895359

Ultradent Products, Inc. — FEI 1718912

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 12, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
South Jordan, UT (United States)

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
358521 CFR 211.110(a)Control procedures to monitor and validate performance
440221 CFR 211.192Written record of investigation incomplete