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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 AN1-0584564-6/1/7

Manufacturer FEI3004353619
Manufacturer NameAmorepacific.co.  
Manufacturer Address line 1181 2ga  
Manufacturer Address line 2Hangang-ro, Yongsan-gu  
Manufacturer's CitySeoul  
Manufacturer Province/StateKR-43  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD03  
Importer's Product DescriptionPERFECT RENEW DUAL TOUCH EX  
Refusal Date20-Dec-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AN1-0584564-6/1/7
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.