1101420
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Upplands Vasby (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |