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


    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/1
    37JGT99   SPICE TRIGUISAR
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/2
    37JGT99   SPICE (RICOSTILLA)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/3
    37JGT99   SAUCE (SALSA BBQ FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/4
    37JGT99   SAUCE (FOR FRUKO BEEF)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/5
    37JGT99   SAUCE (FOR PEPPER FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/6
    37JGT99   SAUCE (SAUCE FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/7
    37JGT99   SAUCE (ENGLAND SAUCE FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/8
    37JGT99   SAUCE (PINK SAUCE FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    C.I. Pike & Repike Ltda.
    Medellin , CO                                  FLA-DO  BOZ-0005739-4/1/9
    37JGT99   SAUCE (SOYA SAUCE FRUKO)
                        04-DEC-2007                        NEEDS FCE
                                                           NO PROCESS

    Dermocell Technologies
    Bogota , CO                                    FLA-DO  KJ1-8272758-2/1/1
    73C--BL   CARBOXITHERAPY
                        10-DEC-2007                        REGISTERED

    Dermocell Technologies
    Bogota , CO                                    FLA-DO  KJ1-8272758-2/1/2
    89I--PF   POWERED MUSCLE STIMULATOR
                        10-DEC-2007                        REGISTERED
                                                           NO 510(K)

    Derclar
    Bogota , CO                                    NOL-DO  112-0314538-1/1/1
    54YGP02   944132448773  Solucion Anticelulitica de L-Carnitina
                        10-DEC-2007                        UNAPPROVED

    Derclar
    Bogota , CO                                    NOL-DO  112-0314538-1/2/1
    56JCP22   944132448773  Clindamicina 600 mg Injectable
                        10-DEC-2007                        UNAPPROVED

    Derclar
    Bogota , CO                                    NOL-DO  112-0314538-1/3/1
    79M--FI   944132448773  Dimethypolysiloxane Biopolymerals Reconstructo
                        10-DEC-2007                        NO PMA

    Multiopticas
    Medellin , CO                                  NOL-DO  112-0553838-5/1/1
    86H--QZ   860632757512 METAL FRAMES
                        12-DEC-2007                        NOT LISTED

    Fabrica de Grasas y Productos quimicos S.A.  Grasco S.A.
    Bogota CO-CUN, CO 20302                        FLA-DO  BOZ-0005906-9/1/1A
    09FGT99   MARGARINE - LA FINA Suave (500 g)
                        18-DEC-2007                        NO ENGLISH
                                                           NUTRIT LBL

    Unilever andina  colombia ltda
    bogota CO-DC, CO 1                             FLA-DO  BOZ-0005906-9/1/1B
    09FGT99   MARGARINE - Rama con Sal
                        18-DEC-2007                        LIST INGRE
                                                           NUTRIT LBL

    Fabrica de Grasas y Productos quimicos S.A.  Grasco S.A.
    Bogota CO-CUN, CO 20302                        FLA-DO  BOZ-0005906-9/1/1C
    09FGT99   Margarine - La Fina (250 g)
                        18-DEC-2007                        NO ENGLISH
                                                           NUTRIT LBL

    Bayer S.A
    Bogota , CO                                    NOL-DO  112-0553511-8/1/1
    68YYY20   864084160611/BAYCOX/1000ML
                        18-DEC-2007                        NEW VET DR

    C.I. AGROFRUT S.A.
    Medellin Co-Ant, CO none                       FLA-DO  900-0051883-8/2/2
    20GGT99   FROZEN LULO   (600 CTNS.)
                        27-DEC-2007                        PESTICIDES