FDA Inspection
Premier Dental Products Company, Inc.Premier Dental Products Company, Inc. – FDA Inspection, Feb 21, 2014
Record Details
This FDA Inspection record concerns Premier Dental Products Company, Inc., with an inspection on February 21, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 21, 2014
- Product Type
- Devices
View Company Profile
ID · 4dde25b6-4344-489f-9c92-ee388749cf2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.75(c)Documentation - review in response to changes or deviations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Premier Dental Products Company, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2016 | 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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