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1276963

Sumitomo Dainippon Pharma Co., Ltd. — FEI 3005619533

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 11, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oita (Japan)

Facility

Other inspections at this facility

  • 1088923 (VAI Tue Apr 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003840 (VAI Fri Feb 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895955 (VAI Fri Sep 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 797370 (VAI Fri Feb 24 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 676813 (VAI Fri Jul 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
143521 CFR 211.42(c)(10)(v)Cleaning System
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products