fda_483 · inspection_citation · high

Zydus Lifesciences Limited -- FDA 483: 3 observations (2025-08-13)

Event date
2025-08-13 00:00:00Z
Observed
2026-07-12 22:31:57Z
Source ID
3005430968-2025-08-13-189399
Payload hash
27653d89a731579bd6fc8700

Summary

Observation 1: The responsibilities and procedures applicable to the qua li ty control unit are not fully fo llowed. Specifica lly, your quality unit did not to take appropriate market action for batc...

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