fda_483 · inspection_citation · high

Somerset Therapeutics Private Limited -- FDA 483: 3 observations (2025-02-21)

Event date
2025-02-21 00:00:00Z
Observed
2026-07-12 22:32:31Z
Source ID
3003821988-2025-02-21-192342
Payload hash
cacb9368728b31c6043b9bb8

Summary

Observation 7: Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, ......_____,,__ Your viable environmental monitoring (EM) results are ...

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