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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 112-5344005-6/1/1


Manufacturer FEI3001184989
Manufacturer NameGutberlet Gmbh  
Manufacturer Address line 1Max-Brod-Str 11  
Manufacturer Address line 2  
Manufacturer's CityNurnberg  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53CH01  
FDA Product DescriptionEYEBROW PENCIL (EYE MAKEUP PREPARATIONS)  
Refusal Date20-Jan-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-5344005-6/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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.  
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