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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/3/2025HONG THAI MEDICINE

Thon Buri

THAILANDMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
321LACKS N/C
+3 more
12/3/2025Washington Surgical International

Sialkot

PAKISTANFORCEPS, GENERAL & PLASTIC SURGERY
118NOT LISTED
479DV QUALITY
12/3/2025DPF FILTERS DANIEL HERBUT_PROJECT 1

Wroclaw

POLANDCOLLAGEN (COSMETIC RAW MATERIAL)
75UNAPPROVED
12/3/2025DPF FILTERS DANIEL HERBUT_PROJECT 1

Wroclaw

POLANDARGAN OIL
75UNAPPROVED
12/3/2025HU YING

Doum 5-Ro

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
12/3/2025BELLROS TRADING LTD N0372787B

Argentona

SPAINOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
75UNAPPROVED
12/3/2025BELLROS TRADING LTD N0372787B

Argentona

SPAINOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
75UNAPPROVED
12/3/2025BELLROS TRADING LTD N0372787B

Argentona

SPAINOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
75UNAPPROVED
12/3/2025Sheth Brothers

Bhavnagar

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/3/2025Dabur India

Solan

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/3/2025Dabur India

Solan

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/3/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
12/3/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
12/3/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED
12/3/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
12/3/2025Boe Dominicana SRL

Santo Domingo

DOMINICAN SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
12/3/2025J. C. Udeozor & Sons Global Industries

Benin City

NIGERIAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
12/3/2025JIGSIMUR HEALTH PLUS DRINK

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/3/2025Neimeth International Pharm., PLC

Oregun

NIGERIAPHENOL (PHARMACEUTIC NECESSITY - PRESERVATIVE)
75UNAPPROVED
12/3/2025Virgin Beauty Industries Nig Ltd

Igbala Sango Ota Ogun State

NIGERIAHAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
12/3/2025TETMOSOL HELLO PRODUCTS

Lagos

NIGERIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
12/3/2025Bayer Mexico S.A. de C.V.

Queretaro

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/3/2025Productos Medix, S.A. de C.V.

Mexico Df

MEXICONUTRIENT/TONIC N.E.C.
75UNAPPROVED
12/3/2025Pfizer SA de CV

Toluca

MEXICOIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/3/2025Productos Maver, S.A. de C.V.

Tlaquepaque

MEXICOANTIBIOTIC N.E.C.
75UNAPPROVED
12/3/2025Wermar Pharmaceuticals Sa De Cv

Santa Maria La

MEXICOAMANTADINE HCL (ANTI-VIRAL)
75UNAPPROVED
12/3/2025Serral, S.A. de C.V.

Ciudad De Mexico

MEXICOPENTOXIFYLLINE (VASODILATOR)
75UNAPPROVED
12/3/2025ANTIBIOTICOS DE MEXICO A DE CV

Ciudad De Mexic

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
12/3/2025GELPHARMA S. A. DE C. V.

Zapopan

MEXICOIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/3/2025GLAXOSMITHKLINE PHARMA LIMITED

Nashik

INDIABETAMETHASONE VALERATE (GLUCOCORTICOID)
75UNAPPROVED
12/3/2025OPELLA HEALTHCARE FRANCE SAS

Gentilly

FRANCEBISACODYL (CATHARTIC)
75UNAPPROVED
12/3/2025MIcro Labs Limited

Bangalore

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
12/3/2025CADILA PHARMA LTD

Ahmebabad

INDIALEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
12/3/2025LEEFORD HEALTHCARE LTD

Tehsill Baddi

INDIATRIHEXYPHENIDYL HCL (ANTI-CHOLINERGIC)
75UNAPPROVED
12/3/2025Laborate Pharmaceuticals India Ltd.

Paonta Sahib

INDIATHIABENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
12/3/2025Laborate Pharmaceuticals India Ltd.

Paonta Sahib

INDIAFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
12/3/2025Intas Pharmaceuticals Limited

Gangtok

INDIAPREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
12/3/2025Intas Pharmaceuticals Limited

Gangtok

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
12/3/2025BIONEXY PHARMA

Solan

INDIAVITAMIN, N.E.C.
75UNAPPROVED
12/3/2025DEAN DRAPER-MONTGOMERY COUNTY

Conroe

UNITED STADULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
12/3/2025CHIESI AUSTRALIA PTY LTD

Melbourne

AUSTRALIABUDENSONIDE
75UNAPPROVED
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/3/2025CASA CUERVO

Ciudad De Mexico

MEXICOMIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
11UNSAFE COL
274COLOR LBLG
12/3/2025SABRITAS, S.de R.L. de C.V.

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/3/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 321 (LACKS N/C), 3260 (NO ENGLISH), 3280 (FRNMFGREG), 473 (LABELING) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 81 of 10,077 • Showing records 4,001-4,050 of 503,850 total