FDA inspection
Coltene /Whaledent AG: FDA inspection ending Sep 19, 2013
FDA inspection 849198 · Voluntary Action Indicated (VAI) · Altstatten Sg
Key facts
| Inspection ID | 849198 |
|---|---|
| Firm | Coltene /Whaledent AG |
| FEI number | 3002806620 |
| Address | Feldwiesenstrasse 20 |
| City | Altstatten Sg |
| Country | Switzerland |
| Fiscal year | 2013 |
| Inspection end date | Sep 19, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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