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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-0779314-0/13/6

Manufacturer FEI2000001160
Manufacturer NameUnilever Foods Philippines-Cavite  
Manufacturer Address line 1Gateway Business Park, General Trias  
Manufacturer Address line 2  
Manufacturer's CityCavite  
Manufacturer Province/StatePH-CAV  
Manufacturer Country/AreaPhilippines  
Product Code53EC01  
Importer's Product DescriptionCREAMSILK - PURPLE  
Refusal Date26-Apr-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0779314-0/13/6
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.