Home / Inspections / 1236864

1236864

Celgene Corporation — FEI 3004991673

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 6, 2024
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Summit, NJ (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Facility

Other inspections at this facility

  • 1275526 (VAI Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247735 (NAI Fri Sep 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1228973 (NAI Wed Jan 31 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208871 (VAI Fri Jun 16 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1165563 (NAI Mon Mar 14 2022 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
21355FDCA 505-1(f)(3)(B)Failure to comply with REMS Elements to Assure Safe Use (ETASU) B
21358FDCA 505-1(f)(3)(E)Failure to comply with REMS Elements to Assure Safe Use (ETASU) E
21360FDCA 505-1(f)(4)Failure to comply with REMS Implementation System