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1101320

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

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 14, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Livermore, CA (United States)

Facility

Other inspections at this facility

  • 1006687 (NAI Thu Mar 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949320 (OAI Thu Dec 03 2015 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
121521 CFR 211.67(b)Written procedures not established/followed
136121 CFR 211.100(a)Absence of Written Procedures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
441821 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination