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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
AEK-0805863-4/1/1 25-Jun-2013 66MCA75 3006740410 Un Escwa Lebanon
 
AEK-1127528-2/1/1/A 24-Jun-2013 66PAJ99 3010179094 Coola Suncare United States
 
315-4026114-1/3/1 07-Jun-2013 66PAL99 1000224360 Estee Lauder N.V. Belgium
 
AEK-9225933-8/1/1 24-Jun-2013 66PAL99 3010189699 Finders International United Kingdom
 
112-2738233-6/2/1 12-Jun-2013 66PBJ07 3004085558 Delta Laboratories Pty Ltd Australia
 
UPS-0966723-1/3/1 13-Jun-2013 66PBY99 1000489288 Riemann & Co Denmark
 
144-6383636-4/1/9 26-Jun-2013 66PBY99 3000316120 Odeyah Industries Ltd. Israel
 
AEK-9238512-5/1/1/B 24-Jun-2013 66PJJ99 3007566644 Fadia Karam Lebanon
 
201-9344196-0/1/1 11-Jun-2013 66SCS48 3009260296 Ucb Manufacturing Ireland Limited Ireland
 
UPS-9675417-7/1/1 04-Jun-2013 66SDY51 3008600087 Etumax Malaysia
 
WYX-2013003-5/1/1 20-Jun-2013 66V99 3004363818 Wuhan Maying long Pharmaceutical Group Ltd. China
 
WYX-2013003-5/2/1 20-Jun-2013 66V99 3005167350 SANJIU ENTERPRISES GROUP China
 
AEK-0805374-2/1/1 19-Jun-2013 66VAL99 3010159416 Bob Sheriff Liberia
 
GP9-0005029-3/1/1 25-Jun-2013 66VAL99 3010179904 Jean Lesly K Haiti
 
BSS-0000370-9/1/1 03-Jun-2013 66VAS99 3002292165 Laboratori Derivati Organici Italy
 
BSS-0000369-1/1/1 03-Jun-2013 66VAS99 3002292165 Laboratori Derivati Organici Italy
 
AEK-0806125-7/1/1 25-Jun-2013 66VAY99 3010185914 Tsering Norbu India
 
AEK-0800188-1/1/1 25-Jun-2013 66VAY99 3009619398 Genius Nature Herbs Pvt India
 
UPS-0873273-9/1/1 07-Jun-2013 66VBA99 3008363646 Inqpharm Europe Limited Germany
 
UPS-0873273-9/2/1 07-Jun-2013 66VBA99 3008363646 Inqpharm Europe Limited Germany
 
BTX-3163956-5/1/1 21-Jun-2013 66VBE99 3009950832 Nugale Pharmaceutical Inc Canada
 
112-7473770-4/1/1 21-Jun-2013 66VBK99 3009529236 Grupo Acacia Mexico
 
KH5-0081868-8/8/1/B 26-Jun-2013 66VBL99 3008399937 Shenzhen Guanyujia Imports & Exports China
 
KM6-0126453-4/20/1 11-Jun-2013 66VBY99 3006115568 Shah Maganlal Chunilal Gandhi India
 
UPS-1013476-7/1/1 18-Jun-2013 66VBY99 3009956886 Your Chemist Shop P/L** Australia
 
KH5-0081868-8/8/1/A 26-Jun-2013 66VBY99 3008399937 Shenzhen Guanyujia Imports & Exports China
 
K74-0164915-0/1/1 19-Jun-2013 66VCA99 3009661471 Alpa As Czech Republic
 
UPS-0874959-2/3/1 20-Jun-2013 66VCA99 3010203509 Kari Brozowski Canada
 
112-6106944-1/1/1 20-Jun-2013 66VCC99 3004841788 Bristol-Myers Squibb De Mexico Mexico
 
112-6106944-1/1/2 20-Jun-2013 66VCC99 3006212599 Bayer De Mexico Sa De Cv Mexico
 
UPS-1100319-3/1/1 25-Jun-2013 66VCK99 3010211241 Edelfina Hernandez Colombia
 
DO7-8292371-1/1/1 27-Jun-2013 66VCK99 3007411173 Shandong Rellet Cosmetic Co Ltd China
 
GEO-8500495-6/1/1 05-Jun-2013 66VCY99 1000132620 Holland America Line - United States
 
UPS-0848975-1/1/1 07-Jun-2013 66VCY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
112-2583532-7/1/2/A 17-Jun-2013 66VCY99 3009958975 Ken'S Beauty And Wellness Shop Philippines
 
112-2583532-7/1/2/B 17-Jun-2013 66VCY99 3004887539 T.P. Drug Laboratories (1969) Co., LTD Thailand
 
112-2583532-7/1/2/C 17-Jun-2013 66VCY99 3006989780 Euro-Med Laboratories Phil Philippines
 
112-2583532-7/1/2/D 17-Jun-2013 66VCY99 3009636430 Sujie Pharmaceutical Ltd Japan
 
AEK-9235221-6/1/1 24-Jun-2013 66VCY99 3010198335 P Ruth Grace India
 
GEO-8500532-6/1/1 26-Jun-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
112-2634478-2/3/1/B 03-Jun-2013 66VDJ99 3009469208 Unilever India Exports Limited India
 
KH5-0081868-8/5/1 26-Jun-2013 66VDL99 3008399937 Shenzhen Guanyujia Imports & Exports China
 
AMG-0092027-6/2/1 04-Jun-2013 66VDR99 3008756534 Essence Master Limited Hong Kong SAR
 
AMG-0092027-6/2/4 04-Jun-2013 66VDR99 3008756534 Essence Master Limited Hong Kong SAR
 
AMG-0092027-6/2/3 04-Jun-2013 66VDR99 3008756534 Essence Master Limited Hong Kong SAR
 
AMG-0092027-6/2/2 04-Jun-2013 66VDR99 3008756534 Essence Master Limited Hong Kong SAR
 
DR7-0072061-5/1/1/A 10-Jun-2013 66VDY99 3010155705 Gulsah Uretim Paz.-Huseyin Kaya Turkey
 
DR7-0072061-5/3/1/A 10-Jun-2013 66VDY99 3010155705 Gulsah Uretim Paz.-Huseyin Kaya Turkey
 
DR7-0072061-5/8/1 10-Jun-2013 66VDY99 3010155705 Gulsah Uretim Paz.-Huseyin Kaya Turkey
 
ESD-0050358-8/2/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/6/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/9/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/10/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/3/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/7/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/5/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/35/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/36/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/4/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0050358-8/39/1 10-Jun-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
M21-0748059-4/2/1/B 11-Jun-2013 66VDY99 3004889121 Laboratorios Rysell Dominican Republic
 
EAM-0014008-6/4/1/C 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/12/1/A 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/12/1/B 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/24/1/A 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/36/1/B 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/65/1/B 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
EAM-0014008-6/65/1/C 14-Jun-2013 66VDY99 3004196619 Tanalize Kozmetik Ve Temizlik Turkey
 
CFX-9911402-4/1/1/B 21-Jun-2013 66VDY99 3004121442 Laboratorios Piersan Para Drodijosa Guatemala
 
R12-0046453-4/78/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/1/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/44/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/64/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/65/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/84/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/37/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/23/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/16/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/58/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/22/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
R12-0046453-4/45/1 25-Jun-2013 66VDY99 3008989637 Chanel Beaute Parfums France
 
AMS-0003223-4/97/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/94/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/96/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/107/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/108/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/106/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/95/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
AMS-0003223-4/98/1 27-Jun-2013 66VDY99 3000243864 Clarins France
 
MH9-2012570-4/2/1 28-Jun-2013 66VDY99 3004123142 Farvital Sl Laboraratorios Carasa Spain
 
MH9-2012570-4/2/2 28-Jun-2013 66VDY99 3004123142 Farvital Sl Laboraratorios Carasa Spain
 
UPS-0848583-3/1/1 03-Jun-2013 66VPJ99 3009347704 Skillingarydsalvan Ab Sweden
 
663-2212743-3/1/1 14-Jun-2013 66YCT99 3002949085 Dr. Reddy's Laboratories Limited CTO VI India
 
9WH-1000490-1/15/1 13-Jun-2013 66YCY99 3009549077 Lightwave Trading Co Pvt. Ltd. India
 
9WH-1000490-1/16/1 13-Jun-2013 66YCY99 3009549077 Lightwave Trading Co Pvt. Ltd. India
 
K09-0058086-9/1/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/2/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/3/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/4/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/5/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/6/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/7/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/8/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/9/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
K09-0058086-9/10/1 18-Jun-2013 66YCY99 3004433773 Labora S.R.O. Czech Republic
 
112-2611764-2/4/1/B 03-Jun-2013 66YDY99 3010158284 MOHD HASSAN ASADI TRADING COMPANY United Arab Emirates
 
112-2611764-2/4/1/D 03-Jun-2013 66YDY99 3010158284 MOHD HASSAN ASADI TRADING COMPANY United Arab Emirates
 
112-2611764-2/4/1/E 03-Jun-2013 66YDY99 3010158284 MOHD HASSAN ASADI TRADING COMPANY United Arab Emirates
 
112-2611764-2/4/1/C 03-Jun-2013 66YDY99 3010158284 MOHD HASSAN ASADI TRADING COMPANY United Arab Emirates
 
9WH-1000490-1/4/1 13-Jun-2013 66YDY99 3009549077 Lightwave Trading Co Pvt. Ltd. India
 
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