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980040

Ophtapharm AG — FEI 3005531475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 25, 2016
Fiscal Year
2016
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))
  • 1034597 (VAI Tue Dec 12 2017 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
110521 CFR 211.22(d)Procedures not in writing, fully followed
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
457621 CFR 211.192No written record of investigation