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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
UPS-2665755-7/1/1 22-Jun-2011 66BCS99 3007324645 Media Karya Etam, Pt Indonesia
 
D51-3100970-1/2/1 03-Jun-2011 66FBJ99 3006644764 AMAR REMEDIES LIMITED India
 
D52-0944983-9/1/1 15-Jun-2011 66FBL99 3004933007 Beijing Tong Ren Tang Company Limited China
 
112-6094871-0/1/1 09-Jun-2011 66JAA05 3008197143 Erfa Sa Belgium
 
112-6229282-8/1/1 08-Jun-2011 66JCA05 3007853804 Erfa Belgium
 
112-6229282-8/2/1 08-Jun-2011 66JCA05 3007853804 Erfa Belgium
 
112-1880396-8/5/1 22-Jun-2011 66KCS01 3007844835 Changzhou Tianhua Pharmaceutical Co Ltd China
 
112-6266943-9/1/1 08-Jun-2011 66MQO99 3008224438 Produlab Pharma Netherlands
 
112-2265258-3/1/2 10-Jun-2011 66NIZ02 1000543247 Toronto Research Chemicals Canada
 
112-1670299-8/1/7 06-Jun-2011 66PBJ99 3007139428 Fanda Hygiene Sdg Bhd Malaysia
 
E8L-1012258-3/31/1 28-Jun-2011 66PBJ99 3010165609 Inel Cosmetics Co., Ltd. Korea, Republic Of (South)
 
349-0927199-0/3/5 29-Jun-2011 66PBJ99 3008381019 Uni-President Biotechnologies Co., Ltd. Taiwan
 
E8L-1012258-3/9/1 28-Jun-2011 66PBU99 3010165609 Inel Cosmetics Co., Ltd. Korea, Republic Of (South)
 
EYD-0102755-0/1/2/A 02-Jun-2011 66PBY99 3007008251 Lioele Cosmetic Co.,Ltd Korea, Republic Of (South)
 
EYD-0102755-0/1/2/B 02-Jun-2011 66PBY99 3007008251 Lioele Cosmetic Co.,Ltd Korea, Republic Of (South)
 
AQZ-0304963-5/1/1 06-Jun-2011 66PBY99 3006746561 Fuzhou Difeng Bio-Tech Co., Ltd. China
 
AQZ-0304964-3/1/1 06-Jun-2011 66PBY99 3006746561 Fuzhou Difeng Bio-Tech Co., Ltd. China
 
AQZ-0304965-0/1/1 06-Jun-2011 66PBY99 3006746561 Fuzhou Difeng Bio-Tech Co., Ltd. China
 
112-6475950-1/1/1 08-Jun-2011 66PBY99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
112-6475950-1/1/2 08-Jun-2011 66PBY99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
WUG-0155068-9/13/1 22-Jun-2011 66PBY99 3008545726 Aiyers International India
 
WUG-0155068-9/13/2 22-Jun-2011 66PBY99 3008545726 Aiyers International India
 
WUG-0155068-9/13/3 22-Jun-2011 66PBY99 3008545726 Aiyers International India
 
WUG-0155068-9/11/2 22-Jun-2011 66PCR99 3008545726 Aiyers International India
 
112-9803481-3/1/1 15-Jun-2011 66QDB10 3000183414 Janssen Ortho Canada
 
EH2-0015417-5/5/1 03-Jun-2011 66SDA28 3008616932 Jsc Technolg Ukraine
 
ADM-0032675-8/8/1 20-Jun-2011 66V99 3005205440 Jell Pharmaceuticals Pvt. Lt India
 
ADM-0032675-8/9/1 20-Jun-2011 66V99 3005205440 Jell Pharmaceuticals Pvt. Lt India
 
BNI-0024185-9/1/1 24-Jun-2011 66V99 3007608480 Inglot Sp Zoo Poland
 
BNI-0024185-9/13/1 24-Jun-2011 66V99 3007608480 Inglot Sp Zoo Poland
 
BNI-0024185-9/22/1 24-Jun-2011 66V99 3007608480 Inglot Sp Zoo Poland
 
AWL-0710528-4/54/1 29-Jun-2011 66V99 3003804868 Trinidad Cosmetics Lab Philippines
 
144-4568640-8/1/1/A 14-Jun-2011 66VAH99 3005137584 JC Bright M Ltd. Canada
 
144-4568640-8/1/1/B 14-Jun-2011 66VAH99 3005137584 JC Bright M Ltd. Canada
 
KM6-0116048-4/18/3 04-Jun-2011 66VAR99 2000004335 Hesh Herbal PVT LTD India
 
M21-0743434-4/7/1/C 07-Jun-2011 66VAY99 3000989764 Laboratorios Dr.Collado, CxA Dominican Republic
 
XXX-0265263-5/1/2 13-Jun-2011 66VAY99 3004362167 Merck S.A. Colombia
 
UPS-1410576-7/5/1 29-Jun-2011 66VAY99 3003471640 Fundacion Laboratorio De Farmacologia Vegetal Colombia
 
XXX-0270063-2/1/7 01-Jun-2011 66VBA99 3006329243 Novartis Farmaceutica S.A De C.V Mexico
 
XXX-0270063-2/1/6 01-Jun-2011 66VBJ99 3007692262 Laboratorios Vargas S.A. Restaurandor Edif. Lab Venezuela
 
XXX-0270063-2/1/9 01-Jun-2011 66VBJ99 3005187820 Laboratorios Cero Sa Colombia
 
AGT-0007236-4/10/1 07-Jun-2011 66VBL99 3007236990 Kentech Badus Ghana
 
UPS-3486211-4/4/1 24-Jun-2011 66VBL99 1000251162 KIK Custom Products - Rexdale Plant Canada
 
KM6-0116048-4/18/4 04-Jun-2011 66VBR99 2000004335 Hesh Herbal PVT LTD India
 
KM6-0116048-4/18/5 04-Jun-2011 66VBR99 2000004335 Hesh Herbal PVT LTD India
 
ARV-2110038-8/13/1/A 01-Jun-2011 66VBY99 3008842276 Hasanet Abdosh Saudi Arabia
 
ARV-2110038-8/13/1/B 01-Jun-2011 66VBY99 3008842276 Hasanet Abdosh Saudi Arabia
 
XXX-0270063-2/1/3 01-Jun-2011 66VBY99 3007692262 Laboratorios Vargas S.A. Restaurandor Edif. Lab Venezuela
 
XXX-0266930-8/1/1 14-Jun-2011 66VBY99 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
XXX-0266930-8/1/5 14-Jun-2011 66VBY99 3008834442 Bayer Sa Guatemala
 
XXX-0266930-8/1/6 14-Jun-2011 66VBY99 3008834442 Bayer Sa Guatemala
 
XXX-0266930-8/1/7 14-Jun-2011 66VBY99 3005723309 Drogueria Santa Lucia Sa De Cv El Salvador
 
XXX-0266720-3/1/2 14-Jun-2011 66VBY99 3006347951 Merck Sa De Cv Mexico
 
M50-0141672-1/2/1 17-Jun-2011 66VBY99 3004822182 Sigan Industries Inc Canada
 
UPS-1410576-7/4/1 29-Jun-2011 66VBY99 3003471640 Fundacion Laboratorio De Farmacologia Vegetal Colombia
 
XXX-0270063-2/1/2 01-Jun-2011 66VCB99 1000406437 Wyeth Medica Ireland Ireland
 
UPS-2205385-0/1/1 09-Jun-2011 66VCC99 3008903376 Vselovodova Russia
 
112-9163623-4/1/1 15-Jun-2011 66VCC99 3002628529 Pharmascience Inc. Canada
 
112-9592679-7/1/1 21-Jun-2011 66VCC99 3005192586 Pfizer Consumer Healthcare United Kingdom
 
112-9592679-7/1/2 21-Jun-2011 66VCC99 1000363020 Glaxo Research & Development United Kingdom
 
112-9592679-7/1/3 21-Jun-2011 66VCC99 1000363020 Glaxo Research & Development United Kingdom
 
112-9592679-7/1/4 21-Jun-2011 66VCC99 1000363020 Glaxo Research & Development United Kingdom
 
EH2-0015787-1/12/1 28-Jun-2011 66VCC99 3008616936 Sic Borshchahivskiy Chemical Pharma Ukraine
 
EH2-0015787-1/9/2 28-Jun-2011 66VCC99 3008616931 Jsc Kievmedpreparat Ukraine
 
EH2-0015787-1/25/1 28-Jun-2011 66VCC99 3000478060 Krka, d.d. Novo mesto Slovenia
 
EH2-0015787-1/10/1 28-Jun-2011 66VCC99 3008616935 Pharmaceutical Company Zdorv'E Ltd Ukraine
 
EH2-0015787-1/8/1 28-Jun-2011 66VCC99 3008616932 Jsc Technolg Ukraine
 
EH2-0015787-1/19/1 28-Jun-2011 66VCC99 3005472282 Borisovskiy Zavod Medicinskikh Preparatov JSC Belarus
 
EH2-0015787-1/23/1 28-Jun-2011 66VCC99 3008840933 Laboratoryy Srevye France
 
EH2-0015787-1/20/1 28-Jun-2011 66VCC99 3008407665 Aventis Pharma LTD. India
 
EH2-0015787-1/22/1 28-Jun-2011 66VCC99 3002807920 Pharmaceutical Works Polpharma S.A. Poland
 
EH2-0015787-1/21/1 28-Jun-2011 66VCC99 3008622014 Bristol Mayers Squibb France
 
EH2-0015787-1/24/2 28-Jun-2011 66VCC99 3008887909 Bofur Ispen Industry France
 
EH2-0015787-1/10/2 28-Jun-2011 66VCC99 3008616935 Pharmaceutical Company Zdorv'E Ltd Ukraine
 
EH2-0015787-1/10/3 28-Jun-2011 66VCC99 3008616935 Pharmaceutical Company Zdorv'E Ltd Ukraine
 
EH2-0015787-1/3/1 28-Jun-2011 66VCC99 3002871444 Ranbaxy Research Laboratories India
 
EH2-0015787-1/11/1 28-Jun-2011 66VCC99 3008789086 JSC "Galichpharm" Ukraine
 
EH2-0015787-1/13/1 28-Jun-2011 66VCC99 3008615590 Mentolatum Company LTD. United Kingdom
 
EH2-0015787-1/22/2 28-Jun-2011 66VCC99 3002807920 Pharmaceutical Works Polpharma S.A. Poland
 
EH2-0015787-1/16/1 28-Jun-2011 66VCC99 3003235721 Berlin-Chemie AG (Menarini Group) Germany
 
EH2-0015787-1/2/1 28-Jun-2011 66VCF99 3008713526 Sc Lekhim Ukraine
 
EH2-0015787-1/5/1 28-Jun-2011 66VCH99 3008882146 Merz Farma GmbH Germany
 
EH2-0015787-1/4/1 28-Jun-2011 66VCH99 3002808518 Astellas Pharma Europe B.V. Netherlands
 
EH2-0015787-1/15/1 28-Jun-2011 66VCH99 3008800370 Usb Pharma Sa Belgium
 
EH2-0015787-1/14/1 28-Jun-2011 66VCJ99 3002807336 Janssen Pharmaceutica, N.V. Belgium
 
EH2-0015787-1/6/1 28-Jun-2011 66VCJ99 3008616930 Jsc Chemical Pharmaceutical Factory Ukraine
 
EH2-0015787-1/18/2 28-Jun-2011 66VCL99 3008795107 Merkle GmbH Germany
 
EH2-0015787-1/18/1 28-Jun-2011 66VCL99 3008795107 Merkle GmbH Germany
 
EH2-0015787-1/7/1 28-Jun-2011 66VCL99 3008887910 Experimental Plant Gncls Ltd Ukraine
 
EH2-0015787-1/24/1 28-Jun-2011 66VCL99 3008887909 Bofur Ispen Industry France
 
AGT-0007236-4/19/1 07-Jun-2011 66VCS99 3002611542 Dannex Limited Ghana
 
KM6-0051433-5/3/2 07-Jun-2011 66VCS99 3008584378 Westend Corporation Inc India
 
KM6-0051433-5/3/3 07-Jun-2011 66VCS99 3008584378 Westend Corporation Inc India
 
EE3-1218890-1/2/1 07-Jun-2011 66VCS99 3007358806 Godiva, Inc. Philippines
 
XXX-0270063-2/1/4 01-Jun-2011 66VCY99 3005116440 Laboratorios Leti Venezuela
 
XXX-0175526-4/1/1 09-Jun-2011 66VCY99 3008914352 Virak Chhun Vietnam
 
XXX-0265352-6/1/3 13-Jun-2011 66VCY99 3004725214 Boehringer Ingelheim S.A. Colombia
 
112-1837415-0/1/1/C 24-Jun-2011 66VCY99 3008870415 Ebi-Electronic Ag Switzerland
 
112-1837415-0/1/1/D 24-Jun-2011 66VCY99 3008870415 Ebi-Electronic Ag Switzerland
 
112-1837415-0/1/1/E 24-Jun-2011 66VCY99 3008870415 Ebi-Electronic Ag Switzerland
 
EH2-0015787-1/9/1 28-Jun-2011 66VCY99 3008616931 Jsc Kievmedpreparat Ukraine
 
EH2-0015787-1/17/1 28-Jun-2011 66VCY99 3008616485 Balkanpharma-Troyan AT Bulgaria
 
EH2-0015787-1/1/1 28-Jun-2011 66VCY99 3008622024 Natur Ltd Ukraine
 
EBX-0801850-3/11/1 09-Jun-2011 66VDI99 3004328659 AABHAR INTERNATIONAL India
 
112-6531209-4/2/1 08-Jun-2011 66VDK99 3008258331 Pharmaceuticals Canada Ltd Canada
 
XXX-0270063-2/1/5 01-Jun-2011 66VDY99 3006989871 Monte Verde Sa Argentina
 
XXX-0270063-2/1/8 01-Jun-2011 66VDY99 3006393427 Monte Verde Argentina
 
XXX-0270079-8/1/1 03-Jun-2011 66VDY99 3003235031 MERCK-MEXICO S.A. Mexico
 
XXX-0270079-8/1/2 03-Jun-2011 66VDY99 3004581852 Laboratorio Farmacaps para Drodijosa Guatemala
 
M21-0743434-4/7/1/A 07-Jun-2011 66VDY99 3000989764 Laboratorios Dr.Collado, CxA Dominican Republic
 
M21-0743434-4/7/1/B 07-Jun-2011 66VDY99 3010098874 Alopecil Corporation, S.R.L. Dominican Republic
 
M21-0743434-4/16/1 07-Jun-2011 66VDY99 3002886473 Alopecil Corporation, C X A Dominican Republic
 
M21-0743434-4/20/1/B 07-Jun-2011 66VDY99 3004588492 Laboratorios Rivas Dominican Republic
 
M21-0743434-4/25/1 07-Jun-2011 66VDY99 3000989764 Laboratorios Dr.Collado, CxA Dominican Republic
 
XXX-0265877-2/1/1 13-Jun-2011 66VDY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0253318-1/1/4 27-Jun-2011 66VDY99 3007566218 GlaxoSmithkline Costa Rica
 
XXX-0265807-9/1/1 29-Jun-2011 66VDY99 3005019811 Laboratorio Donovan Werke A.G.S.A. International Guatemala
 
XXX-0174022-5/1/11 30-Jun-2011 66VDY99 3004108097 Mediproducts Laboratorios Guatemala
 
XXX-0174022-5/1/26 30-Jun-2011 66VDY99 3004740219 Laboratorios Therfam Guatemala
 
XXX-0174022-5/1/35 30-Jun-2011 66VDY99 3007730308 LABORATORIAS SIERRA SOC Guatemala
 
XXX-0174022-5/1/36 30-Jun-2011 66VDY99 3008037893 Laboratoria Caliquimica Guatemala
 
112-2166924-0/1/1 07-Jun-2011 66VIY99 3002807772 Novartis Pharma AG Switzerland
 
UPS-2098456-9/1/1 09-Jun-2011 66VIY99 3008891565 Eurocreme Bv Netherlands
 
UPS-5227283-1/6/1 02-Jun-2011 66VQH99 3004424699 Herbal Homeopathic (Pty) Ltd. South Africa
 
UPS-5227283-1/8/1 02-Jun-2011 66VQL99 3004424699 Herbal Homeopathic (Pty) Ltd. South Africa
 
UPS-5227283-1/7/1 02-Jun-2011 66VQL99 3004424699 Herbal Homeopathic (Pty) Ltd. South Africa
 
EH2-0015417-5/6/1 03-Jun-2011 66VSV99 3002806675 Chinoin Pharmaceutical & Chemical Works Private Co. Ltd. Hungary
 
337-0101868-2/10/1 06-Jun-2011 66YBL99 3004634496 Regi International Italy
 
417-0274358-8/1/1 24-Jun-2011 66YCY99 1000501830 K C Confectionery Ltd Trinidad & Tobago
 
HD8-0099878-7/1/3 16-Jun-2011 66YPL99 3005731350 Leejiham Cosmetics Korea, Republic Of (South)
 
HD8-0099878-7/1/4 16-Jun-2011 66YPL99 3005731350 Leejiham Cosmetics Korea, Republic Of (South)
 
HD8-0099878-7/1/5 16-Jun-2011 66YPL99 3005731350 Leejiham Cosmetics Korea, Republic Of (South)
 
HD8-0099878-7/1/20 16-Jun-2011 66YPL99 3005731350 Leejiham Cosmetics Korea, Republic Of (South)
 
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