1022682
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 24, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hamburg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |