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FDA Inspections, Warning Letters and Import Refusals: Israel

FDA has recorded 255 inspections of firms in Israel, 7 of them (2.7%) classified OAI. It has issued 19 warning letters to firms there and refused 2,871 import shipments. 91 firms in Israel 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.

Israel: FDA inspections per year 2017: 18 inspections1820172018: 3 inspections320182019: 70 inspections7020192020: 6 inspections620202021: 0 inspections020212022: 40 inspections4020222023: 14 inspections1420232024: 0 inspections020242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIOAI shareWarning lettersImport refusals
202600148
2025001103
2024000131
202314321.4%0126
20224012.5%0141
2021001116
2020600.0%277
20197000.0%070
2018300.0%062
20171800.0%198

Latest OAI inspections

DateFacilityProduct type
Jun 22, 2023Stepac L.A., LTD.Devices
Jun 22, 2023Pharmasept Medical Products 1995 Ltd.Devices
Mar 22, 2023Icecure Medical LtdDevices
Jul 28, 2022Fisher Pharmaceuticals Ltd.Drugs
Jun 23, 2011Medical Compression Systems DBN Ltd.Devices
Jun 15, 2011Oridion Medical 1987 Ltd.Devices
Sep 16, 2010Teva Pharmaceutical IndustriesDrugs

Latest warning letters

DateFirmProduct typeFDA center
Apr 27, 2026Estar Technologies Ltd.BiologicsCBER
Aug 6, 2025K & CARE ORGANICSDrugsCDER
Mar 4, 2021OPGAL OPTRONIC INDUSTRIES LTDDevicesCDRH
Jun 10, 2020Www.Outoftheboxremedies.ComDrugsCDER
Apr 10, 2020Herbs Of KedemDrugsCDER
Feb 16, 2017Www.Vap-Cafe.ComTobaccoCTP
Mar 11, 2016Swedish TobaccoTobaccoCTP
Jul 29, 2014Medinol Ltd.DevicesCDRH
Nov 25, 2013Sharplight TechnologiesDevicesCDRH
Jan 9, 2013Curatronic Ltd.DevicesCDRH
Nov 29, 2012Invasix Ltd.DevicesCDRH
Sep 18, 2012Eyal Bar OzDrugsCDER
Sep 18, 2012White Forest SolutionsDrugsCDER
Mar 15, 2012NeuroTrax Israel Ltd.DevicesCDRH
Oct 21, 2011Medical Compression Systems DBN Ltd.DevicesCDRH
Oct 4, 2011Oridion Medical 1987 Ltd.DevicesCDRH
Jan 31, 2011Teva Pharmaceutical IndustriesDrugsCDER
Mar 12, 2010Medispec, Ltd.DevicesCDRH
May 14, 2009Dexcel Ltd.DrugsCDER

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

Latest import refusals

DateFirmProduct category
Oct 21, 2026NAVEH PHARMA (1996) LTDDevices
Sep 30, 2026NAVEH PHARMA (1996) LTDDrugs and Biologics
Sep 23, 2026SYNCHRONY MEDICAL LTDDevices
Sep 19, 2026PHARMA TAMARHuman Foods
Aug 14, 2026Sanlakol Quality Food ProductsHuman Foods
Aug 14, 2026Sanlakol Quality Food ProductsHuman Foods
Aug 14, 2026Leiman Schlussel LtdHuman Foods
Jul 7, 2026Sanlakol Quality Food ProductsHuman Foods
Jul 7, 2026Sanlakol Quality Food ProductsHuman Foods
Jul 7, 2026Sanlakol Quality Food ProductsHuman Foods
Jul 7, 2026Sanlakol Quality Food ProductsHuman Foods
Jul 2, 2026DSI DENTAL SOLUTIONS LTDDevices
Jul 2, 2026DSI DENTAL SOLUTIONS LTDDevices
Jul 2, 2026DSI DENTAL SOLUTIONS LTDDevices
Jun 26, 2026KLA TENCORRadiological Health
Jun 23, 2026TEVA PHARMACEUTICAL INDUSTRIES LTD.Drugs and Biologics
Jun 10, 2026ESHBAL FUNCTIONAL FOODS LTDHuman Foods
Jun 5, 2026NanoPass Technologies Ltd.Devices
Jun 2, 2026CLARITI LTDDevices
May 14, 2026SPA Cosmetics Ltd.Drugs and Biologics
May 13, 2026UNIQA DENTALDevices
May 13, 2026UNIQA DENTALDevices
Apr 29, 2026EYTANDevices
Apr 29, 2026EYTANDevices
Apr 29, 2026EYTANDevices

Showing the latest 25 of 2,871.

Firms on FDA import alerts

PublishedFirmImport alertList
Jun 12, 2026NAVEH PHARMA (1996) LTD66-41red
May 5, 2026TIBULIM MEHAKFAR LTD99-08red
May 5, 2026TIBULIM MEHAKFAR LTD.99-08red
May 27, 2025Hebron Glass99-45red
May 27, 2025Hebron Glass & Ceramics Factory99-45red
Jan 2, 2025SESP GROUP66-41red
Dec 17, 2024E.M.B YARDEN AGRICULTURAL FARM LTD99-39red
May 6, 2024The Prince Tahina Manufacture Ltd99-19red
Oct 31, 2023Shemurei Motola L.T.D.99-08red
Sep 29, 2023Arava Pet Spa Ltd.68-19red
Mar 20, 2023Canary Express99-45red
Mar 13, 2023Hekma Center Ltd.99-39red
Mar 13, 2023Hekma Center Ltd.99-39red
Feb 22, 2023Hekma Center Ltd.54-12red
Feb 3, 2023Hekma Center Ltd.66-41red
Nov 22, 2022TURA ESTATE WINERY99-08red
Nov 22, 2022Tura Oil Press99-08red
Sep 1, 2022Tradis Gat Ltd.66-41red
Jan 4, 2022Mahroum Sweets (2016)Ltd45-02red
Dec 29, 2021A. Ran Shivuk-Kitov Ltd99-19red
Nov 15, 2021KATOM QP LTD66-41red
Nov 12, 2021Muzarim Ze Barur99-08red
May 27, 2021Achdut Factory For Tahini Halva And Sweets99-19red
Mar 23, 2020Nachal Arava LTD99-08red
Jan 16, 2020Sasa Cosmetics ACS Ltd66-41red

Showing the latest 25 of 91.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Padagis Israel Pharmaceuticals Ltd.Yerucham70Sep 20, 2023
Taro Pharmaceutical Industries Ltd.Haifa Bay70Dec 8, 2022
Teva Pharmaceutical Industries Ltd.Kfar Saba60May 23, 2023
Bio-Technology General (Israel), Ltd.Kiryat Malachi50Jan 26, 2023
Wavelength Enterprises Ltd.Beer Sheva40Dec 14, 2022
Dexcel Ltd.Or Akiva40Dec 14, 2022
Teva Pharmaceutical IndustriesJerusalem41Aug 1, 2019
Protalix Ltd.Karmi'El40Jul 11, 2019
Mediplast Israel Ltd.Yavne40Aug 31, 2017
Spatz FGIA, IncRa'Anana30Dec 15, 2022
IMI TAMI Institute For Research & Development LtdKiryat Atta30Dec 8, 2022
OMRIX Biopharmaceuticals Ltd.Ramat Gan30Feb 24, 2020
Rafa Laboratories Ltd.Jerusalem30Nov 25, 2019
Novetide Ltd.Netanya30Nov 14, 2019
Rotem Industries LimitedDimona30Nov 7, 2019

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.