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


    Roche
    Roche , BR                                     FLA-DO  AEK-9575222-2/1/1
    74L--OS   ELECTROCARDIOGRAPH
                        09-JAN-2008                        REGISTERED
                                                           NO 510(K)

    Medley Fdarmaceutica
    Sao Paula , BR                                 NOL-DO  112-0836572-9/2/1
    61FAB56   955736322758/CLARITHROMYCIN
                        10-JAN-2008                        UNAPPROVED

    Kawakami Industrial
    Maringa , BR 8705440                           NOL-DO  112-0836877-2/1/1
    54FEY99   862494010315  Tablets 30.000, Tablets 8.000 & Tablets 3.000
                        10-JAN-2008                        DIETARYLBL
                                                           LACKS FIRM
                                                           LABELING
                                                           NUTRIT LBL

    Vitamega Com Imp
    Pindamonhanga , BR                             NOL-DO  112-7480254-7/1/2
    66PBL99   798721027701 MOISTURE LOTION DAY USE SPF 15
                        15-JAN-2008                        NOT LISTED

    Phibro Sanide Animal International
    Guarilbos, Brazil , BR 47834                   SWI-DO  ANG-0013762-1/1/1
    69AC-79   468 Drums Salinomycin
                        17-JAN-2008                        NEW VET DR

    Fanem Ltda
    Sao Paulo , BR                                 FLA-DO  199-0039244-0/1/1
    80F--MZ   INCUBATORS
                        18-JAN-2008                        REGISTERED
                                                           NO 510(K)