FDA inspection
BIOTRONIK Inc: FDA inspection ending May 20, 2009
FDA inspection 585939 · No Action Indicated (NAI) · Lake Oswego, OR
Key facts
| Inspection ID | 585939 |
|---|---|
| Firm | BIOTRONIK Inc |
| FEI number | 1028232 |
| Address | 6024 Jean Rd |
| City | Lake Oswego |
| State | OR |
| ZIP | 97035 |
| Country | United States |
| Fiscal year | 2009 |
| Inspection end date | May 20, 2009 |
| Classification | No Action Indicated (NAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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