Warning letter
Holy Cross Hospital IRB: warning letter of Sep 26, 2000
FDA warning letter UCM068879 · Center for Devices and Radiological Health
Key facts
| Reference number | UCM068879 |
|---|---|
| Company | Holy Cross Hospital IRB |
| Subject | IRB (Institutional Review Board) |
| Issue date | Sep 26, 2000 |
| Posted date | Sep 26, 2000 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Biologics |
| CFR sections cited | 56.108(c), 56.120, 56.109(f), 56.115(a), 56, 56.108, 56.113, 56.108(a) |
| Country | 3 |
| Inspection city | Ft Lauderdale |
| Inspection ZIP | 33308-4603 |
| Inspection start date | Jun 9, 2000 |
| 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: