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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/17/2025Alcon Research LLC

Fort Worth

UNITED STAEMOLLIENT, LUBRICANT, N.E.C.
118NOT LISTED
2280DIRSEXMPT
+1 more
7/17/2025PT. MEDISAFE TECHNOLOGIES

Deli Serdang

INDONESIASURGEON'S GLOVES
118NOT LISTED
7/17/2025Zhengzhou Lulu Beverage Co., Ltd.

Zhengzhou City

CHINAIMITATION MILK OR MILK TYPE PRODUCT, N.E.C.
83NO PROCESS
7/17/2025Zhengzhou Lulu Beverage Co., Ltd.

Zhengzhou City

CHINAIMITATION MILK OR MILK TYPE PRODUCT, N.E.C.
83NO PROCESS
7/17/2025Merck Healthcare KGaA

Darmstadt

GERMANYBISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/17/2025Procaps S.A.

Barranquilla

COLOMBIAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
7/16/2025AGT Foods Regina Main Plant

Regina

CANADALENTILS, DRIED OR PASTE
3886FSVP VIO
7/16/2025AGT Foods Regina Main Plant

Regina

CANADACHANA DAL, DRIED OR PASTE
3886FSVP VIO
7/16/2025AGRIFOODS AUSTRALIA PTY TLD

Dalby

AUSTRALIACHANA DAL, DRIED OR PASTE
3886FSVP VIO
7/16/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/16/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/16/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/16/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/16/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/16/2025YOIK AB

Gemla

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
7/16/2025APR S NICOTINE AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
7/16/2025APR S NICOTINE AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
+1 more
7/16/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
7/16/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE POUCH
3520TP FLAVOR
7/16/2025Luna Corporate

Suchy Las

POLANDNICOTINE POUCH
3520TP FLAVOR
7/16/2025EVERRICH FOODS INDIA PVT LTD

Bengaluru

INDIACANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS AND FRUIT (WITHOUT CHOCOLATE)
3300ALLERGEN
7/16/2025BYDEAL COSMETICS LDA

Santarem

PORTUGALEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
3280FRNMFGREG
7/16/2025BYDEAL COSMETICS LDA

Santarem

PORTUGALEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
3280FRNMFGREG
7/16/2025Unknown

Unknown

HAITIFISH OIL (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
324NO ENGLISH
7/16/2025CORE NUTRACEUTICAL PVT LTD

Sidhpur

INDIANON FAT MILK PRODUCTS, N.E.C.
488HEALTH C
7/16/2025JUSDA (TAIWAN) CO LTD

Taoyuan County

TAIWANVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
488HEALTH C
7/16/2025Cristo SA

Port-Au-Prince

HAITIVEGETABLE OILS NOT MENTIONED ELSEWHERE, N.E.C.
482NUTRIT LBL
7/16/2025Unknown

Unknown

HAITICHOCOLATE AND COCOA PRODUCTS, N.E.C.
473LABELING
7/16/2025Cristo SA

Port-Au-Prince

HAITISHRIMP & PRAWNS
473LABELING
7/16/2025Unknown

Unknown

HAITICORN STARCH
473LABELING
7/16/2025Unknown

Unknown

HAITIPERFUMES (FRAGRANCE PREPARATIONS)
473LABELING
7/16/2025MENARD LORVENS

Croix Des Bouquets

HAITIRICE, WILD, WHOLE GRAIN
473LABELING
7/16/2025MENARD LORVENS

Croix Des Bouquets

HAITIRICE, WILD, WHOLE GRAIN
473LABELING
7/16/2025Bayer AG

Leverkusen

GERMANYLEVONORGESTREL (ESTROGEN)
472NO ENGLISH
82RX LEGEND
7/16/2025Industria Farmaceutica del Caribe, S.A.

Santo Domingo

DOMINICAN TRICLOSAN (DISINFECTANT)
472NO ENGLISH
75UNAPPROVED
7/16/2025Piramal Healthcare UK Limited

Morpeth

UNITED KINMISOPROSTOL (PROSTAGLANDIN)
472NO ENGLISH
75UNAPPROVED
7/16/2025Unknown

Unknown

HAITIMISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
7/16/2025Unknown

Unknown

UNITED KINBETAMETHASONE DIPROPIONATE (GLUCOCORTICOID)
472NO ENGLISH
7/16/2025Unknown

Unknown

HAITIAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
472NO ENGLISH
7/16/2025BENNET PHARMACEUTICALS LIMITED

Distt Solan

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
472NO ENGLISH
7/16/2025Disfarmaco S.R.L.

Santa Domingo

DOMINICAN DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
472NO ENGLISH
7/16/2025Mitchell Fair & White Pvt. Ltd.

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
7/16/2025CAPLIN POINT LABORATORIES LTD

CHENNAI

INDIAGENTAMICIN (AMINOGLYCOSIDES)
472NO ENGLISH
7/16/2025Axon Drugs

Chenbaranbakkam

INDIADEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
472NO ENGLISH
7/16/2025MANUFACTURER UNKNOWN

Shenzhen

CHINACAMPHORATED OIL
472NO ENGLISH
7/16/2025MENARD LORVENS

Croix Des Bouquets

HAITIVEGETABLE OILS NOT MENTIONED ELSEWHERE, N.E.C.
324NO ENGLISH
482NUTRIT LBL
7/16/2025MENARD LORVENS

Croix Des Bouquets

HAITICORN STARCH
324NO ENGLISH
482NUTRIT LBL
7/16/2025RUBY TOWER SHOP

Mumbaj

INDIADIETARY CONVENTIONAL FOODS, N.E.C.
321LACKS N/C
482NUTRIT LBL
7/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIACAKE WITHOUT CUSTARD OR CREAM FILLING
308MFR INSAN
3821MFR INJ
7/16/2025Haldiram Snacks Pvt. Ltd.

Noida

INDIACAKE WITHOUT CUSTARD OR CREAM FILLING
308MFR INSAN
3821MFR INJ

About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 118 (NOT LISTED), 2280 (DIRSEXMPT), 335 (LACKS N/C), 83 (NO PROCESS), 75 (UNAPPROVED) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 406 of 10,077 • Showing records 20,251-20,300 of 503,850 total