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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 112-8609609-3/2/1

Manufacturer FEI3003200511
Manufacturer NameBiotekne Srl  
Manufacturer Address line 1Via Della Bastia , 9  
Manufacturer Address line 2  
Manufacturer's CityCasalecchio Di Reno  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code80MEG  
FDA Product DescriptionSYRINGE, ANTISTICK  
Refusal Date21-Dec-2005  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8609609-3/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).