895411
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rulzheim (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |