799344
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 18, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Richmond, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |