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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 UPS-5659786-3/1/5


Manufacturer FEI3003339714
Manufacturer NameBioline Cosmetici Srl  
Manufacturer Address line 1Viale Bolognini 78  
Manufacturer Address line 2  
Manufacturer's CityTrento  
Manufacturer Province/StateTN  
Manufacturer Country/AreaItaly  
Product Code53LD06  
Importer's Product DescriptionCOSMETICS ENERGY SOURCE VITAMINIC MILK 50ML  
Refusal Date11-Apr-2012  
FDA DistrictPHI-DO  
Entry/doc/line/sfx UPS-5659786-3/1/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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