• 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 E8P-0003150-1/1/1

Manufacturer FEI3009131322
Manufacturer NameCiencia Cosmetica S.A. De C.V.  
Manufacturer Address line 1Norte 81 # 565col. San Sebastian  
Manufacturer Address line 2  
Manufacturer's CityAzcapotzalcomexico Distrito Federal  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LC99  
Importer's Product DescriptionSLIM BOX  
Refusal Date24-Oct-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx E8P-0003150-1/1/1
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.