1003151
Motion Analysis Corporation — FEI 2939117
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 7, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Santa Rosa, CA (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 |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |