FDA Inspection 1017921 — Gergens Orthodontic Lab
The FDA completed an inspection of Gergens Orthodontic Lab on July 12, 2017 in Dunlap, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dunlap, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3837 | 21 CFR 820.25(b) | Training records |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |