927507
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Parsippany, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |