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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
EPU-0033170-8/1/1 11-Oct-2012 62GBL99 3008978270 Herbolaris Internacional, S.A. De C.V. Mexico
 
FP1-0008186-7/13/2 12-Oct-2012 62GCA18 3004556223 Dexcel Pharma Ltd United Kingdom
 
FP1-0008186-7/13/1 12-Oct-2012 62GCA18 3005673040 TEVA UK Limited United Kingdom
 
112-9846444-2/1/1 18-Oct-2012 62GCZ89 3001027745 Zhejiang Ruibang Laboratories China
 
M21-0746976-1/1/1 25-Oct-2012 62GDL18 3005144955 Chemo S.A. Lugano Branch Switzerland
 
BYA-0124576-0/1/1 25-Oct-2012 62GIP18 3005881726 Glatt Gmbh Process Technology Germany
 
UPS-7974826-1/1/1/B 09-Oct-2012 62GPL99 3007386728 Laboratoire De Demo Cosmetique France
 
UPS-7886373-1/1/1 09-Oct-2012 62GPL99 3009751862 Labaratorie Afmb Umr 6098 Cnrs France
 
BWQ-1029618-1/4/1 09-Oct-2012 62GSP82 3009709096 Alrise Biosystems Gmbh Germany
 
BWQ-1029618-1/2/1 09-Oct-2012 62ISP81 3009709096 Alrise Biosystems Gmbh Germany
 
M21-0746722-9/1/1 17-Oct-2012 62KAE10 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
XXX-0244287-0/1/6 09-Oct-2012 62KCY10 3005325017 La Sante Colombia
 
FP1-0008186-7/23/1 12-Oct-2012 62LCA40 3005848698 Crescent Pharma Ltd United Kingdom
 
XXX-0244287-0/1/19 09-Oct-2012 62LCY09 3006812843 Laproff Colombia
 
XXX-0244287-0/1/12 09-Oct-2012 62LCY40 3007170278 Laboratorios Procaps S.A. Colombia
 
BOZ-0018528-6/3/1 16-Oct-2012 62MBY08 3003842082 EDWARD B BEHARRY AND COMPANY LTD Guyana
 
032-0422690-0/1/14 16-Oct-2012 62MBY08 3005147210 Diana Candy Company Limited Trinidad & Tobago
 
XXX-0244287-0/1/10 09-Oct-2012 62OCY41 3008087129 Genfar Colombia
 
XXX-0244287-0/1/11 09-Oct-2012 62OCY41 3007058331 Laboratories Laproff Colombia
 
UPS-4263009-9/1/1 09-Oct-2012 62ODL49 3000999767 Entreprises Importfab Inc. Canada
 
M21-0746966-2/1/1 24-Oct-2012 62ODZ37 3005144955 Chemo S.A. Lugano Branch Switzerland
 
523-0969677-2/1/1 26-Oct-2012 62QCT07 3006071966 Nan Jing Panda Electronics Im & Ex Corp. China
 
FP1-0008186-7/29/1 12-Oct-2012 62TCL07 3002806542 Takeda GmbH Germany
 
M21-0746765-8/2/1 17-Oct-2012 62VCA18 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
185-0056887-0/1/1 12-Oct-2012 62VCZ43 3004611182 Aurobindo Pharma Limited (Unit XI) India
 
FP1-0008186-7/34/1 12-Oct-2012 62VDY32 3003262904 Glaxo Operations UK Limited United Kingdom
 
EDR-0027747-3/71/1/B 24-Oct-2012 62WAL17 3009710272 Zermat Internacional Sa De Cv Mexico
 
EDR-0027747-3/71/1/A 24-Oct-2012 62WAL17 3009710272 Zermat Internacional Sa De Cv Mexico
 
EDR-0027747-3/73/1/A 24-Oct-2012 62WAL17 3009710272 Zermat Internacional Sa De Cv Mexico
 
AEK-0510815-0/1/1/N 26-Oct-2012 62WBL99 3009726121 Pornsatit Thailand
 
UPS-8032755-0/1/2 30-Oct-2012 62YCY07 3009773229 Teresa Ramirez Ramirez Mexico
 
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