fda_483 · inspection_citation · high
Apotex Inc. -- FDA 483: 8 observations (2025-05-09)
- Event date
- 2025-05-09 00:00:00Z
- Observed
- 2026-07-12 22:32:24Z
- Source ID
- 3001617666-2025-05-09-189935
- Payload hash
- 35e7131d210a68cc7c5eaecc…
Summary
Observation 1: There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of i ts componen ts to meet any of its specifications whether or not the batch has ...
Entities
Informational only. Not legal, financial, or medical advice.