fda_483 · inspection_citation · high
Eagle Pharma Outsourcing LLC -- FDA 483: 5 observations (2025-02-27)
- Event date
- 2025-02-27 00:00:00Z
- Observed
- 2026-07-12 22:32:30Z
- Source ID
- 3011688532-2025-02-27-185964
- Payload hash
- a7a25f62c62d950ec4b1b518…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Specifically, A. Your firm management failed to conduct a smo...
Entities
Informational only. Not legal, financial, or medical advice.