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FDA Inspections, Warning Letters and Import Refusals: Hungary

FDA has recorded 176 inspections of firms in Hungary, 9 of them (5.1%) classified OAI. It has issued 6 warning letters to firms there and refused 786 import shipments. 26 firms in Hungary 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.

Hungary: FDA inspections per year 2017: 13 inspections1320172018: 11 inspections1120182019: 21 inspections2120192020: 0 inspections020202021: 3 inspections320212022: 5 inspections520222023: 19 inspections1920232024: 5 inspections520242025: 15 inspections1520252026: 8 inspections82026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026800.0%013
20251516.7%122
20245120.0%124
20231915.3%026
2022500.0%030
2021300.0%035
202000145
20192114.8%052
20181100.0%039
20171300.0%052

Latest OAI inspections

DateFacilityProduct type
Mar 21, 2025Lavet Kft.Veterinary
Apr 19, 2024Soliteint Cosmetics KFTDrugs
Aug 10, 2023Control-X Medical Zrt.Devices
Oct 17, 2019MANDELAY KFTDevices
Jan 29, 2016Teva Pharmaceutical Works Private Limited CompanyDrugs
Mar 12, 201577 Elektronika Kft.Devices
Apr 13, 2012Meditech KFTDevices
Sep 17, 2009Sanatmetal LTD.Devices
Jun 25, 2009Coloplast Hungary, KFT.Devices

Latest warning letters

DateFirmProduct typeFDA center
Jul 28, 2025Uscom KftDevicesCDRH
Oct 10, 2024Soliteint Cosmetics KFTDrugsCDER
Feb 3, 2020MANDELAY KFTDevicesCDRH
Oct 13, 2016Teva Pharmaceutical Works Private Limited CompanyDrugsCDER
Oct 8, 201577 Elektronika Kft.DevicesCDRH
Jul 18, 2012Meditech KFTDevicesCDRH

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

Latest import refusals

DateFirmProduct category
Jul 31, 2026COLOPLAST A/S - MORDRUP SITEDevices
Jul 15, 2026GEMOSZ ELEKTORNIKA KFTDevices
Jul 15, 2026GEMOSZ ELEKTORNIKA KFTDevices
Jul 15, 2026GEMOSZ ELEKTORNIKA KFTDevices
Jul 15, 2026GEMOSZ ELEKTORNIKA KFTDevices
Jul 15, 2026GEMOSZ ELEKTORNIKA KFTDevices
Jul 9, 2026JUSTFIT TECHNOLOGY KFTDevices
Jun 4, 2026PANNONHERB KFTHuman Foods
Apr 14, 2026Sotiva Seed Kft.Human Foods
Mar 5, 2026SZABO ISTVAN LASZLODrugs and Biologics
Feb 20, 2026Gedeon Richter Nyrt.Drugs and Biologics
Feb 18, 2026GEDEON BIRTOK KFTDrugs and Biologics
Feb 2, 2026ChocoMe KftHuman Foods
Nov 28, 2025CooperVision CL KFTDevices
Oct 20, 2025Greiner Bio-One Hungary KftDevices
Oct 20, 2025Greiner Bio-One Hungary KftDevices
Sep 11, 2025HFI, KFT.Human Foods
Sep 11, 2025HFI, KFT.Human Foods
Sep 11, 2025HFI KFTHuman Foods
Aug 27, 2025Greiner Bio-One Hungary KftDevices
Aug 19, 2025Greiner Bio-One Hungary KftDevices
Aug 5, 2025Gedeon Richter Nyrt.Drugs and Biologics
Aug 5, 2025HFI KFHuman Foods
Jul 21, 2025GLOBAL GREEN EUROPE KFT.Human Foods
Jun 26, 2025HFI, KFT.Human Foods

Showing the latest 25 of 786.

Firms on FDA import alerts

PublishedFirmImport alertList
Jun 12, 2026PANNONHERB KFT99-08red
Nov 7, 2025Major Medical Retail Kft99-34red
Jul 30, 2025GLOBAL GREEN EUROPE KFT.99-37red
Jun 27, 2025HFI, KFT.99-08red
Jun 27, 2025Hungarian Food Ingredients Ltd.99-08red
Jun 6, 2025Skala World Trade99-45red
Oct 4, 2024Soliteint Cosmetics KFT66-40red
Oct 13, 2022CF Pharma Kft.66-79red
Mar 9, 2020MANDELAY KFT89-04red
Jan 30, 2020QX World Kft.89-08red
Jan 23, 2019MANDELAY KFT89-08red
Dec 8, 2017HYD LLC66-41red
May 27, 2016Teva Pharmaceutical Works Private Limited Company66-40red
Mar 11, 2016Hfi Kft99-19red
Jan 21, 2016Maltacourt Hungary Kft. Vecses66-41red
Jan 21, 2016Sopipa-Pharma Ltd66-41red
May 16, 2014ChocoMe Kft45-02red
Oct 6, 2011Reanal Private Ltd66-41red
Sep 28, 2010Kedo Eurocosmetics Kft.66-41red
Aug 23, 2010Naturhelix Ltd.77-01red
Sep 30, 2009Alkaloida Vegyeszeti Gyar Zartkoruen Mukodo Resz.66-66red
Sep 30, 2009Egis Pharmaceuticals PLC66-66red
Sep 30, 2009Expedition Warehouse If Gedeib Richter66-66red
Sep 16, 2009Erxer Bt.89-08red
Sep 16, 2009Gyrugyak Andras99-19red

Showing the latest 25 of 26.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Gedeon Richter Nyrt.Budapest60Jul 4, 2025
Alkaloida Vegyeszeti Gyar Zartkoruen Mukodo Resz.Tiszavasvari60Mar 12, 2025
Gedeon Richter Plc., Dorog SiteDorog50Oct 17, 2024
TAPI Hungary Industries Ltd.Debrecen50Jun 29, 2021
EuroAPI Hungary Ltd.Budapest50Jun 21, 2019
Xellia Pharmaceuticals Ltd.Budapest X40Jul 30, 2025
Egis Pharmaceuticals PLCBudapest40Jul 5, 2024
TAPI Hungary Industries LtdSajobabony30Apr 3, 2025
GlaxoSmithKline Biologicals Kft.Godollo30Jan 31, 2025
Meditech KFTBudapest31Jun 28, 2018
Teva Pharmaceutical Works Private Limited CompanyGodollo31Jan 29, 2016
Sanatmetal LTD.Eger31Nov 19, 2014
Andrea Hornyik, M.D.Encs20May 22, 2026
Diatron MI PlcBudapest20Nov 20, 2025
Lavet Kft.Kistarcsa21Nov 7, 2025

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.