FDA Inspection 1018431 — Vycor Medical, Inc. / NovaVision Vision Technology, Inc.
The FDA completed an inspection of Vycor Medical, Inc. / NovaVision Vision Technology, Inc. on July 19, 2017 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |