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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-9751501-5/1/1 18-Apr-2013 66BAY44 3002807078 GlaxoSmithKline United Kingdom
 
AEK-0833305-2/1/1 15-Apr-2013 66BBK44 3010068071 Sha Hongzhuangyuan Intl Co Ltd China
 
UPS-0110320-1/1/7 19-Apr-2013 66FCA05 3010075631 Natasha Darville Bahamas
 
201-2748967-1/1/1 08-Apr-2013 66JCS02 3002923756 Peptido GmbH Germany
 
AEK-0870147-2/1/1/A 03-Apr-2013 66PAJ99 3009776556 Dermophisiologique Srl Italy
 
AEK-0870147-2/1/1/F 03-Apr-2013 66PAJ99 3009776556 Dermophisiologique Srl Italy
 
AEK-0870147-2/1/1/I 03-Apr-2013 66PAJ99 3009776556 Dermophisiologique Srl Italy
 
AEK-0870147-2/1/1/B 03-Apr-2013 66PAL99 3009776556 Dermophisiologique Srl Italy
 
EFR-0015926-2/1/1 02-Apr-2013 66PBJ99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
EFR-0015926-2/1/2 02-Apr-2013 66PBJ99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
EFR-0015926-2/1/3 02-Apr-2013 66PBJ99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
EFR-0015926-2/1/4 02-Apr-2013 66PBJ99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
EFR-0015926-2/1/5 02-Apr-2013 66PBJ99 3004055664 Unilever de Mexico S de R.L. de C.V. Mexico
 
112-2598755-7/1/1 30-Apr-2013 66PCQ99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
112-2598755-7/1/2 30-Apr-2013 66PCQ99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
112-2598755-7/1/3 30-Apr-2013 66PCQ99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
CDX-0059613-2/1/22 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
CDX-0059613-2/1/18 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
CDX-0059613-2/1/16 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
CDX-0059613-2/1/14 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
CDX-0059613-2/1/12 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
CDX-0059613-2/1/36 02-Apr-2013 66PCY99 3009064446 Zenith Medicosm, S.L. Spain
 
AEK-0828371-1/1/1 17-Apr-2013 66SBF99 3006323551 Enzo Nutraceuticals Limited New Zealand
 
AEK-0828372-9/1/1 17-Apr-2013 66SBF99 3006323551 Enzo Nutraceuticals Limited New Zealand
 
UPS-0110320-1/1/2 19-Apr-2013 66TCA01 3010075631 Natasha Darville Bahamas
 
D68-0135675-2/1/6 18-Apr-2013 66V99 3009429164 Europa Plus Ukraine
 
AEK-0298238-3/1/1 16-Apr-2013 66VAA99 3010056832 Corporacion Emceta Venezuela
 
G01-0361344-7/2/1 08-Apr-2013 66VAJ99 3003097030 Laboratorio Bremer, S.A. De C.V. Mexico
 
AEK-0802032-9/1/1 09-Apr-2013 66VAY99 3008766675 Sanjivni Herbal Care India
 
AEK-0801951-1/1/1 22-Apr-2013 66VAY99 3007536435 Dr. Ketan Patel India
 
DP4-0617207-3/7/4 24-Apr-2013 66VAY99 3007976843 Y L W Baron International Israel
 
788-0316765-6/1/1 18-Apr-2013 66VBL99 3004687204 Unicorn Pacific Corporation Vanuatu
 
KH5-0081414-1/22/1/B 01-Apr-2013 66VBR99 3003465866 Shenzhen 999 Chinese Medicine Investment & Dev. Co., Ltd. China
 
AEK-0857123-0/2/1 02-Apr-2013 66VBR99 3009825039 Sweet Heart Food Industries Malaysia
 
AEK-0857123-0/1/1 02-Apr-2013 66VBY99 3010034751 Nutriline Malaysia
 
UPS-0127900-1/1/1/A 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/B 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/C 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/D 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/E 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/F 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/G 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/H 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/I 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/J 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/K 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/L 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/M 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/N 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/O 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/P 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/Q 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/R 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/S 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/T 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/X 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
UPS-0127900-1/1/1/Y 10-Apr-2013 66VBY99 3008556895 Isha Agro Developers Pvt Ltd India
 
112-2021013-8/1/1 12-Apr-2013 66VBY99 3004342832 Nestmann Pharma GmbH Germany
 
701-5327881-0/5/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/6/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/7/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/8/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/10/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/11/1 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
701-5327881-0/20/1/C 12-Apr-2013 66VBY99 3010049408 Dead Sea Gift Enterprise Jordan
 
FS2-1120315-3/36/1 23-Apr-2013 66VBY99 3009616846 Mcm Klosterfrau Germany
 
FS2-1120315-3/39/1 23-Apr-2013 66VBY99 3009616846 Mcm Klosterfrau Germany
 
UPS-0158763-5/1/1 10-Apr-2013 66VCA99 3010082102 Nutrex Pharmacy United States
 
UPS-0158763-5/1/2 10-Apr-2013 66VCA99 3010082102 Nutrex Pharmacy United States
 
UPS-0158763-5/1/3 10-Apr-2013 66VCA99 3010082102 Nutrex Pharmacy United States
 
J89-0118740-3/3/3 24-Apr-2013 66VCA99 3004046278 Popat Raja & Sons India
 
EBH-0072294-5/1/2 05-Apr-2013 66VCE99 3008567049 Am-Europharma Corporation Philippines
 
EBH-0072294-5/1/3 05-Apr-2013 66VCE99 3008567049 Am-Europharma Corporation Philippines
 
506-0826577-8/1/1 15-Apr-2013 66VCE99 3002653483 Novartis Pharma Stein AG Switzerland
 
506-0826577-8/2/1 15-Apr-2013 66VCE99 3002653483 Novartis Pharma Stein AG Switzerland
 
DP6-2037238-4/2/1 12-Apr-2013 66VCJ99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
DP6-2037236-8/8/1 24-Apr-2013 66VCJ99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
DP6-2037236-8/5/1 24-Apr-2013 66VCL99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
E9A-0003133-1/5/1 02-Apr-2013 66VCS99 3009321553 Fmcg Dis Tic Turkey
 
E9A-0003133-1/5/2 02-Apr-2013 66VCS99 3009321553 Fmcg Dis Tic Turkey
 
E9A-0003133-1/5/3 02-Apr-2013 66VCS99 3009321553 Fmcg Dis Tic Turkey
 
E9A-0003133-1/5/4 02-Apr-2013 66VCS99 3009321553 Fmcg Dis Tic Turkey
 
KM6-0060946-5/13/1 03-Apr-2013 66VCS99 3003652318 Hamdard Warf Laboratories India
 
KM6-0060946-5/22/1 03-Apr-2013 66VCS99 3009046679 Emami Limited India
 
KM6-0060946-5/23/1 03-Apr-2013 66VCS99 3003726991 M/S Vicco Laboratories India
 
KM6-0060946-5/24/1 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/24/3 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/24/5 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/24/6 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/25/3/A 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/25/3/B 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/25/4/A 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/25/4/B 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/26/1/A 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/26/1/B 03-Apr-2013 66VCS99 3004259394 The Himalaya Drug Company India
 
KM6-0060946-5/12/1 03-Apr-2013 66VCT99 3003652318 Hamdard Warf Laboratories India
 
J89-0118740-3/3/2 24-Apr-2013 66VCY99 3001946872 Hindustan Lever Limited India
 
J89-0118740-3/3/1 24-Apr-2013 66VCY99 3001946872 Hindustan Lever Limited India
 
KH5-0081414-1/27/1/C 01-Apr-2013 66VDA99 1000244108 Unknown China
 
KH5-0081414-1/27/1/I 01-Apr-2013 66VDE99 1000244108 Unknown China
 
KH5-0081414-1/27/1/K 01-Apr-2013 66VDE99 1000244108 Unknown China
 
KH5-0081414-1/27/1/M 01-Apr-2013 66VDE99 3007501739 Janssen Pharmaceutical China
 
KH5-0081414-1/27/1/N 01-Apr-2013 66VDE99 3007501739 Janssen Pharmaceutical China
 
KH5-0081414-1/27/1/O 01-Apr-2013 66VDE99 3007501739 Janssen Pharmaceutical China
 
EBH-0072294-5/1/4 05-Apr-2013 66VDR99 3010046444 Biogro New Zealand Ltd New Zealand
 
EBH-0072294-5/1/1 05-Apr-2013 66VDR99 3010046444 Biogro New Zealand Ltd New Zealand
 
AEK-0297918-1/1/2/A 05-Apr-2013 66VDY99 3009564761 Denova Pharmaceutical Ltda Colombia
 
AEK-0297918-1/1/2/B 05-Apr-2013 66VDY99 3009564761 Denova Pharmaceutical Ltda Colombia
 
AEK-0297918-1/2/1/A 05-Apr-2013 66VDY99 3009564761 Denova Pharmaceutical Ltda Colombia
 
AEK-0297918-1/2/1/B 05-Apr-2013 66VDY99 3009564761 Denova Pharmaceutical Ltda Colombia
 
AEK-0296861-4/1/1/A 08-Apr-2013 66VDY99 3010000676 Eveready De Colombia Colombia
 
AEK-0296861-4/1/1/B 08-Apr-2013 66VDY99 3010000676 Eveready De Colombia Colombia
 
R12-0046451-8/11/1 12-Apr-2013 66VDY99 3000248560 Estee Lauder Cosmetics Ltd. Canada
 
R12-0046451-8/132/1 12-Apr-2013 66VDY99 3000248560 Estee Lauder Cosmetics Ltd. Canada
 
R12-0046451-8/76/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/10/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/131/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/12/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/203/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/75/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/186/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/93/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/96/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/81/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/187/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/119/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/13/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/136/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/7/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/114/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/3/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/8/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/161/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/80/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046451-8/133/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/9/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/129/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/130/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/180/1 12-Apr-2013 66VDY99 2418643 Estee Lauder Inc (Len Ron Mfg) United States
 
R12-0046451-8/4/1 12-Apr-2013 66VDY99 1000224360 Estee Lauder N.V. Belgium
 
R12-0046451-8/17/1 12-Apr-2013 66VDY99 3004347567 WHITMAN LABORATORIES LTD. United Kingdom
 
R12-0046361-9/13/1 16-Apr-2013 66VDY99 3008991731 Lancome Parf. & Beaute Cie France
 
ESD-0049686-6/3/1 16-Apr-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
ESD-0049686-6/5/1 16-Apr-2013 66VDY99 3010046442 Clarins S.A Bahamas
 
M21-0747771-5/5/1 16-Apr-2013 66VDY99 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
112-2136420-7/1/1 22-Apr-2013 66VDY99 3010083658 March Pharmaceutical Thailand
 
112-1563711-3/1/1 23-Apr-2013 66VDY99 3010014597 Lc Beauty Spa Italy
 
AMG-0094417-7/2/1 29-Apr-2013 66VDY99 3002651737 Ceras Especiales Martinez De San Vicente S.A. Spain
 
E4W-0005462-8/15/1 29-Apr-2013 66VDY99 1000211046 Wisdom Toothbrushes United Kingdom
 
E4W-0005462-8/13/1 29-Apr-2013 66VDY99 1000211046 Wisdom Toothbrushes United Kingdom
 
E4W-0005462-8/8/1 29-Apr-2013 66VDY99 3009590855 Malibu Health Products Limited United Kingdom
 
E4W-0005462-8/3/1 29-Apr-2013 66VDY99 1000211046 Wisdom Toothbrushes United Kingdom
 
E4W-0005462-8/4/1 29-Apr-2013 66VDY99 1000211046 Wisdom Toothbrushes United Kingdom
 
KH5-0081414-1/27/1/L 01-Apr-2013 66VSE99 1000244108 Unknown China
 
BDD-0779314-0/10/1 26-Apr-2013 66YBK99 3005317612 INTERNATIONAL PHARMACEUTICALS, INC. Philippines
 
KH5-0081414-1/21/1/H 01-Apr-2013 66YCY99 1000244108 Unknown China
 
KH5-0081414-1/22/1/D 01-Apr-2013 66YCY99 3006702621 Guangdong Taicheng China
 
BNI-0033722-8/1/1 26-Apr-2013 66YCY99 3004393843 PLG IMPORT EXPORT LIMITED Jamaica
 
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