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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 438-0810973-0/7/1

Manufacturer FEI3005120437
Manufacturer NameProductos Portala S.A.  
Manufacturer Address line 1Km6 Carr Licey Urb El Copal I  
Manufacturer Address line 2  
Manufacturer's CitySantiago  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53LC99  
Importer's Product DescriptionBODYCREAM "DEMOLEDOR DE GRASA"  
Refusal Date23-Mar-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0810973-0/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.