FDA inspection
Biotronik, AG: FDA inspection ending Mar 17, 2016
FDA inspection 967279 · Official Action Indicated (OAI) · Bulach
Key facts
| Inspection ID | 967279 |
|---|---|
| Firm | Biotronik, AG |
| FEI number | 3002808050 |
| Address | Ackerstrasse 6 |
| City | Bulach |
| Country | Switzerland |
| Fiscal year | 2016 |
| Inspection end date | Mar 17, 2016 |
| Classification | Official Action Indicated (OAI) |
| 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