FDA inspection
Copernicus Group IRB #1: FDA inspection ending Jul 28, 2005
FDA inspection 389051 · No Action Indicated (NAI) · Cary, NC
Key facts
| Inspection ID | 389051 |
|---|---|
| Firm | Copernicus Group IRB #1 |
| FEI number | 3002811733 |
| Address | 5000 Centre Green Way Ste 200 |
| City | Cary |
| State | NC |
| ZIP | 27513-5805 |
| Fiscal year | 2005 |
| Inspection end date | Jul 28, 2005 |
| Classification | No Action Indicated (NAI) |
| Project area | Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|Bio-Research Monit: Human Drugs|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 type | Devices, Drugs |
At a glance
- None Citations
- None 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