FDA inspection
2k Innovations Inc.: FDA inspection ending Apr 12, 2016
FDA inspection 965932 · Voluntary Action Indicated (VAI) · Saint Augustine, FL
Key facts
| Inspection ID | 965932 |
|---|---|
| Firm | 2k Innovations Inc. |
| FEI number | 3010476958 |
| Address | 110 Cumberland Park Dr Ste 205 |
| City | Saint Augustine |
| State | FL |
| ZIP | 32095 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Apr 12, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- No 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