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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-1923442-4/1/1 20-Aug-2008 66BAS44 3007051892 King Folk Enterprises Ltd China
 
UPS-2062523-0/1/1/B 25-Aug-2008 66BAS44 3007086383 Top Machinery &Equipment Ltd /Zhp Hong Kong SAR
 
983-2129582-0/1/1 12-Aug-2008 66BAY05 3004299741 JILIN SHULAN SYNTHETIC PHARMACEUTICAL China
 
112-1794896-0/1/1 21-Aug-2008 66BDY99 3005083562 Synthon Hispania S.L. Spain
 
605-2047165-1/2/1 21-Aug-2008 66HAS06 3005297603 Golden Time Enterprises (Shenzhen) Co. Ltd. China
 
785-4705964-8/1/1 22-Aug-2008 66MCS86 3005560263 R.L Fine Chem India
 
112-1525417-1/1/1 22-Aug-2008 66MCY91 3005062515 Biodim France
 
UPS-8006411-0/3/1 15-Aug-2008 66MIS99 3002806439 Pfizer Canada Inc. Canada
 
UPS-8006412-8/1/1 15-Aug-2008 66MIY99 3002806439 Pfizer Canada Inc. Canada
 
UPS-8006411-0/4/1 15-Aug-2008 66MIY99 3002806439 Pfizer Canada Inc. Canada
 
HD8-0089119-8/1/1/A 05-Aug-2008 66PBJ09 3001385589 Tura International Ltd United Kingdom
 
606-0103170-5/7/1 06-Aug-2008 66PBJ99 3007016001 Diana Stalder Professional Skin Care Philippines
 
606-0103170-5/8/1 06-Aug-2008 66PBJ99 3007016001 Diana Stalder Professional Skin Care Philippines
 
660-0491065-0/3/2 29-Aug-2008 66PBU99 3007069208 Maytech Life Industries Malaysia
 
UPS-2092446-8/1/5/G 19-Aug-2008 66PBY99 3007073736 S/N Spain
 
AEK-9694268-1/1/1 21-Aug-2008 66PBY99 3006012700 Welcos Co.,Ltd Korea, Republic Of (South)
 
AEK-9694268-1/1/2 21-Aug-2008 66PBY99 3006012700 Welcos Co.,Ltd Korea, Republic Of (South)
 
GU6-9941792-4/1/1 07-Aug-2008 66PCY99 3007033764 Topix Pharmaceuticals Inc. United States
 
224-0360975-7/1/7 04-Aug-2008 66SCA28 3003266206 Nesher Pharmaceuticals (USA) LLC United States
 
AEK-9124056-0/1/1 11-Aug-2008 66SCF03 3007025508 Rajendra D Patel India
 
605-4532496-8/2/1 08-Aug-2008 66SCS45 3002806675 Chinoin Pharmaceutical & Chemical Works Private Co. Ltd. Hungary
 
112-3261001-7/1/1 01-Aug-2008 66VAR99 3005734764 Pro Home Mexico
 
U72-0513865-5/26/1/A 26-Aug-2008 66VAR99 3006742009 PZ Nigeria Limited Nigeria
 
112-3303472-0/1/1 01-Aug-2008 66VAY99 3004786430 Sanofi Aventis France
 
112-1559790-0/1/1 22-Aug-2008 66VAY99 3006694191 Homeopatia Landinelli Uruguay
 
336-6506592-9/1/1 28-Aug-2008 66VAY99 3002378141 Goemar Laboratories France
 
336-6506592-9/2/1 28-Aug-2008 66VAY99 3002378141 Goemar Laboratories France
 
F92-0029428-3/10/6 28-Aug-2008 66VBJ99 3003607090 L'Oreal Products De Luxe France
 
F92-0029428-3/10/5 28-Aug-2008 66VBJ99 3003607090 L'Oreal Products De Luxe France
 
AFJ-0040215-1/66/1 08-Aug-2008 66VBL99 3003740869 Reckitt Benkiser Ltd United Kingdom
 
AFJ-0040215-1/67/1 08-Aug-2008 66VBL99 3001072883 Sara Lee Household & Body Care United Kingdom
 
EBH-0061991-9/52/1 26-Aug-2008 66VBU99 3004757334 Dyson Laboratories Philippines
 
HD8-0089119-8/1/1/J 05-Aug-2008 66VBY99 3005699922 Jagal Pharma Limited Nigeria
 
101-7622974-7/8/1/A 07-Aug-2008 66VBY99 3006560388 Agri Foods Sri Lanka
 
101-7622974-7/8/1/B 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
101-7622974-7/8/1/C 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
101-7622974-7/8/1/D 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
101-7622974-7/8/1/E 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
101-7622974-7/8/1/F 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
101-7622974-7/8/1/G 07-Aug-2008 66VBY99 3004196691 Wichithra Vacum Dehydrated Natural Sri Lanka
 
BLW-0524935-0/20/1 07-Aug-2008 66VBY99 3006810442 Top Respect Industrial (Shenzhen) Limited China
 
BLW-0524935-0/21/1 07-Aug-2008 66VBY99 3006810442 Top Respect Industrial (Shenzhen) Limited China
 
BLW-0524935-0/31/1 07-Aug-2008 66VBY99 3006810442 Top Respect Industrial (Shenzhen) Limited China
 
AFJ-0040215-1/65/1 08-Aug-2008 66VBY99 3003740869 Reckitt Benkiser Ltd United Kingdom
 
791-5208693-4/4/1/A 21-Aug-2008 66VBY99 3006848787 Mam Processing United Kingdom
 
112-1453803-8/1/1 21-Aug-2008 66VCE99 2619243 Lilly del Caribe, Inc. (PR01) United States
 
497-2001152-5/1/1 22-Aug-2008 66VCS99 3007038001 Chaitana Biologicals Pvt Ltd India
 
XXX-0149189-4/1/1/A 01-Aug-2008 66VCY99 3005942852 Steierl-Pharma GmbH Germany
 
112-3494099-0/1/1 06-Aug-2008 66VCY99 3006983608 Hwasun Biotechniologist Co Ltd China
 
N77-0158931-9/1/17 13-Aug-2008 66VDJ99 3003771787 A Meshi Cosmetics Industries Ltd Israel
 
UPS-1073700-3/1/1 26-Aug-2008 66VDL99 2000027163 Natures Formulae Health Products Ltd. Canada
 
EBH-0061991-9/51/1 26-Aug-2008 66VDL99 3002945792 Interphil Lab Inc Philippines
 
112-1526385-9/1/1 22-Aug-2008 66VDP99 3004135067 Aventis Pharma S A De C V Mexico
 
UPS-1792716-9/1/1 13-Aug-2008 66VDR99 3005427529 TianZi Biodiversity Research & Development Centre China
 
UPS-1792705-2/1/1 13-Aug-2008 66VDR99 3005427529 TianZi Biodiversity Research & Development Centre China
 
UPS-1792697-1/1/1 13-Aug-2008 66VDR99 3006184948 Mekong Hill Garden China
 
112-3549917-8/1/1 05-Aug-2008 66VDY99 3006477134 Shanghai Multi-med Union Co., Ltd China
 
W16-5014933-1/1/1 11-Aug-2008 66VDY99 3003612034 Milagro De La Selva, S.A. Guatemala
 
112-3878754-6/4/1 14-Aug-2008 66VDY99 3007060331 Chugai Pharmaceutical Corp Japan
 
112-3878754-6/5/1 14-Aug-2008 66VDY99 3003342394 Astra Zeneca AB Sweden
 
112-1884082-8/1/1/B 22-Aug-2008 66VDY99 3006729225 Amana Care Sarl Lebanon
 
BTU-0204092-9/1/1 29-Aug-2008 66VDY99 3006850529 Sanzi Cosmetics China
 
SG5-0418926-0/3/1 26-Aug-2008 66VIA99 1000168130 Merck Sharp & Dohme Limited United Kingdom
 
SG5-0418972-4/3/1 26-Aug-2008 66VIA99 1000168130 Merck Sharp & Dohme Limited United Kingdom
 
112-4007728-2/1/1 25-Aug-2008 66VIP99 3005176444 Bristol-Myers United States
 
112-4007728-2/2/1 25-Aug-2008 66VIP99 3004097716 E. DENK OHG Germany
 
BOY-0000908-1/2/1 12-Aug-2008 66VIS99 3006400391 Conseil De L'Europe France
 
506-0817489-7/5/1 19-Aug-2008 66VIY99 3002653483 Novartis Pharma Stein AG Switzerland
 
112-1761617-9/1/1 21-Aug-2008 66VIY99 3006715982 M S Dabar India Ltd India
 
SG5-0418613-4/1/1 26-Aug-2008 66VIY99 3005340341 Mannkind Corporation United States
 
SG5-0418613-4/1/2 26-Aug-2008 66VIY99 3005340341 Mannkind Corporation United States
 
SG5-0418614-2/1/1 26-Aug-2008 66VIY99 3005340341 Mannkind Corporation United States
 
SG5-0418180-4/1/1 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418180-4/1/2 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418492-3/1/1 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418492-3/1/2 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418492-3/1/3 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418924-5/1/1 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418924-5/1/2 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418926-0/1/1 26-Aug-2008 66VIY99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
SG5-0418926-0/1/2 26-Aug-2008 66VIY99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
SG5-0418972-4/1/1 26-Aug-2008 66VIY99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
SG5-0418972-4/1/2 26-Aug-2008 66VIY99 3002626051 Merck Sharp & Dohm United Kingdom
 
SG5-0418974-0/1/1 26-Aug-2008 66VIY99 2211539 Schering Corporation United States
 
SG5-0418974-0/3/1 26-Aug-2008 66VIY99 3002626051 Merck Sharp & Dohm United Kingdom
 
SG5-0419063-1/3/1 26-Aug-2008 66VIY99 3002626051 Merck Sharp & Dohm United Kingdom
 
SG5-0419063-1/1/1 26-Aug-2008 66VIY99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
UPS-1704055-9/1/12 04-Aug-2008 66VMK99 3004001493 Todo Pak Mexico
 
UPS-1704055-9/1/13 04-Aug-2008 66VMK99 3004001493 Todo Pak Mexico
 
UPS-1704055-9/1/15 04-Aug-2008 66VMK99 3004001493 Todo Pak Mexico
 
AA8-0016692-5/27/1 27-Aug-2008 66YBY99 3005384829 Laboratorios Rangel C. Por A. Dominican Republic
 
112-3781475-4/1/5 27-Aug-2008 66YCY99 3003492806 Sanofi Winthrop Industrie France
 
112-3781475-4/1/4 27-Aug-2008 66YCY99 3004055168 Les Laboratories Servier Industrie France
 
112-3781475-4/1/3 27-Aug-2008 66YCY99 3003516629 Pfizer Laboratoriesfse Comptabilite Fourniss France
 
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