FDA inspection
TEM INNOVATIONS GMBH: FDA inspection ending Oct 22, 2014
FDA inspection 900201 · Official Action Indicated (OAI) · Munich
Key facts
| Inspection ID | 900201 |
|---|---|
| Firm | TEM INNOVATIONS GMBH |
| FEI number | 3005792925 |
| Address | Martin-kollar-str. 13 |
| City | Munich |
| Country | Germany |
| Fiscal year | 2015 |
| Inspection end date | Oct 22, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 447892 |
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