Refusal Actions by FDA as Recorded in OASIS for Switzerland

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


    Jota AG
    Ruthi , CH 9464                                FLA-DO  EQ6-0007697-8/1/1
    80L--DQ   LAB EQ FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR EXPORT O
                        21-MAY-2008                        REGISTERED
                                                           NO 510(K)

    Baxter Healthcare Ba
    Mallisellen , CH                               CHI-DO  DQ4-3612601-4/1/1
    57DF-03   ANTIHEMOPHILIC FACTOR (HUMAN) (BLOOD AND BLOOD DERIVATIVES);
                        21-MAY-2008                        NOT LISTED
                                                           NO LICENSE

    Baxter Healthcare Ba
    Mallisellen , CH                               CHI-DO  DQ4-3612601-4/1/2
    57DF-03   ANTIHEMOPHILIC FACTOR (HUMAN) (BLOOD AND BLOOD DERIVATIVES);
                        21-MAY-2008                        NOT LISTED
                                                           NO LICENSE