676088

Luzier Personalized Cosmetics, Inc. — FEI 1910515

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 12, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Grandview, MO (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
439121 CFR 211.180(e)(2)Items to cover on annual reviews
900121 CFR 211.22(a)Lack of quality control unit