FDA Inspections, Warning Letters and Import Refusals: Hong Kong
FDA has recorded 0 inspections of firms in Hong Kong, 0 of them (0%) classified OAI. It has issued 21 warning letters to firms there and refused 5,923 import shipments. 315 firms in Hong Kong 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.
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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.
Hong Kong: FDA import refusals per year
2017: 167 import refusals 167 2017 2018: 109 import refusals 109 2018 2019: 99 import refusals 99 2019 2020: 216 import refusals 216 2020 2021: 188 import refusals 188 2021 2022: 175 import refusals 175 2022 2023: 123 import refusals 123 2023 2024: 127 import refusals 127 2024 2025: 229 import refusals 229 2025 2026: 91 import refusals 91 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 0 0 2 91 2025 0 0 0 229 2024 0 0 0 127 2023 0 0 0 123 2022 0 0 1 175 2021 0 0 0 188 2020 0 0 5 216 2019 0 0 0 99 2018 0 0 4 109 2017 0 0 0 167
Latest OAI inspections
No OAI inspections are recorded for firms in Hong Kong.
Latest warning letters
Date Firm Product type FDA center
Oct 8, 2026 Yemao Company Limited Tobacco CTP Jun 17, 2026 Mantro Force Drugs CDER Nov 16, 2022 Wizman Limited Tobacco CTP Jun 29, 2020 Epro E-Commerce Limited Devices CDRH Jun 26, 2020 Loyal Great International Ltd. Drugs CDER Jun 10, 2020 Medakit Ltd Devices CDRH May 28, 2020 Cigabuy Tobacco CTP Apr 27, 2020 Wizman Limited Tobacco CTP Jul 26, 2018 SK VAPE TECHNOLOGY CO LTD Tobacco CTP Apr 6, 2018 Luen Wah (HK) Medicine Ltd Drugs CDER Feb 23, 2018 Nan San (HK) Pharmaceutical Factory Ltd. Drugs CDER Jan 11, 2018 Wong Lap Kwong Medicine Company Limited Drugs CDER Dec 15, 2015 Chan Yat Hing Medicine Factory Drugs CDER Jul 23, 2015 Www.200Cigs.Net Tobacco CTP Jun 17, 2015 Www.200Cigsonline.Com Tobacco CTP Sep 23, 2014 Mayfair Medical Supplies Ltd Devices CDRH Jan 31, 2014 CBSCHEM LIMITED Drugs CDER Jul 1, 2013 Chan Yee Jai Food/Cosmetics CFSAN Mar 25, 2013 Peking Medicine Manufactory Drugs CDER Apr 5, 2012 Peking Medicine Manufactory Drugs CDER Nov 17, 2009 Orion Star & Associates Inc. Drugs CDER
Search every letter by company with the FDA warning letter search .
Latest import refusals
Date Firm Product category
Oct 9, 2026 WAH TAI GINSENG TRADING LIMITED Human Foods Sep 11, 2026 Yuen Tai Seafood Co., Human Foods Sep 11, 2026 WINZONE ELECTRONIC TECHNOLOGY LTD Radiological Health Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Sep 2, 2026 SOL-MILLENNIUM HK Devices Aug 31, 2026 EAGLES EQUIPMENT INDUSTRIAL LTD Devices Aug 28, 2026 SK SEAFOOD LIMTED Human Foods Aug 26, 2026 SAITY CORP LIMITED-HD Devices Aug 25, 2026 AMO ASIA LIMITED Devices
Showing the latest 25 of 5,923.
Firms on FDA import alerts
Published Firm Import alert List
Sep 25, 2026 LUEN HOP PHARMACEUTICAL COMPANY 66-41 red Jan 9, 2026 Gui Nan Hong Company Limited 99-39 red Aug 6, 2025 DONGGUAN HONGHE METAL PRODUCTS 89-08 red Jul 24, 2025 Gui Nan Hong Company Limited 99-19 red Jul 23, 2025 Gui Nan Hong Company Limited 99-21 red Jun 30, 2025 FOSUN TRADING (HK) COMPANY LIMITED 89-08 red Jun 6, 2025 Well Packed Gifts Ltd 99-45 red Jun 5, 2025 Smith & Smith Co Ltd 99-45 red Jun 4, 2025 Polyfect Toys Company Litmited 99-45 red May 27, 2025 Kinwa Limited 99-45 red May 21, 2025 Eisenberg & Co., HK LTD 99-45 red May 21, 2025 Free Yon Tranding Company 99-45 red May 20, 2025 Champion Industrial Company 99-45 red May 13, 2025 Wei Wei Trading Co 99-45 red May 13, 2025 YUEN TAT TRADING COMPANY 99-45 red May 12, 2025 HONGKONG TIANBAO FOOD CO.,LIMITED 99-45 red May 12, 2025 Lam Sheng Kee (HK) International Limited. 99-45 red May 1, 2025 Wei Wei Trading Co 99-39 red Mar 31, 2025 Atico International Ltd. 71-04 red Dec 5, 2024 INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED 89-08 red Oct 4, 2024 Kamlord Co, 85-02 red Sep 27, 2024 Eu Yan Sang (Hong Kong) Ltd. 99-39 red Feb 29, 2024 PANG LI TRADING CO 99-08 red Feb 27, 2024 INTCO MEDICAL INTERNATIONAL (HONG KONG) CO LTD 89-08 red Feb 26, 2024 Chiu Kee Trading Co 99-08 red
Showing the latest 25 of 315.
Most-inspected facilities
No inspected facilities are recorded in Hong Kong.
See each facility's Form 483 observations with the FDA 483 search .