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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 AN1-0582509-3/1/31

Manufacturer FEI3005235096
Manufacturer Address line 1181, 2GA HANGANG-RO  
Manufacturer Address line 2  
Manufacturer's CityYONGSAN-GU  
Manufacturer Province/StateKr-11  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC03  
Importer's Product DescriptionREJUVENATING EYE CREAM  
Refusal Date09-May-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AN1-0582509-3/1/31
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.