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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
AR8-0029383-9/6/1/I 09-Sep-2005 57AY19 3004706890 Ooo Protek-50 Russia
 
112-4973161-3/1/1 28-Sep-2005 57CC02 3003561471 Shire Biologics, Div. of Shire Biochem Inc. Canada
 
112-7437985-8/2/1 12-Sep-2005 57DY24 3003767348 Relia Tech Germany
 
112-7774078-3/1/1 13-Sep-2005 57HC33 3004505311 Breakspear Medical United Kingdom
 
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