Import Refusal Records

503,850 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
11/9/2001	Pastificio Riscossa - F.ill Mastromauro spa Corato	ITALY	ARTICHOKE (LEAF & STEM VEGETABLE)	62NEEDS FCE 83NO PROCESS
11/9/2001	Domenico Vitale Srl Polvica Di Nola	ITALY	BEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE)	62NEEDS FCE 83NO PROCESS
11/9/2001	Daewoo Electronics Co, Ltd Seoul	SOUTH KORE	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD
11/9/2001	Yoku Computer Systems Munich	GERMANY	CD PLAYERS (COMPACT DISC PLAYERS)	47NON STD
11/9/2001	Shan Ren Food Company Chong Quing	CHINA	MUSHROOM BROTH, CONCENTRATED	16DIRECTIONS 75UNAPPROVED
11/9/2001	Norman Velasquez Comayagua	HONDURAS	SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED	11UNSAFE COL
11/8/2001	A. Adiohos Laval	CANADA	VITAMIN, N.E.C.	482NUTRIT LBL
11/8/2001	Promo Pouch Inc Burnaby	CANADA	LOBSTER	482NUTRIT LBL
11/8/2001	Promo Pouch Inc Burnaby	CANADA	SALMON (HUMPBACK, SILVER, KING SOCKEYE, ETC.), HOT SMOKED, FISH	482NUTRIT LBL
11/8/2001	Schwan Cosmetics Germany GmbH & Co. KG Heroldsberg	GERMANY	OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	471CSTIC LBLG
11/8/2001	Uab Telemed Vilnius	LITHUANIA	MONITOR, FETAL DOPPLER ULTRASOUND	341REGISTERED 508NO 510(K)
11/8/2001	PLASSE SA Jassans Riottier	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/8/2001	Ftrecal Bulgneville	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/8/2001	Ftrecal Bulgneville	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/8/2001	Ftrecal Bulgneville	FRANCE	SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)	295LISTERIA
11/8/2001	Thomas Bagnac Export Thiais	FRANCE	CHEESE, SEMISOFT	295LISTERIA
11/8/2001	Thomas Bagnac Export Thiais	FRANCE	CHEESE, SEMISOFT	295LISTERIA
11/8/2001	PLASSE SA Jassans Riottier	FRANCE	CHEESE, SEMISOFT	295LISTERIA
11/8/2001	Ching Y Cheng Industrial Co Ltd Kaohsiung	TAIWAN	TILAPIA	281BACTERIA
11/8/2001	C.I. Agrofrut S.A.S Medellin	COLOMBIA	BERRIES, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED, N.E.C.	241PESTICIDE
11/8/2001	Sister Katia Paris	FRANCE	CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)	179AGR RX
11/8/2001	Icds De Rl De Cv Mexico	MEXICO	CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)	179AGR RX
11/8/2001	Holy Stone Healthcare Co Ltd Taiwan	TAIWAN	GLUCOSE-6-PHOSPHATE DEHYDROGENASE (ERYTHROCYTIC), SCREENING	118NOT LISTED 508NO 510(K)
11/8/2001	Rainbow Brothers Ltd Kwun Tong	HONG KONG	TOOTHBRUSH, MANUAL	118NOT LISTED 341REGISTERED
11/8/2001	Glaxo Operations UK Limited Ware	UNITED KIN	EXPECTORANT N.E.C.	118NOT LISTED
11/8/2001	IMCOR Pharmaceuctical Company San Diego	UNITED STA	MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED
11/8/2001	Jean Martin Maussane Les Alpilles	FRANCE	MIXED VEGETABLES, WITH SAUCE, N.E.C.	83NO PROCESS
11/8/2001	Multipack Guadalajara	MEXICO	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
11/8/2001	Podravka Prehrambena Industrija P O Koprivnica Koprivnica	CROATIA	BEET TOPS (LEAF & STEM VEGETABLE)	62NEEDS FCE 83NO PROCESS
11/8/2001	Amistar (Latino America), Inc. Doral	UNITED STA	CD PLAYER COMBINATION SYSTEMS	47NON STD 476NO REGISTR
11/8/2001	Porter Engineering Ltd Richmond	CANADA	LASER PRODUCT FOR NON-MEDICAL USE	47NON STD 476NO REGISTR
11/8/2001	Jds Uniphase Saanichton	CANADA	LASER PRODUCT FOR NON-MEDICAL USE	47NON STD 476NO REGISTR
11/8/2001	Sam Mex Tijuana	MEXICO	SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE	47NON STD
11/8/2001	Sam Mex Tijuana	MEXICO	SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE	47NON STD
11/8/2001	Sam Mex Tijuana	MEXICO	SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE	47NON STD
11/8/2001	Ching Y Cheng Industrial Co Ltd Kaohsiung	TAIWAN	TILAPIA	9SALMONELLA
11/8/2001	Ching Y Cheng Industrial Co Ltd Kaohsiung	TAIWAN	TILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS	9SALMONELLA
11/7/2001	Vacuum Records Inc Shibuya	JAPAN	CD PLAYERS (COMPACT DISC PLAYERS)	476NO REGISTR
11/7/2001	Wang Products Brampton	CANADA	VITAMIN, N.E.C.	473LABELING
11/7/2001	China Machinery & Equipment Imp & Exp Suzhou	CHINA	NEEDLE, ACUPUNCTURE	341REGISTERED 508NO 510(K)
11/7/2001	Dabby International Ltd Kowloon	HONG KONG	TOOTHBRUSH, MANUAL	341REGISTERED
11/7/2001	Mutlu Makarnacilik Sanayi Ve Ticaret Gaziantep	TURKEY	MACARONI, WHOLE WHEAT	328USUAL NAME 473LABELING +1 more
11/7/2001	UNKNOWN UNKNOWN	TURKEY	APRICOT, DRIED OR PASTE	249FILTHY 320LACKS FIRM +1 more
11/7/2001	Jung Hua Cosmetics Co.,Ltd Taiwan	TAIWAN	EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS)	197COSM COLOR 471CSTIC LBLG
11/7/2001	Gambro Lundia AB Lund	SWEDEN	KIT, FIRST AID	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	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

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About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 62 (NEEDS FCE), 83 (NO PROCESS), 47 (NON STD), 16 (DIRECTIONS), 75 (UNAPPROVED) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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