Import Refusal Records

501,854 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
11/7/2001	Gambro Renal Products, Incorporated Englewood	UNITED STA	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	118NOT LISTED 508NO 510(K)
11/7/2001	Gambro Lundia AB Lund	SWEDEN	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	118NOT LISTED 508NO 510(K)
11/7/2001	Sicos et Cie Caudry	FRANCE	ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED
11/7/2001	Cosmelor Ltd. Minato	JAPAN	ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.	118NOT LISTED
11/7/2001	Ittico Sarda Srl Arzachena	ITALY	FISH, N.E.C.	83NO PROCESS
11/7/2001	Bayer Diagnostics Newbury	UNITED KIN	CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)	75UNAPPROVED
11/7/2001	Zhongshan Carlos Health Drinks Co.,Ltd Zhongshan	CHINA	LYCHEE, LICHEE, LITCHI, LEECHEE, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT	62NEEDS FCE 83NO PROCESS
11/7/2001	Zhongshan Carlos Health Drinks Co.,Ltd Zhongshan	CHINA	TEA, N.E.C.	62NEEDS FCE 83NO PROCESS
11/7/2001	Sam Mex Tijuana	MEXICO	SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE	47NON STD
11/7/2001	Pt. Varia Niaga Nusantara Surabaya	INDONESIA	SNAPPER (RED, GRAY, MALABAR, ETC.)	9SALMONELLA
11/7/2001	Pt. Varia Niaga Nusantara Surabaya	INDONESIA	SNAPPER (RED, GRAY, MALABAR, ETC.)	9SALMONELLA
11/7/2001	Pt. Varia Niaga Nusantara Surabaya	INDONESIA	SNAPPER (RED, GRAY, MALABAR, ETC.)	9SALMONELLA
11/6/2001	Custom Color Contacts Inc. New York	UNITED STA	LENS, CONTACT (OTHER MATERIAL) - DAILY	508NO 510(K)
11/6/2001	Siemens Ag Offenbach Am Main	GERMANY	CATHODE RAY TUBE	476NO REGISTR
11/6/2001	LPG Systems Valence Cedex 9	FRANCE	ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY	341REGISTERED 508NO 510(K)
11/6/2001	Sj Harvest International Muuang Raying	THAILAND	TOOTHBRUSH, MANUAL	341REGISTERED
11/6/2001	Scoff Fromageries Francais Grigny	FRANCE	CHEESE, GOAT, N.E.C.	295LISTERIA
11/6/2001	Scoff Fromageries Francais Grigny	FRANCE	CHEESE, GOAT, N.E.C.	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	CHEESE, SWISS, EMMENTALER	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	CHEESE, ROQUEFORT	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	CHEESE (STANDARDIZED),N.E.C.	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	CHEESE (STANDARDIZED),N.E.C.	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/6/2001	LACTALIS LOGISTIQUE EXPORT THIAIS Thiais	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/6/2001	Sai Marine Export Pvt. Ltd. Visakhapatnam	INDIA	SHRIMP & PRAWNS	249FILTHY 9SALMONELLA
11/6/2001	Coreline Exports Kolkata	INDIA	SHRIMP & PRAWNS	249FILTHY 9SALMONELLA
11/6/2001	K.K.Imports And Exports Chennai	INDIA	RICE, BASMATI, PROCESSED (PACKAGED)	249FILTHY
11/6/2001	Dulces Arco Iris De Guadalajara Guadalajara	MEXICO	CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)	249FILTHY
11/6/2001	Productora Y Comercializadora De Productos S.A De C.V Monterrey	MEXICO	CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)	249FILTHY
11/6/2001	Tianjin Tang Gu Latex Factory Tianjin	CHINA	MUSHROOM, COMMON (AGARICUS BISPORUS), BROKEN OR KIBBLED	249FILTHY
11/6/2001	Jorge Rodriguez Quezada Aguascalientes	MEXICO	PEPPER, HOT, DRIED OR PASTE	249FILTHY
11/6/2001	Industrial Deshidratadora,Sa Cv Mexico Df Mx Fn	MEXICO	TAMARIND, DRIED OR PASTE	249FILTHY
11/6/2001	KAIPING CEREALS & OILS, FOODSTUFFS I/E COMPANY OF GUANGDONG Jiangmnsh	CHINA	RICE VERMICELLI	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	NECTARINE (PIT FRUIT)	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	PLUM (PIT FRUIT)	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	PEACH (PIT FRUIT)	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	PLUM (PIT FRUIT)	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	NECTARINE (PIT FRUIT)	249FILTHY
11/6/2001	Gerawan Farming Inc. Sanger	UNITED STA	PEACH (PIT FRUIT)	249FILTHY
11/6/2001	Gerardo Barrondeanda Tonala	MEXICO	TAMARIND (SUBTROPICAL AND TROPICAL FRUIT)	249FILTHY
11/6/2001	Tropical Canning (Thailand) Public Company Hat Yai	THAILAND	TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)	249FILTHY
11/6/2001	Ningbo Today Food Co., Ltd. Ningbo	CHINA	SHRIMP & PRAWNS	249FILTHY
11/6/2001	Jorge Rodriguez Quezada Aguascalientes	MEXICO	PEPPER, HOT, DRIED OR PASTE	249FILTHY
11/6/2001	Exportadora Gomez Cruz, C. Por A. La Vega	DOMINICAN	CHINESE EGGPLANT, THAI EGGPLANT (FRUIT USED AS VEGETABLE)	241PESTICIDE
11/6/2001	Exportadora Gomez Cruz, C. Por A. La Vega	DOMINICAN	CHINESE EGGPLANT, THAI EGGPLANT (FRUIT USED AS VEGETABLE)	241PESTICIDE
11/6/2001	Exportadora Gomez Cruz, C. Por A. La Vega	DOMINICAN	CHINESE EGGPLANT, THAI EGGPLANT (FRUIT USED AS VEGETABLE)	241PESTICIDE
11/6/2001	Delpharm Boucherville Canada, Inc. Boucherville	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	179AGR RX
11/6/2001	Delpharm Boucherville Canada, Inc. Boucherville	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	179AGR RX
11/6/2001	Artesanias Y Ceramicas "Juan Pablo" Juan Pablo Munoz Guzman San Juan De Los Lagos	MEXICO	KITCHEN AND TABLEWARE, N.E.C., (FOODWARE, COOKWARE & TABLEWARE)	171CONTAINER
11/6/2001	Artesanias Y Ceramicas "Juan Pablo" Juan Pablo Munoz Guzman San Juan De Los Lagos	MEXICO	SOUP PAN/POT, ROASTING PAN, ETC (DEEP ITEM CAPABLE OF HOLDING LIQUID W/ OR W/O LID) FOOD/COOK/TABLE	171CONTAINER

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About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 508 (NO 510(K)), 83 (NO PROCESS), 75 (UNAPPROVED), 62 (NEEDS FCE) and 9 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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