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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/13/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
6/13/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
6/13/2025WHITE INDUSTRIES AB

Taby

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
6/13/2025MICROZERO AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
6/13/2025WHITE INDUSTRIES AB

Taby

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
6/13/2025KELLY WHITE

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
6/13/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/13/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/13/2025Swedish Match Ab

Stockholm

DENMARKSNUS
3842TP NO PMTA
6/13/2025NICO TOBACCO

Warsaw

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
6/13/2025Haupt Pharma Wuelfing GmbH

Gronau (Leine)

GERMANYCESIUM CHLORIDE CS 131 (RADIOACTIVE AGENT)
3280FRNMFGREG
75UNAPPROVED
6/13/2025ELQUE VENTURES PRIVATE LIMITED

KOLKATA

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
2860VETDRUGRES
312FILTH
+2 more
6/13/2025Biofarma Spa

Mereto Di Tomba

ITALYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
6/13/2025Fine Foods & Pharmaceuticals N.T.M. S.P.A.

Verdellino

ITALYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
6/13/2025Fine Foods & Pharmaceuticals N.T.M. S.P.A.

Verdellino

ITALYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
6/13/2025MEDSHARE INTERNATIONAL INC

Decatur

UNITED STAGENERAL WELLNESS PRODUCT
508NO 510(K)
6/13/2025MEDSHARE INTERNATIONAL INC

Decatur

UNITED STAGENERAL WELLNESS PRODUCT
508NO 510(K)
6/13/2025Contec Medical Systems Co., Ltd.

Qinhuangdao

CHINAMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
508NO 510(K)
6/13/2025Germain Paul Export

Port-Au-Prince

HAITICORN STARCH
473LABELING
6/13/2025Boe Dominicana C X A

Santo Domingo De Guzman

DOMINICAN TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
6/13/2025MARDAV SOLUTIONS, LTD.

Manchester

UNITED KINTRANSFORMER, ENDOSCOPE
341REGISTERED
6/13/2025Contec Medical Systems Co., Ltd.

Qinhuangdao

CHINASMALL HOSPITAL PRACTICE EQUIPMENT, NEC (NONHUMAN)
336INCONSPICU
6/13/2025MONIQUEMOBI PTY LTD

Cape Town

SOUTH AFRITEA, N.E.C.
321LACKS N/C
324NO ENGLISH
+2 more
6/13/2025MONIQUEMOBI PTY LTD

Cape Town

SOUTH AFRISUGAR PRODUCTS, N.E.C.
321LACKS N/C
324NO ENGLISH
+2 more
6/13/2025MONIQUEMOBI PTY LTD

Cape Town

SOUTH AFRISUGAR PRODUCTS, N.E.C.
321LACKS N/C
324NO ENGLISH
+2 more
6/13/2025MONIQUEMOBI PTY LTD

Cape Town

SOUTH AFRIVEGETABLE (SINGLE INGREDIENT NOT MENTIONED ELSEWHERE) SOUP
321LACKS N/C
324NO ENGLISH
+2 more
6/13/2025MONIQUEMOBI PTY LTD

Cape Town

SOUTH AFRIBISCUITS
321LACKS N/C
324NO ENGLISH
+2 more
6/13/2025CHENGDU SNS BIOTECHNOLOGY CO.,LTD.

Chengdu

CHINASAUCES, N.E.C.
321LACKS N/C
62NEEDS FCE
+1 more
6/13/2025BERGFELD LASERTECH GMBH

Aachen

GERMANYLASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
278NO TAG
476NO REGISTR
6/13/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALCHOLINE (MINERAL)
260FALSE
6/13/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALCHOLINE (MINERAL)
260FALSE
6/13/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALCHOLINE (MINERAL)
260FALSE
6/13/2025ELQUE VENTURES PRIVATE LIMITED

KOLKATA

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
2860VETDRUGRES
+2 more
6/13/2025ELQUE VENTURES PRIVATE LIMITED

KOLKATA

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
2860VETDRUGRES
+2 more
6/13/2025ELQUE VENTURES PRIVATE LIMITED

KOLKATA

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
2860VETDRUGRES
+2 more
6/13/2025M/s Srikanthinternational Pvt Ltd

Kaikaluru Mandal - Khrisna District

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
9SALMONELLA
6/13/2025THANH MINH THANH COMPANY LIMITED

Thu Duc

VIETNAMTAMARIND, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
249FILTHY
6/13/2025Ambikafoods

Chennai

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
6/13/2025Ambikafoods

Chennai

INDIAOTHER BAKERY PRODUCTS, N.E.C.
249FILTHY
6/13/2025SPECTRUM LIFE SCIENCES PVT LTD.

Hyderabad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
249FILTHY
6/13/2025SPECTRUM LIFE SCIENCES PVT LTD.

Hyderabad

INDIAFLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
249FILTHY
6/13/2025Shaanxi Undersun Biomedtech Co.,Ltd

Xianyang

CHINAFUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
249FILTHY
6/13/2025Shaanxi Undersun Biomedtech Co.,Ltd

Xianyang

CHINAMUSHROOM, SHIITAKE, FUNGI PRODUCTS, N.E.C.
249FILTHY
6/13/2025CHANGLE DISTRICT TIANGANG TRADING CO., LTD

Fuzhou

CHINAWOLFBERRY (CHINESE OR SOUTHEAST ASIAN BERRY OF THE CHINESE MATRIMONY VINE, W/SLIGHT LICORICE FLAVOR)
241PESTICIDE
473LABELING
6/13/2025Arpit Agro Industries

Jalgaon

INDIAMUNG BEAN, DRIED OR PASTE
241PESTICIDE
6/13/2025Zhon Glu Food Co Ltd Shandong

Shandong

CHINAPEPPER, SWEET (FRUIT USED AS VEGETABLE)
241PESTICIDE
6/13/2025ANDEAN GROWERS GROUP S.A.C

Lima

PERUSUGAR SNAP PEAS
241PESTICIDE
6/13/2025GUANGZHOU PLUSLIFE BIOTECH CO LT

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025GUANGZHOU PLUSLIFE BIOTECH CO LT

Guangzhou

CHINACOVID-19 TEST HOME COLLECTION KIT DEVICES
118NOT LISTED
3280FRNMFGREG
+1 more
6/13/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINAKIT, TEST, OLFACTORY
118NOT LISTED
3280FRNMFGREG
+1 more

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 3854 (TPLKUSSLLB), 3842 (TP NO PMTA), 3843 (TP NO SE), 3280 (FRNMFGREG), 75 (UNAPPROVED) and 20 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 458 of 10,077 • Showing records 22,851-22,900 of 503,850 total