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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 K83-0125240-0/2/1


Manufacturer FEI3004437085
Manufacturer NameCrystal Claire Cosmetics Inc.  
Manufacturer Address line 120 Overlea Blvd.  
Manufacturer Address line 2  
Manufacturer's CityToronto  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code53LC07  
FDA Product DescriptionNIGHT (SKIN CARE PREPARATIONS)  
Refusal Date18-Sep-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx K83-0125240-0/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).  
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