• 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 D40-0340118-7/2/1

Manufacturer FEI3004512562
Manufacturer NamePph Eveline Cosmetics  
Manufacturer Address line 1Ul. Zythnia 19  
Manufacturer Address line 2  
Manufacturer's CityLesznowola  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53LC07  
Importer's Product DescriptionNIGHT CREAM  
Refusal Date04-Jan-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx D40-0340118-7/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.