FDA inspection
Sivantos GmbH: FDA inspection ending Oct 31, 2013
FDA inspection 857143 · Voluntary Action Indicated (VAI) · Erlangen
Key facts
| Inspection ID | 857143 |
|---|---|
| Firm | Sivantos GmbH |
| FEI number | 3005019184 |
| Address | Henri-Dunant-Str. 100 |
| City | Erlangen |
| Country | Germany |
| Fiscal year | 2014 |
| Inspection end date | Oct 31, 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