871555
Vivax Medical Corp. — FEI 1000513669
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Naugatuck, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |