714300

Wasatch Product Development, LLC — FEI 3003676119

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2011
Fiscal Year
2011
Product Type
Food/Cosmetics
Project Area
Colors and Cosmetics Technology
Location
Draper, UT (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
200921 CFR 211.188Prepared for each batch, include complete information
360321 CFR 211.160(b)Scientifically sound laboratory controls
430621 CFR 211.80(a)Written Procedures Not Followed
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
457621 CFR 211.192No written record of investigation