1288454
Gergens Orthodontic Lab — FEI 3009888648
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dunlap, IL (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |