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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 57-Bio & Licensed In-Vivo & In-Vitro Diag


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
E7E-1026048-2/4/19 20-Aug-2012 57CH02 1035048 GlaxoSmithKline United States
 
112-8633733-7/1/1 16-Aug-2012 57CH03 3004211038 Serum Institute of India Ltd. India
 
112-8633733-7/1/2 16-Aug-2012 57CH18 3004211038 Serum Institute of India Ltd. India
 
E7E-1026048-2/4/3 20-Aug-2012 57EH10 3002888623 Sanofi Pasteur Limited - Cannaught Campus Canada
 
112-8633733-7/1/3 16-Aug-2012 57IH17 3004211038 Serum Institute of India Ltd. India
 
112-8852807-3/1/1 30-Aug-2012 57YL99 3007371071 Emd Serono Canada Canada
 
112-8852807-3/2/1 30-Aug-2012 57YL99 3007371071 Emd Serono Canada Canada
 
112-8852807-3/3/1 30-Aug-2012 57YL99 3007371071 Emd Serono Canada Canada
 
112-8852807-3/4/1 30-Aug-2012 57YL99 3007371071 Emd Serono Canada Canada
 
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