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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
XXX-0175057-0/1/1 08-Mar-2011 66BBY99 3006530029 Guangzhou Wanglaoji Pharmaceutical Company Limited China
 
112-7331744-0/3/1 31-Mar-2011 66BLH99 3003195501 Sanofi-Aventis Deutschland GmbH Germany
 
AEK-8368069-0/1/1 30-Mar-2011 66CAH99 3006381009 Softgel Healthcare Private Limited India
 
112-8931635-2/8/1 23-Mar-2011 66JCA01 1000582249 Abbott Laboratories Ltd Canada
 
112-0985188-5/1/1 02-Mar-2011 66JCE01 3005156049 Glaxo Welcome Gmbh Co Germany
 
112-6811509-8/1/3 25-Mar-2011 66MCB75 3005639348 Medreich United Kingdom
 
112-5818354-4/3/1 15-Mar-2011 66MDB86 3002806439 Pfizer Canada Inc. Canada
 
112-0918761-1/1/1 11-Mar-2011 66MDE76 3003122055 I C N Canada Canada
 
112-8931635-2/2/1 23-Mar-2011 66NCA03 3002807756 Teva Canada Limited Canada
 
112-1077824-2/2/1 11-Mar-2011 66NDA06 3008791635 Laboratoire Bristol France
 
KM6-0050715-6/4/4 04-Mar-2011 66PAJ99 3007796366 CAVIN INDUSTRIES PRIVATE LIMITED India
 
112-8741511-4/1/10 09-Mar-2011 66PAJ99 1000161942 Kryolan GmbH Germany
 
112-8741511-4/1/5 09-Mar-2011 66PAJ99 1000161942 Kryolan GmbH Germany
 
EYD-0102526-5/1/1 08-Mar-2011 66PBJ99 3008397119 Siegranz Chemworks Corporation Philippines
 
EYD-0102526-5/1/5 08-Mar-2011 66PBJ99 3008397119 Siegranz Chemworks Corporation Philippines
 
112-0965618-5/1/1 09-Mar-2011 66PBJ99 3006248191 L'Oreal France
 
DZ1-0423139-1/1/1 10-Mar-2011 66PBJ99 3006809691 Optima Cosmetic Of Switzerland Switzerland
 
KM6-0050378-3/26/1 08-Mar-2011 66PBL99 3006523241 Hindustan Unilever Limited India
 
EB5-1506156-3/4/1/F 09-Mar-2011 66PBL99 1000183699 Laboratories La Prairie Sa Switzerland
 
EB5-1506156-3/4/1/H 09-Mar-2011 66PBL99 1000183699 Laboratories La Prairie Sa Switzerland
 
EB5-1506156-3/4/1/K 09-Mar-2011 66PBL99 1000183699 Laboratories La Prairie Sa Switzerland
 
WIB-1235090-9/22/1 29-Mar-2011 66PBL99 3002655505 Nadri Cosmetic Co.,Ltd Korea, Republic Of (South)
 
WIB-1235090-9/33/1 29-Mar-2011 66PBL99 3002655505 Nadri Cosmetic Co.,Ltd Korea, Republic Of (South)
 
WIB-1235090-9/34/1 29-Mar-2011 66PBL99 3002655505 Nadri Cosmetic Co.,Ltd Korea, Republic Of (South)
 
WIB-1235090-9/35/1 29-Mar-2011 66PBL99 3002655505 Nadri Cosmetic Co.,Ltd Korea, Republic Of (South)
 
WIB-1235090-9/37/1 29-Mar-2011 66PBL99 3002655505 Nadri Cosmetic Co.,Ltd Korea, Republic Of (South)
 
D40-0318812-3/7/1 09-Mar-2011 66PBY99 3003386988 Klapp Cosmetics Gmbh Germany
 
D40-0318812-3/8/1 09-Mar-2011 66PBY99 3003386988 Klapp Cosmetics Gmbh Germany
 
BGZ-0014926-4/1/1 25-Mar-2011 66SAY08 3005074449 Maneesh Pharmaceuticals Ltd India
 
112-5818354-4/1/1/A 15-Mar-2011 66SCB27 3001443914 Bayer Inc Canada
 
112-1003259-0/1/1 17-Mar-2011 66SCR08 3003699053 Jayco Chemical Industries India
 
101-8788771-5/14/1/C 08-Mar-2011 66V99 3008734071 Karkhana Zinda Tilismath India
 
DH5-6012040-3/7/1 11-Mar-2011 66V99 3008432914 WAI YUEN TONG MEDICINE CO., LTD. Hong Kong SAR
 
DH5-6012040-3/4/1 11-Mar-2011 66V99 3008432914 WAI YUEN TONG MEDICINE CO., LTD. Hong Kong SAR
 
EJ8-1121482-7/1/1 18-Mar-2011 66V99 3008651023 Sichuan Chuan Wu Ji Biotech Co. Ltd China
 
112-0905200-5/1/1 25-Mar-2011 66V99 3008770278 Lloyds Laboratories Philippines
 
267-5220068-8/1/1 31-Mar-2011 66V99 3007590008 Changshu Huashun Clothing Co Ltd China
 
144-3203856-3/1/1 16-Mar-2011 66VAL99 3004325305 Heathstock Apiaries New Zealand
 
ADR-0034313-9/56/1 24-Mar-2011 66VAL99 3007302691 Hajisons International Traders Pakistan
 
ADR-0034313-9/60/1 24-Mar-2011 66VAL99 3007483701 MARHABA LABORATORIES Pakistan
 
ADR-0034313-9/54/1 24-Mar-2011 66VAR99 3007483701 MARHABA LABORATORIES Pakistan
 
ADR-0034313-9/55/1 24-Mar-2011 66VAR99 3007483701 MARHABA LABORATORIES Pakistan
 
112-8341461-7/1/1 01-Mar-2011 66VAY99 3008474843 Unda Sa Belgium
 
112-8341461-7/1/3 01-Mar-2011 66VAY99 3008474843 Unda Sa Belgium
 
112-8341461-7/1/2 01-Mar-2011 66VAY99 3008474843 Unda Sa Belgium
 
XXX-0209062-0/1/3 03-Mar-2011 66VAY99 3006072524 Armesso Ltda. Colombia
 
XXX-0209062-0/1/9 03-Mar-2011 66VAY99 3007689123 Farmacia Drogueria San Jorge Ltda Colombia
 
T76-0173938-8/1/1 07-Mar-2011 66VBL99 3008659852 Kwong Fat International Trading Co China
 
KM6-0049570-9/3/1 08-Mar-2011 66VBL99 3003452796 Reckitt Benckiser India
 
KM6-0049570-9/3/2 08-Mar-2011 66VBL99 3003452796 Reckitt Benckiser India
 
KM6-0049570-9/3/3 08-Mar-2011 66VBL99 3003452796 Reckitt Benckiser India
 
906-1072222-6/21/1 08-Mar-2011 66VBL99 3005179578 Promed Laboratories (P) Ltd. India
 
D40-0318812-3/1/1 09-Mar-2011 66VBL99 3003386988 Klapp Cosmetics Gmbh Germany
 
ADR-0034313-9/57/1 24-Mar-2011 66VBL99 3004273572 HAMDARD LABORATORIES ( WAQF ) PAKISTAN Pakistan
 
ADR-0034313-9/58/1 24-Mar-2011 66VBL99 3007302691 Hajisons International Traders Pakistan
 
BSL-0701562-2/14/1 16-Mar-2011 66VBO99 3004096041 Splash Corporation Philippines
 
BSL-0701562-2/14/2 16-Mar-2011 66VBO99 3004096041 Splash Corporation Philippines
 
BSL-0701562-2/26/1 16-Mar-2011 66VBO99 3001421895 Trinidad Cosmetic Lab Philippines
 
BSL-0701562-2/27/1 16-Mar-2011 66VBO99 3007251132 Intelligent Skin Care, Inc. Philippines
 
BSL-0701562-2/27/2 16-Mar-2011 66VBO99 3007251132 Intelligent Skin Care, Inc. Philippines
 
BSL-0701562-2/28/1 16-Mar-2011 66VBO99 3007251132 Intelligent Skin Care, Inc. Philippines
 
BSL-0701562-2/28/2 16-Mar-2011 66VBO99 3007251132 Intelligent Skin Care, Inc. Philippines
 
408-1268336-2/1/1 10-Mar-2011 66VBS99 3004688545 M.S. S. ASAN EXPORTS India
 
408-1268336-2/2/3 10-Mar-2011 66VBS99 3004688545 M.S. S. ASAN EXPORTS India
 
408-1268336-2/2/4 10-Mar-2011 66VBS99 3004688545 M.S. S. ASAN EXPORTS India
 
408-1268336-2/2/2 10-Mar-2011 66VBS99 3004688545 M.S. S. ASAN EXPORTS India
 
408-1268336-2/2/1 10-Mar-2011 66VBS99 3004688545 M.S. S. ASAN EXPORTS India
 
XXX-0261120-1/1/1 18-Mar-2011 66VBY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
112-8916482-7/2/1 23-Mar-2011 66VBY99 3005122434 Colordesign S.R.L. Soc Unipersonale Italy
 
WIB-1235404-2/1/1/A 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/B 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/C 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/D 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/E 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/F 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/G 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/H 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/I 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/J 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/K 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
WIB-1235404-2/1/1/L 23-Mar-2011 66VBY99 3005508084 Wuhan Chinese Rare Stone Museum China
 
ADR-0034313-9/75/1 24-Mar-2011 66VBY99 3008202820 Reckitt Benckiser Pakistan Ltd Pakistan
 
H05-5903066-5/1/2 25-Mar-2011 66VBY99 3008186223 ABC International Limited United Arab Emirates
 
H05-5903066-5/1/3 25-Mar-2011 66VBY99 3008186223 ABC International Limited United Arab Emirates
 
H05-5903066-5/2/1 25-Mar-2011 66VBY99 3008186223 ABC International Limited United Arab Emirates
 
XXX-0209164-4/1/1 30-Mar-2011 66VBY99 3005203073 Bayer S.A. Guatemala
 
XXX-0209164-4/1/4 30-Mar-2011 66VBY99 3005203073 Bayer S.A. Guatemala
 
XXX-0209164-4/1/8 30-Mar-2011 66VBY99 3005138136 Laboratorios Laprin, S.A. Guatemala
 
HK1-0195575-3/18/1/A 30-Mar-2011 66VBY99 3008764463 China Tshuaj Ntsu Ab, China China
 
HK1-0195575-3/18/1/B 30-Mar-2011 66VBY99 3008764463 China Tshuaj Ntsu Ab, China China
 
UPS-1300611-5/1/1 11-Mar-2011 66VCC99 3008784738 K Tracey Canada
 
112-0417961-3/2/1 08-Mar-2011 66VCE99 3001727058 Novartis Healthcare Philippines
 
112-8467805-3/1/1 01-Mar-2011 66VCP99 3004486790 Maharishi Ayurveda Products India
 
112-8467805-3/1/2 01-Mar-2011 66VCP99 3003645093 Shree Baidyanath Ayurved Bhawan India
 
KM6-0050170-4/10/1/A 04-Mar-2011 66VCS99 3006160626 UNILEVER BANGLADESH LIMITED Bangladesh
 
KM6-0050170-4/10/1/B 04-Mar-2011 66VCS99 3006160626 UNILEVER BANGLADESH LIMITED Bangladesh
 
KM6-0050170-4/10/2 04-Mar-2011 66VCS99 3006712348 MNR Agro Processor Bangladesh
 
AGT-0006943-6/2/1/C 23-Mar-2011 66VCS99 3008282047 Ets Sanon Ami Ivory Coast
 
AGT-0006943-6/3/1 23-Mar-2011 66VCS99 3008282047 Ets Sanon Ami Ivory Coast
 
AGT-0006943-6/4/1/A 23-Mar-2011 66VCS99 3008282047 Ets Sanon Ami Ivory Coast
 
AGT-0006943-6/5/1/D 23-Mar-2011 66VCS99 3008282047 Ets Sanon Ami Ivory Coast
 
AGT-0006943-6/6/1/C 23-Mar-2011 66VCS99 3008282047 Ets Sanon Ami Ivory Coast
 
XXX-0272180-2/1/1 03-Mar-2011 66VCY99 3006198949 Laboratory Genfar Sa Colombia
 
XXX-0271482-3/1/1 08-Mar-2011 66VCY99 3004543052 THERFAM Guatemala
 
XXX-0175082-8/1/1/A 10-Mar-2011 66VCY99 3008785583 Energise UK Limited United Kingdom
 
XXX-0175082-8/1/1/B 10-Mar-2011 66VCY99 3008785583 Energise UK Limited United Kingdom
 
XXX-0261124-3/1/1 18-Mar-2011 66VCY99 3006607469 Macleods Pharmaceuticals Limited India
 
XXX-0209164-4/1/5 30-Mar-2011 66VCY99 3007730186 lABORATORIOS SANTE, S.A. Guatemala
 
XXX-0271209-0/1/1 30-Mar-2011 66VCY99 3006372409 Abbott Laboratories Argentina Sa Argentina
 
UPS-1487872-8/1/1 31-Mar-2011 66VDA99 3008805101 Epitech Group Italy
 
UPS-9102917-1/1/1 07-Mar-2011 66VDE99 3008466538 Qinghai Province Xining City Ailida China
 
AV3-0023213-7/1/1 09-Mar-2011 66VDJ99 3007742208 Florri-Feme Pharmaceuticals United Kingdom
 
XXX-0261155-7/1/1 18-Mar-2011 66VDL99 3005567182 Laboratorio Elea S.A.C.I.F. yA. Argentina
 
UPS-1340053-2/1/1 28-Mar-2011 66VDL99 3005191134 Kalichem Italia Srl Italy
 
XXX-0209062-0/1/2 03-Mar-2011 66VDY99 3006072524 Armesso Ltda. Colombia
 
XXX-0271486-4/1/1 07-Mar-2011 66VDY99 3005987451 Calox International, Ca Venezuela
 
FL2-0035955-0/29/1/A 09-Mar-2011 66VDY99 3008224880 Laboratorio Capilo Espanol, C. Por A. Dominican Republic
 
XXX-0272000-2/1/1 15-Mar-2011 66VDY99 3006347951 Merck Sa De Cv Mexico
 
XXX-0272004-4/1/2 15-Mar-2011 66VDY99 3005581604 Laboratorios Saval Sa Chile
 
XXX-0261124-3/1/2 18-Mar-2011 66VDY99 3005290143 Sankyo Pharma Brasil Ltda Brazil
 
H77-0125903-5/6/1 23-Mar-2011 66VDY99 3004793236 Qarshi Industries (PVT) Ltd. Pakistan
 
XXX-0209244-4/1/7 30-Mar-2011 66VDY99 3006489359 Merck S.A. De C.V. Mexico
 
UPS-1455176-2/1/1 24-Mar-2011 66VIJ99 3008574611 Quura Medical Netherlands
 
UPS-1455176-2/1/2 25-Mar-2011 66VIJ99 3008574611 Quura Medical Netherlands
 
UPS-1455176-2/1/3 25-Mar-2011 66VIJ99 3008574611 Quura Medical Netherlands
 
SG5-0426753-8/1/1 22-Mar-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426753-8/1/2 22-Mar-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426753-8/2/1 22-Mar-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426753-8/2/2 22-Mar-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
112-8916482-7/1/6 23-Mar-2011 66VIY99 3005122434 Colordesign S.R.L. Soc Unipersonale Italy
 
112-0900056-6/1/1 23-Mar-2011 66VIY99 3005804997 Rentsch Handels Ag Switzerland
 
112-0667922-2/2/1 04-Mar-2011 66VJO99 3007693973 Laboratoire Lpc France
 
KM6-0050267-8/24/1 04-Mar-2011 66YCL99 3007411652 Unilever Bangladesh Limited) Bangladesh
 
W69-3165976-8/102/1 07-Mar-2011 66YDL99 2000012960 Organic Health Co. Ltd. Taiwan
 
W69-3165976-8/103/1 07-Mar-2011 66YDL99 2000012960 Organic Health Co. Ltd. Taiwan
 
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