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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 UPS-7435472-4/13/1

Manufacturer FEI3009239638
Manufacturer NameCosmondial Gmbh & Co. Kg  
Manufacturer Address line 1Amirastrasse 34a  
Manufacturer Address line 2  
Manufacturer's CityAschaffenburg  
Manufacturer Province/StateBayern  
Manufacturer Country/AreaGermany  
Product Code53GK05  
Importer's Product DescriptionLIPSTICK-TOFFEE  
Refusal Date17-Jan-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-7435472-4/13/1
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.  
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.