FDA Inspection 956623 — DentiMax , Inc
The FDA completed an inspection of DentiMax , Inc on January 22, 2016 in Mesa, 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
- January 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mesa, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3837 | 21 CFR 820.25(b) | Training records |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |