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FDA Inspections, Warning Letters and Import Refusals: Malaysia

FDA has recorded 388 inspections of firms in Malaysia, 26 of them (6.7%) classified OAI. It has issued 30 warning letters to firms there and refused 4,153 import shipments. 219 firms in Malaysia 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.

Malaysia: FDA inspections per year 2017: 81 inspections8120172018: 32 inspections3220182019: 14 inspections1420192020: 0 inspections020202021: 0 inspections020212022: 10 inspections1020222023: 43 inspections4320232024: 19 inspections1920242025: 13 inspections1320252026: 11 inspections112026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20261119.1%2118
202513215.4%1188
202419210.5%4308
202343614.0%4101
20221000.0%0320
2021001243
2020000115
201914214.3%4196
20183213.1%1229
20178144.9%1107

Latest OAI inspections

DateFacilityProduct type
Jan 20, 2026LINGHAM & SONS (MALAYSIA) SDN. BHD.Food/Cosmetics
Jul 18, 2025Fulijaya Manufacturing SDN. BHD.Drugs
Jan 21, 2025ES Food Industries Sdn BhdFood/Cosmetics
Oct 17, 2024Bioasia Worldwide Sdn BhdDrugs
Mar 14, 2024Advance Nature Sdn BhdFood/Cosmetics
Nov 30, 2023Eurolatex Sdn.Bhd.Devices
Nov 17, 2023Ken Prima Cosmeceuticals, Sdn. Bhd.Drugs
Nov 13, 2023Massos Food Industries Sdn BhdFood/Cosmetics
Oct 26, 2023Bionutricia Manufacturing SDN BHDFood/Cosmetics
Oct 24, 2023Sen Up Huat Seafood Trading Sdn BhdFood/Cosmetics
Jul 14, 2023AmLion Toothpaste Mfg SdnDrugs
Jul 26, 2019Poon Goor Soe Manufacture Sdn. Bhd.Drugs
May 30, 2019ITL Asia Pacific Sdn BhdDevices
Dec 14, 2018Luen Fook Medicine Sdn. Bhd.Drugs
Sep 29, 2017Suntraco Food Industries Sdn. Bhd.Food/Cosmetics
May 25, 2017ORI Bionature SDN BHDFood/Cosmetics
May 16, 2017Phyto ScienceFood/Cosmetics
Mar 17, 2017Ket Hoe Trading Sdn BhdFood/Cosmetics
Sep 19, 2014Criticare Systems (Malaysia) Sdn. Bhd.Devices
May 22, 2014QL FIGO (JOHOR) SDN BHDFood/Cosmetics
May 20, 2014Miaow Miaow Food Products Sdn. Bhd.Food/Cosmetics
Dec 6, 2012Unomedical Sdn. Bhd.Devices
Apr 2, 2012Thomyam Food Industries Sdn.Bhd.Food/Cosmetics
Jan 20, 2011Innolatex Sdn. Bhd.Devices
Sep 9, 2010Laglove Sdn Bhd (M) Aka LA GloveDevices

Showing the latest 25 of 26.

Latest warning letters

DateFirmProduct typeFDA center
Sep 25, 2026Beaute BountyBiologicsCBER
Jan 14, 2026Fulijaya Manufacturing SDN. BHD.DrugsCDER
Mar 25, 2025Bioasia Worldwide Sdn BhdDrugsCDER
Jul 1, 2024Advance Nature Sdn BhdFood/CosmeticsCFSAN
Jun 10, 2024Ken Prima Cosmeceuticals, Sdn. Bhd.DrugsCDER
Jun 6, 2024TCT NUTRACEUTICALS SDN BHDDrugsCDER
Mar 6, 2024Sen Up Huat Seafood Trading Sdn BhdFood/CosmeticsCFSAN
Nov 17, 2023AmLion Toothpaste Mfg SdnDrugsCDER
Aug 23, 2023Finest Ounce Vape StoreTobaccoCTP
Aug 23, 2023Https://Www.Vapevandal.ComTobaccoCTP
Aug 23, 2023THE JUICE MACHINE ENTERPRISETobaccoCTP
Sep 13, 2021Furley Bioextracts SDN BHDDrugsCDER
Dec 6, 2019Vape Orb/Slackers Brew EnterpriseTobaccoCTP
Sep 25, 2019ITL Asia Pacific Sdn BhdDevicesCDRH
Apr 8, 2019Luen Fook Medicine Sdn. Bhd.DrugsCDER
Mar 29, 2019Https://Www.Vapevandal.ComTobaccoCTP
Feb 8, 2018Suntraco Food Industries Sdn. Bhd.Food/CosmeticsCFSAN
Feb 28, 2017TS Food Industry Sdn. Bhd.Food/CosmeticsCFSAN
Jul 24, 2015Www.Buyclovecigarettes.ComTobaccoCTP
Jan 15, 2015Criticare Systems (Malaysia) Sdn. Bhd.DevicesCDRH
Nov 5, 2014QL FIGO FOODS SDN BHDFood/CosmeticsCFSAN
Jul 15, 2013Easy Pha-Max MarkeDrugsCDER
Jul 15, 2013Enhance NutraceuticalDrugsCDER
May 25, 2011Innolatex Sdn. Bhd.DevicesCDRH
Jan 20, 2011Laglove Sdn Bhd (M) Aka LA GloveDevicesCDRH

Showing the latest 25 of 30.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026Luen Fook Medicine Sdn. Bhd.Drugs and Biologics
Oct 2, 2026COHERENT MALAYSIA SDN BHDRadiological Health
Sep 28, 2026PROFOUND RUBBER IND SDN BHDDevices
Sep 21, 2026KSG MEDICARE SDN BHDDevices
Sep 21, 2026KSG MEDICARE SDN BHDDevices
Sep 21, 2026KSG MEDICARE SDN BHDDevices
Sep 21, 2026KSG MEDICARE SDN BHDDevices
Sep 10, 2026DRS SECRET WORLDWIDE MANUFACTURING SDN BHDHuman Foods
Sep 9, 2026Golden Fresh Sdn BhdHuman Foods
Sep 9, 2026Golden Fresh Sdn BhdHuman Foods
Sep 9, 2026Golden Fresh Sdn BhdHuman Foods
Sep 9, 2026Golden Fresh Sdn BhdHuman Foods
Sep 4, 2026CAREGLOVE GLOBAL SDNDevices
Sep 1, 2026COMMBAX SDN BHDRadiological Health
Aug 28, 2026GMP Medicare Sdn Bhd(F25)Devices
Aug 28, 2026GMP Medicare Sdn Bhd(F25)Devices
Aug 28, 2026GMP Medicare Sdn Bhd(F25)Devices
Aug 25, 2026DYNAMIC ACE GLOBAL SDN BHDHuman Foods
Aug 25, 2026DYNAMIC ACE GLOBAL SDN BHDHuman Foods
Aug 18, 2026ROBERT BOSCH(POWER TOOL) SDN BHDRadiological Health
Aug 18, 2026ROBERT BOSCH(POWER TOOL) SDN BHDRadiological Health
Aug 18, 2026ROBERT BOSCH(POWER TOOL) SDN BHDRadiological Health
Aug 18, 2026The Origin Foods Sdn BhdHuman Foods
Aug 18, 2026The Origin Foods Sdn BhdHuman Foods
Aug 18, 2026The Origin Foods Sdn BhdHuman Foods

Showing the latest 25 of 4,153.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 27, 2026LINGHAM & SONS (MALAYSIA) SDN. BHD.99-37red
Sep 21, 2026GMP MEDICARE SDN BHD89-08red
Sep 15, 2026OceanBest (M) SDN. BHD.99-39red
Sep 14, 2026OceanBest (M) SDN. BHD.16-04red
Sep 14, 2026OceanBest (M) SDN. BHD.99-47red
Jul 16, 2026KSG MEDICARE SDN BHD80-04red
Jul 15, 2026LANTERN HEALTH & BEAUTY SDN. BHD.66-79red
Jul 10, 2026FISHERGOLD COLD STORAGE SDN BHD16-124red
Dec 11, 2025EB Frozen Food Sdn Bhd16-119red
Oct 22, 2025Welip (M) Sdn Bhd66-41red
Jun 9, 2025ES Food Industries Sdn Bhd16-120red
Jun 2, 2025ES Food Industries Sdn Bhd99-38red
May 27, 2025Inhesion Industrial (M) Sdn.Bhd.99-45red
May 12, 2025Oriental Food Industries Sdn Bhd99-39red
May 8, 2025Appollo Foods Manufacturing99-45red
May 1, 2025Appollo Foods Manufacturing99-39red
Apr 21, 2025VSF SDN BHD99-39red
Apr 1, 2025Eiki International SDN BhD95-04red
Feb 20, 2025Bioasia Worldwide Sdn Bhd66-40red
Feb 7, 2025MBF PRINTING INDUSTRY SDN. BHD.99-08red
Oct 10, 2024Bionutricia Manufacturing SDN BHD66-41red
Oct 1, 2024Asbien Sdn Bhd85-02red
Aug 13, 2024Sen Up Huat Seafood Trading Sdn Bhd16-120red
May 2, 2024Ken Prima Cosmeceuticals, Sdn. Bhd.66-40red
Apr 15, 2024TCT NUTRACEUTICALS SDN BHD66-40red

Showing the latest 25 of 219.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Plexus Manufacturing Sdn. Bhd.Bayan Lepas70Nov 20, 2025
Innolatex Sdn. Bhd.Port Klang51Apr 9, 2026
Plexus Manufacturing Sdn. Bhd.Bayan Lepas50Nov 11, 2022
Symbiotica Speciality Ingredients, Sdn. Bhd.Kulim40May 16, 2025
SM Biomed Sdn BhdSungai Petani40Jul 28, 2023
OceanBest (M) SDN. BHD.Cheras40Dec 5, 2022
Samsung ElectronicsPort Klang40May 15, 2018
Abbott MedicalPenang40May 11, 2018
DXN Industries (M) Sdn. Bhd.Jitra30Mar 4, 2026
Kerry Ingredients (M) Sdn BhdMasai30Nov 14, 2024
Tiger Balm (Malaysia) Sdn BhdJohor Bahru30Nov 1, 2024
Ken Prima Cosmeceuticals, Sdn. Bhd.Perai31Nov 17, 2023
AmLion Toothpaste Mfg SdnPetaling Jaya31Jul 14, 2023
Miaow Miaow Food Products Sdn. Bhd.Batu Pahat31Feb 24, 2023
Hup Seng Perusahaan Makanan (M) SDN. BHD.Batu Pahat30Dec 13, 2022

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.