FDA inspection
Bioptron AG: FDA inspection ending Nov 2, 2017
FDA inspection 1031661 · Voluntary Action Indicated (VAI) · Wollerau
Key facts
| Inspection ID | 1031661 |
|---|---|
| Firm | Bioptron AG |
| FEI number | 3003775404 |
| Address | Sihleggstrasse 23 |
| City | Wollerau |
| Country | Switzerland |
| Fiscal year | 2018 |
| Inspection end date | Nov 2, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 10–99 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