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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
5/2/2025INTERVASCULAR, SAS

La Ciotat Cedex

FRANCEGRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
3280FRNMFGREG
341REGISTERED
5/2/20253M Espe Dental Products

Saint Paul

UNITED STACEMENT, DENTAL
3280FRNMFGREG
5/2/20253M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, TOOTH SHADE, RESIN
3280FRNMFGREG
5/2/20253M Espe Dental Products

Saint Paul

UNITED STAAGENT, TOOTH BONDING, RESIN
3280FRNMFGREG
5/2/20253M Deutschland GmbH

Seefeld

GERMANYCEMENT, DENTAL
3280FRNMFGREG
5/2/20253M Espe Dental Products

Irvine

UNITED STAMATERIAL, TOOTH SHADE, RESIN
3280FRNMFGREG
5/2/2025EDWARDS LIFESCIENCES JAPAN LLC

Shinjuku

JAPANTISSUE, HEART-VALVE
3280FRNMFGREG
5/2/2025Apex Foods

Chittagong

BANGLADESHSHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
3220NITROFURAN
5/2/2025QINGDAO HIGHTOP BIOTECH CO., LTD.

Qingdao

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
508NO 510(K)
5/2/2025Teleflex Medical Sdn. Bhd.

Kamunting

MALAYSIACATHETER, RETENTION TYPE, BALLOON
479DV QUALITY
5/2/2025SHANDONG PETSENSE FOOD CO LTD

Shandong

CHINAPOULTRY PROD PET CAT FOOD
324NO ENGLISH
5/2/2025Hipp GmbH & CO Vertrieb KG

Pfaffenhofen A.d.ilm

GERMANYMILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
321LACKS N/C
324NO ENGLISH
5/2/2025E.M.B YARDEN AGRICULTURAL FARM LTD

Beit Shemesh

ISRAELDIETARY CONVENTIONAL FOODS, N.E.C.
308MFR INSAN
75UNAPPROVED
5/2/2025HOANG HUY DEVELOPMENT AND INVESTMENT TRADING COMPANY LIMITED

Ha Noi

VIETNAMEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
260FALSE
336INCONSPICU
+1 more
5/2/2025YUNNAN HENGCHEN TRADING CO LTD

Kunming

CHINAPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
251POISONOUS
3421MELAMINE
+1 more
5/2/2025YUNNAN HENGCHEN TRADING CO LTD

Kunming

CHINABISCUITS
251POISONOUS
3421MELAMINE
+1 more
5/2/2025Popat Raja & Sons

Mumbai

INDIATAMARIND, DRIED OR PASTE
249FILTHY
5/2/2025JACOB PETERS FRIESSEN

Buenaventura

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
5/2/2025GUANGZHOU NEW HENGDA IMPORT ANDEXPORT TRADING CO

Guangzhou

CHINACHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE
249FILTHY
5/2/2025GUANGZHOU NEW HENGDA IMPORT ANDEXPORT TRADING CO

Guangzhou

CHINACHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA), DRIED OR PASTE
249FILTHY
5/2/2025Jacobo Hiebert Wall

Pueblo Ley Seis De Enero (Ojos Altos)

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
5/2/2025Jacobo Hiebert Wall

Pueblo Ley Seis De Enero (Ojos Altos)

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
5/2/2025Special Fruit & Vegetable Export, S.A. (dba Planesa, S.A.)

Guatemala

GUATEMALASUGAR SNAP PEAS
241PESTICIDE
5/2/2025MBF PRINTING INDUSTRY SDN. BHD.

Puchong

MALAYSIACOPRA MEAL
241PESTICIDE
5/2/2025Exportadora Cruz Bautista

Las Cabuyas

DOMINICAN PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
241PESTICIDE
5/2/2025KOGTA IMPORT EXPORT PVT LTD

Jalgaon

INDIAMUNG BEAN
241PESTICIDE
5/2/2025EMBOTELLADORA JUMEX SA DE CV

Rancheria San Nicolas De Los Garza

MEXICOMANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
238UNSAFE ADD
324NO ENGLISH
+1 more
5/2/2025EMBOTELLADORA JUMEX SA DE CV

Rancheria San Nicolas De Los Garza

MEXICOMANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
238UNSAFE ADD
324NO ENGLISH
+1 more
5/2/2025Guangzhou Tea Star Food and Beverage Management Co., Ltd.

Guangzhou

CHINAPREPARED DRY COOKIE MIX WITH MILK OR EGG N.E.C.
238UNSAFE ADD
5/2/2025Guangzhou Tea Star Food and Beverage Management Co., Ltd.

Guangzhou

CHINAWHEY (DRIED)
238UNSAFE ADD
5/2/2025QINGDAO HIGHTOP BIOTECH CO., LTD.

Qingdao

CHINAREAGENT, CORONAVIRUS SEROLOGICAL
237NO PMA
5/2/2025Shanghai Conant Optics Co., Inc.

Shanghai

CHINALENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
231LENS CERT
341REGISTERED
5/2/2025GUANGZHOU KONMISON

Guangzhou

CHINAMASSAGER, THERAPEUTIC, ELECTRIC
223FALSE
3280FRNMFGREG
+3 more
5/2/2025MR SANICOM GMBH

Munich

GERMANYCOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025Roche Diagnostics GmbH

Mannheim

GERMANYSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025Roche Diagnostics GmbH

Mannheim

GERMANYSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025Becton Dickinson & Company

Franklin Lakes

UNITED STANEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025Becton Dickinson & Company

Franklin Lakes

UNITED STANEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025JOHN SEANNER

Saint-Jerome

CANADASPIROMETER, DIAGNOSTIC
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025LISA YANG

Hongkong

HONG KONGVIBRATOR FOR THERAPEUTIC USE, GENITAL
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025FOSHAN ZIKE

Shenzhen

CHINAMASSAGER, THERAPEUTIC, MANUAL
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025BRILLIANT LABS

Sacramento

UNITED STALENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025SPINEVISION SAS

Antony

FRANCEORTHOSIS, SPINAL INTERVERTEBRAL FUSION
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025MUNCH BABY INC. / MALARKEY KIDS

Burlington

CANADARING, TEETHING, NON-FLUID FILLED
118NOT LISTED
3280FRNMFGREG
+1 more
5/2/2025NUEVOTEK INTELLIGENT SOLUTIONS

North Vancouver

CANADATESTER, PULP
118NOT LISTED
3280FRNMFGREG
5/2/2025POSTNET - UMHLANGA VILLAGE

Umhlanga Rocks

SOUTH AFRICONDOM
118NOT LISTED
3280FRNMFGREG
5/2/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG
5/2/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG
5/2/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG
5/2/2025GUANGZHOU SHIYI TECHNOLOGY CO.,

Guangzhou

CHINAOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG

About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 3280 (FRNMFGREG), 341 (REGISTERED), 2860 (VETDRUGRES), 3220 (NITROFURAN), 508 (NO 510(K)) and 19 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 544 of 10,077 • Showing records 27,151-27,200 of 503,850 total