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1034597

Ophtapharm AG — FEI 3005531475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 12, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Winterthur (Switzerland)

Facility

Other inspections at this facility

  • 1119623 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980040 (VAI Wed May 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878584 (VAI Fri Mar 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754443 (VAI Wed Nov 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
122021 CFR 211.67(b)(3)Cleaning SOPs/instructions
142121 CFR 211.42(c)(10)Aseptic Processing Area
189021 CFR 211.165(e)Test methods
191221 CFR 211.166(a)Written program not followed