FDA inspection
Agnesian Healthcare IRB: FDA inspection ending Nov 13, 2012
FDA inspection 807438 · Official Action Indicated (OAI) · Fond Du Lac, WI
Key facts
| Inspection ID | 807438 |
|---|---|
| Firm | Agnesian Healthcare IRB |
| FEI number | 3009793893 |
| Address | 480 E Division St |
| City | Fond Du Lac |
| State | WI |
| ZIP | 54935 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Nov 13, 2012 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bioresearch Monitoring |
| Product type | Drugs |
| Warning letter | 392652 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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