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1217806

Eli Lilly & Company — FEI 1819470

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 15, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Indianapolis, IN (United States)

Additional Details

Risk Evaluation and Mitigation Strategies (REMS)

Facility

Other inspections at this facility

  • 1298628 (NAI Fri Jan 09 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1270621 (VAI Tue May 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1260339 (VAI Thu Mar 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229895 (NAI Wed Jan 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1207271 (NAI Thu May 18 2023 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

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
21356FDCA 505-1(f)(3)(C)Failure to comply with REMS Elements to Assure Safe Use (ETASU) C
21357FDCA 505-1(f)(3)(D)Failure to comply with REMS Elements to Assure Safe Use (ETASU) D
21359FDCA 505-1(f)(3)(F)Failure to comply with REMS Elements to Assure Safe Use (ETASU) F