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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/21/2025Forever 18 International

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+3 more
11/21/2025DILAN

Jungnang District

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
11/21/2025DILAN

Jungnang District

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
11/21/2025IBSA Farmaceutici Italia Srl

Lodi

ITALYIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
11/21/2025Teoxane S.A.

Geneva

SWITZERLANIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
11/21/2025EXCELLENT HI CARE

Chennai

INDIALENS, INTRAOCULAR
118NOT LISTED
237NO PMA
+1 more
11/21/2025Kenvue Brands LLC

Summit

UNITED STAWATER, PURIFIED (EYEWASH)
118NOT LISTED
11/21/2025PYMDS TECHNOLOGY CORPORATION

New Taipei City

TAIWANTUBE, ASPIRATING, FLEXIBLE, CONNECTING
118NOT LISTED
11/21/2025SHENZHEN ASIA UNIVERSAL TECHNOLOGY CO.,LTD

Shenzhen

CHINASELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER
118NOT LISTED
11/21/2025Hetero Labs Ltd

Sanath Nagar

INDIAMIRABEGRON (ADRENERGIC)
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKACINNAMON, CASSIA, GROUND, CRACKED (SPICE)
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKACINNAMON, CASSIA, GROUND, CRACKED (SPICE)
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKAESSENTIAL OILS FOR FLAVORING, N.E.C.
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKAESSENTIAL OILS FOR FLAVORING, N.E.C.
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKAESSENTIAL OILS FOR FLAVORING, N.E.C.
75UNAPPROVED
11/21/2025SANCAN EXPORTS LANKA (PRIVATE) LIMITED

Southern Province

SRI LANKAESSENTIAL OILS FOR FLAVORING, N.E.C.
75UNAPPROVED
11/21/2025LUCIUS PHARMACEUTICALS

Vientiane

LAOSIMMUNOSUPPRESS N.E.C.
75UNAPPROVED
11/21/2025EMS S/A

Campo

BRAZILHYDROCHLOROTHIAZIDE (DIURETIC)
75UNAPPROVED
11/21/2025BIOLAB

Sao Paulo

BRAZILLOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/21/2025ASPEN INDUSTRIA FARMACEUTICA LTD

Rio De Janeiro

BRAZILTRAZODONE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
11/21/2025JANNSSEN PHARMACEUTICA N.V.

Beerse

BELGIUMDOMPERIDONE
75UNAPPROVED
11/21/2025Vanity Vision

Faridabad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/21/2025Vianex

Pallini

GREECEONDANSETRON (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
11/21/2025E11EMENT INC.

Scarborough

CANADAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/21/2025NOVARTIS PHARMACEUTICALS CANADA

Montreal

CANADACARBAMAZEPINE (ANALGESIC)
75UNAPPROVED
11/21/2025ADAMED PHARMA S.A.

Pabianice

POLANDACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
11/21/2025BIOFARM Ltd.

Poznan

POLANDSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
11/21/2025BIOFARM Ltd.

Poznan

POLANDSERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
11/21/2025NEURAXPHARM GMBH

Langenfeld

GERMANYBUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
11/21/2025Merck Kommanditgesellschaft auf Aktien

Darmstadt

GERMANYBISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/21/2025Sonofi Winthorp

Cedex

FRANCEIRBESARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/21/2025Boehringer Ingelheim Pharma Gmbh & Co Kg

Biberach An Der Ris

GERMANYINTERFERON BETA-1B
75UNAPPROVED
11/21/2025Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/21/2025VTS LIFE SCEINCE

Punjab

INDIAVITAMIN, N.E.C.
75UNAPPROVED
11/21/2025PRODUCT FRANCHISE

Chandigarh

INDIAVITAMIN, N.E.C.
75UNAPPROVED
11/21/2025COSMENOVA

Panchkula

INDIAVITAMIN, N.E.C.
75UNAPPROVED
11/21/2025SAMRVIR BIOTECH PRIVATE LIMITED

Haryana

INDIAVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
11/21/2025COSMOSENTIALS

Bihar

INDIANICOTINAMIDE (NIACINAMIDE) (VITAMIN)
75UNAPPROVED
11/21/2025DERMAVILLE

Haryana

INDIAVITAMIN C (ASCORBIC ACID)
75UNAPPROVED
11/21/2025COSMENOVA

Panchkula

INDIANICOTINAMIDE (NIACINAMIDE) (VITAMIN)
75UNAPPROVED
11/21/2025ZUVENTUS HEALTHCARE

Mumbai

INDIAANTIBIOTIC N.E.C.
75UNAPPROVED
11/21/2025ELI LILLY CANADA INC

Toronto

CANADADULAGLUTIDE
75UNAPPROVED
11/21/2025Ursapharm Arzneimittel GmbH

Saarbrucken

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/21/2025KDC/ONE Development Corporation, Inc.

Knowlton

CANADAMENTHOL (ANTI-PRURITIC)
75UNAPPROVED
11/21/2025Janssen Inc.

North York

CANADAPALIPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/21/2025Bausch Health Companies Inc.

Laval

CANADAANALGESIC, N.E.C.
75UNAPPROVED
11/21/2025FAES FARMA PORTUGAL, S.A.

Amadora

PORTUGALPROTECTANT N.E.C.
75UNAPPROVED
11/21/2025Novo Nordisk A/S

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
11/21/2025RHETT HEALTHCARE PVT LTD

Telangana

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/21/2025ZIOU KOREA

Gangseo

SOUTH KORELASER MARKER OR ENGRAVER
47NON STD

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 118 (NOT LISTED), 237 (NO PMA), 3280 (FRNMFGREG), 341 (REGISTERED), 84 (RX DEVICE) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 63 of 10,038 • Showing records 3,101-3,150 of 501,854 total