| Jan 27, 2025 | Drugs · Drug Quality Assurance | 10 cited references- 21 CFR 211.198(b)(2). Complaint Investigation/Follow-Up Findings Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
- 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and 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.
- 21 CFR 211.42(c)(5). Mfg / Processing Operations Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
- 21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
- 21 CFR 211.25(b). Supervisor Training/Education/Experience Individuals responsible for supervising the manufacture, processing, packing and holding of a drug product lack the education, training and 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.
- 21 CFR 211.68(b). Computer control of master formula records Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
| Official Action Indicated (OAI) |
| Nov 16, 2018 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.170(b). Annual visual exams of drug products Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
- 21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures designed to assure that components, drug product containers, closures and drug products conform to appropriate standards of identity, strength, quality and purity.
| Voluntary Action Indicated (VAI) |
| Nov 16, 2018 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Sep 28, 2017 | Drugs · Drug Quality Assurance | 3 cited references- 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and 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.
- 21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
- 21 CFR 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
| Voluntary Action Indicated (VAI) |
| Aug 28, 2015 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | 6 cited references- 21 CFR 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and 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.
- 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy and 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.
- 21 CFR 211.180(e). Records reviewed annually Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
- 21 CFR 211.165(e). Test methods The accuracy, specificity, and reproducibility of test methods have not been established.
- 21 CFR 211.182. Written records kept in individual logs Written records of major equipment use are not included in individual equipment logs.
- 21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
| Voluntary Action Indicated (VAI) |
| Apr 14, 2014 | Devices · Compliance: DevicesDrugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Apr 14, 2014 | Drugs · Drug Quality AssuranceDevices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Jul 2, 2013 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices; Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jun 26, 2012 | Drugs · Drug Quality Assurance | 8 cited references- 21 CFR 211.166(a)(2). Stability sample storage conditions described The written stability program for drug products does not describe the storage conditions for samples retained for testing.
- 21 CFR 211.167(a). Sterility/pyrogen-free testing Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
- 21 CFR 211.170(b)(1). Retention time of reserve samples, in general Reserve samples for drug products are not retained for one year after the expiration date of the drug product.
- 21 CFR 211.113(b). Validation lacking for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
- 21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
- 21 CFR 211.166(a)(3). Valid stability test methods The written stability program for drug products does not include meaningful test methods.
- 21 CFR 211.84(d)(2). Reports of Analysis (Components) Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
| Voluntary Action Indicated (VAI) |
| May 29, 2012 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Jan 5, 2011 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
| Mar 31, 2010 | Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices | None posted | No Action Indicated (NAI) |
