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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 H67-1282729-3/7/1

Manufacturer FEI3003320746
Manufacturer NameExportadora Campo Verde S.A.  
Manufacturer Address line 1Sabaneta Km 8  
Manufacturer Address line 2  
Manufacturer's CityLa Vega  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code22AFB05  
FDA Product DescriptionBITTER MELON (VINE FRUIT)  
Refusal Date15-Dec-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx H67-1282729-3/7/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
USUAL NAME   403(i)(1), 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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be [Misbranded, Section 403(i)(1)].