842096
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vancouver, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |