FDA inspection
CORTRONIK GmbH: FDA inspection ending Sep 17, 2015
FDA inspection 947093 · Voluntary Action Indicated (VAI) · Rostock
Key facts
| Inspection ID | 947093 |
|---|---|
| Firm | CORTRONIK GmbH |
| FEI number | 3011574793 |
| Address | Friedrich-Barnewitz-Str. 4a |
| City | Rostock |
| Fiscal year | 2015 |
| Inspection end date | Sep 17, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical Devices|Product Evaluation: Medical 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