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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 442-6437178-0/40/1

Manufacturer FEI3009109548
Manufacturer NameEmmediciotto Srl  
Manufacturer Address line 1Via Dell'Industria 11  
Manufacturer Address line 2  
Manufacturer's CityMarzocca Di Senigalli  
Manufacturer Province/StateFN  
Manufacturer Country/AreaItaly  
Product Code53ED07  
Importer's Product DescriptionSTEM-C ANTI- HAIR LOSS  
Refusal Date17-Feb-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 442-6437178-0/40/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.