• 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 K83-0120810-5/1/1

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 Code53LC06  
Importer's Product DescriptionDAY FACIAL CREAM LOTION COSMETIC  
Refusal Date02-Nov-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx K83-0120810-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.