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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
EBX-0803139-9/3/1 26-Nov-2012 66FBL99 3008459891 Pankaj Exports India
 
AEK-0314618-6/2/2 07-Nov-2012 66MCA86 3009758584 Anil Sondhi India
 
112-0218999-5/1/1 30-Nov-2012 66NCB06 1000527885 Bristol Myers Squibb P.G. Canada
 
UPS-8262545-6/1/1 08-Nov-2012 66PBJ99 3004632050 Golfmaster Canada
 
101-3152540-4/9/1 13-Nov-2012 66PBL99 3008989108 Produits De Beaute' Produktions Gmbh Germany
 
336-7436167-4/2/1 02-Nov-2012 66PDL06 3003074262 P M International Gmbh Germany
 
AEK-0289424-0/1/1 20-Nov-2012 66VAA99 3002890029 Laboratorio Sanderson S.A. Chile
 
AEK-0289424-0/2/1 20-Nov-2012 66VAA99 3005579246 Hospira Inc. United States
 
AEK-0289424-0/2/2 20-Nov-2012 66VAA99 1717759 Sandoz Incorporated United States
 
AEK-0289424-0/2/3 20-Nov-2012 66VAA99 3006138169 A. P. Pharma, Inc. United States
 
AEK-0289424-0/2/4 20-Nov-2012 66VAA99 2517175 Teva Pharmaceuticals USA, Inc. United States
 
AEK-0289424-0/2/5 20-Nov-2012 66VAA99 3006388565 Glaxosmithkline -Onology Chemistry United States
 
AEK-0289424-0/2/6 20-Nov-2012 66VAA99 3004148087 Qualitest Pharm Manuf United States
 
AEK-0289424-0/2/7 20-Nov-2012 66VAA99 3005579246 Hospira Inc. United States
 
AEK-0289424-0/2/8 20-Nov-2012 66VAA99 3004410504 Glaxosmith-Kline United States
 
AEK-0289424-0/2/9 20-Nov-2012 66VAA99 1282497 Covidien LLC United States
 
112-0109572-2/9/1 15-Nov-2012 66VAR99 3008455217 Dena Casemtik Thailand
 
112-0109572-2/9/2 15-Nov-2012 66VAR99 3008455217 Dena Casemtik Thailand
 
DH5-6208160-3/31/1 19-Nov-2012 66VAR99 3004713733 Shanghai Tiayuan P China
 
DH5-6208160-3/12/1 19-Nov-2012 66VAR99 3004262234 Shanghai Tian Yuan Botanical Products Co. China
 
DH5-6208160-3/16/1 19-Nov-2012 66VAR99 3004713733 Shanghai Tiayuan P China
 
DH5-6208160-3/17/1 19-Nov-2012 66VAR99 3004713733 Shanghai Tiayuan P China
 
112-8833558-6/1/1 28-Nov-2012 66VAR99 3009194180 Shanghai Shenghua China
 
9MU-0237425-3/28/1 30-Nov-2012 66VBB99 3007390719 SETHI INTERNATIONAL India
 
112-0109572-2/10/1 15-Nov-2012 66VBJ99 3003678610 Unilever Thai Olding Ltd. Thailand
 
AEK-0578201-2/1/1 27-Nov-2012 66VBJ99 3008415402 Redrose United Kingdom
 
112-0263420-6/2/1 30-Nov-2012 66VBJ99 3009426377 Nanomed Co.,Ltd. Thailand
 
UPS-8407013-1/2/1 21-Nov-2012 66VBL99 3004285723 MONTEIL SA France
 
UPS-8407013-1/2/2 21-Nov-2012 66VBL99 3004285723 MONTEIL SA France
 
UPS-8407013-1/2/3 21-Nov-2012 66VBL99 3004285723 MONTEIL SA France
 
112-0039480-3/2/1 23-Nov-2012 66VBL99 3007645944 Wizcoz Co., Ltd. Korea, Republic Of (South)
 
112-0039480-3/2/2 23-Nov-2012 66VBL99 3004989717 Able C & C Co., Ltd. Korea, Republic Of (South)
 
112-0039480-3/2/4 23-Nov-2012 66VBL99 3007645944 Wizcoz Co., Ltd. Korea, Republic Of (South)
 
112-0039480-3/2/5 23-Nov-2012 66VBL99 3007645944 Wizcoz Co., Ltd. Korea, Republic Of (South)
 
AEK-0364417-2/1/1/B 16-Nov-2012 66VBO99 3009726121 Pornsatit Thailand
 
9MU-0237425-3/8/1 30-Nov-2012 66VBR99 3007390719 SETHI INTERNATIONAL India
 
315-8611325-5/1/1 05-Nov-2012 66VBY99 3005817361 Union Swiss South Africa
 
315-8611551-6/1/1 05-Nov-2012 66VBY99 3005817361 Union Swiss South Africa
 
551-2141536-4/3/1 07-Nov-2012 66VBY99 3004146122 Maxigen Biotec, Inc. Taiwan
 
AEK-0364417-2/3/1/B 16-Nov-2012 66VBY99 3009726121 Pornsatit Thailand
 
AEK-0364417-2/3/1/A 16-Nov-2012 66VBY99 3009726121 Pornsatit Thailand
 
K80-1016408-6/11/6 19-Nov-2012 66VBY99 3009624711 Dabur India Ltd. India
 
300-7280467-5/16/1 09-Nov-2012 66VBZ99 3008872359 Obson International Pvt. Ltd. India
 
UPS-8131302-1/1/1 13-Nov-2012 66VCA99 3002806542 Takeda GmbH Germany
 
UPS-8190163-5/1/5 14-Nov-2012 66VCA99 3009806082 Carlos Lrodolfo Cortes Perez Mexico
 
UPS-8327719-0/1/1/A 19-Nov-2012 66VCA99 3009812076 Lebedeva Russia
 
UPS-8327719-0/1/1/B 19-Nov-2012 66VCA99 3009812076 Lebedeva Russia
 
UPS-8327719-0/1/1/C 19-Nov-2012 66VCA99 3009812076 Lebedeva Russia
 
UPS-8168581-6/1/1 30-Nov-2012 66VCA99 3009633536 Avanztec Inc Canada
 
G33-0167549-9/9/2 27-Nov-2012 66VCY99 3004120038 Ruchi Worldwide Soy Industries Limited India
 
H77-0133635-3/10/1 15-Nov-2012 66VDK99 3002817109 W. WOODWARD PAKISTAN LTD. Pakistan
 
371-4229353-1/25/1/C 02-Nov-2012 66VDO99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/D 02-Nov-2012 66VDO99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/O 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/b 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/M 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/m 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/n 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/o 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/p 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/25/1/r 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/26/1/A 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/26/1/B 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/27/1/F 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/27/1/Q 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
371-4229353-1/28/1/A 02-Nov-2012 66VDY99 3007330486 Dr. Babor GMBH & Co. KG Germany
 
UPS-8088395-8/1/1 08-Nov-2012 66VDY99 3009785515 Trotti Maddalena Italy
 
AMG-0088948-9/1/7/B 09-Nov-2012 66VDY99 3008697900 Alcantara Espana Cosmetica Spain
 
AMG-0088948-9/1/8/B 09-Nov-2012 66VDY99 3008697900 Alcantara Espana Cosmetica Spain
 
AMG-0088948-9/2/1/B 09-Nov-2012 66VDY99 3008697900 Alcantara Espana Cosmetica Spain
 
BTD-0007246-0/124/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/4/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/125/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/45/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/85/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/105/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/64/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
BTD-0007246-0/5/1 13-Nov-2012 66VDY99 3006108214 Clarins Paris France
 
AM4-0224850-5/6/4 21-Nov-2012 66VDY99 3008692617 Genomma Lab Int'L Sa Mexico
 
AV3-0038284-1/6/1 23-Nov-2012 66VDY99 3009796094 Alterna, Llc United States
 
E7E-1028561-2/1/10 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/1/13 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/1/14 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/24 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/39 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/40/A 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/40/B 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/51 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/62 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/69 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/2/75 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/3/2 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1028561-2/3/11 27-Nov-2012 66VDY99 3008878813 SESDERMA SL Spain
 
201-1939539-9/1/1/A 27-Nov-2012 66VDY99 3008693276 Nouvelle Parfumerie Gandour Ghana Ltd. Ghana
 
201-1939539-9/1/1/B 27-Nov-2012 66VDY99 3008693276 Nouvelle Parfumerie Gandour Ghana Ltd. Ghana
 
201-1939539-9/1/1/C 27-Nov-2012 66VDY99 3008693276 Nouvelle Parfumerie Gandour Ghana Ltd. Ghana
 
201-1939539-9/1/1/D 27-Nov-2012 66VDY99 3008693276 Nouvelle Parfumerie Gandour Ghana Ltd. Ghana
 
201-1939539-9/1/1/E 27-Nov-2012 66VDY99 3008693276 Nouvelle Parfumerie Gandour Ghana Ltd. Ghana
 
AV3-0038294-0/1/2/B 28-Nov-2012 66VDY99 3005474564 Dermalogica Inc United States
 
AV3-0038294-0/1/5 28-Nov-2012 66VDY99 3005474564 Dermalogica Inc United States
 
AV3-0038294-0/1/7 28-Nov-2012 66VDY99 3005474564 Dermalogica Inc United States
 
AV3-0038294-0/1/10 28-Nov-2012 66VDY99 3005474564 Dermalogica Inc United States
 
112-9204205-3/1/1 05-Nov-2012 66VIP99 1000198729 Medimmune LLC United States
 
AEK-0577540-4/1/1 27-Nov-2012 66VPJ99 3008415402 Redrose United Kingdom
 
112-9854032-4/4/1 30-Nov-2012 66YIE99 3003770697 YEM-KEM International Nigeria
 
336-4548585-9/1/1 23-Nov-2012 66YIK99 3005721395 Laboratorio Pablo Cassara Srl Argentina
 
112-9820619-9/1/1 14-Nov-2012 66YIR99 3009786515 Mouty Diomande Ivory Coast
 
112-9854032-4/3/1 30-Nov-2012 66YIR99 3009790760 Odoulana Akesan Nigeria
 
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