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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 Q15-0153644-5/14/1

Manufacturer FEI3007006220
Manufacturer NameLoccitane International  
Manufacturer Address line 112 Route De La Galaise  
Manufacturer Address line 2  
Manufacturer's CityGeneve  
Manufacturer Province/State  
Manufacturer Country/AreaSwitzerland  
Product Code53LD03  
Importer's Product DescriptionCREAMS & LOTIONS  
Refusal Date25-Mar-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx Q15-0153644-5/14/1
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.