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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 112-8613022-9/1/4

Manufacturer FEI3007793393
Manufacturer NameRodial Ltd.  
Manufacturer Address line 1535 Kings Road  
Manufacturer Address line 2Suite 1.24 The Plaza  
Manufacturer's CityLondon  
Manufacturer Province/StateGB-LND  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LC01  
Importer's Product Description512257409798 BOOB JOB CREAM  
Refusal Date17-Aug-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8613022-9/1/4
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.