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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 M21-0742286-9/12/2

Manufacturer FEI2000003379
Manufacturer NameProcesadora Vizcaya, C por A  
Manufacturer Address line 1Calle Hatillo Sampana No. 364  
Manufacturer Address line 2Barrio San Miguel  
Manufacturer's CitySanto Domingo  
Manufacturer Province/StateDO-01  
Manufacturer Country/AreaDominican Republic  
Product Code36BHT99  
FDA Product DescriptionSYRUPS AND MOLASSES, N.E.C.  
Refusal Date10-Jan-2011  
FDA DistrictFLA-DO  
Entry/doc/line/sfx M21-0742286-9/12/2
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.  
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. [Misbranded, Section 403(i)(2)]."