FDA Inspection
Premier Dental Products Company, Inc.Premier Dental Products Company, Inc. – FDA Inspection, Jun 8, 2011
Record Details
This FDA Inspection record concerns Premier Dental Products Company, Inc., with an inspection on June 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- June 8, 2011
- Product Type
- Devices
View Company Profile
ID · ce9e639e-1852-4431-9116-98a3d4c71661
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730978
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
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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 |
| February 21, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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