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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 315-8160129-6/4/1/A

Manufacturer FEI3008030968
Manufacturer NameElemis LTD  
Manufacturer Address line 1The Lodge, 92 Uxbridge Road  
Manufacturer Address line 2  
Manufacturer's CityHarrow Weald Middlesex  
Manufacturer Province/StateGB-UKM  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LC03  
Importer's Product DescriptionBODY SCULPTING FIRMING CREAM 200ML  
Refusal Date25-Oct-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 315-8160129-6/4/1/A
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.