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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 AEK-8961199-6/2/1

Manufacturer FEI3003253414
Manufacturer NameUrban Decay Cosmetics Llc  
Manufacturer Address line 1833 W 16th St  
Manufacturer Address line 2  
Manufacturer's CityNewport Beach  
Manufacturer Province/StateCA  
Manufacturer Country/AreaUnited States  
Product Code53LC06  
Importer's Product DescriptionTINTED MOISTURIZER  
Refusal Date19-Dec-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-8961199-6/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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