fda_483 · inspection_citation · high

Olympia Pharmaceuticals -- FDA 483: 3 observations (2025-08-08)

Event date
2025-08-08 00:00:00Z
Observed
2026-07-12 22:31:57Z
Source ID
3009724085-2025-08-08-188647
Payload hash
fb604dee446c9bb82d905202

Summary

Observation 1: Procedures designed to prevent microbiological contamination of mug products pmp o1ting to be sterile did not inclu de adequate validation of the aseptic process. Specifically, A. Durin...

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