Warning letter
Irvine Regional Hospital & Medical Center: warning letter of Jun 14, 2002
FDA warning letter UCM144975 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM144975 |
|---|---|
| Company | Irvine Regional Hospital & Medical Center |
| Subject | Institutional Review Board |
| Issue date | Jun 14, 2002 |
| Posted date | Jun 14, 2002 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 50.25, 56.110(b)(1), 56.120, 50, 50.20, 56.107(e), 56.107(f), 56.108(a), 56.109(a), 56.109(f), 56.115(a)(2), 50.27(a) and 3 more |
| Country | 3 |
| Inspection city | Irvine |
| Inspection ZIP | 92618-3714 |
| Inspection start date | Apr 5, 2001 |
| 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: