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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 655-1676941-5/5/1


Manufacturer FEI3007808836
Manufacturer NameJabones Y Productos Especializados Sa De Cv  
Manufacturer Address line 1Privada Del Gallo 1525  
Manufacturer Address line 2  
Manufacturer's CityJalisco  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53JY01  
FDA Product DescriptionBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date26-Jun-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 655-1676941-5/5/1
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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