• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

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  
FDA Product DescriptionWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)  
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  
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).  
-
-