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FDA Inspections, Warning Letters and Import Refusals: Sweden

FDA has recorded 384 inspections of firms in Sweden, 18 of them (4.7%) classified OAI. It has issued 34 warning letters to firms there and refused 23,677 import shipments. 82 firms in Sweden 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.

All countries · Check one supplier with the free FDA compliance check.

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.

Sweden: FDA inspections per year 2017: 21 inspections2120172018: 23 inspections2320182019: 33 inspections3320192020: 1 inspections120202021: 2 inspections220212022: 17 inspections1720222023: 24 inspections2420232024: 18 inspections1820242025: 20 inspections2020252026: 6 inspections62026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026600.0%413,540
20252000.0%57,706
20241815.6%21,420
20232428.3%120
202217211.8%235
2021200.0%030
2020100.0%025
20193300.0%117
20182328.7%277
20172114.8%120

Latest OAI inspections

DateFacilityProduct type
Sep 6, 2024Rechon Life Science ABDrugs
Jun 9, 2023Samhall ABDevices
Jun 7, 2023Sonesta Medical ABDevices
Nov 17, 2022RAYSEARCH LABORATORIES ABDevices
Nov 14, 2022Medifactia ABDevices
Dec 13, 2018Kitron ABDevices
May 11, 2018Boule Medical ABDevices
Jan 19, 2017Svar Life Science ABDevices
Mar 31, 2015Cepheid AbDevices
Mar 25, 2014MKL DIAGNOSTICS ABDevices
Dec 13, 2013Sanmina-SCI ABDevices
Sep 13, 2013Maquet Critical Care ABDevices
Jan 20, 2011Octapharma ABBiologics
Oct 14, 2010Elos Medtech Timmersdala ABDevices
Sep 2, 2010Orkla Care ABDevices
Jul 9, 2010Q-Med ABDevices
Apr 1, 2010Neoventa Medical ABDevices
Mar 19, 2009AMO Uppsala ABDevices

Latest warning letters

DateFirmProduct typeFDA center
Oct 8, 2026SNUSI ABTobaccoCTP
Feb 13, 2026SWEDISHPRODUCTS.ONLINETobaccoCTP
Jan 30, 2026Https://Gotpouches.ComTobaccoCTP
Jan 30, 2026SYSTRARNAS LIVS HandelsbolagTobaccoCTP
Dec 30, 2025SNUZYNTobaccoCTP
Aug 6, 2025Kalani ABDrugsCDER
Jul 25, 2025Snusport (Silverton AB)TobaccoCTP
Jul 18, 2025Mynicco.ComTobaccoCTP
Apr 30, 2025Rechon Life Science ABDrugsCDER
Apr 3, 2024INVICTA SWEDEN ABTobaccoCTP
Apr 3, 2024TWINROLLTobaccoCTP
Dec 4, 2023Sonesta Medical ABDevicesCDRH
Nov 17, 2022H-E-B 70TobaccoCTP
Sep 22, 2022GN TOBACCO SWEDEN ABTobaccoCTP
Feb 22, 2019Make Webo ABTobaccoCTP
Oct 2, 2018Boule Medical ABDevicesCDRH
Jun 14, 2018M Dialysis ABDevicesCDRH
Sep 20, 2017Svar Life Science ABDevicesCDRH
Sep 16, 2015SwedLex / SwedsnusTobaccoCTP
Jul 23, 2015Cepheid AbDevicesCDRH
Jul 8, 2015Www.Kiwicigs.ComTobaccoCTP
Jul 29, 2014MKL DIAGNOSTICS ABDevicesCDRH
Apr 11, 2014Sanmina-SCI ABDevicesCDRH
Jan 31, 2014Stille ABDevicesCDRH
Jan 8, 2014Www.Gotlandssnus.Com Www.Jakobssonssnus.ComTobaccoCTP

Showing the latest 25 of 34.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026ANOTHER SNUS FACTORY STOCKHOLM ABTobacco Products
Oct 22, 2026ANOTHER SNUS FACTORY STOCKHOLM ABTobacco Products
Oct 22, 2026YOIK ABTobacco Products
Oct 22, 2026VONT ABTobacco Products
Oct 22, 2026VONT ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products
Oct 22, 2026Chainpop Sweden ABTobacco Products
Oct 22, 2026Chainpop Sweden ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products
Oct 22, 2026EMPLICURE CONSUMER ABTobacco Products
Oct 22, 2026MANUFACTURER OF KAPZTobacco Products
Oct 22, 2026LEWA Of Sweden ABTobacco Products
Oct 22, 2026HAGA FACTORY ABTobacco Products
Oct 22, 2026HAGA FACTORY ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products
Oct 22, 2026SWEDISH SMOKELESS SOLUTIONSTobacco Products
Oct 22, 2026YOIK ABTobacco Products
Oct 22, 2026SWEDISH SMOKELESS SOLUTIONSTobacco Products
Oct 22, 2026Snusport (Silverton AB)Tobacco Products
Oct 22, 2026HS FACTORY SWEDEN ABTobacco Products
Oct 22, 2026HS FACTORY SWEDEN ABTobacco Products
Oct 22, 2026HS FACTORY SWEDEN ABTobacco Products
Oct 22, 2026TWINROLL SERVICE ABTobacco Products

Showing the latest 25 of 23,677.

See every import refusal from Sweden.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 4, 2026Coletta Sverige Ab45-02red
Nov 2, 2026ORKLA CONF45-02red
Oct 13, 2026Franssons Konfektyrer AB45-02red
Oct 8, 2026Candy People45-02red
Sep 29, 2026Aroma Konfektyrfabriken Aroma45-02red
Sep 29, 2026Cloetta Produktion Sverige AB45-02red
Sep 29, 2026ORKLA FOODS SVERIGE AB45-02red
Aug 25, 2026Snusport (Silverton AB)98-06red
Aug 24, 2026LEWA Of Sweden AB98-06red
Aug 24, 2026LEWA OF SWEDEN AB98-06red
Aug 24, 2026LEWA OF SWEDEN AB98-06red
Aug 13, 2026HELIX SWEDEN AB98-06red
Aug 13, 2026HS FACTORY SWEDEN AB98-06red
Aug 7, 2026SMOGENSNUS AB98-06red
Jul 31, 2026Nordicgoods Ab98-06red
Jul 31, 2026NORDICGOODS AB98-06red
Jul 31, 2026NORDICGOODS AB98-06red
Jul 31, 2026VIKA SVENSSON GOTHENBURG98-06red
Jul 31, 2026VK NORDIC AB98-06red
Jul 31, 2026VK NORDIK98-06red
Jul 22, 2026BRITISH AMERICAN TOBACCO98-08red
Jul 22, 2026British American Tobacco Sweden Ab98-08red
Jul 15, 2026TWINROLL SERVICE AB98-08red
Jun 24, 2026TWINROLL SERVICE AB98-06red
May 29, 2026Grahns Konfektyr AB45-02red

Showing the latest 25 of 82.

Most-inspected facilities

FacilityCityInspectionsOAILatest
AstraZeneca ABSodertalje100Dec 12, 2025
AstraZeneca ABSodertalje90Mar 19, 2026
Fresenius Kabi ABUppsala90Jan 24, 2025
Q-Med ABUppsala91Jan 19, 2023
Pfizer Health ABStrangnas70Mar 6, 2026
Rechon Life Science ABLimhamn71Sep 6, 2024
Swedish Orphan Biovitrum AB (Publ)Stockholm70Aug 29, 2019
Octapharma ABStockholm61Sep 19, 2023
Meribel Pharma Karlskoga ABKarlskoga50Aug 29, 2025
McNeil ABHelsingborg50Feb 27, 2025
PolyPeptide Laboratories (Sweden) ABLimhamn50Jan 23, 2025
ALS Scandinavia ABLulea50Oct 10, 2024
Eurofins BioPharma Product Testing Sweden ABUppsala50Jun 19, 2024
Cambrex Karlskoga ABKarlskoga50May 24, 2024
Apotek Produktion & Laboratorier ABMalmo50Feb 29, 2024

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.