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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 112-0234244-6/2/1

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 Code53AD01  
Refusal Date05-Dec-2012  
FDA DistrictDET-DO  
Entry/doc/line/sfx 112-0234244-6/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).