Warning letter
Agnesian Healthcare IRB: warning letter of Mar 25, 2013
FDA warning letter 392652 · Center for Drug Evaluation and Research
Key facts
| Reference number | 392652 |
|---|---|
| Company | Agnesian Healthcare IRB |
| Subject | Institutional Review Board (IRB) |
| Issue date | Mar 25, 2013 |
| Posted date | Mar 25, 2013 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 50.25, 56.108, 50.25(a), 50.25(a)(2), 56.108(a), 56.108(b), 56.115(a)(1), 56.115(a)(2), 56.109(b), 56.109(e), 56.115(a)(6) |
| Inspection city | Fond Du Lac |
| Inspection ZIP | 54935 |
| Inspection start date | Nov 7, 2012 |
| 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: