fda_483 · inspection_citation · high
Intas Pharmaceutical Limited -- FDA 483: 3 observations (2025-09-17)
- Event date
- 2025-09-17 00:00:00Z
- Observed
- 2026-07-12 22:31:37Z
- Source ID
- 3005890633-2025-09-17-192689
- Payload hash
- 44582f52d1769692b37a7cd1…
Summary
Observation 1: There is a failure to thoroughly review any unexplained discrep ancy whether or n ot the batch has been ah eady distributed. Specifically, A. Shelf-life of the diug product <6>< 4 > Tab...
Entities
Informational only. Not legal, financial, or medical advice.