FDA 483报告（缺陷报告），也称现场观察报告（Inspectional Observation），它是FDA 检查官根据cGMP规范，对医药企业的质量体系进行现场检查过程中所发现的不符合cGMP 之处列出的总结清单。
Drugs
| Center Name | Cite Id | Ref No | Frequency | Short Description | Long Description |
|---|---|---|---|---|---|
| Drugs | 1105 | 21 CFR 211.22(d) | 155 | Procedures not in writing, fully followed | The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, *** |
| 2027 | 21 CFR 211.192 | 131 | 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, *** | |
| 1361 | 21 CFR 211.100(a) | 106 | 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, *** | |
| 3603 | 21 CFR 211.160(b) | 99 | 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] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. Specifically, *** | |
| 1215 | 21 CFR 211.67(b) | 77 | 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, *** | |
| 1451 | 21 CFR 211.113(b) | 76 | Procedures for sterile drug products | Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed]. Specifically, *** | |
| 1213 | 21 CFR 211.67(a) | 71 | 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, *** | |
| 1883 | 21 CFR 211.165(a) | 66 | 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, *** | |
| 3585 | 21 CFR 211.110(a) | 65 | 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, *** | |
| 1914 | 21 CFR 211.166(a) | 62 | Lack of written stability program | There is no written testing program designed to assess the stability characteristics of drug products. Specifically, *** | |
| 1358 | 21 CFR 211.100(b) | 59 | 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, *** | |
| 1274 | 21 CFR 211.68(a) | 56 | 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, *** | |
| 2009 | 21 CFR 211.188 | 56 | 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, *** | |
| 4314 | 21 CFR 211.84(d)(2) | 53 | 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 reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals]. Specifically, *** | |
| 1177 | 21 CFR 211.63 | 49 | 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, *** | |
| 1112 | 21 CFR 211.25(a) | 44 | 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, *** | |
| 2419 | 21 CFR 211.198(a) | 44 | 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, *** | |
| 1452 | 21 CFR 211.113(b) | 43 | 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, *** | |
| 1890 | 21 CFR 211.165(e) | 39 | Test methods | The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented]. Specifically, *** | |
| 1111 | 21 CFR 211.25(a) | 38 | 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, *** | |
| 1133 | 21 CFR 211.25(a) | 36 | 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, *** | |
| 1809 | 21 CFR 211.160(a) | 34 | Following/documenting laboratory controls | Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, *** | |
| 1943 | 21 CFR 211.180(e)(1) | 34 | 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, *** | |
| 4402 | 21 CFR 211.192 | 32 | 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, *** | |
| 1159 | 21 CFR 211.28(a) | 31 | 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, *** | |
| 1434 | 21 CFR 211.42(c)(10)(iv) | 31 | Environmental Monitoring System | Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, *** | |
| 1810 | 21 CFR 211.160(a) | 29 | 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]. Specifically, *** | |
| 1767 | 21 CFR 211.137(a) | 28 | 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, *** | |
| 2026 | 21 CFR 211.192 | 28 | 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, *** | |
| 4389 | 21 CFR 211.198(a) | 28 | 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, *** | |
| 1891 | 21 CFR 211.165(f) | 27 | Failing drug products not rejected | Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, *** | |
| 1885 | 21 CFR 211.165(b) | 26 | Microbiological testing | Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing. Specifically, *** | |
| 2028 | 21 CFR 211.192 | 26 | 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 specific failure or discrepancy]. Specifically, *** | |
| 2031 | 21 CFR 211.194(a) | 26 | 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, , *** | |
| 3632 | 21 CFR 211.170(b) | 26 | 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, *** | |
| 4303 | 21 CFR 211.67 b) | 26 | 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 methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation]. Specifically, *** | |
| 4342 | 21 CFR 211.142(b) | 26 | 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, *** | |
| 4352 | 21 CFR 211.160(b)(4) | 26 | 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]. Specifically, *** | |
| 9001 | 21 CFR 211.22(a) | 26 | Lack of quality control unit | There is no quality control unit. Specifically, *** | |
| 1450 | 21 CFR 211.113(a) | 25 | 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, *** | |
| 1787 | 21 CFR 211.80(a) | 25 | 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, *** | |
| 3572 | 21 CFR 211.100(b) | 25 | Procedure Deviations Recorded and Justified | Deviations from written production and process control procedures are not [recorded] [justified]. Specifically, *** | |
| 1448 | 21 CFR 211.111 | 24 | 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, *** | |
| 4391 | 21 CFR 211.180(e)(2) | 23 | 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, *** | |
| 4576 | 21 CFR 211.192 | 22 | 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, *** | |
| 1920 | 21 CFR 211.166a)(3) | 21 | Valid stability test methods | The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods. Specifically, *** | |
| 1435 | 21 CFR 211.42(c)(10)(v) | 20 | Cleaning System | Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions. Specifically, *** | |
| 1833 | 21 CFR 211.84(d)(1) | 20 | 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, *** | |
| 3559 | 21 CFR 211.56(a) | 20 | 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, *** | |
| 1926 | 21 CFR 211.166(b) | 18 | 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, *** | |
| 1975 | 21 CFR 211.182 | 18 | Written records kept in individual logs | Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs. Specifically, *** | |
| 3547 | 21 CFR 211.46(b) | 18 | 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, *** | |
| 3565 | 21 CFR 211.58 | 18 | 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, *** | |
| 1033 | 21 CFR 211.22(a) | 17 | 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, *** | |
| 1263 | 21 CFR 211.68(b) | 17 | 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, *** | |
| 1912 | 21 CFR 211.166(a) | 17 | Written program not followed | The written stability testing program is not followed. Specifically, *** | |
| 3571 | 21 CFR 211.100(a) | 17 | 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, *** | |
| 3602 | 21 CFR 211.160(a) | 17 | Deviations from laboratory control requirements | Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, *** | |
| 4413 | 21 CFR 211.194(a)(8) | 17 | 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, *** | |
| 1098 | 21 CFR 211.22(c) | 16 | 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, *** | |
| 1550 | 21 CFR 211.125(f) | 16 | Procedures Written and Followed | Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, *** | |
| 6732 | 21 CFR 314.80(c)(1)(i) | 16 | 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, *** | |
| 1194 | 21 CFR 211.42(c) | 15 | Defined areas of adequate size for operations | The [separate or defined areas][control systems] necessary to prevent contamination or mix-ups are deficient. Specifically, *** | |
| 1932 | 21 CFR 211.167(a) | 15 | 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, *** | |
| 2008 | 21 CFR 211.186(a) | 15 | Written procedures followed | Procedures for the preparation of master production and control records are not [described in a written procedure] [followed]. Specifically, *** | |
| 2619 | 21 CFR 211.198(b)(2) | 15 | Complaint Investigation/Follow-Up Findings | Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up]. Specifically, *** | |
| 3561 | 21 CFR 211.56(b) | 15 | 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, *** | |
| 8907 | 21 CFR 314.81(b)(1)(ii) | 15 | 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, *** | |
| 1162 | 21 CFR 211.28(a) | 14 | Protective Apparel Not Worn | Protective apparel is not worn as necessary to protect drug products from contamination. Specifically, *** | |
| 1540 | 21 CFR 211.125(a) | 14 | Strict control not exercised over labeling issued | Strict control is not exercised over labeling issued for use in drug product labeling operations. Specifically, *** | |
| 4340 | 21 CFR 211.142 | 14 | Written warehousing procedures established/followed | Procedures describing the warehousing of drug products are not [established] [followed]. Specifically, *** | |
| 4372 | 21 CFR 211.188(b)(8) | 14 | 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, *** | |
| 1261 | 21 CFR 211.68(a) | 13 | 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, *** | |
| 2205 | 21 CFR 211.186(b)(9) | 13 | 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, *** | |
| 3616 | 21 CFR 211.165(d) | 13 | 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 their approval and release. Specifically, *** | |
| 3629 | 21 CFR 211.170(b) | 13 | 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, *** | |
| 4401 | 21 CFR 211.186(b)(9) | 13 | 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, *** | |
| 17764 | 21 CFR 212.20(e) | 13 | Written QA procedures established, followed | You did not [establish] [follow] written quality assurance procedures. Specifically,*** | |
| 1086 | 21 CFR 211.22(b) | 12 | 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, *** | |
| 1227 | 21 CFR 211.67(c) | 12 | Cleaning/maintenance records not kept | Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, *** | |
| 1433 | 21 CFR 211.42(c)(10)(iii) | 12 | Air Supply | Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure. Specifically, *** | |
| 1942 | 21 CFR 211.180(e) | 12 | 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, *** | |
| 2007 | 21 CFR 211.186(a) | 12 | 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, *** | |
| 4336 | 21 CFR 211.150 | 12 | Written distribution procedure | Written distribution procedures are not [established] [followed]. Specifically, *** | |
| 4357 | 21 CFR 211.166(a) | 12 | Results not used for expiration dates, storage cond. | Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates]. Specifically, *** | |
| 6730 | 21 CFR 314.80(b) | 12 | 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, *** | |
| 8911 | 21 CFR 314.81(b)(1)(ii) | 12 | 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, *** | |
| 17812 | 21 CFR 212.50 | 12 | 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,*** | |
| 1169 | 21 CFR 211.42(a) | 11 | 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, *** | |
| 1395 | 21 CFR 211.103 | 11 | 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, *** | |
| 1802 | 21 CFR 211.84(b) | 11 | Representative Samples | Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination. Specifically, *** | |
| 3570 | 21 CFR 211.100(a) | 11 | 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, *** | |
| 3583 | 21 CFR 211.110(a) | 11 | 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, *** | |
| 1626 | 21 CFR 211.130 | 10 | 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, *** | |
| 1049 | 21 CFR 211.22(a) | 9 | 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, *** | |
| 1270 | 21 CFR 211.68(b) | 9 | input/output verification | Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy. Specifically, *** | |
| 1505 | 21 CFR 211.122(d) | 9 | Label storage access limited to authorized personnel | Access to the storage area for labels and labeling materials is not limited to authorized personnel. Specifically, *** | |
| 1790 | 21 CFR 211.80(b) | 9 | 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, *** | |
| 1801 | 21 CFR 211.84(a) | 9 | 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, *** | |
| 4317 | 21 CFR 211.84(d)(3) | 9 | Certificates of Testing (Containers, Closures) | Certificates of testing of [containers] [closures] are accepted in lieu of testing without [a visual identification] [establishing the reliability of the supplier’s test results through appropriate validation of the test results at appropriate intervals]. Specifically, *** | |
| 4406 | 21 CFR 211.194(a)(2) | 9 | Suitability of testing methods verified | The suitability of all testing methods is not verified under actual conditions of use. Specifically, *** | |
| 1134 | 21 CFR 211.25(b) | 8 | 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, identity, strength, quality and purity that it purports or is represented to possess. Specifically, *** | |
| 1136 | 21 CFR 211.25(c) | 8 | Inadequate number of personnel | The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product. Specifically, *** | |
| 4338 | 21 CFR 211.150(b) | 8 | 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, *** | |
| 1421 | 21 CFR 211.42(c)(10) | 7 | 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,*** | |
| 1454 | 21 CFR 211.115(a) | 7 | 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, *** | |
| 1869 | 21 CFR 211.94(c) | 7 | 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, *** | |
| 3591 | 21 CFR 211.110(b) | 7 | 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 where appropriate]. Specifically, *** | |
| 3613 | 21 CFR 211.160(b)(4) | 7 | 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, *** | |
| 4306 | 21 CFR 211.80(a) | 7 | 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, *** | |
| 4315 | 21 CFR 211.84(d)(2) | 7 | 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, *** | |
| 17763 | 21 CFR 212.20(d) | 7 | 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,*** | |
| 1163 | 21 CFR 211.28(b) | 6 | Habits of good sanitation & health | Production personnel were not practicing good sanitation and health habits. Specifically, *** | |
| 1844 | 21 CFR 211.84(d)(2) | 6 | 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, *** | |
| 1879 | 21 CFR 211.180(c) | 6 | 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, *** | |
| 2012 | 21 CFR 211.188(b) | 6 | 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, *** | |
| 4320 | 21 CFR 211.84(d)(6) | 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, *** | |
| 4324 | 21 CFR 211.110(b) | 6 | In-process materials specifications testing | Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, *** | |
| 4351 | 21 CFR 211.160(b)(3) | 6 | Drug products – samples representative, identified properly | Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, *** | |
| 4359 | 21 CFR 211.170(a)(1), (b)(1) | 6 | Retention time of reserve samples, in general | Reserve samples for [active ingredients] [drug products] are not retained for one year after the expiration date of the drug product. | |
| 4377 | 21 CFR 211.188(b(3) | 6 | 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, *** | |
| 6823 | 21 CFR 314.80(c) | 6 | Failure by applicant to report ADE | Adverse drug experience information has not been reported to FDA. Specifically, *** | |
| 17749 | 21 CFR 212.30(a) | 6 | 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,*** | |
| 1266 | 21 CFR 211.42(d) | 5 | 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, *** | |
| 1495 | 21 CFR 211.122(a) | 5 | 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, *** | |
| 1632 | 21 CFR 211.130(c) | 5 | 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, *** | |
| 1728 | 21 CFR 211.87 | 5 | 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 subsequent approval or rejection by the quality control unit. Specifically, *** | |
| 1803 | 21 CFR 211.84(b) | 5 | Representative Samples Criteria | The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria. Specifically, *** | |
| 1886 | 21 CFR 211.165(c) | 5 | 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, *** | |
| 1918 | 21 CFR 211.166(a)(2) | 5 | Stability sample storage conditions described | The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, *** | |
| 1976 | 21 CFR 211.182 | 5 | Specific information required in individual logs | Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, *** | |
| 2044 | 21 CFR 211.196 | 5 | 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, *** | |
| 3557 | 21 CFR 211.52 | 5 | 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, *** | |
| 4302 | 21 CFR 211.56(b) | 5 | Written sanitation procedures not followed | Written procedures for sanitation are not followed. Specifically, *** | |
| 4350 | 21 CFR 211.160(b)(3) | 5 | 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, *** | |
| 4353 | 21 CFR 211.160(b)(4) | 5 | Instruments, apparatus, et. al. not meeting specs | The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed. Specifically, *** | |
| 4368 | 21 CFR 211.188(b)(12) | 5 | 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, *** | |
| 4378 | 21 CFR 211.188(b)(2) | 5 | 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, *** | |
| 4382 | 21 CFR 211.198(b)(2) | 5 | 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, *** | |
| 4418 | 21 CFR 211.42(b) | 5 | 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. Specifically, *** | |
| 6736 | 21 CFR 314.80(c)(1)(ii) | 5 | 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, *** | |
| 6831 | 21 CFR 314.80(c)(2) | 5 | 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, *** | |
| 17722 | 21 CFR 212.10 | 5 | Lack Adequate Resources, Facilities, Equipment. | You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions. Specifically, *** | |
| 1388 | 21 CFR 211.101(d) | 4 | Component addition checked by 2nd person | Each component is not added to a batch by one person and verified by a second person. Specifically, *** | |
| 1393 | 21 CFR 211.103 | 4 | Yield calculations not verified by 2nd person | Yield calculations are not performed by one person and independently verified by a second person. Specifically, *** | |
| 1504 | 21 CFR 211.122(d) | 4 | Labels and labeling stored separately | Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents. Specifically, *** | |
| 1545 | 21 CFR 211.125(c) | 4 | 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, *** | |
| 1633 | 21 CFR 211.130(d) | 4 | 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, *** | |
| 1636 | 21 CFR 211.130(e) | 4 | 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, *** | |
| 1774 | 21 CFR 211.142(a) | 4 | Quarantine – actual practice | Drug products are not quarantined before being released by the quality control unit. Specifically, *** | |
| 1777 | 21 CFR 211.150(b) | 4 | 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, *** | |
| 1842 | 21 CFR 211.84(d)(1) | 4 | 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,*** | |
| 1843 | 21 CFR 211.84(d)(2) | 4 | 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, *** | |
| 1868 | 21 CFR 211.94(b) | 4 | 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, *** | |
| 1876 | 21 CFR 211.180(a), (b) | 4 | 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, *** | |
| 1917 | 21 CFR 211.166(a)(1) | 4 | 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, *** | |
| 1922 | 21 CFR 211.166(a)(4) | 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, *** | |
| 1928 | 21 CFR 211.166(c)(1) | 4 | 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 degradation of the product for the normal or expected period of use]. Specifically, *** | |
| 2003 | 21 CFR 211.184(c) | 4 | 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 drug product. Specifically, *** | |
| 2033 | 21 CFR 211.194(c) | 4 | 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, *** | |
| 2034 | 21 CFR 211.194(d) | 4 | Laboratory equipment calibration records | Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices]. Specifically, *** | |
| 2567 | 21 CFR 211.198(a) | 4 | 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, *** | |
| 2569 | 21 CFR 211.198(b) | 4 | 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, *** | |
| 3445 | 21 CFR 211.65(a) | 4 | 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 requirements. Specifically, *** | |
| 3594 | 21 CFR 211.110(d) | 4 | 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, *** | |
| 4373 | 21 CFR 211.188(b)(7) | 4 | 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, *** | |
| 4388 | 21 CFR 211.198(a) | 4 | 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 for an investigation of any unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications]. Specifically, *** | |
| 4399 | 21 CFR 211.186(b)(7) | 4 | 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, *** | |
| 4410 | 21 CFR 211.194(a)(5) | 4 | Calculations performed are in the records | Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, *** | |
| 6728 | 21 CFR 314.80(b) | 4 | Failure to review ADE information | Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers]. Specifically, *** | |
| 17741 | 21 CFR 212.30(b) | 4 | Equipment not clean | You did not implement procedures to ensure that all your equipment is clean. Specifically, *** | |
| 17742 | 21 CFR 212.30(b) | 4 | Equipment not suitable | You did not implement procedures to ensure that all your equipment is suitable for its intended purposes. Specifically,*** | |
| 17851 | 21 CFR 212.60(c) | 4 | 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,*** | |
| 1174 | 21 CFR 211.42(b) | 3 | 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, *** | |
| 1722 | 21 CFR 211.134(a) | 3 | 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, *** | |
| 1725 | 21 CFR 211.134(c) | 3 | Examinations documented | The results of the examination of the packaged and labeled products were not documented in the batch production or control records. Specifically, *** | |
| 1798 | 21 CFR 211.82(b) | 3 | 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, *** | |
| 1851 | 21 CFR 211.84(e) | 3 | 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, *** | |
| 1927 | 21 CFR 211.166(b) | 3 | 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, *** | |
| 1933 | 21 CFR 211.167(a) | 3 | Sterility/pyrogens – test methods written, followed | Test procedures relative to appropriate laboratory testing for [sterility] [pyrogens] are not [written] [followed]. Specifically, ****** | |
| 2035 | 21 CFR 211.194(e) | 3 | Stability testing records not included | Laboratory records do not include complete records of all stability testing performed. Specifically, *** | |
| 3553 | 21 CFR 211.48(a) | 3 | Plumbing System Defects | The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, *** | |
| 3562 | 21 CFR 211.56(c) | 3 | 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] [packaging, labeling materials] [drug products]. Specifically, *** | |
| 3569 | 21 CFR 211.89 | 3 | 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, *** | |
| 3582 | 21 CFR 211.105(a) | 3 | 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, *** | |
| 3611 | 21 CFR 211.160(b)(3) | 3 | Acceptance of drug products | Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products. Specifically, *** | |
| 3614 | 21 CFR 211.160(b)(4) | 3 | 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]. Specifically, *** | |
| 3623 | 21 CFR 211.170(a) | 3 | 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, *** | |
| 3639 | 21 CFR 211.204 | 3 | Returned drug procedures in writing and followed | Procedures describing the [holding] [testing] [reprocessing] of returned drug products are not [in writing] [followed]. Specifically, *** | |
| 4305 | 21 CFR 211.68(b) | 3 | 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, *** | |
| 4328 | 21 CFR 211.122(a) | 3 | Written procedures not followed | Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed. Specifically, *** | |
| 4330 | 21 CFR 211.130(e) | 3 | Packaging line inspection documentation | Results of inspection of packaging and labeling facilities are not documented in the batch production records. Specifically, *** | |
| 4343 | 21 CFR 211.160(b)(1) | 3 | 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] used in the manufacture, processing, packing, or holding of drug products. Specifically, *** | |
| 4344 | 21 CFR 211.160(b)(1) | 3 | Sampling and testing procedures described | Written specifications for laboratory controls do not include a description of the [sampling] [testing] procedures used. Specifically, *** | |
| 4356 | 21 CFR 211.166(b) | 3 | 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 expiration date was verified or the appropriate expiration date determined. Specifically, *** | |
| 4369 | 21 CFR 211.188(b)(11) | 3 | 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, *** | |
| 4371 | 21 CFR 211.188(b)(9) | 3 | 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, *** | |
| 4400 | 21 CFR 211.186(b)(8) | 3 | 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 for the approval of labeling]. Specifically, *** | |
| 4404 | 21 CFR 211.194(a)(1) | 3 | 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 taken] [the date the sample was received for testing]. Specifically, *** | |
| 4409 | 21 CFR 211.194(a)(4) | 3 | 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] [closure] [in-process material] [lot tested] [drug product tested]. Specifically, *** | |
| 6832 | 21 CFR 314.80(c)(2) | 3 | 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, *** | |
| 6842 | 21 CFR 314.80(i) | 3 | Failure to maintain records | Records relating to all adverse drug experiences known to you, including raw data and any correspondence, have not been maintained for the required ten year period. Specifically, *** | |
| 8912 | 21 CFR 314.81(b)(2) | 3 | 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, *** | |
| 17850 | 21 CFR 212.60(b) | 3 | Lab sampling and test procedures | Each laboratory did not have sampling procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,*** | |
| 17932 | 21 CFR 212.60(b) | 3 | Testing Procedures- Conformance to Standards | Each laboratory did not have testing procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity. Specifically,*** | |
| 17940 | 21 CFR 212.71(a) | 3 | Non-Conforming Product Investigation Incomplete | The investigation of the cause of the nonconforming batch of a PET drug product did not include examination of the [processes] [operations] [records] [complaints] [other relevant sources of information] concerning the nonconforming product. Specifically*** | |
| 1079 | 21 CFR 211.22(a) | 2 | 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, *** | |
| 1218 | 21 CFR 211.67(b)(1) | 2 | Cleaning SOP/responsibility | Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment. Specifically, *** | |
| 1413 | 21 CFR 211.42(c)(5) | 2 | Mfg / Processing Operations Area | Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations. Specifically, *** | |
| 1430 | 21 CFR 211.42(c)(10)(i) | 2 | 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,*** | |
| 1449 | 21 CFR 211.111 | 2 | Deviations of production time limits | Deviations from production time limits [are not justified] [are not documented] [compromise the quality of the drug product]. Specifically, *** | |
| 1456 | 21 CFR 211.115(b) | 2 | Reprocessing/quality control unit | Reprocessing was performed without the [review] [approval] of the quality control unit. Specifically, *** | |
| 1496 | 21 CFR 211.122(a) | 2 | 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, *** | |
| 1629 | 21 CFR 211.130(a) | 2 | 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, *** | |
| 1630 | 21 CFR 211.130(b) | 2 | 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, *** | |
| 1637 | 21 CFR 211.130(e) | 2 | Packaging line inspection after use | Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed. Specifically, *** | |
| 1724 | 21 CFR 211.134(b) | 2 | Representative samples after completion | Samples of representative units were not [collected] [visually examined] for correct labeling at the completion of finishing operations. Specifically, *** | |
| 1791 | 21 CFR 211.80(c) | 2 | 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, *** | |
| 1797 | 21 CFR 211.82(a) | 2 | Examination on receipt, before acceptance | Each container or grouping of containers of [components] [drug product containers] [closures] is not examined visually upon receipt and before acceptance for [appropriate labeling as to contents] [container damage] [broken seals] [contamination]. Specifically, *** | |
| 1846 | 21 CFR 211.84(d)(3) | 2 | Establish reliability of supplier’s C of A | Establishment of the reliability of the [container] [closure] supplier’s report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. Specifically, *** | |
| 1958 | 21 CFR 211.180(f) | 2 | Responsible firm officials notified in writing | Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices]. Specifically, *** | |
| 1978 | 21 CFR 211.182 | 2 | 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, *** | |
| 2014 | 21 CFR 211.188(b)(2) | 2 | Identification of Equipment and Lines | The batch production and control records are deficient in that they do not include the identity of major [equipment] [lines] used. Specifically, *** | |
| 2196 | 21 CFR 211.186(b)(1) | 2 | Product Name and Strength | The master production and control records are deficient in that they do not include the [name] [strength] of the drug product and a description of the dosage form. Specifically, *** | |
| 2401 | 21 CFR 211.194(a)(4) | 2 | Complete Test Data | Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, *** | |
| 3548 | 21 CFR 211.46(c) | 2 | Air filtration system lacking in production area | The production area air supply lacks an appropriate air filtration system. Specifically, *** | |
| 3550 | 21 CFR 211.46(c) | 2 | 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, *** | |
| 3551 | 21 CFR 211.46(d) | 2 | 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, *** | |
| 3573 | 21 CFR 211.101(b) | 2 | Measured components for manufacturing | Components for drug product manufacturing are not [weighed] [measured] [subdivided as appropriate]. Specifically, *** | |
| 3581 | 21 CFR 211.101(d) | 2 | Verification of component addition | Each component is not added to the batch by one person and verified by a second person.. Specifically, *** | |
| 3588 | 21 CFR 211.110(a)(3) | 2 | 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, *** | |
| 3592 | 21 CFR 211.110(c) | 2 | 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, *** | |
| 3610 | 21 CFR 211.160(b)(3) | 2 | Drug product sample | Drug product samples are not [representative of the entire batch] [properly identified]. Specifically, *** | |
| 3631 | 21 CFR 211.170(b) | 2 | Investigation of reserve sample deterioration | Evidence of reserve drug product sample deterioration was not [investigated] [recorded and maintained with other stability data]. Specifically, *** | |
| 4304 | 21 CFR 211.68(b) | 2 | 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, *** | |
| 4307 | 21 CFR 211.80(d) | 2 | 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, *** | |
| 4345 | 21 CFR 211.160(b)(1) | 2 | 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]. Specifically, *** | |
| 4355 | 21 CFR 211.165(c) | 2 | Sampling and testing plans not followed | Written procedures for sampling and testing plans are not followed for each drug product. Specifically, *** | |
| 4360 | 21 CFR 211.170(b) | 2 | 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, *** | |
| 4366 | 21 CFR 211.188(a) | 2 | 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, *** | |
| 4374 | 21 CFR 211.188(b)(6) | 2 | Inspection of packaging and labeling area | Batch production and control records do not include results of the inspection of the packaging and labeling area [before] [after] use for each batch of drug product produced. Specifically, *** | |
| 4383 | 21 CFR 211.198(b)(1) | 2 | 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, *** | |
| 4386 | 21 CFR 211.198(b) | 2 | 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 manufactured, processed or packed provided the written records are readily available for inspection at that other facility]. Specifically, *** | |
| 4403 | 21 CFR 211.194(b) | 2 | 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 being tested as the established method]. Specifically, *** | |
| 4405 | 21 CFR 211.194(a)(2) | 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 product tested]. Specifically, *** | |
| 4415 | 21 CFR 211.204 | 2 | 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 the drug products do meet all the necessary parameters]. Specifically, *** | |
| 4416 | 21 CFR 211.204 | 2 | 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, *** | |
| 6735 | 21 CFR 314.80(c)(1)(ii) | 2 | Failure to investigate serious, unexpected events | Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated. Specifically, *** | |
| 6830 | 21 CFR 314.80(c)(2) | 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, *** | |
| 6833 | 21 CFR 314.80(c)(2)(ii) | 2 | 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 reported as a post marketing 15-day Alert report] [an index containing a line listing of your patient identification number and adverse reaction term(s)] [a history of actions taken since the last report because of adverse drug experiences]. Specifically, *** | |
| 8935 | FDCA 760(b)(1) | 2 | 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, *** | |
| 17743 | 21 CFR 212.30(b) | 2 | Equipment procedures overall | You did not implement procedures to ensure that all your equipment is [properly installed] [maintained] [capable of repeatedly producing valid results]. Specifically,*** | |
| 17745 | 21 CFR 212.30(b) | 2 | Equipment not properly maintained | You did not document your activities in accordance with your procedures for ensuring the equipment suitability for its intended purposes. Specifically,*** | |
| 17755 | 21 CFR 212.20(a) | 2 | 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 supposed to have]. Specifically, *** | |
| 17769 | 21 CFR 212.40(a) | 2 | Content of written procedures | You did not [establish] [maintain] [follow] appropriate written procedures that describe the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures]. Specifically,*** | |
| 17772 | 21 CFR 212.40(b) | 2 | Written specs – components | You did not establish appropriate written specifications for the [identity] [quality] [purity] of components. Specifically,*** | |
| 17813 | 21 CFR 212.50(a) | 2 | Written control procedures | You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified]. Specifically,*** | |
| 17842 | 21 CFR 212.50(d) | 2 | Records of checks made | You did not keep a record of checks of the [production area] [all equipment in the production area] for cleanliness and suitability immediately before use. Specifically,*** | |
| 17849 | 21 CFR 212.60(a) | 2 | Testing procedures | Each laboratory used to conduct testing of [components] [in-process materials] [finished PET drug products] does not [have written procedures] [follow written procedures] for the conduct of each test. Specifically,*** | |
| 17858 | 21 CFR 212.60(f) | 2 | Documenting procedures | You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment. Specifically,*** | |
| 17859 | 21 CFR 212.60(g) | 2 | 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,*** | |
| 17883 | 21 CFR 212.70(d)(3) | 2 | Final dated signature | You did not [establish] [follow] procedures to ensure that a PET drug was not given final release before a designated qualified individual authorized the final release by dated signature. Specifically,*** | |
| 1167 | 21 CFR 211.34 | 1 | Qualifications lacking | Consultants lack sufficient education, training and experience to advise on the subject for which they are retained. Specifically, *** | |
| 1168 | 21 CFR 211.34 | 1 | Consultant Records | Records are not maintained stating the consultant’s [name] [address] [qualifications] [type of service provided]. Specifically, *** | |
| 1219 | 21 CFR 211.67(b)(2) | 1 | Cleaning SOPs/schedules | Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules. Specifically, *** | |
| 1220 | 21 CFR 211.67(b)(3) | 1 | 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 necessary to assure proper cleaning and maintenance. Specifically, *** | |
| 1222 | 21 CFR 211.67(b)(4) | 1 | 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, *** | |
| 1224 | 21 CFR 211.67(b)(6) | 1 | Cleaning SOP/inspection | Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use. Specifically, *** | |
| 1251 | 21 CFR 211.42(c)(1) | 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, testing, or examination by the quality control unit before release for manufacturing or packaging. Specifically, *** | |
| 1256 | 21 CFR 211.68(b) | 1 | Backup file not maintained | Failure to maintain a backup file of data entered into the computer or related system. Specifically, *** | |
| 1371 | 21 CFR 211.101(a) | 1 | 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, *** | |
| 1384 | 21 CFR 211.101(c) | 1 | Weighing/measuring/subdividing operations | Component [weighing] [measuring] [subdividing] operations are not adequately supervised. Specifically, *** | |
| 1396 | 21 CFR 211.42(c)(2) | 1 | 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,*** | |
| 1411 | 21 CFR 211.105(b) | 1 | 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, *** | |
| 1418 | 21 CFR 211.42(c)(7) | 1 | 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, *** | |
| 1431 | 21 CFR 211.42(c)(10)(ii) | 1 | Temperature / Humidity Controls | Aseptic processing areas are deficient regarding [temperature] [humidity] controls. Specifically, *** | |
| 1436 | 21 CFR 211.42(c)(10)(vi) | 1 | Equipment to control conditions | Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. Specifically, *** | |
| 1509 | 21 CFR 211.122(h) | 1 | Printing devices | Printing devices used to imprint labeling upon the drug product [unit label] [case] are not monitored to assure that all imprinting conforms to the print specified in the batch production record. Specifically, *** | |
| 1726 | 21 CFR 211.86 | 1 | Rotation of components/containers/closures | There is a lack of rotation so that the oldest approved stock of [components] [drug product containers] [closures] is used first. Specifically, *** | |
| 1794 | 21 CFR 211.80(d) | 1 | Disposition recorded by lot identification | The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot. Specifically, *** | |
| 1796 | 21 CFR 211.80(d) | 1 | 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, *** | |
| 1818 | 21 CFR 211.84(c)(2) | 1 | Appropriate Opening of Component Containers | The containers of components, or drug product containers or closures which are sampled are not opened in a manner to prevent [contamination of their contents] [contamination of other components] [contamination of other drug product containers] [contamination of other closures]. Specifically, *** | |
| 1824 | 21 CFR 211.84(c)(5) | 1 | Identifying Sample Containers | Sample container identification of sampled item is deficient in that it does not include the [name of the material sampled] [lot number] [container from which the sample was taken] [date on which the sample was taken] [name of the person who collected the sample]. Specifically, *** | |
| 1845 | 21 CFR 211.84(d)(3) | 1 | Container/Closure Written Test Procedure | Drug product container and closure test procedures are deficient in that [containers] [closures] are not tested for conformance in accordance with appropriate written procedures. Specifically, *** | |
| 1849 | 21 CFR 211.84(d)(6) | 1 | 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, *** | |
| 1852 | 21 CFR 211.94(a) | 1 | 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, *** | |
| 1870 | 21 CFR 211.94(d) | 1 | 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, *** | |
| 1938 | 21 CFR 211.167(c) | 1 | 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, *** | |
| 1941 | 21 CFR 211.180(d) | 1 | Reader/Photocopy equipment not made available | Suitable reader or photocopying equipment was not made readily available for [drug product] [component] records maintained using reduction techniques. Specifically, *** | |
| 1957 | 21 CFR 211.180(e)(2) | 1 | 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, *** | |
| 1999 | 21 CFR 211.184(a) | 1 | 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 manufacturer if different from the supplier] [location of the prime manufacturer]. Specifically, *** | |
| 2020 | 21 CFR 211.188(b)(8) | 1 | 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, *** | |
| 2023 | 21 CFR 211.188(b)(11) | 1 | 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, *** | |
| 2200 | 21 CFR 211.186(b)(4) | 1 | 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, *** | |
| 2201 | 21 CFR 211.186(b)(5) | 1 | Calculated Excess of Components Used | The master production and control records are deficient in that they do not include a statement concerning any calculated excess of component. Specifically, *** | |
| 2402 | 21 CFR 211.194(a)(5) | 1 | Testing Calculations | Laboratory records are deficient in that they do not include all calculations performed during testing. Specifically, *** | |
| 2406 | 21 CFR 211.194(a)(8) | 1 | 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, *** | |
| 2420 | 21 CFR 211.198(a) | 1 | 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, *** | |
| 2572 | 21 CFR 211.198(b) | 1 | 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, *** | |
| 2621 | 21 CFR 211.198(b)(3) | 1 | 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, *** | |
| 3554 | 21 CFR 211.48(a) | 1 | Potable water standards not met | The potable water being permitted for use in the potable water system fails to meet standards prescribed by the Environmental Protection Agency. Specifically, *** | |
| 3558 | 21 CFR 211.52 | 1 | Washing and toilet facilities not provided and accessible | Washing and toilet facilities are not [provided] [easily accessible to working areas]. Specifically, *** | |
| 3567 | 21 CFR 211.84(d)(2) | 1 | Component identification test | Specific identification tests are not conducted on components that have been accepted based on the supplier’s report of analysis. Specifically, *** | |
| 3597 | 21 CFR 211.122(g)(3) | 1 | 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 performed by one person and independently verified by a second person]. Specifically, **** | |
| 3630 | 21 CFR 211.170(b) | 1 | 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, *** | |
| 4310 | 21 CFR 211.84(c)(3) | 1 | Sterile Equipment, Aseptic Techniques in sample collecting | Failure to use [sterile equipment] [aseptic sampling techniques] when necessary in collecting a sample. Specifically, *** | |
| 4313 | 21 CFR 211.84(c)(6) | 1 | Containers Marked to Show Samples Taken | Containers from which samples have been taken are not marked to show that samples have been taken from them. Specifically, *** | |
| 4316 | 21 CFR 211.84(d)(3) | 1 | Testing Containers & Closures Conformity with Specs | Containers and closures are not tested for conformance with all appropriate written procedures. Specifically, *** | |
| 4322 | 21 CFR 211.101(d) | 1 | 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 properly identified]. Specifically, *** | |
| 4325 | 21 CFR 211.110(a) | 1 | 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,*** | |
| 4349 | 21 CFR 211.160(b)(2) | 1 | In-process samples representative, identified properly | Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, *** | |
| 4354 | 21 CFR 211.165(d) | 1 | Acceptance/Rejection Levels | The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, *** | |
| 4370 | 21 CFR 211.188(b)(10) | 1 | 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, *** | |
| 4375 | 21 CFR 211.188(b)(5) | 1 | 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, *** | |
| 4376 | 21 CFR 211.188(b)(4) | 1 | 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, *** | |
| 4379 | 21 CFR 211.188(b)(1) | 1 | Dates not included for each significant step | Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced. Specifically, *** | |
| 4387 | 21 CFR 211.198(a) | 1 | 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 and Drug Administration. Specifically, *** | |
| 4390 | 21 CFR 211.180c) | 1 | Photocopying of records not allowed | Records or copies of records were not made available for photocopying or other means of reproduction. Specifically, *** | |
| 4411 | 21 CFR 211.194(a)(6) | 1 | 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 product] tested. Specifically, *** | |
| 4412 | 21 CFR 211.194(a)(7) | 1 | 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, *** | |
| 4414 | 21 CFR 211.204 | 1 | Record information maintained | Records of returned drug products are not maintained. Specifically, *** | |
| 6825 | 21 CFR 314.80(c)(1)(iii) | 1 | Non-applicant reports to applicant | You, as a non-applicant, elected to submit to the applicant (rather than to FDA) all reports of adverse drug experiences that were both serious and unexpected. However, you did not submit each report to the applicant [within five calendar days of your receipt of the information]. Specifically, *** | |
| 6827 | 21 CFR 314.80(c)(1)(iv) | 1 | Failure to identify report content | Each post marketing 15-day Alert report submitted to FDA did not have its contents prominently identified, i.e. [post marketing 15-day report] [post marketing 15-day report follow-up]. Specifically, *** | |
| 6829 | 21 CFR 314.80(c)(2) | 1 | 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, *** | |
| 6835 | 21 CFR 314.80(d)(1) | 1 | Failure to submit scientific article | Not all post marketing 15-day Alert reports based upon scientific literature were accompanied by a copy of the published article. Specifically, *** | |
| 6838 | 21 CFR 314.80(e)(1) | 1 | Failure to report post-marketing study ADEs | Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience. Specifically, *** | |
| 8914 | 21 CFR 314.81(b)(2)(iv)(b) | 1 | 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, *** | |
| 8922 | 21 CFR 314.81(b)(2)(viii) | 1 | Post marketing study status report for other studies | An annual report did not include a status report for all post marketing studies being performed by, or on behalf of, the applicant and not covered by the requirements of 21 CFR 314.81(b)(2)(vii). Specifically, *** | |
| 17002 | FDCA 501(a) | 1 | Drug Field Exam | During a field examination of drug products at your facility the following [was] [were] observed: | |
| 17744 | 21 CFR 212.30(b) | 1 | Equipment not properly installed | You did not document your activities in accordance with your procedures for cleaning all of your equipment. Specifically,*** | |
| 17753 | 21 CFR 212.30(c) | 1 | Contact surfaces | Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs. Specifically,*** | |
| 17757 | 21 CFR 212.20(b) | 1 | Examine, approve or reject | You did not approve or reject [components] [containers] [closures] [in-process materials] [packaging materials] [labeling] [finished dosage forms] in a manner that ensures compliance with procedures and specifications affecting the identity, strength, quality or purity of a PET drug. Specifically,*** | |
| 17761 | 21 CFR 212.20(c) | 1 | Proposed changes to existing specs/methods | You did not approve or reject, before implementation, proposed changes to existing [specifications] [methods] [processes] [procedures] to ensure that they would maintain the identity, strength, quality and purity of a PET drug. Specifically,*** | |
| 17765 | 21 CFR 212.20(d) | 1 | Review of records for errors | You did not review production records to determine whether errors had occurred. Specifically,*** | |
| 17770 | 21 CFR 212.40(a) | 1 | Suitable for intended use | Your written procedures are not adequate to ensure that the [components] [containers] [closures] are suitable for their intended use. Specifically,*** | |
| 17821 | 21 CFR 212.50(b)(6) | 1 | Action limits on radiochemical yield | Your master production and control records did not contain a statement of action limits on radiochemical yield. Specifically,*** | |
| 17822 | 21 CFR 212.50(b)(7) | 1 | 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,*** | |
| 17823 | 21 CFR 212.50(b)(8) | 1 | Container & label descriptions | Your master production and control records did not contain [a description of the PET drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling]. Specifically,*** | |
| 17832 | 21 CFR 212.50(c)(4) | 1 | Each major production step | Your batch production records do not [always] include each major production step (obtained from the approved appropriate master production and control record). Specifically,*** | |
| 17846 | 21 CFR 212.50(f)(2) | 1 | Documentation of activities | You did not document your process verification [activities] [results]. Specifically,*** | |
| 17853 | 21 CFR 212.60(d) | 1 | Supplies adequately controlled | Your [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled. Specifically,*** | |
| 17855 | 21 CFR 212.60(e) | 1 | Equipment | All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,*** | |
| 17865 | 21 CFR 212.60(g)(5) | 1 | Initials, signature, date | Laboratory test records did not contain the initials or signature of the person performing the test. Specifically,*** | |
| 17869 | 21 CFR 212.61(a) | 1 | Samples representative, stored properly | The samples tested for stability were [not representative of the lot or batch from which they were obtained] [not stored under suitable storage conditions]. Specifically,*** | |
| 17870 | 21 CFR 212.61(b) | 1 | Use of stability test results | The stability test results were not [documented] [used in determining appropriate storage conditions] [used in determining appropriate expiration dates and times] for each PET drug product you produce. Specifically,*** | |
| 17872 | 21 CFR 212.70(a) | 1 | Specifications | You did not establish [adequate] specifications for each PET drug product, including criteria for determining [identity, strength, quality and purity] [sterility] [pyrogens]. Specifically,*** | |
| 17874 | 21 CFR 212.70(b) | 1 | Before implementing new procedure establish accuracy etc. | You implemented a new test procedure in a specification, but you did not first [establish] [document] the [accuracy] [sensitivity] [specificity] [reproducibility] of the procedure. Specifically,*** | |
| 17877 | 21 CFR 212.70(c) | 1 | Conform to specs prior to release | You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug conforms to specifications before final release. Specifically,*** | |
| 17886 | 21 CFR 212.70(e) | 1 | When 30 hour rule is exceeded | A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period. Specifically,*** | |
| 17896 | 21 CFR 212.71(a) | 1 | Rejection of nonconforming product | You did not reject the batch of a PET drug product that did not conform to specifications. Specifically,*** | |
| 17897 | 21 CFR 212.71(b) | 1 | Investigation of nonconforming product | You did not [completely] document the investigation of a PET drug product that did not meet specifications. Specifically,*** | |
| 17898 | 21 CFR 212.71(c) | 1 | 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,*** | |
| 17904 | 21 CFR 212.80(d) | 1 | Labeling and product mix-ups | Labeling and packaging operations for PET drug products were not controlled to prevent labeling and product mix-ups. Specifically,*** | |
| 17913 | 21 CFR 212.100(a) | 1 | Written complaint procedures | You have not [developed] [followed] written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. Specifically,*** | |
| 17927 | 21 CFR 212.110(b) | 1 | Record quality | All records including those not stored at your inspected establishment are not [legible] [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees]. Specifically,*** | |
| 17937 | 21 CFR 212.70(e) | 1 | Notification to Facilities Re: Received PET Drug Sterility | You did not notify all facilities that received a PET drug product that failed to meet a criterion for sterility of the findings from your investigation. Specifically*** | |
| 17939 | 21 CFR 212.71(a) | 1 | 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, *** | |
| 17941 | 21 CFR 212.71(b) | 1 | Documentation of Non-Conforming Product Investigation | You did not document [the results of the investigation] [what happened to the rejected PET drug product] for a PET drug product that did not meet specifications. Specifically*** |
原文链接：http://www.fda.gov/iceci/enforcementactions/ucm381526.htm#drugs
