• 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 AEK-0414828-0/2/1


Manufacturer FEI3004795940
Manufacturer NamePaloma Dead Sea, Ltd.  
Manufacturer Address line 138900 Caesarea  
Manufacturer Address line 2  
Manufacturer's CityCaesarea  
Manufacturer Province/StateIL-NOTA  
Manufacturer Country/AreaIsrael  
Product Code53LC09  
Importer's Product DescriptionMOISTURIZER AND NOURSHING CREAM  
Refusal Date10-Aug-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0414828-0/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
-
-