• 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 112-8282339-7/3/1


Manufacturer FEI3009618603
Manufacturer NamePrestige  
Manufacturer Address line 12-2-41 Hyakunin-Cho  
Manufacturer Address line 2  
Manufacturer's CityTokyo  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code53LC06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date27-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8282339-7/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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).  
-
-