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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
112-2653179-2/1/1 17-May-2013 66NCC06 3006725106 Otsuka Pharmaceutical Co Ltd Japan
 
315-4025905-3/82/1 29-May-2013 66PAL99 3001651340 Nippon Shikizai Inc Japan
 
AM1-0186390-1/5/11 29-May-2013 66PBL08 3005168915 Trilogy New Zealand
 
AM1-0186390-1/5/16 29-May-2013 66PBL08 3005168915 Trilogy New Zealand
 
112-0838863-2/2/1 16-May-2013 66SDA48 3004979469 Laboratorios Baldacci S/A Brazil
 
024-1534606-9/1/1 20-May-2013 66VAS99 3008325306 SIC "Borshchahivskiy Chemical Pharmaceutical Plant" CJSC Ukraine
 
024-1534606-9/4/1 20-May-2013 66VAS99 3006723373 Krewel Meuselbach Gmbh Germany
 
AEK-0803590-5/1/1 28-May-2013 66VAY99 3010103834 Emeka Anya Nigeria
 
BYR-0007758-8/3/1 10-May-2013 66VBA99 3008291663 Schwabe Mexico S.A. De C.V. Mexico
 
BYR-0007837-0/1/1 10-May-2013 66VBA99 3008291663 Schwabe Mexico S.A. De C.V. Mexico
 
112-2358230-1/1/1 16-May-2013 66VBA99 3010109637 Healthinsight United Kingdom
 
AZZ-2102628-2/1/3 14-May-2013 66VBJ99 3007308033 Huini Beauty Co China
 
AZZ-2102628-2/1/4 14-May-2013 66VBJ99 3007308033 Huini Beauty Co China
 
T77-1170021-3/1/1 01-May-2013 66VBL99 3008756917 Kandamkulathu Vaidyasala India
 
T77-1170021-3/1/2 01-May-2013 66VBL99 3008756917 Kandamkulathu Vaidyasala India
 
T77-1170021-3/1/3 01-May-2013 66VBL99 3008756917 Kandamkulathu Vaidyasala India
 
KG2-0529496-3/6/1 27-May-2013 66VBP99 3008336699 Armesso S A Colombia
 
112-2387504-4/1/1 03-May-2013 66VBY99 3006349217 Biogenie International France
 
112-2387504-4/1/3 03-May-2013 66VBY99 3006349217 Biogenie International France
 
112-2387504-4/1/4 03-May-2013 66VBY99 3006349217 Biogenie International France
 
112-2387504-4/1/2 03-May-2013 66VBY99 3006349217 Biogenie International France
 
AYG-1002814-5/13/1 13-May-2013 66VBY99 3004272360 Unique Fragrances India
 
112-2373190-8/4/1/A 16-May-2013 66VBY99 3009786013 Yusra United Arab Emirates
 
EBH-0072262-2/30/1 21-May-2013 66VBY99 3003725684 Unilever Philippines, Inc. Philippines
 
EBH-0072262-2/30/2 21-May-2013 66VBY99 3003725684 Unilever Philippines, Inc. Philippines
 
EBH-0072262-2/40/3 21-May-2013 66VBY99 3005421272 Psalmstre Enterprises Philippines
 
EBH-0072262-2/41/1 21-May-2013 66VBY99 3010067558 Greenstone Pharmaceutical H.K.Inc Philippines
 
EBH-0072262-2/42/1 21-May-2013 66VBY99 3010067561 Blooming Stars Enterprises Philippines
 
FV4-5041763-2/1/1 23-May-2013 66VBY99 3010122103 Rebom Cosmetics Co Ltd Korea, Republic Of (South)
 
FV4-5041763-2/1/2 23-May-2013 66VBY99 3010122103 Rebom Cosmetics Co Ltd Korea, Republic Of (South)
 
FV4-5041763-2/1/3 23-May-2013 66VBY99 3010122103 Rebom Cosmetics Co Ltd Korea, Republic Of (South)
 
FV4-5041763-2/1/4 23-May-2013 66VBY99 3010122103 Rebom Cosmetics Co Ltd Korea, Republic Of (South)
 
112-9789657-8/1/1 29-May-2013 66VCE99 3006942906 Vemo 99 Bulgaria
 
UPS-0492298-7/1/1 20-May-2013 66VCS99 3010114436 Vonckx Belgium
 
AGT-0009644-7/7/1/I 28-May-2013 66VCS99 3010103499 dependable pharmacy LTD Ghana
 
AGT-0009644-7/7/1/J 28-May-2013 66VCS99 3006091721 Mighty Power Company Ghana
 
AGT-0009644-7/7/1/K 28-May-2013 66VCS99 3005280876 ADUTWUMWAA BITTERS Ghana
 
AGT-0009644-7/7/1/L 28-May-2013 66VCS99 3005280822 Karafi Ltd. Ghana
 
AGT-0009644-7/7/1/N 28-May-2013 66VCS99 3007906385 CAPITAL 02 Natural Health Co. Ltd. Ghana
 
AGT-0009644-7/7/1/O 28-May-2013 66VCS99 3002494649 Alafia Bitters Ghana
 
AGT-0009644-7/7/1/P 28-May-2013 66VCS99 3007906385 CAPITAL 02 Natural Health Co. Ltd. Ghana
 
AGT-0009644-7/7/1/R 28-May-2013 66VCS99 3008069912 William Ransom And Sons Plc United Kingdom
 
XXX-0248155-5/1/3 13-May-2013 66VCY99 3005677069 Laboratorios Recalcine, S.A. Chile
 
AEK-0977280-3/1/1 14-May-2013 66VCY99 3008158114 Life Wave Llc United States
 
GEO-8500461-8/1/1 22-May-2013 66VCY99 1000132620 Holland America Line - United States
 
GEO-8500462-6/1/1 22-May-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-8500463-4/1/1 22-May-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-8500464-2/1/1 22-May-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-8500465-9/1/1 22-May-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-8500466-7/1/1 22-May-2013 66VCY99 1000135041 Bellegrove Medical Supply United States
 
112-2540778-8/12/1/A 24-May-2013 66VCY99 3009547380 Al Qasimiya United Arab Emirates
 
112-2540778-8/12/1/B 24-May-2013 66VCY99 1000349168 Unilever Arabia United Arab Emirates
 
112-2540778-8/12/1/C 24-May-2013 66VCY99 1000349168 Unilever Arabia United Arab Emirates
 
112-2540778-8/12/1/D 24-May-2013 66VCY99 1000349168 Unilever Arabia United Arab Emirates
 
112-2540778-8/12/1/F 24-May-2013 66VCY99 3007532570 Naturelle Llc United Arab Emirates
 
112-2540778-8/12/1/G 24-May-2013 66VCY99 3007532570 Naturelle Llc United Arab Emirates
 
112-2540778-8/12/1/H 24-May-2013 66VCY99 3007532570 Naturelle Llc United Arab Emirates
 
BDD-0752870-2/9/1 29-May-2013 66VCY99 3003725684 Unilever Philippines, Inc. Philippines
 
HH7-0306700-4/1/1 03-May-2013 66VDJ99 2000037283 Laboratorios Dr. Collado Dominican Republic
 
HH7-0306700-4/1/2 03-May-2013 66VDJ99 2000037283 Laboratorios Dr. Collado Dominican Republic
 
UPS-0624033-9/1/1 23-May-2013 66VDL99 3009991217 Moores Pharmacy Ltd United Kingdom
 
KG2-0529496-3/1/1 27-May-2013 66VDP99 3008336699 Armesso S A Colombia
 
UPS-0586964-1/1/1 01-May-2013 66VDY99 3010131599 S. Barakath Nisha India
 
AMS-0003239-0/20/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/136/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/150/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/149/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/147/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/140/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/133/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/90/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/138/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/137/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/139/1 03-May-2013 66VDY99 3000243864 Clarins France
 
AMS-0003239-0/104/1 03-May-2013 66VDY99 3000243864 Clarins France
 
201-1960885-8/1/8 06-May-2013 66VDY99 3008878813 SESDERMA SL Spain
 
201-1960885-8/1/28 06-May-2013 66VDY99 3008878813 SESDERMA SL Spain
 
201-1960885-8/1/32 06-May-2013 66VDY99 3008878813 SESDERMA SL Spain
 
201-1960885-8/1/62 06-May-2013 66VDY99 3008878813 SESDERMA SL Spain
 
201-1960885-8/3/1 06-May-2013 66VDY99 3008878813 SESDERMA SL Spain
 
R12-0046550-7/1/1 13-May-2013 66VDY99 3008991731 Lancome Parf. & Beaute Cie France
 
AEK-0299277-0/2/3 13-May-2013 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
516-2049460-2/15/1 15-May-2013 66VDY99 3009854207 Distribuidora Y Comercializadora De Productos En G Peru
 
516-2049460-2/16/1 15-May-2013 66VDY99 3009854207 Distribuidora Y Comercializadora De Productos En G Peru
 
516-2049460-2/17/1 15-May-2013 66VDY99 3009854207 Distribuidora Y Comercializadora De Productos En G Peru
 
516-2049460-2/22/1 15-May-2013 66VDY99 1525778 Procter & Gamble Co United States
 
516-2049460-2/25/1 15-May-2013 66VDY99 1525778 Procter & Gamble Co United States
 
516-2049460-2/26/1 15-May-2013 66VDY99 1525778 Procter & Gamble Co United States
 
516-2049460-2/28/1 15-May-2013 66VDY99 1525778 Procter & Gamble Co United States
 
AEK-0299380-2/1/1 20-May-2013 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
AEK-0299380-2/1/2 20-May-2013 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
AEK-0299380-2/1/3 20-May-2013 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
M21-0748072-7/3/1 30-May-2013 66VDY99 3006497359 Research Pharmaceutical Colombia
 
AEK-0832405-1/1/1 02-May-2013 66VKL99 3006097966 Immunall Ltd. Uk. United Kingdom
 
UPS-6448916-7/1/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/4/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/6/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/9/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/11/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/12/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/10/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/7/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/5/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448916-7/3/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/4/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/6/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/3/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/5/1 15-May-2013 66YBA99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/10/1 15-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/13/1 15-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/15/1 15-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/12/1 15-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/7/1 16-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/8/1 16-May-2013 66YBL99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/1/1 15-May-2013 66YBY99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/2/1 15-May-2013 66YBY99 2000026312 W. Last CC South Africa
 
UPS-6448915-9/14/1 16-May-2013 66YBY99 2000026312 W. Last CC South Africa
 
073-0097420-6/18/1 03-May-2013 66YCY99 3009146363 Biljana Dd Bosnia-Hercegovina
 
073-0097420-6/19/1 03-May-2013 66YCY99 3009146363 Biljana Dd Bosnia-Hercegovina
 
DO7-8289275-9/1/1/A 09-May-2013 66YCY99 3008870741 Profimade Spain
 
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