FDA Inspection
Dentonics, IncDentonics, Inc – FDA Inspection, Dec 19, 2014
Record Details
This FDA Inspection record concerns Dentonics, Inc, with an inspection on December 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dentonics, Inc
- Inspection Date
- December 19, 2014
- Product Type
- Devices
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ID · 98f9fad6-4a69-43be-8859-511c4151b232
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 911725
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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Other FDA inspections of Dentonics, Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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