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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/G

Manufacturer FEI3008832587
Manufacturer NameSiam Yoko Co.,Ltd.  
Manufacturer Address line 1300 Moo 4 Soi Sriboonrueng 1 Tepharak  
Manufacturer Address line 2  
Manufacturer's CitySamutprakarn  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53JY01  
Importer's Product DescriptionCOSMETIC CREAMS  
Refusal Date26-Oct-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0510815-0/1/1/G
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).