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1153711

I. Shay Cosmetics Inc — FEI 3002757783

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Harbor City, CA (United States)

Facility

Other inspections at this facility

  • 1034137 (VAI Thu Dec 07 2017 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
113321 CFR 211.25(a)GMP Training Frequency
127021 CFR 211.68(b)input/output verification
179021 CFR 211.80(b)Handling and Storage to Prevent Contamination
188521 CFR 211.165(b)Microbiological testing
202721 CFR 211.192Investigations of discrepancies, failures
439121 CFR 211.180(e)(2)Items to cover on annual reviews