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1255957

Novo Nordisk Inc. — FEI 2244771

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 7, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Plainsboro, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Facility

Other inspections at this facility

  • 1194065 (NAI Wed Dec 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013344 (VAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983531 (NAI Fri Jul 22 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 968597 (NAI Tue Apr 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883733 (NAI Thu Jun 19 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1802521 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report
673521 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events