Refusal Actions by FDA as Recorded in OASIS for Australia

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


    SOU'WEST SEAFOODS PTY LTD
    PORT FAIRY  VICTORIA AU-VI, AU 3284            NYK-DO  H67-1309023-0/1/1
    16EEE01   CANNED ABALONE
                        02-APR-2008                        NO PROCESS

    Great Southern Waterd Ltd
    Indednted , AU                                 LOS-DO  T79-0859797-6/1/2
    16EET09   CANNED ABALONE IN BRINE
                        09-APR-2008                        NEEDS FCE
                                                           NO PROCESS

    Hardip Narayan & Sons Ltd.
    Suva , FJ                                      SAN-DO  K80-0945060-3/5/1
    09CCT16   REWA FULL CREAM MILK POWDER
                        11-APR-2008                        NUTRIT LBL

    Laserex Technology
    Export Park , AU                               SEA-DO  112-1918996-9/1/1
    84G--ZJ   7983-5967-4810 - LaserTENS 1000 x eight units
                        11-APR-2008                        DIRECTIONS
                                                           NO REGISTR
                                                           NO 510(K)

    Reckitt Benckiser
    New South Whales , AU                          SEA-DO  603-1080182-8/77/1
    53JI-02   REXONA DEOD ICE COOL
                        23-APR-2008                        NOT LISTED

    Reckitt Benckiser
    New South Whales , AU                          SEA-DO  603-1080182-8/85/1
    53JI-02   REDWIN/REXONA DEODRANT
                        23-APR-2008                        NOT LISTED