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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/7/2026Vantive Manufacturing Pte. Ltd.

Singapore

SINGAPOREDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
118NOT LISTED
3280FRNMFGREG
+1 more
1/7/2026IDEAL MEDICAL INDUSTRIES CO LTD

Shangrao

CHINAGLOVE, PATIENT EXAMINATION, LATEX
118NOT LISTED
3280FRNMFGREG
+1 more
1/7/2026NACHANG XIONGPENG MEDICAL EQUIPMENT

Nanchang

CHINASPONGE, GAUZE
118NOT LISTED
3280FRNMFGREG
1/7/2026ISHGA

Stornoway

UNITED KINISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
3280FRNMFGREG
1/7/2026Body Clock Health Care Ltd

London

UNITED KINSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
118NOT LISTED
508NO 510(K)
1/7/20263M Deutschland GmbH

Seefeld

GERMANYCEMENT, DENTAL
118NOT LISTED
508NO 510(K)
1/7/20263M Deutschland GmbH

Seefeld

GERMANYCROWN AND BRIDGE, TEMPORARY, RESIN
118NOT LISTED
508NO 510(K)
1/7/20263M Deutschland GmbH

Seefeld

GERMANYCEMENT, DENTAL
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Irvine

UNITED STACEMENT, DENTAL
118NOT LISTED
508NO 510(K)
1/7/20263M UNITEK

Monrovia

UNITED STAADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN
118NOT LISTED
508NO 510(K)
1/7/2026KURARAY NORITAKE DENTAL NIIGATA PLANT

Tainai

JAPANAGENT, TOOTH BONDING, RESIN
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STAAGENT, TOOTH BONDING, RESIN
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, IMPRESSION
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STACEMENT, DENTAL
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STACEMENT, DENTAL
118NOT LISTED
508NO 510(K)
1/7/20263M Espe Dental Products

Saint Paul

UNITED STASEALANT, PIT AND FISSURE, AND CONDITIONER
118NOT LISTED
508NO 510(K)
1/7/2026Abbott Biologicals BV

Olst

NETHERLANDDYDROGESTERONE (PROGESTIN)
118NOT LISTED
75UNAPPROVED
1/7/2026Gufic Biosciences Limited

Navsari

INDIACHORIONIC GONADOTROPIN
118NOT LISTED
75UNAPPROVED
1/7/2026RANGMANTH ENTERPRISE

Pradesh

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
1/7/2026LA PRISTINE BIOCEUTICALS

Pradesh

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
1/7/2026DR. REDDYS LAB LTD

Hyderabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
1/7/2026SAVIOUR LIFESCIENCES

Maharashtra

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
1/7/2026TRITON HEALTHCARE PVT LTD

Kancheepuram

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
1/7/2026VITABIOTICS LIMITED

London

UNITED KINMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026Ipca Laboratories Ltd(for Phyto-Riker (GIHOC) Pharmaceutical

Accra

GHANAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026Dannex Ltd

Accra

GHANAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026Skg Pharma Limited

Lagos

NIGERIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026TIL HEALTHCARE PVT LTD

Irugulam Post

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026TIL HEALTHCARE PVT LTD

Irugulam Post

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026Shalina Laboratories Limited

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026DREAM COSMETICS

Abigian

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/7/2026UNIVERSAL GLOBAL TECH

Suzhou

CHINAUPC READER (BAR CODE RECORDER), UTILITY/PERIPHERAL LASER PRODUCTS
47NON STD
1/7/2026Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
1/7/2026Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
1/7/2026Tangerine Confectionary

Pontefract

UNITED KINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
1/7/2026Alimentos Maravilla S.A.

Escuintla

GUATEMALASOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED
11UNSAFE COL
253STD IDENT
+3 more
1/6/2026HECHO EN MEXICO POR LABORATORIOS

Cuajimalpa De Morelos

MEXICOVITAMIN E (TOCOPHEROL)
75UNAPPROVED
1/6/2026CHEMISTRY LABORATORIES SONS SA

Mexico City

MEXICOHYDROCORTISONE (GLUCOCORTICOID)
75UNAPPROVED
1/6/2026HEALING PHARMA INDIA PVT LTD

Mumbai

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026ELDER PHARMA LTD

Maharashtra

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026HEALING PHARMA INDIA PVT LTD

Mumbai

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/6/2026USV Private Limited

Vadodara

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026Pfizer

Manhattan

UNITED STAPREDNISONE (GLUCOCORTICOID)
75UNAPPROVED
1/6/2026SANOFI & BRISTOL-MYERS

Bridgewater

UNITED STAIRBESARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1...303132...10077

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 75 (UNAPPROVED), 47 (NON STD) and 7 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 31 of 10,077 • Showing records 1,501-1,550 of 503,850 total