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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 112-6447870-7/1/1

Manufacturer FEI3007234732
Manufacturer NameChromavis Srl  
Manufacturer Address line 1Via Francesco Sforza 19  
Manufacturer Address line 2  
Manufacturer's CityMilano  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code53CC99  
Importer's Product Description898538478809 SHEER CREAM EYE  
Refusal Date30-Mar-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6447870-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COLOR LBLG   602(e), 801(a)(3); MISBRANDING   The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.