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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 AEK-0276561-4/3/6

Manufacturer FEI3008085497
Manufacturer NameJencare Skin Farm  
Manufacturer Address line 182 Hope Rd  
Manufacturer Address line 2  
Manufacturer's CityKingston  
Manufacturer Province/State  
Manufacturer Country/AreaJamaica  
Product Code53HY99  
Importer's Product DescriptionFUNGUS FIX NAIL TREATMENT  
Refusal Date05-Jul-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AEK-0276561-4/3/6
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.