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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/27/2025Sterimax, Inc.

Oakville

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
10/27/2025Boehringer Ingelheim

Paris

FRANCEEMPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
10/27/2025MSN LABORATORIES PRIVATE LIMITED

Hyderabad

INDIAINHIBITOR N.E.C.
118NOT LISTED
10/27/2025STERIMEDIX LTD

Redditch

UNITED KINKNIFE, OPHTHALMIC
118NOT LISTED
10/27/2025REVIVE INNOVATIONS PVT LTD

Rajkot

INDIANONCARBONATED SOFT DRINK, N.E.C.
83NO PROCESS
10/27/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
10/27/2025APPLIED COMMUNICATION AND CONTRO

Uttrakhand

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
10/27/2025CU-V-KAR GENETIC MEDICINES

Uttarakhand

INDIADOXYCYCLINE (TETRACYCLINES)
75UNAPPROVED
10/27/2025APPLIED COMMUNICATION AND CONTRO

Uttrakhand

INDIAOCTOPAMINE (HERBAL AND BOTANICALS, NOT TEAS II)
75UNAPPROVED
10/27/2025AMSTER LABS

Baddi

INDIAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
10/27/2025Galeno

Caracas

VENEZUELARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
10/27/2025ITF LABOMED FARMACEUTICA LTDA

Santiago

CHILEAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
10/27/2025LABORATORIOS LA SANTE SA

Bogota

COLOMBIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
10/27/2025MASCOT HEALTH SERIES PCT LTD

Uttarakhand

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
10/27/2025Sun Pharma Laboratories Ld

East-Sikkim

INDIAOLMESARTAN MEDOXOMIL
75UNAPPROVED
10/27/2025ERIS THERAPEUTICS LTD

Ahmedabad

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
10/27/2025PHARMACOM SP SOLUCOES FARMACEUTI

Sao Paulo

BRAZILVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
10/27/2025PHARMACOM SP SOLUCOES FARMACEUTI

Sao Paulo

BRAZILVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
10/27/2025PHARMACOM SP SOLUCOES FARMACEUTI

Sao Paulo

BRAZILNICOTINAMIDE (NIACINAMIDE) (VITAMIN)
75UNAPPROVED
10/27/2025PHARMACOM SP SOLUCOES FARMACEUTI

Sao Paulo

BRAZILMECOBALAMIN (VITAMIN)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICONAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOHYDROCHLOROTHIAZIDE (DIURETIC)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOLOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOETANERCEPT
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOHYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOPREDNISONE (GLUCOCORTICOID)
75UNAPPROVED
10/27/2025ULTRA LABORATORIOS

Guadalajara

MEXICOSULFASALAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
10/27/2025Laboratorios Intecfa

Guatemala City

GUATEMALADAPSONE (ANTI-BACTERIAL)
75UNAPPROVED
10/27/2025CANTABRIA LABS

Santander

SPAINSALICYLIC ACID (KERATOLYTIC)
75UNAPPROVED
10/27/2025Laboratorios Grossman, S.A.

Ciudad De Mexico

MEXICOCLINDAMYCIN PHOSPHATE (LINCOMYCINS)
75UNAPPROVED
10/27/2025LAB DROGUERIA SAN JORGE

Cali

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025LABORATORIO HALEON COLOMBIA SAS

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025SANFER LAB

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025LA SANTE

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
10/27/2025AMERICAN GENERICS S.A.S.

Cali

COLOMBIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
10/27/2025LA SANTE

Bogota

COLOMBIAOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
10/27/2025LA SANTE

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
10/27/2025Procter & Gamble Colombia Sa

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025GSK

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025AMERICAN GENERICS S.A.S.

Cali

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/27/2025Eli Lilly Italia SPA

Sesto Fiorentino

ITALYTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
10/27/2025Hugel, Inc.

Chuncheon-si

SOUTH KOREONABOTULINUMTOXINA
75UNAPPROVED
10/27/2025Hugel, Inc.

Chuncheon-si

SOUTH KOREONABOTULINUMTOXINA
75UNAPPROVED
10/27/2025Casmara Cosmetics, S.A.

Paterna

SPAINOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
10/27/2025Intas Pharmaceuticals Ltd

South Sikkim

INDIADIVALPROEX SODIUM (ANTI-CONVULSANT)
27DRUG GMPS
10/27/2025ORCHID LIFESCIENCES

Kathwada

INDIACALAMINE (PROTECTANT)
27DRUG GMPS
10/27/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
75UNAPPROVED
10/27/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
75UNAPPROVED
10/27/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 83 (NO PROCESS), 75 (UNAPPROVED), 27 (DRUG GMPS), 11 (UNSAFE COL). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 176 of 10,077 • Showing records 8,751-8,800 of 503,850 total