fda_483 · inspection_citation · high
SCA Pharmaceuticals LLC -- FDA 483: 2 observations (2026-03-13)
- Event date
- 2026-03-13 00:00:00Z
- Observed
- 2026-07-12 22:30:45Z
- Source ID
- 3013736415-2026-03-13-192262
- Payload hash
- bc437f7836bfe81d43ecebff…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. Specifically, Procedures designed to prevent mic...
Entities
Informational only. Not legal, financial, or medical advice.