649026

Beauty Manufacturing Solutions Corp. — FEI 1610490

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 18, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Coppell, TX (United States)

Citations

IDCFRDescription
138821 CFR 211.101(d)Component addition checked by 2nd person
145421 CFR 211.115(a)Reprocessing procedures not written or followed
163021 CFR 211.130(b)Unlabeled filled containers controls
189021 CFR 211.165(e)Test methods
197521 CFR 211.182Written records kept in individual logs
200921 CFR 211.188Prepared for each batch, include complete information
355321 CFR 211.48(a)Plumbing System Defects
358221 CFR 211.105(a)Identification of containers, lines, equipment
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.