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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 |
|---|---|---|---|
| The establishment failed to thoroughly review any unexplained discrepancy in batch production records. Ultragenyx Pharmaceutical Inc. |
17 Sep 2026 | Normal | Justification: The lack of actions on sterility test failures directly relates to inadequacies in sample testing processes. Excerpt: No documented investigation or corrective actions taken concerning the out-of-specification results for sterility testing. View Details |
| Laboratory controls do not include the establishment of scientifically sound and appropriate specifications RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: Testing limitations directly affect sample testing processes by preventing accurate measurement of product quality. Excerpt: Your firm releases this product using a subvisible particulate matter specification of (b) (4). View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: Observation demonstrates procedural shortcuts in Sample Testing during UV Spectrometry analyses. Excerpt: No justification provided by your QC Analyst about how testing of multiple samples was completed in the shorter time. View Details |
| Written records of investigations into unexplained discrepancies Frontage Laboratories, Inc. |
14 Apr 2026 | Normal | Justification: The high variability observed during retesting directly implicates issues with the sample testing process. Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting. View Details |
| Written records of investigations into unexplained discrepancies Frontage Laboratories, Inc. |
14 Apr 2026 | Normal | Justification: The high variability observed during retesting directly implicates issues with the sample testing process. Excerpt: No justifications were provided for the high (~6%) testing variabilities observed during the retesting. View Details |
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