fda_483 · inspection_citation · high
Sanofi-Aventis Deutschland GmbH -- FDA 483: 4 observations (2025-01-16)
- Event date
- 2025-01-16 00:00:00Z
- Observed
- 2026-07-12 22:32:49Z
- Source ID
- 3003195501-2025-01-16-186637
- Payload hash
- cf9615d8108c42a399142ce0…
Summary
Observation 1: (bTC4l 0 Procedures designed to prevent microbiological contamination of products purpo1i ing to be sterile are not established and fo llowed.------ A. Environmental monitoring of criti...
Entities
Informational only. Not legal, financial, or medical advice.