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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 DO7-8385353-7/1/1

Manufacturer FEI3006005635
Manufacturer NameGuangzhou Barburly Cosmetic Company  
Manufacturer Address line 1Rm 309 Jinzhong Bldg 695697 South Baiyun  
Manufacturer Address line 2  
Manufacturer's CityGuang Zhouguang Zhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53LC99  
Importer's Product DescriptionSLIM ESSENCE HOT CREAM  
Refusal Date20-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx DO7-8385353-7/1/1
FDA Sample AnalysisNo  
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.