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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 AD1-0500541-8/1/1


Manufacturer FEI3002862831
Manufacturer NameStick With Us Products  
Manufacturer Address line 1Po Box 26190  
Manufacturer Address line 2  
Manufacturer's CityRichmond  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53KC99  
Importer's Product DescriptionMOOM ORGANIC HAIR REMOVAL KIT WITH TEA TREE  
Refusal Date06-Jun-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx AD1-0500541-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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