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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 256-0321297-5/15/2

Manufacturer FEI3007783628
Manufacturer NameProductos Portela, S.A.  
Manufacturer Address line 1Carretera Duarte Km 6.5 Copal  
Manufacturer Address line 2  
Manufacturer's CitySantiago Dominican Republic  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53ED99  
Importer's Product DescriptionCREMA BLAQUEADORA 2 OZ  
Refusal Date02-Oct-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 256-0321297-5/15/2
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.