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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 66-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
ALA-0047122-9/3/6 26-Sep-2012 66P99 3003809189 Sa Guinot France
 
KR4-0043735-5/14/1 13-Sep-2012 66PBJ07 3003029000 Jafra Manufactuing S.A. de C.V. Mexico
 
791-1825285-1/13/1 25-Sep-2012 66PBK99 3003735006 Ilcsi Szepitoe Fuvek Biokozmetikai Hungary
 
EE6-7192694-1/1/1 27-Sep-2012 66PBK99 3004491807 Harmeling Sports Netherlands
 
BDN-0063338-3/1/1 05-Sep-2012 66PBY99 3009704119 Chabio&Diostech Co., Ltd Korea, Republic Of (South)
 
UPS-7488118-2/1/1 24-Sep-2012 66PBY99 3006687938 Eulberg Project Germany
 
DQ7-1510373-4/1/1 27-Sep-2012 66PBY99 3009593984 Dewytree Korea, Republic Of (South)
 
UPS-7586917-8/1/1 28-Sep-2012 66PBY99 3009401048 Skoah Distribution Inc Canada
 
112-2441278-8/1/27 11-Sep-2012 66SCA27 3008938510 Phizer Hosp Pdts Group United States
 
AEK-0309963-3/1/1 21-Sep-2012 66VAA99 3008575899 Sanofi Aventis France France
 
AEK-0312071-0/1/1 21-Sep-2012 66VAY99 3009704086 Reeja Biju India
 
112-9021400-1/1/2 14-Sep-2012 66VBJ99 3009485856 Labeen General Trading United Arab Emirates
 
AEK-0309963-3/2/1/A 21-Sep-2012 66VBJ99 3009440403 Laboratorie Leo France
 
AEK-0309963-3/2/1/B 21-Sep-2012 66VBJ99 3009712104 Laboratoires Bailleul-Biorga France
 
112-8731081-2/1/1 14-Sep-2012 66VBK99 3008855266 Shree Marwal Sevashram India
 
AEK-0304323-5/1/2 12-Sep-2012 66VBR99 3008766675 Sanjivni Herbal Care India
 
H77-0133024-0/13/1 19-Sep-2012 66VBR99 3003240705 Hanif Food Industries Pakistan
 
EYK-1151458-1/1/1/A 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/E 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/K 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/L 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/M 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/N 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
EYK-1151458-1/1/1/O 13-Sep-2012 66VBY99 3005821393 Choi Fung Hong Hong Kong SAR
 
112-9021400-1/5/1/A 14-Sep-2012 66VBY99 3009485856 Labeen General Trading United Arab Emirates
 
575-0296082-6/1/1 18-Sep-2012 66VBY99 3001549937 Urist Cosmetics Inc Canada
 
UPS-6681988-5/1/1 12-Sep-2012 66VCA99 3009579676 Sara Galeas Honduras
 
XXX-0240334-4/1/5 07-Sep-2012 66VCH99 3004543052 THERFAM Guatemala
 
UPS-7429505-2/1/1 14-Sep-2012 66VCS99 3003265951 Paladin Labs Inc Canada
 
UPS-7417311-9/1/1 28-Sep-2012 66VCS99 3003265951 Paladin Labs Inc Canada
 
UPS-7267378-9/1/1 28-Sep-2012 66VCS99 3003265951 Paladin Labs Inc Canada
 
AEK-0312386-2/2/1 21-Sep-2012 66VCY99 3009711055 Care Hospital India
 
AEK-0312386-2/1/1 21-Sep-2012 66VCY99 3009711055 Care Hospital India
 
GEO-8500111-9/1/1 26-Sep-2012 66VCY99 1000132620 Holland America Line - United States
 
XXX-0240334-4/1/3 07-Sep-2012 66VDE99 3007417394 Laboratorio Vida Guatemala
 
112-8705644-9/4/1/F 14-Sep-2012 66VDJ99 3003197056 France International Co Ltd Thailand
 
112-8705644-9/5/1/F 14-Sep-2012 66VDJ99 3006771927 Meso Private Limited India
 
112-8705644-9/5/1/C 14-Sep-2012 66VDJ99 1000340562 Rico Skin Care Ltd. United Kingdom
 
E6G-0159004-6/1/1 26-Sep-2012 66VDJ99 3003628958 Tokyo Kikaku Hanbai Co.,Ltd. Japan
 
XXX-0240334-4/1/1 07-Sep-2012 66VDK99 3003256551 Farmamedica, S.A. Guatemala
 
XXX-0240334-4/1/2 07-Sep-2012 66VDK99 3003256551 Farmamedica, S.A. Guatemala
 
XXX-0240531-5/1/2 19-Sep-2012 66VDK99 3004641553 Merck, S.A. de C.V. Mexico
 
FL2-0039507-5/2/1 11-Sep-2012 66VDL99 3009622900 Nature & Mer International Sas Colombia
 
FL2-0039507-5/2/3 11-Sep-2012 66VDL99 3009622900 Nature & Mer International Sas Colombia
 
FL2-0039507-5/2/4 11-Sep-2012 66VDL99 3009622900 Nature & Mer International Sas Colombia
 
FL2-0039507-5/2/12 11-Sep-2012 66VDL99 3009622900 Nature & Mer International Sas Colombia
 
FL2-0039507-5/2/13 11-Sep-2012 66VDL99 3009622900 Nature & Mer International Sas Colombia
 
KM6-0057782-9/3/1 21-Sep-2012 66VDR99 3009626641 Amrutanjan Health Care Ltd India
 
KM6-0057782-9/3/2 21-Sep-2012 66VDR99 3009626641 Amrutanjan Health Care Ltd India
 
KM6-0057782-9/3/3 21-Sep-2012 66VDR99 3008843383 Emami Limited India
 
KM6-0057782-9/3/4 21-Sep-2012 66VDR99 3008843383 Emami Limited India
 
AMS-0002351-4/48/1 07-Sep-2012 66VDY99 3000243864 Clarins France
 
AMS-0002351-4/49/1 07-Sep-2012 66VDY99 3000243864 Clarins France
 
AMS-0002351-4/50/1 07-Sep-2012 66VDY99 3000243864 Clarins France
 
AMS-0002351-4/51/1 07-Sep-2012 66VDY99 3000243864 Clarins France
 
371-4229673-2/1/1 12-Sep-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
BOY-0002896-6/1/1 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
BOY-0002896-6/1/5 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
BOY-0002896-6/1/6 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
BOY-0002896-6/1/9 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
BOY-0002896-6/1/10 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
BOY-0002896-6/1/11 14-Sep-2012 66VDY99 3009709385 Cesar Gaona Jaramillo Ecuador
 
EJ2-0106852-8/14/1 14-Sep-2012 66VDY99 3005855966 Jewell International Corp. Taiwan
 
EJ2-0106852-8/14/2 14-Sep-2012 66VDY99 3005855966 Jewell International Corp. Taiwan
 
EJ2-0106852-8/14/3 14-Sep-2012 66VDY99 3005855966 Jewell International Corp. Taiwan
 
UPS-7446820-4/1/1 18-Sep-2012 66VDY99 3009703217 Canan Delibasner Turkey
 
UPS-7446820-4/1/2 18-Sep-2012 66VDY99 3009703217 Canan Delibasner Turkey
 
XXX-0243228-5/1/3 18-Sep-2012 66VDY99 3005019811 Laboratorio Donovan Werke A.G.S.A. International Guatemala
 
XXX-0224450-8/1/3 18-Sep-2012 66VDY99 3009603219 GLOBAFARM LTDA. Brazil
 
XXX-0224450-8/1/4 18-Sep-2012 66VDY99 3004186512 Factor Estetic Spain
 
XXX-0224450-8/1/6 18-Sep-2012 66VDY99 3005200369 Gefab de Genebstheraputakim Germany
 
XXX-0224435-9/1/2 19-Sep-2012 66VDY99 3005583681 Menarini Laboratory S A Spain
 
MH9-2002580-5/2/2 28-Sep-2012 66VDY99 3007198388 Luxana Perfumes Spain
 
XXX-0240334-4/1/7 07-Sep-2012 66VIY99 3008485466 Shanghai Channelmed Import & Export Co Ltd China
 
N28-0153590-8/1/1/A 13-Sep-2012 66YAY99 3005126598 Au Natural Stones Pakistan
 
N28-0153590-8/1/1/B 13-Sep-2012 66YAY99 3005126598 Au Natural Stones Pakistan
 
FS2-8019518-1/2/3/B 21-Sep-2012 66YBY99 3005331646 Shanghai Pharmaceutical Co., Ltd China
 
FS2-8019518-1/2/3/C 21-Sep-2012 66YBY99 3005331646 Shanghai Pharmaceutical Co., Ltd China
 
FS2-8019518-1/2/3/D 21-Sep-2012 66YBY99 3005331646 Shanghai Pharmaceutical Co., Ltd China
 
FS2-8019518-1/2/3/E 21-Sep-2012 66YBY99 3005331646 Shanghai Pharmaceutical Co., Ltd China
 
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