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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 WIB-1236976-8/5/1


Manufacturer FEI3007239704
Manufacturer NameThe Doctor'S Cosmetic Co.,Ltd.  
Manufacturer Address line 1Taechi 4 Dong 966 5  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateSeoul  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53CC04  
Importer's Product DescriptionEYE GEL  
Refusal Date11-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx WIB-1236976-8/5/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
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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