FDA Inspection 1328414 — Amgen Europe BV
The FDA completed an inspection of Amgen Europe BV on Jul 16, 2025 in Breda. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 16, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Breda (Netherlands)
Additional Details
Mutual Recognition Agreement (MRA)