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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 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
XXX-0204392-6/1/1 05-Oct-2012 61FCY53 3008087131 Syntofarma Colombia
 
FP1-0008186-7/7/1 12-Oct-2012 61FDJ54 3002037047 n.v. Alcon-Couvreur s.a. Belgium
 
FP1-0008186-7/8/1 12-Oct-2012 61FDJ54 3005642286 Ranbaxy Ireland Ltd Ireland
 
SQ4-0087588-7/2/1 12-Oct-2012 61HAY99 3009800979 Hangzhou Qimei Nonwovens Industries Ltd China
 
XXX-0244287-0/1/13 09-Oct-2012 61JCY12 3008251121 Laboratorio Labinco Colombia
 
UPS-7819973-0/1/1 16-Oct-2012 61JCY14 3009742435 Sens Farma Tibbi Mlz Ecza Deposu Turkey
 
FP1-0008186-7/27/1 12-Oct-2012 61LDA38 3006750335 Actavis Uk Ltd United Kingdom
 
FP1-0008186-7/26/1 12-Oct-2012 61LDA38 3003259844 Sanofi Winthrop Industrie France
 
554-2823004-3/1/1 11-Oct-2012 61MCS31 3003130103 Harman Finochem Ltd. India
 
AEK-0491651-2/1/1 25-Oct-2012 61NDS69 3003878169 Zhejiang Chiral Medicine Chemicals Co., Ltd. China
 
FP1-0008186-7/19/1 12-Oct-2012 61PCL10 3009516423 Novo Nordisk Ltd United Kingdom
 
XXX-0224410-2/1/2 05-Oct-2012 61PCY55 3009499341 Anglopharma S.A. Colombia
 
FP1-0008186-7/28/1 12-Oct-2012 61RDK15 3005206955 Wockhardt Uk Ltd United Kingdom
 
EG6-2726880-8/1/1 30-Oct-2012 61TDA06 3002807989 Recordati Industri Chimica E Pharmaceutical Spa Italy
 
FP1-0008186-7/11/1 12-Oct-2012 61TDY03 1000541557 Aventis Pharma Ltd. United Kingdom
 
XXX-0262480-8/1/1 15-Oct-2012 61XBY99 3009168631 Laprin Laboratories Guatemala
 
XXX-0262480-8/1/2 15-Oct-2012 61XBY99 3007837100 Wellco Hong Kong SAR
 
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