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853928

Takeda Pharmaceutical Company Limited — FEI 3002808311

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yodogawa-Ku (Japan)

Facility

Other inspections at this facility

  • 1238763 (NAI Fri Apr 12 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100693 (VAI Fri Aug 09 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028828 (NAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 943082 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793427 (VAI Thu Aug 02 2012 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
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance