fda_483 · inspection_citation · high

Shilpa Medicare Limited -- FDA 483: 3 observations (2025-11-21)

Event date
2025-11-21 00:00:00Z
Observed
2026-07-12 22:31:18Z
Source ID
3009876430-2025-11-21-190616
Payload hash
669d70bfc6d10e1d4b3902d6

Summary

Observation 3: Aseptic processing areas are deficient regarding the system fo r cleaning and disinfecting the equipment to produce aseptic conditions. Specifically, I CbH.il> I used in the manufacture...

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