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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/H

Manufacturer FEI1000410270
Manufacturer NameMilott Laboratories Co., Ltd.  
Manufacturer Address line 184/55 Moo 11 Soi Tanasit,  
Manufacturer Address line 2Teparak Road  
Manufacturer's CityBangplee Samutprakarn  
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/H
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).