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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 112-2404727-9/1/1

Manufacturer FEI3008793309
Manufacturer NameHbeautylines  
Manufacturer Address line 1Doblinger Hauptstrausse  
Manufacturer Address line 2  
Manufacturer's CityVienna  
Manufacturer Province/State  
Manufacturer Country/AreaAustria  
Product Code53CY08  
Importer's Product Description871248157809 PERMANENT EYE LINER  
Refusal Date04-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-2404727-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.  
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.  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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