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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 AMS-0002422-3/97/1

Manufacturer FEI3000243864
Manufacturer NameClarins  
Manufacturer Address line 14 Rue Berteaux Dumas  
Manufacturer Address line 2BP 174  
Manufacturer's CityNeuilly Sur Seine  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD10  
Importer's Product Description110319 MA DAY EARLY WRINKLE CORRECT. LOTION / NDC # 058668-1031  
Refusal Date06-Aug-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AMS-0002422-3/97/1
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.