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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
10/25/2001Optical Groove Inc

Richmond Hill

CANADAENDOSCOPE, OPHTHALMIC
508NO 510(K)
10/25/2001Aiwa Latinoamerica Panama) S.A.

Paitilla

PANAMACD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
10/25/2001Aiwa Latinoamerica Panama) S.A.

Paitilla

PANAMACD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
10/25/2001Aiwa Latinoamerica Panama) S.A.

Paitilla

PANAMACD PLAYERS (COMPACT DISC PLAYERS)
476NO REGISTR
10/25/2001Xom Sur

Jacksonville

UNITED STADEVICE, GENERAL MEDICAL
476NO REGISTR
10/25/2001Alltec Gmbh & Co Kg

Lubeck

GERMANYLASER PRINTERS
476NO REGISTR
10/25/2001Atcor Medical Pty Ltd.

West Ryde

AUSTRALIADEVICE, GENERAL PURPOSE HEMATOLOGY
341REGISTERED
508NO 510(K)
10/25/2001STERIS Deutschland GmbH

Tuttlingen

GERMANYTUBE, ORTHODONTIC
341REGISTERED
10/25/2001Dal Nova Ind Lacto Alimentar Sa

21-321 Oliveira De Azemeis

PORTUGALCHEESE, SEMISOFT
308MFR INSAN
324NO ENGLISH
+1 more
10/25/2001H J Nolan (Dublin) Limited

Dublin

IRELANDSALMON (HUMPBACK, SILVER, KING, SOCKEYE, ETC.), COLD SMOKED, FISH
295LISTERIA
10/25/2001Ann Agato Tabol Dairy Ltd. Inc.

Lower Galile

ISRAELCHEESE PRODUCTS, NON-STANDARDIZED, N.E.C.
253STD IDENT
276PRESRV LBL
10/25/2001Manex Food Srl

Jesus Maria

PERUSWORDFISH
251POISONOUS
10/25/2001Sarda Affumicati SRL

Buggerru

ITALYSWORDFISH
251POISONOUS
10/25/2001Lorin International (HK) Co.

San Po Kong

HONG KONGSHRIMP & PRAWNS
249FILTHY
9SALMONELLA
10/25/2001Jiamei Foods Co Ltd

Bangkok

THAILANDSHRIMP & PRAWNS
249FILTHY
9SALMONELLA
10/25/2001Jiamei Foods Co Ltd

Bangkok

THAILANDSHRIMP & PRAWNS
249FILTHY
9SALMONELLA
10/25/2001B.S.A. FOOD PRODUCTS CO., LTD

Muang Samut Sakhon

THAILANDSHRIMP & PRAWNS
249FILTHY
9SALMONELLA
10/25/2001Sun Wing Sharks Fin

Hong Kong

HONG KONGFISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001D. Martin

Kingston

JAMAICATAMARIND, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
10/25/2001Conservas Y Derivados Del Mar Sa

El Dorado

PANAMASHARK FIN, FISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001Li Si Comercio Importacao Ltda

Belo Horizonte

BRAZILSHARK FIN, FISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001Eddy Lam Chung

Guayaquil

ECUADORFISH MAW, FISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001Eddy Lam Chung

Guayaquil

ECUADORSHARK FIN, FISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001Leung Chiu Kee

Kowloon

HONG KONGSHARK FIN, FISHERY PRODUCTS, N.E.C.
249FILTHY
10/25/2001Empaque De Chile Y Semilla La Occidental

Guadalajara

MEXICOPEPPER, HOT, DRIED OR PASTE
249FILTHY
10/25/2001GRUPO FRATO SA DE CV

Ciudad De Mexico

MEXICOCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
10/25/2001Distribuidora Express Tijuana

Tijuana Bc Mexico

MEXICOCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
10/25/2001Fabrica De Dulces Cisne S.De R.L..

Morelia

MEXICOCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
10/25/2001Pamir Import & Export

Hamburg

GERMANYRAISINS (DRIED GRAPES) (BERRY)
249FILTHY
10/25/2001JINNY MARINE TRADERS

Veraval

INDIASHRIMP & PRAWNS
249FILTHY
10/25/2001Shenzhen Food Subsidary Imp & Exp

Shenzhen

CHINAFUNGUS, BLACK (CLOUD EARS), WHOLE (BUTTON) (FUNGI)
249FILTHY
10/25/2001Granville Island Smokery Ltd

Vancouver

CANADASALMON, ALL, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
249FILTHY
10/25/2001Zhejiang Medicines & Health Products Import & Export Co. Ltd

Hangzhou

CHINASHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
10/25/2001PT Comextra Majora

Makassar

INDONESIACASHEW, SHELLED
241PESTICIDE
10/25/2001Ann Agato Tabol Dairy Ltd. Inc.

Lower Galile

ISRAELCHEESE PRODUCTS, NON-STANDARDIZED, N.E.C.
218LIST INGRE
276PRESRV LBL
+1 more
10/25/2001Zimmer Austin, Inc

Austin

UNITED STAINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
10/25/2001Medsystems Diagnostics Gmbh

Vienna

AUSTRIABLOOD GROUP SPECIFIC SUBSTANCE A (BLOOD AND BLOOD DERIVATIVES)
118NOT LISTED
10/25/2001Airox Srl

Cedex

FRANCEANALYZER, MEDICAL IMAGE
118NOT LISTED
10/25/2001Propostaltalia

Milano

ITALYAMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
118NOT LISTED
10/25/2001Ika-Maschinenbau Gmbh & Co.Kg

Staufen

GERMANYINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
10/25/2001Elymonic Design Incorporated

Dorchester

CANADAAIDS, SPEECH TRAINING FOR THE HEARING IMPAIRED (AC-POWERED AND PATIENT-CONTACT)
118NOT LISTED
10/25/2001Pharmaplan International

Obe

GERMANYDEVICE, GENERAL MEDICAL
118NOT LISTED
10/25/2001Medtronic Powered Surgical Solutions

Haltom City

UNITED STADRILL, DENTAL, INTRAORAL
118NOT LISTED
10/25/2001Ortho Express Limited

Amersham

UNITED KINHANDPIECE, AIR-POWERED, DENTAL
118NOT LISTED
10/25/2001STERIS Deutschland GmbH

Tuttlingen

GERMANYWIRE, SURGICAL
118NOT LISTED
10/25/2001Ooo Meridian

Sankt-Peterburg

RUSSIAMUSHROOM, SHIITAKE, PIECES AND STEMS, SLICED
83NO PROCESS
10/25/2001Ooo Meridian

Sankt-Peterburg

RUSSIASAURY
83NO PROCESS
10/25/2001BERZCIEMS SIA

Engures Pagasts

LATVIASARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
83NO PROCESS
10/25/2001City Rice Corporation Limited

Bangkok

THAILANDOYSTER SAUCE, FISHERY PRODUCTS, N.E.C.
83NO PROCESS
10/25/2001Nuboon Co. Ltd

Bangkok

THAILANDGRASS JELLY DRINK BEVERAGE BASE
83NO PROCESS

About This Page

This page displays 50 FDA import refusal records from 24 countries. Records on this page involve violations including 508 (NO 510(K)), 476 (NO REGISTR), 341 (REGISTERED), 308 (MFR INSAN), 324 (NO ENGLISH) and 12 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 10024 of 10,038 • Showing records 501,151-501,200 of 501,854 total