Home / Countries / Netherlands

FDA Inspections, Warning Letters and Import Refusals: Netherlands

FDA has recorded 672 inspections of firms in Netherlands, 26 of them (3.9%) classified OAI. It has issued 17 warning letters to firms there and refused 3,057 import shipments. 104 firms in Netherlands 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.

Netherlands: FDA inspections per year 2017: 60 inspections6020172018: 99 inspections9920182019: 59 inspections5920192020: 5 inspections520202021: 10 inspections1020212022: 27 inspections2720222023: 30 inspections3020232024: 62 inspections6220242025: 50 inspections5020252026: 24 inspections242026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20262400.0%076
20255012.0%2127
20246246.5%064
20233026.7%271
20222713.7%060
20211000.0%066
2020500.0%167
20195900.0%082
20189922.0%075
20176023.3%2207

Latest OAI inspections

DateFacilityProduct type
Jan 17, 2025Philips Medical Systems Nederland B.V.Devices
Oct 18, 2024NWL Netherlands Services B.V.Drugs
Sep 17, 2024Zalmhuys ProcessingFood/Cosmetics
Sep 13, 2024Zalmhuys SmokeryFood/Cosmetics
Jul 11, 2024Future Diagnostics Solutions B.V.Devices
Jan 26, 2023PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Devices
Jan 19, 2023Future Diagnostics Solutions B.V.Devices
Oct 25, 2022Eurovet Animal Health B.V.Veterinary
Aug 28, 2018Delarange Cosmetics BVDrugs
Mar 27, 2018BiB Production & Packaging B.V.Drugs
Mar 30, 2017VitalScientific B.V.Devices
Mar 23, 2017Ophtec BVDevices
Jun 3, 2016Delarange Cosmetics BVDrugs
Feb 3, 2016Viroclinics Biosciences B.V.Devices
Nov 19, 2015Medical Measurement Systems B.V.Devices
Feb 13, 2015GREENYEARD PREPARED NETHERLANDSBVFood/Cosmetics
Feb 13, 2015Okechamp B.V.Food/Cosmetics
Nov 20, 2014Prothya Biosolutions Netherlands B.V.Biologics
May 22, 2014Eurotrol B.V.Devices
Mar 7, 2014NWL Netherlands Services B.V.Drugs
Aug 29, 2013A-Ware Packaging B.V.Food/Cosmetics
Aug 29, 2013Drents-Overijsselse Coop. Kaas B.A.Food/Cosmetics
Jun 4, 2013Prothya Biosolutions Netherlands B.V.Biologics
Mar 27, 2013Enraf-Nonius B.V.Devices
Jun 7, 2012Wacker Biotech B.V.Drugs

Showing the latest 25 of 26.

Latest warning letters

DateFirmProduct typeFDA center
Dec 16, 2025Trans-Missie B.V.DevicesCDRH
Apr 1, 2025NWL Netherlands Services B.V.DrugsCDER
Jun 16, 2023Mr-Joy Group Holding B.V. D/B/A MR. JOYTobaccoCTP
Jan 30, 2023Monkeypox-Treatment.ComDrugsCDER
Jan 22, 2020Neptunus Seafood B.V.Food/CosmeticsCFSAN
Sep 20, 2017VitalScientific B.V.DevicesCDRH
Jul 20, 2017QLRADDevicesCDRH
Sep 29, 2016Delarange Cosmetics BVDrugsCDER
Sep 1, 2015D.O.R.C. Dutch Opthalmic Research Center Intl B.V.DevicesCDRH
Nov 19, 2014Eurotrol B.V.DevicesCDRH
Aug 29, 2013Prothya Biosolutions Netherlands B.V.BiologicsCBER
Jul 5, 2013Enraf-Nonius B.V.DevicesCDRH
Dec 13, 2012TMS InternationalDevicesCDRH
Jun 25, 2012Cigar Web ServiceTobaccoCTP
Jun 11, 2012Valeant Amsterdam Logistics CenterDevicesCDRH
Dec 2, 2010Herbal-Supplements-For-YouFood/CosmeticsCFSAN
Jun 2, 2010Privacyprotect.OrgFood/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 21, 2026RCBEAUTYDrugs and Biologics
Oct 21, 2026RCBEAUTYDrugs and Biologics
Oct 21, 2026RCBEAUTYDrugs and Biologics
Oct 21, 2026RCBEAUTYDrugs and Biologics
Oct 13, 2026Maasoever Cold Store B.V.Human Foods
Oct 2, 2026DIGITAL BUILDERSDevices
Sep 30, 2026SE FACTORYDevices
Sep 25, 2026HAIR GENETIXDevices
Sep 18, 2026HAIRGENETIXDevices
Sep 18, 2026Matthijs B.V.Human Foods
Sep 8, 2026UNIVERSAL DELIVERY SOLUTIONS B.V.Devices
Sep 4, 2026IMPERIAL FEET B.V.Cosmetics
Aug 25, 2026BEPPY BVDevices
Aug 18, 2026Abbott Biologicals BVDrugs and Biologics
Aug 18, 2026BEIERSDORF AGDrugs and Biologics
Aug 13, 2026MEVSIM STOREDevices
Aug 10, 2026Kroeske BvAnimal Feed
Jul 28, 2026Janssen Biologics B.V.Drugs and Biologics
Jul 21, 2026AMPELMANN OPERATIONS BVRadiological Health
Jul 14, 2026COLGATE-PALMOLIVEDevices
Jul 13, 2026SUIKERUNIEDrugs and Biologics
Jul 13, 2026IMPERIAL FEET B.V.Cosmetics
Jul 13, 2026IMPERIAL FEET B.V.Cosmetics
Jul 13, 2026IMPERIAL FEET B.V.Cosmetics
Jul 13, 2026Profero CosmeticsCosmetics

Showing the latest 25 of 3,057.

Firms on FDA import alerts

PublishedFirmImport alertList
May 29, 2026CLOETTA HOLLAND BV45-02red
May 18, 2026Matthijs B.V.45-02red
Nov 21, 2024Future Diagnostics Solutions B.V.89-04red
Jul 12, 2024SE FACTORY99-34red
Jul 12, 2024SE FACTORY99-34red
Mar 11, 2024INNOFAITH BEAUTY SCIENCE89-08red
Feb 13, 2024Cloetta Holland BV45-02red
Feb 12, 2024RED BAND SUCKERS45-02red
Nov 28, 2023Lelypharma BV66-41red
Sep 14, 2023N&M HANDELSONDERNEMING66-41red
May 11, 2023IMPERIAL FEET B.V.66-41red
Feb 28, 2023Het Urker Zalmhuys16-125green
Feb 28, 2023Zalmhuys Processing16-125green
Oct 27, 2022IMPERIAL FEET BV66-41red
Oct 27, 2022IMPERIAL FEET B.V.66-41red
Sep 21, 2022NATURE BIO FOODS BV99-19red
Aug 1, 2022Kloosterboer Vlissingen99-08red
Apr 4, 2022INZEK INTERNATIONAL TRADING BV89-08red
Mar 28, 2022A-Ware Packaging B.V.99-45red
Mar 28, 2022Visser Kaashandel B.V.99-45red
Jan 5, 2022H&A HOLLAND66-41red
Dec 20, 2021H&A HOLLAND99-39red
Nov 15, 2021Potentia Trium B.V40-05red
Nov 12, 2021AGRIDIENT B V99-08red
May 4, 2021INZEK INTERNATIONAL TRADING89-08red

Showing the latest 25 of 104.

Most-inspected facilities

FacilityCityInspectionsOAILatest
N.V. OrganonOss110Sep 8, 2022
Nestle Nederland BVNunspeet100Sep 11, 2026
Janssen Biologics B.V.Leiden70Jun 1, 2023
Merck Sharp & Dohme BVHaarlem60Oct 17, 2024
Pharmachemie B.V.Haarlem60Oct 17, 2024
B.V. KATWIJK CHEMIEKatwijk Zh60Sep 26, 2024
Curium Netherlands B.V.Petten60Jun 13, 2024
AstraZeneca Nijmegen B.V.Nijmegen60Apr 10, 2024
Abbott Biologicals BVOlst60Apr 5, 2024
Prothya Biosolutions Netherlands B.V.Amsterdam63Mar 30, 2018
Synergy Health Ede BVEde50Feb 12, 2026
Nutricia NVZoetermeer50Sep 19, 2025
Purac Biochem BVGorinchem50Dec 11, 2024
Patheon Biologics B.V.Groningen50Aug 21, 2024
Niacet B.V.Tiel50Jan 10, 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.