Import Refusal Records

501,854 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
10/3/2001	Basaran Tarim Urunleri Tic Ltd. Izmir	TURKEY	RAISINS, DRIED OR PASTE	157FOREIGN OB
10/3/2001	UQUIFA Mexico, S.A. de C.V. Jiutepec	MEXICO	RANITIDINE HYDROCHLORIDE (ANTACID)	118NOT LISTED 27DRUG GMPS
10/3/2001	Aurobindo Pharma Limited Ameerpet	INDIA	MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED
10/3/2001	Aurobindo Pharma Limited Ameerpet	INDIA	PENICILLIN G, NATURAL	118NOT LISTED
10/3/2001	Aurobindo Pharma Limited Ameerpet	INDIA	MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED
10/3/2001	Aurobindo Pharma Limited Ameerpet	INDIA	PENICILLIN G, NATURAL	118NOT LISTED
10/3/2001	Gerald Wise & Co Ltd London	UNITED KIN	MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED
10/3/2001	Sea-Air Export Co Ltd Pathum Wan	THAILAND	BANDAGE, ELASTIC	118NOT LISTED
10/3/2001	R-Biopharm Darmstadt	GERMANY	CONTAINER, SPECIMEN MAILER AND STORAGE	118NOT LISTED
10/3/2001	ASCA APICOLA S?O CAETANO Brazopolis	BRAZIL	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
10/3/2001	C. I. Vega & Vega Ltda. Medellin	COLOMBIA	PEPPER, HOT, WITH SAUCE	62NEEDS FCE 83NO PROCESS
10/3/2001	LG Electronics Reynosa SA de CV Reynosa	MEXICO	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD
10/2/2001	Kaanlar Sut Ve Gida Sanayii Istanbul	TURKEY	SOFT RIPENED CHEESE MADE FROM GOAT'S MILK (E.G., CHEVRE, FETA, GOAT)	308MFR INSAN
10/2/2001	Vasquezfuentas, Cesar Arturo Morazan	EL SALVADO	CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC)	251POISONOUS
10/2/2001	Carnes Frias Del Mar Ltda Tumaco	COLOMBIA	CRAB	249FILTHY 320LACKS FIRM
10/2/2001	Intermares,S.A. De C.V. Ensenada	MEXICO	SHRIMP & PRAWNS	249FILTHY
10/2/2001	Ramdev Food Products Pvt Ltd Changodar	INDIA	PIGEON PEAS, BEAN AND PEA SPROUTS	241PESTICIDE
10/2/2001	Tzong Rong Optical Co., Ltd. Guangzhou	CHINA	SPECTACLE, MAGNIFYING	235NOT IMPACT
10/2/2001	Win Merry Ltd., Hong Kong	HONG KONG	NONALCOHOLIC BEVERAGES, N.E.C.	218LIST INGRE
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	SAUCES, N.E.C.	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	BARBECUE SAUCE	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	COCONUT MILK BEVERAGE BASE	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	BEVERAGE BASE, PIT FRUIT	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	FRUIT BEVERAGE BASE, N.E.C.	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	FRUIT BEVERAGE BASE, N.E.C.	62NEEDS FCE 83NO PROCESS
10/2/2001	Lynford Dillon Garvey Meade	JAMAICA	BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.	62NEEDS FCE 83NO PROCESS
10/2/2001	Power Root (M) Sdn Bhd Johor Bahru	MALAYSIA	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	11UNSAFE COL 218LIST INGRE +1 more
10/2/2001	Ramdev Food Products Pvt Ltd Changodar	INDIA	HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	11UNSAFE COL
10/2/2001	Grupo Embotelladoras Unidas, S.A. De C.V. Guadalajara	MEXICO	SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED	11UNSAFE COL
10/2/2001	Confecciones de Juarez, S.A. de C.V Juarez	MEXICO	MINT CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)	11UNSAFE COL
10/2/2001	Lotte Confectionery Co., Ltd. Seoul	SOUTH KORE	HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	11UNSAFE COL
10/2/2001	Crown Confectionery Co Ltd Yongsan-Gu Seoul	SOUTH KORE	HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	11UNSAFE COL
10/1/2001	GlaxoSmithKline Biologicals SA Rixensart	BELGIUM	EXPECTORANT N.E.C.	118NOT LISTED
10/1/2001	Makaira Guayaquil	ECUADOR	MAHI MAHI	2360HISTAMINE
10/1/2001	Nissho Corporation Osaka	JAPAN	DIALYZER, CAPILLARY, HOLLOW FIBER	341REGISTERED 508NO 510(K)
10/1/2001	South Ocean Company Ho Chi Minh	VIETNAM	CLAMS	320LACKS FIRM 482NUTRIT LBL +1 more
10/1/2001	Agrocomercial Sumpango Sa Guatemala City	GUATEMALA	PEAS	241PESTICIDE
10/1/2001	Parke-Davis Div Scarborough	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	179AGR RX
10/1/2001	Diagnostic Biochem Canada Inc. London	CANADA	REAGENT, GENERAL PURPOSE	118NOT LISTED 508NO 510(K)
10/1/2001	Verathon, Inc. Bothell	UNITED STA	CLEANER, ULTRASONIC, MEDICAL INSTRUMENT	118NOT LISTED 508NO 510(K)
10/1/2001	GlaxoSmithKline Biologicals SA Rixensart	BELGIUM	SYRINGE, PISTON	118NOT LISTED
10/1/2001	Smithkline Beecham Brentford	UNITED KIN	EXPECTORANT N.E.C.	118NOT LISTED
10/1/2001	Nancy Edwards Channel-Port-Aux-Basques	CANADA	STIMULATOR, MUSCLE, POWERED	118NOT LISTED
10/1/2001	Handtronix, Inc Draper	UNITED STA	AUDIOMETER	118NOT LISTED
10/1/2001	Mediq Prn Phoenix	UNITED STA	DEVICE, GENERAL MEDICAL	118NOT LISTED
10/1/2001	Compania Galletas Pozuelo DCR S.A Uruca	COSTA RICA	PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)	83NO PROCESS
10/1/2001	LG ELECTRONICS (MANAUS) INC. Manaus	BRAZIL	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD
10/1/2001	LG Electronics Reynosa SA de CV Reynosa	MEXICO	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD
10/1/2001	LG Electronics Reynosa SA de CV Reynosa	MEXICO	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD

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About This Page

This page displays 50 FDA import refusal records from 22 countries. Records on this page involve violations including 157 (FOREIGN OB), 118 (NOT LISTED), 27 (DRUG GMPS), 75 (UNAPPROVED), 62 (NEEDS FCE) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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