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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/6/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
3280FRNMFGREG
10/6/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
3280FRNMFGREG
10/6/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
3280FRNMFGREG
10/6/2025YIWU JIARUN E-COMMERCE CO., LTD

Jinhua

CHINATOOTHBRUSH, MANUAL
118NOT LISTED
3280FRNMFGREG
10/6/2025CLASSY CARDS CREATIVE

Greenhill

CANADABANDAGE, ELASTIC
118NOT LISTED
3280FRNMFGREG
10/6/2025Senseonics, Inc.

Germantown

UNITED STAINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM WITH SENSOR CONTAINING DEXAMETHASONE ACETATE
118NOT LISTED
3280FRNMFGREG
10/6/2025MOOG ENTERPRISE TURIZM GIDA IC VE DIS TICARET LIMITED SIRKETI

Sisli

TURKEYSHIELD, NIPPLE
118NOT LISTED
3280FRNMFGREG
10/6/2025SIDA

Hefei

CHINAMASSAGER, THERAPEUTIC, MANUAL
118NOT LISTED
3280FRNMFGREG
10/6/2025Taiwan Spectacles Industry Assoc.

Taipei

TAIWANSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3280FRNMFGREG
10/6/2025Across Co., Ltd

Chuncheon-si

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
10/6/2025Centro de Construccion de Cardioestimuladores del Uruguay SA

Montevideo

URUGUAYSTIMULATOR, NERVE TERMINUS, TOTALLY IMPLANTED FOR CHRONIC INTRACTABLE POST-AMPUTATION PAIN OF THE LO
118NOT LISTED
237NO PMA
10/6/2025Ocean Export Sociedade Unipessoal, Lda.

Moura

PORTUGALOLIVES (PIT FRUIT)
83NO PROCESS
10/6/2025Ocean Export Sociedade Unipessoal, Lda.

Moura

PORTUGALOLIVES (PIT FRUIT)
83NO PROCESS
10/6/2025HOA NAM PHARMA

Ha Noi

VIETNAMVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
10/6/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
10/6/2025BEYONCE INFOTECH PVT LTD

Coimbatore

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
10/6/2025BEYONCE INFOTECH PVT LTD

Coimbatore

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
10/6/2025BEYONCE INFOTECH PVT LTD

Coimbatore

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
10/6/2025BEYONCE INFOTECH PVT LTD

Coimbatore

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
10/6/2025BEYONCE INFOTECH PVT LTD

Coimbatore

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
10/6/2025OXYMORON AG

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/6/2025PATANJALI AYURVED LIMITED

Haridwar

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
10/6/2025MEGALABS

San Salvador

EL SALVADORIVAROXABAN
75UNAPPROVED
10/6/2025Grunenthal Latin America Inc

Coral Gables

UNITED STATRAMADOL HCL (ANALGESIC)
75UNAPPROVED
10/6/2025DROGERIA NUEVA SAN CARLOS

El Salvador

EL SALVADOLANSOPRAZOLE (ANTI-SECRETORY)
75UNAPPROVED
10/6/2025CORPORACION BONIMA

San Salvador

EL SALVADOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
10/6/2025TEOFARMA S.R.L.

Valle Salimbene

ITALYALLOPURINOL (XANTHINE OXIDASE INHIBITOR)
75UNAPPROVED
10/6/2025Recordati Industria Chimica E Farmaceutica S.P.A

Milan

ITALYBISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
10/6/2025Novartis Farma S.P.A.

Torre Annunziata

ITALYVALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
10/6/2025MK

San Salvador

EL SALVADOCIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
10/6/2025CRISTALIA PRODUTOS QUIMOCOS

Sao Paulo

BRAZILFLUVOXAMINE MALEATE (ANTI-DEPRESSANT)
75UNAPPROVED
10/6/2025Bausch and Lomb, Inc

Bridgewater

UNITED STANAPHAZOLINE HCL (ADRENERGIC)
75UNAPPROVED
10/6/2025EMS SA

Sao Paulo

BRAZILNAPHAZOLINE HCL (ADRENERGIC)
75UNAPPROVED
10/6/2025ALTHAIA PHARMACEUTICAL

Atibaia - Sp

BRAZILROSUVASTATIN CALCIUM
75UNAPPROVED
10/6/2025USV PRIVATE LIMITED

Solan

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
10/6/2025MERCK SPECIALTIES PVT LTD

Aurangabad

INDIABISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
10/6/2025TORRENT PHARMA LIMITED

Sikkim

INDIAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
10/6/2025INNOVA CAPTAB

Baddi

INDIAMETOPROLOL (ANTI-ADRENERGIC)
75UNAPPROVED
10/6/2025SUN PHARMA LABORATIROES

Sikkim

INDIARANOLAZINE (ANTI-ANGINAL)
75UNAPPROVED
10/6/2025Macleods Pharmaceuticals

Ranipool

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
10/6/2025LABORATORIO ULTRA SA DE CV

Guadalajara

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/6/2025PHARMACEUTICA MANIPULACAO

Sao Paulo

BRAZILCLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
10/6/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
10/6/2025Innova Captab Limited

Baddi

INDIAITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
10/6/2025Gelnova Laboratories (India) Private Ltd.

Navi Mumbai

INDIACLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
10/6/2025INVERSIONES GARAN

La Ceiba

HONDURASDYPHYLLINE TABLETS
75UNAPPROVED
10/6/2025ELBIA BLANCA RAMIR

Guatemala

GUATEMALAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
10/6/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
75UNAPPROVED
10/6/2025EYSYS PHARM PVT LTD

Channai

INDIANUTRIENT/TONIC N.E.C.
75UNAPPROVED
10/6/2025LUPIN LTD

Sikkim

INDIANUTRIENT/TONIC N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 19 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 237 (NO PMA), 83 (NO PROCESS), 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 225 of 10,077 • Showing records 11,201-11,250 of 503,850 total