fda_483 · inspection_citation · high

Ipca Laboratories Limited -- FDA 483: 3 observations (2025-12-05)

Event date
2025-12-05 00:00:00Z
Observed
2026-07-12 22:31:15Z
Source ID
3006057101-2025-12-05-190994
Payload hash
f99de3cdddaec8009e3f7d8a

Summary

Observation 1: Buildings and facilities used to manufacture APis are not maintained appropriately to facilitate cleaning and to minimize potential contamination. Specifically, the clean rooms in manuf...

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