734689
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 8, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Munich (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14719 | 21 CFR 820.30(h) | Incorrect translation to production specifications |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |