fda_483 · inspection_citation · high

Sun Pharmaceutical Industries Ltd. -- FDA 483: 2 observations (2025-06-13)

Event date
2025-06-13 00:00:00Z
Observed
2026-07-12 22:32:07Z
Source ID
3002809586-2025-06-13-187479
Payload hash
7c0c3333d540f108bf23cb71

Summary

Observation 5: Your fom failed to establish adequate written procedures for production and process controls design ed to assure that the diug products have the identity, strength, purity, and quality ...

Informational only. Not legal, financial, or medical advice.