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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 MWT-0075734-4/1/1

Manufacturer FEI3003274527
Manufacturer NameSimex Trading Ag  
Manufacturer Address line 1Gass Steinegg  
Manufacturer Address line 2  
Manufacturer's CityAppenzel  
Manufacturer Province/State  
Manufacturer Country/AreaSwitzerland  
Product Code53LD03  
Importer's Product DescriptionCLARINS HIGH DEFINITION BODY LIFT CREAM 400 ML  
Refusal Date13-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MWT-0075734-4/1/1
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.