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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 575-0001220-8/1/1

Manufacturer FEI3001549937
Manufacturer NameUrist Cosmetics Inc  
Manufacturer Address line 111871 Horseshoe Way #1167  
Manufacturer Address line 2  
Manufacturer's CityRichmond  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53ED06  
Importer's Product DescriptionSCALP THERAPY SHAMPOO  
Refusal Date25-May-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 575-0001220-8/1/1
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.