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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
XXX-0284848-0/1/4 16-May-2012 64BCY24 3007861661 Genfar Colombia
XXX-0284848-0/1/3 16-May-2012 64BCY37 3008251123 Winthrop Pharmaceuticals Colombia
112-8774621-2/1/4 30-May-2012 64FAY24 3006781192 Acme Formulation Pyt Ltd India
112-0345100-5/4/1 24-May-2012 64GCB19 3005192091 Bayer Venezuela
337-0515077-0/2/1 18-May-2012 64GDY29 3009473708 Fouad Emil Fouad Nakhla Egypt
UPS-3532304-3/17/1 08-May-2012 64HRC99 2000026312 W. Last CC South Africa
112-7052064-1/4/1/B 11-May-2012 64LAJ67 3002807078 Glaxo Operations U.K. Ltd. United Kingdom
112-7381139-3/5/1 25-May-2012 64LAJ67 3003208074 Glaxo Smith Kline United Arab Emirates
820-4542448-6/1/1 15-May-2012 64LAS37 1000189256 Yangzhou Pharmaceutical Co., Ltd China
112-8774621-2/1/1 30-May-2012 64LAY50 3006153270 Wyeth Ltd India
112-7122504-2/3/1/B 22-May-2012 64LCJ67 3002624237 Glaxo Saudi Arabia Ltd. Saudi Arabia
AEK-0123127-9/2/1 11-May-2012 64LCK61 3009442283 General Hospital Of The Air Force China
XXX-0284942-1/1/4 22-May-2012 64LCY07 3005156141 Genfar S A Colombia
UPS-6419424-0/1/1 30-May-2012 64LCY20 3009545575 Louisele B. Haiti
112-6632570-8/1/1 24-May-2012 64NAY10 1000225411 Inalco S.P.A. Italy
112-9645341-2/1/1 24-May-2012 64RCY16 3002807849 POLYPEPTIDE LABORATORIES A/S Denmark
UPS-6047485-1/1/1 03-May-2012 64RCY21 3009490711 Enrique Cundapi Mexico
AEK-0203039-9/1/1 25-May-2012 64RIY18 3009544970 Newatel United Kingdom
XXX-0284942-1/1/1 22-May-2012 64TCY08 3002989060 Procaps S.A. Colombia
112-7110654-9/2/4 23-May-2012 64UDB06 3005696217 Relanchem Ltd United Kingdom
M50-0209983-1/2/1 04-May-2012 64XAR06 3008930897 Sino Great Enterprise Ltd China