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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-0778872-8/5/5/L

Manufacturer FEI3004034232
Manufacturer NameRdl Pharmaceutical Laboratory Inc  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CityDavao City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53JD01  
Importer's Product DescriptionSOAP-PAPAYA  
Refusal Date20-Nov-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0778872-8/5/5/L
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.