Warning letter
Mercy Hospital Medical Center IRB: warning letter of Jan 10, 2014
FDA warning letter 408285 · Center for Devices and Radiological Health
Key facts
| Reference number | 408285 |
|---|---|
| Company | Mercy Hospital Medical Center IRB |
| Subject | Institutional Review Board (IRB) |
| Issue date | Jan 10, 2014 |
| Posted date | Jan 27, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 21, 56, 56.108, 56.108(a)(1), 50, 56.108(a), 56.115(a)(2), 56.115(b), 56.108(c), 56.111(c), 56.115(a), 56.115(a)(6) |
| Inspection city | Chicago |
| Inspection ZIP | 60616 |
| Inspection start date | May 6, 2013 |
| 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: