Import Refusal Records

501,854 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
10/30/2001	El Yucateco Salsas y Condimentos, S.A. de C.V. Merida	MEXICO	MIXED SPICES AND SEASONING WITH SALT, N.E.C.	83NO PROCESS
10/30/2001	Dongwon Industries Kwangju Factory Kwangju	SOUTH KORE	OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.	83NO PROCESS
10/30/2001	Dongwon Industries Kwangju Factory Kwangju	SOUTH KORE	OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.	83NO PROCESS
10/30/2001	Dongwon Industries Kwangju Factory Kwangju	SOUTH KORE	OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.	83NO PROCESS
10/30/2001	Dongwon Industries Kwangju Factory Kwangju	SOUTH KORE	OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.	83NO PROCESS
10/30/2001	Dongwon Industries Kwangju Factory Kwangju	SOUTH KORE	OTHER FRUITS AND FRUIT PRODUCTS, OTHER FRUIT JUICES OR CONCENTRATES, N.E.C.	83NO PROCESS
10/30/2001	Bayer Milano	ITALY	CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)	75UNAPPROVED
10/30/2001	Bayer St Clements	CANADA	CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)	75UNAPPROVED
10/30/2001	Bayer AG Leverkusen	GERMANY	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
10/30/2001	A & M Foods Distribution Montreal	CANADA	CHINESE EGGPLANT,THAI EGGPLANT, WITH SAUCE	62NEEDS FCE 83NO PROCESS
10/30/2001	A & M Foods Distribution Montreal	CANADA	CUCUMBERS (FRUIT USED AS VEGETABLE)	62NEEDS FCE 83NO PROCESS
10/30/2001	Sam Mex Tijuana	MEXICO	SOUND PRODUCT (OTHER THAN ULTRASOUND) FOR NON-MEDICAL USE	47NON STD
10/30/2001	Gerhard Mann Berlin	GERMANY	FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	16DIRECTIONS 75UNAPPROVED
10/30/2001	Gerhard Mann Berlin	GERMANY	FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS	16DIRECTIONS 75UNAPPROVED
10/30/2001	AMOLES NORISANA JALISCO	MEXICO	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)	16DIRECTIONS 75UNAPPROVED
10/30/2001	INDUSTRIALIZADORA DE PRODUCTOS COMESTIBLES SA DE CV Col. Purisima Del Progreso	MEXICO	CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)	11UNSAFE COL
10/30/2001	INDUSTRIALIZADORA DE PRODUCTOS COMESTIBLES SA DE CV Col. Purisima Del Progreso	MEXICO	CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)	11UNSAFE COL
10/30/2001	Sabritas S.A. de R.L. de C.V Planta Toluca Toluca	MEXICO	CHEWING GUM (WITHOUT CHOCOLATE)	11UNSAFE COL
10/30/2001	Sabritas S.A. de R.L. de C.V Planta Toluca Toluca	MEXICO	CHEWING GUM (WITHOUT CHOCOLATE)	11UNSAFE COL
10/30/2001	Nam Hai Company Ltd. Ho Chi Minh City	VIETNAM	EEL	9SALMONELLA
10/29/2001	Covidien (formerly Mallinckrodt Medical) Athlone	IRELAND	INSTRUMENT, MANUAL, GENERAL SURGICAL	508NO 510(K)
10/29/2001	Prosalmar S.A. de C.V. Conchagua	EL SALVADO	SPINY LOBSTER, ROCK LOBSTER	249FILTHY
10/29/2001	B & M Products Co., Ltd. Samutsakorn	THAILAND	TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)	249FILTHY
10/29/2001	Magda Aranda Samalus	SPAIN	MISCELLANEOUS PATENT MEDICINES, ETC.	179AGR RX
10/29/2001	Joann Walker Victoria	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	179AGR RX
10/29/2001	Mycountry Brasil Ltda Brazil	BRAZIL	BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)	152SOAKED/WET
10/29/2001	Micro Direct, Inc. Lewiston	UNITED STA	ANALYZER, NITRIC OXIDE	118NOT LISTED 508NO 510(K)
10/29/2001	San Jose Trading Company Guadalajara	MEXICO	FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)	11UNSAFE COL
10/28/2001	Kontinent Spedition Gmbh Jena	GERMANY	LASER PRODUCT FOR NON-MEDICAL USE	476NO REGISTR
10/28/2001	DSM Nutritional Products Canada Dartmouth	CANADA	FISH OIL (FATS AND LIPID SUBSTANCES)	256INCONSPICU
10/28/2001	Cardio Control Nv Delft	NETHERLAND	ELECTROCARDIOGRAPH	126FAILS STD 341REGISTERED
10/28/2001	Theralase Inc. Markham	CANADA	LASER FOR PAIN THERAPY	118NOT LISTED 341REGISTERED +2 more
10/28/2001	Menia Design Gmbh Sinsheim	GERMANY	FRAME, SPECTACLE	118NOT LISTED 341REGISTERED
10/26/2001	Stabburet Fredrikstad	NORWAY	FISH CAKES, BALLS, ETC., N.E.C.	324NO ENGLISH 482NUTRIT LBL +2 more
10/26/2001	Mannasol Limited Runcorn	UNITED KIN	BYPROD FOR ANIMAL, N.E.C.	308MFR INSAN
10/26/2001	Exveco S.A. Comayagua	HONDURAS	TAMARIND (SUBTROPICAL AND TROPICAL FRUIT)	249FILTHY
10/26/2001	Phuong Nam Thanh Co. Hochiminhn City	VIETNAM	TAMARIND, DRIED OR PASTE	249FILTHY
10/26/2001	Atlantic Exports Mumbai	INDIA	OTHER BAKERY PRODUCTS, N.E.C.	249FILTHY
10/26/2001	Clemente Trevino Gonzalez Reynosa	MEXICO	PEPPER, HOT, DRIED OR PASTE	249FILTHY
10/26/2001	Lions Gate Fisheries Ltd. Delta	CANADA	COD	249FILTHY
10/26/2001	Imres Wezep Ac	NETHERLAND	ANTIBIOTIC N.E.C.	118NOT LISTED 16DIRECTIONS
10/26/2001	Imres Wezep Ac	NETHERLAND	ANTIBIOTIC N.E.C.	118NOT LISTED 16DIRECTIONS
10/26/2001	Imres Wezep Ac	NETHERLAND	FERROUS SULFATE (HEMATINIC)	118NOT LISTED 16DIRECTIONS
10/26/2001	Imres Wezep Ac	NETHERLAND	ANTIBIOTIC N.E.C.	118NOT LISTED 16DIRECTIONS
10/26/2001	Bayer Pharma Puteaux Cedex	FRANCE	ANTIBIOTIC N.E.C.	75UNAPPROVED
10/26/2001	Bayer Inc Etobicoke	CANADA	ANTIBIOTIC N.E.C.	75UNAPPROVED
10/26/2001	China Nat'L Import/Export Corp Guangzhou	CHINA	BAMBOO SHOOTS (LEAF & STEM VEGETABLE)	62NEEDS FCE 83NO PROCESS
10/26/2001	Yik Hoi Trading Co. To Kwa Wan	HONG KONG	PEPPER, WHITE, GROUND, CRACKED (SPICE)	9SALMONELLA
10/26/2001	Al Kanater S.A.L. Beirut	LEBANON	SOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	9SALMONELLA
10/25/2001	Nike/Ocg Edmonton	CANADA	FRAME, SPECTACLE	508NO 510(K)

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About This Page

This page displays 50 FDA import refusal records from 21 countries. Records on this page involve violations including 83 (NO PROCESS), 75 (UNAPPROVED), 62 (NEEDS FCE), 47 (NON STD), 16 (DIRECTIONS) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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