Refusal Actions by FDA as Recorded in OASIS for Colombia

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


    Cooperativa Colanta Ltda.
    Medellin Antioquia, CO                         FLA-DO  E84-0054742-6/1/1
    12BFO13   CHEESE
                        01-JUL-2008                        BACTERIA

    Cadbury Adams Colombia Sa
    Cali , CO                                      FLA-DO  BFV-0157226-2/28/1
    33UGT99   CHEWING GUM
                        15-JUL-2008                        NO ENGLISH
                                                           LABELING

    C.I. AGROFRUT S.A.
    Medellin Co-Ant, CO none                       FLA-DO  900-0053397-7/2/1
    20GGT99   FROZEN LULO PULP 5 CARTONS
                        16-JUL-2008                        PESTICIDES

    Henri Laboratorios
    Bogota , CO                                    NOL-DO  112-3161476-2/1/1
    61HCJ99   969315191690 HERI
                        30-JUL-2008                        DR QUALITY

    Chalver Lab
    Bogota , CO                                    NOL-DO  112-3161476-2/1/3
    61WCJ04   969315191690 TROGEMTAX
                        30-JUL-2008                        DR QUALITY

    Novartis
    Bogota , CO                                    NOL-DO  112-3161476-2/1/4
    62GCY90   969315191690 VOLTAREN
                        30-JUL-2008                        UNAPPROVED