763185
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cherry Hill, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3696 | 21 CFR 820.100(b) | Documentation |