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FDA Inspections, Warning Letters and Import Refusals: Austria

FDA has recorded 237 inspections of firms in Austria, 7 of them (3.0%) classified OAI. It has issued 7 warning letters to firms there and refused 1,212 import shipments. 15 firms in Austria 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.

Austria: FDA inspections per year 2017: 12 inspections1220172018: 18 inspections1820182019: 13 inspections1320192020: 3 inspections320202021: 3 inspections320212022: 8 inspections820222023: 19 inspections1920232024: 15 inspections1520242025: 9 inspections920252026: 5 inspections52026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026500.0%029
2025900.0%044
20241500.0%147
202319210.5%066
2022800.0%0105
2021300.0%074
2020300.0%074
20191300.0%1195
20181815.6%091
20171218.3%160

Latest OAI inspections

DateFacilityProduct type
Mar 22, 2023Safersonic Medizinprodukte Handelsges MBHDevices
Jan 19, 2023I.T.S. GmbHDevices
Oct 25, 2018Greiner Bio-One GmbHDevices
Jul 19, 2017Schrofner Cosmetics GmbhDrugs
Jan 24, 2013Tecan Austria GmbHDevices
Dec 13, 2012Care Diagnostica GmbHDevices
Oct 23, 2012Fareva Unterach GmbHDrugs

Latest warning letters

DateFirmProduct typeFDA center
Mar 15, 2024I.T.S. GmbHDevicesCDRH
Mar 8, 2019Aidaccess.OrgDrugsCDER
Dec 20, 2017Schrofner Cosmetics GmbhDrugsCDER
Jun 30, 2014I.T.S. GmbHDevicesCDRH
May 28, 2013Fareva Unterach GmbHDrugsCDER
Apr 23, 2013Care Diagnostica GmbHDevicesCDRH
Jan 4, 2013Www.Hqcigs.ComTobaccoCTP

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

Latest import refusals

DateFirmProduct category
Oct 7, 2026Austria Pet Food GmbHAnimal Feed
Sep 24, 20264TRENDS GMBHDrugs and Biologics
Sep 23, 2026Machland Obst- Und Gemuesedelikatessen GmbhHuman Foods
Sep 21, 2026SKYLINE HANDELS GMBHDrugs and Biologics
Sep 19, 2026BIOGENA GMBH AND CO KGHuman Foods
Sep 11, 20264TRENDS GMBHDrugs and Biologics
Sep 3, 2026GALDERMA AUSTRIA GMBHDevices
Sep 3, 2026GALDERMA AUSTRIA GMBHDevices
Aug 13, 2026GW Cosmetics GmbHCosmetics
Aug 13, 2026GW Cosmetics GmbHCosmetics
Aug 13, 2026GW Cosmetics GmbHCosmetics
Aug 13, 2026GW Cosmetics GmbHCosmetics
Jul 24, 2026CROMA-PHARMA GMBHDevices
Jul 21, 2026OXYMORON AGDrugs and Biologics
Jul 15, 2026BiogenaHuman Foods
Jul 8, 2026Leonhard Lang GmbHDevices
Jul 2, 2026Sandoz GmbHDrugs and Biologics
May 14, 2026Red Bull GmbhHuman Foods
Apr 27, 2026QIMIQ HANDELS GMBHHuman Foods
Apr 7, 2026AGRANA STAERKE GMBHHuman Foods
Apr 2, 2026NovaLabs GmbHHuman Foods
Mar 31, 2026AGRANA STAERKE GMBHHuman Foods
Mar 16, 2026AGRANA STAERKE GMBHHuman Foods
Mar 16, 2026Agrana Zucker GmbhHuman Foods
Jan 26, 2026Greiner Bio-One GmbHDevices

Showing the latest 25 of 1,212.

Firms on FDA import alerts

PublishedFirmImport alertList
Aug 16, 2022Andora-Cosmetic53-06red
Aug 16, 2022W. Pauli53-06red
Mar 16, 2022Nowicky Pharma66-41red
Mar 2, 2020GW Cosmetics GmbH53-06red
Aug 1, 2019SKYLINE HANDELS GMBH66-41red
Dec 13, 2018WOMEN'S BEST99-39red
Feb 1, 2018BeverageScouts Production & Development45-02red
Oct 20, 2017Schrofner Cosmetics Gmbh66-40red
Oct 2, 2015APO Fruchtsaefte GmbH99-39red
Oct 2, 2015Rey GmbH99-39red
Jun 3, 2014Englert Kg99-36red
Sep 30, 2009Sandoz GmbH66-66red
Sep 18, 2009Bomba Energia Getrankevertriebs GMBH45-02red
Sep 18, 2009HAB Handels Ges.mbH45-02red
Sep 18, 2009Hermann Pfanner Getraenke GmbH45-02red

Most-inspected facilities

FacilityCityInspectionsOAILatest
Fresenius Kabi Austria GMBHGraz110Mar 21, 2024
Boehringer Ingelheim RCV GmbH & Co KGVienna100Jul 4, 2025
Sandoz GmbHKundl100Nov 17, 2023
Takeda Manufacturing Austria AGVienna80Jul 17, 2026
Sandoz GmbHLangkampfen80Feb 27, 2024
Fareva Unterach GmbHUnterach Am Attersee71Jun 2, 2022
Takeda Austria GmbHLinz60Sep 11, 2025
Fresenius Kabi Austria GmbhLinz60May 23, 2025
Sanochemia Pharmazeutika AgNeufeld An Der Leitha60Mar 2, 2018
Patheon Austria GmbH & Co. KGLinz50Sep 12, 2024
Octapharma Pharmazeutika Produktionsgesellschaft M.B.H.Vienna50Dec 16, 2022
Loba Feinchemie GmbHFischamend50Oct 13, 2022
Osterreichische Agentur Fur Gesundheit And Ernahrungssicherheit GmbhGraz40Jun 11, 2024
Intervet GesmbHVienna40May 11, 2023
MED-EL Elektromedizinische Gereate, GmbhInnsbruck40May 7, 2015

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.