Refusal Actions by FDA as Recorded in OASIS for Malaysia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Etumax Coporation Sdn Bhd
    Selangorselangor , MY 46000                    NYK-DO  UPS-0223523-0/1/1
    54FCH47   PHYTO SHAPE WEIGHT LOSS SUPPLEMENT
                        02-MAY-2008                        UNSFDIETLB

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0012406-7/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        06-MAY-2008                        NO REGISTR

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0012407-5/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        06-MAY-2008                        NO REGISTR

    Apollo Food Industries ( Sdn Bhd
    Johor , MY                                     LOS-DO  610-2830282-8/1/1
    33LGT06   GUMMY CANDY
                        06-MAY-2008                        UNSAFE COL
                                                           DISEASED

    Dahfa Foods Manufacturing Sdn Bhd
    Kuching Sarawak, MY 1234                       CHI-DO  G83-9602148-3/2/1B
    16SGT12   Sesame Cod Fish Fillet
                        23-MAY-2008                        LIST INGRE
                                                           LACKS FIRM
                                                           LACKS N/C
                                                           USUAL NAME
                                                           NUTRIT LBL

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0012471-1/1/1
    95L--31   MINI HI FI COMPONENTS / FOR EXPORT ONLY
                        23-MAY-2008                        NON STD

    Plexus Manufacturing Sdn Bhd
    Penang , MY 11900                              CHI-DO  004-5011564-7/1/1
    74N--VZ   CARELINK MONITOR FOR CANADA (IFE)
                        29-MAY-2008                        UNAPPROVED

    Plexus Manufacturing Sdn Bhd
    Penang , MY 11900                              CHI-DO  004-5011517-5/1/1
    74N--VZ   CARELINK MONITOR FOR CANADA (IFE)
                        29-MAY-2008                        UNAPPROVED

    Plexus Manufacturing Sdn Bhd
    Penang , MY 11900                              CHI-DO  004-5011517-5/2/1
    74D--XY   CARELINK MONITOR FOR CANADA
                        29-MAY-2008                        UNAPPROVED

    Plexus Manufacturing Sdn Bhd
    Penang , MY 11900                              CHI-DO  004-5011251-1/1/1
    74N--VZ   MODEL 2490C0022K CARELINK MONITOR
                        29-MAY-2008                        UNAPPROVED