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U.S. Department of Health and Human Services

Import Refusal Report

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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  
Importer's Product DescriptionPOST DEPILATORY SOLUTION PRO  
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  
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.