• 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 EMO-0017977-1/9/1

Manufacturer FEI3007554929
Manufacturer NameDead Sea Premier Cosmetics Lab  
Manufacturer Address line 121 Hashaked St  
Manufacturer Address line 2  
Manufacturer's CityShoham  
Manufacturer Province/State  
Manufacturer Country/AreaIsrael  
Product Code53LC04  
Importer's Product DescriptionEYE CREAM  
Refusal Date11-Apr-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx EMO-0017977-1/9/1
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.