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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-8381790-6/1/1/A 23-Jun-2010 66BAS44 3007086380 Shenzhen Sailebao Tech Co Ltd China
 
UPS-8381790-6/1/1/B 23-Jun-2010 66BAS44 3007086380 Shenzhen Sailebao Tech Co Ltd China
 
UPS-8381790-6/1/1/C 23-Jun-2010 66BAS44 3007086380 Shenzhen Sailebao Tech Co Ltd China
 
UPS-8421486-3/3/1 23-Jun-2010 66BAS44 3007565370 Shenzhen Saixing Industrial Co.,Ltd China
 
AEK-8014328-8/1/1 04-Jun-2010 66BAY44 3004043268 Glaxo Smithline Ireland
 
EH2-0012879-9/1/1 08-Jun-2010 66BAY44 3007522382 First Union Group Co Ltd Hong Kong SAR
 
EH2-0012879-9/2/1 08-Jun-2010 66BAY44 3007522382 First Union Group Co Ltd Hong Kong SAR
 
AEK-8152103-7/1/1 30-Jun-2010 66BBQ44 3008328633 Heyuan Hilite Electronic Factory China
 
112-6769182-6/16/1 02-Jun-2010 66GAO05 1000535645 Shaoxing County Import & Export Corporation China
 
CFX-1000066-6/2/1 11-Jun-2010 66MBJ99 3007828231 Infarma Honduras
 
EI5-2260727-0/2/1 21-Jun-2010 66P07 1000222390 Levlad, LLC United States
 
322-0265589-4/1/1/A 28-Jun-2010 66P07 3004855087 Aruba Aloe Balm N Aruba
 
322-0265589-4/1/1/B 28-Jun-2010 66P07 3004855087 Aruba Aloe Balm N Aruba
 
322-0265589-4/3/1/B 28-Jun-2010 66P07 3004855087 Aruba Aloe Balm N Aruba
 
WIB-1227631-0/4/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/31/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/43/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/17/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/19/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/5/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/6/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/7/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/20/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/21/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/22/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/23/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/26/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/28/1 01-Jun-2010 66PAY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
B08-0804400-0/1/1 18-Jun-2010 66PBJ06 1000131550 Parfums Christian Dior France
 
B08-0804400-0/2/1 18-Jun-2010 66PBJ06 1000131550 Parfums Christian Dior France
 
B08-0804400-0/3/1 18-Jun-2010 66PBJ06 1000131550 Parfums Christian Dior France
 
112-7282994-0/2/8 11-Jun-2010 66PBJ99 3008345478 J C Laboratory Philippines
 
CAY-1019214-1/1/1 15-Jun-2010 66PBJ99 3008248948 Libinvest Sa Belgium
 
CAY-1019214-1/2/1 15-Jun-2010 66PBJ99 3008248948 Libinvest Sa Belgium
 
UPS-8263211-6/1/2 09-Jun-2010 66PBL99 3008300711 France Beaute Industry France
 
300-3492243-3/1/1 09-Jun-2010 66PBL99 1000413630 Iwk Verpackungstechnik Gmbh Germany
 
B08-0804400-0/9/1 18-Jun-2010 66PBL99 1000131550 Parfums Christian Dior France
 
AEK-8188487-2/1/1 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/9 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/5 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/3 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/4 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/2 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/6 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
AEK-8188487-2/1/8 15-Jun-2010 66PBO99 3008144135 Coola Suncare United States
 
UPS-8224783-2/1/1 07-Jun-2010 66PBR99 3006289486 Palomu Dead Sea Ltd. Israel
 
UPS-8521349-2/1/5 15-Jun-2010 66PCJ99 3006343585 Alex Cosmetic Germany
 
WIB-1227631-0/18/1 01-Jun-2010 66PQY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
WIB-1227631-0/27/1 01-Jun-2010 66PQY05 3006755618 Hanbul Cosmetics Co., Ltd Korea, Republic Of (South)
 
112-6769182-6/14/1 02-Jun-2010 66SAA27 3008173089 Medopharm India
 
DO7-8358083-3/1/1/A 01-Jun-2010 66SBA51 2000036347 HENAN FENGTAI INDUSTRY&COMMERCE LTD. China
 
656-0630463-5/1/5 17-Jun-2010 66VAY99 3008281123 First Lotus Worldwide Limited Hong Kong SAR
 
656-0630463-5/2/19 17-Jun-2010 66VAY99 3008281123 First Lotus Worldwide Limited Hong Kong SAR
 
UPS-8510395-8/1/1 22-Jun-2010 66VAY99 3005126598 Au Natural Stones Pakistan
 
UPS-8510519-3/1/1 22-Jun-2010 66VAY99 3005126598 Au Natural Stones Pakistan
 
EA5-0022421-0/1/2 01-Jun-2010 66VBJ99 3007026382 Adwin Korea Corp. Korea, Republic Of (South)
 
EA5-0022421-0/1/7 01-Jun-2010 66VBJ99 3007026382 Adwin Korea Corp. Korea, Republic Of (South)
 
938-0069771-1/10/1 03-Jun-2010 66VBL99 3007915521 Four M Import & Export Egypt
 
938-0069771-1/15/1/A 03-Jun-2010 66VBL99 3007915521 Four M Import & Export Egypt
 
UPS-8600584-8/1/1 21-Jun-2010 66VCA99 3008376970 Easy Caddie,S.L. Spain
 
XXX-0173580-3/1/1 04-Jun-2010 66VCB99 3006454530 Polski Lek S.A. Poland
 
UPS-8358574-3/1/2 10-Jun-2010 66VCY99 2510592 Merck Sharpe & Dohme Corp United States
 
DO7-8226735-8/2/1 21-Jun-2010 66VCY99 3008305363 Muhammad Shakeel Pakistan
 
XXX-0173812-0/1/1 25-Jun-2010 66VCY99 3008352975 Teresiah Kabura Kenya
 
UPS-8239485-7/1/5 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/1 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/6 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/2 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/3 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/4 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8239485-7/1/7 24-Jun-2010 66VDY99 3008334352 Aliza Halfon Israel
 
UPS-8284163-4/1/1 24-Jun-2010 66VDY99 3008341012 D'Angelo Italo (Dngtli37d07l728x) Italy
 
UPS-8284163-4/1/2 24-Jun-2010 66VDY99 3008341012 D'Angelo Italo (Dngtli37d07l728x) Italy
 
UPS-8284163-4/1/3 24-Jun-2010 66VDY99 3008341012 D'Angelo Italo (Dngtli37d07l728x) Italy
 
112-7148851-6/1/1 28-Jun-2010 66VDY99 3007378157 Azzaro Loris Crea France
 
112-7246501-8/1/1 11-Jun-2010 66VIP99 3008341914 Kalbe Farma Pt India
 
112-7187134-9/1/1 25-Jun-2010 66VIP99 3002806906 Merck KGaA Germany
 
SG5-0424602-9/1/1 16-Jun-2010 66VIY99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
SG5-0424609-4/1/1 16-Jun-2010 66VIY99 1000122400 Catalent Pharma Solutions LLC United States
 
SG5-0424680-5/1/1 16-Jun-2010 66VIY99 1000122400 Catalent Pharma Solutions LLC United States
 
SG5-0424691-2/1/1 16-Jun-2010 66VIY99 3007849394 Graceway Pharm United States
 
SG5-0424692-0/1/1 16-Jun-2010 66VIY99 3007849394 Graceway Pharm United States
 
SG5-0424831-4/4/1 16-Jun-2010 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0424831-4/5/1 16-Jun-2010 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0424831-4/6/1 16-Jun-2010 66VIY99 1000432766 Hex Ag Germany
 
SG5-0424831-4/7/1 16-Jun-2010 66VIY99 1000432766 Hex Ag Germany
 
SG5-0424831-4/8/1 16-Jun-2010 66VIY99 3003760303 Ratiopharm Inc. Canada
 
SG5-0424852-0/1/1 16-Jun-2010 66VIY99 3007849394 Graceway Pharm United States
 
SG5-0424869-4/3/1 16-Jun-2010 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0424870-2/3/1 16-Jun-2010 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0424971-8/1/1 16-Jun-2010 66VIY99 3007849394 Graceway Pharm United States
 
XXX-0173669-4/1/1 22-Jun-2010 66VIY99 3008308886 Ranbaxy Laboratories India
 
BMU-0010397-4/2/1 22-Jun-2010 66VLY99 3007070719 Suave Y Facil Sa De Cv Mexico
 
554-5283969-3/1/1 23-Jun-2010 66VRY99 3008772184 Boehringer Ingelheim Espana S.A. Spain
 
J11-0049014-0/11/1 01-Jun-2010 66YBH99 3005723275 Biokemikal El Salvador
 
CFX-1000066-6/1/1 11-Jun-2010 66YBL99 3007828231 Infarma Honduras
 
CFX-1000066-6/1/2 11-Jun-2010 66YBL99 3007828233 Laboratorio Quimipar Honduras
 
CFX-1000066-6/1/3 11-Jun-2010 66YBL99 3007828233 Laboratorio Quimipar Honduras
 
CFX-1000066-6/1/4 11-Jun-2010 66YBL99 3007828231 Infarma Honduras
 
CFX-1000066-6/1/5 11-Jun-2010 66YBL99 3007828231 Infarma Honduras
 
WUG-0149972-1/12/1 01-Jun-2010 66YDL99 1000200006 M/S KESHAV EXPORTS PVT LTD India
 
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