1017921
Gergens Orthodontic Lab — FEI 3009888648
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 |