778400
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 25, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Westford, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |