fda_483 · inspection_citation · high

Revive Rx LLC -- FDA 483: 6 observations (2025-02-07)

Event date
2025-02-07 00:00:00Z
Observed
2026-07-12 22:32:46Z
Source ID
3016710945-2025-02-07-185963
Payload hash
33c25eacdf0233a97bb75301

Summary

Observation 1: Sterile chugs and Materials were exposed to lower than ISO 5 quality air. Specifically, A.Your fom 's:~uproduct, Trimix Gel (300 mcg / 100 mcg / 1000 mcg per ml), is prepared with nonst...

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