fda_483 · inspection_citation · high

QuVa Pharma Inc -- FDA 483: 3 observations (2026-05-04)

Event date
2026-05-04 00:00:00Z
Observed
2026-07-12 22:28:54Z
Source ID
3012053582-2026-05-04-193419
Payload hash
73298062a2e15cd10dc0e98c

Summary

Observation 1: Procedures designed to prevent microbiological contamination of mug products pmp o1ting to be sterile are not established, written and followed. Specifically, your fnm fail ed to adequa...

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