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FDA Inspections, Warning Letters and Import Refusals: Denmark

FDA has recorded 351 inspections of firms in Denmark, 9 of them (2.6%) classified OAI. It has issued 13 warning letters to firms there and refused 7,459 import shipments. 48 firms in Denmark are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

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By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

Denmark: FDA inspections per year 2017: 20 inspections2020172018: 20 inspections2020182019: 11 inspections1120192020: 4 inspections420202021: 9 inspections920212022: 14 inspections1420222023: 21 inspections2120232024: 43 inspections4320242025: 10 inspections1020252026: 6 inspections62026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026600.0%04,668
20251000.0%01,399
20244300.0%2172
20232100.0%058
20221400.0%063
2021900.0%062
2020400.0%122
20191119.1%015
20182000.0%066
20172000.0%162

Latest OAI inspections

DateFacilityProduct type
Sep 19, 2019DermaPharm A/SDrugs
Jun 7, 2013R82 A/SDevices
Mar 14, 2013Agilent Technologies Denmark ApSDevices
Aug 2, 2012Tonica Elektronik A/SDevices
Jun 1, 2012Medart A /SDevices
Mar 20, 2012Novo Nordisk A/SDrugs
Feb 16, 2012COSMED Nordic ApSDevices
Jun 26, 2009Interacoustics A/SDevices
Jun 16, 2009Leo Pharma A/SDrugs

Latest warning letters

DateFirmProduct typeFDA center
Aug 13, 2024Agustson A/SFood/CosmeticsCFSAN
Aug 13, 2024Agustson A/SFood/CosmeticsCFSAN
Mar 10, 2020DermaPharm A/SDrugsCDER
Apr 27, 2017Hardcore Vapers, B.VTobaccoCTP
Sep 16, 2015Ferrosan Medical Devices A/SDevicesCDRH
Oct 18, 2013R82 A/SDevicesCDRH
Aug 29, 2013Agilent Technologies Denmark ApSDevicesCDRH
Dec 12, 2012Novo Nordisk A/SDrugsCDER
Nov 19, 2012Medart A /SDevicesCDRH
Nov 6, 2012Tonica Elektronik A/SDevicesCDRH
Jun 4, 2012COSMED Nordic ApSDevicesCDRH
Mar 14, 2011R82 A/SDevicesCDRH
Dec 10, 2009Interacoustics A/SDevicesCDRH

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 22, 2026Chemometec AsDevices
Oct 22, 2026NGP TOBACCO APSTobacco Products
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 22, 2026NGP TOBACCO APSTobacco Products
Oct 22, 2026NGP TOBACCO APSTobacco Products
Oct 22, 2026INSURGENT VENTURES IIITobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NORDIC SNUS ABTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products
Oct 21, 2026NGP TOBACCO APSTobacco Products

Showing the latest 25 of 7,459.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 1, 2026Advanced Nordic Nutrition APS99-43red
Sep 29, 2026Toms Confectionery Group45-02red
Aug 26, 2026HOUSE OF POUCHE98-06red
Jul 22, 2026NORDIC SNUS AB98-08red
Mar 24, 2026INSURGENT VENTURES III98-06red
Jan 27, 2026NGP TOBACCO98-06red
Jan 27, 2026NGP TOBACCO APS98-06red
Nov 17, 2025TROPICAL HOUSE OF POUCHES98-06red
Oct 8, 2025NGP TOBACCO APS98-08red
Apr 21, 2025NGP TOBACCO98-08red
Apr 21, 2025Swedish Match Ab98-06red
Jan 27, 2025MINISTRY A/S98-06red
Jan 27, 2025MINISTRY OF SNUS98-06red
Dec 10, 2024Swedish Match Ab98-08red
Nov 25, 2024Agustson A/S16-120red
May 30, 2023Danalife ApS89-08red
Mar 9, 2020DermaPharm A/S66-40red
Jan 2, 2020POLAR SEAFOODS DK A/S16-04red
May 14, 2019Funksjonell Mat AS99-39red
Apr 19, 2016Vetcur Biotec Aps68-19red
Aug 5, 2015Plum A/S66-41red
Jun 22, 2015Organic Hemp Food Products99-39red
Jan 21, 2015Jens Moller Products ApS45-02red
Sep 16, 2014TETRA PAK PROCESSING SYSTEMS A/S16-124red
Aug 28, 2014Chr. Hansen A/S45-02red

Showing the latest 25 of 48.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Novo Nordisk A/SKalundborg100Jun 10, 2025
Novo Nordisk A/SBagsvard101Oct 3, 2024
Novo Nordisk A/S - HaxGentofte100Jun 1, 2023
Xellia Pharmaceuticals ApSCopenhagen S80Dec 4, 2025
Novo Nordisk A/S - 25A-BHillerod80Sep 17, 2025
Novo Nordisk A/SMalov70Apr 17, 2026
Pharmacosmos A/SHolbak70Sep 25, 2025
Novo Nordisk A/SSoborg60Jan 23, 2026
Leo Pharma A/SBallerup61Sep 26, 2024
SmartPractice Denmark ApSHillerod60Aug 16, 2024
FUJIFILM Diosynth Biotechnologies Denmark ApSHillerod60Jun 30, 2023
Particle Analytical ApSHorsholm50Jan 9, 2025
Dansk Salt A/SMariager50Nov 13, 2024
Eurofins Biopharma Product Testing, Denmark A/SGlostrup50May 17, 2023
H. Lundbeck A/SValby50Dec 16, 2022

See each facility's Form 483 observations with the FDA 483 search.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.