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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/17/2002Pharma Exp

Montreal

CANADAQUINAPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
115DR QUALITY
10/17/2002Famous House Food Industrial Corp.

Yunlin

TAIWANGRASS JELLY DRINK BEVERAGE BASE
83NO PROCESS
10/17/2002Pfizer Canada Inc. - Kirkland, QC Administrative Site

Kirkland

CANADACARDIAC DEPRESSANT N.E.C.
75UNAPPROVED
10/17/2002L. E. West & Co.Ltd

London

UNITED KINMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/17/2002Bausch Health Companies Inc.

Steinbach

CANADATRAMADOL HCL (ANALGESIC)
75UNAPPROVED
10/17/2002Marutsune Corporation

Tatsuno

JAPANNOODLES, WHEAT AND SOY
62NEEDS FCE
83NO PROCESS
10/17/2002Toin Foods Co.,Ltd.

Gifu

JAPANNOODLES, IMITATION
62NEEDS FCE
83NO PROCESS
10/17/2002Hanyoung Food

Kyunggi Do

SOUTH KOREGARLIC BULB (ROOT & TUBER VEGETABLE)
62NEEDS FCE
83NO PROCESS
10/17/2002Dalls Co

Cairo

EGYPTGELATIN, FLAVORED
11UNSAFE COL
320LACKS FIRM
+2 more
10/17/2002Al-Lewaa Trading Co.

Dubai

UNITED ARASODA WATER, CARBONATED
11UNSAFE COL
274COLOR LBLG
10/17/2002Borrelli Distributors

Windsor

CANADAPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
218LIST INGRE
+1 more
10/17/2002Borrelli Distributors

Windsor

CANADAPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
218LIST INGRE
+1 more
10/17/2002Pt Dharmala Lampung

Bandarlampung

INDONESIASNAPPER (RED, GRAY, MALABAR, ETC.)
9SALMONELLA
10/17/2002Conservas Alguazas

Murcia

SPAINARTICHOKE (LEAF & STEM VEGETABLE)
482NUTRIT LBL
10/17/2002Naan Irrigation Systems

Naan

ISRAELLASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINASYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINABLADE, SCALPEL
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINABAG, URINE COLLECTING, URETEROSTOMY
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINADEPRESSOR, TONGUE
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINAPOUCH, COLOSTOMY
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINASINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINACHANGER, TUBE, ENDOTRACHEAL
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINACLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINACHANGER, TUBE, ENDOTRACHEAL
341REGISTERED
508NO 510(K)
10/17/2002Shanghai Jiu He Import And Export Co.

Shanghai

CHINASTETHOSCOPE, ELECTRONIC
341REGISTERED
508NO 510(K)
10/17/2002A.M. Solutions

Bogota

COLOMBIADEVICE, GENERAL MEDICAL
341REGISTERED
508NO 510(K)
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOBOWLS, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOCUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOPLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOPLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOPLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOCUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOCUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOBOWLS, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOPLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOCUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOBOWLS, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Uriarte Talavera (aka Fabrica de Loza Blanca Azulejo...)

Puebla

MEXICOPLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
251POISONOUS
10/17/2002Masterfeeds

Prescott

CANADAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
249FILTHY
10/17/2002Ridley USA Inc.

Mankato

UNITED STAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
249FILTHY
10/17/2002Agraimpex Sp. z o.o.

Warsaw

POLANDSTRAWBERRIES (BERRY)
238UNSAFE ADD
10/17/2002Lee Yong Chul

Seoul

SOUTH KORENEEDLE, ACUPUNCTURE
118NOT LISTED
341REGISTERED
+1 more
10/17/2002P.J. Exports

Mumbai

INDIAANTACID, N.E.C.
118NOT LISTED
16DIRECTIONS
+2 more
10/17/2002Saeng Green Co., Ltd

Seoul

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
16DIRECTIONS
+3 more
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
10/17/2002Sicos et Cie

Caudry

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED

About This Page

This page displays 50 FDA import refusal records from 17 countries. Records on this page involve violations including 115 (DR QUALITY), 83 (NO PROCESS), 75 (UNAPPROVED), 62 (NEEDS FCE), 11 (UNSAFE COL) and 18 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 9790 of 10,077 • Showing records 489,451-489,500 of 503,850 total