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FDA Inspections, Warning Letters and Import Refusals: Singapore

FDA has recorded 240 inspections of firms in Singapore, 15 of them (6.3%) classified OAI. It has issued 17 warning letters to firms there and refused 1,700 import shipments. 66 firms in Singapore 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.

Singapore: FDA inspections per year 2017: 10 inspections1020172018: 16 inspections1620182019: 24 inspections2420192020: 14 inspections1420202021: 1 inspections120212022: 12 inspections1220222023: 16 inspections1620232024: 15 inspections1520242025: 12 inspections1220252026: 7 inspections72026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026700.0%127
20251200.0%388
20241516.7%17
202316212.5%117
202212216.7%020
2021100.0%126
20201400.0%125
201924312.5%4156
20181600.0%012
20171000.0%128

Latest OAI inspections

DateFacilityProduct type
Dec 13, 2024Vantive Manufacturing Pte. Ltd.Drugs
Nov 9, 2023BIOPTIMAL INTERNATIONAL PTE. LTD.Devices
Apr 20, 2023Biosensors Interventional Technologies Pte LtdDevices
Sep 1, 2022Opto-Pharm Pte Ltd.Drugs
Aug 19, 2022Haw Par Healthcare LimitedDrugs
Jun 25, 2019EE HUI FOOD MANUFACTURE PTE LTDFood/Cosmetics
Mar 1, 2019Haw Par Healthcare LimitedDrugs
Jan 25, 2019Opto-Pharm Pte Ltd.Drugs
Mar 24, 2016Biosensors Interventional Technologies Pte LtdDevices
Mar 22, 2016Opto-Pharm Pte Ltd.Drugs
Aug 21, 2014Reka Health Pte LtdDevices
Jun 13, 2013Licht Far East (Singapore) Pte LtdDrugs
Jun 6, 2013Racer Technology Pte LtdDevices
Jan 28, 2010JMS Singapore PTE Ltd.Devices
Oct 29, 2009Haw Par Healthcare LimitedDrugs

Latest warning letters

DateFirmProduct typeFDA center
Oct 22, 2026TSP Solutions Pte. Ltd.DrugsCDER
Dec 16, 2025The FluxionDevicesCDRH
Dec 16, 2025TOMSCOUTDevicesCDRH
Oct 9, 2025Magicsmog.ComTobaccoCTP
Apr 3, 2024BIOPTIMAL INTERNATIONAL PTE. LTD.DevicesCDRH
Jan 30, 2023Fei Fah Medical Manufacturing Pte. Ltd.DrugsCDER
Mar 4, 2021OMNISENSE SYSTEMS PTE LTDDevicesCDRH
Aug 14, 2020SilveryGuyDrugsCDER
Nov 22, 2019EE HUI FOOD MANUFACTURE PTE LTDFood/CosmeticsCFSAN
Oct 25, 2019E-Cigarette-Mart.ComTobaccoCTP
Aug 19, 2019Haw Par Healthcare LimitedDrugsCDER
Jun 5, 2019Any CigTobaccoCTP
Mar 17, 2017Opto-Pharm Pte Ltd.DrugsCDER
Oct 26, 2015Http://Www.Supercigarettesshop.ComTobaccoCTP
Dec 19, 2014Reka Health Pte LtdDevicesCDRH
Dec 12, 2013Racer Technology Pte LtdDevicesCDRH
Jul 20, 2010Haw Par Healthcare LimitedDrugsCDER

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

Latest import refusals

DateFirmProduct category
Oct 19, 2026ELECTRO SCIENTIFIC INDUSTRIES (SRadiological Health
Oct 8, 2026LINH HUNG COMPANYDrugs and Biologics
Jul 7, 2026Vantive Manufacturing Pte. Ltd.Devices
Jul 7, 2026Vantive Manufacturing Pte. Ltd.Devices
Jun 26, 2026TREASURE ORBIT (SINGAPORE) PTE.Human Foods
Jun 9, 2026TREASURE ORBIT (SINGAPORE) PTE.Human Foods
May 28, 2026TREASURE ORBIT (SINGAPORE) PTE.Human Foods
May 26, 2026MSD International GmbH (Singapore Branch)Drugs and Biologics
May 7, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
May 5, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Apr 23, 2026PETGUARDRKDrugs and Biologics
Apr 16, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Apr 3, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Apr 3, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Apr 3, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Apr 3, 2026Kla Tencor Singapore Pte LtdRadiological Health
Mar 26, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Jan 30, 2026KLA-TENCOR (SINGAPORE) PTE LTD.Radiological Health
Jan 30, 2026SAI GON US EXPRESSHuman Foods
Jan 22, 2026BC LTD C/O PASTUREDrugs and Biologics
Jan 21, 2026BC LTD C/O PASTUREDrugs and Biologics
Jan 8, 2026PTB INTERNATIONAL LIMITEDDrugs and Biologics
Jan 8, 2026PTB INTERNATIONAL LIMITEDDrugs and Biologics
Jan 8, 2026PTB INTERNATIONAL LIMITEDDrugs and Biologics
Jan 8, 2026PTB INTERNATIONAL LIMITEDDrugs and Biologics

Showing the latest 25 of 1,700.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 6, 2026Fei Fah Medical Manufacturing Pte. Ltd.66-40red
Aug 14, 2026TSP Solutions Pte. Ltd.66-40red
May 12, 2025Kee Wee Hup Kee Food Manufacture Pte. Ltd.99-45red
May 12, 2025Kee Wee Hup Kee Manufacture PTE Ltd99-45red
May 12, 2025Meng Chong Foodstuffs Pte Ltd99-45red
May 1, 2025Kee Wee Hup Kee Food Manufacture Pte. Ltd.99-39red
May 1, 2025Meng Chong Foodstuffs Pte Ltd99-39red
Oct 13, 2022Kee Wee Hup Kee Food Manufacture Pte. Ltd.99-42red
Oct 13, 2022Tris Enterprises99-42red
Dec 3, 2021Vela Operations Singapore Pte Ltd89-08red
Sep 30, 2021AIBIOTECH PTE LTD89-08red
Sep 30, 2021AMT PTE. LTD.89-08red
Sep 30, 2021CREDO DIAGNOSTICS BIOMEDICAL PTE89-08red
Sep 30, 2021Forefront Medical Technology (Pte) Ltd.89-08red
Sep 30, 2021MIRXES PTE LTD89-08red
May 14, 2021Racer Technology Pte Ltd89-08red
Oct 28, 2020CELL ID PTE LTD89-08red
Oct 28, 2020SENSING SELF PTE LTD89-08red
Jul 17, 2020BIOLIDICS LIMITED89-08red
Feb 11, 2020EE HUI FOOD MANUFACTURE PTE LTD16-120red
May 15, 2019Opto-Pharm Pte Ltd.66-40red
Mar 13, 2019Barramundi Asia Pte Ltd16-125green
Oct 4, 2018Jal Innovations89-08red
Nov 8, 2017Beacons Pharmaceuticals Pte Ltd66-41red
Mar 7, 2017ONECARE WELLNESS66-41red

Showing the latest 25 of 66.

Most-inspected facilities

FacilityCityInspectionsOAILatest
MSD International GmbH (Singapore Branch)Singapore80Aug 17, 2026
Roche Singapore Technical Operations Pte. Ltd.Singapore60Nov 14, 2025
MSD International GmbH (Singapore Branch)Singapore60Oct 24, 2025
Sanofi Aventis Singapore Pte. Ltd.Singapore60Jun 13, 2025
Haw Par Healthcare LimitedSingapore63Sep 27, 2024
Pfizer Asia Manufacturing Pte Ltd.Singapore60Oct 18, 2023
Glaxo Wellcome Manufacturing Pte LimitedSingapore60Oct 13, 2023
MSD International GmbH (Singapore Branch)Singapore50Jun 20, 2025
MSD International GmbH (Singapore Branch)Singapore50May 30, 2025
Lonza Biologics Tuas Pte LtdSingapore50Jun 27, 2023
Life Technologies Holdings Pte LtdSingapore50Dec 15, 2022
MSD International GmbH (Singapore Branch)Singapore50Sep 26, 2019
Flextronics Manufacturing (Singapore) Pte. Ltd.Singapore50Apr 21, 2017
Mead Johnson (Asia Pacific) Pte. Ltd.Singapore40May 22, 2026
Borden Company (Private) LimitedSingapore40May 23, 2025

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.