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878584

Ophtapharm AG — FEI 3005531475

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 28, 2014
Fiscal Year
2014
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))
  • 980040 (VAI Wed May 25 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754443 (VAI Wed Nov 09 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures