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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
4/10/2025ECAR LABORATORIES

Antioquia

COLOMBIAVITAMIN B1 (THIAMINE)
75UNAPPROVED
4/10/2025Bussie Sa

Bogota

COLOMBIAPOLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
75UNAPPROVED
4/10/2025GENFAR SANOFI

Bogata

COLOMBIAPOTASSIC SALINE (INJECTION) (REPLENISHER)
75UNAPPROVED
4/10/2025LAB COASPHARMA

Bogota

COLOMBIAPREDNISONE (GLUCOCORTICOID)
75UNAPPROVED
4/10/2025Abbot Laboratorios De Colombia S.A.

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025SIEGFRIED LABORATORIES

Bogot

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025TECNOQUIMICAS

Bogota

COLOMBIADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
75UNAPPROVED
4/10/2025Lafrancol

Bogota

COLOMBIAANTI-PERISTALTIC N.E.C.
75UNAPPROVED
4/10/2025Laboratorios Coaspharma

Bogota

COLOMBIASODIUM BICARBONATE (REPLENISHER)
75UNAPPROVED
4/10/2025GENFAR SANOFI

Bogata

COLOMBIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
4/10/2025Sanofi Aventis De Colombia S.A.

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025SIEGFRIED LABORATORIES

Bogot

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025ABBOTT LABORATORIES COLOMBIA

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025GENFAR SANOFI

Bogata

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
4/10/2025LA SANTE

Bogota

COLOMBIACEPHALEXIN (CEPHALOSPORINS)
75UNAPPROVED
4/10/2025GENFAR SANOFI

Bogata

COLOMBIALINCOMYCIN N.E.C.
75UNAPPROVED
4/10/2025GENFAR SANOFI

Bogata

COLOMBIAFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
4/10/2025COLMED INTERNATIONAL

Barranquilla

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
4/10/2025Procaps S.A.

Barranquilla

COLOMBIADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
4/10/2025LABORATORIOS BLASKOV LTDA

Bogota

COLOMBIADEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOPOTATO SNACKS (FLAVORED OR UNFLAVORED), VEGETABLE SNACKS (OTHER THAN PULSES) BAKED
11UNSAFE COL
274COLOR LBLG
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOPOTATO SNACKS (FLAVORED OR UNFLAVORED), VEGETABLE SNACKS (OTHER THAN PULSES) BAKED
11UNSAFE COL
274COLOR LBLG
4/10/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
4/10/2025Food Industries Inc.

Metro Manila

PHILIPPINEGIFT PACKS OF ASSORTED FOODS, READY-TO-EAT
11UNSAFE COL
4/10/2025Food Industries Inc.

Metro Manila

PHILIPPINEGIFT PACKS OF ASSORTED FOODS, READY-TO-EAT
11UNSAFE COL
4/10/2025Universal Robina Corporation

Cebu

PHILIPPINEGIFT PACKS OF ASSORTED FOODS, READY-TO-EAT
11UNSAFE COL
4/9/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
4/9/2025Monte Vista Farming Company, LLC

Denair

UNITED STAALMOND, SHELLED
3897MYCOTOXIN
4/9/2025Swedish Match Denmark

Silkeborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
4/9/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
4/9/2025HRJ PRODUCTION OU

Tallinn

ESTONIASNUS
3842TP NO PMTA
3843TP NO SE
4/9/2025MINISTRY OF SNUS

Svendborg

DENMARKNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
4/9/2025HRJ PRODUCTION OU

Tallinn

ESTONIANICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
4/9/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
4/9/2025HABIT FACTORY IN SWEDEN AB

Norsborg

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
4/9/2025Fiedler & Lundgren Ab

Malmo

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
4/9/2025Fiedler & Lundgren Ab

Malmo

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
4/9/2025HABIT FACTORY IN SWEDEN AB

Norsborg

SWEDENSNUS
3842TP NO PMTA
3843TP NO SE
4/9/2025HABIT FACTORY IN SWEDEN AB

Norsborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
4/9/2025MINISTRY A/S

Svendborg

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
4/9/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
4/9/2025MINISTRY A/S

Svendborg

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
4/9/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
4/9/2025Luna Corporate

Suchy Las

POLANDNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
4/9/2025FEWO INTELLIGENT MANUFACTURING

Dongguan

CHINAVAPE PEN
3842TP NO PMTA
3843TP NO SE
4/9/2025FEWO INTELLIGENT MANUFACTURING

Dongguan

CHINAVAPE PEN
3842TP NO PMTA
3843TP NO SE
4/9/2025FEWO INTELLIGENT MANUFACTURING

Dongguan

CHINAVAPE PEN
3842TP NO PMTA
3843TP NO SE

About This Page

This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 3904 (3904), 3905 (3905) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 584 of 10,077 • Showing records 29,151-29,200 of 503,850 total