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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 277-0134045-0/7/1

Manufacturer FEI3005033868
Manufacturer NameIds Manufacturing Limited  
Manufacturer Address line 121/7 Moo 6,Kookot,Lamlukka  
Manufacturer Address line 2  
Manufacturer's CityPathumthani  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LC03  
Importer's Product DescriptionFACIAL CREAM  
Refusal Date21-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 277-0134045-0/7/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.