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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 AEK-0115511-4/1/1

Manufacturer FEI3004997022
Manufacturer NamePangaea Laboratories  
Manufacturer Address line 158 Crewys Rd  
Manufacturer Address line 2  
Manufacturer's CityLondonlondon  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LY99  
Importer's Product DescriptionSKIN PREPARATIONS  
Refusal Date11-May-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0115511-4/1/1
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.