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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
AEK-8393165-5/1/1 10-Feb-2012 62FAR53 3009308445 Florentina Zimolong Germany
 
TZ6-0116646-3/2/1 27-Feb-2012 62FAY23 3006851654 Wuxi Medicall lnstrument Factory China
 
TZ6-0117610-8/2/1 27-Feb-2012 62FBY23 3006851654 Wuxi Medicall lnstrument Factory China
 
TZ6-0117610-8/2/2 27-Feb-2012 62FBY23 3006851654 Wuxi Medicall lnstrument Factory China
 
GPL-0001979-9/1/1 29-Feb-2012 62GAQ76 3009318364 Max Relief % Bourke Business Advisors Australia
 
AEK-8382811-7/1/1 10-Feb-2012 62GCA99 3009081854 George Barry Pakistan
 
XXX-0278349-7/1/2 23-Feb-2012 62GCB41 3005076800 Corporacion Bonima, S.A. El Salvador
 
UPS-5013183-4/1/1 09-Feb-2012 62GCY18 3009322866 Asif Mehmood Pakistan
 
253-0103304-6/1/1 08-Feb-2012 62IDP60 3002320821 Thymoorgan Pharmazie Gmbh Germany
 
429-0777028-5/6/1 21-Feb-2012 62IDP77 3005673040 TEVA UK Limited United Kingdom
 
429-0777028-5/4/1 21-Feb-2012 62IDP83 1000261013 Baxter Heathcare Corporation United Kingdom
 
429-0777028-5/3/1 21-Feb-2012 62IDP99 3007022409 Roche Registration Limited United Kingdom
 
344-0812156-3/1/2 10-Feb-2012 62IIR91 1000280888 Indena S.p.A. Italy
 
344-0812156-3/1/1 10-Feb-2012 62IIR91 1000280888 Indena S.p.A. Italy
 
336-6232878-4/1/1 06-Feb-2012 62JIY09 3008853777 Egis Hungary Hungary
 
336-6232878-4/2/1 06-Feb-2012 62JIY09 3008853777 Egis Hungary Hungary
 
336-6232878-4/4/1 06-Feb-2012 62JIY09 3008853777 Egis Hungary Hungary
 
336-6232878-4/5/1 06-Feb-2012 62JIY09 3008853777 Egis Hungary Hungary
 
336-6232878-4/3/1 06-Feb-2012 62JIY09 3008853777 Egis Hungary Hungary
 
AEK-0048607-2/1/1/H 17-Feb-2012 62KAY08 3008978745 Nature Gift Thailand
 
AEK-0047461-5/1/1/N 13-Feb-2012 62KAY10 3008978745 Nature Gift Thailand
 
AEK-0047461-5/1/1/O 13-Feb-2012 62KAY10 3008978745 Nature Gift Thailand
 
AEK-0048607-2/1/1/E 17-Feb-2012 62KAY10 3008978745 Nature Gift Thailand
 
AEK-0048607-2/1/1/B 17-Feb-2012 62KAY10 3008978745 Nature Gift Thailand
 
ES6-4009744-1/23/1 16-Feb-2012 62MBJ01 3004116897 Mondey Holding Peach Brand Co Ltd Thailand
 
U79-0080716-6/1/1 16-Feb-2012 62MBJ08 3004634418 Bertram Chemical (1982) Co.,Ltd. Thailand
 
U79-0080716-6/16/1 16-Feb-2012 62MBJ08 3009241071 Muhi Ikeda Mohando Co., Ltd. Japan
 
U79-0080716-6/4/1 16-Feb-2012 62MBK08 3009241079 Mega Good Industrial Limited. Hong Kong SAR
 
U79-0080716-6/11/1 16-Feb-2012 62MBK08 3009241075 Pua Loong Trading & Co. Singapore
 
U79-0080716-6/14/1 16-Feb-2012 62MBL01 3009282034 pt Tulus IndoJaya Indonesia
 
U79-0080716-6/2/1 16-Feb-2012 62MBL08 3005440817 Chan Yat Hing Medicine Factory Hong Kong SAR
 
MK2-0102468-6/16/1 23-Feb-2012 62MBO01 3009304203 Global Industries Nig Ltd Nigeria
 
U79-0080716-6/13/1 16-Feb-2012 62MBR08 3009241073 Shell Medicine Company Hong Kong SAR
 
112-4897012-6/1/1 27-Feb-2012 62MQR05 3003984954 Pcas France
 
112-4898293-1/1/1 27-Feb-2012 62MRR05 3009225726 Pcas France France
 
AEK-8393452-7/2/2 10-Feb-2012 62OCA09 3009313631 Mazur Portugal
 
AEK-8393452-7/2/3 10-Feb-2012 62OCA22 3009313631 Mazur Portugal
 
112-4064145-1/15/1 21-Feb-2012 62TAA06 3007566390 Astrazeneca Sweden
 
UPS-5013183-4/2/1 09-Feb-2012 62TCC07 3009322866 Asif Mehmood Pakistan
 
KR3-0110317-1/2/1 07-Feb-2012 62UAY99 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
112-4064145-1/5/1 21-Feb-2012 62VBE45 3000977939 F.Hoffmann -La Roche Ag Div Switzerland
 
112-6051554-4/1/1 24-Feb-2012 62VIY53 3008394466 Piramal Pharmaceutical Development Services India
 
336-0612594-0/1/1/B 16-Feb-2012 62WBK99 3003690512 Les Emballages Knowlton Inc. Canada
 
EK4-0508404-8/14/2 14-Feb-2012 62WBY99 3009195547 Komplex-Torus Sp Zoo Poland
 
429-0777028-5/5/1 21-Feb-2012 62ZDP01 3005673040 TEVA UK Limited United Kingdom
 
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