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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/12/2003Rosalba Lopez

Coli

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
9/12/2003Otc

Oakville

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
9/12/2003Otc

Oakville

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
9/12/2003Otc

Oakville

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
9/12/2003Otc

Oakville

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
9/12/2003Siam Pewter Co.,Ltd

Bangkok

THAILANDLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
508NO 510(K)
9/12/2003Columbia Fire & Safety Ltd.

Victoria

CANADAKIT, FIRST AID
118NOT LISTED
341REGISTERED
9/12/2003Growdent Surgical Company (PVT) Ltd.

Sialkot

PAKISTANSCISSORS, GENERAL USE, SURGICAL
118NOT LISTED
290DE IMP GMP
9/12/2003Bio-rad Laboratories, Inc.

Irvine

UNITED STAMIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES
118NOT LISTED
9/12/2003Mikrogen Gmbh

Planegg

GERMANYBIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
118NOT LISTED
9/12/2003Oxford Analytic

Oxford

UNITED KINLISINOPRIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
9/12/2003Oxford Analytic

Oxford

UNITED KINAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
9/12/2003Rosalba Lopez

Coli

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/12/2003Fedex

Caracas

VENEZUELAHORMONE N.E.C.
75UNAPPROVED
9/12/2003Fedex

Caracas

VENEZUELAANTIBIOTIC N.E.C.
75UNAPPROVED
9/12/2003Martine Mcalpin

Melbourne

AUSTRALIACORTISONE ACETATE (GLUCOCORTICOID)
75UNAPPROVED
9/12/2003Romona Clarke

St John

BARBADOSGRANISETRON HYDROCHLORIDE (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
9/12/2003Labbe Sylvie

West Vancouver

CANADAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
9/12/2003Pasar Express Efectivo Ctg

Cartagen

COLOMBIAADRENERGIC N.E.C.
75UNAPPROVED
9/12/2003Centrale Chiasso

Chiasso

SWITZERLANMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
9/12/2003Alshifa Pharmacy

Winnipeg

CANADALAMOTRIGINE (ANTI-CONVULSANT)
75UNAPPROVED
9/12/2003Vee Excel Drugs & Pharmaceutical

Delhi

INDIASILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
9/12/2003Nam Aujan & Bros

Seoul

SOUTH KOREBEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
9/12/2003Hitachi Printing Solutions

Dublin 2

IRELANDLASER PRINTERS
47NON STD
9/12/2003Lever Bros

New Brunswick

UNITED STASODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
16DIRECTIONS
9/12/2003Union Beverages Factory

Sharjah

UNITED ARAMANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT
11UNSAFE COL
9/12/2003PT Dharma Samudera Fishing Industries TBK

Jakarta

INDONESIASNAPPER (RED, GRAY, MALABAR, ETC.)
9SALMONELLA
9/12/2003Kader Exports Private Limited, Unit 04

Pattanamarudur

INDIASHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
9SALMONELLA
9/12/2003Pt. Kelola Mina Laut- Integrated Seafood Industries

Gresik

INDONESIASNAPPER (RED, GRAY, MALABAR, ETC.)
9SALMONELLA
9/12/2003Pt. Kelola Mina Laut- Integrated Seafood Industries

Gresik

INDONESIASNAPPER (RED, GRAY, MALABAR, ETC.)
9SALMONELLA
9/12/2003PT. KAMAL CAHAYA PUTRA

KENDARI

INDONESIATUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
9SALMONELLA
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Superfish

Ustronie

POLANDHERRING
482NUTRIT LBL
62NEEDS FCE
+1 more
9/11/2003Galdem

Comayaguela

HONDURASCARBONATED SOFT DRINK, N.E.C.
473LABELING
482NUTRIT LBL
9/11/2003Grace Kennedy (Ontario)

Richmond Hill

CANADAIMITATION CHOCOLATE AND COCOA BEVERAGE BASE
473LABELING
482NUTRIT LBL
9/11/2003Bonne Bell

Lakewood

UNITED STALIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
474COSMETLBLG
+1 more
9/11/2003Bonne Bell

Lakewood

UNITED STALIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
471CSTIC LBLG
474COSMETLBLG
+1 more
9/11/2003Hector Rivera

Santo Domingo Oeste

DOMINICAN PEPPER SAUCE (HOT, MILD, ETC.)
324NO ENGLISH
482NUTRIT LBL
9/11/2003Hector Rivera

Santo Domingo Oeste

DOMINICAN PEPPER SAUCE (HOT, MILD, ETC.)
324NO ENGLISH
482NUTRIT LBL
9/11/2003Hector Rivera

Santo Domingo Oeste

DOMINICAN PEPPER SAUCE (HOT, MILD, ETC.)
324NO ENGLISH
482NUTRIT LBL
9/11/2003SABRITAS, S.de R.L. de C.V.

Ciudad De Mexico

MEXICOPOTATO CHIPS,FRIED
324NO ENGLISH
473LABELING
+1 more
9/11/2003Apotheke Am Oberen Tor

Villingen-Schwenningen

GERMANYCOSMETIC PACKAGING AND LABELING, N.E.C.
324NO ENGLISH
75UNAPPROVED
9/11/2003Osama Talafha Est

Amman

JORDANTEA, GREEN
324NO ENGLISH
9/11/2003Orkla Confectionary & Snacks Latvija (Laima A/S)

Riga

LATVIAFLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITH FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
9/11/2003Jor Dim

Plo

BULGARIAVITAMIN, N.E.C.
324NO ENGLISH
9/11/2003Orkla Confectionary & Snacks Latvija (Laima A/S)

Riga

LATVIACHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS
321LACKS N/C
324NO ENGLISH
+1 more

About This Page

This page displays 50 FDA import refusal records from 23 countries. Records on this page involve violations including 179 (AGR RX), 118 (NOT LISTED), 508 (NO 510(K)), 341 (REGISTERED), 290 (DE IMP GMP) and 14 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 9502 of 10,077 • Showing records 475,051-475,100 of 503,850 total