Warning letter
Irvine Stem Cell Treatment Center: warning letter of Dec 30, 2015
FDA warning letter 483320 · Center for Biologics Evaluation and Research
Key facts
| Reference number | 483320 |
|---|---|
| Company | Irvine Stem Cell Treatment Center |
| Subject | CGMP/Deviations/Biologics License Application (BLA) |
| Issue date | Dec 30, 2015 |
| Posted date | Jan 12, 2016 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 211.22(a), 211.188, 312, 211.42(c)(10)(iv), 211.67(b), 211.68(a), 211.80(a), 211.80(d), 211.84(a), 211.100(a), 211.113(b), 211.160(b) and 8 more |
| Inspection city | Irvine |
| Inspection ZIP | 92606 |
| Inspection start date | Jul 27, 2015 |
| 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: