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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-0510815-0/1/1/J

Manufacturer FEI3009726121
Manufacturer NamePornsatit  
Manufacturer Address line 1159/2 Moo 1 T. Vieng  
Manufacturer Address line 2  
Manufacturer's CityA. Thoeng Chiang Rai  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LC99  
Importer's Product DescriptionCOSMETIC CREAMS  
Refusal Date26-Oct-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0510815-0/1/1/J
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.