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


    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409054-4/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409284-7/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409286-2/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Panasonic Trading Malaysia
    Johor Bahru , MY                               FLA-DO  BJM-0110737-6/1/1
    95L--32   COMPACT AUDIO SYSTEM SC-AK250GCPS
                        07-JAN-2008                        NON STD

    Panasonic Trading Malaysia
    Johor Bahru , MY                               FLA-DO  BJM-0110737-6/1/2
    95L--32   COMPACT AUDIO SYSTEM SC-AK350GCPS
                        07-JAN-2008                        NON STD

    Panasonic Trading Malaysia
    Johor Bahru , MY                               FLA-DO  BJM-0110737-6/1/3
    95L--32   COMPACT AUDIO SYSTEM SC-AK450GCPK
                        07-JAN-2008                        NON STD

    Panasonic Trading Malaysia
    Johor Bahru , MY                               FLA-DO  BJM-0110737-6/1/4
    95L--32   COMPACT AUDIO SYSTEM SC-AK750GCPK
                        07-JAN-2008                        NON STD

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0011886-1/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0011889-5/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Sony Corporation
    Penang , MY                                    FLA-DO  TW2-0011889-5/2/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        07-JAN-2008                        NON STD

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409732-5/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        15-JAN-2008                        NON STD
                                                           NO REGISTR

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409929-7/2/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        15-JAN-2008                        NON STD

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0409923-0/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        18-JAN-2008                        NO REGISTR

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0410805-6/1/1
    95R--FV   COMPACT AUDIO SYSTEM- FOR EXPORT ONLY
                        30-JAN-2008                        NON STD

    Besfomec Industries Sdn Bhd
    Melaka , MY                                    SAN-DO  DZ1-0364923-9/2/2
    29YCE99   FOMEC'S INSTINT BIRD'S NEST CONCENTRATE
                        30-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Besfomec Industries Sdn Bhd
    Melaka , MY                                    SAN-DO  DZ1-0364923-9/1/1
    29YCE99   FOMEC'S BIRD'S NEST WITH ROCK SUGAR
                        30-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Besfomec Industries Sdn Bhd
    Melaka , MY                                    SAN-DO  DZ1-0364923-9/2/1
    29YCE99   FOMEC'S INSTINT BIRD'S NEST CONCENTRATE
                        30-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Alliance Rubber Products SDN BHD
    Pulau, Pinang Nibong Tebal, MY 14300           PHI-DO  433-0938505-2/1/1
    80L--ZA   GLOVE, PATIENT EXAMINATION, POLY
                        31-JAN-2008                        HOLES

    Alliance Rubber Products SDN BHD
    Pulau, Pinang Nibong Tebal, MY 14300           PHI-DO  433-0938505-2/1/2
    80L--ZA   GLOVE, PATIENT EXAMINATION, POLY
                        31-JAN-2008                        HOLES