FDA Inspection
American Dental Airsonic Technologies, Inc.American Dental Airsonic Technologies, Inc. – FDA Inspection, Nov 8, 2017
Record Details
This FDA Inspection record concerns American Dental Airsonic Technologies, Inc., with an inspection on November 8, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 8, 2017
- Product Type
- Devices
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ID · 9a30793c-e93d-44ac-9d15-e6e0e56c6281
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030982
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(d)Service reports
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Other FDA inspections of American Dental Airsonic Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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