FDA inspection
STRATEC SE: FDA inspection ending Apr 18, 2019
FDA inspection 1087247 · Voluntary Action Indicated (VAI) · Birkenfeld
Key facts
| Inspection ID | 1087247 |
|---|---|
| Firm | STRATEC SE |
| FEI number | 3003413192 |
| Address | Gewerbestr. 37 |
| City | Birkenfeld |
| Country | Germany |
| Fiscal year | 2019 |
| Inspection end date | Apr 18, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Project Evaluation: 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