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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 EUX-0100709-5/3/1

Manufacturer FEI3002813253
Manufacturer NameDulceria Rodriguez  
Manufacturer Address line 1Ingenio Km. 76  
Manufacturer Address line 2  
Manufacturer's CityBonao  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code33HGT02  
Importer's Product DescriptionDULCE DE LECHE EN PASTA  
Refusal Date14-Jan-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx EUX-0100709-5/3/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
TRANSFAT   403(q), 801(a)(3) ;MISBRANDING   The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].