887570
DOMINO S.R.L. — FEI 3006153348
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 5, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Codogne' (Italy)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |