897764
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Madison, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |