fda_483 · inspection_citation · high
Catalent Indiana LLC -- FDA 483: 5 observations (2025-07-14)
- Event date
- 2025-07-14 00:00:00Z
- Observed
- 2026-07-12 22:32:04Z
- Source ID
- 3005949964-2025-07-14-190143
- Payload hash
- 2577c1849f2b75761bebd62d…
Summary
Observation 1: Written records of investigations into the failme of a batch or any of its components to meet specific.ations do not always inclu de the conclusions and follow-up. Specifically, A. REC ...
Entities
Informational only. Not legal, financial, or medical advice.