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FDA Inspections, Warning Letters and Import Refusals: Taiwan

FDA has recorded 990 inspections of firms in Taiwan, 62 of them (6.3%) classified OAI. It has issued 37 warning letters to firms there and refused 8,691 import shipments. 534 firms in Taiwan 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.

Taiwan: FDA inspections per year 2017: 101 inspections10120172018: 64 inspections6420182019: 54 inspections5420192020: 8 inspections820202021: 1 inspections120212022: 8 inspections820222023: 108 inspections10820232024: 79 inspections7920242025: 67 inspections6720252026: 36 inspections362026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20263625.6%1181
202567710.4%1227
20247956.3%188
202310854.6%0139
20228112.5%0104
2021100.0%0132
2020800.0%1237
20195400.0%2154
20186411.6%3141
201710187.9%1168

Latest OAI inspections

DateFacilityProduct type
Jun 23, 2026Scinopharm Taiwan, Ltd.Drugs
Mar 13, 2026TCI Co., Ltd. - BioCosme PABP BRANCHDrugs
Nov 13, 2025Shian Jia Meei Enterprise Co., Ltd.Devices
Jun 19, 2025Foremount Enterprise Co., Ltd.Devices
Mar 21, 2025Fu Shing Preserved Vegetables StoreFood/Cosmetics
Mar 19, 2025LYU YUAN PASTURE CO LTDFood/Cosmetics
Mar 6, 2025Leltek Inc.Devices
Feb 27, 2025Visgeneer, Inc.Devices
Feb 7, 2025Paonan Biotech Co LtdDevices
Sep 5, 2024Shian Jia Meei Enterprise Co., Ltd.Devices
Aug 8, 2024GALEMED CORP.Devices
Jul 11, 2024Rolence Ent. Inc.Devices
May 27, 2024DALAI BIOTECH COMPANY LTDFood/Cosmetics
Apr 2, 2024Nang Kuang Pharmaceutical Co., Ltd.Drugs
Nov 23, 2023TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.Devices
Sep 7, 2023Inno Health Technology, Inc.Devices
Apr 17, 2023Tailift Co., Ltd.Devices
Apr 13, 2023BroadMaster Biotech Corp.Devices
Jan 19, 2023Advanced Medical Design Co., Ltd.Devices
Sep 20, 2022TAIWAN BIOTECH CO., LTD.Drugs
Dec 13, 2018Vida International, Inc.Drugs
Dec 21, 2017Taiwan Sing Rong Food Co.,LTDFood/Cosmetics
Sep 15, 2017Polaroisin International Co., Ltd.Drugs
Sep 13, 2017Sunder Biomedical Tech Co., Ltd.Devices
Sep 11, 2017TAIWAN BIOTECH CO., LTD.Drugs

Showing the latest 25 of 62.

Latest warning letters

DateFirmProduct typeFDA center
Sep 2, 2026TCI Co., Ltd. - BioCosme PABP BRANCHFood/CosmeticsCFSAN
Jul 17, 2025Leltek Inc.DevicesCDRH
Oct 1, 2024DALAI BIOTECH COMPANY LTDFood/CosmeticsCFSAN
Mar 2, 2020E-Care Technology Corp.DevicesCDRH
Aug 15, 2019Shang Jiuan Co.,LTDFood/CosmeticsCFSAN
May 29, 2019Vida International, Inc.DrugsCDER
Jun 4, 2018TAIWAN BIOTECH CO., LTD.DrugsCDER
Apr 9, 2018Taiwan Sing Rong Food Co.,LTDFood/CosmeticsCFSAN
Jan 26, 2018Polaroisin International Co., Ltd.DrugsCDER
May 26, 2017Pacific Hospital Supply Co., LtdDevicesCDRH
Oct 4, 2016BroadMaster Biotech Corp.DevicesCDRH
Sep 30, 2016Shin Ho Sing Ocean Enterprise Co., Ltd.Food/CosmeticsCFSAN
Sep 15, 2016Cheng Fong Chemical Co., Ltd. Dayuan FactoryDrugsCDER
Aug 31, 2016HMD Biomedical Inc.DevicesCDRH
Jul 28, 2016JIN TZER MARINE PRODUCTS CO.,LTD.Food/CosmeticsCFSAN
May 27, 2016Austin Biotechnology Inc.DrugsCDER
May 27, 2016Ko Da Pharmaceutical Co LtdDrugsCDER
May 9, 2016Fu Fa Flour Food Enterprise Co., Ltd.Food/CosmeticsCFSAN
Feb 4, 2016Hochico Marine Processing Corp.Food/CosmeticsCFSAN
Jan 14, 2016Hsien-Pin Frozen Foods Co., Ltd.Food/CosmeticsCFSAN
Nov 24, 2015E-Care Technology Corp.DevicesCDRH
Nov 5, 2015Linkwin Technology Co LtdDevicesCDRH
Aug 25, 2015High Spot Health Technology Co. Ltd.DevicesCDRH
Nov 14, 2013Cheen Houng Enterprise Co., Ltd.DevicesCDRH
Aug 26, 2013St. Shine Optical Co., Ltd.DevicesCDRH

Showing the latest 25 of 37.

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

Latest import refusals

DateFirmProduct category
Oct 14, 2026Tsang Lin Industries Corp.Human Foods
Oct 14, 2026Tsang Lin Industries Corp.Human Foods
Oct 9, 2026Sheng Foong Co.,LtdHuman Foods
Oct 9, 2026Sun Ten Pharmaceutical Co., LtdHuman Foods
Oct 9, 2026Sheng Foong Co.,LtdHuman Foods
Oct 9, 2026Sheng Foong Co.,LtdHuman Foods
Oct 6, 2026TAIWAN SHUNTAI FOOD CO., LTD.Human Foods
Oct 6, 2026TAIWAN SHUNTAI FOOD CO., LTD.Human Foods
Oct 2, 2026PEGAVISION CORPORATIONDevices
Sep 29, 2026Jellico Food Co, Ltd.Human Foods
Sep 29, 2026Jellico Food Co, Ltd.Human Foods
Sep 29, 2026Jellico Food Co, Ltd.Human Foods
Sep 29, 2026Jellico Food Co, Ltd.Human Foods
Sep 28, 2026ROOF CHEMICAL BIOTECHDevices
Sep 25, 2026YOURS OPTICAL CO. LTD.Devices
Sep 25, 2026YOURS OPTICAL CO. LTD.Devices
Sep 25, 2026YOURS OPTICAL CO. LTD.Devices
Sep 23, 2026Jellico Food Co, Ltd.Human Foods
Sep 23, 2026Jellico Food Co, Ltd.Human Foods
Sep 18, 2026TaiDoc Technology CorporationDevices
Sep 18, 2026HAN SHUO FOOD CO.,LTDHuman Foods
Sep 18, 2026HAN SHUO FOOD CO.,LTDHuman Foods
Sep 18, 2026HAN SHUO FOOD CO.,LTDHuman Foods
Sep 18, 2026HAN SHUO FOOD CO.,LTDHuman Foods
Sep 18, 2026HAN SHUO FOOD CO.,LTDHuman Foods

Showing the latest 25 of 8,691.

See every import refusal from Taiwan.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 20, 2026Tai Ying Co., Ltd.20-07red
Aug 4, 2026Triko Foods Co., Ltd. Factory 133-15red
Aug 4, 2026Triko Foods Co., Ltd. Factory 233-15red
Aug 4, 2026Triko Foods Co., Ltd Factory 333-15red
Jul 22, 2026JUN DA BEAUTY-TEC CO., LTD.66-79red
Mar 27, 2026HWA NAN FOOD INDUSTRIAL CO., LTD.99-39red
Mar 13, 2026LYU YUAN PASTURE CO LTD20-07red
Mar 12, 2026CHEN HSIANG FOODS INDUSTRIAL CO., LTD.99-42red
Oct 21, 2025Jellico Food Co, Ltd.33-15red
Sep 15, 2025YOU HONG FOODS CO.,LTD.45-02red
Aug 7, 2025Tsang Lin Industries Corp.33-15red
Jul 17, 2025Visgeneer, Inc.89-04red
Jun 16, 2025LANDMACY HEALTHCSARE TECH COMPANY66-41red
Jun 5, 2025Transpop Co., Ltd.99-45red
Jun 2, 2025HAN SHUO FOOD CO.,LTD33-15red
May 27, 2025Grand Bonanza Enterprise99-45red
May 27, 2025Gresco Mercandise99-45red
May 13, 2025S&W FOOD RESOURCES CO LTD99-45red
May 8, 2025Chang Wei Chih99-45red
Apr 23, 2025FEIYANG SEAFOODS CO., LTD.16-04red
Apr 10, 2025Chuan Hsin Frozen Foods Co Ltd16-81red
Apr 10, 2025Penseto Seafood Co16-81red
Apr 10, 2025Seabank Inc16-81red
Apr 10, 2025Yelin Enterprises16-81red
Apr 2, 2025FONG YUAN LEATHER CO., LTD71-04red

Showing the latest 25 of 534.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Scinopharm Taiwan, Ltd.Tainan City81Jun 23, 2026
Bora Pharmaceuticals Laboratories, IncMiaoli County70Jul 21, 2025
Cheng Fong Chemical Co., Ltd. Dayuan FactoryTaoyuan City72Aug 2, 2024
Chunghwa Chemical Synthesis & Biotech Co., LtdNew Taipei City70Apr 12, 2024
Yung Shin Pharmaceutical Industry Co., Ltd.Taichung City71Oct 22, 2019
TAIWAN BIOTECH CO., LTD.Taoyuan City62May 21, 2026
Savior Lifetec Corporation Tainan BranchTainan City60Oct 23, 2025
Chirogate International Inc.Taoyuan City60Jul 29, 2025
Delta Synthetic Co., Ltd.New Taipei City60May 29, 2025
Formosa Laboratories, Inc.Taoyuan60Jul 25, 2024
Lotus Pharmaceutical Co., Ltd.Nan Tou Xian60Apr 12, 2024
Teh Seng Pharmaceutical Mfg. Co., Ltd. 3Rd PlantTainan City50Sep 11, 2026
Syntec Scientific CorporationShenkang Hsiang, Changhua Hsien50Mar 26, 2026
Seven Star Pharmaceutical Co., Ltd.New Taipei City50Mar 20, 2026
EPS Bio Technology Corp.Hsinchu51Jan 15, 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.