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1119623

Ophtapharm AG — FEI 3005531475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 28, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Winterthur (Switzerland)

Facility

Other inspections at this facility

  • 1034597 (VAI Tue Dec 12 2017 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
113421 CFR 211.25(b)Supervisor Training/Education/Experience
139521 CFR 211.103Actual vs. theoretical yields not determined
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved