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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 BGK-0204100-3/1/1

Manufacturer FEI3008964045
Manufacturer NameClarins  
Manufacturer Address line 113 Rue Madeleine Michelis  
Manufacturer Address line 2  
Manufacturer's CityNeuilly Sur Seine  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LY99  
Importer's Product DescriptionVITAL LIGHT SERUM FACIAL CREAM  
Refusal Date04-Jan-2012  
FDA DistrictNWE-DO  
Entry/doc/line/sfx BGK-0204100-3/1/1
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.