1062329
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aachen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |