FDA inspection
Somatex Medical Technologies GMBH: FDA inspection ending Oct 16, 2014
FDA inspection 899832 · Official Action Indicated (OAI) · Berlin
Key facts
| Inspection ID | 899832 |
|---|---|
| Firm | Somatex Medical Technologies GMBH |
| FEI number | 1000408433 |
| Address | Hohenzollerndamm 150/151 |
| City | Berlin |
| Country | Germany |
| Fiscal year | 2015 |
| Inspection end date | Oct 16, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 444474 |
At a glance
- 1–9 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