| Apr 13, 2026 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Dec 18, 2024 | Drugs · Bioresearch Monitoring | 3 cited references- 21 CFR 314.80(c)(2). Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
- 21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
- 21 CFR 314.80(c)(2). Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
| Voluntary Action Indicated (VAI) |
| Nov 8, 2023 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.204. Returned drug procedures in writing and followed Procedures describing the holding, testing and reprocessing of returned drug products are not in writing and followed.
- 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 211.22(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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which 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.
| Voluntary Action Indicated (VAI) |
| Feb 10, 2023 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.22(c). Approve or reject procedures or specs The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
- 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- 21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
- 21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
| Voluntary Action Indicated (VAI) |
| Sep 17, 2021 | Drugs · Drug Quality Assurance | 5 cited references- 21 CFR 211.22(a). Approve or reject components, products The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling and drug products.
- 21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
- 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 , Education , Experience overall Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education and experience required to perform their assigned functions.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
| Official Action Indicated (OAI) |
| Jan 7, 2020 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Jan 7, 2020 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Nov 15, 2019 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 3 cited references- 21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established.
- 21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and maintained.
- 21 CFR 820.50. Purchasing controls, Lack of or inadequate procedures Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
| Voluntary Action Indicated (VAI) |
| Mar 29, 2019 | Drugs · Bioresearch Monitoring | 2 cited references- 21 CFR 314.81(b)(2). Timely submission An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
- 21 CFR 314.80(c)(2). Late submission of annual safety reports Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
| Voluntary Action Indicated (VAI) |
| Mar 8, 2017 | Drugs · Bioresearch Monitoring | 3 cited references- 21 CFR 314.81(b)(2). Timely submission An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
- 21 CFR 314.80(c)(2). Interval Periodic reports of non-alert adverse drug experiences have not been submitted quarterly for an application which was approved less than three years ago and yearly for an application which was approved three or more years ago.
- 21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the receipt of post marketing adverse drug experiences.
| Voluntary Action Indicated (VAI) |
| Oct 28, 2015 | Drugs · Unapproved and Misbranded DrugsDrugs · Drug Quality Assurance | 3 cited references- 21 CFR 111.455(a). Hold - temperature, humidity, light You did not hold dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
- 21 CFR 211.142(b). Storage under appropriate conditions Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.
| Voluntary Action Indicated (VAI) |
| May 28, 2015 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
| Sep 10, 2014 | Drugs · Bioresearch Monitoring | None posted | No Action Indicated (NAI) |
| Jan 29, 2014 | Drugs · Drug Quality Assurance | 2 cited references- 21 CFR 111.560(b). Quality control, review, approve; investigate, follow-up Your quality control personnel did not review and approve decisions about whether to investigate a product complaint and review and approve the findings and follow-up action of an investigation.
- 21 CFR 111.455(a). Hold - temperature, humidity, light You did not hold dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.
| Voluntary Action Indicated (VAI) |
| Oct 31, 2013 | Drugs · Drug Quality AssuranceDrugs · Unapproved and Misbranded Drugs | 8 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 211.180(f). 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, and any regulatory actions brought by FDA relating to good manufacturing practices.
- 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
- 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 211.25(a). GMP Training Frequency GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
- 21 CFR 211.165(e). Test methods The accuracy, sensitivity, specificity, and reproducibility of test methods have not been documented.
- 21 CFR 211.22(a). Contract drug products--lack of responsibility The quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed, packed, and held under contract by another company.
- 21 CFR 211.180(e)(2). Items to cover on annual reviews Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
| Voluntary Action Indicated (VAI) |
| Mar 22, 2012 | Drugs · Drug Quality Assurance | 3 cited references- 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.
- 21 CFR 211.150(b). Recall facilitation A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
- 21 CFR 211.204. Returned drug procedures in writing and followed Procedures describing the holding of returned drug products are not in writing.
| Voluntary Action Indicated (VAI) |
| Dec 20, 2010 | Drugs · Drug Quality Assurance | None posted | Voluntary Action Indicated (VAI) |
| Apr 2, 2010 | Drugs · Drug Quality Assurance | 4 cited references- 21 CFR 211.192. Quality control unit review of records Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
- 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
- 21 CFR 211.198(b)(1). Written complaint record must include Written complaint records do not include, where known, lot number.
- 21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
| Voluntary Action Indicated (VAI) |
| Feb 24, 2010 | Drugs · Drug Quality Assurance | None posted | Official Action Indicated (OAI) |
| Aug 18, 2009 | Drugs · Drug Quality Assurance | None posted | No Action Indicated (NAI) |
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