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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 594-0167814-5/25/1

Manufacturer FEI3005142605
Manufacturer NameProliv  
Manufacturer Address line 1Kirova 41  
Manufacturer Address line 2  
Manufacturer's CityKerch  
Manufacturer Province/State  
Manufacturer Country/AreaUkraine  
Product Code16AEE09  
FDA Product DescriptionCARP  
Refusal Date27-Sep-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 594-0167814-5/25/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NUTRIT LBL   403(q); 801(a)(3); Misbranding   The article appears to be misbranded in that the label or labeling fails to bear the required nutrition information.