Atlas

FDA-Inspected Site

Novo Nordisk A/S

17 FDA inspections are on record for Novo Nordisk A/S in Kalundborg, Denmark.

483· Form 483 issued

Kalundborg, Denmark · Last updated July 10, 2026

Overview

  • 17 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-03-25.

At a glance

Inspections

17

Form 483s

7

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Mar 2024 – 25 Mar 2024Human Drugs483On file
27 Apr 2023 – 4 May 2023Biologics483On file
12 Dec 2019 – 20 Dec 2019Human DrugsClean
29 Aug 2019 – 6 Sep 2019Human DrugsClean
28 Feb 2018 – 7 Mar 2018BiologicsClean
21 Aug 2017 – 29 Aug 2017Human DrugsClean
19 Oct 2015 – 6 Nov 2015Biologics483On file
15 Jun 2015 – 18 Jun 2015Medical Devices & Rad HealthClean
3 Mar 2014 – 7 Mar 2014Human DrugsClean
2 May 2013 – 10 May 2013Biologics483On file
9 Mar 2012Not recorded483On file
8 Feb 2011Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Cynthia Jim2 insp.
Helen B Ricalde2 insp.
Lindsey J Brown1 insp.
Ralph M Bernstein1 insp.
Unnee Ranjan1 insp.
Prabhu P Raju1 insp.
Mikhail V Ovanesov1 insp.
Dennis Cantellops Paite1 insp.
Joanne E King1 insp.
Pankaj H Amin1 insp.
Ashley J Burns1 insp.
Frederick Razzaghi1 insp.
Simone E Pitts1 insp.
Debra M Emerson1 insp.
Stephen D Eich1 insp.
Yumi J Hiramine1 insp.
Ramon E Martinez1 insp.

Full site report

Get the verbatim findings behind Novo Nordisk A/S' 7 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat