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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 Colombia

Entry/doc/line/sfx Refusal Date Product
UPS-5703783-6/1/1 11-May-2012 54YCH99 1000651194 Laboratorios Prana Ltda
ALA-0045362-3/1/1 15-May-2012 20KFD06 3006667884 Alimentos Sas S.A.
XXX-0284848-0/1/3 16-May-2012 64BCY37 3008251123 Winthrop Pharmaceuticals
XXX-0284848-0/1/4 16-May-2012 64BCY24 3007861661 Genfar
XXX-0284848-0/1/5 16-May-2012 66VDY99 3008251123 Winthrop Pharmaceuticals
XXX-0284848-0/1/6 16-May-2012 66JCY01 3009071919 Tecnoquimicas S.A
XXX-0284848-0/1/7 16-May-2012 62OCY28 3007861661 Genfar
XXX-0284848-0/1/9 16-May-2012 61PCY55 3008251123 Winthrop Pharmaceuticals
XXX-0284848-0/1/10 16-May-2012 62OCY22 3009075476 Sanofi-Aventis De Colombia
XXX-0284848-0/1/11 16-May-2012 61JDY08 3005653467 Genfar Sa
XXX-0284942-1/1/1 22-May-2012 64TCY08 3002989060 Procaps S.A.
XXX-0284942-1/1/2 22-May-2012 66VDY99 3002989060 Procaps S.A.
XXX-0284942-1/1/4 22-May-2012 64LCY07 3005156141 Genfar S A
BFV-0431855-6/27/1 29-May-2012 34FGE99 3004385404 QUALA S.A.
H67-1390457-0/9/1 29-May-2012 28AGC04 3004687274 BIOHERBS C.I. E.U
H67-1391277-1/14/1 29-May-2012 28AGC04 3004687274 BIOHERBS C.I. E.U
E10-0208456-7/1/1 31-May-2012 78KOG 3009522935 Sanitas Lab Technology
112-0215448-5/1/1 31-May-2012 61JCC11 3008688666 Gemfibronilo Labs Tecnoquimicas
112-0215448-5/1/2 31-May-2012 61PCC11 3008206286 Labs Roche
112-9955602-1/1/1 31-May-2012 61LCA13 3008648357 Ophalac