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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 |
|---|---|---|---|
| Procedures for the maintenance of equipment used in the manufacture and testing of FAYUVI are not followed. Ultragenyx Pharmaceutical Inc. |
17 Sep 2026 | Normal | Justification: Preventive Maintenance is linked because the issue pertains directly to the failure to perform scheduled equipment maintenance. Excerpt: Records indicate that the preventive maintenance for the autoclave (ID #AU-202) was not conducted according to the schedule. View Details |
| Failure to maintain equipment used in the collection of blood and blood products in a clean and orderly manner BioLife Plasma Services, L.P. |
22 Apr 2026 | Normal | Justification: The issue is directly linked to Preventive Maintenance because the critical failure was related to the neglected PM tasks as per the manufacturer's guidelines. Excerpt: I reviewed preventive maintenance (PM) records and found that the required maintenance for the apheresis devices had not been performed as specified in the device Operator's Manual. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. AstraZeneca AB |
10 Apr 2026 | Normal | Justification: Failure to update the preventive maintenance program was directly linked to the deviation caused by equipment wear. Excerpt: The preventative maintenance program was not updated to address the equipment wear condition that caused this deviation. View Details |
| Buildings used in the holding of a drug product are not maintained in a good state of repair. Granules Pharmaceuticals Inc. |
03 Apr 2026 | Normal | Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here. Excerpt: Preventive maintenance failed to detect the improper wiring. View Details |
| Buildings used in the holding of a drug product are not maintained in a good state of repair. Granules Pharmaceuticals Inc. |
03 Apr 2026 | Normal | Justification: Preventive maintenance should detect potential failures, but lacked depth in identifying issues here. Excerpt: Preventive maintenance failed to detect the improper wiring. View Details |
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