FDA Inspection
Centric Dental Lab IncCentric Dental Lab Inc – FDA Inspection, Nov 10, 2010
Record Details
This FDA Inspection record concerns Centric Dental Lab Inc, with an inspection on November 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Centric Dental Lab Inc
- Inspection Date
- November 10, 2010
- Product Type
- Devices
View Company Profile
ID · d08e35a4-f458-4020-ac75-fae8298ac7bd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699408
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(c)Management review dates
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