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  406-0418012-1/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        02-JUL-2008                        NON STD

    Seiko Marine Products Sdn Bhd
    Klang, Selangor , MY                           CHI-DO  113-4297666-6/1/1
    16JGD05   FROZEN SHRIMPS
                        08-JUL-2008                        VETDRUGRES
                                                           NITROFURAN

    Panasonic Asia Ltd
    Singapore , SG 199555                          FLA-DO  406-0418482-6/1/1
    95R--FV   COMPACT AUDIO SYSTEM - FOR EXPORT ONLY
                        17-JUL-2008                        NON STD

    Bio Gulf Sdn Bhd
    Kuala Lumpur , MY                              NOL-DO  112-3396889-3/1/1
    54FEA99   798465229869  Male Herbal Supplement
                        21-JUL-2008                        UNAPPROVED

    Bio Gulf Sdn Bhd
    Kuala Lumpur , MY                              NOL-DO  112-3512275-4/1/1
    54FCA48   799347968399 SUPPLIMENTS
                        23-JUL-2008                        HEALTH C

    Thomyam Food Industries Sdn.Bhd.(Pvt.Ltd)
    Kuantan MY-C, MY 25350                         SAN-DO  D52-0928120-8/2/3
    35DHT99   ASSORTED MINI PUDDING
                        29-JUL-2008                        UNSAFE COL
                                                           INCONSPICU

    Bio Gulf Sdn Bhd
    Kuala Lumpur , MY                              NOL-DO  112-3161411-9/1/1
    54FCA48   792710796624  Eurocoma Longifolia Complex (HERBAL SUPPLEMENT
                        31-JUL-2008                        FALSE