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


    Intermelon Comercial Imp E Exp Ltda
    Corozinho, Ce , BR                             FLA-DO  ALL-0056662-0/1/1
    22AFC99   FRESH GALIA MELONS (3000 CTN)
                        06-DEC-2007                        FILTHY

    Cosmeticos Ltda
    Sao Paulo , BR                                 NOL-DO  112-0187436-2/1/1
    53ED-99   863243746532  Amazonutry Booster(102 pcs) and Amazonutry Mas
                        06-DEC-2007                        UNSAFE COL

    Alcon Lab Do Brasi
    Sao Paulo , BR                                 NOL-DO  112-0330394-9/1/1
    62OCK17   864089185400/BETOPTIC
                        10-DEC-2007                        UNAPPROVED

    Predilecia Alimentos, LTDA
    Matao BR-MS, BR 15999000                       NYK-DO  DP4-0418923-6/5/1
    24AGT51   GREEN PEAS
                        19-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    Abbott Laboratorios Do Brasil Ltda
    Sao Paulo/Sp. , BR 04566                       NOL-DO  112-0678781-7/1/1
    61FDA56   864083473760 KLARICID 500MG
                        27-DEC-2007                        UNAPPROVED

    Abbott Laboratorios Do Brasil Ltda
    Sao Pablo , BR                                 NOL-DO  112-0678781-7/1/2
    62TDA02   864083473760 OGASTRO 30MG
                        27-DEC-2007                        UNAPPROVED

    Abbott Laboratorios Do Brasil Ltda
    Sao Paulo/Sp. , BR 04566                       NOL-DO  112-0678781-7/1/3
    56BCA03   864083473760 AMOXIDEL 1G
                        27-DEC-2007                        UNAPPROVED