• 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 UPS-5665562-0/1/1

Manufacturer FEI3004634496
Manufacturer NameRegi International  
Manufacturer Address line 1Via M.Bucnaract 2/4/6  
Manufacturer Address line 2  
Manufacturer's CityCrema  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code53CY06  
Importer's Product DescriptionMASCARA  
Refusal Date16-Mar-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-5665562-0/1/1
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.