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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 256-0324032-3/1/2

Manufacturer FEI3008451180
Manufacturer NameBoe Dominicana  
Manufacturer Address line 1Carretera De Cueta Km 2 Villa Mella  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53LD99  
Importer's Product DescriptionCREMA ADELGAZANTE 20 OZ  
Refusal Date03-Apr-2013  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 256-0324032-3/1/2
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.