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1100693

Takeda Pharmaceutical Company Limited — FEI 3002808311

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 9, 2019
Fiscal Year
2019
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))
  • 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))
  • 853928 (VAI Fri Sep 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 793427 (VAI Thu Aug 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145221 CFR 211.113(b)Validation lacking for sterile drug products
203121 CFR 211.194(a)Complete test data included in records
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
360321 CFR 211.160(b)Scientifically sound laboratory controls