867537
LumiQuick Diagnostics Inc. — FEI 3005984081
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 24, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Santa Clara, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 502 | 21 CFR 820.60 | Identification procedures, Lack of or inadequate procedures |