• 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-7280421-0/1/3


Manufacturer FEI3008645760
Manufacturer NameEtude House  
Manufacturer Address line 1Myonmok 7 Dong 2 9a  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/StateSeoul  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date09-Aug-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-7280421-0/1/3
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).  
-
-