FDA inspection
Alvotech HF: FDA inspection ending Sep 17, 2024
FDA inspection 1252377 · Voluntary Action Indicated (VAI) · Reykjavik
Key facts
| Inspection ID | 1252377 |
|---|---|
| Firm | Alvotech HF |
| FEI number | 3013702557 |
| Address | Saemundargotu 15-19 |
| City | Reykjavik |
| Country | Iceland |
| Fiscal year | 2024 |
| Inspection end date | Sep 17, 2024 |
| 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