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1277224

Daiichi Sankyo, Inc. — FEI 3003089536

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Basking Ridge, NJ (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Facility

Other inspections at this facility

  • 1192012 (NAI Wed Nov 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1176597 (NAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1168866 (NAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141831 (NAI Tue Mar 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076061 (VAI Tue Jan 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
21354FDCA 505-1(f)(3)(A)Failure to comply with REMS Elements to Assure Safe Use (ETASU) A
21360FDCA 505-1(f)(4)Failure to comply with REMS Implementation System