ImportRefusal LogoImportRefusal

Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/23/2025WOOLTARI KOREA

Seoul

SOUTH KOREDIETARY CONVENTIONAL FOODS, N.E.C.
2300DIETARYLBL
320LACKS FIRM
+3 more
9/23/2025Mega Marine Pride

Pasuruan

INDONESIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2040SULFITELBL
9/23/2025HANSBIOMED CORP

Seongpa

SOUTH KOREFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR)
508NO 510(K)
9/23/2025Hekma Center Ltd.

Ar'Ara

ISRAELVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
9/23/2025Hekma Center Ltd.

Ar'Ara

ISRAELVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
9/23/2025Hekma Center Ltd.

Ar'Ara

ISRAELVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
9/23/2025Hekma Center Ltd.

Ar'Ara

ISRAELVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
9/23/2025Ortho Solutions Sdn. Bhd.

Prai

MALAYSIAORTHOPEDIC MANUAL SURGICAL INSTRUMENT
341REGISTERED
9/23/2025LABORATORIOS NUTRIMED

Ciudad De Mexico

MEXICODIETARY CONVENTIONAL FOODS, N.E.C.
324NO ENGLISH
3864NCONTACT
+2 more
9/23/2025LABORATORIOS NUTRIMED

Ciudad De Mexico

MEXICODIETARY CONVENTIONAL FOODS, N.E.C.
324NO ENGLISH
3864NCONTACT
+2 more
9/23/2025LABORATORIOS DE FUERZA DE LA SALUD S.A DE CV

Distrito Federal

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
324NO ENGLISH
3864NCONTACT
+1 more
9/23/2025LABORATORIOS DE FUERZA DE LA SALUD S.A DE CV

Distrito Federal

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
324NO ENGLISH
3864NCONTACT
+1 more
9/23/2025PT. Bahari Makmur Sejati

Serang

INDONESIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
308MFR INSAN
3821MFR INJ
9/23/2025PT. Bahari Makmur Sejati

Serang

INDONESIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
308MFR INSAN
3821MFR INJ
9/23/2025PT. Bahari Makmur Sejati

Serang

INDONESIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
308MFR INSAN
3821MFR INJ
9/23/2025Innovative Cuisine Pvt Ltd

VADODARA

INDIAMIXED VEGETABLES, N.E.C.
308MFR INSAN
3821MFR INJ
9/23/2025Innovative Cuisine Pvt Ltd

VADODARA

INDIAMIXED VEGETABLES, N.E.C.
308MFR INSAN
3821MFR INJ
9/23/2025Innovative Cuisine Pvt Ltd

VADODARA

INDIACLUSTER BEAN, BEAN AND PEA SPROUTS
308MFR INSAN
3821MFR INJ
9/23/2025REGENT FOODS CORPORATION

Metro Manila

PHILIPPINEBISCUITS
274COLOR LBLG
9/23/2025Hipp GmbH & CO Vertrieb KG

Pfaffenhofen A.d.ilm

GERMANYMILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA
260FALSE
9/23/2025GUANGZHOU NEW HENGDA IMPORT ANDEXPORT TRADING CO

Guangzhou

CHINAPOTATO SNACKS (FLAVORED OR UNFLAVORED), VEGETABLE SNACKS (OTHER THAN PULSES) BAKED
251POISONOUS
3421MELAMINE
+1 more
9/23/2025Desai Foods Private Limited

Pune

INDIATAMARIND, DRIED OR PASTE
249FILTHY
9/23/2025Touton Negoce Cote D'Ivoire

Abidjan

IVORY COASCOCOA BEAN N.E.C.
249FILTHY
9/23/2025Innovative Cuisine Pvt Ltd

VADODARA

INDIACLUSTER BEAN, BEAN AND PEA SPROUTS
241PESTICIDE
9SALMONELLA
9/23/2025Special Fruit & Vegetable Export, S.A. (dba Planesa, S.A.)

Guatemala

GUATEMALASUGAR SNAP PEAS
241PESTICIDE
9/23/2025WOOLTARI KOREA

Seoul

SOUTH KOREFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
218LIST INGRE
2300DIETARYLBL
+5 more
9/23/2025Kendal Nutricare Ltd.

Kendal

UNITED KINTODDLER MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULA
218LIST INGRE
321LACKS N/C
+2 more
9/23/2025COMRON CORPORATION

Kyoto

JAPANSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025WUXI XINDI MEDICAL TECHNOLOGY CO., LTD

Wuxi

CHINASPONGE, GAUZE
118NOT LISTED
3280FRNMFGREG
+2 more
9/23/2025AVISH JAISWAR

Mumbai

INDIAENDOSCOPE, TRANSCERVICAL (AMNIOSCOPE)(AND ACCESSORIES)
118NOT LISTED
3280FRNMFGREG
+2 more
9/23/2025CASNDA*TRADING*CO.*LIMITED

Hong Kong

HONG KONGHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/20253M Espe Dental Products

Irvine

UNITED STAMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025Guilin Woodpecker Medical Instrument Co., Ltd.

Guilin

CHINAUNIT, X-RAY, EXTRAORAL WITH TIMER
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025B-K Medical A/S

Herlev

DENMARKSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025OTSUKA PHARMACEUTICAL CO LTD

Minato

JAPANEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025Almirall

Barcelona

SPAINTILDRAKIZUMAB-ASMN
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025MALLOR BIOMEDICAL

San Giovanni In Marignano

ITALYEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
9/23/2025Cynosure, LLC

Westford

UNITED STAPOWERED LASER SURGICAL INSTRUMENTS
118NOT LISTED
3280FRNMFGREG
+2 more
9/23/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3280FRNMFGREG
9/23/2025Huaian Angel Medical Instrument Co., Ltd.

Huaian

CHINASINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
118NOT LISTED
3280FRNMFGREG
9/23/2025NAOS SKIN CARE INDIA PVT LTD

Thane

INDIAULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3280FRNMFGREG
9/23/2025MERZ PHARMA

Hemel Hempstead

UNITED KINIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
3280FRNMFGREG
9/23/2025DERMAKOR

Incheon

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
9/23/2025COSMODERMA

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
9/23/2025DERMAKOR

Incheon

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
9/23/2025Nature Intro Co., Ltd.

Namdong

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
9/23/2025ACROSS CO. LTD

Gwangwon

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
9/23/2025Sears Bio Co

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
9/23/2025ALLERGAN

Koeln

GERMANYLIDOCAINE
118NOT LISTED
9/23/2025ALLERGAN

Koeln

GERMANYLIDOCAINE
118NOT LISTED

About This Page

This page displays 50 FDA import refusal records from 19 countries. Records on this page involve violations including 2300 (DIETARYLBL), 320 (LACKS FIRM), 321 (LACKS N/C), 324 (NO ENGLISH), 482 (NUTRIT LBL) and 22 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 255 of 10,077 • Showing records 12,701-12,750 of 503,850 total