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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
M21-0746765-8/3/1 17-Oct-2012 64BCS24 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
XXX-0244287-0/1/1 09-Oct-2012 64BCY24 3005456691 Genfar Colombia
FP1-0008186-7/6/1 12-Oct-2012 64GCA29 3002808086 Bayer Pharma AG Germany
112-9846041-6/1/1 22-Oct-2012 64GDR07 3008860909 Zhejiang Xianju Wanjie Arts & Crafts Factory China
FP1-0008186-7/18/1 12-Oct-2012 64LCJ27 1000295137 Bioglan AB Sweden
FP1-0008186-7/12/1 12-Oct-2012 64LCK20 3002037047 n.v. Alcon-Couvreur s.a. Belgium
XXX-0244603-8/1/3 09-Oct-2012 64LCY50 3004161285 Laboratorios Farkot, S.A. Guatemala
XXX-0204495-7/1/1 05-Oct-2012 64LDY03 3003916517 Unipharma International, SA Guatemala
XXX-0244603-8/1/1 09-Oct-2012 64LDY06 3005541483 Laboratorios Piersan S. A. Guatemala
FP1-0008186-7/30/1 12-Oct-2012 64LDY61 3002806546 Bristol-Myers Squibb Italy
UPS-7866086-3/1/1 30-Oct-2012 64MCK04 3002806821 MSD Organon BV Netherlands
FP1-0008186-7/32/1 12-Oct-2012 64PDK04 1000654629 Pfizer Manufacturing Belgium NV Belgium
DO7-8400205-0/1/1 25-Oct-2012 64RCY99 3009770638 Zhuang Rui Trading Co China
UPS-7875198-5/1/1 29-Oct-2012 64RKK99 3002886659 Peptech Animal Health Pty Ltd. Australia
AEK-0510815-0/1/1/C 26-Oct-2012 64XBY06 3008933183 Taisho Pharmaceutical Indones Indonesia