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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/8/2025NBF Holdings USA Inc.

Lancaster

UNITED STANONALCOHOLIC BEVERAGES, N.E.C.
238UNSAFE ADD
473LABELING
8/8/2025GURU NANAK ENTERPRISES Company

Hoshiarpur

INDIAMUSTARD OIL, REFINED, SINGLE INGREDIENT, SEE 28O FOR MUSTARD OIL AS A FLAVORING
238UNSAFE ADD
256INCONSPICU
+4 more
8/8/2025NINGBO BAICHEN MEDICAL DEVICES CO., LTD

Ningbo

CHINAWHEELCHAIR, POWERED
118NOT LISTED
39043904
+1 more
8/8/2025BRAND ADDITION LTD ASIAPACK

Shenzhen

CHINASKIN MICRONEEDLING MANUAL ROLLER (EXPORT ONLY)
118NOT LISTED
3280FRNMFGREG
+1 more
8/8/2025VIS GMBH

Treuen

GERMANYMONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)
118NOT LISTED
3280FRNMFGREG
+1 more
8/8/2025VAGUSTIM SAGLIK TEKNOLOJILERI AN

Istanbul

TURKEYNON-INVASIVE VAGUS NERVE STIMULATOR - HEADACHE
118NOT LISTED
3280FRNMFGREG
+1 more
8/8/2025NINGBO BAICHEN MEDICAL DEVICES CO., LTD

Ningbo

CHINAWHEELCHAIR, POWERED
118NOT LISTED
3280FRNMFGREG
+4 more
8/8/2025Arrow International CR, a.s.

Hradec Kralove 4

CZECH REPUWIRE, GUIDE, CATHETER
118NOT LISTED
3280FRNMFGREG
8/8/2025LABORATOIRES FILL-MED

Paris

FRANCEVITAMIN, N.E.C.
118NOT LISTED
3280FRNMFGREG
8/8/2025Anteis Sa

Plan-les-ouates

SWITZERLANLIDOCAINE
118NOT LISTED
3280FRNMFGREG
8/8/2025ALLERGAN

Annecy

FRANCELIDOCAINE
118NOT LISTED
3280FRNMFGREG
8/8/2025Berpu Medical Technology Co Ltd

Wenzhou

CHINANEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
8/8/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIASET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
118NOT LISTED
3280FRNMFGREG
8/8/2025Tokai Medical Products Inc

Kasugai

JAPANCATHETER, PERCUTANEOUS
118NOT LISTED
3280FRNMFGREG
8/8/2025NIBILU TECH(BEIJING) CO.,LTD.

Shanghai

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+1 more
8/8/2025PRIYANKA RAGHURAM

Bengaluru

INDIAGLIMEPIRIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
8/8/2025VIDA NATURAL

Belo Horizonte

BRAZILVITAMIN, N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025VIDA NATURAL

Belo Horizonte

BRAZILVITAMIN E (TOCOPHEROL)
118NOT LISTED
75UNAPPROVED
8/8/2025VIDA NATURAL

Belo Horizonte

BRAZILVITAMIN C (ASCORBIC ACID)
118NOT LISTED
75UNAPPROVED
8/8/2025VIDA NATURAL

Belo Horizonte

BRAZILBIOTIN (VITAMIN H, COENZYME R)
118NOT LISTED
75UNAPPROVED
8/8/2025VIDA NATURAL

Belo Horizonte

BRAZILDUTASTERIDE
118NOT LISTED
75UNAPPROVED
8/8/2025AJANTA PHARMACEUTICAL LTD

Himachal Pradesh

INDIAREPAGLINIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
8/8/2025MSD PHARMACEUTICALS PVT LTD

New Delhi

INDIAMETFORMIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
8/8/2025SUN PHARMACEUTICAL INDUSTRIES LT

Solan

INDIAOLMESARTAN MEDOXOMIL
118NOT LISTED
75UNAPPROVED
8/8/2025ERBOZETA SPA

Chiesanuova

ITALYVITAMIN, N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025AFRIC PHAR

Mohammedia

MOROCCORIVAROXABAN
118NOT LISTED
75UNAPPROVED
8/8/2025Bottu S.A.

Casablanca

MOROCCOATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
118NOT LISTED
75UNAPPROVED
8/8/2025VICENTE DI BELLA JUNIOR

Sao Paulo Sp

BRAZILLAMOTRIGINE (ANTI-CONVULSANT)
118NOT LISTED
75UNAPPROVED
8/8/2025PHARLAB INDUSTRIA FARMACEUTICA

Americo Silva

BRAZILANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025ENDERECO R ASA

Goiania

BRAZILSUPPRESSANT N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025Ache Laboratories Farmaceuticos

Caruhos

BRAZILANALGESIC, N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILAMIKACIN SULFATE (AMINOGLYCOSIDES)
118NOT LISTED
75UNAPPROVED
8/8/2025Famar Health Care Services Madrid S.A.

Alcorcon

SPAINMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
8/8/2025Cosmax Inc

Gyeonggi-do

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
75UNAPPROVED
8/8/2025INKE S.A.

Castellbisbal

SPAINGLYCOPYRROLATE (ANTI-CHOLINERGIC)
118NOT LISTED
75UNAPPROVED
8/8/2025INKE S.A.

Castellbisbal

SPAINGLYCOPYRROLATE (ANTI-CHOLINERGIC)
118NOT LISTED
75UNAPPROVED
8/8/2025SIMPLIPHARM PHARMACY

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
8/8/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/8/2025CIPLA LIMITED

Mumbai

INDIAMEBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
8/8/2025SANOFI MEDLEY FARMACEUTICA LTDA

Sao Paula

BRAZILLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
8/8/2025EMS PHARMA

Hortolandia

BRAZILROSUVASTATIN CALCIUM
75UNAPPROVED
8/8/2025BIOLAB FARMACEUTICA

Jandiera

BRAZILATENOLOL (ANTI-ADRENERGIC)
75UNAPPROVED
8/8/2025FELIX HEALTH

Toronto

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
8/8/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/8/2025SIAS CO.,LTD

Cheongju-si

SOUTH KORERICE, GLUTINOUS, PROCESSED (PACKAGED)
62NEEDS FCE
83NO PROCESS
8/8/2025Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
8/8/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/8/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/8/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/8/2025Sabritas S. de R.L. de C.V. , Planta ABC

Ciudad De Mexico

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
256INCONSPICU
+2 more

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 238 (UNSAFE ADD), 473 (LABELING), 256 (INCONSPICU), 321 (LACKS N/C), 482 (NUTRIT LBL) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 356 of 10,077 • Showing records 17,751-17,800 of 503,850 total