ImportRefusal LogoImportRefusal

Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/22/2003GUANGZHOU HE JI GONG PHARMACEUTICAL COMPANY LIMITED

Guangzhou

CHINAANTIBIOTIC N.E.C.
342PERSONALRX
8/22/2003Datax-Ohmedia Divison

Omhmeda

FINLANDTIMER FOR DIAGNOSTIC USE
341REGISTERED
508NO 510(K)
8/22/2003Datax-Ohmedia Divison

Omhmeda

FINLANDTIMER FOR DIAGNOSTIC USE
341REGISTERED
508NO 510(K)
8/22/2003Datax-Ohmedia Divison

Omhmeda

FINLANDTIMER FOR DIAGNOSTIC USE
341REGISTERED
508NO 510(K)
8/22/2003Go Int'L Ltd.

London

UNITED KINKIT, FIRST AID
341REGISTERED
8/22/2003Remed Pharma SA/NV

Uccle

BELGIUMCONDOM
341REGISTERED
8/22/2003Michel Gilberthe

Port Au Prince

HAITIVITAMIN, N.E.C.
324NO ENGLISH
8/22/2003Crown Confectionery Ltd

Seoul

SOUTH KOREFLAVORED OR PARTY CRACKERS
274COLOR LBLG
8/22/2003General Mill Bakeries Food Service

Mississauga

CANADAOAT FLAKES, ROLLED OATS,PUFFS,KRISPIES,LOOPS READY TO EAT
260FALSE
473LABELING
8/22/2003Valco Trade S A C

Lima

PERUMAHI MAHI
249FILTHY
8/22/2003Valco Trade S A C

Lima

PERUMAHI MAHI
249FILTHY
8/22/2003SCH Group Of Company

Kaohsiung

TAIWANLYCHEE, LICHEE, LITCHI, LEECHEE (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
8/22/2003Russian Canadian Trade Inc

Richmond

CANADAFRESH SHREDDED MIXED VEGETABLES FOR SALADS (MIXED VEGETABLES)
218LIST INGRE
482NUTRIT LBL
+2 more
8/22/2003Shikikamaboko Honten

Okawa

JAPANFISH PASTE, FISHERY PRODUCTS, N.E.C.
218LIST INGRE
328USUAL NAME
+1 more
8/22/2003General Mill Bakeries Food Service

Mississauga

CANADAOAT FLAKES, ROLLED OATS,PUFFS,KRISPIES,LOOPS READY TO EAT
218LIST INGRE
256INCONSPICU
+2 more
8/22/2003Herbapol Lublin S.A.

Lublin

POLANDBANDAGE, ELASTIC
118NOT LISTED
341REGISTERED
8/22/2003Herbapol Lublin S.A.

Lublin

POLANDTHERMOMETER, CLINICAL MERCURY
118NOT LISTED
341REGISTERED
8/22/2003PHC Corporation

Ora-gun

JAPANEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE
118NOT LISTED
341REGISTERED
8/22/2003Sto Nino Botanical Center

Marikina City

PHILIPPINEHERBALS & BOTANICAL TEAS, N.E.C.
118NOT LISTED
75UNAPPROVED
8/22/2003Sto Nino Botanical Center

Marikina City

PHILIPPINEHERBALS & BOTANICAL TEAS, N.E.C.
118NOT LISTED
75UNAPPROVED
8/22/2003Glaxosmithkline

Brentford

UNITED KINANTI-ASTHMATIC, N.E.C.
118NOT LISTED
8/22/2003New Medical Technology Group Plc

Livingston

UNITED KINSYRINGE, IRRIGATING
118NOT LISTED
8/22/2003Zoria S.C.

Cracow

POLANDANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
8/22/2003Mofels Food International, Corp.

Makati Metro Manila

PHILIPPINEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
8/22/2003TABLETS (INDIA) LIMITED

Madras

INDIACYPROHEPTADINE HCL (ANTI-HISTAMINIC)
118NOT LISTED
8/22/2003Ho-Jin Medical Cp.,Ltd.

Seoul

SOUTH KORECHISEL, SURGICAL, MANUAL
118NOT LISTED
8/22/2003Ho-Jin Medical Cp.,Ltd.

Seoul

SOUTH KOREFORCEPS, GENERAL & PLASTIC SURGERY
118NOT LISTED
8/22/2003Mercedes Do Carmo

Lima

PERUMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
8/22/2003Glaxosmithkline

Brentford

UNITED KINMAGNESIA (ANTACID)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADATAMSULOSIN HCL (REGULATOR)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADASIMVASTATIN (ANTI-CHOLESTEREMIC)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADACLOPIDOGREL BISULFATE (ANTI-COAGULANT)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADADILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADAFINASTERIDE (INHIBITOR (DECARBOXYLASE))
75UNAPPROVED
8/22/2003Northgate Pharmacy

Winnipeg

CANADAMETOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/22/2003Scholl Plough Canada Inc

Mississauga

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/22/2003Pharmascience Inc.

Montreal

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/22/2003Pharmascience Inc.

Montreal

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/22/2003Prehrambena Industria D.D.

Koprivnica

CROATIAPEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
62NEEDS FCE
83NO PROCESS
8/22/2003Dls S.A.

Suchy Las

POLANDVEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
8/22/2003Dls S.A.

Suchy Las

POLANDVEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
8/22/2003Lg International

Seoul

SOUTH KORETV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
47NON STD
476NO REGISTR
8/22/2003Tecnomac Srl

Villavara

ITALYLASER PRODUCT FOR NON-MEDICAL USE
47NON STD
476NO REGISTR
8/22/2003Zetro Electronic Co

Incheon

SOUTH KORETV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
47NON STD
476NO REGISTR
8/22/2003Pullmax Ursviken Ab

Ursviken

SWEDENTV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
47NON STD
476NO REGISTR
8/22/2003Cray Japan Inc

Nihonba

JAPANTV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
47NON STD
476NO REGISTR
8/22/2003Data Care

Russelsheim

GERMANYTV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
47NON STD
476NO REGISTR
1...951995209521...10077

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 342 (PERSONALRX), 341 (REGISTERED), 508 (NO 510(K)), 324 (NO ENGLISH), 274 (COLOR LBLG) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 9520 of 10,077 • Showing records 475,951-476,000 of 503,850 total