FDA inspection
Copernicus Group IRB #1: FDA inspection ending Mar 8, 2010
FDA inspection 660246 · Voluntary Action Indicated (VAI) · Cary, NC
Key facts
| Inspection ID | 660246 |
|---|---|
| Firm | Copernicus Group IRB #1 |
| FEI number | 3002811733 |
| Address | 5000 Centre Green Way Ste 200 |
| City | Cary |
| State | NC |
| ZIP | 27513 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Mar 8, 2010 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| 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
- 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