FDA inspection
TRACOE Medical GmbH: FDA inspection ending Jun 18, 2015
FDA inspection 932187 · Voluntary Action Indicated (VAI) · Nieder-Olm
Key facts
| Inspection ID | 932187 |
|---|---|
| Firm | TRACOE Medical GmbH |
| FEI number | 3003361161 |
| Address | Reichelsheimer Str. 1/3 |
| City | Nieder-Olm |
| Country | Germany |
| Fiscal year | 2015 |
| Inspection end date | Jun 18, 2015 |
| 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