810422
Vycor Medical, Inc. / NovaVision Vision Technology, Inc. — FEI 3005880844
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 5, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |