Warning letter
Wayne State University IRB [ARCHIVED]: warning letter of Apr 15, 2010
FDA warning letter 96105 · Center for Devices and Radiological Health
Key facts
| Reference number | 96105 |
|---|---|
| Company | Wayne State University IRB [ARCHIVED] |
| Subject | Institutional Review Board (IRB) |
| Issue date | Apr 15, 2010 |
| Posted date | Apr 15, 2010 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 56, 56.115(a)(2), 56.115(a)(5), 56.108(c) |
| Inspection city | Detroit |
| Inspection ZIP | 48202 |
| Inspection start date | Jan 19, 2010 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 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: