870746
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 27, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Bristol, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 5802 | 21 CFR 1002.13 | Lack of required elements |