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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
820-4507906-6/4/1 02-Dec-2010 62FBK08 3008488727 Krasnaya Zvezda Chemical-Pharmaceutical Factory Ukraine
 
315-6518070-5/1/1 15-Dec-2010 62FOR03 3008001801 Pharmasi Instrument Company Limited China
 
M21-0742601-9/1/1 21-Dec-2010 62GAA46 3005144955 Chemo S.A. Lugano Branch Switzerland
 
AEK-8360116-7/2/1 03-Dec-2010 62GAA48 3008582802 Aprna Devi India
 
112-9565164-3/1/1 03-Dec-2010 62GAY92 3005656362 Reckitt Benckiser Healthcare International Ltd. United Kingdom
 
112-9009669-5/1/1 13-Dec-2010 62GCB89 3003477170 Novartis Argentina Sa Argentina
 
112-9009669-5/1/2 13-Dec-2010 62GCB89 3003477170 Novartis Argentina Sa Argentina
 
112-9076853-3/1/1 13-Dec-2010 62GCF42 3004611767 Omnica Laboratories P Ltd Nepal
 
N28-0130233-3/1/1 16-Dec-2010 62GCR46 3004459466 Yicheng Goto Pharmaceuticals Co Ltd China
 
112-9305109-4/1/7 01-Dec-2010 62ICE32 3008573270 Davenben Enterprises Corp Philippines
 
112-9652494-9/1/2 03-Dec-2010 62IDK99 3003426453 Stanislaw R Burzynski, MD United States
 
112-9652494-9/1/1 03-Dec-2010 62IDK99 3003426453 Stanislaw R Burzynski, MD United States
 
112-9696453-3/1/1 08-Dec-2010 62IIA99 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
112-9569546-8/1/1 15-Dec-2010 62JCA12 3008330103 Betapharm Arzneimittel Gmbh Germany
 
112-9569546-8/1/2 15-Dec-2010 62JCA12 3008330103 Betapharm Arzneimittel Gmbh Germany
 
112-9569546-8/2/1 15-Dec-2010 62JCA12 3003989770 Cobalt Pharmaceuticals, Inc. Canada
 
UPS-0282257-1/1/3 13-Dec-2010 62KCH10 3005666129 Maxima Distincion S.A De C.V Mexico
 
820-4507906-6/11/1 02-Dec-2010 62MBH08 3000478060 Krka, d.d. Novo mesto Slovenia
 
820-4508349-8/2/1 03-Dec-2010 62MBJ01 3008419088 Ooo Iq Cosmetic Russia
 
F30-0046131-7/3/1 09-Dec-2010 62MBL01 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
U79-0074900-4/1/1 03-Dec-2010 62MBY01 3006451015 Henan Lingrui Pharmaceutical Holding Co.,Ltd. China
 
820-4507906-6/6/1 02-Dec-2010 62MDH08 3008309182 Open Joint-Stock Company "Kyiv Vitamin Plant" Ukraine
 
820-4507906-6/10/1 02-Dec-2010 62MDH08 3000478060 Krka, d.d. Novo mesto Slovenia
 
KM6-0048850-6/1/3 09-Dec-2010 62MDJ08 3008611461 Emami Limited India
 
AR8-2007370-8/3/1 21-Dec-2010 62MDJ08 3004341027 M & A COMPANY Hong Kong SAR
 
AM4-0207251-7/2/1 29-Dec-2010 62MNS08 3004100638 Cadbury Adams Mexico S De R L De C V Mexico
 
AM4-0207251-7/2/2 29-Dec-2010 62MNS08 3004100638 Cadbury Adams Mexico S De R L De C V Mexico
 
112-9305109-4/1/4 01-Dec-2010 62OAA16 3006659689 Therapharma Inc Philippines
 
M21-0742646-4/1/1 21-Dec-2010 62OAB22 3005144955 Chemo S.A. Lugano Branch Switzerland
 
820-4507906-6/3/1 02-Dec-2010 62OCA20 3008488726 Kievmedpreparat Ukraine
 
112-9966926-1/2/1 08-Dec-2010 62OCF41 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
UPS-0366337-0/1/1 21-Dec-2010 62OCY14 3008615949 Linea S.R.L Dominican Republic
 
UPS-0366337-0/1/2 21-Dec-2010 62OCY19 3008615949 Linea S.R.L Dominican Republic
 
M21-0742594-6/1/1 21-Dec-2010 62ODZ12 3005144955 Chemo S.A. Lugano Branch Switzerland
 
AEK-9625602-5/2/1 06-Dec-2010 62OIS37 3007236445 Sanofi-Synthelabo India India
 
112-0177120-6/3/1 27-Dec-2010 62OLC34 3002906944 Apotex Inc. Canada
 
820-4507906-6/8/1 02-Dec-2010 62VDA18 3008488726 Kievmedpreparat Ukraine
 
820-4507906-6/7/1/A 02-Dec-2010 62VDO18 3008488726 Kievmedpreparat Ukraine
 
820-4507906-6/7/1/B 02-Dec-2010 62VDO18 3008488726 Kievmedpreparat Ukraine
 
AEK-9625602-5/1/1 06-Dec-2010 62VIA15 3003215132 Cipla Limited India
 
UPS-0459268-5/4/1 07-Dec-2010 62WAL17 3004941340 Helena Rubinstein Monaco
 
UPS-0442828-6/1/1 10-Dec-2010 62WBY99 3008624416 Purax International Gmbh Austria
 
UPS-0442828-6/2/1 10-Dec-2010 62WOL17 3008624416 Purax International Gmbh Austria
 
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