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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 BTF-4014613-2/1/1

Manufacturer FEI3008623815
Manufacturer NameGowoonsesang Cosmetics Co Ltd  
Manufacturer Address line 1Shindang 4 Dong 3f  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateSeoul  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC99  
Importer's Product DescriptionSKIN CLEARING FOAM CREAM  
Refusal Date27-Dec-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BTF-4014613-2/1/1
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.