FDA inspection
ORGENTEC Diagnostika Gmbh: FDA inspection ending May 2, 2013
FDA inspection 835430 · Voluntary Action Indicated (VAI) · Mainz
Key facts
| Inspection ID | 835430 |
|---|---|
| Firm | ORGENTEC Diagnostika Gmbh |
| FEI number | 3003232042 |
| Address | Carl-Zeiss-Str. 49 |
| City | Mainz |
| Country | Germany |
| Fiscal year | 2013 |
| Inspection end date | May 2, 2013 |
| 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