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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/O

Manufacturer FEI3009208390
Manufacturer NameDft (Thailand) Co.,Ltd.  
Manufacturer Address line 138 Moo 7 Pantainorasingha,Muang  
Manufacturer Address line 2  
Manufacturer's CitySamuthsakorn  
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/O
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
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).