Process records - forms missing information 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] [t 7
1471 21 CFR 113.83 Scheduled processes not established Scheduled processes for low-acid foods have not been established by qualified persons having expert knowledge of thermal processing.  Specifically, *** 7
1711 21 CFR 110.80(b)(15) Proper pH controls 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, *** 7
4296 21 CFR 110.80(a)(5) Temperature and humidity Failure to hold [raw materials] [rework materials] [ingredients] at proper temperature and humidity to prevent the food from becoming adulterated.  Specifically, *** 7
6012 21 CFR 123.8(a)(3)(iii) Calibration record review adequacy 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 w 7
6017 21 CFR 123.7(c) Corrective action per regulation 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] [t 7
9939 21 CFR 120.7(c) All hazards not considered 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] [na 7
12732 21 CFR 120.10(a) Corrective action - predetermined plan 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 de 7
12750 21 CFR 120.8(b)(6) HACCP plan - valid procedures / frequency - none listed 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, *** 7
15526 21 CFR 111.30(c) Equipment - automated - calibrate, inspect You did not routinely [calibrate] [inspect] [check] the automated, mechanical, or electronic equipment to ensure proper performance.  Specifically, *** 7
15741 21 CFR 111.210(h)(3)(i) Components, verify weight,  measure The written instructions in your master manufacturing record did not include instructions to verify the weight or measure and addition of components.  Specifically,  *** 7
15761 21 CFR 111.205(b)(1) Master manufacturing record - specifications; quality  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, *** 7
15790 21 CFR 111.403  Written procedures - labeling operations  You did not [establish] [follow] written procedures for labeling operations.  Specifically, *** 7
15800 21 CFR 111.560(a)(2) Product complaint - quality control investigate  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, *** 7
15871 21 CFR 111.75(c)(2) Specifications met - test, examinations; compliance  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 7
15882 21 CFR 111.75(h)(2)  Tests, examinations - scientifically valid  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, *** 7
16040 21 CFR 111.610(a) Records - available; FDA  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, *** 7
16120 21 CFR 118.4 Written SE plan lacks required elements Your written SE prevention plan lacks appropriate SE prevention measures.  Specifically,*** 7
1428 21 CFR 110.20(b)(6) Adequate ventilation Failure to provide [adequate ventilation] [control equipment] to minimize odors and vapors in areas where they may contaminate food.  Specifically, *** 6
1568 21 CFR 110.35(d)(2) Before use and after interruption Failure to clean and sanitize food-contact surfaces in wet-processing [before use] [after any interruption during which they may have been contaminated], to preclude contamination with microorganisms.  Specifically, *** 6
2396 21 CFR 110.80(b)(6) Conveyor transportation Failure to take effective measures to protect food transported by conveyor from contamination.  Specifically, *** 6
3653 21 CFR 110.37(d) Readily accessible Failure to provide employees with [readily accessible] [adequate] toilet facilities.  Specifically, *** 6
3660 21 CFR 110.37(e)(4) Devices and fixtures Devices and fixtures are not designed and constructed to protect against recontamination of clean, sanitized hands.  Specifically, *** 6
4524 21 CFR 108.35(g) Approved school Failure to have personnel involved in [retorts] [thermal processing systems] [aseptic processing and packaging systems] [thermal processing systems] [container closure inspections] under the operating supervision of a person who has attended and satisfact 6
4529 21 CFR 108.35(c)(2)(ii) Process change reporting to CFSAN For an intentional change in a previously filed scheduled process, failure to submit to CFSAN, 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 qua 6
15351 FDCA 761(b)(1) No AE report made (dietary supplement) No report was made of a serious adverse event associated with a dietary supplement marketed in the United States.  Specifically, *** 6
15401 21 CFR 111.12(b) Personnel - quality control operations You have not identified personnel to be responsible for your quality control operations.  Specifically, *** 6
15410 21 CFR 111.14(b)(2) Personnel - records - training You did not make and keep documentation of training.  Specifically, *** 6
15480 21 CFR 111.20(h) Physical plant - screening against pests Your physical plant did not use adequate screening or other protection against pests.  Specifically, *** 6
15494 21 CFR 111.25(c) Procedures - equipment - cleaning, sanitizing 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, ** 6
15496 21 CFR 111.27(b) Instruments - calibration 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 accur 6
15546 21 CFR 111.260(f)  Batch record - yield 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, *** 6
15736 21 CFR 111.353   Manufacturing operations - written procedures  You  did not [establish] [follow] written procedures for manufacturing operations.  Specifically, *** 6
15831 21 CFR 111.70(b)(3) Specifications - contamination limits  You did not establish limits for contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Specifically, *** 6
15840 21 CFR 111.70(e) Specifications -  contamination limits  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, *** 6
15928 21 CFR 111.103 Written procedure quality control operations material review You did not [establish] [follow] written procedures for quality control operations for conducting a material review and making a disposition decision.  Specifically, *** 6
15930 21 CFR 111.105 Ensure quality; package, labeled, master record Your quality control personnel did not ensure that your [manufacturing] [packaging] [labeling] [holding] operations ensure the quality of the dietary supplement.  Specifically, *** 6
15933 21 CFR 111.105(b)   Quality control - supplier qualification Your quality control personnel did not review and approve the documentation setting forth the basis for qualification of suppliers.  Specifically, *** 6
15944 21 CFR 111.105(i)   QC - required operations master manufacturing/batch records  Your quality control personnel did not perform required operations for the [master manufacturing record] [batch record] [manufacturing operations]. Specifically, *** 6
15986 21 CFR 111.123(b)(2)   Quality control - batch, product specifications Your quality control personnel approved and released for distribution a batch of dietary supplement that did not meet established product specifications.  Specifically, *** 6
16070 21 CFR 111.35(b)(2) Document-equipment date of use, maintain, clean, sanitize You did not make and keep documentation of [the date of the use] [maintenance] [cleaning] [sanitizing] of the equipment.  Specifically, *** 6
16071 21 CFR 111.35(b)(3) Documentation - instruments, controls; calibrations  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, *** 6
16192 21 CFR 118.10(a)(3)(1) Biosecurity measures documentation You did not maintain records documenting compliance with biosecurity measures.  Specifically,*** 6
16288 21 CFR 113.100(b) Review of processing and production records 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, *** 6
1040 21 CFR 113.10 Operators 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.  Specificall 5
1529 21 CFR 113.89 Process deviation log/file Process deviations were not recorded in a separate file or log that details both the deviations and the actions taken.  Specifically, *** 5
1577 21 CFR 110.37(f) Contamination of food, contact surfaces, water supplies, etc The [conveyance] [storage] [disposal] of [rubbish] [offal] does not protect against contamination of [food] [food-contact surfaces] [water supplies] [ground surfaces].  Specifically, *** 5
1641 21 CFR 113.100(b) Review not timely 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.  Speci 5
1670 21 CFR 110.80(a)(4) Safety assurance - pests/extraneous materials There is no assurance that [raw materials] [ingredients] [rework materials] which are susceptible to contamination with [pests] [undesirable microorganisms] [extraneous materials] comply with current FDA standards and defect action levels.  Specifically,  5
1708 21 CFR 110.80(b)(12) Batters, breading, gravies, sauces, etc. Failure to treat and maintain [batters] [breading] [sauces] [gravies] [dressings and similar preparations] in a manner that protects against [contamination] [growth of microorganisms].  Specifically, *** 5
1766 21 CFR 110.35(b)(1) Unacceptable toxic compounds 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 operati 5
3083 21 CFR 114.89 Process deviation evaluation 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, *** 5
3650 21 CFR 110.35(d)(1) Wet cleaning Failure to sanitize and thoroughly dry, prior to use,  food-contact surfaces which have been wet cleaned.  Specifically, *** 5
4181 21 CFR 113.89 Process deviation identification Failure to identify, from processor check or otherwise, deviations from the scheduled process or critical factors which are out of control.  Specifically, *** 5
6009 21 CFR 123.8(a)(3)(iii) Verification - record review - calibration You did not review [some of] your calibration records within a reasonable time after the records were made.  Specifically, *** 5
9917 21 CFR 120.10(c) Corrective action documentation You do not have records that [fully] document corrective actions that were taken.  Specifically, *** 5
9953 21 CFR 120.11(a)(1)(iv)(A) CCP record review adequacy 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, *** 5
15491 21 CFR 111.25 Equipment - procedures You did not [establish] [follow] written procedures for fulfilling the requirements for equipment and utensils.  Specifically, *** 5
15570 21 CFR 111.153 Written procedures - components You did not [establish] [follow] written procedures for the requirements for components of dietary supplements.  Specifically, *** 5
15652 21 CFR 111.465(b) Retain reserve samples - 1 year, 2 years  You did not retain reserve samples for the required time.  Specifically, *** 5
15723 21 CFR 111.365(i) Metal, foreign material  You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements].  Specifically, *** 5
15746 21 CFR 111.210(h)(1)   Instructions; specifications; quality 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 supplement.  Specifically, *** 5
15791 21 CFR 111.403  Written procedures -packaging operations  You did not [establish] [follow] written procedures for packaging operations.  Specifically, *** 5
15843 21 CFR 111.70(g) Specifications - finished packaging, labeling  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, *** 5
15853 21 CFR 111.73 Specifications met - identity, purity, strength, composition You did not determine whether you met established product specifications for [identity] [purity] [strength] [composition of the finished batch of the dietary supplement].  Specifically, *** 5
15977 21 CFR 111.123(a)(1)   QC operations - master manufacturing record, modifications Your quality control operations did not include reviewing and approving [master manufacturing records] [modifications to the master manufacturing records]. Specifically, *** 5
15978 21 CFR 111.123(a)(2)   Quality control operations - batch production records Your quality control operations did not include reviewing and approving all batch production-related records.  Specifically, *** 5
16046 21 CFR 111.503  Written procedures returned dietary supplement investigation You did not [establish] [follow] written procedures for conducting an investigation of your manufacturing processes and other batches for a returned dietary supplement.  Specifically, *** 5
929 21 CFR 123.8(b) Verification - corrective action 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 acti 4
1196 21 CFR 110.10(a) Employees with illness,  lesions, contamination source 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 contaminat 4
1331 21 CFR 113.100(a)(1) Still retorts 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, *** 4
1563 21 CFR 110.35(d)(1) Low-moisture food requirements Food contact surfaces used for [manufacturing] [holding] low-moisture food were [wet] [insanitary] at time of use.  Specifically, *** 4
1643 21 CFR 113.100(e) Incomplete information 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, *** 4
1734 21 CFR 113.40(a)(2)(iii) Adjusted to agree with TID 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, *** 4
2301 21 CFR 129.80(f) Bacteriological swab, rinse count - containers, closures (S) 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, *** 4
2387 21 CFR 110.80(a)(1) Washing and cleaning Failure to adequately [wash] [clean] raw materials as necessary to remove soil or other contamination.  Specifically, *** 4
2391 21 CFR 110.80(a)(6) Thawed appropriately Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated.  Specifically, *** 4
2848 21 CFR 113.40(g)(1)(i)(B)(3) Adjusted to agree with TID A temperature-recording device was not adjusted with sufficient frequency to ensure agreement as nearly as possible with, but to be in no event higher than, the temperature-indicating device during processing.  Specifically, *** 4
3072 21 CFR 114.80(a)(1) Thermal processing 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, *** 4
3077 21 CFR 114.80(b) Visible code Each container is not marked with an identifying code permanently visible to the naked eye.  Specifically, *** 4
3090 21 CFR 114.100(d) Product distribution Records identifying initial distribution of finished product are not maintained.  Specifically, *** 4
3866 21 CFR 113.60(a)(1)(i)(a) Required can seam measurements (micrometer) Measurements were not [taken] [recorded] for the can seam [cover hook] [body hook] [width (length, height)] [tightness] [thickness].  Specifically, *** 4
3872 21 CFR 113.60(a)(3) Closures other than double seams and glass 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, *** 4
4295 21 CFR 110.40(a) Food contact - non-toxic materials Food-contact surfaces are not made of non-toxic materials.  Specifically, *** 4
6002 21 CFR 123.11(b) Sanitation corrections You did not correct sanitation deficiencies in a timely manner.  Specifically,*** 4
9943 21 CFR 120.8(a) HACCP plan - location and type of juice Your HACCP plan is not specific to [each location where juice is processed] [each type of juice processed].  Specifically, *** 4
9986 21 CFR 120.24(c) Process controls - not exempt, single facility 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, *** 4
12733 21 CFR 120.11(a)(1)(iv)(C) Calibration, testing - record review timeliness 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, *** 4
12751 21 CFR 120.8(b)(7) HACCP plan - recordkeeping system Your HACCP plan does not provide for a recordkeeping system that documents the monitoring of critical control points.  Specifically, *** 4
15302 21 CFR 120.11(a)(2) Calibration, testing - no records You do not maintain records of [calibration of process-monitoring instruments] [periodic end-product or in-process testing].  Specifically, *** 4
15381 21 CFR 111.8 Written procedures - hygienic practices You did not [establish] [follow] written procedures for hygienic practices.  Specifically, *** 4
15391 21 CFR 111.10(b)(3) Hand washing 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, *** 4
15404 21 CFR 111.12(c) Personnel - education, training, experience 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, *** 4
15434 21 CFR 111.15(d)(2) Pest control measures 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, *** 4
15498 21 CFR 111.27(d) Equipment - maintain, clean, sanitize You did not [maintain] [clean] [sanitize] equipment and utensils used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 4
15499 21 CFR 111.27(a) Equipment - design - suitable 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, *** 4
15505 21 CFR 111.27(a)(3)(v) Equipment - protect from contamination Your equipment or utensils are not maintained to protect components and dietary supplements from being contaminated.  Specifically, *** 4
15549 21 CFR 111.260(i) Batch record - specifications Your batch production records did not include documentation that the finished dietary supplement meets established specifications.  Specifically, *** 4
15573 21 CFR 111.153 Written procedures - product received; packaging, labeling You did not [establish] [follow] written procedures for the requirements for product received for packaging or labeling as a dietary supplement.  Specifically, *** 4
15598 21 CFR 111.160(d)(1) Packaging - identify  You did not identify each unique lot within each unique shipment of packaging in a manner that allows you to trace the lot to [the supplier] [the date received] [the name of the packaging] [the status of the packaging] [the dietary supplement that you dis 4
15642 21 CFR 111.455(a) Hold - temperature, humidity, light  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, *** 4
15759 21 CFR 111.205(b)(2) Master manufacturing record - controls, procedures  Your master manufacturing record did not establish [controls] [procedures] to ensure that each batch met specifications. Specifically,  *** 4
15796 21 CFR 111.430(b) Records - packaging, labeling operations  You did not make and keep records of the written procedures for [packaging] [labeling] operations.  Specifically, *** 4
15799 21 CFR 111.560(a)(1) Product complaint - quality control review  A qualified person did not review a product complaint to determine whether the product complaint involves a possible failure of a dietary supplement to meet specifications or any other requirements.  Specifically, *** 4
15867 21 CFR 111.75(b)(1) Specifications met, in-process - quality finished batch  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, *** 4
15883 21 CFR 111.75(i)  Corrective action plan  You did not establish a corrective action plan to use when an established specification is not met.  Specifically, *** 4
15885 21 CFR 111.77(a) Specifications not met - reject, quality control  Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] for which a specification was not met.  Specifically, *** 4
15890 21 CFR 111.80(a) Components packaging, labels used You did not collect representative samples of each unique lot of [components] [packaging][ labels] that you used to determine whether the [components] [packaging] [labels] meet(s) established specifications.  Specifically, *** 4
15893 21 CFR 111.80(c) Specifications - representative samples; finished batch  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.  4
15973 21 CFR 111.120(c) QC operations - material review, disposition decision 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, *** 4
16122 21 CFR 118.4(a)(2)(i) Pullet environment testing Your pullet environment is not tested for SE when pullets are 14 to 16 weeks of age.  Specifically,*** 4
1060 21 CFR 123.11(a) SSOP(S) You [do not have] [have not implemented] a written sanitation standard operating procedure (SSOP).  Specifically, *** 3
1290 21 CFR 110.20(a)(4) Waste disposal Failure to properly maintain operating systems for waste treatment and disposal so that they do not constitute a source of contamination in areas where food is exposed.  Specifically, *** 3
1316 21 CFR 113.87(c) Initial temperature of container contents 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 proce 3
1329 21 CFR 113.100(a) Process records - not done; not timely 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, *** 3
1486 21 CFR 113.87(b) Retort room: traffic control system not established A system of traffic control to prevent unretorted product from bypassing the retort process was not established.  Specifically, *** 3
1534 21 CFR 113.100(b) Entry not made An entry on a [processing record] [production record] was not made by the retort or processing system operator or other designated person.  Specifically, *** 3
1569 21 CFR 110.35(d)(2) Continuous operations Failure to clean and sanitize utensils and food-contact surfaces of equipment in continuous wet-processing operations as necessary.  Specifically, *** 3
1640 21 CFR 113.100(b) Record form not signed A [processing] [production] record form was not signed or initialed by a processing system operator or other designated person.  Specifically, *** 3
1669 21 CFR 110.80(a)(3) Aflatoxin and other natural toxins 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, *** 3
1688 21 CFR 110.80 Supervisory competence 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, *** 3
1691 21 CFR 113.40(a)(4) Steam controller A retort was not equipped with an automatic steam controller to maintain the retort temperature.  Specifically, *** 3
1735 21 CFR 113.40(a)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, *** 3
1944 21 CFR 129.80(d) Sanitizing operations inadequate Sanitizing operations were not adequate to sanitize the intended [product water-contact surfaces] [critical areas]. Specifically, *** 3
2389 21 CFR 110.80(a)(5) Identify rework Failure to identify material scheduled for rework as such. Specifically, *** 3
2840 21 CFR 113.40(g)(1)(i)(A) TID accuracy test frequency 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, *** 3
3644 21 CFR 110.10(b)(5) Impermeable (S) Gloves used for food handling are not impermeable.  Specifically,  *** 3
3708 21 CFR 110.80(a)(1) Water quality -- wash, rinse, convey food Water [used] [re-used] to [wash] [rinse] [convey] food is not [safe] [of adequate sanitary quality].  Specifically, *** 3
3709 21 CFR 110.80(a)(1) Inspection of containers and carriers upon receipt 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, *** 3
4062 21 CFR 113.100(a) Critical factors - no record 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, *** 3
4465 21 CFR 114.100(c) Process deviations - action to rectify Failure to record the action taken to rectify a departure from a scheduled process.  Specifically, *** 3
4476 21 CFR 108.25(c)(3)(ii) Process information availability Failure to provide the FDA, after written request, any process and procedure information deemed necessary to determine the adequacy of the process. Specifically, *** 3
4514 21 CFR 108.35(c)(1) Registration Failure to register with the FDA information including the name, principal place of business and the location of the processing establishment within 10 days after engaging in the manufacture, processing and packaging of low-acid canned foods. Specifically 3
9926 21 CFR 120.14(a) Importer - written procedures You do not have written procedures that describe [product specifications] [affirmative steps] to ensure that juice you receive for import into the United States was processed in accordance with the juice HACCP regulation.  Specifically, *** 3
9981 21 CFR 120.12(b)(4) Records - actual values Your records do not [always] contain the actual values and observations obtained during monitoring.  Specifically, *** 3
15382 21 CFR 111.8 Written procedures - personnel qualifications You did not [establish] [follow] written procedures for determining personnel qualification requirements.  Specifically, *** 3
15403 21 CFR 111.12(b) Personnel - quality control operations; responsibilities 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.  3
15429 21 CFR 111.15(k) Sanitation supervisors - assigned You did not assign one or more employees to supervise overall sanitation.  Specifically, *** 3
15447 21 CFR 111.15(c)(3) Cleaning compounds and toxic materials - holding 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, *** 3
15452 21 CFR 111.15(f)(5) Plumbing - backflow, cross connection The plumbing in your physical plant allows [backflow from] [cross connection between] piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for 3
15458 21 CFR 111.20(d)(1)(i) Floors, walls, ceilings Your [floors] [walls] [ceilings] were not designed and constructed so they can be adequately cleaned and kept clean and in good repair.  Specifically, *** 3
15492 21 CFR 111.25(a) Procedures - calibrating instruments 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, *** 3
15547 21 CFR 111.260(g) Batch record - results; monitoring Your batch production records did not include the actual results obtained during a monitoring operation. Specifically,  *** 3
15548 21 CFR 111.260(h) Batch record - results; testing, examination; batch 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, *** 3
15550 21 CFR 111.260(j) Batch record - manufacture Your batch production records did not include documentation, at the time of performance, of the manufacture of the batch.  Specifically, *** 3
15552 21 CFR 111.260(j)(2)  Batch record - initials; each step Your batch production records did not include initials of the persons performing each step.  Specifically, *** 3
15554 21 CFR 111.260(j)(2)(ii) Batch record - initials; verifying weight 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, *** 3
15556 21 CFR 111.260(j)(2)(iv) Batch record - initials; verifying component  Your batch production records did not include initials of the person responsible for verifying the addition of components to the batch.  Specifically, *** 3
15562 21 CFR 111.260(l)(1) Batch record - quality control review; production Your batch production records did not include documentation that quality control personnel reviewed the batch production record.  Specifically, *** 3
15567 21 CFR 111.260(l)(4) Batch record - approved, released, rejected   Your batch production records did not include documentation that quality control personnel approved and released, or rejected, the packaged and labeled dietary supplement.  Specifically, *** 3
15579 21 CFR 111.155(c)(1) Components - representative samples You did not collect representative samples of components while the components were quarantined.  Specifically, *** 3
15586 21 CFR 111.155(e) Components - contamination, deterioration, mix-ups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  Specifically, *** 3
15665 21 CFR 111.303 Written procedures - tests, examinations; specifications met You did not [establish] [follow] written procedures for the tests and examinations conducted to determine whether specifications are met.  Specifically, *** 3
15698 21 CFR 111.320(a) Examination, testing; appropriate You did not verify that the laboratory examination and testing methodologies are appropriate for their intended use.  Specifically, *** 3
15734 21 CFR 111.360   Manufacturing operations - sanitation  You did not conduct manufacturing operations in accordance with adequate sanitation principles.  Specifically, *** 3
15739 21 CFR 111.210(h)(3)(ii)(B) Components; add, verify 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, *** 3
15786 21 CFR 111.410(b) Labels - issuance, use  You did not control the [issuance] [use] of labels, Specifically, *** 3
15817 21 CFR 111.570(b)(2)(ii)(F) Record - product complaint; findings  The written record of a product complaint did not include the [findings of the investigation] [follow-up action taken].  Specifically, *** 3
15841 21 CFR 111.70(f) Specifications - product received for packaging, labeling  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,  3
15860 21 CFR 111.75(a)(2) Component - confirm identity; specifications met  You did not confirm the identity of components.  Specifically, *** 3
15872 21 CFR 111.75(c)(3) Specifications met identity,purity, strength, comp,; basis  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 specificati 3
15878 21 CFR 111.75(e)  Product - visually examine, identified   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, *** 3
15881 21 CFR 111.75(g)  Packaging, labeling - visual examination   You did not conduct a visual examination of the [packaging] [labeling] of the finished [packaged] [labeled] dietary supplements to determine whether you [used] [applied] the specified label.  Specifically, *** 3
15898 21 CFR 111.83(b)(1) Reserve sample -container-closure system  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, *** 3
15921 21 CFR 111.95(b)(2) Documentation - supplier qualification  You did not make and keep documentation of your qualification of a supplier.  Specifically,  *** 3
15951 21 CFR 111.110(c)   Quality control operations - tests, examinations; results Your quality control operations did not include reviewing and approving the results of required [tests] [examinations].  Specifically, *** 3
15954 21 CFR 111.113(a)(2)   QC master manufacturing record; material review, disposition 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, *** 3
15963 21 CFR 111.113(b)(2)   Quality control - reject; specification not met Your quality control personnel did not reject a [component] [dietary supplement] [package] [label] when an established specification was not met.  Specifically, *** 3
15964 21 CFR 111.113(c)   Document - material review, disposition The person who conducted a material review and made the disposition decision did not document the material review and the disposition decision [at the time of performance].  Specifically, *** 3
15975 21 CFR 111.120(e)   Quality control operations - quarantine Your quality control operations did not include approving, and releasing from quarantine, all [components] [packaging] [labels] before they were used.  Specifically, *** 3
15980 21 CFR 111.123(a)(4) QC operations - material review, disposition decision Your quality control operations for [the master manufacturing record] [the batch production record] [manufacturing operations] did not include conducting a required material review and making a required disposition decision.  Specifically, *** 3
15983 21 CFR 111.123(a)(7)   Quality control operations - finished batch, specifications Your quality control operations did not include determining whether each finished batch conforms to established product specifications.  Specifically, *** 3
15984 21 CFR 111.123(a)(8)   Quality control - finished batch, distribution Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution.  Specifically, *** 3
16008 21 CFR 111.135 Quality control operations - product complaints; investigate 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].  Specif 3
16013 21 CFR 111.140(b)(1)   Records - quality control operations; responsibilities You did not make and keep written procedures for the responsibilities of the quality control operations.  Specifically, *** 3
16014 21 CFR 111.140(b)(1)   QC ops; written procedures; material review, disposition 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, * 3
16043 21 CFR 111.503  Written procedures - returned dietary supplement; destroyed  You did not [establish] [follow] written procedures for when a returned dietary supplement must be destroyed, or otherwise suitably disposed.  Specifically, *** 3
16058 21 CFR 111.535(b)(2) Records - ret'nd dietary supplement: material review, dispos You did not make and keep records of a material review and disposition decision on a returned dietary supplement. Specifically, *** 3
16152 21 CFR 118.5(a) Testing when laying hens 40 to 45 weeks 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,*** 3
16204 21 CFR 118.10(b)(2) Date and time of activity All your required records do not include the [date] [time] of the activity that the records reflect.  Specifically,*** 3
939 21 CFR 123.9(f) Computerized records Your computerized records do not provide that appropriate controls are implemented to ensure the integrity of the electronic data and signatures.  Specifically, *** 2
1045 21 CFR 113.10 Supervisors Supervisors have not satisfactorily completed training in a school approved by the Commissioner for areas under their responsibility.   Specifically, *** 2
1093 21 CFR 110.40(g) Compressed air/gases 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.  Specificall 2
1176 21 CFR 110.40(f) Insufficient number of Q.C. instruments An inadequate number of instruments used for [measuring] [regulating] [recording] conditions that control or prevent the growth of undesirable microorganisms.  Specifically,*** 2
1245 21 CFR 113.81(a) Raw ingredients There was no means to assure that raw materials and ingredients susceptible to microbiological contamination were suitable for use in processing low-acid food.  Specifically, *** 2
1379 21 CFR 129.35(a)(4)(iv) Quality standards - compliance Finished bottled water did not comply with the bottled water quality standards. Specifically, *** 2
1483 21 CFR 113.87(a) Operating processes not posted 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, *** 2
1484 21 CFR 113.87(a) Vent not posted 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, * 2
1487 21 CFR 113.87(b) Visual indicators not used 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, *** 2
1499 21 CFR 113.89 No corrective action taken No corrective action was taken, e.g. fully reprocessing or setting the lot aside for evaluation, when a deviation from the scheduled process was found.  Specifically, *** 2
1595 21 CFR 110.37(b)(1) Sufficient quantities of water 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, *** 2
1639 21 CFR 113.100(b) Entry not timely An entry on a [processing record] [production record] was not made at the time the specific retort or processing system condition or operation occurred.  Specifically, *** 2
1645 21 CFR 113.100(e) Insufficient frequency of management review Records of container closure examinations were not reviewed by management with sufficient frequency to ensure that the containers were hermetically sealed.  Specifically, *** 2
1651 21 CFR 113.40(a)(1) TID accuracy test frequency 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, *** 2
1761 21 CFR 129.80(a) Records - equipment inspection 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 2
1812 21 CFR 129.80(c) Sample, test - cleaning, sanitizing solutions You did not [sample] [test] cleaning and sanitizing solutions [as often as necessary] to assure adequate performance.  Specifically, *** 2
1945 21 CFR 129.80(d) Records - sanitizing times, intensities (S) 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, *** 2
2271 21 CFR 129.80(e) Package identification 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, *** 2
2362 21 CFR 110.80 Reject and rework Food which has become contaminated to the extent of being adulterated within the meaning of the Act is not rejected or if permissible, treated or processed to eliminate the contamination..  Specifically, *** 2
2887 21 CFR 113.40(j) Processing: conform to other systems A system for processing a low-acid food in hermetically sealed containers did not conform to the requirements for [manufacturing] [processing] [packing] low-acid foods.  Specifically, *** 2
2888 21 CFR 113.40(j) Critical factors - frequency measured, recorded 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  2
3068 21 CFR 114.80(a)(1) pH control Acidified foods are not manufactured, processed and packaged to [achieve within the time designated in the scheduled process] [maintain]  a pH value of 4.6 or lower in all finished foods.  Specifically,  *** 2
3091 21 CFR 114.100(e) Retention Required records are not maintained at the processing plant or other reasonably accessible location for a period of three years from the date of manufacture. Specifically, *** 2
3645 21 CFR 110.10(d) Supervision Responsibility for assuring compliance with current good manufacturing practices relating to personnel  has not been assigned to competent supervisory personnel.  Specifically, *** 2
3710 21 CFR 110.80(b)(16) Ice manufacturing Ice in contact with food has been made from water which is [unsafe] [of inadequate sanitary quality].  Specifically, *** 2
3859 21 CFR 113.60(a) Frequency: visual closure examinations, record 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, 2
3874 21 CFR 113.60(b) Cooling water - not chlorinated, sanitized Container cooling water was not chlorinated or otherwise sanitized [for cooling canals] [for recirculated water supplies].  Specifically, *** 2
3892 21 CFR 113.60(a) Regular observations for gross closure defects Regular observations for gross container closure defects were not made during production runs.  Specifically *** 2
4419 21 CFR 110.10(c) Level of competency (S) Personnel responsible for identifying [sanitation failures] [food contamination] lack a background of education and experience to provide a needed level of competency.  Specifically, *** 2
4512 21 CFR 108.25(g) Record retention Failure to prepare, review and retain at [the processing plant] [a reasonably accessible location] for three years all records [of processing] [of deviations in processing] [specified in 21 CFR 114]. Specifically, *** 2
4523 21 CFR 108.35(f) Recall procedures Failure to prepare and maintain in files current procedures for [recalling products which may be injurious to health] [identifying, collecting, warehousing and controlling products] [determining effectiveness of recalls] [notifying FDA] [implementing reca 2
9929 21 CFR 120.12(b)(4) Records - information not entered when observed Processing and other information is not [always] entered on your records at the time it is observed.  Specifically, *** 2
9932 21 CFR 120.6(a) Sanitation SSOP - none or not implemented 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, *** 2
9938 21 CFR 120.7(d) Hazard analysis - evaluation of effect on safety (S) You did not evaluate [product ingredients] [processing procedures] [packaging] [storage] [intended use] [facility and equipment function and design] [plant sanitation, including employee hygiene] to determine the potential effect on the safety of the fini 2
9959 21 CFR 120.12(d)(1) Record retention - general You do not retain [all of] the required records at your facility for the required time period.  Specifically, *** 2
12744 21 CFR 120.8(b)(4) HACCP plan - monitoring procedures - none listed 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, *** 2
15305 21 CFR 120.14(a)(2) Importer - implementation of affirmative steps 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, ***  2
15380 21 CFR 111.8 Written procedures - sick or infected personnel You did not [establish] [follow] written procedures for preventing microbial contamination from sick or infected personnel.  Specifically, *** 2
15388 21 CFR 111.10(b) Personnel - hygienic practices Your personnel did not use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, or contact surfaces.  Specifically, *** 2
15396 21 CFR 111.10(b)(6) Hair restraints Your personnel did not wear [effective] hair restraints [in an effective manner].  Specifically, *** 2
15402 21 CFR 111.12 Personnel - quality control personnel - qualified 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, *** 2
15409 21 CFR 111.14(b)(1) Personnel - records - written procedures You did not make and keep written procedures for [preventing microbial contamination from sick or infected personnel] [hygienic practices] [determining personnel qualification requirements].  Specifically, *** 2
15433 21 CFR 111.15(d)(1) Animals and pests in facility You allowed [animals] [pests] in your physical plant. Specifically, *** 2
15437 21 CFR 111.15(a)(1) Grounds - equipment, litter, weeds You did not [properly store equipment] [remove litter and waste] [cut weeds or grass] within the immediate vicinity of the physical plant.  Specifically, ***        2
15443 21 CFR 111.15(b)(2) Physical plant - repair You did not maintain your physical plant in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated.  Specifically, *** 2
15456 21 CFR 111.20(b) Physical plant - space; equipment, materials 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 2
15529 21 CFR 111.30(e) Equipment - controls, intended use You did not [establish] [use] appropriate controls to ensure that your automated, mechanical, or electronic equipment functions in accordance with its intended use.  Specifically, *** 2
15535 21 CFR 111.255(d)  Batch record - 1 year, 2 years You did not keep batch production records for the required time period.  Specifically, *** 2
15542 21 CFR 111.260(b)  Batch record - date, time; maintenance Your batch production records did not include the identity of equipment and processing lines used in producing the batch.  Specifically, *** 2
15544 21 CFR 111.260(d) Batch record - component; unique identifier 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, ** 2
15559 21 CFR 111.260(k)(1) Batch record - identifier; labels 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, *** 2
15560 21 CFR 111.260(k)(2) Batch record - label 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, *** 2
15566 21 CFR 111.260(l)(3) Batch record - approved, released, rejected; batch Your batch production records did not include documentation that quality control personnel approved and released, or rejected, a batch for distribution.  Specifically, *** 2
15568 21 CFR 111.260(m) Batch record - performance Your batch production records did not include documentation [at the time of performance] of a required material review and disposition decision.  Specifically, *** 2
15572 21 CFR 111.153  Written procedures - labels  You did not [establish] [follow] written procedures for the requirements for labels received.  Specifically, *** 2
15578 21 CFR 111.155(c) Components - quarantine You did not quarantine components before you used them in the manufacture of a dietary supplement.  Specifically, *** 2
15580 21 CFR 111.155(c)(2) Quality control - components; tests, examination results Your quality control personnel did not review and approve the results of [tests] [examinations] conducted on components while the components were quarantined. Specifically, *** 2
15599 21 CFR 111.160(d)(1) Labels - identify 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] 2
15606 21 CFR 111.165(c)(1) Product received - quarantine; representative samples  You did not collect representative samples of received product while the received product was quarantined.  Specifically, *** 2
15610 21 CFR 111.165(d)(1)  Product received - identify 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 th 2
15620 21 CFR 111.180(b)(1) Written procedures - product received  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, 2
15627 21 CFR 111.180(b)(3) Documentation - product received; packaging, labeling  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, *** 2
15645 21 CFR 111.455(c) Hold - mix-up, contamination, deterioration  You held [components] [dietary supplements] [packaging] [labels] under conditions that  lead to mix-up, contamination, or deterioration. Specifically, *** 2
15648 21 CFR 111.465(a)(2) Hold - reserve sample; closure system  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, *** 2
15660 21 CFR 111.475(b)(2)  Records - product distribution  You did not make and keep records of product distribution.  Specifically, *** 2
15675 21 CFR 111.315(b) Sampling plans; establish, follow You did not [establish] [follow] sampling plans for obtaining representative samples.  Specifically, *** 2
15681 21 CFR 111.315(d) Standard reference materials; criteria for selecting You did not [establish] [follow] laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations.  Specifically, *** 2
15712 21 CFR 111.325(b)(2)(ii) Records - document; results  The documentation for laboratory tests and examinations did not include the results of the testing and examination.  Specifically, *** 2
15721 21 CFR 111.365(k) Processing lines, major equipment - contents  You did not identify [processing lines] [major equipment] used during manufacturing to indicate their contents.  Specifically, *** 2
15725 21 CFR 111.365(g) Identifying, holding - contamination, mix-ups  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 m 2
15732 21 CFR 111.365(a) Conditions, controls -protect; microorganisms, contamination You did not perform manufacturing operations under conditions and controls that protect against [the potential for growth of microorganisms] [the potential for contamination].  Specifically, *** 2
15733 21 CFR 111.365  Manufacturing operations - prevent contamination  You did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of [components] [dietary supplements].  Specifically, *** 2
15742 21 CFR 111.210(h)(3) Specific actions; packaged, labeled The written instructions in your master manufacturing record did not include specific actions to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure that the dietary supplement is packaged and labe 2
15745 21 CFR 111.210(h)(1) Instructions; specifications; packaged, labeled 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 i 2
15760 21 CFR 111.205(b)(1) Master manufacturing record-specifications; packaged, label 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 manufacturin 2
15765 21 CFR 111.430(a) Packaging, labeling operations:originals, copies, electronic You did not keep the records required for your packaging and labeling operations as original records, true copies, or as electronic records.  Specifically, *** 2
15774 21 CFR 111.415(f)(1) Batch-lot,control number packaged, labeled dietary supplemen 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, *** 2
15783 21 CFR 111.410(d) Manufacturing history  You were not able to determine the complete manufacturing history and control of a packaged and labeled dietary supplement through distribution.  Specifically, *** 2
15785 21 CFR 111.410(b) Label, packaging - discrepancies  You did not control the reconciliation of any issue and use [label discrepancies] [packaging discrepancies].  Specifically,  *** 2
15801 21 CFR 111.560(b) Quality control, review, approve; investigate, follow-up 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, *** 2
15821 21 CFR 111.60(a) Production, in- process control system - design, quality 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 supplement.  Specifically, *** 2
15832 21 CFR 111.70(c)(1) In-process identity, purity, strength, composition 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, *** 2
15834 21 CFR 111.70(c)(2) Specifications identity, purity strength, composition  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] [composit 2
15842 21 CFR 111.70(f) Specifications - product received for packaging, labeling  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, *** 2
15850 21 CFR 111.73  Specifications met  in-process purity, strength, composition You did not determine whether you met in-process specifications to ensure the [purity] [strength] [composition] of the dietary supplements.  Specifically, *** 2
15854 21 CFR 111.73 Specifications met - contamination limits  You did not determine whether you met established limits on contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement.  Specifically, *** 2
15870 21 CFR 111.75(c)(1) Specifications met - verify; production, process control  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 2
15891 21 CFR 111.80(a) Components packaging, labels received 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, *** 2
15903 21 CFR 111.87 Material review, disposition - quality control  Your quality control personnel did not [conduct required material reviews] [make required disposition decisions].  Specifically, 2
15908 21 CFR 111.90(b)(1) Reprocessed, dietary supplement - no material review  You reprocessed a dietary supplement for which quality control personnel did not [conduct a material review] [make a disposition decision to approve the reprocessing].  Specifically, *** 2
15939 21 CFR 111.105(g) Quality control - reserve samples Your quality control personnel did not ensure that required reserve samples were collected and held.  Specifically, *** 2
15941 21 CFR 111.105(i)   QC required operations production and process control Your quality control personnel did not perform required operations for the production and process control system.  Specifically, *** 2
15943 21 CFR 111.105(i)   QC required operations components packaging labels Your quality control personnel did not perform required operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement. Specifically,  *** 2
15952 21 CFR 111.113 Quality control operations - material review, disposition You do not have quality control operations for a material review and disposition decision.  Specifically, *** 2
15953 21 CFR 111.113(a)(1)   QC production, process control; material review, disposition 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, *** 2
15970 21 CFR 111.120 Quality control operations - components, packaging, labels You do not have quality control operations for [components] [packaging] [labels] before use in the manufacture of a dietary supplement.  Specifically, *** 2
15972 21 CFR 111.120(b) QC operations -specifications; components, packaging, labels Your quality control operations did not include determining whether [components] [packaging] [labels] conform to established specifications.  Specifically,  *** 2
15995 21 CFR 111.127(d)   QC operations - packaged, labeled; specifications Your quality control operations did not include determining whether the finished [packaged] [labeled] dietary supplement conforms to established specifications.  Specifically, *** 2
16047 21 CFR 111.510 Returned dietary supplement - material review, disposition  You did not identify and quarantine returned dietary supplements until quality control personnel conducted a material review and made a disposition decision.  Specifically, ***  2
16052 21 CFR 111.530 Returned dietary supplement - investigation  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, *** 2
16132 21 CFR 118.4(b)(1) Limiting visitors Visitors are not limited [on the farm] [in the poultry houses].  Specifically,*** 2
16141 21 CFR 118.4(c)(2) Satisfactory fly control methods When your monitoring indicated unacceptable fly activity within a poultry house, appropriate methods were not used to achieve satisfactory fly control.  Specifically,*** 2
16142 21 CFR 118.4(c)(3) Removal of pest harborages 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,*** 2
16145 21 CFR 118.4(d) (1) Visible manure As part of a cleaning and disinfecting operation, all visible manure was not removed from the poultry house.  Specifically,*** 2
16153 21 CFR 118.5(a)(1) Poultry house has multiple groups of laying hens 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,*** 2
16172 21 CFR 118.7(a) Plan appropriate to layout The poultry house environmental sampling plan was not appropriate to the poultry house layout. Specifically,*** 2
16193 21 CFR 118.10(a)(3)(ii) Rodent and pest control documentation   You did not maintain records documenting compliance with rodent and other pest control measures.  Specifically,*** 2
16194 21 CFR 118.10(a)(3)(iii) Depopulation cleaning and disinfection procedures You did not maintain records documenting compliance with cleaning and disinfection procedures performed at depopulation. Specifically,***  2
16195 21 CFR 118.10(a)(3)(iv) Refrigeration requirements documentation You do not maintain records documenting compliance with refrigeration requirements.  Specifically*** 2
16449 21 CFR 113.40(g)(1)(i)(A) Aseptic processing: TID accuracy test, traceable A temperature-indicating device was not tested for accuracy [against a reference device for which the accuracy is traceable to a National Institute of Standards and Technology, or other national metrology institute, standard reference device] [by appropri 2
16461 21 CFR 113.40(g)(1)(i)(B)(1) Aseptic processing: recorder, appropriate chart The appropriate chart was not used with a temperature-recording device that records to a chart.  Specifically, *** 2
16490 21 CFR 113.40(j) Other systems: Commercial sterility A system for processing a low-acid food in hermetically sealed containers was not operated and administered in a manner adequate to ensure that commercial sterility was achieved.  Specifically, *** 2
899 21 CFR 123.16 Process controls Your HACCP Plan for [smoked] [smoke flavored] fishery product does not include controls for Clostridium botulinum. Specifically, *** 1
949 21 CFR 123.12(c) Records, English The records that document the performance and results of the affirmative step you chose are not in English.   Specifically, *** 1
972 21 CFR 123.8(a)(1) Modification HACCP plan You did not immediately modify your HACCP plan after a reassessment revealed the plan to no longer be adequate.  Specifically, *** 1
1197 21 CFR 110.10(a) Lack of instruction/reporting of health conditions Personnel with  adverse health conditions are not instructed to report to their supervisors.  Specifically, *** 1
1255 21 CFR 129.20(a) Bottling room separation, plant operations The bottling room was not separated from other plant operations by [tight walls] [ceilings] [self-closing doors] to protect against contamination.  Specifically, *** 1
1277 21 CFR 129.20(d) Wash, sanitize - enclosed room You did not [wash] [sanitize] containers for bottled drinking water in an enclosed room.  Specifically, *** 1
1288 21 CFR 110.20(a)(2) Roads/yards/parking lots Failure to properly maintain [roads] [yards] [parking lots] so that they do not constitute a source of contamination in areas where food is exposed. Specifically, *** 1
1300 21 CFR 113.81(c) Fill The filling of containers is not controlled to ensure that the filling requirements specified in the scheduled process are met.  Specifically, *** 1
1325 21 CFR 113.100(g) Record retention Copies of required records were not maintained [at the processing plant for a period of not less than 1 year from the date of manufacture] [at the processing plant or other reasonably accessible location for an additional 2 years after the initial 1 year  1
1353 21 CFR 129.35(a)(3)(i) Sample - total coliforms 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, *** 1
1453 21 CFR 129.40(a)(1) Suitability - equipment, utensils Plant equipment or utensils were not suitable for their intended use.  Specifically, *** 1
1472 21 CFR 113.83 Critical factors not stated A critical factor that may affect the scheduled process was not specified in the scheduled process.  Specifically, *** 1
1500 21 CFR 113.89 Evaluation by process authority Failure to have a deviation from the scheduled process evaluated for public health significance by a competent processing authority.  Specifically, *** 1
1532 21 CFR 113.100(a)(7) Other systems - records; critical factors Records were not maintained for critical factors specified [in the formulation of the product] [in the scheduled process].  Specifically, *** 1
1533 21 CFR 113.100(b) Recording device records - dated; retort number 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, *** 1
1559 21 CFR 110.35(c) Guard/guide dogs The [guard dog][guard dogs][guide dog][guide dogs] in the plant [is][are] likely to result in the contamination of [food][food-contact surfaces][food-packaging materials].  Specifically, *** 1
1648 21 CFR 113.40(a)(1) No TID Each retort did not have at least one temperature-indicating device that accurately indicated the temperature during processing.  Specifically, *** 1
1653 21 CFR 113.40(a)(1)(v) TID not accurately, easily read A temperature-indicating device was not installed where it could be accurately and easily read.  Specifically, *** 1
1665 21 CFR 110.80(a)(2) Pasteurization or other adequate treatment [Raw materials] [Ingredients] which contain levels of microorganisms that may produce food poisoning or other disease are not pasteurized or otherwise adequately treated.  Specifically, *** 1
1731 21 CFR 113.40(a)(2) Present each retort, accurate Each retort did not have an accurate temperature-recording device.    Specifically, *** 1
1745 21 CFR 113.40(a)(5) Location opposite vent Steam did not enter the top or bottom portion of the retort that was opposite the vent.  Specifically, *** 1
1751 21 CFR 113.40(a)(8) Bleeder size A bleeder was not 1/8-inch (3 millimeters) or larger.  Specifically, *** 1
1865 21 CFR 113.40(a)(12) Timing before vent, before temperature reached Timing of a process began [before the retort was properly vented] [before the processing temperature was reached].  Specifically, *** 1
2056 21 CFR 123.28(a) HACCP plan Your HACCP plan for raw molluscan shellfish does not include controls to ensure the molluscan shellfish are harvested from an approved source.  Specifically, *** 1
2065 21 CFR 123.28(c) Shellstock records You do not maintain records that document the [date of harvest] [location of harvest by State and site] [quantity and type of shellfish received] [date of receipt] [name of the harvester OR registration number of the harvester vessel OR the identification 1
2101 21 CFR 113.40(a)(13) Measured, recorded 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, *** 1
2134 21 CFR 113.40(d)(4) No steam controller A retort was not equipped with an automatic steam controller to maintain the retort temperature.  Specifically, *** 1
2144 21 CFR 113.40(b)(1) TID accuracy test frequency 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, *** 1
2151 21 CFR 113.40(b)(2)(i) Range, chart graduations 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, *** 1
2165 21 CFR 113.40(b)(7) Container positioning The positioning of containers in the retort was not in accordance with the scheduled process.  Specifically, *** 1
2166 21 CFR 113.40(b)(7) Flexible containers Dividers, racks, trays, or other means of positioning of flexible containers were not [designed] [employed] to ensure even circulation of the heating medium around all containers in the retort.  Specifically, *** 1
2272 21 CFR 129.80(e) Records - product, volume, date, code, distribution 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, *** 1
2273 21 CFR 129.80(g)(1) Representative samples - bottled water 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, *** 1
2275 21 CFR 129.80(g)(2) Chemical, physical, radiological tests - bottled water 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, *** 1
2309 21 CFR 113.40(c)(1)(v) TID not accurately, easily read A temperature-indicating device was not installed where it could be accurately and easily read.  Specifically, *** 1
2321 21 CFR 113.40(c)(2)(iii) Unauthorized adjustment A means of preventing unauthorized adjustment to the temperature-recording device was not provided.  Specifically, *** 1
2427 21 CFR 110.80(b)(9) Proper disposal of adulterated product Failure to dispose of adulterated [food] [raw materials] in a manner which protects against the contamination of other food.  Specifically, *** 1
2428 21 CFR 110.80(b)(9) Proper reconditioning Failure to use a proven effective method of reconditioning adulterated food.  Specifically, *** 1
2461 21 CFR 113.40(d)(2) Present each retort, accurate Each retort did not have an accurate temperature-recording device.  Specifically, *** 1
2494 21 CFR 113.40(e)(1) TID accuracy test frequency 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, *** 1
2513 21 CFR 113.40(e)(9) Critical Factors measured, recorded 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, *** 1
2837 21 CFR 113.40(g)(4) Critical factors record - frequency 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, *** 1
2844 21 CFR 113.40(g)(1)(i)(B) Present each sterilizer, accurate  Each product sterilizer did not have an accurate temperature-recording device.  Specifically, *** 1
2846 21 CFR 113.40(g)(1)(i)(B)(1) Recorder range, chart graduations 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, *** 1
2852 21 CFR 113.40(g)(1)(i)(c) Range Graduations on the temperature recorder-controller chart exceeded 2 degrees F within a range of 10 degrees F of the product sterilization  temperature.  Specifically, *** 1
2869 21 CFR 113.40(g)(1)(ii)(E) TID reading, holding tube outlet - start packaging The temperature indicated by the temperature-indicating device in the holding tube outlet was not [observed] [recorded] at the start of aseptic packaging operations.  Specifically, *** 1
2886 21 CFR 113.40(i) Thermal process crit factors-measurement adequate & accurate The [time] [temperature] of processing [was] [were] not measured with an instrument having the accuracy and dependability adequate to ensure that the requirements of the scheduled process were met.  Specifically, *** 1
3074 21 CFR 114.80(a)(2) Using pH meter Failure to [use a potentiometer to measure pH] [relate in-process measurements by titration or colorimetry to the finished equilibrium pH] when the finished equilibrium pH is above 4.0. Specifically, *** 1
3079 21 CFR 114.80(b) Code - packing period The packing period is not changed often enough to enable ready identification of lots during sale and distribution  Specifically, *** 1
3663 21 CFR 110.40(e) Lack of automatic control / alarm (S) 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, *** 1
3773 21 CFR 113.40(a)(7) Number and size of steam spreader perforations (S) In a still steam retort, the total cross-sectional area of steam spreader perforations was [less than 1 1/2] [greater than 2] times the cross-sectional area of the smallest restriction in the steam inlet line.  Specifically, *** 1
3799 21 CFR 113.40(d)(1) TID identity - tag, seal A temperature-indicating device did not have a tag, seal, or other means of identity.  Specifically, *** 1
3821 21 CFR 113.40(g)(1)(i)(A) TID identity - tag, seal A temperature-indicating device did not have a tag, seal, or other means of identity.  Specifically, *** 1
3824 21 CFR 113.40(c)(1)(ii) TID record of accuracy Records of the accuracy of a temperature-indicating device were not established.  Specifically, *** 1
3826 21 CFR 113.40(e)(1)(ii) TID record of accuracy Records of the accuracy of a temperature-indicating device were not established.  Specifically, *** 1
3834 21 CFR 113.40(g)(1)(i)(I) Operator monitor seals, barriers (S) Appropriate means were not provided to permit the operator to monitor the performance of the seals or barriers at access points downstream from the holding tube.  Specifically, *** 1
3848 21 CFR 113.40(g)(4) Critical factors record - 15 minutes (S) A critical factor specified in the scheduled process was not [measured] [recorded] at intervals of 15 minutes or less.  Specifically, *** 1
3856 21 CFR 113.60(a) Frequency: visual closure examination, qualified person. A qualified container closure inspection person did not visually examine [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 *** 1
3857 21 CFR 113.60(a) Record: visual closure examination, qualified person A qualified container closure inspection person did not record visual observations of gross closure defects.  Specifically, *** 1
3861 21 CFR 113.60(a) Closure defects - Corrective actions taken and recorded Corrective action for gross container closure defects was not [taken] [recorded].  Specifically, *** 1
3862 21 CFR 113.60(a)(1) Teardown examinations - did not perform Teardown examinations for double-seam cans were not performed [by a qualified individual].  Specifically, *** 1
3864 21 CFR 113.60(a)(1) Recording of teardown examinations Teardown examinations for double-seam cans were not performed on enough containers from each seaming station to ensure maintenance of seam integrity.  Specifically, *** 1
3870 21 CFR 113.60(a)(2) Glass containers; cold water vacuum check The capper efficiency for glass containers with vacuum closures was not checked by a measurement of the cold water vacuum before filling operations.  Specifically, *** 1
3871 21 CFR 113.60(a)(2) Record of cold water vacuum check The results of glass container capper cold water vacuum tests were not recorded.  Specifically, *** 1
3875 21 CFR 113.60(b) Cooling water - residual sanitizer (S) There was no measurable residual of the cooling water sanitizer at the water discharge point of the container cooler.  Specifically, *** 1
3876 21 CFR 113.60(c) Coding - no mark, permanently visible Hermetically sealed containers of low-acid processed food were not marked with an identifying code [that was permanently visible to the naked eye].  Specifically, *** 1
3878 21 CFR 113.60(c) Coding - Change of pack period The packing period code for hermetically sealed containers was not changed with sufficient frequency to enable ready identification of lots during their sale and distribution.  Specifically, *** 1
4179 21 CFR 113.83 Records of process establishment Complete records [covering all aspects of the establishment of the scheduled process] [for incubation tests associated with establishing the scheduled process] were not [prepared] [permanently retained] by the person or organization making the determinati 1
4421 21 CFR 110.20(a) Maintenance of grounds Maintenance of the grounds is inadequate to protect against contamination of food.  Specifically, ***  1
4460 21 CFR 114.80(a)(1) Use of preservatives (S) Failure to use preservatives (in lieu of thermal processing) to inhibit reproduction of microorganisms of non-health significance. Specifically, ***  1
4507 21 CFR 114.100(c) Process deviations - affected portion The affected portion of a product having a departure from a scheduled process is not identified.  Specifically, *** 1
4520 21 CFR 108.35(c)(3)(ii) Process information availability Failure to provide FDA, when requested in writing, with information concerning processes and procedures deemed necessary to determine the adequacy of the process. Specifically, *** 1
4526 21 CFR 108.35(h) Record inspection and copying Failure to permit [inspection] [copying] of records [of processing] [of deviations in processing] [of container closure inspections] [specified in 21 CFR 113], upon written demand by FDA, to verify the adequacy of processing, the integrity of container cl 1
4528 21 CFR 108.35(c)(2)(ii) Process change recording For an intentional change in a previously filed scheduled process, substantiation was not [promptly recorded] [verified in writing by the authority] [placed in your files for review by FDA].  Specifically, *** 1
6011 21 CFR 123.8(a)(3)(ii) Corrective action record review adequacy Your review of corrective action records does not [ensure that the records are complete] [verify that the appropriate corrective actions have been taken].  Specifically, *** 1
9919 21 CFR 120.10(a) Corrective action - predetermined plan inadequate You did not take corrective action that ensured [affected product was not entered into commerce] [the cause of the deviation was corrected]. Specifically, *** 1
9921 21 CFR 120.10(b) Corrective action - no predetermined plan Your HACCP plan does not include a corrective action plan.  There was a deviation from a critical limit and you did not take corrective action that ensured [affected product was segregated and held] [a review of the affected product by someone who is adeq 1
9962 21 CFR 120.24(b) Process controls - direct treatment  - not exempt Your treatments intended to achieve a 5-log reduction in the most resistant microorganism of public health significance are not applied directly to the juice, and the exemption for surface treatment of fruit does not apply.  Specifically, *** 1
9964 21 CFR 120.25 Finished product not analyzed for E.coli You do not [always] analyze your finished juice product for biotype I Escherichia coli.   Specifically, *** 1
9965 21 CFR 120.25(b) Process verification - sampling each product You do not [always] take samples from each juice product you produce that is subject to the requirements for Escherichia coli analysis.  Specifically, *** 1
12704 21 CFR 129.80(a) Product water samples - Analysis frequency You did not analyze product water samples as often as necessary to assure uniformity and effectiveness of the treatment processes performed by the plant.  Specifically, *** 1
12709 21 CFR 129.80(c) Records - cleaning, sanitizing solutions You did not maintain records of [sampling] [testing] of cleaning and sanitizing solutions.  Specifically, *** 1
12735 21 CFR 120.12(d)(3) Records - seasonal pack - retrieval Your records were transferred to another location at the end of the seasonal pack and they were not returned immediately to the processing facility upon request for official review.  Specifically, *** 1
15310 21 CFR 70.25 Color additive labeling Color additive was not labeled with [the name of the straight color] [the name of each ingredient comprising  the color additive] [a statement indicating general limitations for use] [the amount of each straight color in terms of weight per unit/volume or 1
15349 FDCA 761(d) MedWatch form not used (dietary supplements) A serious adverse event report for a dietary supplement was not submitted on a MedWatch form. Specifically, *** 1
15358 FDCA 761(c)(1) Timing of AE report submission (dietary supplement) 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, *** 1
15392 21 CFR 111.10(b)(4) Jewelry and objects - remove Your personnel did not remove unsecured [jewelry] [objects] that might fall into components, dietary supplements, equipment, or packaging.  Specifically, *** 1
15397 21 CFR 111.10(b)(7) Personal belongings Your personnel stored clothing or other personal belongings in areas where [components, dietary supplements, or contact surfaces are exposed] [contact surfaces are washed].  Specifically, *** 1
15400 21 CFR 111.12(a) Personnel - qualified - general Your personnel are not qualified to [manufacture] [package] [label] [hold] dietary supplements.  Specifically, *** 1
15405 21 CFR 111.13(a) Supervisor - qualified You have not assigned qualified personnel to supervise the [manufacturing] [packaging] [labeling] [holding] of dietary supplements].  Specifically, *** 1
15408 21 CFR 111.14(a) Personnel - records - availability You did not have  records or copies of  records required for personnel readily available during the required retention period for inspection and copying by FDA when requested.  Specifically, *** 1
15423 21 CFR 111.15(j) Trash disposal You did not convey, store, and dispose of trash to [minimize development of odors] [minimize potential for the trash to attract, harbor, or become a breeding place for pests] [protect against contamination of components, dietary supplements, contact surfa 1
15436 21 CFR 111.15(a) Grounds - condition You did not keep the grounds of your physical plant in a condition that protects against contamination.  Specifically, *** 1
15445 21 CFR 111.15(c)(1) Sanitizing agents You did not use sanitizing agents that [are free from microorganisms of public health significance] [are safe and adequate under the conditions of use].  Specifically, *** 1
15446 21 CFR 111.15(c)(2) Toxic materials - use You [used] [held] toxic materials in your physical plant that were not necessary to maintain clean and sanitary conditions, for use in laboratory testing procedures, for maintaining or operating your physical plant or equipment, or for use in your plant's 1
15450 21 CFR 111.15(f)(3) Plumbing - source of contamination 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, *** 1
15462 21 CFR 111.20(d)(1)(iv) Physical plant - temperature, humidity controls Your physical plant did not have equipment that controls temperature and humidity when it is necessary to ensure the quality of the dietary supplement.  Specifically, *** 1
15467 21 CFR 111.20(c)(1) Physical plant - receiving, holding, identifying You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components and dietary supplements during receiving, identifying, holding, and withholding from use components, die 1
15468 21 CFR 111.20(c)(2) Physical plant - material review and disposition You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplements by separating components, dietary supplements, packaging, and labels that are to  1
15469 21 CFR 111.20(c)(3) Physical plant - separate areas for products You [did not have] [did not use] separate or defined areas of adequate size or other control systems to prevent contamination or mix-ups of components or dietary supplement  by separating the [manufacturing] [packaging] [labeling] [holding] of different p 1
15493 21 CFR 111.25(b) Procedures - calibrating automated, mechanical equip You did not [establish] [follow] written procedures for calibrating, inspecting, and checking automated, mechanical, and electronic equipment.  Specifically, *** 1
15500 21 CFR 111.27(a)(2) Equipment - design - no contamination You used equipment or utensils that were not of appropriate design and construction so that the use resulted in contamination of components or dietary supplements.  Specifically, *** 1
15502 21 CFR 111.27(a)(3)(ii) Equipment - corrosion-resistant Your equipment or utensils that contact components or dietary supplements are not corrosion-resistant.  Specifically, *** 1
15508 21 CFR 111.27(a)(5)(ii) Refrigerator, freezer - alarm Your freezer, refrigerator, or other cold storage compartments that you use to hold components or dietary supplements does not have either an automated device for regulating temperature or an automated alarm system to indicate a significant temperature ch 1
15510 21 CFR 111.27(a)(7) Compressed air, gases The compressed air or other gases you introduced mechanically into or onto a component, dietary supplement, or contact surface or that you used to clean any contact surface was not treated in such a way that the component, dietary supplement, or contact s 1
15511 21 CFR 111.27(d) Equipment - maintain - general You did not [maintain] [clean] [sanitize]  equipment, utensils, and contact surfaces used to manufacture, package, label, or hold components or dietary supplements.  Specifically, *** 1
15521 21 CFR 111.27(d)(6) Cleaning compounds - adequate, safe Cleaning compounds or sanitizing agents were not [adequate for their intended use] [safe under their conditions of use].  Specifically, *** 1
15534 21 CFR 111.255(c)   Batch record - each step You did not perform each step in the production of a batch, according to the master production record.  Specifically, *** 1
15545 21 CFR 111.260(e) Batch record - component; identity, weight Your batch production records did not include the [identity] [weight or measure] of each component used.  Specifically, *** 1
15557 21 CFR 111.260(k) Batch record - packaging, labeling Your batch production records did not include documentation, at the time of performance, of [packaging] [labeling] operations.  Specifically, *** 1
15558 21 CFR 111.260(k)(1) Batch record - identifier; packaging Your batch production records did not include [the unique identifier assigned to packaging used] [the quantity of the packaging used].  Specifically, *** 1
15564 21 CFR 111.260(l)(1)(ii) Batch record - quality control; tests, examinations Your batch production records did not include documentation that quality control personnel reviewed the results of tests and examinations.  Specifically, *** 1
15577 21 CFR 111.155(b) Visually examine - supplier's invoice 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, *** 1
15581 21 CFR 111.155(c)(3) Quality control - components, approve, release 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, *** 1
15582 21 CFR 111.155(e) Components - contamination, deterioration, mix-ups You did not hold components under conditions that will [protect against contamination] [protect against deterioration] [avoid mix-ups].  Specifically, *** 1
15584 21 CFR 111.155(d)(1) Components - identify lot produced  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 di 1
15594 21 CFR 111.160(c)(2) Packaging - quality control; tests, examination 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, *** 1
15597 21 CFR 111.160(c)(3) Labels - quality control; approve, release Your quality control personnel did not approve labels for use in the manufacture of a dietary supplement and release them from quarantine.  Specifically, *** 1
15602 21 CFR 111.160(e) Packaging, labels - mix-ups  You did not hold [packaging] [labels] under conditions that will avoid mix-ups.  Specifically, *** 1
15605 21 CFR 111.165? Product received - quarantine  You did not quarantine received product.  Specifically, *** 1
15607 21 CFR 111.165(c)(2) Product received - quality control; documentation; specs Your quality control personnel did not review and approve documentation to determine whether quarantined received product meets established specifications.  Specifically,  *** 1
15618 21 CFR 111.180(b)(1) Written procedures - components  You did not make and keep written procedures for fulfilling the requirements that apply to components of dietary supplements.  Specifically,  *** 1
15619 21 CFR 111.180(b)(1)  Written procedures - packaging, labeling received  You did not make and keep written procedures for fulfilling the requirements that apply to packaging and labeling received.  Specifically, *** 1
15623 21 CFR 111.180(b)(2) Records - receiving; components, packaging, labels, products You did not make and keep receiving records for [components] [packaging] [labels] [products you received for packaging or labeling as a dietary supplement].  Specifically,  *** 1
15628 21 CFR 111.180(b)(3) Documentation - rejected components, packaging, labels  You did not make and keep documentation that the requirements that apply to production and process control for rejected components, packaging, or labels were met.  Specifically, *** 1
15632 21 CFR 111.180(b)(3)(ii)(B) Documentation - required operation; initials  Your documentation of a required operation did not include the initials of the person performing the required operation.  Specifically, *** 1
15633 21 CFR 111.180(b)(3)(ii)(C) Documentation - required operation; results  Your documentation of a required operation did not include the results of [tests or examinations conducted on components, packaging, or labels] [visual examination of product that you received for packaging or labeling as a dietary supplement].  Specifica 1
15646 21 CFR 111.460(a)  Hold, identify - in-process material  You did not identify and hold in-process material under conditions that protect against mix-up, contamination, or deterioration.  Specifically, *** 1
15656 21 CFR 111.475(a)  Records-holding, distribution: originals, copies, electronic You did not keep the records required for your holding and distributing operations as original records, true copies, or as electronic records.  Specifically, *** 1
15662 21 CFR 111.303 Written procedures - laboratory operations  You did not [establish] [follow] written procedures for laboratory operations. Specifically, *** 1
15667 21 CFR 111.310 Laboratory facilities -  component specifications  You did not use adequate laboratory facilities to perform [testing] [examinations] necessary to determine whether your components met specifications.  Specifically, *** 1
15669 21 CFR 111.310(c) Laboratory facilities -  dietary supplement specifications  You did not use adequate laboratory facilities to perform [testing] [examinations] necessary to determine whether your dietary supplements met specifications.  Specifically, *** 1
15672 21 CFR 111.315  Laboratory control  processes - reviewed, approved  The laboratory control processes that you established and followed were not reviewed and approved by quality control personnel. Specifically, *** 1
15673 21 CFR 111.315(a) Criteria for establishing specifications  You did not [establish] [follow] laboratory control processes for use of criteria for establishing appropriate specifications.  Specifically, *** 1
15680 21 CFR 111.315(d) Standard reference materials; criteria for selecting, QC Your laboratory control processes for use of criteria for selecting standard reference materials used in performing tests and examinations were not reviewed and approved by quality control personnel.  Specifically, *** 1
15696 21 CFR 111.315(e) Examination, testing; established criteria You did not [establish] [follow] laboratory control processes for use of test methods and examinations in accordance with established criteria.  Specifically, *** 1
15708 21 CFR 111.325(a) Written procedures, laboratory operations You did not make and keep written procedures for laboratory operations. Specifically, *** 1
15709 21 CFR 111.325(b)(2) Laboratory methodology followed You did not make and keep documentation that established laboratory methodology was followed.  Specifically, *** 1
15715 21 CFR 111.375(b) Records - manufacturing operations; written procedures  You did not make and keep records of the written procedures for manufacturing operations.  Specifically, *** 1
15722 21 CFR 111.365(j) Containers - segregating, identifying   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, *** 1
15750 21 CFR 111.210(d) Master manufacturing record - ingredients list  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, *** 1
15752 21 CFR 111.210(c) Master manufacturing record - components; weight, measure  Your master manufacturing record did not include an accurate weight or measure of each component to be used.  Specifically, *** 1
15753 21 CFR 111.210(b) Master manufacturing record - list components Your master manufacturing record did not include a complete list of components to be used.  Specifically, *** 1
15755 21 CFR 111.205(c) Master manufacturing record:  readily available  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, *** 1
15758 21 CFR 111.205(c) Master manufacturing record: 1 year, 2 years  You did not keep a master manufacturing record for the required time period.  Specifically, *** 1
15767 21 CFR 111.425   Quarantine - rejected packaged, labeled dietary supplement  You did not clearly [identify] [hold] [control] under a quarantine system for appropriate disposition packaged and labeled dietary supplement rejected for distribution.  Specifically, *** 1
15772 21 CFR 111.415(g)  Representative sample - packaged, labeled dietary supplement You did not examine a representative sample of each batch of packaged and labeled dietary supplement to determine whether the dietary supplement meets established specifications.  Specifically,  *** 1
15775 21 CFR 111.415(e)  Dietary supplement containers - mix-ups  You did not [identify] [identify by effective means] filled dietary supplement containers that are set aside and held in unlabeled condition for future label operations, to prevent mix-ups.  Specifically, *** 1
15777 21 CFR 111.415(c) Filling, assembling, packaging, labeling - sanitary handling You did not use sanitary handling procedures during [filling] [assembling] [packaging] [labeling] operations.  Specifically, *** 1
15779 21 CFR 111.415(a)  Clean, sanitize - filling, packaging equipment  You did not clean and sanitize [filling and packaging equipment] [utensils] [dietary supplement packaging], as appropriate.  Specifically, *** 1
15805 21 CFR 111.570(a) Records - product complaints: 1 year, 2 years You did not keep the records required for product complaints for the required time period.  Specifically, *** 1
15810 21 CFR 111.570(b)(2)  Record - product complaint; good manufacturing practice  You did not make and keep a written record of every product complaint that was related to good manufacturing practice.  Specifically, *** 1
15820 21 CFR 111.55 Production, process controls - packaged, labeled  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 man 1
15826 21 CFR 111.65 Quality control - packaged, labeled  You did not implement quality control operations to ensure that the dietary supplement is [packaged] [labeled] as specified in the master manufacturing record.  Specifically, *** 1
15833 21 CFR 111.70(c)(1) Specifications - in-process contamination limits  You did not establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary for limits on contamination that may adulterate or may lead to adulteration of the finished dietary supplement.  Spec 1
15845 21 CFR 111.73 Specifications met - quality  You did not determine whether you met specifications established to ensure the quality of the dietary supplement.  Specifically, *** 1
15855 21 CFR 111.73   Specifications met - received product identified  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, *** 1
15880 21 CFR 111.75(f)(2) Label - visual examination, review supplier's documentation  You did not [conduct a visual examination of the label] [review the supplier's invoice, guarantee, or certification] to determine whether label specifications are met.  Specifically, *** 1
15886 21 CFR 111.77(b)  Specifications not met - identity; component, reject  Your quality control personnel did not reject a component that did not meet an identity specification.  Specifically,  *** 1
15894 21 CFR 111.80(d) Specifications - representative samples; unique lot  You did not collect representative samples of [each unique shipment] [each unique lot within each unique shipment] product that you received for packaging or labeling as a dietary supplement to determine whether the received product meets established spec 1
15899 21 CFR 111.83(b)(1)  Reserve sample container-closure contamination,deterioration 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 w 1
15901 21 CFR 111.83(b)(3) Reserve sample - retained   You did not retain reserve samples for the required time.  Specifically, *** 1
15935 21 CFR 111.105(d)   Quality control - basis; tests, examinations Your quality control personnel did not review and approve the documentation setting forth the basis for why the results of appropriate tests or examinations for each product specification will ensure that the finished batch of the dietary supplement meets 1
15937 21 CFR 111.105(e)  Quality control - verification, periodic testing Your quality control personnel did not review and approve the basis and documentation for why a component, in-process testing, examination, monitoring, or other method will ensure that an exempted product specification is met without verification through  1
15938 21 CFR 111.105(f)   Quality control - representative samples Your quality control personnel did not ensure that required representative samples are collected.  Specifically, *** 1
15949 21 CFR 111.110(a) QC-Laboratory control processes; production, process control Your quality control operations did not include reviewing and approving laboratory control processes associated with the production and process control system.  Specifically, *** 1
15969 21 CFR 111.117(d)   Quality control operations - equipment functions Your quality control operations did not include reviewing and approving controls to ensure that [automated] [mechanical] [electronic] equipment functions according to [its] [their] intended use.  Specifically, *** 1
15982 21 CFR 111.123(a)(6)   Quality control operations - in-process specifications Your quality control operations did not include determining whether established in-process specifications were met.  Specifically, *** 1
15985 21 CFR 111.123(b)(1)   Quality control - components, identity specifications 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, *** 1
15991 21 CFR 111.127(a) Quality control operations - labeling; visual examinations Your quality control operations for labeling did not include reviewing the results of [visual examinations] [documentation] to ensure that established specifications were met for products that you receive for labeling.  Specifically, *** 1
15994 21 CFR 111.127(c)   Quality control operations - packaging, labeling; records Your quality control operations did not include reviewing and approving all records for [packaging] [label] operations.  Specifically, *** 1
16011 21 CFR 111.140(a)   Records - quality control operations:  electronic Your electronic records for your quality control operations do not comply with the electronic records requirements.  Specifically,  *** 1
16016 21 CFR 111.140(b)(2)(ii)   Signature; review, approval, rejection; reprocessing 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, *** 1
16017 21 CFR 111.140(b)(3)   Records - material review, disposition You did not make and keep documentation of your material review and disposition decision. Specifically, *** 1
16025 21 CFR 111.140(b)(3)(vii)     material review, disposition, follow-up; signature Your documentation of your material review and disposition decision and follow-up did not include the signature [of the individual designated to perform the quality control operation] [of each qualified individual who provides information relevant to that 1
16038 21 CFR 111.605(b)  Records - original, true copies  You did not keep original records, true copies, or electronic records. Specifically,   *** 1
16051 21 CFR 111.525(b) Returned dietary supplement - release  Your quality control personnel did not approve or reject the release for distribution of a returned dietary supplement that was reprocessed.  Specifically, *** 1
16067 21 CFR 111.35(b)(1)(ii) Procedures - equipment; calibrating, inspecting, checking You did not make and keep written procedures for [calibrating] [inspecting] [checking] automated, mechanical, or electronic equipment.  Specifically, *** 1
16068 21 CFR 111.35(b)(1)(iii) Equipment, utensils; maintaining, cleaning, sanitizing  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, *** 1
16074 21 CFR 111.35(b)(4)  Records - equipment; calibrations, inspections, checks  You did not make and keep written records of calibrations, inspections, or checks of automated, mechanical, or electronic equipment.  Specifically, *** 1
16085 21 CFR 111.75(c)(3)  Specifications met limits on contamination ; basis   You did not provide adequate documentation of your basis for determining that compliance with the specification[s] you selected for the limits on contamination that may adulterate or that may lead to adulteration of the dietary supplement will ensure that 1
16133 21 CFR 118.4(b)(2) Cross contamination from equipment You do not maintain practices that will protect against cross contamination when equipment is moved among poultry houses.  Specifically,*** 1
16134 21 CFR 118.4(b)(3) Cross contamination from people You do not maintain practices that will protect against cross contamination when people move between poultry houses.  Specifically,*** 1
16136 21 CFR 118.4(b)(5) Employees keeping birds at home Employees are allowed to keep birds at home.  Specifically,*** 1
16138 21 CFR 118.4(c)(1) Monitoring for rodents The presence of rodents is not monitored by appropriate monitoring methods.  Specifically,*** 1
16140 21 CFR 118.4(c)(2) Monitoring for flies The presence of flies is not monitored by appropriate monitoring methods. Specifically,*** 1
16156 21 CFR 118.5(b) Environmental testing after induced molting period Environmental testing of SE in a poultry house was not performed at 4 to 6 weeks after the end of the molting process which followed your inducing of a molt in a flock or a group in the flock.  Specifically,*** 1
16157 21 CFR 118.5(b)(1) SE testing 4 to 6 weeks after each molting process You did not perform environmental testing for SE 4 to 6 weeks after the end of the molting process each time a flock or group within the flock was molted.  Specifically*** 1
16171 21 CFR 118.7(a) Environmental test An environmental test for SE was not done for each poultry house as required.  Specifically,*** 1
16179 21 CFR 118.8(a) Method to be used, environmental samples 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, prec 1
16189 21 CFR 118.10(c) Records retention time All records are not retained for 1 year after the flock to which they pertain has been taken permanently out of production.  Specifically,***  1
16190 21 CFR 118.10(a)(1) Written SE prevention plan You do not have a written SE prevention plan.  Specifically,***  1
16191 21 CFR 118.10(a)(2) Pullets records documentation  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,*** 1
16205 21 CFR 118.10(b)(3) Signatures or initials on operational records All required records do not have the signature or initials of the person performing the operation or creating the record.  Specifically,*** 1
16293 21 CFR 113.100(c)(3) Accuracy record: outside facility, traceability A record of a temperature-indicating device accuracy test conducted by an outside facility did not include a guarantee, certificate of accuracy, certificate of calibration, or other document from the facility that includes a statement or other documentati 1
16307 21 CFR 113.40(a)(8) Still steam retorts: Bleeder not wide open during process A bleeder was not wide open during the entire process [including the come-up time].  Specifically, ***  1
16327 21 CFR 113.40(a)(12)(i)(B) Horizontal still retorts: manifold vents, length A horizontal retort with vents that discharged through a manifold into the atmosphere did not have one 1 inch (2.5 centimeter) vents for every 5 feet (1.5 meters) of retort length. Specifically, *** 1
16381 21 CFR 113.40(d)(1)(i) TID design; electromagnetic, environmental interference. A temperature-indicating device was not designed to ensure that the accuracy was not affected by [electromagnetic interference] [environmental conditions].  Specifically, *** 1
16448 21 CFR 113.40(g)(1)(i)(A) Aseptic processing: TID sensor, display A temperature-indicating device did not have a [sensor] [display].  Specifically, *** 1
16450 21 CFR 113.40(g)(1)(i)(A)(1) TID design, electromagnetic interference, environmental A temperature-indicating device was not designed to ensure that the accuracy was not affected by [electromagnetic interference] [environmental conditions].  Specifically, *** 1
16489 21 CFR 113.40(j) Other systems: Methods, controls - scheduled process The methods and controls used for the [manufacture] [processing] [packing] of a low-acid food [was not] [were not] as established in the scheduled process.  Specifically, *** 1
16494 FDCA 601(c) Insanitary conditions; contaminated with filth Your cosmetic was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth.  Specifically, *** 1
16508 21 CFR 129.80(f) Container sample results Your container sample results indicated [that more than one sample exceeded more than one bacteria per milliliter of capacity or one colony per square centimeter of surface area] [the presence of coliform organisms].  Specifically, *** 1
16509 21 CFR 129.20(a) Bottling room separation, storage areas The bottling room was not separated from storage areas by [tight walls] [ceilings] [selfclosing doors] to protect against contamination. Specifically, *** 1
17004 FDCA 402(a) Food Field Exam During a field examination of food products at your facility the following [was] [were] observed: 1
Cite Id Reference Number Short Description Long Description Frequency
12213 21 CFR 1271.47(a) Donor eligibility procedures 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, *** 14
12229 21 CFR 1271.50(a) Determination based on screening and testing HCT/P donors were not determined to be eligible based on the results of donor screening and testing.  Specifically, *** 9
12277 21 CFR 1271.75(a)(1) Risk factors, clinical evidence Donors were not screened by a review of relevant medical records for [risk factors]  [clinical evidence] of communicable disease agents and diseases.  Specifically, *** 9
12247 21 CFR 1271.55(d)(2) Accurate, indelible, legible Donor eligibility records are not [accurate] [indelible] [legible].  Specifically, *** 8
12416 21 CFR 1271.260(e) Storage temperatures recorded, maintained Storage temperatures of HCT/Ps were not [recorded] [maintained].  Specifically, *** 8
12221 21 CFR 1271.47(a) Procedures for all steps 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, *** 7
12286 21 CFR 1271.80(b) Specimen collections not  timely Donor specimens used for testing of communicable disease agents were not collected at the appropriate time.  Specifically, *** 7
12493 21 CFR 1271.90(b) Eligibility not required--warning labels HCT/Ps for which the donor eligibility determination was not performed were not prominently labeled with the appropriate warning statements.  Specifically, *** 7
12230 21 CFR 1271.50(a) Responsible person to determine, document 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, *** 6
12336 21 CFR 1271.180(a) Procedures to meet core CTGP 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, *** 5
12242 21 CFR 1271.55(c) Name and personal info on accompanying records The accompanying records for HCT/Ps included [the donor's name] [personal information that might identify the donor].  Specifically, *** 4
12283 21 CFR 1271.75(e) Abbreviated procedure  The abbreviated donor screening procedure [was used for donors who had no complete donor screening procedure in the previous six months] [did not determine and document changes in the donor's medical history that would make the donor ineligible].  Specifi 4
12223 21 CFR 1271.47(b) Review and approval of procedures Donor eligibility procedures were not [reviewed] [approved] by a responsible person before implementation.  Specifically, *** 3
12237 21 CFR 1271.55(a)(3) Summary--records used to make determination 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, *** 3
12246 21 CFR 1271.55(d)(1)(iii) Documentation--determination, by whom, date 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, *** 3
12272 21 CFR 1271.65(b)(2) Labeled re: biohazard, risks, test results 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, *** 3
12282 21 CFR 1271.75(d) Donors with risks not determined ineligible 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, *** 3
12310 21 CFR 1271.160(a) All core requirements covered in program 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 3
12326 21 CFR 1271.160(c) Quality audits performed periodically Periodic quality audits of activities related to core CGTP requirements have not been performed.  Specifically, *** 3
12373 21 CFR 1271.200(d) Inspected routinely Equipment was not routinely inspected for [cleanliness] [sanitation] [calibration] [adherence to maintenance schedules].  Specifically, *** 3
12222 21 CFR 1271.47(a) Design of procedures to ensure compliance Procedures were not designed to ensure compliance with the donor eligibility requirements.  Specifically, *** 2
12231 21 CFR 1271.50(b)(1) Donor screening standards 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  2
12238 21 CFR 1271.55(b)(1) Statement re: certified testing lab 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 equival 2
12239 21 CFR 1271.55(b)(2) Listing and interpretation of CD tests performed The summary of records for HCT/Ps did not contain [a listing] [an interpretation of results] of all communicable disease tests performed.  Specifically, *** 2
12287 21 CFR 1271.80(c) Kits not FDA approved, specifically labeled 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 o 2
12325 21 CFR 1271.160(b)(6) Deviations--evaluation, cause, corrective action 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].  Specifical 2
12333 21 CFR 1271.170(b) Not qualified, authorized for functions Personnel perform functions for which they are not [qualified] [authorized].  Specifically, *** 2
12334 21 CFR 1271.170(c) Trained or re-trained as necessary Personnel have not been [trained] [re-trained as necessary] to adequately perform their assigned responsibilities.  Specifically, *** 2
12353 21 CFR 1271.190(d)(1) Description of methods, schedule Facility cleaning and sanitation procedures did not describe [the cleaning methods to be used] [the schedule for cleaning].  Specifically, *** 2
12365 21 CFR 1271.195(d) Documentation not maintained Documentation of environmental control and monitoring activities was not maintained.  Specifically, *** 2
12372 21 CFR 1271.200(c) Calibrated per established schedules Equipment used for [inspection] [measuring] [testing] was not calibrated  according to established schedules.  Specifically, *** 2
12378 21 CFR 1271.210(d)(1) Receipt documentation maintained Documentation of the receipt of [supplies] [reagents] was not maintained.  Specifically, *** 2
12398 21 CFR 1271.230(a) Validation & approval--established procedures Processes with results which could not be fully verified by inspection and tests, were not validated and approved according to established procedures.  Specifically, *** 2
12405 21 CFR 1271.250(a) Controlling the labeling of HCT/Ps Procedures to control the labeling of HCT/Ps were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 2
12417 21 CFR 1271.260(e) Periodic review of temperatures Recorded storage temperatures were not periodically reviewed to ensure that temperatures have been within acceptable limits.  Specifically, *** 2
12431 21 CFR 1271.265(e) Procedures and release criteria Procedures including  release criteria for activities relating to  the [receipt] [shipment] [distribution] of HCT/Ps were not [established] [maintained] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 2
12433 21 CFR 1271.265(f) Return to inventory--procedures Procedures for determining if HCT/Ps that were returned to the establishment are suitable to be returned to inventory were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 2
12457 21 CFR 1271.320(a) Procedures re complaints Procedures for the [review] [evaluation] [documentation] [investigation] of complaints relating to core CGTP requirements were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 2
12496 21 CFR 1271.85(b)(2) SOP for release; reactive for CMV 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] [followed] [reviewed] [revised].  Specifically. *** 2
12224 21 CFR 1271.47(c) Availability of procedures 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, *** 1
12232 21 CFR 1271.50(b)(2) Donor testing not negative for CD agents Donor testing of HCT/P donors considered eligible was not negative  or nonreactive for relevant communicable disease agents.  Specifically, *** 1
12236 21 CFR 1271.55(a)(2) Eligibility statement--basis of determination 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, *** 1
12240 21 CFR 1271.55(b)(3) Name and address on summary The summary of records for HCT/Ps did not contain the [name] [address] of the establishment that made the donor-eligibility determination.  Specifically, *** 1
12243 21 CFR 1271.55(d)(1) Documentation maintained (general) Documentation was not maintained after the donor-eligibility determination was complete.  Specifically, *** 1
12252 21 CFR 1271.60(a) Completion of eligibility determination HCT/Ps were not kept in quarantine until completion of the donor-eligibility determination.  Specifically, *** 1
12271 21 CFR 1271.65(b)(2) Prominently labeled (limited use) HCT/Ps from ineligible donors which were made available for limited use were not prominently labeled.  Specifically, *** 1
12273 21 CFR 1271.65(b)(2) Required accompanying records--limited use HCT/Ps from ineligible donors which were made available for limited use were not accompanied by required records.  Specifically, *** 1
12278 21 CFR 1271.75(a)(2)  Risks associated with xenotransplantation Donors were not screened by a review of relevant medical records for disease risks associated with xenotransplantation.  Specifically, *** 1
12280 21 CFR 1271.75(c) Reproductive cells/ tissues- general 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. 1
12288 21 CFR 1271.80(c) Manufacturer instructions not followed Testing for communicable disease agents was not performed in accordance with the manufacturer's instructions.  Specifically, *** 1
12290 21 CFR 1271.80(d)(1) Reactive tests--not determined ineligible Donors whose specimens test reactive on screening tests for communicable disease agents were not determined to be ineligible.  Specifically, *** 1
12301 21 CFR 1271.150(c)(1)(iii) Ensurane of compliance You did not ensure that establishment(s) that  by contract, agreement or arrangement, perform manufacturing steps for you were in compliance with [applicable CGTP requirements prior to the initiation of the contract, agreement of arrangement] [applicable  1
12309 21 CFR 1271.160(a) Program is appropriate for the HCT/Ps A quality program appropriate for the  HCT/Ps manufactured and manufacturing steps performed has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised].  Specifically, *** 1
12311 21 CFR 1271.160(b)(1) Ensuring appropriate core requirements followed The quality program has not ensured that appropriate procedures related to core CGTP requirements were  [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [approved] [revised].  Specifically, *** 1
12315 21 CFR 1271.160(b)(2) Sharing of information (general) The quality program has not ensured that procedures exist for sharing of information pertaining to the possible contamination or communicable disease transmission of HCT/Ps.  Specifically, *** 1
12322 21 CFR 1271.160(b)(4) Training of personnel The quality program has not ensured the proper training and education of personnel involved in core GTP activities.  Specifically, *** 1
12338 21 CFR 1271.180(b) Review and approval-responsible person Procedures for core CGTP requirements were not [reviewed] [approved] by a responsible person before implementation.  Specifically, *** 1
12339 21 CFR 1271.180(c) Availability of procedures Procedures for core CTGP requirements were not available to personnel  in the area where operations are performed, or in a nearby area when such availability is impractical.  Specifically, *** 1
12340 21 CFR 1271.180(d) Adopted from another organization Current standard procedures adopted from another organization were [not verified to be consistent with the requirements of the CGTP regulations] [not appropriate for your operations].  Specifically, *** 1
12345 21 CFR 1271.190(b)(1) Clean, sanitary, orderly manner Facilities were not maintained in a [clean] [sanitary] [orderly] manner to prevent the introduction, transmission, or spread of communicable disease.  Specifically, *** 1
12354 21 CFR 1271.190(d)(2) Documentation of activities Documentation of facility cleaning and sanitation activities was not maintained.  Specifically, *** 1
12356 21 CFR 1271.195(a) Adequate control, proper conditions Environmental conditions existed in which [contamination or cross contamination of HCT/Ps or equipment] [the accidental exposure of HCT/Ps to communicable disease agents] could occur, and [environmental conditions were not adequately controlled] [proper c 1
12369 21 CFR 1271.200(b) Procedures inadequate Procedures for the [cleaning] [sanitizing] [maintenance] of equipment were not [established] [maintained] [defined] [documented] [implemented] [followed] [revised].  Specifically, *** 1
12382 21 CFR 1271.210(d)(3) Lot documentation maintained Documentation of the lot of [supplies] [reagents] used in the manufacture of each HCT/P was not maintained.  Specifically, *** 1
12385 21 CFR 1271.150(c)(2) Responsibility for review before distribution HCT/Ps were determined to meet all release criteria and made available for distribution without review of [manufacturing] [tracking] records to determine that all applicable requirements were met.  Specifically, *** 1
12400 21 CFR 1271.230(a) Documented, dated, signed The validation [activities] [results] were not [documented] [dated and signed by the individual(s) approving the validation].  Specifically, *** 1
12402 21 CFR 1271.230(c) Changes to validated process A validated process that was changed was not [reviewed] [evaluated] [revalidated].  Specifically, ** 1
12419 21 CFR 1271.265(a) Evaluation--microorganisms, damage Incoming HCT/Ps were [not evaluated for the presence and significance of microorganisms] [not inspected for damage and contamination].  Specifically, *** 1
12424 21 CFR 1271.265(c)(1) Release criteria verified, documented  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, *** 1
12425 21 CFR 1271.265(c)(1) Release of HCT/Ps by responsible person A  responsible person did not [document] [date] the determination that an HCT/P is available for distribution.  Specifically, *** 1
12429 21 CFR 1271.265(d) Shipping conditions appropriate Appropriate shipping conditions were not [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] for each type of HCT/P.  Specifically, *** 1
12437 21 CFR 1271.270(a) Records incomplete 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, *** 1
12447 21 CFR 1271.290(b) Establishing a system 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, **** 1
12452 21 CFR 1271.290(d) Recording I.D. code and type of HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system to record [the distinct identification code] [the type] of each HCT/P distributed to a consignee.  Specifically, * 1
12453 21 CFR 1271.290(e) Documenting disposition of each HCT/P A method has not been [established] [maintained] [defined] [documented] [implemented] [followed] [reviewed] [revised] in the tracking system [to document the disposition of each HCT/P] [to permit the prompt identification of the consignee of the HCT/P, if 1
12470 21 CFR 1271.350(a)(2) 15 day reporting timeframe Adverse reactions were not reported to FDA using form FDA 3500A within 15 calendar days of initial receipt of information.  Specifically, *** 1
12473 21 CFR 1271.350(b)(2) Deviations not reported to FDA 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, *** 1
12490 21 CFR 1271.85(b)(1) Cell-associated CD  Donors of leukocyte-rich cells or tissues were not tested for cell-associated communicable diseases.  Specifically, *** 1
12492 21 CFR 1271.85(a) Infection with communicable disease agents Donors were not tested for evidence of infection with communicable disease agents.  Specifically, *** 1
12495 21 CFR 1271.85(d) Retesting of semen donors Anonymous semen donors were not retested for evidence of infection with communicable disease agents at least six months after collection of the semen.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
7036 21 CFR 1250.67 Prevention of contamination 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, *** 31
7051 21 CFR 1250.75(a) Contamination of passenger stations Failure to dispose of human wastes in such a manner as to avoid contamination of passenger [areas] [stations].  Specifically, *** 11
6569 21 CFR 1250.33(b) Equipment kept clean Failure to keep all equipment clean.  Specifically, *** 10
6558 21 CFR 1250.30(d) Plumbing design, installation, maintenance Plumbing is not [designed] [installed] [maintained] so as to prevent contamination of [the water supply] [food] [food utensils].  Specifically, *** 9
7032 21 CFR 1250.63 Prevention of the spread of communicable diseases Servicing area are not [provided with all necessary sanitary facilities] [operated] [maintained] as to prevent the spread of communicable diseases.  Specifically, ***  9
6560 21 CFR 1250.32(a) Contamination Not all food-handling operations are accomplished so as to minimize the possibility of contaminating [food] [drink] [utensils].  Specifically, *** 8
6555 21 CFR 1250.30(a) Clean and free from flies, rodents, and other vermin Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are [clean] [free from flies, rodents, and other vermin].  Specifically, *** 7
6581 21 CFR 1250.38(b) Soap, sanitary towels, water Hand washing facilities for use by food-handling employees lack [soap] [sanitary towels] [hot and cold running water].  Specifically, *** 7
6570 21 CFR 1250.33(c) Storage and handling after bactericidal treatment Failure to [store] [handle] utensils, after bactericidal treatment, in such a manner as to prevent contamination before reuse.  Specifically, *** 6
7089 21 CFR 1250.82(d) Identification marks on tanks and piping Not all [tanks] [piping] bear clear marks of identification.  Specifically, *** 6
6552 21 CFR 1250.28 Handling to avoid contamination Ice coming into contact with [food] [drink] is not [handled] [stored] in such a manner as to avoid contamination.  Specifically, *** 5
6567 21 CFR 1250.33(b) Cleaning of multiuse eating and drinking utensils Failure to [thoroughly clean in warm water] [subject to an effective bactericidal treatment] multiuse eating and drinking utensils after each use.  Specifically, *** 4
6580 21 CFR 1250.38(b) Signs Signs directing food-handling employees to wash their hands after each use of toilet facilities are not [posted] [readily observable by such employees].  Specifically, *** 4
7053 21 CFR 1250.75(b) Sanitary sewers or alternative methods Failure to dispose of toilet wastes through [sanitary sewers] [methods assuring sanitary disposal].  Specifically, *** 4
7090 21 CFR 1250.82(e) Backflow prevention - general Lack of backflow prevention in the installation of [pipes] [fittings] conveying potable water to [fixtures] [apparatus] [equipment].  Specifically, *** 4
6549 21 CFR 1250.27 Storage of perishables Failure to keep perishable [food] [drink] at or below 50 degrees Fahrenheit except when being prepared or kept hot for serving.  Specifically, *** 3
6564 21 CFR 1250.33(a) Maintained in good repair Not all [utensils] [working surfaces] used in connection with [preparation] [storage] [serving] of [food] [beverages] are maintained in good repair.  Specifically, *** 3
6565 21 CFR 1250.33(a) Adequate facilities for cleaning, bactericidal treatment 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, *** 3
6579 21 CFR 1250.38(a) Suitable design and construction Failure to provide [toilet] [lavatory] facilities of suitable design and construction for use by food-handling employees.  Specifically, *** 3
6585 21 CFR 1250.39 Containers - close-fitting covers Garbage containers lack close-fitting covers.  Specifically, *** 3
7038 21 CFR 1250.67 Signs for non-potable water Outlets for non-potable water are not posted with [permanent] signs warning that the water is unfit for drinking.  Specifically, *** 3
6572 21 CFR 1250.34 Thermometers Failure to equip each refrigerator with a thermometer located in the warmest region thereof.  Specifically, *** 2
6593 21 CFR 1250.42(b) Connections easily cleanable, located and protected Filling connections not [easily cleanable] [located and protected] so as to minimize the hazard of contamination of the water supply.  Specifically, *** 2
7081 21 CFR 1250.82(a) Separate systems The potable water system is [not separate and distinct from other water systems] [used for other purposes].  Specifically, *** 2
6509 21 CFR 1240.61(b) Inadequate pasteurization Pasteurization of [milk] [milk products] does not meet minimum time-temperature requirements.  Specifically, *** 1
6551 21 CFR 1250.28 Approved sources Ice coming into contact with [food] [drink] is not manufactured on board, but rather is obtained from a source not approved by competent health authorities.  Specifically, *** 1
6554 21 CFR 1250.30(a) Ventilation and lighting Not all [kitchens] [galleys] [pantries] [places] where food is prepared, served, or stored are adequately [lighted] [ventilated].  Specifically, *** 1
6561 21 CFR 1250.32(b) Clean hands Persons with unclean hands were engaged in handling [food] [drink] [utensils] [equipment].  Specifically, *** 1
6563 21 CFR 1250.33(a) Easily cleaned, self-draining 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, *** 1
6573 21 CFR 1250.34 Backflow protection for waste water drains Waste water drains from [ice boxes] [refrigerating equipment] [refrigerated spaces] are not so installed as to prevent backflow of contaminating liquids.  Specifically, *** 1
6582 21 CFR 1250.38(c) Maintained in clean condition Failure to maintain toilet rooms in a clean condition.  Specifically, *** 1
6586 21 CFR 1250.39 Frequency of disposition Failure to dispose of [garbage] [refuse] as frequently as necessary and practicable.  Specifically, *** 1
6588 21 CFR 1250.41 Submittal of construction plans Failure to submit plans for the [construction] [major reconstruction] of [sanitary equipment] [facilities] to FDA for review.  Specifically, *** 1
6590 21 CFR 1250.42(a) Complete and closed A water system which is not [complete] [closed] from the filling ends to the discharge taps (except for protected vent openings).  Specifically, *** 1
6591 21 CFR 1250.42(a) Backflow protection A water system not protected against backflow.  Specifically, *** 1
6602 21 CFR 1250.45(a) Double sinks Lack of [double sinks] [3-compartment sinks] in the [kitchen] [pantry], one of which is of sufficient size and depth to permit complete immersion of a basket of dishes during bactericidal treatment.  Specifically, *** 1
6609 21 CFR 1250.49 Clean and free of flies and mosquitoes Not all conveyances were kept [clean] [free of flies and mosquitoes] while in transit.  Specifically, *** 1
7039 21 CFR 1250.67 Bulk ice 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  1
7041 21 CFR 1250.70(a) Adequate and readily accessible 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, *** 1
7042 21 CFR 1250.70(a) Clean and sanitary Failure to maintain [toilet] [washroom] [locker] [essential sanitary] facilities for use of employees in a clean and sanitary condition.  Specifically, *** 1
7055 21 CFR 1250.75(b) Equipment for cleaning and flushing 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].  Specif 1
7056 21 CFR 1250.75(c) Persons handling soil cans and other containers Persons who have handled [soil cans] [containers which have come in contact with human wastes] do not [wash their hands thoroughly with soap and warm water] [remove any garments which have become soiled with human wastes] before engaging in work connected 1
7058 21 CFR 1250.79(a) Container construction Containers used to [receive] [store] garbage are not [water-tight] [readily cleanable] [nonabsorbent] [equipped with close-fitting covers].  Specifically, *** 1
7092 21 CFR 1250.82(f) Cleaning, disinfecting, flushing Failure to [clean] [disinfect] [flush] a potable water system when required by FDA to prevent the introduction, transmission, or spread of communicable diseases.  Specifically, *** 1
Cite Id Reference Number Short Description Long Description Frequency
5007 21 CFR 1002.13 Failure to submit You did not submit an annual report [by the September 1 deadline] for products requiring one.  Specifically, *** 6
5700 21 CFR 1002.10 Failure to submit, distinct marking 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, *** 3
5008 21 CFR 1002.20(a) Failure to report 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, *** 2
5012 21 CFR 1003.10(a) FDA not notified of defect or noncompliance  You did not notify the Secretary, in accordance with 21 CFR 1003.20, of an electronic product which [was defective] [failed to comply with an applicable Federal standard] which you [produced] [assembled] [imported] [distributed].  Specifically, *** 2
5034 21 CFR 1010.2(c) Certification not based on adequate test/testing program Certification was not based upon [a test, in accordance with the standard] [a testing program in accordance with good manufacturing practices].  Specifically, *** 2
5802 21 CFR 1002.13 Lack of required elements An annual report which you submitted did not [summarize the contents of the records required by 21 CFR 1002.30(a)] [provide the volume of products produced, sold, or installed] [cover the 12-month period ending on June 30 preceding the due date of the rep 2
5812 21 CFR 1002.30(a)(2) Results of tests 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, *** 2
5940 21 CFR 1030.10(c)(3)(i) tests--errors and uncertainties accounted for 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, *** 2
5005 21 CFR 1002.11 Failure to submit You did not submit a required supplemental report, prior to the introduction of the product into commerce, for a new or modified model within a model or chassis family.  Specifically, *** 1
5031 21 CFR 1010.2(a) Lack of certification of conformance Failure to furnish to the [dealer] [distributor], at the time of delivery of a product, a certification that the product conforms to all applicable standards.  Specifically, *** 1
5043 21 CFR 1010.3(a)(1) ID label lacks name and address An identification label failed to provide the name and address of the [manufacturer] [individual or company under whose name the product was sold].  Specifically, *** 1
5046 21 CFR 1010.3(a)(2)(ii) Manufacture date abbreviated or unapproved date coding The date of manufacture provided on the identification label is [not clear and legible] [abbreviated] [not stated in the prescribed manner].  Specifically, *** 1
5071 21 CFR 1020.40(c)(4)(i) Multiple interlocks on doors A door of a cabinet x-ray system does not have at least two safety interlocks.  Specifically, *** 1
5073 21 CFR 1020.40(c)(4)(i) Door interlock dependent upon moving part other than door A door safety interlock which disconnects the energy supply circuit for the high-voltage generator of a cabinet x-ray system is dependent upon a moving part other than the door.  Specifically, *** 1
5077 21 CFR 1020.40(c)(5) Ground fault A ground fault in a cabinet x-ray system can result in the generation of x-rays.  Specifically, *** 1
5082 21 CFR 1020.40(c)(6)(iii) Exposure indication - two independent means For a cabinet x-ray system, lack of two independent means [to indicate when and only when x-rays are being generated] [to indicate for one-half second when x-rays are being generated for less than one-half second].  Specifically, *** 1
5195 21 CFR 1040.10(g)(10) Labels legible, visible, permanent Labels which are legible and clearly visible during operation, maintenance, or service are not permanently affixed to or inscribed on laser products.  Specifically, *** 1
5199 21 CFR 1040.10(h)(1)(iii) Legible reproductions Legible reproductions of all labels and hazard warnings required by the regulations [were not affixed to the laser product] [were not provided with the laser product] [did not  include the information required for positions 1, 2, and 3 of the logotype spe 1
5208 21 CFR 1040.11(a)(2) Calibration of measurement system The Class [III] [IV] medical laser product is not supplied with instructions specifying a procedure and schedule for calibration of the measurement system.  Specifically, *** 1
5443 21 CFR 1020.30(g) Providing adequate assembly information Instructions for [assembly] [installation] [adjustment] [testing] of components adequate to assure that the product will comply with the regulations, when [assembled] [installed] [adjusted]  [tested] as directed, was not provided to [assemblers] [persons  1
5472 21 CFR 1020.30(k) Compliance measurements--diagnostic source assembly Compliance for radiation leakage from the diagnostic source assembly was not determined by measurements averaged over an area of 100 square centimeters with no linear dimension greater than 20 centimeters.  Specifically, *** 1
5811 21 CFR 1002.30(a)(1) Quality control procedures You have not [established] [maintained] records containing a description of quality control procedures with respect to electronic product radiation safety.  Specifically, *** 1
5910 21 CFR 1020.30(h)(1)(ii) Maintenance schedule (all x-ray eqpt) Manuals or instruction sheets which include a schedule of the maintenance necessary to keep the equipment in compliance with the regulations were not provided to [purchasers] [persons other than purchasers, upon request, at a cost not to exceed the cost o 1
Cite Id Reference Number Short Description Long Description Frequency
4185 FDCA 402(a)(4) Record keeping Treatment records were not [maintained] [complete].  Specifically,***  189
4093 21 CFR 530.11(d) Tissue residue 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, *** 131
7001 FDCA 402(a)(4) Drug inventory You lack an adequate inventory system for determining the quantities of drugs used to medicate your [cows] [calves] [livestock].  Specifically, *** 62
13509 FDCA 402(a)(4) Identity of animals 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, *** 46
1360 FDCA 501(a)(5) Expired drugs Expired drug(s) were observed in the drug storage area.  Specifically, *** 41
1442 FDCA 402(a)(4) Records review prior to slaughter 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, *** 27
1446 FDCA 402(a)(4) Hospital pen Failure to [identify] [segregate] [quarantine] treated animals.  Specifically, *** 27
13521 21 CFR 530.41(a) Drugs prohibited for extralabel use in food producing animal A prohibited [drug] [substance] was administered in an extralabel manner to [a] food-producing animal(s).  Specifically, *** 26
4182 FDCA 501(a)(5) Extra label use w/o veterinary client-patient relationship Use of [a human] [an animal] drug in a manner contrary to label directions without benefit of a valid veterinary client-patient relationship.  Specifically, *** 25
4298 21 CFR 530.11(a) Rx not followed 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, *** 23
4097 21 CFR 530.20(a)(2)(iv) Tissue residue 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 withdraw 21
1362 21 CFR 530.11(a) Species or class 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, *** 19
4186 FDCA 402(a)(4) System for administration of drugs Failure to have a system to control administration of drug treatments to your animals.  Specifically, *** 17
1366 21 CFR 530.11(a) Dosage level Administration of an approved animal drug in excess of the indicated dosage, without benefit of a valid veterinarian-client-patient relationship.  Specifically, *** 16
13508 FDCA 402(a)(4) Medication status of animals  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, *** 16
1389 21 CFR 530.11(a) Withdrawal period 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, *** 15
1373 21 CFR 530.11(a) Route of administration 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 relationshi 12
1811 21 CFR 225.58(b)(1) Three assays per year 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, *** 7
2076 21 CFR 225.102(b)(1) Elements of the MRF The Master Record File does not contain [the name of the medicated feed] [the name and weight percentage or measure of each drug or drug combination and each nondrug ingredient to be used in manufacturing a stated weight of medicated feed] [a copy or desc 6
4184 FDCA 501(a)(5) Conditions of use Administration of a drug for conditions not [specified in its labeling] [prescribed].  Specifically, *** 6
4545 21 CFR 225.120 Vermin and pest infestation Buildings and grounds are not constructed and maintained in a manner to minimize vermin and pest infestation.  Specifically, *** 6
13541 FDCA 501(a)(5) Use of veterinary prescription drugs without a prescription Administration of veterinary prescription drugs was performed without the lawful written or oral order of a licensed veterinarian. Specifically, *** 6
1376 21 CFR 530.11(a) Frequency and duration Administration of an approved animal drug [more frequently] [for a longer time period] than specified in the labeling, without benefit of a valid veterinarian-client-patient relationship.  Specifically, *** 5
4111 21 CFR 530.12(c) Directions for use 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, *** 5
4552 21 CFR 225.142 Adequate procedures for Type A and Type B articles 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.  Specifical 5
1760 21 CFR 225.42(b)(6) Lot number or shipment I.D. number The daily inventory records for drugs do not include [the manufacturer's lot number] [the feed manufacturer's shipment identification number].  Specifically, *** 4
1765 21 CFR 225.42(b)(6)(i) - (v) Information required 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 eac 4
4094 21 CFR 530.11(b) Use in animal feed An approved drug was used in or on an animal feed in a manner not in accordance with the approved labeling. Specifically, *** 4
4099 21 CFR 530.20(a)(2)(ii) Extended withdrawal period A substantially extended withdrawal period, supported by appropriate scientific information, was not established for the use of an approved drug in a food-producing animal, in an extralabel manner.  Specifically, *** 4
4560 21 CFR 225.165 Establishment and use of adequate procedures 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, *** 4
1457 FDCA 402(a)(4) Feeding colostrum Feeding colostrum or milk from treated cows to calves intended for slaughter.  Specifically, *** 3
1466 21 CFR 225.20(b)(2) Maintained in clean and orderly condition Buildings are not maintained in a reasonably clean and orderly manner.  Specifically, *** 3
1469 21 CFR 225.20(b)(3) Pest access minimized The building is not constructed to minimize access by [rodents] [birds] [insects] [pests].  Specifically, *** 3
1782 21 CFR 225.42(b)(7) Daily comparison, actual vs theoretical 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, *** 3
1850 21 CFR 225.58(d) Assay results out of specification 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,*** 3
4113 21 CFR 530.12(e) Withdrawal, withholding, or discard time Failure to provide labeling containing [withdrawal] [withholding] [discard] time as specified by the veterinarian for a human or animal drug prescribed for use in an animal contrary to the drug's labeling.  Specifically, *** 3
4183 FDCA 501(a)(5) Frequency of administration Administration of a drug [over a longer time period] [more frequently] than [specified in its labeling] [prescribed].  Specifically, *** 3
4564 21 CFR 225.180 Bagged or bulk deliveries All deliveries of medicated feeds, whether bagged or in bulk, are not adequately labeled to assure that the feed can be properly used.  Specifically, *** 3
1447 FDCA 402(a)(4) Feeding areas Failure to adequately clean feed and water containers to prevent cross-contamination of medicated and non-medicated feeds and liquids.  Specifically, *** 2
1465 21 CFR 225.20(b)(1) Building grounds maintenance The building grounds are not routinely maintained so that they are reasonably free from [litter, waste, and refuse] [uncut weeds and grass] [improperly stored equipment].  Specifically, *** 2
1482 21 CFR 225.30(b)(1) Capability to produce a medicated feed Equipment does not possess the capability to produce a medicated feed of intended [potency] [safety] [purity].  Specifically, *** 2
1493 21 CFR 225.30(b)(4) Calibration of scales and metering devices 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, *** 2
1535 21 CFR 225.42(b)(2) Storage of packaged drugs Packaged drugs are not stored  in their original closed containers.  Specifically, *** 2
1638 21 CFR 225.42(b)(5) Elements of receipt record Drug receipt records do not accurately indicate the [identity] [quantity] [name of the supplier] [supplier's lot number or other identifying number] [date of receipt] [condition of the drug when received] [return of any damaged drugs] for each lot of drug 2
1744 21 CFR 225.42(b)(6) Daily inventory record kept Failure to maintain a daily inventory record for each drug used in the manufacture of medicated feeds.  Specifically, *** 2
1955 21 CFR 225.80(a) Appropriate labeling for medicated feed Medicated feed is not identified by appropriate labeling which provides the user with directions for use which if adhered to, will assure the article is safe and effective for its intended purpose.  Specifically, *** 2
2075 21 CFR 225.102(b)(1) Preparation of MRF 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, *** 2
2093 21 CFR 225.102(b)(2)(i)-(iv) Elements of production record(s) Production record(s) fail to include [the product identification] [the date of production] [a written endorsement in the form of a signature or initials by a responsible individual] [the quantity and name of drug components used] [the theoretical quantity 2
2232 21 CFR 225.115(b)(1) Maintaining records of complaints The original or copy of a record of each oral or written complaint received relating to the safety and effectiveness of the product produced is not maintained on the premises.  Specifically, *** 2
4100 21 CFR 530.20(a)(2)(iii) Identity of treated animals Failure to assure that the identity of a food-producing animal was maintained, where you had prescribed or dispensed an approved human or animal drug contrary to the drug's labeling.  Specifically, *** 2
4132 21 CFR 589.2000(d)(1) Protein blenders, feed manufacturers, distributors Products that contain or may contain prohibited material fail to bear the caution statement, "Do not feed to cattle or other ruminants."  Specifically, *** 2
4541 21 CFR 225.42(b) Adequate procedures established 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, *** 2
4555 21 CFR 225.142 Use in accord with directions All [Type A medicated articles] [Type B medicated feeds] are not used in accordance with their labeled mixing directions.  Specifically, *** 2
4562 21 CFR 225.180 Assuring correct labels are used Labels are not [received] [handled] [stored] in a manner that [prevents label mix-ups] [assures that the correct labels are used for the medicated feed].  Specifically, *** 2
1464 21 CFR 225.20(b)(1) Adequate drainage The building grounds are not adequately drained so that they are free from standing water.  Specifically, *** 1
1530 21 CFR 225.42(b)(1) Examination of incoming drugs Failure to visually examine incoming drug shipments for [identity] [damage].  Specifically, *** 1
1539 21 CFR 225.42(b)(3) Identification and storage of bulk drugs Bulk drugs are not [identified] [stored] in a manner such that their identity, strength, quality, and purity will be maintained.  Specifically, *** 1
1575 21 CFR 225.42(b)(4) Integrity and identity Failure to properly [identify] [store] [handle] [control] drugs in the mixing areas to maintain their integrity and identity.  Specifically, *** 1
1634 21 CFR 225.42(b)(5) Receipt for each lot of drug received Failure to [prepare] [maintain] a receipt record for each lot of drug received.  Specifically, *** 1
1792 21 CFR 225.42(b)(7) Discrepancies Failure to [investigate] [take corrective action for] a significant discrepancy between actual drug usage and theoretical drug usage.  Specifically, *** 1
1826 21 CFR 225.58(b)(1) Alternate  testing of drugs in combination Where only one drug is assayed in a medicated feed containing a combination of drugs, there was a failure to test a different drug from the one(s) previously tested during the calendar year.  Specifically,*** 1
1882 21 CFR 225.58(e) Subsequent production Following distribution of a medicated feed which failed to meet its labeled drug potency, subsequent production of that feed  was resumed prior to the establishment of proper control procedures.  Specifically, *** 1
1923 21 CFR 225.65(b) Reasonable and effective procedures followed 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, *** 1
1925 21 CFR 225.65(b)(2) Flush material handling Material used for cleanout by flushing is not properly [identified] [stored] [used in a manner] to prevent unsafe contamination of other feeds.  Specifically, *** 1
1953 21 CFR 225.80(b)(2) Maintaining proofread label 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, *** 1
1954 21 CFR 225.80(b)(3) Complete Bulk Labeling Where medicated feeds are distributed in bulk, complete labeling [does not accompany the shipment] [is not supplied the consignee at the time of delivery].  Specifically, *** 1
2098 21 CFR 225.102(b)(4) Discrepancies investigated, reported 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, *** 1
4118 21 CFR 530.13(b)(3) Outside of scope of professional practice Compounding  of an approved drug for use in an extralabel manner was not performed by a licensed [pharmacist] [veterinarian] within the scope of a professional practice.  Specifically, *** 1
4140 21 CFR 589.2000(f) Maintaining records Failure to maintain copies of [purchase invoices] [labeling] for all feeds received containing animal protein products.  Specifically, *** 1
4157 21 CFR 225.42(b)(7) Detention of feeds with yield discrepancies 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, *** 1
4159 21 CFR 226.58(d) Components uniformly dispersed and stable No determination has been made that the drug components remain uniformly dispersed and stable in Type A medicated articles under ordinary conditions of shipment, storage and use.  Specifically, *** 1
4453 21 CFR 225.10(b)(1) Employees lack understanding All employees involved in the manufacture of medicated feeds do not have an understanding of the [manufacturing or control operations they perform] [location and proper use of equipment].  Specifically, *** 1
4454 21 CFR 225.20(a) Facilities features  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 hy 1
4544 21 CFR 225.120 Buildings--space and access Buildings for the production of medicated feed lack adequate space for [equipment] [processing] [orderly receipt and storage of medicated feed] [access to equipment for routine maintenance and cleaning].  Specifically, *** 1
4547 21 CFR 225.130 Cleanliness, inspection, cleanout  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].  Specifica 1
4548 21 CFR 225.130 Scales and metering devices The [scales] [liquid metering devices] are not of suitable [size] [design] [construction] [precision] [accuracy] for their intended purpose.  Specifically, *** 1
4553 21 CFR 225.142 Packaged Type A and Type B designated areas The [packaged Type A medicated articles] [packaged Type B medicated feed] are not [stored in designated areas] [stored in their original closed containers].  Specifically, *** 1
4554 21 CFR 225.142 Bulk Type A and Type B storage 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, ***  1
4557 21 CFR 225.158 Investigation and corrective action 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, *** 1
4567 21 CFR 225.202 Facilitation of recall The [formula] [production] [distribution] records are not adequate to facilitate the recall of specific batches of medicated feed that have been distributed.  Specifically, ***  1
13511 21 CFR 530.4 Advertising and promotion The extralabel use of an approved drug in animals was [advertised] [promoted] .  Specifically, *** 1
13531 21 CFR 511.1(b)(7)(iii) Reports: Adequate and Timely The investigator did not furnish adequate and timely reports of the investigation to the sponsor.  Specifically, *** 1
13567 21 CFR 589.2001(c)(2)(iv) Label "Do not feed to animals" Failure to conspicuously label [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with the statement "Do not feed to animals".  Specifically,*** 1
13568 21 CFR 589.2001(c)(2)(v) Marking with readily detected agent Failure to mark [cattle materials prohibited in animal feed] [products that contain or may contain cattle materials prohibited in animal feed] with an agent that can be readily detected on visual inspection.  Specifically,*** 1
13574 21 CFR 589.2001(c)(3)(i) Adequacy of records from firms supplying segregated material Records concerning suppliers which have segregated cattle materials prohibited for use in feed fail to demonstrate [that such suppliers have adequate procedures in place to effectively exclude prohibited cattle materials] [certification or other documenta 1

Back to Top

Back to Inspectional Observation Summaries

 

Page Last Updated: 01/22/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English