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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 AEK-0380751-4/1/1

Manufacturer FEI3009604015
Manufacturer NameNguyen Thi Bong  
Manufacturer Address line 1100 41 Tran Hung Bao  
Manufacturer Address line 2  
Manufacturer's CityHo Chi Minh City  
Manufacturer Province/State  
Manufacturer Country/AreaVietnam  
Product Code53LD01  
Importer's Product DescriptionFACE WHITENING CREAM  
Refusal Date20-Jul-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0380751-4/1/1
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.