Warning letter
Great Lakes College of Clinical Medicine IRB: warning letter of Mar 9, 2000
FDA warning letter UCM068204 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM068204 |
|---|---|
| Company | Great Lakes College of Clinical Medicine IRB |
| Subject | IRB (Institutional Review Board) |
| Issue date | Mar 9, 2000 |
| Posted date | Mar 9, 2000 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 312.7, 56.111, 56.115, 56.120, 80, 50, 56.107(a), 56.107(e), 56.108(a), 56.109(a), 56.109(f), 56.120(b) and 10 more |
| Country | 3 |
| Inspection city | Bluffton |
| Inspection ZIP | 45817-1306 |
| Inspection start date | Nov 16, 1999 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: