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


    Glaxo Saudi Arabia Ltd.
    Unknown , SA                                   SWI-DO  XXX-0154562-4/1/1E
    64LAJ67   Dermovate
                        07-JUL-2008                        DIRECTIONS
                                                           UNAPPROVED

    Ismail Jama Est.
    Jeddah SA-03, SA 55555                         MIN-DO  322-2683237-9/4/1
    23KAY08   NATURAL MILLET
                        23-JUL-2008                        FILTHY

    Abdulkadir Sh. Nahim Trading Est
    Jeddah , SA                                    SEA-DO  471-0085904-1/11/1A
    02GGT99   Juwar
                        30-JUL-2008                        FILTHY
                                                           LACKS FIRM
                                                           NUTRIT LBL

    Abdulkadir Sh. Nahim Trading Est
    Jeddah , SA                                    SEA-DO  471-0085904-1/8/1B
    52AJI26   Tea Cup Sets
                        30-JUL-2008                        UNSAFE ADD

    Abdulkadir Sh. Nahim Trading Est
    Jeddah , SA                                    SEA-DO  471-0085904-1/8/1A
    52AJI26   DRINKING CUPS
                        30-JUL-2008                        UNSAFE ADD