FDA inspection
BIOTRONIK Inc: FDA inspection ending Sep 13, 2005
FDA inspection 395858 · Voluntary Action Indicated (VAI) · Lake Oswego, OR
Key facts
| Inspection ID | 395858 |
|---|---|
| Firm | BIOTRONIK Inc |
| FEI number | 1028232 |
| Address | 6024 Jean Rd |
| City | Lake Oswego |
| State | OR |
| ZIP | 97035-5571 |
| Fiscal year | 2005 |
| Inspection end date | Sep 13, 2005 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med 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
- 10–99 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