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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-1248520-0/3/1

Manufacturer FEI3009634387
Manufacturer NamePacific Dream Inc  
Manufacturer Address line 1D-8109 Sk Gwangmyoung Techno Park 1345  
Manufacturer Address line 2  
Manufacturer's CityGyounngi Do  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
Refusal Date26-Jul-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx WIB-1248520-0/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.