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


    Claudia Rodrigues
    Sorocaba , BR                                  NOL-DO  112-0714020-6/1/1
    41YGE99   855356233143-DIETARY CONVENTIONAL FOODS
                        02-JUN-2008                        NUTRIT LBL
                                                           HEALTH C

    Productos Roche Quimicos E Farmaceuticos
    Jaguare Sao Paolo , BR                         FLA-DO  AEK-9581142-4/1/1
    80L--DQ   MEDICAL EQPT
                        09-JUN-2008                        NOT LISTED
                                                           NO 510(K)

    Productos Roche Quimicos E Farmaceuticos
    Jaguare Sao Paolo , BR                         FLA-DO  AEK-9581145-7/1/1
    80L--DQ   MEDICAL EQPT
                        09-JUN-2008                        NOT LISTED
                                                           NO 510(K)

    Aventis Pharma Ltda
    Sao Paulo , BR 04693                           NOL-DO  112-2839835-3/2/1
    61PCB31   865281612097/AMARYL 2MG
                        20-JUN-2008                        UNAPPROVED

    Gilvan de P. Silva
    Braganca BR-PA, BR 68600000                    FLA-DO  826-0124056-5/1/1
    16AGC37   Snapper W/G
                        23-JUN-2008                        FILTHY
                                                           LACKS FIRM
                                                           LACKS N/C
                                                           USUAL NAME

    Fmormaii
    Garopapa , BR                                  NOL-DO  112-2933419-1/1/1
    86H--QY   865798676215 SUNGLASSES
                        24-JUN-2008                        NOT LISTED