Warning letter
St. Joseph Mercy Oakland Instiutional Review Board: warning letter of Sep 15, 2015
FDA warning letter 470506 · Center for Devices and Radiological Health
Key facts
| Reference number | 470506 |
|---|---|
| Company | St. Joseph Mercy Oakland Instiutional Review Board |
| Subject | Institutional Review Board (IRB)/Investigational Device Exemptions |
| Issue date | Sep 15, 2015 |
| Posted date | Sep 29, 2015 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 56, 56.109(f), 56.115(a)(2), 56.115(a)(5) |
| Inspection city | Pontiac |
| Inspection ZIP | 48341 |
| Inspection start date | Apr 8, 2015 |
| 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: