Refusal Actions by FDA as Recorded in OASIS for Costa Rica

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


    Costa Rican Coffee Company
    Aservi San Jose , CR                           NOL-DO  112-0260601-1/1/1
    31AFY99   861865438589 COFFEE
                        10-DEC-2007                        LACKS N/C

    Verania Morin Murillo
    Aserri San Jose , CR 5261000                   NOL-DO  112-0247375-0/1/1
    31AVF01   863533040072-COFFEE
                        10-DEC-2007                        LACKS N/C

    Allergan Costa Rica ,S.A.
    La Aurora De He , CR 99999                     NOL-DO  112-0515997-6/1/1
    79M--WZ   941082126979 TISSUE EXPANDER
                        13-DEC-2007                        NOT LISTED
                                                           NO PMA
                                                           NO 510(K)

    Allergan Costa Rica ,S.A.
    La Aurora De He , CR 99999                     NOL-DO  112-0515997-6/2/1
    79F--TR   941082126979  BREAST IMPLANTS
                        17-DEC-2007                        NOT LISTED
                                                           NO PMA
                                                           NO 510(K)