Refusal Actions by FDA as Recorded in OASIS for Saudi Arabia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
GlaxoSmithKline Unknown , SA ATL-DO XXX-0151234-3/1/1 64LDO67 Fabric (Personal Effects) - ( Undeclared Commercial Amounts 13-MAR-2008 UNAPPROVED GlaxoSmithKline Unknown , SA ATL-DO XXX-0151234-3/1/2 64LDO67 Fabric (Personal Effects) - ( Undeclared Commercial Amounts 13-MAR-2008 UNAPPROVED