1017154
Vivonic GmbH — FEI 3010850471
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 19, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sailauf (Germany)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3696 | 21 CFR 820.100(b) | Documentation |