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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 EPS-1196529-8/3/1

Manufacturer FEI3009154432
Manufacturer NameUnhwa Life Corporation  
Manufacturer Address line 14f 68-22 Cheongdam-Dong Gangnam Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD99  
Importer's Product DescriptionDDOBYUL SKIN THERAPY--ANTI AGING F2  
Refusal Date16-Mar-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx EPS-1196529-8/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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).