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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
231-1785694-1/1/1 25-Jan-2005 57CC02 3004931892 Pharma Tradehouse Marketing Canada
 
231-1786425-9/1/1 25-Jan-2005 57CC02 3004931892 Pharma Tradehouse Marketing Canada
 
XXX-0099143-1/1/1 03-Jan-2005 57CY02 3004836827 Shire Biochem Inc Canada
 
112-5001274-7/1/1 03-Jan-2005 57CY02 3003986397 Sgs Nederland Bv Netherlands
 
112-5102451-9/1/1 04-Jan-2005 57CY02 3003945772 Aventis Pasteur Sa France
 
112-5111617-4/1/1 07-Jan-2005 57CY02 3001314775 Novartis Vaccines and Diagnostics GmbH & Co. KG Germany
 
XXX-0102551-0/1/1 26-Jan-2005 57CY02 3002972083 Sanofi Pasteur SA France
 
112-4974485-5/1/1 31-Jan-2005 57CY02 3003561471 Shire Biologics, Div. of Shire Biochem Inc. Canada
 
112-5217162-4/1/1/B 06-Jan-2005 57YY99 3003016870 MiraTes Europe B.V. Netherlands
 
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