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FDA Inspections, Warning Letters and Import Refusals: Germany

FDA has recorded 2,395 inspections of firms in Germany, 92 of them (3.8%) classified OAI. It has issued 92 warning letters to firms there and refused 11,532 import shipments. 187 firms in Germany 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.

Germany: FDA inspections per year 2017: 214 inspections21420172018: 212 inspections21220182019: 108 inspections10820192020: 49 inspections4920202021: 36 inspections3620212022: 125 inspections12520222023: 134 inspections13420232024: 156 inspections15620242025: 126 inspections12620252026: 67 inspections672026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20266711.5%3419
202512643.2%3873
202415653.2%3582
202313410.7%1339
202212586.4%2361
20213600.0%1368
20204900.0%1362
201910832.8%1288
201821220.9%1268
201721473.3%6564

Latest OAI inspections

DateFacilityProduct type
May 8, 2026Milchwerke "Mittelelbe" GmbHFood/Cosmetics
Nov 21, 2025Olympus Winter & IBE GmbhDevices
Sep 26, 2025Simtra Deutschland GmbHDrugs
May 28, 2025Gueldenkron Fruchtsaft GmbHFood/Cosmetics
Jan 9, 2025Kabe Labortechnik GmbhDevices
Nov 14, 2024Bio-Gen Milchserum Marketing GmbHFood/Cosmetics
Nov 7, 2024DRG Instruments GmbHDevices
Jul 31, 2024Argon Medical Productions & Vertrieb Gesellschaft MBH & CODevices
Apr 25, 2024WISSNER-BOSSERHOFF GMBHDevices
Mar 7, 2024Philips Medizin Systeme Boeblingen GmbhDevices
Nov 9, 2023HIDREX GmbHDevices
Nov 4, 2022Barkey GmbH & Co. KGDevices
Nov 4, 2022Fischer ANalysen Instrumente GmbHDevices
Oct 20, 2022Richard Wolf GmbHDevices
Oct 13, 2022BERLIN HEART GMBHDevices
Oct 13, 2022Karl Storz SE & Co. KGDevices
Jul 21, 2022GETSCH+HILLER MEDIZINTECHNIK GmbHDevices
Jun 24, 2022Maquet Cardiopulmonary GmbHDevices
Feb 18, 2022System Kosmetik Produktionsgesellschaft Fur Kosmetische GmbhDrugs
Aug 23, 2019USHIO GERMANY GmbHDevices
Mar 22, 2019Bayer AGDrugs
Mar 20, 2019Plantafood Medical GmbhFood/Cosmetics
Nov 8, 2018WEBER MEDICAL GMBHDevices
Sep 6, 2018Aap Biomaterials, GmbHDevices
Sep 7, 2017Dreve Otoplastik GmbhDrugs

Showing the latest 25 of 92.

Latest warning letters

DateFirmProduct typeFDA center
Oct 7, 2026Olympus Winter & IBE GmbhDevicesCDRH
Jul 30, 2026Thomas Brunner Hygiene GmbHDrugsCDER
Mar 3, 2026Simtra Deutschland GmbHDrugsCDER
Sep 9, 2025GLP-1 SolutionDrugsCDER
May 9, 2025Kabe Labortechnik GmbhDevicesCDRH
Mar 31, 2025DRG Instruments GmbHDevicesCDRH
Oct 22, 2024Argon Medical Productions & Vertrieb Gesellschaft MBH & CODevicesCDRH
Aug 30, 2024WISSNER-BOSSERHOFF GMBHDevicesCDRH
Jan 31, 2024Barkey GmbH & Co. KGBiologicsCBER
Feb 3, 2023Fischer ANalysen Instrumente GmbHDevicesCDRH
Dec 27, 2022GETSCH+HILLER MEDIZINTECHNIK GmbHDevicesCDRH
Sep 20, 2022System Kosmetik Produktionsgesellschaft Fur Kosmetische GmbhDrugsCDER
Apr 13, 2021Orphic NutritionFood/CosmeticsCFSAN
Jan 16, 2020Dental-Kosmetik GmbH & Co. KGDrugsCDER
Dec 4, 2019USHIO GERMANY GmbHDevicesCDRH
Dec 31, 2018Merete GmbHDevicesCDRH
Nov 14, 2017Bayer AGDrugsCDER
Sep 27, 2017DRG Instruments GmbHDevicesCDRH
Sep 15, 2017Alber GmbHDevicesCDRH
Aug 23, 2017Curasan AG, Frankfurt FacilityDevicesCDRH
Jun 1, 2017Maris Food GmbHFood/CosmeticsCFSAN
Feb 23, 2017NARVA Lichtquelle GmbH + Co. KGDevicesCDRH
Sep 1, 2016Biotronik SE & Co. KGDevicesCDRH
May 16, 2016BBT Biotech GmbhDrugsCDER
Apr 28, 2016My-Food-OnlineTobaccoCTP

Showing the latest 25 of 92.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026JOHNSON & JOHNSON GMBHDevices
Oct 22, 2026Ursapharm Arzneimittel GmbHDevices
Oct 22, 2026Ursapharm Arzneimittel GmbHDevices
Oct 22, 2026Kettenbach GmbH & Co. KGDevices
Oct 22, 2026Kettenbach GmbH & Co. KGDevices
Oct 21, 2026Boehringer Ingelheim Pharma GmbH & Co. KGDrugs and Biologics
Oct 20, 2026HOPHDANSKES VEJTobacco Products
Oct 20, 2026HOPHDANSKES VEJTobacco Products
Oct 19, 2026Beiersdorf AGCosmetics
Oct 16, 2026Leina-Werke GmbHDevices
Oct 16, 2026Leina-Werke GmbHDevices
Oct 16, 2026Leina-Werke GmbHDevices
Oct 16, 2026Haribo Produktions GmbH & Co. KG - BonnHuman Foods
Oct 16, 2026LINDEN-APOTHEKE M. SPIEGEL E.K.Drugs and Biologics
Oct 9, 2026Merz Pharma GmbH & Co., KGaADrugs and Biologics
Oct 9, 2026Merz Pharma GmbH & Co., KGaADrugs and Biologics
Oct 9, 2026Froximun AgHuman Foods
Oct 8, 2026Thymoorgan Pharmazie GmbhDrugs and Biologics
Oct 8, 2026Menarini-Von HeydenDrugs and Biologics
Oct 8, 2026Merz Pharmaceuticals GmbHDrugs and Biologics
Oct 8, 2026INTUITIVE SURGICAL OPTICS GMBHDevices
Oct 8, 2026INTUITIVE SURGICAL OPTICS GMBHDevices
Oct 8, 2026INTUITIVE SURGICAL OPTICS GMBHDevices
Oct 8, 2026INTUITIVE SURGICAL OPTICS GMBHDevices
Oct 6, 2026Rottendorf Pharma GmbhDrugs and Biologics

Showing the latest 25 of 11,532.

See every import refusal from Germany.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 1, 2026Milchwerke "Mittelelbe" GmbH99-43red
Jun 26, 2026Milchwerke "Mittelelbe" GmbH40-05red
Jan 30, 2026Tadim GmbH Production Facility23-14red
Jan 23, 2026Pekana Naturheilmittel GmbH66-41red
Jan 9, 2026Spreewalder Arzneimittel GmbH66-79red
Oct 15, 2025ABNOBA GmbH66-41red
Sep 19, 2025Gueldenkron Fruchtsaft GmbH99-38red
Aug 29, 2025MorySkin GmbH99-34red
Aug 29, 2025MORYSKIN GMBH99-34red
Jul 22, 2025ALTRUAN99-34red
Jul 22, 2025ALTRUAN GMBH99-34red
Jun 5, 2025Kabe Labortechnik Gmbh89-04red
May 19, 2025Asia Mix Najib Habib Import Export99-45red
Apr 15, 2025Bio-Gen Milchserum Marketing GmbH54-14red
Apr 4, 2025Wilhelm Naumann71-04red
Apr 3, 2025Froximun Ag66-41red
Apr 3, 2025Poske Gmbh & Co Kg71-04red
Aug 15, 2024Beiersdorf AG53-06red
Dec 1, 2023Beiersdorf Manufacturing Hamburg Gmbh53-06red
Aug 21, 2023Aquanova AG99-39red
Aug 21, 2023Worlee NaturProdukte GmbH99-08red
Jun 12, 2023ARCERA GMBH89-08red
Jun 7, 2023WELLCOMET GMBH89-08red
Jun 7, 2023WELLCOMET GMBH89-08red
Apr 5, 2023Krauter Mix GmbH99-39red

Showing the latest 25 of 187.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Milupa GmbHFulda150Apr 17, 2026
Roche Diagnostics GmbHMannheim130Oct 29, 2021
Simtra Deutschland GmbHHalle (Westf.)111Sep 26, 2025
Roche Diagnostics GmbHPenzberg110Aug 1, 2025
Rommelag CDMO GmbHSulzbach-Laufen110Mar 20, 2025
Sanofi-Aventis Deutschland GmbHFrankfurt Am Main111Mar 25, 2022
Bayer AGLeverkusen102Mar 20, 2025
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen)Ravensburg100Jul 21, 2023
Boehringer Ingelheim Pharma GmbH & Co. KgBiberach An Der Riss100Jul 22, 2022
Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse)Ravensburg100Jul 13, 2022
Boehringer Ingelheim Pharma GmbH & Co. KGIngelheim Am Rhein91May 15, 2025
Thymoorgan Pharmazie GmbhGoslar90Mar 26, 2025
Bayer AGBerlin90Jun 6, 2024
Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse)Langenargen90Mar 20, 2024
GSK Vaccines GmbHMarburg80Feb 27, 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.