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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-4759516-6/1/1

Manufacturer FEI3009283394
Manufacturer NameFlawless Effect  
Manufacturer Address line 1500 Bic Driveground Floor, Building 4  
Manufacturer Address line 2  
Manufacturer's CityMilfordmilford  
Manufacturer Province/StateCT  
Manufacturer Country/AreaUnited States  
Product Code53LC10  
Importer's Product DescriptionFLAWLESS WRINKLE CREAM  
Refusal Date29-Dec-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-4759516-6/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).