FDA inspection
Genesiscare: FDA inspection ending Dec 17, 2015
FDA inspection 954425 · Voluntary Action Indicated (VAI) · Naples, FL
Key facts
| Inspection ID | 954425 |
|---|---|
| Firm | Genesiscare |
| FEI number | 3007009870 |
| Address | 733 4th Ave N |
| City | Naples |
| State | FL |
| ZIP | 34102 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Dec 17, 2015 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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