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1274944

Astellas Pharma Inc. — FEI 3002807001

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 6, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Takaoka (Japan)

Facility

Other inspections at this facility

  • 1081668 (VAI Tue Mar 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963371 (NAI Fri Mar 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 874760 (VAI Fri Apr 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 756552 (VAI Mon Nov 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 548559 (VAI Fri Nov 07 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
136121 CFR 211.100(a)Absence of Written Procedures
145221 CFR 211.113(b)Validation lacking for sterile drug products