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1111495

Takeda Pharmaceutical Company Limited — FEI 3004664162

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 26, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hikari (Japan)

Facility

Other inspections at this facility

  • 1224917 (VAI Mon Nov 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1148832 (VAI Mon Jul 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1033814 (NAI Tue Nov 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951603 (VAI Fri Oct 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851370 (VAI Wed Sep 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
189121 CFR 211.165(f)Failing drug products not rejected
202821 CFR 211.192Extent of discrepancy, failure investigations
430321 CFR 211.67(b)Written procedures fail to include