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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: A critical process failure didn't prompt Field Alert initiation, likely due to SOP ambiguities and awareness gaps. Excerpt: No Field Alert was initiated for this media fill failure. View Details |
| There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components Lupin Limited |
21 Nov 2025 | Normal | Justification: Negligence in Field Alert Reporting post-recall led to critical non-compliance with FDA regulations. Excerpt: Despite the recall action, no Field Alert Report (FAR) was submitted to the FDA as required. 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: Field Alert Reports are essential in signaling potential significant quality issues to the FDA, which were missed here. Excerpt: Your initial QA did not have a provision for timely submission of Field Alert Reports. View Details |
| Written records of investigation of a drug complaint do not include the follow-up. Cohance Lifesciences Limited |
12 Aug 2025 | Normal | Justification: The absence of communication and potential failure to file required Field Alert Reports indicates process lapses. Excerpt: SOP QA084-02, Field Alert Report... However, there is no documented explanation... View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Cohance Lifesciences Limited |
12 Aug 2025 | Normal | Justification: Directly linked to the unlogged complaints in Field Alert Report Log, violating SOP requirements. Excerpt: Complaint investigations that are involved with field alert reporting activities are not logged into the Field Alert Report Log. View Details |
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