1043687
CNMC Company, Inc. — FEI 3006073271
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 9, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Nashville, TN (United States)
Citations
| ID | CFR | Description |
|---|
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3686 | 21 CFR 820.90(b)(2) | Product rework documentation, DHR {see also 820.184} |
| 3696 | 21 CFR 820.100(b) | Documentation |