Refusal Actions by FDA as Recorded in OASIS for Austria

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


    Thomas Hofinger
    Salzburg , AT 5020                             LOS-DO  267-5133461-1/1/1
    31AEE99   ICE COFFEE IN CANS
                        01-MAY-2008                        NEEDS FCE
                                                           NO PROCESS

    Komptech Farwick Gmbh
    Frohnleiten , AT                               CHI-DO  322-4566482-9/13/1
    79L--RR   FIRST AID KIT
                        05-MAY-2008                        NOT LISTED
                                                           REGISTERED

    Fresenius Kabi Austria Gmbh
    Linz, Austria , AT A-4020                      NYK-DO  DO7-8718461-6/1/1
    63HCS10   LACTULOSE
                        19-MAY-2008                        NOT LISTED
                                                           DIRECTIONS