FDA Inspection
Premier Dental Products Company, Inc.Premier Dental Products Company, Inc. – FDA Inspection, Dec 1, 2016
Record Details
This FDA Inspection record concerns Premier Dental Products Company, Inc., with an inspection on December 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5cdf4e47-eb26-4b78-a7a8-d3d055753c25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 994688
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Premier Dental Products Company, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 8, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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