FDA inspection
Vycor Medical, Inc. / NovaVision Vision Technology, Inc.: FDA inspection ending Nov 6, 2018
FDA inspection 1105446 · Voluntary Action Indicated (VAI) · Boca Raton, FL
Key facts
| Inspection ID | 1105446 |
|---|---|
| Firm | Vycor Medical, Inc. / NovaVision Vision Technology, Inc. |
| FEI number | 3005880844 |
| Address | 951 Broken Sound Pkwy Ste 320 |
| City | Boca Raton |
| State | FL |
| ZIP | 33487-3531 |
| Fiscal year | 2019 |
| Inspection end date | Nov 6, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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