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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 |
|---|---|---|---|
| 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. Zydus Lifesciences Limited |
13 Aug 2025 | Normal | Justification: Observation indicates correlation between sampling examination lapses and chronic quality complaints affecting complaint management. Excerpt: In the period of 01-Jan-2022 to 11-Aug-2025, your Quality Unit received about 237 complaints of which 125 complaints were related to physical defects and count variabilities. View Details |
| Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. Zydus Lifesciences Limited |
13 Aug 2025 | Normal | Justification: The observation highlights failures in complaint management due to missed batch collection and sample inadequacies. Excerpt: Your firm neither made sufficient attempt to know the batch number nor tried to collect the complaint sample. 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 observation directly addresses the processes of managing customer complaints, specifically noting deficiencies in follow-up and documentation. Excerpt: Written records of investigation of a drug complaint do not include the follow-up. Specifically,... View Details |
| Complaint records are deficient in that they do not include the findings of the investigation and follow-up AnazaoHealth Corporation |
08 Aug 2025 | Normal | Justification: Complaint Management is directly involved as the investigations were found lacking due to missing sample analyses. Excerpt: Complaint records are deficient in that they do not include the findings of the investigation and follow-up. View Details |
| There is a failure to evaluate and investigate any unexplained discrepancy whether or not the batch has been already distributed Not available |
01 Aug 2025 | Normal | Justification: Inadequate handling and resolution of product complaints is directly tied to flaws in the 'Complaint Management' process. Excerpt: Product defect complaints related to Batch #1225 were logged without proper investigation follow-up... View Details |
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