768896
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 19, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maplewood, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |