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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 BTD-0007246-0/2/1

Manufacturer FEI3006108214
Manufacturer NameClarins Paris  
Manufacturer Address line 1Po Box 42585  
Manufacturer Address line 2  
Manufacturer's CityGrand Bahama Island  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC99  
Importer's Product DescriptionCREAM  
Refusal Date13-Nov-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BTD-0007246-0/2/1
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.