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Novo Nordisk A/S — FDA Facility Profile

FEI 3002807751

Novo Nordisk A/S is an FDA-registered facility (FEI 3002807751) located in Kalundborg Sjalland, DK. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Kalundborg Sjalland (DK)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
both

Recent inspections

  • 1326428 (VAI Tue Jun 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 861829 (VAI Fri May 10 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 777396 (VAI Fri Mar 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730949 (VAI Tue Feb 08 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 574834 (VAI Tue Feb 24 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • AEK-9296360-0/10002/1 (Wed Jan 28 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9296321-2/10002/1 (Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9211729-8/10002/1 (Tue Jan 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7209865-8/12/1 (Mon Jun 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7622704-2/22/3 (Tue Jun 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5125198-9/11/1 (Sun May 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4051426-5/11/1 (Fri Oct 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources