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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
112-6463897-9/1/1 31-May-2012 66BAZ05 3008898233 Breathable Foods France
 
AEK-0301064-8/1/1 17-May-2012 66JCA01 3009487611 Haluk Gure Sakayik Turkey
 
AEK-0112413-6/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109196-2/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0112578-6/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0112414-4/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109202-8/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
AEK-0109194-7/1/1 11-May-2012 66JCA99 3006181452 Universal Drug Ser Canada
 
XXX-0284848-0/1/6 16-May-2012 66JCY01 3009071919 Tecnoquimicas S.A Colombia
 
112-9493606-1/1/1 31-May-2012 66JDB01 3003004151 Erfa Canada Canada
 
UPS-3532304-3/15/1 08-May-2012 66MRR99 2000026312 W. Last CC South Africa
 
AEK-0278750-1/1/1 31-May-2012 66NAA05 3004063802 Laboratorios Pfizer Ltda Brazil
 
112-7385323-9/1/1 23-May-2012 66NAB03 3009519921 Sanofi Aventis France France
 
KR4-0042563-2/38/1 30-May-2012 66PBJ07 3003029000 Jafra Manufactuing S.A. de C.V. Mexico
 
112-7052064-1/4/1/A 11-May-2012 66PBJ99 3008898733 Queen Corner Textile United Arab Emirates
 
112-6915953-4/1/9/C 23-May-2012 66PBJ99 3006551843 Dermophisiologique Srl Italy
 
UPS-6272824-7/1/1 29-May-2012 66PBL99 3003818446 La Roche-Posay Laboratories Pharmaceutique (L.R.P) France
 
112-7245075-5/1/3 24-May-2012 66PBU99 3004611628 Taiyen Biotech Co., Ltd. Taiwan
 
UPS-3556671-4/4/1 08-May-2012 66PBY05 1000251162 KIK Custom Products - Rexdale Plant Canada
 
UPS-3532304-3/11/1 08-May-2012 66QDC99 2000026312 W. Last CC South Africa
 
F57-9006747-7/8/1 08-May-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-9006747-7/9/1 08-May-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-9004866-7/6/1 08-May-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
F57-9004866-7/8/1 08-May-2012 66VAJ99 3004737602 Willard Manufacturing Inc. Canada
 
ALM-0404987-9/14/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/1/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/13/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/12/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/11/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/10/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/6/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/2/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/3/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/4/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/5/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/7/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/9/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
ALM-0404987-9/8/1 01-May-2012 66VAY99 3005291538 Pebani Inversiones Sa Peru
 
UPS-6307615-8/1/1 11-May-2012 66VAY99 3009403422 Union-Swiss South Africa
 
XXX-0177952-0/1/1 17-May-2012 66VAY99 3009509147 faruk shipping Turkey
 
AEK-0302004-3/1/1 21-May-2012 66VAY99 3009506311 Issouf Kabore Burkina Faso
 
AEK-0302153-8/1/1 21-May-2012 66VAY99 3009508743 Salia Traore Mali
 
AEK-0302488-8/1/1 21-May-2012 66VAY99 3009517675 Mamadou Dembele Senegal
 
112-9043899-7/1/1 24-May-2012 66VAY99 3008542074 Nill Nigeria
 
112-9872866-2/1/1 29-May-2012 66VAY99 3007952973 Ssl International United Kingdom
 
112-8774621-2/1/3 30-May-2012 66VAY99 3006373110 Commed Pharm India
 
UPS-5981963-7/1/1/B 03-May-2012 66VBJ99 3008835306 Reckitt Benckiser Healthcare Uk United Kingdom
 
UPS-5981963-7/1/1/D 03-May-2012 66VBJ99 3004717968 Forest Tosara Ltd. Ireland
 
UPS-6307615-8/2/1 11-May-2012 66VBJ99 3004717968 Forest Tosara Ltd. Ireland
 
BZJ-1073121-2/1/1 11-May-2012 66VBJ99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
BZJ-1073121-2/5/1 11-May-2012 66VBJ99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
BZJ-1073121-2/7/1 11-May-2012 66VBJ99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
112-6915953-4/1/2 23-May-2012 66VBJ99 3006551843 Dermophisiologique Srl Italy
 
112-8579439-6/1/2 30-May-2012 66VBJ99 3008490617 Anupamaa India
 
112-8579439-6/1/3 30-May-2012 66VBJ99 3008490617 Anupamaa India
 
112-8579439-6/1/1 30-May-2012 66VBJ99 3008490617 Anupamaa India
 
BZJ-1073121-2/4/1 11-May-2012 66VBL99 3008543538 Khang Thinh Import Export Co,, Ltd Vietnam
 
H87-0196178-6/4/1 16-May-2012 66VBL99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/4/3 16-May-2012 66VBL99 3003898365 Centro Botanico Azteca SA Mexico
 
112-4959919-7/1/1 24-May-2012 66VBL99 3005811155 New Techniques Laboratory Ltd Georgia
 
112-7177447-8/1/1 25-May-2012 66VBL99 3009498631 Bioderme Manipulaco Brazil
 
112-6023033-4/1/1/B 25-May-2012 66VBL99 3006551843 Dermophisiologique Srl Italy
 
112-6023033-4/1/11 25-May-2012 66VBL99 3006551843 Dermophisiologique Srl Italy
 
112-6023033-4/1/10 25-May-2012 66VBL99 3006551843 Dermophisiologique Srl Italy
 
H87-0196178-6/1/3 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/1/5 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/1/6 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/1/8 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/1/9 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
H87-0196178-6/4/2 16-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/1 24-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/3 24-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/5 24-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/7 24-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/9 24-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/10 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/11 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/12 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/13 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/14 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/17 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/18 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/20 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
AM4-0218874-3/2/21 29-May-2012 66VBR99 3003898365 Centro Botanico Azteca SA Mexico
 
F23-9059444-8/13/1/A 09-May-2012 66VBY99 3008179628 Shavit Natural Quality Product Israel
 
U47-0490395-2/2/1 09-May-2012 66VBY99 3003768979 JSC Farmak Ukraine
 
U47-0490395-2/3/1 09-May-2012 66VBY99 3008615590 Mentolatum Company LTD. United Kingdom
 
U47-0490395-2/6/1 09-May-2012 66VBY99 3008616889 Pharmaplant Elpha A.T. Poland
 
U47-0490395-2/8/1 09-May-2012 66VBY99 3008244351 Borshyagovskiy Chemical Pharmace Ukraine
 
U47-0490395-2/11/1 09-May-2012 66VBY99 3008789086 JSC "Galichpharm" Ukraine
 
EL0-0230055-5/19/1 09-May-2012 66VBY99 3007489630 Unilever Bangladesh Ltd. Bangladesh
 
AEK-0127160-6/1/1 11-May-2012 66VBY99 3006947211 Atisan Phumchucsh Thailand
 
U47-0490395-2/1/1 15-May-2012 66VBY99 3008309182 Open Joint-Stock Company "Kyiv Vitamin Plant" Ukraine
 
AGT-0008340-3/8/1 21-May-2012 66VBY99 3002494649 Alafia Bitters Ghana
 
112-7345029-1/1/2 17-May-2012 66VCA99 3005939426 Ind-Swift Laboratories Ltd. India
 
112-9878961-5/1/1 24-May-2012 66VCA99 3004806428 Kenrico LTD Japan
 
112-1263895-6/1/1 31-May-2012 66VCH99 3007417394 Laboratorio Vida Guatemala
 
112-1263895-6/1/4 31-May-2012 66VCH99 3007417394 Laboratorio Vida Guatemala
 
112-1263895-6/1/3 31-May-2012 66VCH99 3007417394 Laboratorio Vida Guatemala
 
112-1263895-6/1/2 31-May-2012 66VCH99 3007417394 Laboratorio Vida Guatemala
 
UPS-6098986-6/2/1 31-May-2012 66VCK99 3009532130 Di Giacomo Antonietta Italy
 
UPS-6098986-6/1/2 31-May-2012 66VCK99 3009532130 Di Giacomo Antonietta Italy
 
112-1263895-6/1/5 31-May-2012 66VCK99 3007417394 Laboratorio Vida Guatemala
 
K74-0163384-0/2/1 03-May-2012 66VCO99 3007393544 Harika Foods & Innovations Ltd India
 
112-7224131-1/1/1 31-May-2012 66VCR99 3004324554 Kirsch Pharma GmbH Germany
 
UPS-5177530-8/2/1 15-May-2012 66VCS99 3009414302 Janina Varneckiene Lithuania
 
UPS-5177530-8/3/1 15-May-2012 66VCS99 3009414302 Janina Varneckiene Lithuania
 
UPS-5177530-8/4/1 15-May-2012 66VCS99 3009414302 Janina Varneckiene Lithuania
 
UPS-5177530-8/5/1 15-May-2012 66VCS99 3009414302 Janina Varneckiene Lithuania
 
H77-0131851-8/21/1 18-May-2012 66VCS99 3006308914 AKSHAR IMPEX India
 
H77-0131851-8/21/2 18-May-2012 66VCS99 3006308914 AKSHAR IMPEX India
 
UPS-6085754-3/1/1 09-May-2012 66VCY99 3000235541 Lilly S.A. Spain
 
UPS-5924247-5/1/1 11-May-2012 66VCY99 3009474599 Jose Delgado Mexico
 
E9G-1011004-6/1/1 23-May-2012 66VCY99 3007907782 Naveh Pharmacy Israel
 
GEO-6403397-6/1/1 25-May-2012 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-6403398-4/1/1 25-May-2012 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-6403404-0/1/1 25-May-2012 66VCY99 1000135041 Bellegrove Medical Supply United States
 
GEO-6403405-7/1/1 25-May-2012 66VCY99 1000135041 Bellegrove Medical Supply United States
 
WC1-8500838-8/1/1 09-May-2012 66VDC99 3001362772 Selder S.A. de C.V. Mexico
 
AEK-0301378-2/1/1 08-May-2012 66VDE99 3009491624 S Anupadha India
 
AEK-0301377-4/1/1 17-May-2012 66VDE99 3009491624 S Anupadha India
 
112-0174611-7/1/1 31-May-2012 66VDI99 3008682894 Nagarjuna Herbal Concentrates India
 
112-0174611-7/1/2 31-May-2012 66VDI99 3008682892 Arya Vaidya Sala India
 
UPS-5810126-8/1/1 11-May-2012 66VDJ99 3007225366 Herbal Technologies Bv Netherlands
 
XXX-0177973-7/1/1 21-May-2012 66VDJ99 3009518589 Evan & Mayer International Pakistan
 
E4P-0017725-3/1/1 04-May-2012 66VDL99 3009271465 Henan Kangdi Medical Devices Co. Ltd China
 
AEK-0302154-6/1/2 21-May-2012 66VDL99 3009508757 Ajd Pareekh India
 
AEK-0302154-6/1/1 21-May-2012 66VDL99 3009508757 Ajd Pareekh India
 
AEK-0302154-6/1/3 21-May-2012 66VDL99 3009508757 Ajd Pareekh India
 
D51-1123982-3/6/1 30-May-2012 66VDL99 3007615087 Yangzhou Qianna Cosmetic Factroy China
 
AEK-0301378-2/1/2 08-May-2012 66VDR99 3009491624 S Anupadha India
 
AEK-0301377-4/1/2 17-May-2012 66VDR99 3009491624 S Anupadha India
 
814-0195096-9/2/1 08-May-2012 66VDS99 3010098874 Alopecil Corporation, S.R.L. Dominican Republic
 
814-0195096-9/2/2 08-May-2012 66VDS99 3010098874 Alopecil Corporation, S.R.L. Dominican Republic
 
231-9173292-7/1/1 02-May-2012 66VDY99 3008254930 Matis Sa France
 
231-9173292-7/1/2 02-May-2012 66VDY99 3008254930 Matis Sa France
 
BOZ-0017574-1/1/1 04-May-2012 66VDY99 3006981196 Sviredenko Maria Russia
 
BOZ-0017574-1/2/1 04-May-2012 66VDY99 3006981196 Sviredenko Maria Russia
 
251-1472236-3/7/2/C 09-May-2012 66VDY99 3008357396 El Captain Co. (Cap Pharm) Egypt
 
251-1472236-3/7/2/B 09-May-2012 66VDY99 3008357396 El Captain Co. (Cap Pharm) Egypt
 
251-1472236-3/7/2/A 09-May-2012 66VDY99 3008357396 El Captain Co. (Cap Pharm) Egypt
 
XXX-0284630-2/1/5 14-May-2012 66VDY99 3004641553 Merck, S.A. de C.V. Mexico
 
KM6-0056628-5/14/1 16-May-2012 66VDY99 3009430446 Hawaban Harde Depot India
 
XXX-0284848-0/1/5 16-May-2012 66VDY99 3008251123 Winthrop Pharmaceuticals Colombia
 
XXX-0284942-1/1/2 22-May-2012 66VDY99 3002989060 Procaps S.A. Colombia
 
AMS-0002196-3/40/1 31-May-2012 66VDY99 3000243864 Clarins France
 
AMS-0002196-3/46/1 31-May-2012 66VDY99 3000243864 Clarins France
 
643-0001030-9/1/1 10-May-2012 66VIA99 3002649889 Merck SL Spain
 
112-7895692-9/1/1 21-May-2012 66VIE99 3008413159 Ayurvedant Private Limited India
 
112-7089613-2/1/1 25-May-2012 66VIF99 3008273811 Ardeypharm GmbH Germany
 
112-9803095-2/1/1 29-May-2012 66VIQ99 3005757640 Viridis Biopharma Pvt Ltd India
 
UPS-6336961-1/1/1 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/2 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/3 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/4 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/5 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/6 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/7 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/8 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/9 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6336961-1/1/10 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
UPS-6137351-6/1/1 18-May-2012 66VPR99 3004971758 Medichin Nv Belgium
 
KM6-0056632-7/18/1 22-May-2012 66YAL99 3005360075 ashwin fine chemicals & pharmaceuticals India
 
BZJ-1073101-4/4/1 11-May-2012 66YBL99 3008740951 Chiara Ambra Cosmetics & Health Products Gmbh Germany
 
337-0515093-7/5/1/A 18-May-2012 66YBY99 3008104442 H Cosmetiques Ivory Coast
 
337-0515093-7/5/1/B 18-May-2012 66YBY99 3009065724 Angel Cosmetics Congo, Dem Rep of (Kinshasa)
 
337-0515093-7/5/1/D 18-May-2012 66YBY99 3009065724 Angel Cosmetics Congo, Dem Rep of (Kinshasa)
 
337-0515093-7/5/1/E 18-May-2012 66YBY99 3009065724 Angel Cosmetics Congo, Dem Rep of (Kinshasa)
 
337-0515093-7/5/1/F 18-May-2012 66YBY99 3009065724 Angel Cosmetics Congo, Dem Rep of (Kinshasa)
 
112-9429218-4/1/1 31-May-2012 66YCK99 3005708184 Shire Biochem Inc Canada
 
OHL-0073819-9/1/1 03-May-2012 66YDL99 3004250913 Catalent Australia Pty Ltd Australia
 
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