FDA inspection
Amgen Europe BV: FDA inspection ending Jul 16, 2025
FDA inspection 1328414 · Voluntary Action Indicated (VAI) · Breda
Key facts
| Inspection ID | 1328414 |
|---|---|
| Firm | Amgen Europe BV |
| FEI number | 3005889661 |
| City | Breda |
| Country | Netherlands |
| Fiscal year | 2025 |
| Inspection end date | Jul 16, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data