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949320

G.S. Cosmeceutical USA, Inc. — FEI 3002749414

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 3, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Livermore, CA (United States)

Facility

Other inspections at this facility

  • 1101320 (VAI Wed Aug 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006687 (NAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 778290 (VAI Mon Apr 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 698009 (VAI Thu Nov 18 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 598175 (VAI Mon Jul 13 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls