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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 F57-3797036-1/1/1

Manufacturer FEI3004737602
Manufacturer NameWillard Manufacturing Inc.  
Manufacturer Address line 15295 John Lucas Drive  
Manufacturer Address line 2  
Manufacturer's CityBurlington  
Manufacturer Province/StateOn  
Manufacturer Country/AreaCanada  
Product Code53ID01  
Importer's Product DescriptionFD SPRING MINT MOUTH WASH 1.25L NDC# 67933-0012  
Refusal Date29-Dec-2011  
FDA DistrictNYK-DO  
Entry/doc/line/sfx F57-3797036-1/1/1
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.