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FDA Inspection 1326428 — Novo Nordisk A/S

Novo Nordisk A/S — FEI 3002807751

The FDA completed an inspection of Novo Nordisk A/S on June 10, 2025 in Kalundborg. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 10, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kalundborg (Denmark)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1209127 (VAI Thu May 04 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1230597 (VAI Fri Dec 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107225 (NAI Fri Sep 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028554 (NAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872670 (NAI Fri Mar 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources