FDA Inspection 1288454 — Gergens Orthodontic Lab
The FDA completed an inspection of Gergens Orthodontic Lab on October 24, 2025 in Dunlap, IL. 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
- October 24, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: 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 |