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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
066-0223944-1/2/1 16-Feb-2012 57DL20 3008855410 Sera Laboratories International Ltd United Kingdom
 
066-0223944-1/3/1 16-Feb-2012 57DL20 2435350 Bioreclamation, LLC United States
 
066-0223944-1/4/1 16-Feb-2012 57DL20 2435350 Bioreclamation, LLC United States
 
066-0223944-1/5/1 16-Feb-2012 57DL20 3008855410 Sera Laboratories International Ltd United Kingdom
 
066-0223944-1/1/1 16-Feb-2012 57DL32 3004604674 Trina Bioreactives Ag Switzerland
 
FR1-0014241-8/1/1 13-Feb-2012 57YH02 3003238685 Shanghai Amsino Medical Devices Co., Ltd. China
 
BYA-1084629-3/1/1 07-Feb-2012 57YL99 3009200277 Molecular Medicines Italy
 
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