FDA inspection
Great Lakes College of Clinical Medicine IRB: FDA inspection ending Dec 1, 1999
FDA inspection 6716 · Official Action Indicated (OAI) · Bluffton, OH
Key facts
| Inspection ID | 6716 |
|---|---|
| Firm | Great Lakes College of Clinical Medicine IRB |
| FEI number | 1000305947 |
| Address | 122 Thurman St |
| City | Bluffton |
| State | OH |
| ZIP | 45817-1306 |
| Fiscal year | 2000 |
| Inspection end date | Dec 1, 1999 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bio-Research Monit: Human Drugs |
| Product type | Drugs |
| Warning letter | UCM068204 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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