FDA Inspection 1052154 — Gergens Orthodontic Lab, Inc.
The FDA completed an inspection of Gergens Orthodontic Lab, Inc. on May 16, 2018 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |