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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 64-Human and Animal Drugs

Entry/doc/line/sfx Refusal Date Product
224-4224198-4/4/1/C 06-Apr-2012 64ACY99 3007532570 Naturelle Llc United Arab Emirates
109-0848756-3/1/1 03-Apr-2012 64ADY05 3007420666 Sultan Healthcare United States
112-6865810-6/1/3 30-Apr-2012 64BCA24 3008650746 Sanis Health Inc Canada
112-2950157-7/1/1 26-Apr-2012 64BCO43 3008153396 Gsk Pharamceuticals India
112-6421853-3/1/1 13-Apr-2012 64FOK23 3004636230 Dsm Nutritional Products Switzerland
AEK-8400003-9/1/1 27-Apr-2012 64GBA19 3009471710 Anastasia Hattay South Africa
AEK-8397779-9/2/1 09-Apr-2012 64GCA13 3007517883 Zydus Healthcare India
AEK-8397779-9/1/1 09-Apr-2012 64GCP99 3007501341 Ferring Pharmaceuticals Pvt Ltd India
112-6319511-2/1/1 30-Apr-2012 64GCZ99 3009403158 Sunbow Biotech Ltd Hong Kong SAR
AEK-8398902-6/1/1 27-Apr-2012 64GDB27 3009451354 R&T Services Ltd Israel
CFX-9907518-3/3/1 06-Apr-2012 64HDK04 3009269115 Laboratorio S Y M S.A. De C.V. El Salvador
DO7-8265331-8/1/1 19-Apr-2012 64LCB56 3007068880 Sankt Hubertus Studienbuero Germany
112-6845288-0/2/1 25-Apr-2012 64LCK56 1000194719 Ranbaxy Laboratories Limited India
UPS-5994239-7/1/3 17-Apr-2012 64LDK04 3008543885 Schering Plough Sa Colombia
AEK-0130231-0/1/1 12-Apr-2012 64RCK21 3002807097 Pfizer Manufacturing Deutschland GmbH Germany
112-9228724-4/1/5 26-Apr-2012 64TCA99 3008562526 G D Gupta India
UPS-3543307-1/1/1 09-Apr-2012 64XAS06 1000251162 KIK Custom Products - Rexdale Plant Canada
UPS-3550036-6/2/1 09-Apr-2012 64XBL06 1000251162 KIK Custom Products - Rexdale Plant Canada
112-6666343-9/1/1 10-Apr-2012 64XCB11 3008095848 Valeant Pharmaceutical Brazil
AEK-8400001-3/1/1 27-Apr-2012 64XCF11 3009468919 Rekesh Kumar India
112-4539007-0/2/1 20-Apr-2012 64XCY11 3005890633 Intas Pharmaceuticals India