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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 GR9-9021467-2/1/4

Manufacturer FEI3007967170
Manufacturer NameNATURAL PALACE S. A. DE C. V.  
Manufacturer Address line 1MANUEL DOBLADO #37  
Manufacturer Address line 2ZONA CENTRO  
Manufacturer's CityIrapuato  
Manufacturer Province/StateMX-GUA  
Manufacturer Country/AreaMexico  
Product Code53LC99  
Importer's Product DescriptionHERBAL BALM  
Refusal Date06-Apr-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx GR9-9021467-2/1/4
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.