• 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 K83-0125240-0/2/1

Manufacturer FEI3004437085
Manufacturer NameCrystal Claire Cosmetics Inc.  
Manufacturer Address line 120 Overlea Blvd.  
Manufacturer Address line 2  
Manufacturer's CityToronto  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code53LC07  
Importer's Product DescriptionGEL LOTION  
Refusal Date18-Sep-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx K83-0125240-0/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NO ENGLISH   403(f), 801(a)(3); MISBRANDING   Required label or labeling appears to not be in English per 21 CFR 101.15(c).