fda_483 · inspection_citation · high
Patheon Italia S.p.A. -- FDA 483: 6 observations (2025-02-18)
- Event date
- 2025-02-18 00:00:00Z
- Observed
- 2026-07-12 22:32:46Z
- Source ID
- 3004110157-2025-02-18-191892
- Payload hash
- 5767491694bf6733b848c071…
Summary
Observation 1: : Quality Unit (QU) oversight over the manufacturing process is inadequate. Specifically, A. Written records of investigations into unexplained d iscrepancies, the failure of a batch or...
Entities
Informational only. Not legal, financial, or medical advice.