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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 AJ1-0243142-3/3/2


Manufacturer FEI3009062771
Manufacturer NameNadree Cosmetics Co.,Ltd.  
Manufacturer Address line 168-22 Cheongdam-Dong Gangnam Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
Importer's Product DescriptionWHITENING TESTER SET  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AJ1-0243142-3/3/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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