FDA Inspection 932333 — All Star Orthodontics, LLC
The FDA completed an inspection of All Star Orthodontics, LLC on June 29, 2015 in Columbus, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 29, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Columbus, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3696 | 21 CFR 820.100(b) | Documentation |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |