FDA Inspection 1279389 — DGI Group LLC
The FDA completed an inspection of DGI Group LLC on August 19, 2025 in Howell, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 19, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |