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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| A Field Alert Report was not submitted within three working days of receipt of information concerning a failure Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: The issue highlights deficiencies in submitting required Field Alert Reports as per regulatory timelines. Excerpt: A Field Alert Report was not submitted within three working days of receipt of information concerning a failure. View Details |
| Complaint records are deficient in that they do not include the findings of the investigation and follow-up. Bausch and Lomb Incorporated |
20 Mar 2026 | Normal | Justification: The critical issue of missing Field Alert Report filings emphasizes deficiencies in the Field Alert Reporting process. Excerpt: Your firm failed to file a Field Alert Report (FAR) for Complaint# 1329875 opened on 08/07/2024 as an Adverse Event (AE). View Details |
| 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. EUGIA Pharma Specialities Limited |
27 Feb 2026 | Normal | Justification: The observation highlights failure to evaluate container closure systems despite numerous field alert reports, implicating 'Field Alert Report' processes. Excerpt: There has been no review of the container closure systems of either product since they were initially marketed. View Details |
| Written procedures have not been developed for the reporting to FDA of post marketing adverse drug experiences. Misemer Pharmaceutical, Inc. |
23 Feb 2026 | Normal | Justification: The observation directly mentions deficiencies in postmarketing adverse drug experience reporting SOPs, linking it to Field Alert Report processes. Excerpt: SOP does not describe the procedure for filing the Postmarketing Adverse Drug Experience Reports or Annual Reports with the FDA. View Details |
| Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. Misemer Pharmaceutical, Inc. |
23 Feb 2026 | Normal | Justification: Timely submission of Periodic Adverse Drug Experience Reports is crucial for field alert reporting to ensure drug safety and compliance. Excerpt: quarterly Periodic Adverse Drug Experience Reports (PADERS) for Fenoprofen (ANDA 215548) were not submitted. View Details |
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