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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-0778588-0/1/10

Manufacturer FEI3003483565
Manufacturer NameHbc Inc  
Manufacturer Address line 1548 Mindanao Ave  
Manufacturer Address line 2  
Manufacturer's CityQuezon City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53LD03  
Importer's Product DescriptionDERMATOX FACIAL CREAM  
Refusal Date14-Sep-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0778588-0/1/10
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.