FDA inspection
BioStem Life Sciences: FDA inspection ending Sep 15, 2023
FDA inspection 1219616 · Official Action Indicated (OAI) · Pompano Beach, FL
Key facts
| Inspection ID | 1219616 |
|---|---|
| Firm | BioStem Life Sciences |
| FEI number | 3013239405 |
| Address | 2836 Center Port Cir |
| City | Pompano Beach |
| State | FL |
| ZIP | 33064 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Sep 15, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
| Warning letter | 673788 |
At a glance
- 1–9 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