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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 P09-3050962-8/2/1

Manufacturer FEI1000224532
Manufacturer NameGuerlain Paris  
Manufacturer Address line 168-88 Avenue Des Champs-Elysees  
Manufacturer Address line 2  
Manufacturer's CityParis  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LC03  
Importer's Product DescriptionGU AB ROYALE 11 TRILOGY TR/ EYE/LIP CRM 15ML  
Refusal Date27-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx P09-3050962-8/2/1
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.