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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 HD8-0103163-8/1/25

Manufacturer FEI3009215518
Manufacturer NameAmi Cosmetic Co.  
Manufacturer Address line 1Hanall Bldg Songsu 2 Ga 3 Dong 1 5  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateSeoul  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC01  
Importer's Product DescriptionSEAWEED MEDICLEAR STEMCELL BB CREAM 35G  
Refusal Date05-Apr-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx HD8-0103163-8/1/25
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.