742349

Luzier Personalized Cosmetics, Inc. — FEI 1910515

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grandview, MO (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
188321 CFR 211.165(a)Testing and release for distribution
189021 CFR 211.165(e)Test methods
189121 CFR 211.165(f)Failing drug products not rejected
194321 CFR 211.180(e)(1)Review of representative number of batches
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
361621 CFR 211.165(d)Acceptance criteria for sampling & testing
438921 CFR 211.198(a)Procedures to be written and followed