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


    Dentales Unidas De Colombia Sa
    Medellin , CO                                  NOL-DO  112-7772362-5/1/1
    76E--LM   860632801979 ACRYLIC TEETH
                        14-JAN-2008                        NOT LISTED
                                                           NO 510(K)

    Pulpafruit Ltda
    Bogota , CO                                    FLA-DO  JJ8-6101699-3/6/4
    21XCT14   FROZEN TAMARIND PULP WITH SUGAR ADDED
                        18-JAN-2008                        FILTHY

    Mada Spa
    Milano , IT                                    NOL-DO  112-0880590-6/1/1
    73C--AF   863826463699/ NEBULIZER - VOYAGER
                        22-JAN-2008                        NOT LISTED

    Comestibles La Dulzura
    Bogota , CO                                    FLA-DO  BFV-0153462-7/17/1
    33JGT07   TAMARIND
                        25-JAN-2008                        FILTHY

    CARNES FRIAS ENRIKO LTDA
    CALI CO-VAC, CO 57                             FLA-DO  BFV-0153053-4/1/1
    37JHI24   GARLIC SAUCE
                        25-JAN-2008                        NEEDS FCE