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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/18/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOTOBACCO

Sokolow

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOTOBACCO

Sokolow

POLANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOBROS OU

Tallinn

ESTONIANICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOPODS EHF

Sudurnesjabar

ICELANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025NICOPODS EHF

Sudurnesjabar

ICELANDNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/18/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/18/2025Delarange Cosmetics BV

Zeewolde

NETHERLANDUNIT, LIQUID-OXYGEN, PORTABLE
3280FRNMFGREG
508NO 510(K)
12/18/2025THE BEAUTY TECH GROUP

Manchester

UNITED KINLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
3280FRNMFGREG
508NO 510(K)
12/18/2025NESTLE NIGERIA

Ilupeju

NIGERIASPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C.
482NUTRIT LBL
12/18/2025LABIALFARMA SA

Ovoa

PORTUGALCHOLINE (MINERAL)
482NUTRIT LBL
12/18/2025Grupo Industrial Maseca S.A.B. De C.V.

San Pedro Garza Garcia

MEXICOCORN, BOLTED MEAL OR FLOUR
324NO ENGLISH
12/18/2025ZIDADU TRADING

Kibirizi

TANZANIAFISH, HOT SMOKED N.E.C.
308MFR INSAN
328USUAL NAME
12/18/2025ZIDADU TRADING

Kibirizi

TANZANIATILAPIA, HOT SMOKED, FISH
308MFR INSAN
12/18/2025ZIDADU TRADING

Kibirizi

TANZANIAOCEAN PERCH (RED PERCH, PACIFIC PERCH, REDFISH), HOT SMOKED, FISH
308MFR INSAN
12/18/2025ZIDADU TRADING

Kibirizi

TANZANIAHERRING
308MFR INSAN
12/18/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
260FALSE
274COLOR LBLG
+1 more
12/18/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
260FALSE
12/18/2025LABIALFARMA SA

Ovoa

PORTUGALVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
12/18/2025LABIALFARMA SA

Ovoa

PORTUGALCHOLINE (MINERAL)
260FALSE
12/18/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALHERBALS & BOTANICALS (NOT TEAS), N.E.C.
260FALSE
12/18/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALHERBALS & BOTANICALS (NOT TEAS), N.E.C.
260FALSE
12/18/2025SWEET BEE FARM CO.

BANGKOK

THAILANDTAMARIND (SUBTROPICAL/TROPICAL FRUIT PULP)
249FILTHY
12/18/2025SHREE URJAA FOODS

Pardi

INDIACANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
12/18/2025SERGIO SOLIS FLORES

Acatzingo

MEXICOPRICKLE PEAR (CORE FRUIT)
241PESTICIDE
12/18/2025MAOMING HONGYE AQUATIC PRODUCTS CO., LTD.

Huazhou

CHINATILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
241PESTICIDE
12/18/2025MAOMING HONGYE AQUATIC PRODUCTS CO., LTD.

Huazhou

CHINATILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
241PESTICIDE
12/18/2025Vision Science Co., Ltd.

Dong

SOUTH KORELENSES, SOFT CONTACT, DAILY WEAR
237NO PMA
12/18/2025DIMALASH AND DIMALENS

Dubai

UNITED ARALENSES, SOFT CONTACT, DAILY WEAR
237NO PMA
12/18/2025Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
12/18/2025Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
12/18/2025Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
12/18/2025Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
12/18/2025DREAM COSMETICS

Abigian

IVORY COASLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025EXCELLENT HI-CARE

Tamil Nadu

INDIAEXTENDED RANGE OF VISION INTRAOCULAR LENS
118NOT LISTED
3280FRNMFGREG
+2 more
12/18/2025SPECTRUM LIFE SCIENCES PVT LTD.

Hyderabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Fit For Life

Samut Prakan

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025JUVENOR IMPEX

Nagpur

INDIAFENBENDAZOLE (ANTHELMINTIC)
118NOT LISTED
3280FRNMFGREG
+1 more
12/18/2025Lactona Europe

Bergen Op Zoom

NETHERLANDTOOTHBRUSH, MANUAL
118NOT LISTED
3280FRNMFGREG
12/18/2025Lactona Europe

Bergen Op Zoom

NETHERLANDDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
118NOT LISTED
3280FRNMFGREG
12/18/2025Roche Diagnostics GmbH

Mannheim

GERMANYINVESTIGATIONAL USE ONLY - IMMUNOLOGY
118NOT LISTED
508NO 510(K)

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 3842 (TP NO PMTA), 3843 (TP NO SE), 3280 (FRNMFGREG), 508 (NO 510(K)), 482 (NUTRIT LBL) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 13 of 10,038 • Showing records 601-650 of 501,854 total