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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 AAJ-0038711-4/1/8

Manufacturer FEI3008228330
Manufacturer NameTonic Life S de RL  
Manufacturer Address line 1Acambaro 1008  
Manufacturer Address line 2Colonia Plan Guanajuato  
Manufacturer's CityIrapuato  
Manufacturer Province/StateGuanajuato  
Manufacturer Country/AreaMexico  
Product Code53LC01  
Importer's Product DescriptionBABA DE CARACOL  
Refusal Date05-Dec-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx AAJ-0038711-4/1/8
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.