FDA inspection
BIOTRONIK Inc: FDA inspection ending Jan 22, 2004
FDA inspection 313478 · Official Action Indicated (OAI) · Lake Oswego, OR
Key facts
| Inspection ID | 313478 |
|---|---|
| Firm | BIOTRONIK Inc |
| FEI number | 1028232 |
| Address | 6024 Jean Rd |
| City | Lake Oswego |
| State | OR |
| ZIP | 97035-5571 |
| Fiscal year | 2004 |
| Inspection end date | Jan 22, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Product Evaluation: Med Devices |
| Product type | Devices |
| Warning letter | UCM146857 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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