Warning letter
Memorial Hospital Of South Bend, IRB: warning letter of Sep 21, 2012
FDA warning letter 345938 · Center for Drug Evaluation and Research
Key facts
| Reference number | 345938 |
|---|---|
| Company | Memorial Hospital Of South Bend, IRB |
| Subject | Institutional Review Board (IRB) |
| Issue date | Sep 21, 2012 |
| Posted date | Sep 21, 2012 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 56.107(e), 50.50, 50.51, 50, 56.108(b), 56.109(f), 56.115(a)(2), 56.109(h), 56.115(a)(6) |
| Inspection city | South Bend |
| Inspection ZIP | 46601 |
| Inspection start date | Apr 11, 2012 |
| 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: