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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
2/21/2025Amgen Canada Inc

Mississauga

CANADAETANERCEPT
75UNAPPROVED
2/21/2025Novartis Pharmaceuticals Canada Inc.

Dorval

CANADAOMALIZUMAB
75UNAPPROVED
2/21/2025Novartis Pharmaceuticals Canada Inc.

Dorval

CANADAOMALIZUMAB
75UNAPPROVED
2/21/2025AbbVie Inc.

North Chicago

UNITED STAANTI-PSORIATIC N.E.C.
75UNAPPROVED
2/21/2025Novartis Pharmaceuticals Canada Inc.

Dorval

CANADAANTI-ASTHMATIC, N.E.C.
75UNAPPROVED
2/21/2025ELI LILLY CANADA INC

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
2/21/2025Janssen Pharmaceuticals, Inc

Titusville

UNITED STAANTI-PSORIATIC N.E.C.
75UNAPPROVED
2/21/2025Productos Farmaceuticos Collins, S.A. De C.V.

Guadalajara

MEXICOCLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
2/21/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
2/21/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
2/21/2025Dru Era (Pvt) Ltd

Dehiwala

SRI LANKACINNAMON, CASSIA, GROUND, CRACKED (SPICE)
75UNAPPROVED
2/21/2025Alkem Laboratories Limited

Baddi

INDIADOMPERIDONE
75UNAPPROVED
2/21/2025AVIGHNA MEDICARE

Delhi

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
2/21/2025LUPIN

Assam

INDIAMUCOLYTIC N.E.C.
75UNAPPROVED
2/21/2025Dr. Reddy's Laboratories Ltd.

Medchal-Malkajgiri District

INDIAGUAIFENESIN (EXPECTORANT)
75UNAPPROVED
2/21/2025HJ HEINZ WIGAN

Manchester

UNITED KINBEAN, CORN, PEA WITH SAUCE, N.E.C. (VEGETABLE)
62NEEDS FCE
83NO PROCESS
2/21/2025Unique Fragrances

Sonepat

INDIAMANGO, DRIED OR PASTE
11UNSAFE COL
3865COLORLABEL
2/21/2025Unique Fragrances

Sonepat

INDIAMANGO, DRIED OR PASTE
11UNSAFE COL
3865COLORLABEL
2/21/2025Unique Fragrances

Sonepat

INDIAMANGO, DRIED OR PASTE
11UNSAFE COL
3865COLORLABEL
2/21/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
2/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
274COLOR LBLG
2/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINESAUCES, N.E.C.
11UNSAFE COL
274COLOR LBLG
2/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
11UNSAFE COL
238UNSAFE ADD
+2 more
2/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINECHILI SAUCE
11UNSAFE COL
238UNSAFE ADD
+2 more
2/21/2025CAPITAL FOODS PRIVATE LIMITED

KANDLA

INDIAMULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
11UNSAFE COL
2/21/2025Ana Maria Moreira De Aquino

Vinhedo

BRAZILPEPPER, BLACK, GROUND, CRACKED (SPICE)
9SALMONELLA
2/21/2025Balaji Wafers Pvt Ltd

Rajkot

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
9SALMONELLA
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALLUPIN BEAN
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALLUPIN BEAN
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALLUPIN BEAN
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, GREEN, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, GREEN, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, BLACK, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, GREEN, (PIT FRUIT)
83NO PROCESS
2/20/2025ALCIDES MARQUES PEREIRA LOPES LDA

Espinho

PORTUGALOLIVES, GREEN, (PIT FRUIT)
83NO PROCESS
2/20/2025Unique Fragrances

Sonepat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
2/20/2025Unique Fragrances

Sonepat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
2/20/2025CIPLA LIMITED

Mumbai

INDIABUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
2/20/2025MEDIXA SRL

San Sebastiano Al Vesuvio

ITALYEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
2/20/2025VENOME SPOLKA Z O. O

Rodawska 25

POLANDEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
2/20/2025APIS NATURAL COSMETICS SP Z O.O.

Bydgoszcz

POLANDEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
2/20/2025Jebacoci Company Ltd

Dansoman-Accra

GHANAMEBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
2/20/2025Jebacoci Company Ltd

Dansoman-Accra

GHANAOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED
2/20/2025Jebacoci Company Ltd

Dansoman-Accra

GHANAOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 12 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 11 (UNSAFE COL), 3865 (COLORLABEL) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 667 of 10,077 • Showing records 33,301-33,350 of 503,850 total