FDA Inspection 1204167 — Amgen Europe BV
The FDA completed an inspection of Amgen Europe BV on May 3, 2022 in Breda. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 3, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Breda (Netherlands)
Additional Details
Mutual Recognition Agreement (MRA)