FDA Inspection 1018699 — Motion Analysis Corporation
The FDA completed an inspection of Motion Analysis Corporation on July 21, 2017 in Santa Rosa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Rosa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 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 |