• 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 231-4940247-5/1/62


Manufacturer FEI1000276682
Manufacturer NameAcademie Scientifique De Beaute  
Manufacturer Address line 183, Ave. Henri-Barbusse  
Manufacturer Address line 2  
Manufacturer's CityColombes  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC08  
FDA Product DescriptionPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)  
Refusal Date04-Apr-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 231-4940247-5/1/62
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.  
-
-