FDA inspection
Alvotech HF: FDA inspection ending Mar 17, 2023
FDA inspection 1208850 · Official Action Indicated (OAI) · Reykjavik
Key facts
| Inspection ID | 1208850 |
|---|---|
| Firm | Alvotech HF |
| FEI number | 3013702557 |
| Address | Saemundargotu 15-19 |
| City | Reykjavik |
| Fiscal year | 2023 |
| Inspection end date | Mar 17, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| 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