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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
112-0433697-1/1/1 12-Dec-2007 66BAQ44 3006285300 Solarium Tanning Canada
 
820-0573913-9/1/1 21-Dec-2007 66GAY03 3005443828 Ckf Industrial, S.A. Peru
 
820-0573913-9/1/3 21-Dec-2007 66GAY03 3005443828 Ckf Industrial, S.A. Peru
 
820-0573913-9/1/2 21-Dec-2007 66GAY03 3005443828 Ckf Industrial, S.A. Peru
 
112-0478432-9/1/1 11-Dec-2007 66MCA36 3006437198 Zydus Cadilla India
 
112-0478432-9/1/2 11-Dec-2007 66MCA36 3006437198 Zydus Cadilla India
 
112-0618700-0/1/1 21-Dec-2007 66MDB75 3006595918 Roche Cintex Mexico
 
112-0389361-8/1/3 11-Dec-2007 66SCB40 3006570153 Al Hokamaa Pharmacy United Arab Emirates
 
336-8078611-1/1/1 10-Dec-2007 66SCS08 3003699053 Jayco Chemical Industries India
 
112-0572647-7/1/1 18-Dec-2007 66SDP03 3004366048 Solvay Pharma Inc Canada
 
ES3-3007531-9/1/1 31-Dec-2007 66VAR99 3004265006 XI'AN QIYUAN KEGONGMAO CO., LTD China
 
BQL-0012522-7/33/15 04-Dec-2007 66VAY99 2000010255 Moskovksaya Pharmfabrika Russia
 
427-2198779-2/3/5 12-Dec-2007 66VAY99 3004969349 Kanebo Cosmetics Inc. Japan
 
427-2198779-2/3/6 12-Dec-2007 66VAY99 3004969349 Kanebo Cosmetics Inc. Japan
 
427-2198779-2/3/14 12-Dec-2007 66VAY99 3004969349 Kanebo Cosmetics Inc. Japan
 
427-2198779-2/3/15 12-Dec-2007 66VAY99 3004969349 Kanebo Cosmetics Inc. Japan
 
427-2198779-2/3/17 12-Dec-2007 66VAY99 3004969349 Kanebo Cosmetics Inc. Japan
 
112-0584795-0/1/4 20-Dec-2007 66VAY99 3006591757 Bajay Consumer Care Ltd India
 
112-0584795-0/1/5 20-Dec-2007 66VAY99 3006591761 Sando Beothee Pvt Ltd India
 
112-0584795-0/1/3 20-Dec-2007 66VAY99 3006591758 Dubur Indea Ltd India
 
BQL-0012522-7/33/1 04-Dec-2007 66VBA99 2000010255 Moskovksaya Pharmfabrika Russia
 
112-0451232-4/1/1 18-Dec-2007 66VBB99 3003403597 Fortius Inc Canada
 
AW6-0072293-4/1/1/G 05-Dec-2007 66VBJ99 3004571458 Dpc Limited Hong Kong SAR
 
AW6-0072293-4/1/1/T 05-Dec-2007 66VBJ99 3004571458 Dpc Limited Hong Kong SAR
 
AW6-0072293-4/1/1/X 05-Dec-2007 66VBJ99 3004571458 Dpc Limited Hong Kong SAR
 
AW6-0072293-4/1/1/F 20-Dec-2007 66VBJ99 3004571458 Dpc Limited Hong Kong SAR
 
300-1452419-1/18/1 04-Dec-2007 66VBL99 3004254426 Thakar Exports India
 
946-0603462-0/160/1 17-Dec-2007 66VBL99 3003740869 Reckitt Benkiser Ltd United Kingdom
 
ES3-3007531-9/3/1 31-Dec-2007 66VBR99 3005095227 Hongze Chenguang Fine Cchemical Co. Ltd. China
 
XXX-0152422-3/1/1/A 05-Dec-2007 66VBY99 3006513052 Bluefield Associates, Inc. Canada
 
XXX-0152422-3/1/1/C 05-Dec-2007 66VBY99 3009853808 Beltapharma SPA Subsidary of Strides Arcolab International Italy
 
XXX-0152422-3/1/1/D 05-Dec-2007 66VBY99 1000167943 MCA Medical And Chemical Agency S.R.L. Italy
 
XXX-0152422-3/1/1/B 05-Dec-2007 66VBY99 3007018612 Labo. DERMA France
 
XXX-0152422-3/1/1/E 05-Dec-2007 66VBY99 3004081233 Adefolorunsho Tech. Ent. Nigeria
 
XXX-0152422-3/1/1/F 05-Dec-2007 66VBY99 3006237462 Elko Org. Ltd. Switzerland
 
XXX-0152422-3/1/1/G 05-Dec-2007 66VBY99 3003475851 Vinco Corporation Italy
 
XXX-0152422-3/1/1/H 05-Dec-2007 66VBY99 3002949418 Niuma Belleza Spain
 
XXX-0152422-3/1/1/I 05-Dec-2007 66VBY99 3004822484 Roberts Laboratories Ltd. United Kingdom
 
XXX-0152422-3/1/1/K 05-Dec-2007 66VBY99 3008491351 Esapharma Srl Italy
 
XXX-0152422-3/1/1/O 05-Dec-2007 66VBY99 3006513052 Bluefield Associates, Inc. Canada
 
XXX-0152422-3/1/1/L 05-Dec-2007 66VBY99 3006513148 Beneks Pharmaceuticals LTF United Kingdom
 
XXX-0152422-3/1/1/M 05-Dec-2007 66VBY99 3000227446 Elliot Irving Ltd. United Kingdom
 
XXX-0152422-3/1/1/N 05-Dec-2007 66VBY99 3002480794 Edward Cook and Company United Kingdom
 
XXX-0152422-3/1/1/R 05-Dec-2007 66VBY99 3002807078 GlaxoSmithKline United Kingdom
 
XXX-0152422-3/1/1/P 05-Dec-2007 66VBY99 3006513157 Tura International Ltd. Nigeria
 
XXX-0152422-3/1/1/V 05-Dec-2007 66VBY99 3008491351 Esapharma Srl Italy
 
XXX-0152422-3/1/1/T 05-Dec-2007 66VBY99 3003527983 Fairtrade International Co.Ltd. United Kingdom
 
XXX-0152422-3/1/1/J 05-Dec-2007 66VBY99 3002496612 SIVOP - C.I. Nigeria
 
XXX-0152422-3/1/1/Q 05-Dec-2007 66VBY99 3002496612 SIVOP - C.I. Nigeria
 
ASW-1027254-9/8/1 18-Dec-2007 66VBY99 3006504892 Korea C & B Korea, Republic Of (South)
 
ASW-1027254-9/7/1 18-Dec-2007 66VBY99 3006504892 Korea C & B Korea, Republic Of (South)
 
ASW-1027254-9/9/1/A 18-Dec-2007 66VBY99 3006504892 Korea C & B Korea, Republic Of (South)
 
DQ7-0172076-4/9/1 18-Dec-2007 66VBY99 3006520091 Woojin T.N.D Co. Korea, Republic Of (South)
 
BQL-0012522-7/41/1 04-Dec-2007 66VBZ99 3003991573 Vifiteh Pkp Russia
 
112-0601809-8/1/1 20-Dec-2007 66VBZ99 3006593859 China European Ltd China
 
110-0712625-9/1/1 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/5 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/4 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/3 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/2 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/8 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/7 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
110-0712625-9/1/6 10-Dec-2007 66VCA99 3005870248 Mercado Rubio Adolfo Fermin Mexico
 
XXX-0152017-1/2/1/A 28-Dec-2007 66VCA99 1000244108 Unknown China
 
XXX-0152017-1/2/1/B 28-Dec-2007 66VCA99 1000244108 Unknown China
 
110-0922497-9/1/1 10-Dec-2007 66VCK99 3005835043 Pakamil Pachuca Mexico
 
AEK-7684855-1/1/1 03-Dec-2007 66VCL99 3004768374 SCHUMACHER PHARMACEUTICALS PTY.LTD Australia
 
112-8062614-6/1/1 05-Dec-2007 66VCN99 3006443468 Synthetek Industries Pty Ltd Australia
 
112-0675934-5/2/1 27-Dec-2007 66VCY99 1000643779 Swiss Herbal Remedies Canada
 
ES3-3007531-9/2/1 31-Dec-2007 66VCZ99 3005095227 Hongze Chenguang Fine Cchemical Co. Ltd. China
 
XXX-0217983-7/1/2 03-Dec-2007 66VDA99 3005176444 Bristol-Myers United States
 
BQL-0012522-7/33/2 04-Dec-2007 66VDA99 2000010255 Moskovksaya Pharmfabrika Russia
 
112-8894445-9/1/1 04-Dec-2007 66VDY99 3006530044 A D I Drugs Limited Canada
 
BJM-0110449-8/15/1 14-Dec-2007 66VDY99 3004092690 Sarl Pharmacosm France
 
BJM-0110449-8/31/1 14-Dec-2007 66VDY99 3004092690 Sarl Pharmacosm France
 
112-0148283-6/1/1 05-Dec-2007 66VIP99 3002887171 Dr. Kalyan Banerjee India
 
112-0496473-1/1/1 11-Dec-2007 66VIP99 1000479100 Wyeth-Ayerst Canada Inc Canada
 
112-0578486-4/1/1 13-Dec-2007 66VIP99 3003082936 Aptalis Pharma Inc. Canada
 
112-0555370-7/1/1 18-Dec-2007 66VIP99 3002806462 Bayer Pharma AG Germany
 
ES3-3007531-9/4/1 31-Dec-2007 66VOR99 3005095227 Hongze Chenguang Fine Cchemical Co. Ltd. China
 
112-0292749-0/1/1 10-Dec-2007 66YBL99 3006561014 Central Naturista Uruguay
 
N77-0156893-3/1/1 11-Dec-2007 66YCA99 3003768979 JSC Farmak Ukraine
 
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