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


    Beiersdorf S.A.
    Cali , CO 1234                                 ATL-DO  XXX-0149700-8/1/5
    66VDY99   Various Rx Creams, Rx
                        06-OCT-2008                        PERSONALRX
                                                           NO ENGLISH

    Aquanox
    Bogotabogota , CO 02100                        CIN-DO  UPS-2318906-9/1/1A
    89L--BF   EQUIPO VACUMTERAPIA
                        14-OCT-2008                        NOT LISTED
                                                           NO 510(K)

    Aquanox
    Bogotabogota , CO 02100                        CIN-DO  UPS-2318906-9/1/1B
    89L--PQ   GIMNASIA PASIVA
                        14-OCT-2008                        NOT LISTED
                                                           NO 510(K)

    Aquanox
    Bogotabogota , CO 02100                        CIN-DO  UPS-2318906-9/1/2
    89L--BF   DEVICE THERAPY/THERMO VIBRATOR BLANKET-FOR PERSOANLUSE ONLY
                        14-OCT-2008                        NOT LISTED
                                                           FAILS STD
                                                           NO ENGLISH
                                                           NO 510(K)

    Comercializadora Lesc
    Cali , CO                                      FLA-DO  WMV-0476852-0/1/1
    56GBL99   Lescmicot Solucion (Antifungal Cream)
                        14-OCT-2008                        NOT LISTED
                                                           UNAPPROVED

    Sociedad Industrial De Grasas Vegetales Sigra, S.A
    Bogota , CO                                    FLA-DO  AMG-0072893-5/1/1
    26FGB99   MARGARINE MOJAPAN (2500 CTNS)
                        20-OCT-2008                        STD IDENT

    Allergan Westport
    Bogota , CO                                    NOL-DO  112-5721648-3/1/1
    62GCP89   857148483820  RESTASIS 0.05%
                        23-OCT-2008                        UNAPPROVED