1279389
DGI Group LLC — FEI 3014527929
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Howell, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |