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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 144-4159553-7/10/1/B

Manufacturer FEI3009272968
Manufacturer NameAnne Cosmetics Co Ltd  
Manufacturer Address line 1Futian Market Of Yiwu International  
Manufacturer Address line 2  
Manufacturer's CityInternational Trade City  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53ED06  
Importer's Product DescriptionVITKA SHAMPOO - ESTIMATED INFO  
Refusal Date31-Jan-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 144-4159553-7/10/1/B
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.