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1034137

I. Shay Cosmetics Inc — FEI 3002757783

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 7, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Harbor City, CA (United States)

Facility

Other inspections at this facility

  • 1153711 (VAI Mon Sep 20 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 823917 (VAI Thu Mar 14 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769908 (OAI Tue Feb 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 683282 (VAI Thu Sep 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 615932 (VAI Thu Sep 24 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202021 CFR 211.188(b)(8)Labeling Control Records and Label Copies
202721 CFR 211.192Investigations of discrepancies, failures
2129621 CFR 211.186(a)Master production and control records, batch uniformity
358521 CFR 211.110(a)Control procedures to monitor and validate performance
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
439121 CFR 211.180(e)(2)Items to cover on annual reviews