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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 |
|---|---|---|---|
| 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. Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: Complaints about sub-potent or super-potent products were not adequately tested for potency, evidencing gaps in complaint management. Excerpt: Complaints involving drug product efficacy were not tested for assay as part of your investigation. 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 Dr. Reddy's Laboratories Limited |
12 Dec 2025 | Normal | Justification: The observation states market complaints were mishandled, linking to complaint management processes. Excerpt: You unsubstantiated the Market Complaints for the (b)(4) batches that were not part of this campaign. 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 Fresenius Kabi Compounding, LLC |
06 Nov 2025 | Normal | Justification: Complaint Management processes failed to capture and resolve customer complaints related to defective IV bags. Excerpt: Your firm has received customer complaints for leaking IV bags and in some cases not identified the specific root cause. View Details |
| There is a failure to thoroughly review any unexplained discrepancy Lonza Guangzhou Pharmaceutical Ltd. |
31 Oct 2025 | Normal | Justification: The observation highlights inadequate complaint handling, pointing to flaws in the Complaint Management process requiring rectification. Excerpt: The quality unit failed to provide adequate complaint investigations...failed to evaluate reserve/retention samples... View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. UBI Pharma Inc. |
14 Oct 2025 | Normal | Justification: Complaint Management is directly impacted by failure to investigate and address complaints as stipulated in the expired QA. Excerpt: Your customer, decided not to investigate and file FAR. According to your (expired) QA, you are responsible for complaint investigation. View Details |
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