1119327
DiAgam Societe Anonyme (S.A.) — FEI 3003749380
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ath (Belgium)
Citations
| ID | CFR | Description |
|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |