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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/6/2026Sejun Food Co., Ltd

Gwangju

SOUTH KORENONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
1/6/2026Sejun Food Co., Ltd

Gwangju

SOUTH KORENONALCOHOLIC BEVERAGES, N.E.C.
83NO PROCESS
1/6/2026Vara Food & Drink Co., Ltd.

Dontoom

THAILANDMULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
83NO PROCESS
1/6/2026HUL TEA UNIT

Uttar Pradesh

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
1/6/2026HUL TEA UNIT

Uttar Pradesh

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
1/6/2026HUL

Kolkata

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
1/6/2026Banaskantha District Co-operative Milk Producers' Union Ltd

Palanpur

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
1/6/2026Novo Nordisk A/S

Kalundborg

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026LABORATORIOS QUIMPHARMA, S.A.

Ciudad De Mexico

MEXICOTRAMADOL HCL (ANALGESIC)
75UNAPPROVED
1/6/2026LABORATORIOS PISA

Coyoacan

MEXICOACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/6/2026Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield

UNITED STAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026Alpha Pharmacy & Stores Ltd

Lagos

NIGERIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/6/2026Novartis

Maharashtra

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/6/2026Novartis

Maharashtra

INDIABROMOCRIPTINE MESYLATE (ENZYME INHIBITOR)
75UNAPPROVED
1/6/2026NAMAN PHARMA DRUGS

Mumbai

INDIACABERGOLINE (ANTI-PARKINSONIAN)
75UNAPPROVED
1/6/2026Charak Pharma Pvt Ltd

Naroli

INDIAPROGESTERONE (PROGESTIN)
75UNAPPROVED
1/6/2026BAADER SCHULZ LABORATORIES

Daman

INDIACEFUROXIME AXETIL (CEPHALOSPORINS)
75UNAPPROVED
1/6/2026Accord Healthcare Ltd

Harrow

UNITED KINANASTROZOLE (HORMONE)
75UNAPPROVED
1/6/2026EGYPTIAN INTERNATIONAL PHARMACEU

Teulti

EGYPTAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026Bayer Weimar GmbH und Co. KG

Weimar

GERMANYMESTEROLONE (ANDROGEN)
75UNAPPROVED
1/6/2026BENZOCAINALABORATORIOS LIOMONT

Ciudad De Mexico

MEXICOACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/6/2026RAYERE PHARMACEUTICALS

Ciudad De Mexico

MEXICOACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/6/2026TECNOFARMA S.A. de C.V

SAN JUAN DEL RIO

MEXICORIBAVIRIN (ANTI-VIRAL)
75UNAPPROVED
1/6/2026NEOLPHARMA S.A.

Ciudad De Mexico

MEXICOISOCONAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/6/2026HECHO EN MEXICO POR LABORATORIOS

Cuajimalpa De Morelos

MEXICOVITAMIN E (TOCOPHEROL)
75UNAPPROVED
1/6/2026CHEMISTRY LABORATORIES SONS SA

Mexico City

MEXICOHYDROCORTISONE (GLUCOCORTICOID)
75UNAPPROVED
1/6/2026HEALING PHARMA INDIA PVT LTD

Mumbai

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026ELDER PHARMA LTD

Maharashtra

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026HEALING PHARMA INDIA PVT LTD

Mumbai

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/6/2026USV Private Limited

Vadodara

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026Pfizer

Manhattan

UNITED STAPREDNISONE (GLUCOCORTICOID)
75UNAPPROVED
1/6/2026SANOFI & BRISTOL-MYERS

Bridgewater

UNITED STAIRBESARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/6/2026Pfizer

Manhattan

UNITED STAMETHOTREXATE (ANTI-NEOPLASTIC)
75UNAPPROVED
1/6/2026Janytree Inc.

Geumcheon

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/6/2026MEGALABS COLOMBIA SAS

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026Tecnoquimicas S.A.

Cali

COLOMBIADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
1/6/2026Altea Farmaceutica

Bogota

COLOMBIAGUAIFENESIN (EXPECTORANT)
75UNAPPROVED
1/6/2026TECNOFAR TQ SAS

Cauca

COLOMBIAZINC SULFATE ASTRINGENT/ANTI-PERSPIRANT)
75UNAPPROVED
1/6/2026SANOFI MEDLEY FARMACEUTICA LTDA

Sao Paulo

BRAZILFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
1/6/2026MUNDIAL FARMACEUTICA

Bogota

COLOMBIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/6/2026SALUD PHARMA LABS

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026LABORATORIOS RICHMOND COLOMBIA S.A.S.

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026MUNDIAL FARMACEUTICA

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026PHARMETIQUE SA

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/6/2026SIEGFRIED

Bogota

COLOMBIAEXPECTORANT N.E.C.
75UNAPPROVED
1/6/2026Syntofarma

Bogata

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026COASPHARMA S.A.S.

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 83 (NO PROCESS), 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 34 of 10,077 • Showing records 1,651-1,700 of 503,850 total