FDA Inspection 1030982 — American Dental Airsonic Technologies, Inc.
The FDA completed an inspection of American Dental Airsonic Technologies, Inc. on November 8, 2017 in Corpus Christi, TX. 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
- November 8, 2017
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Corpus Christi, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |