FDA inspection
Duke University Health System IRB: FDA inspection ending Mar 1, 2019
FDA inspection 1083586 · No Action Indicated (NAI) · Durham, NC
Key facts
| Inspection ID | 1083586 |
|---|---|
| Firm | Duke University Health System IRB |
| FEI number | 1045114 |
| Address | 2424 Erwin Rd Ste 405 |
| City | Durham |
| State | NC |
| ZIP | 27705 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 1, 2019 |
| Classification | No Action Indicated (NAI) |
| Project area | Bioresearch Monitoring |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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