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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 HD8-0105522-3/1/9

Manufacturer FEI3009827110
Manufacturer NameLeejiham Cosmetics  
Manufacturer Address line 12f Seoul B/D Nonhunro 710, Gangnam-Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD09  
Importer's Product DescriptionCELLABEL SERUM  
Refusal Date26-Dec-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx HD8-0105522-3/1/9
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).