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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 AEK-7063845-3/2/3


Manufacturer FEI3005313676
Manufacturer NameMethodos S Pa  
Manufacturer Address line 1Via San Michele De Carso 4  
Manufacturer Address line 2  
Manufacturer's CityMilano  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code61LCE99  
FDA Product DescriptionANTI-COAGULANT, N.E.C.  
Refusal Date31-Oct-2005  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-7063845-3/2/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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