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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/24/2025Swiss Bionic Solutions GmbH

Schindellegi

SWITZERLANMASSAGER, THERAPEUTIC, ELECTRIC
237NO PMA
508NO 510(K)
7/24/2025SWISS BIONIC SOLUTIONS SCHWEIZ

Reichenburg

SWITZERLANMASSAGER, THERAPEUTIC, ELECTRIC
237NO PMA
7/24/2025Zhongshan Dai Sing Frozen Food Company Ltd.

Zhongshan

CHINAFISH, N.E.C.
218LIST INGRE
260FALSE
+4 more
7/24/2025Beiersdorf AG

Hamburg

GERMANYOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
7/24/2025Medica Corporation

Bedford

UNITED STAELECTRODE, ION SPECIFIC, SODIUM
118NOT LISTED
3280FRNMFGREG
+1 more
7/24/2025WENZHOU LANSON INTERNATIONAL CO., LTD.

Wenzhou

CHINAFRAME, SPECTACLE
118NOT LISTED
3280FRNMFGREG
+1 more
7/24/2025A.H. GEIGER

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
7/24/2025HALEON UK TRADING LIMITED

Weybridge

UNITED KINDICLOFENAC SODIUM (ANTI-INFLAMMATORY)
118NOT LISTED
3280FRNMFGREG
7/24/2025Pfizer

Richmond

UNITED STAZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT)
118NOT LISTED
3280FRNMFGREG
7/24/2025OPTICA VISUAL GROUP SPA

Santiago

CHILELENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
3280FRNMFGREG
7/24/2025The Kuwaiti Danish Dairy Company KCSC

Sabhan

KUWAITCREAM, SWEET, WHIPPING, TABLE, ETC.
83NO PROCESS
7/24/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
7/24/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
7/24/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
7/24/2025BRITISH PHARMACOPOEIA

London

UNITED KINEPINEPHRINE (ADRENERGIC)
75UNAPPROVED
7/24/2025BRITISH PHARMACOPOEIA

London

UNITED KINATENOLOL (ANTI-ADRENERGIC)
75UNAPPROVED
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIAYAMS, DRIED OR PASTE (ROOT & TUBER VEGETABLE)
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIACAPSICUMS (CAYENNE CHILI, HOT PEPPERS), GROUND, CRACKED (SPICE)
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIAEDIBLE SEEDS, N.E.C.
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIAPALM KERNEL OIL, REFINED, SINGLE INGREDIENT
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIAEEL
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025MACLARA XPORT NIG LTD

Lagos

NIGERIACRAYFISH (CRAWFISH), FRESH WATER, CAKES, BALLS, ETC.
218LIST INGRE
320LACKS FIRM
+3 more
7/23/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
3280FRNMFGREG
+1 more
7/23/2025UNION MEDICO APS

Copenhagen

DENMARKCATHETER INTRODUCER
118NOT LISTED
3280FRNMFGREG
+1 more
7/23/2025CREATION FOODS

Manchester

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+2 more
7/23/2025CREATION FOODS

Manchester

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+2 more
7/23/2025CHANGZHOU CHENGHONG INTL

Jiangsu

CHINASURGICAL MASK WITH ANTIMICROBIAL/ANTIVIRAL AGENT
118NOT LISTED
3280FRNMFGREG
+2 more
7/23/2025Olympus Optical Co (Europa) Gmbh

Hamburg

GERMANYDUODEDOSCOPE, ESOPHAGO GASTRO
118NOT LISTED
3280FRNMFGREG
+2 more
7/23/2025OXYMORON AG

Lorrach

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
7/23/2025Abbott India Limited

Salcette

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
7/23/2025RIGOR INSTRUMENTS

Sialkot

PAKISTANFORCEPS
118NOT LISTED
3280FRNMFGREG
7/23/2025MARCSON HEALTHCARE

Lagos

NIGERIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
3280FRNMFGREG
7/23/2025PAL PHARMACEUTICAL IND., LTD.

Kano

NIGERIACHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
118NOT LISTED
3280FRNMFGREG
7/23/2025Procept BioRobotics Corporation

San Jose

UNITED STAUNIT,ELECTROSURGICAL,ENDOSCOPIC(WITH OR WITHOUT ACCESSORIES),REPROCESSED
118NOT LISTED
3280FRNMFGREG
7/23/2025NIPRO CORP.

Odate

JAPANPUMP, INFUSION, ELASTOMERIC
118NOT LISTED
508NO 510(K)
7/23/2025NIPRO CORP.

Odate

JAPANPURIFIER, WATER (ABSORPTION, DEIONIZATION, MEMBRANE FILTER, REVERSE OSMOSIS)
118NOT LISTED
508NO 510(K)
7/23/2025NIPRO CORP.

Odate

JAPANDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
118NOT LISTED
508NO 510(K)
7/23/2025Nipro Medical Industries, Ltd.

Tatebayashi

JAPANWIRE, GUIDE, CATHETER
118NOT LISTED
508NO 510(K)
7/23/2025Nipro Medical Industries, Ltd.

Tatebayashi

JAPANNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
118NOT LISTED
508NO 510(K)
7/23/2025NIPRO CORP.

Odate

JAPANSTOPCOCK, I.V. SET
118NOT LISTED
508NO 510(K)
7/23/2025MAESTRO SURGICAL

Sialkot

PAKISTANINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
290DE IMP GMP
+1 more
7/23/2025BIOCON BIOLOGICS

Etobicoke

CANADAINSULIN (INJ) (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
7/23/2025Eli Lilly & Co

Indianapolis

UNITED STAINSULIN (INJ) (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
7/23/2025ALCON MANAGEMENT S.A.

Vernier

SWITZERLANTRAVOPROST (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
7/23/2025VIATRIS HEALTHCARE LTD

Dublin

IRELANDATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
118NOT LISTED
75UNAPPROVED
7/23/2025Bayer AG

Leverkusen

GERMANYASPIRIN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
7/23/2025IBN SAVIO SRL

Pomezia

ITALYMETFORMIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
7/23/2025Boehringer Ingelheim Pharma GmbH & Co. KG

Ingelheim am Rhein

GERMANYEMPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
7/23/2025Grossman

Ciudad De Mexico

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
7/23/2025Merck

Guatamala

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 237 (NO PMA), 508 (NO 510(K)), 218 (LIST INGRE), 260 (FALSE), 320 (LACKS FIRM) and 13 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 391 of 10,077 • Showing records 19,501-19,550 of 503,850 total