Refusal Actions by FDA as Recorded in OASIS for Chile

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


    Laboratories Coesam
    La Reina , CL                                  FLA-DO  W16-5013968-8/1/1
    66PBJ99   ANTIOXIDANT CORPORAL LOTION
                        03-APR-2008                        DRUG NAME
                                                           UNAPPROVED

    Laboratories Coesam
    La Reina , CL                                  FLA-DO  W16-5013968-8/1/3
    66VDY99   SLIMMING GEL (MASSAGE REDUCTION GEL)
                        03-APR-2008                        UNAPPROVED

    Laboratories Coesam
    La Reina , CL                                  FLA-DO  W16-5013968-8/1/6
    66VDY99   NOURISHING R.HIP OIL CREAM WITH GLYCOPROTEINS
                        03-APR-2008                        UNAPPROVED

    Laboratories Coesam
    La Reina , CL                                  FLA-DO  W16-5013968-8/2/1
    66VDY99   HAND AND BODY ROSE HIP OIL CREAM
                        03-APR-2008                        UNAPPROVED

    Laboratories Coesam
    La Reina , CL                                  FLA-DO  W16-5013968-8/3/1
    53JY-01   UVATHERAPY SOAP BAR
                        03-APR-2008                        COL ADDED

    Salmoprocesos
    Los Lagos , CL                                 LOS-DO  221-1004874-5/1/1
    16XGD03   FRESH FILLET SALMON TRIM C 1-2
                        15-APR-2008                        IMPTRHACCP

    Salmoprocesos
    Los Lagos , CL                                 LOS-DO  221-1004874-5/1/2
    16XGD03   FRESH FILLET SALMON TRIM C 2-3
                        15-APR-2008                        IMPTRHACCP

    Salmoprocesos
    Los Lagos , CL                                 LOS-DO  221-1004874-5/1/3
    16XGD03   FRESH FILLET SALMON TRIM C 3-4
                        15-APR-2008                        IMPTRHACCP

    Salmoprocesos
    Los Lagos , CL                                 LOS-DO  221-1004874-5/1/4
    16XGD03   FRESH FILLET SALMON TRIM C 4-5
                        15-APR-2008                        IMPTRHACCP

    South Pacific Abalone S.A.
    Las Condes Santiago De Chile , CL              NYK-DO  FY4-0053242-7/2/1
    16AVD46   FRESH TURBOT
                        29-APR-2008                        MFR INSAN