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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/1/2025WHITE INDUSTRIES AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/1/2025WHITE INDUSTRIES AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/1/2025WHITE INDUSTRIES

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
6/1/2025WHITE INDUSTRIES

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
6/1/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
6/1/2025THE SNUS FACTPRY

Odeshog

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025THE SNUS FACTORY

Lidkoping

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025THE SNUS FACTORY

Lidkoping

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025MAKE WEBO AB

Uppsala

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025THE SNUS FACTORY

Lidkoping

SWEDENNICOTINE POUCH
3842TP NO PMTA
6/1/2025ALTRUAN GMBH

Massing

GERMANYKIT, TEST, OLFACTORY
118NOT LISTED
3280FRNMFGREG
+1 more
6/1/2025Shenzhen Microprofit Biotech Co., Ltd.

Shenzhen

CHINACOVID-19 MULTI-ANALYTE ANTIGEN DEVICE
118NOT LISTED
3280FRNMFGREG
+1 more
6/1/2025Kashmir Surgical Works

Ambala

INDIAFLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS)
118NOT LISTED
3280FRNMFGREG
+1 more
5/30/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/30/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
5/30/2025Shan Foods (Private) Limited

Karachi

PAKISTANMANGO (SUBTROPICAL AND TROPICAL FRUIT)
3898INADPRCCTL
5/30/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
5/30/2025Swedish Match Ab

Stockholm

DENMARKSMOKELESS TOBACCO, NOT ELSEWHERE CLASSIFIED (N.E.C.)
3854TPLKUSSLLB
5/30/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025NGP TOBACCO APS

Norager

DENMARKSMOKELESS TOBACCO POUCHES
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
+1 more
5/30/2025NICOTECH OU

Harjumaa

ESTONIANICOTINE POUCH
3842TP NO PMTA
5/30/2025Dr Ma's Laboratories, Inc.

Burnaby

CANADAASTRAGALUS (MILK VETCH ROOT), (HERBAL & BOTANICALS, NOT TEAS)
3560SUPPL GMP
75UNAPPROVED
5/30/2025Dr Ma's Laboratories, Inc.

Burnaby

CANADAMACA (HERBAL & BOTANICALS, NOT TEAS II)
3560SUPPL GMP
5/30/2025Dr Ma's Laboratories, Inc.

Burnaby

CANADABILBERRY (HERBAL & BOTANICALS, NOT TEAS)
3560SUPPL GMP
5/30/2025ZHEJIANG BAOLAI OPTICAL CO LTD

Jinhua

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3280FRNMFGREG
341REGISTERED
5/30/2025Bioland Technology Ltd.

Shenzhen

CHINASYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
508NO 510(K)
5/30/2025Shanghai Berry Electronic Tech Co. Ltd.

Shanghai

CHINAPULSE OXIMETER FOR OVER-THE-COUNTER USE
508NO 510(K)
5/30/2025GUANGZHOU EKAI ELECTRONIC TECHNO

Guangzhou

CHINAPOWERED MICRONEEDLE DEVICE
508NO 510(K)
5/30/2025Safe Harbor Hardware & Electronics

Shenzhen

CHINA3D LASER SCANNING SYSTEM
476NO REGISTR
5/30/2025MOZAMBIQUE XINHONG INTL TRADING

Maputo

MOZAMBIQUEOYSTERS
473LABELING
5/30/2025Yamaishi Corporation

Aomori

JAPANSCALLOPS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
320LACKS FIRM
324NO ENGLISH
5/30/2025SOSYO HAJOORI BEVERAGE PVT LTD.

Surat

INDIABOTTLED WATER, CARBONATED WATER (NONMEDICINAL)
320LACKS FIRM
5/30/2025SOSYO HAJOORI BEVERAGE PVT LTD.

Surat

INDIABOTTLED WATER, CARBONATED WATER (NONMEDICINAL)
320LACKS FIRM
5/30/2025SOSYO HAJOORI BEVERAGE PVT LTD.

Surat

INDIABOTTLED WATER, CARBONATED WATER (NONMEDICINAL)
320LACKS FIRM
5/30/2025SOSYO HAJOORI BEVERAGE PVT LTD.

Surat

INDIABOTTLED WATER, CARBONATED WATER (NONMEDICINAL)
320LACKS FIRM
5/30/2025BIOCOL PHARMA, LDA

Alcabideche

PORTUGALCHOLINE (MINERAL)
260FALSE
5/30/2025Minature Wellness Pvt Ltd

Ahmedabad

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
256INCONSPICU
324NO ENGLISH
+1 more
5/30/2025Minature Wellness Pvt Ltd

Ahmedabad

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
256INCONSPICU
324NO ENGLISH
+1 more
5/30/2025Goknur Gida Maddeleri Enerji Imalat Ithalat Ihracat Tic. ve San. A.S.

Nigde

TURKEYPOMEGRANATE, JUICE, OTHER FRUIT JUICES OR CONCENTRATES
251POISONOUS
5/30/2025QUEENETH ORJI

Ajah

NIGERIASNAILS, AQUATIC, OTHER AQUATIC SPECIES
249FILTHY
473LABELING
5/30/2025NSIKAN AKPABIO

Uyo

NIGERIASNAILS, AQUATIC, OTHER AQUATIC SPECIES
249FILTHY
473LABELING
5/30/2025Lanka Canneries (Pvt) Ltd.

Atthanagalla

SRI LANKATAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
5/30/2025Lanka Canneries (Pvt) Ltd.

Atthanagalla

SRI LANKATAMARIND, DRIED OR PASTE
249FILTHY
1...481482483...10077

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 3842 (TP NO PMTA), 3843 (TP NO SE), 3854 (TPLKUSSLLB), 118 (NOT LISTED), 3280 (FRNMFGREG) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 482 of 10,077 • Showing records 24,051-24,100 of 503,850 total