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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 E8L-1016785-1/1/1

Manufacturer FEI3009629136
Manufacturer NameFranklin Botanical Laboratory Inc  
Manufacturer Address line 119201 Parthenia St Suite F  
Manufacturer Address line 2  
Manufacturer's CityNorthridge  
Manufacturer Province/StateCA  
Manufacturer Country/AreaUnited States  
Product Code53IH01  
Importer's Product DescriptionDENTAL POWDER  
Refusal Date17-Sep-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx E8L-1016785-1/1/1
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.