fda_483 · inspection_citation · high
Catalent Indiana LLC -- FDA 483: 8 observations (2026-04-24)
- Event date
- 2026-04-24 00:00:00Z
- Observed
- 2026-07-12 22:28:53Z
- Source ID
- 3005949964-2026-04-24-193455
- Payload hash
- ed9592c187aed62d4d08711b…
Summary
Observation 1: Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up. Specifically, A. Extri...
Entities
Informational only. Not legal, financial, or medical advice.