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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 GV3-1207889-4/70/1

Manufacturer FEI3009421630
Manufacturer NameNatural Benefits Sa De Cv  
Manufacturer Address line 1Lago Texcoco  
Manufacturer Address line 2  
Manufacturer's CityMexico  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LD99  
Importer's Product DescriptionORGALEO LIQUID MASK  
Refusal Date06-Apr-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx GV3-1207889-4/70/1
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.