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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
M21-0746765-8/1/1 17-Oct-2012 65FCK04 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
UPS-7844627-1/1/1 30-Oct-2012 65JIY31 3009751943 Sens Farma Tibbi Malz.Ecza Dep.Ilac Turkey
 
JK8-0120648-8/1/2 15-Oct-2012 65LBJ99 3007928872 Makaya Laboratorios S.A.C. Peru
 
AEK-0558292-5/1/1 30-Oct-2012 65PDA02 3006979750 Akums Drugs & Pharmaceuticals India
 
UPS-6622135-5/1/1 22-Oct-2012 65PDE02 3008209579 Kunnath Pharmeceuticals India
 
112-9575900-0/1/1 31-Oct-2012 65QCK64 3002608066 Fresenius Kabi Norge As Norway
 
WUB-1006365-3/2/1 26-Oct-2012 65QCS37 3004090732 CSPC Innovation Pharmaceutical Co., Ltd. China
 
BER-4081122-4/1/1 26-Oct-2012 65QCS37 3002807400 BASF PharmaChemikalien Gmbh & Co. KG Germany
 
AEK-0461057-8/1/1 26-Oct-2012 65QIY99 3007459201 Shanghai Passiono International Co Ltd China
 
CFX-9909819-3/1/1 23-Oct-2012 65RAR18 3006551280 GlaxoSmithKline Costa Rica SA Costa Rica
 
KM6-0058201-9/13/1 16-Oct-2012 65RBZ18 3004283646 ANIL & COMPANY India
 
FP1-0008186-7/4/1 12-Oct-2012 65RDK01 3002807877 Hameln Pharmaceuticals Gmbh Germany
 
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