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FDA Inspections, Warning Letters and Import Refusals: Vietnam

FDA has recorded 551 inspections of firms in Vietnam, 23 of them (4.2%) classified OAI. It has issued 19 warning letters to firms there and refused 8,493 import shipments. 503 firms in Vietnam 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.

Vietnam: FDA inspections per year 2017: 82 inspections8220172018: 66 inspections6620182019: 58 inspections5820192020: 36 inspections3620202021: 0 inspections020212022: 2 inspections220222023: 51 inspections5120232024: 37 inspections3720242025: 13 inspections1320252026: 40 inspections402026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20264012.5%1323
20251317.7%0349
20243738.1%4302
20235123.9%2295
20222150.0%0275
2021000288
20203600.0%0149
20195800.0%1293
20186611.5%0283
20178233.7%3279

Latest OAI inspections

DateFacilityProduct type
Apr 14, 2026Rohto-Mentholatum (Vietnam) Co., Ltd.Drugs
Aug 14, 2025SEN WILD AND FARMED FOOD JOINT STOCK COMPANYFood/Cosmetics
Oct 14, 2024NOSAFOOD JOINT STOCK COMPANY - BEN LUC BRANCHFood/Cosmetics
Oct 8, 2024CHAUGIAFOOD TRADING PRODUCTION CO.,LTDFood/Cosmetics
Jul 9, 2024Duong Ha Processing Trading Seafood Company LimitedFood/Cosmetics
Dec 21, 2023YAHON ENTERPRISE CO., LTDDrugs
Dec 12, 2023Golden Shrimp Seafood Joint Stock CompanyFood/Cosmetics
Sep 22, 2022Wu's Tech (Vietnam) Co., Ltd.Devices
Jan 19, 2018Dona Newtower Natural Drink And Food Joint Stock CompanyFood/Cosmetics
Jun 27, 2017Thang Loi Frozen Food EnterpriseFood/Cosmetics
May 19, 2017Nam Long Seafood Export Processing FactoryFood/Cosmetics
Apr 27, 2017Duy Thao Co., Ltd.Food/Cosmetics
Sep 14, 2016Co So San Xuat Keo Yen NhungFood/Cosmetics
Sep 6, 2016Thanh Ha Fish Sauce Co.Food/Cosmetics
May 19, 2016Asahi Intecc Hanoi Co., Ltd.Devices
Jun 5, 2015THANH HUNG LONG PRODUCTION CO.Food/Cosmetics
Jun 2, 2015BaRia-VungTau Seafood Processing & Import- Export J.S.C.Food/Cosmetics
Apr 22, 2014Minh Anh Co., LtdFood/Cosmetics
Apr 11, 2014Hung Loi Manufacturing And Trading Co. Ltd.Food/Cosmetics
Apr 8, 2014D & N Foods Processing Co., LTD.Food/Cosmetics
Mar 30, 2014West Food Processing Export Joint Stock CompanyFood/Cosmetics
May 15, 2012Rohto-Mentholatum (Vietnam) Co., Ltd.Drugs
Sep 23, 2010KIEN LONG COMPANYFood/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Oct 14, 2026Rohto-Mentholatum (Vietnam) Co., Ltd.DrugsCDER
Nov 26, 2024Duong Ha Processing Trading Seafood Company LimitedFood/CosmeticsCFSAN
Jun 5, 2024YAHON ENTERPRISE CO., LTDDrugsCDER
May 16, 2024Golden Shrimp Seafood Joint Stock CompanyFood/CosmeticsCFSAN
Apr 2, 2024Thuan Thien Producing Trading Limited CompanyFood/CosmeticsCFSAN
Nov 16, 2023WIPRO CONSUMER CARE VIETNAM CO., LTDDrugsCDER
Nov 3, 2023Trang Thuy Seafood Company LimitedFood/CosmeticsCFSAN
Apr 29, 2019Matxi S.G.DrugsCDER
Nov 16, 2017Thang Loi Frozen Food EnterpriseFood/CosmeticsCFSAN
Mar 21, 2017BA HAI Joint Stock CompanyFood/CosmeticsCFSAN
Feb 28, 2017Thanh Ha Fish Sauce Co.Food/CosmeticsCFSAN
Nov 24, 2014CJ CAUTRE FOODS JOINT STOCK COMPANY BRANCH LONG ANFood/CosmeticsCFSAN
Oct 16, 2014D & N Foods Processing Co., LTD.Food/CosmeticsCFSAN
Oct 2, 2014West Food Processing Export Joint Stock CompanyFood/CosmeticsCFSAN
Jun 11, 2014MANI HANOI CO. LTDDevicesCDRH
Nov 15, 2013Hong Ngoc PTEFood/CosmeticsCFSAN
Aug 8, 2012Www.Vietnamtobacco.ComTobaccoCTP
Jun 18, 2012Hai Nam Co., Ltd.Food/CosmeticsCFSAN
Mar 30, 2009Dragon Waves Frozen Food Factory Company LimitedFood/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026DAVID HELATH VIETNAM JOINT STOCKHuman Foods
Oct 22, 2026FPT LONG CHAU PHARMA JOINT STOCKHuman Foods
Oct 21, 2026(JLVN) JD Vietnam Investment Company LIMIDevices
Oct 21, 2026(JLVN) JD Vietnam Investment Company LIMIDevices
Oct 21, 2026(JLVN) JD Vietnam Investment Company LIMIDevices
Oct 21, 2026(JLVN) JD Vietnam Investment Company LIMIDevices
Oct 21, 2026(JLVN) JD Vietnam Investment Company LIMIDevices
Oct 21, 2026LAAN BUSINESS HOUSEHOLDHuman Foods
Oct 14, 2026AN KHANG FOODHuman Foods
Oct 9, 2026UnknownDevices
Oct 9, 2026Vinahankook Medical Supplies Co. Ltd.Devices
Oct 9, 2026Lucky Shing Company LtdHuman Foods
Oct 7, 2026HASAKI BEAUTYCosmetics
Oct 7, 2026Emdees Foods Limited Liability CompanyHuman Foods
Oct 6, 2026SOFT GRASS NATURAL COSMETICS JSCCosmetics
Oct 2, 2026MINJYNCosmetics
Oct 2, 2026CHIAKI TRADING JSCCosmetics
Oct 2, 2026HASAKI BEAUTY & CLINIC JSCCosmetics
Oct 2, 2026TRAN THI THU HIENCosmetics
Oct 1, 2026GALLANT OCEAN (VIET NAM) ., JSCHuman Foods
Oct 1, 2026GALLANT OCEAN (VIET NAM) ., JSCHuman Foods
Oct 1, 2026GALLANT OCEAN (VIET NAM) ., JSCHuman Foods
Oct 1, 2026TRUONG DATHuman Foods
Sep 30, 2026Song Tran Import And Export Co., LtdHuman Foods
Sep 25, 2026Tan Do Refreshing WaterHuman Foods

Showing the latest 25 of 8,493.

See every import refusal from Vietnam.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 10, 2026Long Uyen Company Limited - Branch99-08red
Nov 10, 2026Special Aquatic Products Joint Stock Company - Seafood Processing Factory - Business Location16-124red
Nov 5, 2026Tan Thanh Loi Frozen Food Co., Ltd.16-125red
Oct 29, 2026PHI LONG FOOD MANUFACTORY CO.,99-39red
Oct 29, 2026Southern Fresh Foods Co., Ltd16-81red
Oct 29, 2026SOUTHERN FRESH FOODS CO LTD16-81red
Oct 27, 2026FrieslandCampina Vietnam Company Limited99-38red
Oct 27, 2026HAPPY SUN FOOD JOINT STOCK COMPANY16-81red
Oct 23, 2026CO NAM FOOD PRODUCTION CO.,LTD99-08red
Oct 16, 2026QUYNH ANH AQUATIC PRODUCT IMPORT EXPORT BUSINESS COMPANY LIMITED16-124red
Sep 30, 2026Trung Vy Phat Limited Company16-81red
Sep 29, 2026THE LIGHT SEAFOOD COMPANY16-124red
Sep 28, 2026Agrimexco99-53red
Sep 28, 2026Lucky Shing Company Ltd99-53red
Sep 28, 2026Vinamit Jsc99-53red
Sep 28, 2026Vinamit JSC99-53red
Sep 16, 2026Vinamit Jsc31-03red
Sep 16, 2026Vinamit JSC31-03red
Sep 15, 2026GALLANT OCEAN (VIET NAM) ., JSC16-129red
Aug 24, 2026Emdees Foods Limited Liability Company16-138red
Aug 13, 2026Rohto-Mentholatum (Vietnam) Co., Ltd.66-40red
Jul 31, 2026Ho Chi Minh City Branch - Phuc Hau Import Export Trading Company Ltd.16-120red
Jul 28, 2026PHUOC PHUC VINH IMPORT EXPORT TRADING COMPANY LIMITED99-08red
Jul 27, 2026Tan Thanh Loi Frozen Food Co., Ltd.16-119red
Jul 6, 2026(JLVN) JD Vietnam Investment Company LIMI99-34red

Showing the latest 25 of 503.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Rohto-Mentholatum (Vietnam) Co., Ltd.Ho Chi Minh52Apr 14, 2026
Hoang Phong Seafood Factory - Branch Of Utxi Aquatic Products Processing CorporationCan Tho City30Mar 19, 2026
Thuan Thien Producing Trading Limited CompanyLong An City30Sep 8, 2023
West Food Processing Export Joint Stock CompanyCan Tho City31Sep 5, 2023
Dragon Waves Frozen Food Factory Company LimitedCam Lam30Jul 13, 2023
D & N Foods Processing Co., LTD.Danang31May 9, 2023
Hung Phat Tea CorporationHo Chi Minh30Feb 5, 2020
Hua Heong Food Industries (Vietnam) CO., LtdHo Chi Minh30Oct 14, 2019
CJ CAUTRE FOODS JOINT STOCK COMPANY BRANCH LONG ANHo Chi Minh City,30Apr 16, 2018
Trang Thuy Seafood Company LimitedBinh Kien Ward20Aug 4, 2026
BRANCH OF OLAM VIETNAM LIMITED IN BIEN HOA II INDUSTRIAL ZONETran Bien Ward20Jun 5, 2026
BA HAI Joint Stock CompanyDong Hoa Town20May 9, 2025
Terumo BCT Vietnam Co. Ltd.Tinh Dong Thap20Apr 5, 2024
Nha Trang Bay JSCCam Lam20Dec 8, 2023
BASEAFOOD HOCHIMINH BRANCHHOCHIMINH CITY20Sep 22, 2023

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.