FDA inspection
Biotronik, AG: FDA inspection ending Jan 24, 2019
FDA inspection 1087258 · Voluntary Action Indicated (VAI) · Bulach
Key facts
| Inspection ID | 1087258 |
|---|---|
| Firm | Biotronik, AG |
| FEI number | 3002808050 |
| Address | Ackerstrasse 6 |
| City | Bulach |
| Country | Switzerland |
| Fiscal year | 2019 |
| Inspection end date | Jan 24, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Project Evaluation: Devices |
| Product type | Devices |
At a glance
- None 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