657853
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 20, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Topsfield, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3396 | 21 CFR 820.80(d)(1) | DMR required activities {see also 820.181} |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4208 | 21 CFR 806.20(a) | Records not kept |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |