FDA inspection
Avera McKennan Hospital IRB #1 DBA Avera IRB #1: FDA inspection ending Oct 28, 2005
FDA inspection 401565 · Voluntary Action Indicated (VAI) · Sioux Falls, SD
Key facts
| Inspection ID | 401565 |
|---|---|
| Firm | Avera McKennan Hospital IRB #1 DBA Avera IRB #1 |
| FEI number | 1721635 |
| Address | 1325 S Cliff Ave |
| City | Sioux Falls |
| State | SD |
| ZIP | 57105-1007 |
| Fiscal year | 2006 |
| Inspection end date | Oct 28, 2005 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med 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