Import Refusal Records

503,850 FDA import refusal records

Country

Start Date

End Date

Date	Firm	Country	Product	Violations
9/26/2003	Shanghai Jiu He Import And Export Co. Shanghai	CHINA	SYRINGE, ENT	237NO PMA 2380NO PMA/PDP
9/26/2003	Shanghai Jiu He Import And Export Co. Shanghai	CHINA	CATHETER, INTRAVASCULAR, SHORT TERM	237NO PMA 2380NO PMA/PDP
9/26/2003	Shanghai Jiu He Import And Export Co. Shanghai	CHINA	DOUCHE APPARATUS, VAGINAL, THERAPEUTIC	237NO PMA 2380NO PMA/PDP
9/26/2003	Shanghai Jiu He Import And Export Co. Shanghai	CHINA	BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE	237NO PMA 2380NO PMA/PDP
9/26/2003	Shanghai Jiu He Import And Export Co. Shanghai	CHINA	BOTTLE, HOT/COLD WATER	237NO PMA 2380NO PMA/PDP
9/26/2003	Shanghai Jiu Mao Foreign Trade Shanghai	CHINA	MONITOR, OXYGEN, CUTANEOUS, FOR INFANT NOT UNDER GAS ANESTHESIA	237NO PMA 2380NO PMA/PDP
9/26/2003	Sa Orhei Vit Orhei	MOLDOVA	TOMATOES (FRUIT USED AS VEGETABLE)	218LIST INGRE 324NO ENGLISH +2 more
9/26/2003	Elvira Elle & Vire Conde Sur Vire	FRANCE	CREAM, SWEET, WHIPPING, TABLE, ETC.	156NO PERMIT
9/26/2003	COSMED Nordic ApS Odense S	DENMARK	CALCULATOR, PULMONARY FUNCTION INTERPRETATOR (DIAGNOSTIC)	118NOT LISTED 508NO 510(K)
9/26/2003	Unique Fragrances Sonepat	INDIA	DENTAL CARIES PROPHYLACTIC N.E.C.	118NOT LISTED 344WARNINGS +2 more
9/26/2003	Gimmicky Gifts Pty Ltd Homebush West	AUSTRALIA	CONDOM	118NOT LISTED 341REGISTERED +1 more
9/26/2003	Creative Square Limited Tuen Mun	HONG KONG	FRAME, SPECTACLE	118NOT LISTED 341REGISTERED
9/26/2003	Mini Med Corporation New Delhi	INDIA	CUSHION, HEMORRHOID	118NOT LISTED 341REGISTERED
9/26/2003	GlaxoSmithKline Panama S.A. Panama	PANAMA	MAGNESIA (ANTACID)	118NOT LISTED
9/26/2003	GlaxoSmithKline Panama S.A. Panama	PANAMA	MAGNESIA (ANTACID)	118NOT LISTED
9/26/2003	GlaxoSmithKline Panama S.A. Panama	PANAMA	MAGNESIA (ANTACID)	118NOT LISTED
9/26/2003	GlaxoSmithKline Panama S.A. Panama	PANAMA	MAGNESIA (ANTACID)	118NOT LISTED
9/26/2003	GlaxoSmithKline Panama S.A. Panama	PANAMA	MAGNESIA (ANTACID)	118NOT LISTED
9/26/2003	Sahmyook Foods Chugnamn	SOUTH KORE	BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C.	83NO PROCESS
9/26/2003	Laprovet Tours	FRANCE	DIAGOSTIC AID (DRUGS) N.E.C.	75UNAPPROVED
9/26/2003	Larrearx Inc Vancouver	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
9/26/2003	Larrearx Inc Vancouver	CANADA	MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED
9/26/2003	Carmelo Brito Arroyo Hondo	DOMINICAN	MISCELLANEOUS PATENT MEDICINES, ETC.	72NEW VET DR
9/26/2003	AL NAKHIL CO. Beyrouth	LEBANON	VINE FRUIT, N.E.C.	62NEEDS FCE
9/26/2003	Quantel Medical Cournon d Auvergne CEDEX	FRANCE	LASER, SYSTEM, EXCIMER	47NON STD 476NO REGISTR
9/26/2003	Akia-Ibm Japan Ltd Mimato	JAPAN	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD 476NO REGISTR
9/26/2003	Bookham Technology San Jose	UNITED STA	LASER PRODUCT FOR NON-MEDICAL USE	47NON STD 476NO REGISTR
9/26/2003	Sony Perai	MALAYSIA	CD PLAYER COMBINATION SYSTEMS	47NON STD
9/26/2003	Sony Perai	MALAYSIA	CD PLAYER COMBINATION SYSTEMS	47NON STD
9/26/2003	Lite-On Technology Corp Taipei	TAIWAN	TV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR	47NON STD
9/26/2003	Shanghai Fairlong International Trading Shanghai	CHINA	ANALYTICAL X-RAY SYSTEM OR COMPONENT FOR NON-MEDICAL USE	47NON STD
9/26/2003	Canon (Suzhou) Inc. Jiangsu Province	CHINA	LASER PRINTERS	47NON STD
9/26/2003	Seqirus Vaccines Limited Liverpool	UNITED KIN	INFLUENZA VIRUS VACCINE	27DRUG GMPS
9/26/2003	Natural Medicine Company Plc Etchingham	UNITED KIN	PROGESTERONE (PROGESTIN)	16DIRECTIONS 75UNAPPROVED
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL
9/26/2003	Bodega Juarez Tijuana Bc	MEXICO	ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)	11UNSAFE COL

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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 237 (NO PMA), 2380 (NO PMA/PDP), 218 (LIST INGRE), 324 (NO ENGLISH), 62 (NEEDS FCE) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

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