fda_483 · inspection_citation · high

SMS Pharmaceutical Limited - Unit VII -- FDA 483: 1 observation (2025-12-12)

Event date
2025-12-12 00:00:00Z
Observed
2026-07-12 22:31:13Z
Source ID
3008654585-2025-12-12-191858
Payload hash
9e966c8f61debd852fb95699

Summary

Observation 1: Failure to ens ure that all sp ecifications are sc ientifi cally sound and appropriate to ensure that your API confo1m to establish ed standards of quality and, or pmity. Specifi cally,...

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