FDA inspection
Puracon GmbH: FDA inspection ending Feb 26, 2026
FDA inspection 1312646 · Voluntary Action Indicated (VAI) · Rosenheim
Key facts
| Inspection ID | 1312646 |
|---|---|
| Firm | Puracon GmbH |
| FEI number | 3004638532 |
| Address | Isar Str. 1 |
| City | Rosenheim |
| Country | Germany |
| Fiscal year | 2026 |
| Inspection end date | Feb 26, 2026 |
| 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