FDA inspection
Oertel Medical GmbH: FDA inspection ending Jan 27, 2012
FDA inspection 764312 · Official Action Indicated (OAI) · Tuttlingen
Key facts
| Inspection ID | 764312 |
|---|---|
| Firm | Oertel Medical GmbH |
| FEI number | 3002809480 |
| Address | Obere Vorstadt 19/20 |
| City | Tuttlingen |
| Country | Germany |
| Fiscal year | 2012 |
| Inspection end date | Jan 27, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 303918 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes 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