• 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 M41-0783068-7/9/1/A

Manufacturer FEI3006672051
Manufacturer NameSabesa  
Manufacturer Address line 1Km 28 Carretera A Santa Ana  
Manufacturer Address line 2  
Manufacturer's CitySan Juan, Opico  
Manufacturer Province/State  
Manufacturer Country/AreaEl Salvador  
Product Code53EC01  
Importer's Product DescriptionHAIR PRODUCTS  
Refusal Date21-Dec-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx M41-0783068-7/9/1/A
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.