Warning letter
Christus St. Patrick Hospital IRB [ARCHIVED]: warning letter of Jul 2, 2009
FDA warning letter 63684 · Center for Devices and Radiological Health
Key facts
| Reference number | 63684 |
|---|---|
| Company | Christus St. Patrick Hospital IRB [ARCHIVED] |
| Subject | Institutional Review Board (IRB) |
| Issue date | Jul 2, 2009 |
| Posted date | Jul 2, 2009 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 56.108(a), 56.111, 56.108(c), 56.115(a)(2) |
| Inspection city | Lake Charles |
| Inspection ZIP | 70601 |
| Inspection start date | Mar 9, 2009 |
| 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: