1083114
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Edison, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |