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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/14/2003Dimeda Instrumente GmbH

Tuttlingen

GERMANYFORCEPS, OBSTETRICAL
508NO 510(K)
10/14/2003Whilma King

St James

BARBADOSRHINOANEMOMETER (MEASUREMENT OF NASAL DECONGESTION)
508NO 510(K)
10/14/2003Whilma King

St James

BARBADOSMISCELLANEOUS PATENT MEDICINES, ETC.
483DRUG NAME
10/14/2003MSI COMPUTER CO., LTD

Shen-Zhen City

CHINALASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
10/14/2003Shang Zhen

Fujian

CHINATV RECEIVER OR PRODUCT CONT. TV RECEIVER, TELEVISION, COMPUTER MONITOR
476NO REGISTR
10/14/2003Ets Diana De Beaute

Beyrouth

LEBANONBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
10/14/2003Darnel Dobson

Kingston

JAMAICACONDOM
341REGISTERED
508NO 510(K)
10/14/2003Meunerie Robitaille

Farnham

CANADAMONENSIN CATEGORY I, MEDICATED ANIMAL FEED
331DR QUALITC
10/14/2003Vitor Goncalves

Carvoeira Tvd

PORTUGALCHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS
324NO ENGLISH
10/14/2003Vitor Goncalves

Carvoeira Tvd

PORTUGALCHOCOLATE PLAIN COOKIES,BISCUITS AND WAFERS
324NO ENGLISH
10/14/2003Fromagerie Guilloteau

Pelussin

FRANCESOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)
281BACTERIA
306INSANITARY
+2 more
10/14/2003Lubar Cia Ltda

Manta

ECUADORSWORDFISH
251POISONOUS
10/14/2003Kun Fung Trading Co

Hong Kong

HONG KONGROOT & TUBER VEGETABLE, DRIED OR PASTE, N.E.C.
249FILTHY
328USUAL NAME
10/14/2003Kun Fung Trading Co

Hong Kong

HONG KONGROOT & TUBER VEGETABLE, DRIED OR PASTE, N.E.C.
249FILTHY
319WRONG IDEN
10/14/2003Kun Fung Trading Co

Hong Kong

HONG KONGROOT & TUBER VEGETABLE, DRIED OR PASTE, N.E.C.
249FILTHY
319WRONG IDEN
10/14/2003Wilkins-Rogers Incorporated

Ellicott City

UNITED STACAKE PREPARED DRY MIX WITHOUT CUSTARD OR CREAM FILLING
249FILTHY
10/14/2003XINHUI FOODSTUFFS CO. OF GUANGDONG

Jiangmen

CHINAMUSHROOM, COMMON (AGARICUS BISPORUS), WHOLE (BUTTON) (FUNGI)
249FILTHY
10/14/2003Kraft Jacobs Suchard-Cote D'0r

Halle

BELGIUMCHOCOLATE AND COCOA, N.E.C.
249FILTHY
10/14/2003Hai Son Foods

Nhatrang

VIETNAMMAHI MAHI
249FILTHY
10/14/2003LA REGINA DI SAN MARZANO di Antonio Romano SPA

Scafati

ITALYTOMATOES, WITH SAUCE
249FILTHY
10/14/2003Culantreros S.A.

Limon

COSTA RICACILANTRO (LEAF & STEM VEGETABLE)
241PESTICIDE
10/14/2003Dom-Asia Export

La Vega

DOMINICAN CHINESE EGGPLANT, THAI EGGPLANT (FRUIT USED AS VEGETABLE)
241PESTICIDE
10/14/2003Caliman Agricola SA

Linhares

BRAZILPAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT)
241PESTICIDE
10/14/2003Miami Express S.A.

Panama

PANAMALENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
84RX DEVICE
10/14/2003Bijan Katebian

Windsor

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
179AGR RX
10/14/2003Carre

Chalon Sur Sa

FRANCEANTIBIOTIC N.E.C.
179AGR RX
10/14/2003Longyan Foreign Trade General Corp.

Fujian

CHINASET, ADMINISTRATION, INTRAVASCULAR
118NOT LISTED
508NO 510(K)
10/14/2003Biological E. Limited

Hyderabad

INDIAPAPAVERINE HCL (RELAXANT)
118NOT LISTED
10/14/2003School Based Wellness Center

Pueblo

UNITED STABIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
118NOT LISTED
10/14/2003Nymox Pharmaceutical Corporation

Saint-Laurent

CANADADEVICE, SPECIMEN COLLECTION
118NOT LISTED
10/14/2003Nihon Kenko Zoushin Kenk

Mississauga

CANADAINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
118NOT LISTED
10/14/2003Electromedicas Tarma Sa

Bilbao

SPAINORTHOPEDIC IMPLANT MATERIAL
118NOT LISTED
10/14/2003Ets Diana De Beaute

Beyrouth

LEBANONFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
10/14/2003G Production, Inc.

Baie-D'Urfe

CANADAMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
115DR QUALITY
118NOT LISTED
10/14/2003Laboratoire Gibro Sa

Fleurier

SWITZERLANFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
10/14/2003Laboratoire Gibro Sa

Fleurier

SWITZERLANFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
10/14/2003Saint Michaels Wellesley Central Hospital

Toronto

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/14/2003Sdx

Utrecht

NETHERLANDVASODILATOR N.E.C.
75UNAPPROVED
10/14/2003Demtrio Tan

Richmond

CANADAANALGESIC, N.E.C.
75UNAPPROVED
10/14/2003Gnosis S.R.L.

Cairate

ITALYMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
75UNAPPROVED
10/14/2003Alexandxra De Leon

Santo Dgo

DOMINICAN MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/14/2003Alexandxra De Leon

Santo Dgo

DOMINICAN MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
10/14/2003Carre

Chalon Sur Sa

FRANCEANTIBIOTIC N.E.C.
75UNAPPROVED
10/14/2003Carre

Chalon Sur Sa

FRANCEANTIBIOTIC N.E.C.
75UNAPPROVED
10/14/2003Bloomage Biotechnology Corp., Ltd.

Jinan

CHINASOLUTION, SODIUM HYALURONATE
16DIRECTIONS
10/14/2003Wildly Delicious Preserve Co

North York

CANADABEVERAGE BASE OF NON-FRUIT ORIGIN, N.E.C.
11UNSAFE COL
218LIST INGRE
+1 more
10/14/2003Wildly Delicious Preserve Co

North York

CANADACOCOA (EXCEPT CHOCOLATE CANDY AND CHOCOLATE BEVERAGE BASE)
11UNSAFE COL
218LIST INGRE
+1 more
10/13/2003Organon (India) Limited

Kolkata

INDIATESTOSTERONE (ANDROGEN)
342PERSONALRX
10/13/2003Jiangsu Huada Foodstuff Industry Co., Ltd.

Jiangsu

CHINASTRAWBERRIES (BERRY)
241PESTICIDE
10/13/2003Patheon Manfacturing Services LLC

Ridgefield

UNITED STAFLUID, HYLAN (FOR TMJ USE)
223FALSE
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About This Page

This page displays 50 FDA import refusal records from 22 countries. Records on this page involve violations including 508 (NO 510(K)), 483 (DRUG NAME), 476 (NO REGISTR), 473 (LABELING), 341 (REGISTERED) and 22 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 9475 of 10,077 • Showing records 473,701-473,750 of 503,850 total