Home / Countries / China

FDA Inspections, Warning Letters and Import Refusals: China

FDA has recorded 4,692 inspections of firms in China, 383 of them (8.2%) classified OAI. It has issued 381 warning letters to firms there and refused 55,164 import shipments. 3,212 firms in China 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.

China: FDA inspections per year 2017: 369 inspections36920172018: 342 inspections34220182019: 346 inspections34620192020: 45 inspections4520202021: 69 inspections6920212022: 31 inspections3120222023: 212 inspections21220232024: 352 inspections35220242025: 442 inspections44220252026: 246 inspections2462026
YearInspectionsOAIOAI shareWarning lettersImport refusals
202624693.7%162,120
2025442296.6%313,672
2024352298.2%354,272
2023212146.6%191,658
20223139.7%121,805
202169811.6%202,059
20204512.2%153,683
20193463710.7%241,740
2018342175.0%232,622
20173694311.7%262,469

Latest OAI inspections

DateFacilityProduct type
Jul 15, 2026Liaoning Taihong Biotechnology Co., Ltd.Food/Cosmetics
Jun 26, 2026Shandong Anhong Pharmaceutical Co., Ltd.Drugs
Jun 16, 2026Hefei Yili Dairy Co., LtdFood/Cosmetics
Apr 24, 2026Jiangsu Hansoh Pharmaceutical Group Co., LtdDrugs
Apr 24, 2026Zhejiang Huahai Pharmaceutical Co., Ltd.Drugs
Apr 15, 2026Sichuan Chuan Wazi Food Co., Ltd.Food/Cosmetics
Mar 18, 2026CABIO Biotech (Wuhan) Co., Ltd. Gedian BranchFood/Cosmetics
Mar 13, 2026Haikou Ye Cai Food Co., LtdFood/Cosmetics
Jan 23, 2026Fuzhou Mintian Food Industry Park Co., LtdFood/Cosmetics
Nov 21, 2025Hunan Xiangyikang Pharmaceutical Co., Ltd.Drugs
Nov 11, 2025Rizhao Rongjin Aquatic Products Co., Ltd.Food/Cosmetics
Nov 7, 2025DANDONG SAMJIN FOOD CO.,LTDFood/Cosmetics
Nov 7, 2025Harbin Jixianglong Biotech Co., Ltd.Drugs
Nov 7, 2025Hubei Gedian Humanwell Pharmaceutical Co., Ltd.Drugs
Nov 4, 2025Sichuan Cai Hua Xiang Food Co., LtdFood/Cosmetics
Oct 24, 2025Yangzhou H&R Plastic Daily Chemical Co., Ltd.Drugs
Oct 24, 2025Foshan Miwei Cosmetics Co., Ltd.Drugs
Sep 18, 2025Dezhou Lingcheng Taoyuan Food Co., Ltd.Food/Cosmetics
Aug 15, 2025Xiamen Kang Zhongyuan Biotechnology Co., Ltd.Drugs
Aug 7, 2025Hong Qiangxing (Shen Zhen) Electronics LimitedDevices
Jul 31, 2025SHENZHEN YUEZHONGXING TECHNOLOGY CO LTDDevices
Jul 3, 2025Hubei Qianjiang Kingphar Medical Material Co. Ltd.Devices
Jul 2, 2025Jiangsu Dehui Food Co., Ltd.Food/Cosmetics
Jun 25, 2025Sichuan Shifang Danshi Food Co., LtdFood/Cosmetics
Jun 20, 2025Weifang Green Life Foods Co.,LtdFood/Cosmetics

Showing the latest 25 of 383.

Latest warning letters

DateFirmProduct typeFDA center
Oct 22, 2026Sanrace Biotechnology Co., Ltd.DrugsCDER
Oct 1, 2026Zhejiang Gaorong Cosmetic Co., LtdDrugsCDER
Sep 23, 2026JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTDDrugsCDER
Sep 9, 2026Zhejiang Jifu Daily Chemical Co., Ltd.DrugsCDER
Aug 7, 2026Tianjin Kilo Pharmaceutical Sci-Tech Co., Ltd.Food/CosmeticsCFSAN
Jun 15, 2026Yangzhou Hongshengding Chemical Co., Ltd.DrugsCDER
Jun 3, 2026Hubei Gedian Humanwell Pharmaceutical Co., Ltd.DrugsCDER
Jun 2, 2026SHANTOU Qiwei Industrial Co., LtdDrugsCDER
May 21, 2026BMC Medical Co., Ltd.DevicesCDRH
May 1, 2026Harbin Jixianglong Biotech Co., Ltd.DrugsCDER
Apr 23, 2026Jadepouch.ComTobaccoCTP
Apr 20, 2026Foshan Miwei Cosmetics Co., Ltd.DrugsCDER
Apr 15, 2026Hangzhou Yiqi Biotechnology Co., LtdDrugsCDER
Apr 3, 2026Xiamen Kang Zhongyuan Biotechnology Co., Ltd.DrugsCDER
Mar 26, 2026Henan Lvyuan Pharmaceutical Co., Ltd.DrugsCDER
Mar 18, 2026Yangzhou H&R Plastic Daily Chemical Co., Ltd.DrugsCDER
Dec 16, 2025Guangdong Renhe Guozhuang Biotechnology Co., Ltd.DrugsCDER
Nov 28, 2025Yuyao City Boss Vegetable Factory Co., Ltd.Food/CosmeticsCFSAN
Nov 6, 2025Kellin Chemicals (Zhangjiagang) Co., LtdDrugsCDER
Oct 10, 2025Foshan Yiying Hygiene Products Co., LtdDrugsCDER
Oct 9, 2025Taizhou Kangping Medical Science And Technology Co., Ltd.DrugsCDER
Oct 2, 2025Contec Medical Systems Co., Ltd.DevicesCDRH
Sep 30, 2025Guangxi Yulin Pharmaceutical Group Co. Ltd.DrugsCDER
Sep 12, 2025Chengdu Brilliant Biopharmaceutical Co., Ltd.DrugsCDER
Sep 9, 2025YANGZHOU YULOU PAPER PRODUCTS CO., LTDDrugsCDER

Showing the latest 25 of 381.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices
Oct 22, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices
Oct 22, 2026EKAI ELECTRONIC TECHNOLOGY CO LTDrugs and Biologics
Oct 22, 2026Ningbo J&S Botanics Inc.Human Foods
Oct 22, 2026HASCO VISION TECHNOLOGY CO., LTD.Radiological Health
Oct 22, 2026BOTU LONGSHENG FRUIT CO LTDHuman Foods
Oct 22, 2026QINGDAO MAGIC FALSE EYELASHES CO., LTD.Cosmetics
Oct 22, 2026QINGDAO MAGIC FALSE EYELASHES CO., LTD.Cosmetics
Oct 22, 2026Qingdao Magefy False Eyelash Co., Ltd.Cosmetics
Oct 21, 2026Guoduo Food Science And Technology (Hainan)Human Foods
Oct 21, 2026Taizhou Xinkang Medical Materials Co., Ltd.Devices
Oct 21, 2026BIO BOTANICAL CO LTDHuman Foods
Oct 19, 2026Nanjing Chengong Pharmaceutical Co., Ltd.Drugs and Biologics
Oct 19, 2026Lishui Baixing Mushrooms Co., Ltd.Human Foods
Oct 19, 2026DASENLIN FOOD CO., LTDHuman Foods
Oct 19, 2026DASENLIN FOOD CO., LTDHuman Foods
Oct 16, 2026DONGGUAN ZHENGYUAN PACKAGING MATDevices
Oct 16, 2026Yantai Fubao Foodstuffs Co.Ltd.Human Foods
Oct 16, 2026Hefei Donghetai Pharmaceutical Technology Co., LtdDrugs and Biologics
Oct 16, 2026Bioland Technology Ltd.Devices
Oct 15, 2026Jiangsu Caina Medical Co., LtdDevices
Oct 15, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices
Oct 15, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices
Oct 15, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices
Oct 15, 2026GUANGZHOU EKAI ELECTRONIC TECHNODevices

Showing the latest 25 of 55,164.

See every import refusal from China.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 6, 2026WUHAN HJZ LASER TECHNOLOGY CO95-05red
Nov 5, 2026Foshan Gaoming Huaguanying Import And Export99-42red
Nov 2, 2026Guangdong Gourmet Aquatic Products Co., Ltd.16-124red
Oct 29, 2026JINAN CONSURE ELECTRONIC TECHNOLOGY CO LTD95-05red
Oct 29, 2026Zhejiang Ushas Cosmetics Co., Ltd.53-06red
Oct 23, 2026Hefei Yili Dairy Co., Ltd45-06red
Oct 23, 2026ZHONGSHAN POURINGLIGHT TECHNOLOGY CO., LTD95-05red
Oct 22, 2026Chaohu Daxin Foodstuffs Co., Ltd.16-120red
Oct 22, 2026Guangdong Xinzi Beauty Cosmetics Co., Ltd.53-06red
Oct 22, 2026Liaoning Taihong Biotechnology Co., Ltd.16-120red
Oct 22, 2026Wuhan Juyang Technology Co., Ltd.95-05red
Oct 20, 2026An Yuan County Tian Hua Modern Faromg Co., Ltd.99-35red
Oct 20, 2026Jinzhong Yili Dairy Co., Ltd.45-06red
Oct 9, 2026GUANGDONG NONGFU VILLAS FOODSTUFF INDUSTRY CO., LTD.99-45red
Oct 9, 2026Shantou North Moon Biotechnology Co., Ltd.66-41red
Oct 7, 2026CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD.89-08red
Oct 7, 2026DEMARK (WUHAN) TECHNOLOGY CO., LTD95-05red
Oct 2, 2026QINGDAO MEKTEX ELECTRONIC TECHNOLOGY CO., LTD95-05red
Oct 1, 2026Nanjing Chengong Pharmaceutical Co., Ltd.66-40red
Oct 1, 2026NINGBO CHENGMEI MEDICAL PRODUCTSCO., LTD66-41red
Sep 30, 2026Shandong Runxin Biotechnology Co., Ltd.68-19red
Sep 30, 2026Shangqiu Yuxin Tools Co., Ltd95-05red
Sep 30, 2026Shenzhen Benliju Bio-Tech Co., Ltd.66-40red
Sep 29, 2026Anhui Province, Lu'an City Hongyuan Food Co., Ltd.16-120red
Sep 28, 2026Qingdao Magefy False Eyelash Co., Ltd.53-21red

Showing the latest 25 of 3,212.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Zhejiang Hisun Pharmaceutical Co., Ltd.Taizhou121Jun 21, 2024
Zhejiang Huahai Pharmaceutical Co., Ltd.Linhai83Apr 24, 2026
Jianerkang Medical Co., LtdChangzhou81May 22, 2025
CSPC Ouyi Pharmaceutical Co., Ltd.Shijiazhuang80Sep 5, 2024
Ningxia Qiyuan Pharmaceutical Co., Ltd.Yinchuan70Sep 12, 2025
Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical FactoryXinchang71Mar 7, 2025
Hisun Pharmaceutical Hangzhou Co., LtdHangzhou71Mar 26, 2024
Changzhou Pharmaceutical FactoryChangzhou70Jan 12, 2024
Winiadaewoo Microwave Oven (Tianjin) Co., Ltd.Dagang71Jun 6, 2019
Bath Concepts Cosmetics (Dongguan) Co., Ltd.Dongguan60Aug 13, 2026
Shandong Anxin Pharmaceutical Co., Ltd.Jinan60Jul 16, 2026
Shandong Lukang Shelile Pharmaceutical Co., Ltd.Jining60Apr 30, 2026
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site)Lianyungang60Apr 15, 2026
Yantai Dongcheng Biochemicals Co., Ltd.Yantai60Dec 11, 2025
Changzhou Qianhong Biopharma Co., Ltd.Changzhou60Oct 31, 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.