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FDA Inspections, Warning Letters and Import Refusals: Switzerland

FDA has recorded 808 inspections of firms in Switzerland, 24 of them (3.0%) classified OAI. It has issued 18 warning letters to firms there and refused 3,174 import shipments. 79 firms in Switzerland 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.

Switzerland: FDA inspections per year 2017: 74 inspections7420172018: 65 inspections6520182019: 42 inspections4220192020: 7 inspections720202021: 0 inspections020212022: 24 inspections2420222023: 65 inspections6520232024: 58 inspections5820242025: 45 inspections4520252026: 17 inspections172026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20261700.0%0319
20254512.2%1135
20245835.2%181
20236534.6%2102
20222414.2%062
202100079
2020700.0%094
20194212.4%0110
20186511.5%0118
20177400.0%078

Latest OAI inspections

DateFacilityProduct type
Apr 9, 2025LEVO AGDevices
Jul 25, 2024NAVISWISS AGDevices
Apr 25, 2024Z-SYSTEMS AGDevices
Jan 24, 2024F. Hunziker + Co. AGFood/Cosmetics
Sep 28, 2023Swiss Bionic Solutions GmbHDevices
Jun 15, 2023Acrostak (Schweiz) AGDevices
Apr 4, 2023Similasan AGDrugs
Jul 21, 2022Hamilton Medical AGDevices
Jun 4, 2019Balik, A Branch Of Caviar House & Prunier (Suisse) SAFood/Cosmetics
Jun 21, 2018Nouvag AgDevices
Jun 23, 2016Laboratoire Sintyl S.A.Drugs
Jun 17, 2016Temmentech AGDrugs
Sep 11, 2014Combo AGDevices
Sep 11, 2014Combo AGDevices
Sep 10, 2013SPINEART SADevices
Jan 29, 2013Rubimed AGDevices
Jan 16, 2013Gexfix SADevices
Nov 16, 2012Teoxane S.A.Devices
Apr 27, 2012Bracco Suisse SADrugs
Jun 16, 2011Merck Serono SADrugs
Jun 9, 2011Merck Serono SA (Vevey)Drugs
Aug 19, 2010BUHLMANN Laboratories AGDevices
Mar 19, 2010Storz Medical, AGDevices
Feb 5, 2009STORZ ENDOSKOP PRODUKTIONS GMBHDevices

Latest warning letters

DateFirmProduct typeFDA center
Jul 16, 2025LEVO AGDevicesCDRH
Aug 2, 2024Z-SYSTEMS AGDevicesCDRH
Oct 31, 2023Acrostak (Schweiz) AGDevicesCDRH
Sep 11, 2023Similasan AGDrugsCDER
Nov 30, 2016FRED & FLY SARLTobaccoCTP
Sep 29, 2016Laboratoire Sintyl S.A.DrugsCDER
Mar 17, 2015Www.Snusworld.ComTobaccoCTP
Jan 12, 2015Combo AGDevicesCDRH
Aug 7, 2014Explora LaboratoriesDrugsCDER
May 15, 2013Gexfix SADevicesCDRH
May 6, 2013Rubimed AGDevicesCDRH
Apr 19, 2013Teoxane S.A.DevicesCDRH
Jan 25, 2013Tecval Medical SarlDevicesCDRH
Aug 23, 2012Madeleine Rausis, Raus LTDTobaccoCTP
Nov 18, 2011Novartis Pharma AGDrugsCDER
Aug 24, 2010Storz Medical, AGDevicesCDRH
Apr 8, 2010Storz Medical, AGDevicesCDRH
May 12, 2009STORZ ENDOSKOP PRODUKTIONS GMBHDevicesCDRH

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026Philipip Morris IntlTobacco Products
Oct 22, 2026Philipip Morris IntlTobacco Products
Oct 22, 2026Moser-Baer AGDevices
Oct 22, 2026Moser-Baer AGDevices
Oct 21, 2026HOLLE FOODHuman Foods
Oct 21, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 20, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026OXYMORON AGDrugs and Biologics
Oct 14, 2026OXYMORON AGDrugs and Biologics
Oct 14, 2026OXYMORON AGDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026OXYMORON AGDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 14, 2026OXYMORON AGDrugs and Biologics
Oct 13, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 13, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 13, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 9, 2026Teoxane S.A.Cosmetics
Oct 8, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 8, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics
Oct 8, 2026ZOTEA TEEHANDEL GMBHDrugs and Biologics

Showing the latest 25 of 3,174.

Firms on FDA import alerts

PublishedFirmImport alertList
Mar 5, 2026Apotheke Paracelsus66-41red
Aug 14, 2025LEVO AG89-04red
Jul 10, 2025Peschke Meditrade68-19red
Jul 10, 2025Peschke Meritrade Gmbh68-19red
Jul 10, 2025Peschke Trade Gmbh68-19red
Jul 10, 2025PESCHKE TRADE GMBH68-19red
Jul 16, 2024PROFESSIONAL DERMA89-08red
May 10, 2024Holle Baby Food GmbH40-05red
May 9, 2024Acrostak (Schweiz) AG89-08red
Nov 1, 2023Soeder AG66-40red
Sep 12, 2023Similasan AG66-41red
Sep 12, 2023Similasan T&M Ag66-41red
Jul 7, 2023NAHRIN AG99-39red
Aug 16, 2022Anifa SA53-06red
Oct 25, 2021Esapharma SA66-41red
May 14, 2021SPRING HEALTHCARE SERVICES AG89-08red
Mar 2, 2021ZENUM SARL89-08red
Jan 26, 2021BLOOM DIAGNOSTICS AG89-08red
Jan 26, 2021Swisstronics Contract Manufacturing AG89-08red
Apr 7, 2020ESAPHARMA SWISS SA66-41red
Feb 24, 2020Mila D'Opiz Ag66-41red
Feb 24, 2020M. Opitz & Co. AG66-41red
Nov 26, 2019Balik, A Branch Of Caviar House & Prunier (Suisse) SA16-120red
Sep 13, 2019Interlab-Sercoex S C66-41red
Aug 14, 2019Nouvag Ag89-08red

Showing the latest 25 of 79.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Novartis Pharma Stein AGStein Ag120May 19, 2026
Novartis Pharma AGBasel Town100Dec 18, 2025
Solvias AGKaiseraugst100Aug 7, 2025
IBSA Institut Biochimique SAPazzallo100Jun 11, 2024
Medion Grifols Diagnostics AGDudingen90Aug 28, 2026
F. Hoffmann-La Roche AGBasel Town90May 9, 2025
F. Hoffmann - La Roche Ltd.Kaiseraugst90Mar 21, 2025
Nestle Suisse S.A.Konolfingen80Feb 27, 2026
Cilag AGSchaffhausen80Nov 21, 2025
Merck Serono SAAubonne81May 2, 2023
Lonza AGVisp80Mar 28, 2023
Novartis Pharma Schweizerhalle AgPratteln70Mar 27, 2025
Allpack Group AGReinach BL70Apr 28, 2023
Similasan AGJonen61Apr 27, 2026
Ferring International Center S.A.St-Prex60Feb 6, 2026

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.