1025860
Ivoclar Vivadent Manufacturing, Inc. — FEI 2244842
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 20, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |