FDA inspection
Materialise N.V.: FDA inspection ending Mar 13, 2025
FDA inspection 1264936 · Voluntary Action Indicated (VAI) · Leuven
Key facts
| Inspection ID | 1264936 |
|---|---|
| Firm | Materialise N.V. |
| FEI number | 3003998208 |
| Address | Technologielaan 15 |
| City | Leuven |
| Country | Belgium |
| Fiscal year | 2025 |
| Inspection end date | Mar 13, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 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