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


    Nestle Brasil Ltda
    Aracatuba , BR                                 SAN-DO  J14-0060048-9/61/1
    09CEE99   MILK AND CREAM
                        21-MAY-2008                        NEEDS FCE
                                                           NO PROCESS

    Rego, Richard (Mesoone)
    Fort - CE , BR                                 FLA-DO  XXX-0153345-5/1/1
    66VDK99   Unknown clear liquid in vials
                        22-MAY-2008                        UNAPPROVED
                                                           RX LEGEND

    Rego, Richard (Mesoone)
    Fort - CE , BR                                 FLA-DO  XXX-0153344-8/1/1A
    66VDK99   Unknown Clear Sterile Injectable Liquid
                        22-MAY-2008                        UNAPPROVED
                                                           RX LEGEND

    Rego, Richard (Mesoone)
    Fort - CE , BR                                 FLA-DO  XXX-0153344-8/1/1B
    66VDK99   Unknown Sterile Injectable Liquid in Amber Vials
                        22-MAY-2008                        UNAPPROVED
                                                           RX LEGEND

    PESCMAR INDUSTRIA E COMERCIO DE PESCADO LTDA.
    NATAL BR-RN, BR 59012040                       FLA-DO  WKV-0069661-2/1/1
    16AGC42   SWORDFISH HG
                        27-MAY-2008                        POISONOUS

    PESCMAR INDUSTRIA E COMERCIO DE PESCADO LTDA.
    NATAL BR-RN, BR 59012040                       FLA-DO  WKV-0069662-0/1/1
    16AGC42   SWORDFISH HG
                        27-MAY-2008                        POISONOUS