FDA Inspection
Oral Arts Dental Laboratories, Inc.Oral Arts Dental Laboratories, Inc. – FDA Inspection, Apr 5, 2017
Record Details
This FDA Inspection record concerns Oral Arts Dental Laboratories, Inc., with an inspection on April 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c9b0fcc9-bf75-4393-b815-89b81b20e166
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1006558
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Oral Arts Dental Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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