• 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 AEK-7147235-7/4/1

Manufacturer FEI3005997006
Manufacturer NameOmer Basebrain  
Manufacturer Address line 1Alaziziah Dist  
Manufacturer Address line 2  
Manufacturer's CityJeddah  
Manufacturer Province/State  
Manufacturer Country/AreaSaudi Arabia  
Product Code62GCA89  
Refusal Date06-Dec-2006  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AEK-7147235-7/4/1
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.