FDA inspection
Irvine Stem Cell Treatment Center: FDA inspection ending Sep 8, 2015
FDA inspection 942963 · Official Action Indicated (OAI) · Irvine, CA
Key facts
| Inspection ID | 942963 |
|---|---|
| Firm | Irvine Stem Cell Treatment Center |
| FEI number | 3011681925 |
| Address | 3500 Barranca Pkwy Ste 315 |
| City | Irvine |
| State | CA |
| ZIP | 92606 |
| Country | United States |
| Fiscal year | 2015 |
| Inspection end date | Sep 8, 2015 |
| Classification | Official Action Indicated (OAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
| Warning letter | 483320 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data