1162566
Sunnex, LLC — FEI 1000583780
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |