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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/24/2025LABORATORIO DE LA SANTE

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025GRUPO COLOMBIANO TECNOQUIMICAS

Valle Del Cauca

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025Procaps S.A.

Barranquilla

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025LABORATORIO DE LA SANTE

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025American Generis

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025American Generis

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025American Generis

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025American Generis

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025American Generis

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025MEDERILAB C METALURGIA

Guadalajara

MEXICOPHENOBARBITAL (ANTI-CONVULSANT)
75UNAPPROVED
1/24/2025ALVITA PHARMA PRIVATE LIMITED

Mumbai

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
1/24/2025INCEPTA PHARMACEUTICALS LTD

Dhaka

BANGLADESHERYTHROMYCIN (MACROLIDES)
75UNAPPROVED
1/24/2025BHD INDUSTRIES LTD

Mumbai

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
1/24/2025PONDCHY PHARMACUTICALS

Punucherry

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/24/2025GSK CANADA

Mississauga

CANADAAZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
75UNAPPROVED
1/24/2025DAVID MENESES

Cantera Puente De Pie

MEXICOADALIMUMAB
75UNAPPROVED
1/24/2025Sanofi-Aventis Deutschland GmbH

Frankfurt Am Main

GERMANYANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
1/24/2025Abbvie Biotechnology Gmbh

Ludwigshafen Am Rhein

GERMANYADALIMUMAB
75UNAPPROVED
1/24/2025MR JAYAKUMAR VEERA

Thiruvannamal

INDIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025OMEGA NUTRITION

Hidalgo Del Parral

MEXICOHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
1/24/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
1/24/2025HEALTHBEST PRIVATE LIMITED

Ahmedabad

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/24/2025SHREE BAIDYANATH AYURVED BHAWAN

Mumbai

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025Aimil Pharmaceuticals India

New Delhi

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025Himalaya Wellness Company

Bengaluru

INDIAPROMPT INSULIN ZINC (SUSP) (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025Dabur India

Solan

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMETANERCEPT
75UNAPPROVED
1/24/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025The Exchange Tower

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025NOVO NORDISK

Mississauga

CANADAANTI-DIABETIC N.E.C.
75UNAPPROVED
1/24/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/24/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/24/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/24/2025English Biscuit Manufacturers (Pvt.) Ltd.

Karachi

PAKISTANFRUIT FILLED PLAIN COOKIES,BISCUITS AND WAFERS
11UNSAFE COL
274COLOR LBLG
1/24/2025PALM BITES

Mississauga

CANADACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
1/24/2025PALM BITES

Mississauga

CANADACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
1/24/2025PALM BITES

Mississauga

CANADACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
1/24/2025nilamel exports

Trivandrum

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
11UNSAFE COL
1/24/2025Atlantic Seafood freezing factory N.V

Can Tho City

VIETNAMTILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
9SALMONELLA
1/24/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
1/24/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
1/24/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
1/24/2025Caninos Plus S.A.S

Bogota

COLOMBIAPET CHEWS CONTAINING GULLET, TRACHEA OR ESOPHAGUS (NON-NUTRITIVE)
9SALMONELLA
1/24/2025Atlantic Seafood freezing factory N.V

Can Tho City

VIETNAMTILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
9SALMONELLA
1/24/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENSNUS
3842TP NO PMTA
1/24/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENSNUS
3842TP NO PMTA
1/24/2025RSL BLUNT PRODUCTIONS

Santiago

DOMINICAN ROLL-YOUR-OWN PAPER
3520TP FLAVOR
3842TP NO PMTA
1/24/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR
1/24/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3520TP FLAVOR

About This Page

This page displays 50 FDA import refusal records from 12 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 9 (SALMONELLA), 3842 (TP NO PMTA) and 1 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 708 of 10,077 • Showing records 35,351-35,400 of 503,850 total