fda_483 · inspection_citation · high
Stokes Healthcare Inc. dba Epicur Pharma -- FDA 483: 5 observations (2025-05-23)
- Event date
- 2025-05-23 00:00:00Z
- Observed
- 2026-07-12 22:32:22Z
- Source ID
- 3002815949-2025-05-23-188173
- Payload hash
- b30d15e977a987a80f234899…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. This is a repeat observation. Specifica...
Informational only. Not legal, financial, or medical advice.