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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-0779318-1/24/1/B


Manufacturer FEI3009296989
Manufacturer NameMandalay Trading Corporation  
Manufacturer Address line 148 Calbayog Street  
Manufacturer Address line 2  
Manufacturer's CityMandaluyong  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53JD01  
Importer's Product DescriptionBAR SOAP PAPAYA  
Refusal Date19-Apr-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BDD-0779318-1/24/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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