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888701

COSMAX, INC. — FEI 3005710896

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 4, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hwaseong-si (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1251979 (VAI Fri Oct 18 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1071488 (VAI Wed Oct 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 999717 (VAI Thu Jan 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
144821 CFR 211.111Establishment of time limitations
191721 CFR 211.166(a)(1)Sample size - test intervals
256721 CFR 211.198(a)Adverse Drug Experience
344521 CFR 211.65(a)Equipment construction - reactive surfaces
431521 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs