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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/10/2025LINHAISHI WANDA GLASSES FACTORY

LINHAI

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
11/10/2025FOTONA D.O.O.

Ljubljana

SLOVENIAGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
126FAILS STD
11/10/2025ULTRA MEDICAL GMBH

Saarbrucken

GERMANYSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025BELEGA CO., LTD

Kita

JAPANMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025GO VISIONARY

Varese

ITALYLENS, CONTACT, FOR COLOR VISION DEFICIENCY
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025Vnx Trade

Subang Jaya Ind Estate Selangor

MALAYSIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+2 more
11/10/2025YA MAN USA LTD

Koto

JAPANMASK, SURGICAL
118NOT LISTED
3280FRNMFGREG
+2 more
11/10/202521st Century Optics

Long Island City

UNITED STALENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+2 more
11/10/2025EG INDUSTRIES

Santo Domingo

DOMINICAN DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025PHARMA KIMYA

Kayseri

TURKEYTUBING, FLUID DELIVERY
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025SUPER BUY LIMITED

Kwai Chung

HONG KONGPOWERED MICRONEEDLE DEVICE
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025WERFEN USA

Bedford

UNITED STASYSTEM, TEST, AUTOMATED BLOOD GROUPING AND ANTIBODY
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025Itelemetric Technologies

Saginaw

UNITED STATESTER, DEFIBRILLATOR
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025Q-Med AB

Uppsala

SWEDENIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025MPA VETERINARY

Barcelona

SPAINREPLENISHER N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025INOVET

Arques

FRANCEALBENDAZOLE (ANTHELMINTIC)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025INOVET

Arques

FRANCEANTIPARASITIC, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025LELY PHARMA BV

Lelystad

NETHERLANDANTI-MICROBIAL N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025LELY PHARMA BV

Lelystad

NETHERLANDCARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025LELY PHARMA BV

Lelystad

NETHERLANDRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025Produlab Pharma

Raamsdonksveer

NETHERLANDIVERMECTIN AND COMBINATIONS (ANTIPARASITIC)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025PRONAFIT BV

Kaatsheuvel

NETHERLANDMENTHOL (ANTI-PRURITIC)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025Produlab Pharma

Raamsdonksveer

NETHERLANDIVERMECTIN AND COMBINATIONS (ANTIPARASITIC)
118NOT LISTED
3280FRNMFGREG
+1 more
11/10/2025TaiDoc Technology Corporation

New Taipei City

TAIWANNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
118NOT LISTED
3280FRNMFGREG
11/10/2025SAMPHIRE NEUROSCIENCE LTD

London

UNITED KINNEUROMODULATOR FOR OBESITY
118NOT LISTED
3280FRNMFGREG
11/10/2025ASIEL GARCIA GONZALEZ

Pachuca

MEXICOSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
118NOT LISTED
3280FRNMFGREG
11/10/2025MAUR-HI-LENS

Guadalajara

MEXICOLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
11/10/2025LLOYD LAB

Qyezib City

PHILIPPINEANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
3280FRNMFGREG
11/10/2025LLOYD LAB

Qyezib City

PHILIPPINEANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
3280FRNMFGREG
11/10/2025LLOYD LAB

Qyezib City

PHILIPPINEANTI-HYPERTENSIVE N.E.C.
118NOT LISTED
3280FRNMFGREG
11/10/2025LLOYD LAB

Qyezib City

PHILIPPINEFENOFIBRATE (ANTI-CHOLESTEREMIC)
118NOT LISTED
3280FRNMFGREG
11/10/2025Lloyd Laboratories Inc.

Bulacan

PHILIPPINELOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
3280FRNMFGREG
11/10/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
3280FRNMFGREG
11/10/2025JUVENOR IMPEX

Nagpur

INDIAIVERMECTIN AND COMBINATIONS (ANTIPARASITIC)
118NOT LISTED
3280FRNMFGREG
11/10/2025Philips Oral Healthcare Inc

Bothell

UNITED STAULTRASOUND, SKIN PERMEATION
118NOT LISTED
3280FRNMFGREG
11/10/2025SENOVA BIOPHARM CO LTD

Kowloon

HONG KONGTIRZEPATIDE (ANTI-DIABETIC)
118NOT LISTED
3280FRNMFGREG
11/10/2025Mc Medical Inc

Minato

JAPANCATHETER, ULTRASOUND, INTRAVASCULAR
118NOT LISTED
3280FRNMFGREG
11/10/2025Mc Medical Inc

Minato

JAPANCATHETER, MAPPING, INTRACARDIAC, REPROCESSED
118NOT LISTED
3280FRNMFGREG
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 20 countries. Records on this page involve violations including 235 (NOT IMPACT), 341 (REGISTERED), 126 (FAILS STD), 118 (NOT LISTED), 3280 (FRNMFGREG) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 99 of 10,038 • Showing records 4,901-4,950 of 501,854 total