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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 |
|---|---|---|---|
| Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination Lupin Limited |
21 Nov 2025 | Normal | Justification: Risk assessments were cited but failed to adequately address cleaning deviations and impurity control. Excerpt: The evaluation of Risk Assessment Number: QRM/25/L008/P/056/00 revealed procedural inadequacies. 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 specification Empower Clinic Services, L.L.C. dba Empower Pharma |
14 Nov 2025 | Normal | Justification: Management cited risk-based prioritization, yet lacked documentation for assessments and criteria. Excerpt: Investigations are delayed due to onboarding of new writers, prioritized "by risk," yet no documented risk assessment provided. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Fresenius Kabi Compounding, LLC |
06 Nov 2025 | Normal | Justification: The observation highlights a risk management failure in not addressing critical defects in CSP containers adequately. Excerpt: Your firm released lots with port defects above %, such as vancomycin HCl 1 gram added to 250 mL 0.9% Sodium Chloride Injection USP IV Bag. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Hetero Labs Limited, Unit-IX |
26 Sep 2025 | Normal | Justification: Using an unregistered lab without formal agreements points to deficiencies in assessing and managing quality risks. Excerpt: Unregistered laboratory is not referenced in any of your Drug Master Files (DMF) filed with FDA. View Details |
| During the Transition Period of Study RGB-14-101 Hikma Pharmaceuticals USA Inc. |
23 Sep 2025 | Normal | Justification: The process type 'Quality Risk Management' is linked to the issue as proper risk assessments could prevent or mitigate these adverse events. Excerpt: Hypocalcemia adverse events reported...with the vast majority of these events mild in severity. View Details |
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