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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
112-8392899-7/1/1/A 03-Aug-2012 54GMR99 3009630346 Pontificia Javeriana University,
112-8392899-7/1/1/B 03-Aug-2012 07HHH01 3009630346 Pontificia Javeriana University,
HG8-0137585-5/1/1/A 06-Aug-2012 53LD02 3008245889 Natasha Kanaskaya
HG8-0137585-5/1/1/C 06-Aug-2012 66VDY99 3008484202 Denova Pharmaceutical Ltda.
HG8-0137585-5/1/1/F 06-Aug-2012 53YY99 3008245889 Natasha Kanaskaya
E84-0075159-8/3/1 10-Aug-2012 66VDY99 3009526643 Farmacia Drogueria San Jorge Ltda
XXX-0289719-8/1/18 10-Aug-2012 89OMW 3007351653 Bsn Medical
XXX-0289769-3/1/1 13-Aug-2012 66VDY99 3005325017 La Sante
XXX-0289769-3/1/2 13-Aug-2012 66VDY99 3006475565 Genfar
XXX-0242772-3/1/2 27-Aug-2012 50OYY35 3003954683 New Stetic Ltda
XXX-0242793-9/1/5 27-Aug-2012 61XCY45 3002989060 Procaps S.A.
XXX-0242818-4/1/1 27-Aug-2012 60LCY05 3008251123 Winthrop Pharmaceuticals
XXX-0242818-4/1/3 27-Aug-2012 61JCY12 3004399994 Laboratorio Franco Colombiano Lafrancol S.A.
XXX-0242818-4/1/5 27-Aug-2012 62OCY41 3005632939 Laboratories La Sante
XXX-0242818-4/1/7 27-Aug-2012 62OCY41 3006198949 Laboratory Genfar Sa
XXX-0242818-4/1/8 27-Aug-2012 62KCY10 3004399994 Laboratorio Franco Colombiano Lafrancol S.A.
XXX-0242818-4/1/9 27-Aug-2012 64BCY25 3008087129 Genfar
XXX-0242818-4/1/10 27-Aug-2012 62OCY22 3008226274 Sanofi Aventis
XXX-0242860-6/1/5 27-Aug-2012 61PCY55 3008226274 Sanofi Aventis
XXX-0242924-0/1/16 29-Aug-2012 56ICY76 3005777351 Laboratory La Sante
XXX-0243010-7/1/3 29-Aug-2012 64LCY04 3005794246 Laboratorios Chalver De Colombia S.A
XXX-0243010-7/1/23 29-Aug-2012 61WDY04 3005794246 Laboratorios Chalver De Colombia S.A
XXX-0243010-7/1/26 29-Aug-2012 66VDY99 3005439651 Laboratorios Bussie S.A.
XXX-0243010-7/1/27 29-Aug-2012 66VDY99 3005439651 Laboratorios Bussie S.A.
XXX-0243010-7/1/31 29-Aug-2012 61FCY14 3008087131 Syntofarma
XXX-0243010-7/1/39 29-Aug-2012 60SCY25 3005632939 Laboratories La Sante
AEK-0283388-3/1/1 30-Aug-2012 62MBL08 3009021883 Inverpal Eu
AEK-0283388-3/1/2 30-Aug-2012 66VDY99 3009021883 Inverpal Eu
AEK-0283388-3/1/6 30-Aug-2012 53AY02 3009021883 Inverpal Eu
AEK-0283388-3/1/7 30-Aug-2012 65LBK11 3009021882 Dermclar Sa
AEK-0283388-3/1/8 30-Aug-2012 53AC02 3009021884 Mediestetica Sa
XXX-0178624-4/3/1 30-Aug-2012 80FQM 3009213313 Fajas Salome