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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 BDD-0779328-0/5/1

Manufacturer FEI3005317612
Manufacturer Address line 1JUAN LUNA AVENUE  
Manufacturer Address line 2MABOLO  
Manufacturer's CityCEBU CITY  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53BD01  
Importer's Product DescriptionEFFICASCENT OIL  
Refusal Date05-Feb-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0779328-0/5/1
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.