914376
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |