FDA inspection
Stemell Inc: FDA inspection ending Mar 8, 2019
FDA inspection 1081909 · Official Action Indicated (OAI) · San Juan Capistrano, CA
Key facts
| Inspection ID | 1081909 |
|---|---|
| Firm | Stemell Inc |
| FEI number | 3013956190 |
| Address | 27122b Paseo Espada Ste 1004 |
| City | San Juan Capistrano |
| State | CA |
| ZIP | 92675 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 8, 2019 |
| Classification | Official Action Indicated (OAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
| Warning letter | 579013 |
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