fda_483 · inspection_citation · high
SCA Pharmaceuticals Inc -- FDA 483: 3 observations (2025-10-30)
- Event date
- 2025-10-30 00:00:00Z
- Observed
- 2026-07-12 22:31:32Z
- Source ID
- 3010683157-2025-10-30-190196
- Payload hash
- c1451ab41c0595ad9c17460d…
Summary
Observation 1: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. Specifically, Your firm failed to establish adequate procedur...
Entities
Informational only. Not legal, financial, or medical advice.