FDA inspection
EPISURF OPERATIONS AB: FDA inspection ending Nov 11, 2025
FDA inspection 1294074 · Voluntary Action Indicated (VAI) · Stockholm
Key facts
| Inspection ID | 1294074 |
|---|---|
| Firm | EPISURF OPERATIONS AB |
| FEI number | 3015341893 |
| Address | Karlavagen 60 |
| City | Stockholm |
| Country | Sweden |
| Fiscal year | 2026 |
| Inspection end date | Nov 11, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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