722502
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 7, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nonnweiler (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |