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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 582-5332073-3/1/1


Manufacturer FEI3004086760
Manufacturer NameTony Pharm LTD  
Manufacturer Address line 1Kapon Street 11/33  
Manufacturer Address line 2  
Manufacturer's CityRishon Lezion  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code54YCY99  
Importer's Product DescriptionURICARE DIETARY SUPPLEMENT CAPSULES  
Refusal Date14-Aug-2003  
FDA DistrictCIN-DO  
Entry/doc/line/sfx 582-5332073-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
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