Refusal Actions by FDA as Recorded in OASIS for Chile

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


    Corpora Tresmontes S.A.
    Macul , CL                                     LOS-DO  J82-0015259-5/1/1
    28MFT02   POWDERED DRINK
                        05-MAY-2008                        FILTHY

    Watt'S S A
    San Bernardo , CL                              LOS-DO  442-0139076-0/1/1
    21VDF05   NECTAR W EXP MANGO
                        12-MAY-2008                        NEEDS FCE
                                                           NO PROCESS

    Watt'S S A
    San Bernardo , CL                              LOS-DO  442-0139076-0/1/4
    21KDF01   NECTAR W EXP DAMASCO (APRICOT)
                        12-MAY-2008                        NEEDS FCE
                                                           NO PROCESS

    Laboratorios LAFI Ltda.
    Santiago , CL                                  CIN-DO  UPS-0651331-9/1/1
    61GCY70   FLORFENICOL, LABELING IN SPANISH, LARGE DRUM , NO LABELING
                        14-MAY-2008                        NOT LISTED
                                                           DIRECTIONS
                                                           NO ENGLISH