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


    Agroaroma Ltda
    Bogota-Colombia , CO                           FLA-DO  NL7-0105023-8/5/1
    28AGB04   BASIL
                        22-AUG-2008                        PESTICIDE

    Agroaroma Ltda
    Bogota-Colombia , CO                           FLA-DO  NL7-0105023-8/5/2
    28AGB04   BASIL
                        22-AUG-2008                        NONNUT SUB

    Phoenix Em
    Bogota , CO                                    FLA-DO  BPH-3042355-7/1/1
    89I--SA   ELECTRIC MASSAGE THERAPY
                        25-AUG-2008                        REGISTERED

    Phoenix Em
    Bogota , CO                                    FLA-DO  BPH-3042355-7/3/1
    89N--ZF   CELULITE REMOVALE MACHINE
                        25-AUG-2008                        REGISTERED

    Phoenix Em
    Bogota , CO                                    FLA-DO  BPH-3042355-7/2/1
    97R--AL   ULTRASOUND CELULLITE REMOVAL MACHINE
                        25-AUG-2008                        NON STD

    Tecser Laboratorios Ltda.
    Bogota , CO                                    LOS-DO  461-0067464-0/1/1A
    64XBJ06   HOT FIRMING GEL
                        27-AUG-2008                        NOT LISTED

    Tecser Laboratorios Ltda.
    Bogota , CO                                    LOS-DO  461-0067464-0/1/1C
    62QAJ99   CAMPHOR CREAM
                        27-AUG-2008                        NOT LISTED