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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/7/2025Bayer

Warsaw

POLANDHOMEOPATHIC GASTROINTESTINAL
75UNAPPROVED
3/7/2025Altea Farmaceutica

Bogota

COLOMBIABISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
3/7/2025Emami Limited

Kolkata

INDIASALICYLAMIDE (ANALGESIC)
75UNAPPROVED
3/7/2025KAILAS JEEVAN

Maharashtra

INDIAANTIBIOTIC N.E.C.
75UNAPPROVED
3/7/2025Himalaya Wellness Company

Bengaluru

INDIAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
3/6/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
3/6/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
3/6/2025MINISTRY A/S

Svendborg

DENMARKSNUS
3842TP NO PMTA
3/6/2025MTR Foods Private Limited

Bangalore

INDIASPICES AND SEASONING, GROUND, CRACKED, WITH SALT, N.E.C.
3300ALLERGEN
473LABELING
3/6/2025NIPRO INDIA CORPORATION PVT.LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025Nipro Medical Hefei Co. Ltd

Hefei City

CHINADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025Webest Medical Products Co Ltd

Jiangsu

CHINASET, BLOOD TRANSFUSION
3280FRNMFGREG
3/6/2025NIPRO INDIA CORPORATION PVT.LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025Nipro Medical Industries, Ltd.

Tatebayashi

JAPANNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
3280FRNMFGREG
3/6/2025P.T. Nipro Indonesia Jaya

Karawang

INDONESIANEEDLE, HYPODERMIC, SINGLE LUMEN
3280FRNMFGREG
3/6/2025NIPRO INDIA CORPORATION PVT. LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025NIPRO THAILAND CORP LTD

Ayuthaya

THAILANDNEEDLE, HYPODERMIC, SINGLE LUMEN
3280FRNMFGREG
3/6/2025Greiner Bio-One GmbH

Kremsmunster

AUSTRIATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
3280FRNMFGREG
3/6/2025Greiner Bio-One GmbH

Kremsmunster

AUSTRIADEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC
3280FRNMFGREG
3/6/2025NIPRO INDIA CORPORATION PVT. LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025NIPRO CORP.

Odate

JAPANPUMP, INFUSION, ELASTOMERIC
3280FRNMFGREG
3/6/2025NIPRO CORP.

Odate

JAPANDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
3280FRNMFGREG
3/6/2025NIPRO CORP.

Odate

JAPANNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
3280FRNMFGREG
3/6/2025NIPRO CORP.

Odate

JAPANSTOPCOCK, I.V. SET
3280FRNMFGREG
3/6/2025Colgate-Palmolive (Thailand) Limited - Branch

Amphur Muang

THAILANDSODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
3280FRNMFGREG
3/6/2025THE 8TH ELEMENT

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
260FALSE
+3 more
3/6/2025THE 8TH ELEMENT

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
260FALSE
+2 more
3/6/2025NIPRO CORP.

Odate

JAPANDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
508NO 510(K)
3/6/2025Greiner Bio-One GmbH

Kremsmunster

AUSTRIATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
508NO 510(K)
3/6/2025Greiner Bio-One Hungary Kft

Mosonmagyarovar

HUNGARYDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC
508NO 510(K)
3/6/2025Greiner Bio-One GmbH

Kremsmunster

AUSTRIATUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
508NO 510(K)
3/6/2025NIPRO RENAL SOLUTIONS SPAIN S.R.

Mollerussa

SPAINDIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
508NO 510(K)
3/6/2025Marudhar Impex

Ahmedabad

INDIAMAGNESIUM (MINERAL)
482NUTRIT LBL
3/6/2025HONGKONG LASERSPEED TECH CO LTD

Dan Dong

CHINAIR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER
476NO REGISTR
3/6/2025KLA TENCOR KOREA

GYEONGGI-DO

SOUTH KOREGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
3/6/2025BAHADIR OZTUNA

Bursa

TURKEYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
324NO ENGLISH
3/6/2025Polizoidou Anastasia

Alexandroupoli

GREECESESAME SEED PASTE (E.G., TAHINA), EDIBLE SEED PROD.
295LISTERIA
3/6/2025L. Dometita & Sons Food Industries

Quezon City

PHILIPPINESAFFRON, WHOLE (SPICE)
265SUBSTITUTE
274COLOR LBLG
+1 more
3/6/2025Sagacomex

Quito

ECUADORCHEESE PRODUCTS, NON-STANDARDIZED, N.E.C.
251POISONOUS
308MFR INSAN
+1 more
3/6/2025PHAM THI MAI CHI

Ho Chi Minh

VIETNAMPLUM, DRIED OR PASTE
251POISONOUS
3/6/2025FRESH SOURCING SA DE CV

San Luis Rio Colorado

MEXICODATES (PIT FRUIT), (PIT FRUIT)
249FILTHY
3/6/2025FRESH SOURCING SA DE CV

San Luis Rio Colorado

MEXICODATES (PIT FRUIT), (PIT FRUIT)
249FILTHY
3/6/2025EDATTEN LLC

Tolga

ALGERIADATES, DRIED OR PASTE
249FILTHY
3/6/2025KRISHNA OVERSEAS INC.

New Delhi

INDIACANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3/6/2025KRISHNA OVERSEAS INC.

New Delhi

INDIACANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
3/6/2025MARTIN TEODORO TEODORO

Ixhuatlan Del Cafe

MEXICOTARO, DASHEEN (ROOT & TUBER VEGETABLE)
241PESTICIDE
3/6/2025Taishan Xinrun food Co., LTD

Jiangmen

CHINACHINESE CABBAGE, DRIED OR PASTE
241PESTICIDE
3/6/2025HECTOR FLORES ZARATE

Tepeaca

MEXICOSCALLIONS, GREEN ONIONS (ROOT & TUBER VEGETABLE)
241PESTICIDE
3/6/2025RAMIRO ALVAREZ CERVANTEZ

Veracruz

MEXICOPINEAPPLE (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
3/6/2025NIPRO CORP.

Odate

JAPANPUMP, INFUSION, ELASTOMERIC
237NO PMA

About This Page

This page displays 50 FDA import refusal records from 21 countries. Records on this page involve violations including 75 (UNAPPROVED), 3842 (TP NO PMTA), 3843 (TP NO SE), 3300 (ALLERGEN), 473 (LABELING) and 19 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 644 of 10,077 • Showing records 32,151-32,200 of 503,850 total