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1093207

TAKA USA, INC. dba Cosmetic Innovations — FEI 3013239969

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 6, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Coppell, TX (United States)

Facility

Other inspections at this facility

  • 1196944 (OAI Tue Feb 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152898 (OAI Mon Sep 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
200921 CFR 211.188Prepared for each batch, include complete information
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include
431421 CFR 211.84(d)(2)Reports of Analysis (Components)