• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

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  
Importer's Product DescriptionSOAP, DEODORANT, .5 OZ  
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  
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.