fda_483 · inspection_citation · high
Baxter Oncology GmbH -- FDA 483: 1 observation (2025-09-26)
- Event date
- 2025-09-26 00:00:00Z
- Observed
- 2026-07-12 22:31:34Z
- Source ID
- 3002806419-2025-09-26-190881
- Payload hash
- b8a4776b670ca46874517b6b…
Summary
Observation 2: Procedures designed to prevent microbiological contamination of dmg products purp01ting to be sterile are not established and fo llowed. 4 1. Aseptic behavior procedure SOP-01007, which...
Entities
Informational only. Not legal, financial, or medical advice.