Refusal Actions by FDA as Recorded in OASIS for Brazil

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


    Bayonne Alimentos
    Curitiba Parana, BR 81460-040                  SWI-DO  231-5465049-5/3/6
    41EGE99   FIBRA LIFE-FIBER SUPPLEMENT-CALCIUM
                        06-MAR-2008                        SALMONELLA

    Conap - Cooperativa Nacional De
    Nova Lima , BR                                 NOL-DO  112-0103960-2/1/1
    28CYT99   845082704583 PROPOLIS EXTRACT
                        06-MAR-2008                        NO ENGLISH

    Native Industria Farmaceutica
    Sao Paulo, Brasil , BR                         NOL-DO  112-8819032-7/1/1
    54FIA99   674156651365  Agaricus Blazei mushroom tablets
                        07-MAR-2008                        LIST INGRE
                                                           DIETARYLBL
                                                           NUTRIT LBL

    Comercial Kodo Electronics Ltda
    Sao Paulo , BR 01230                           NOL-DO  112-1620762-4/2/1
    64LDK67   850699550599  Psorex
                        13-MAR-2008                        UNAPPROVED

    Produmar
    Natal , BR                                     FLA-DO  WKV-0071230-2/3/1
    16AGC42   SWORDFISH HG
                        28-MAR-2008                        POISONOUS