Refusal Actions by FDA as Recorded in OASIS for Argentina

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


    Antonio Barillari S.A.
    Buenos Aires , AR 1086                         NYK-DO  AMQ-0558894-5/1/1
    16AGT49   FROZEN WHITING  FILLETS
                        15-JUL-2008                        FILTHY

    Digital Dinamic Sistem S.A.
    Buenos Aires , AR                              FLA-DO  EM8-0007538-1/1/1
    79N--LQ   ELECTROBISTURIES
                        22-JUL-2008                        NOT LISTED
                                                           NO 510(K)

    Sherring
    Argentina , AR                                 NOL-DO  112-3143485-6/2/1
    62GAO99   865717903876/SCHEDERMA
                        23-JUL-2008                        UNAPPROVED