Refusal Actions by FDA as Recorded in OASIS for Ireland

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


    Werthenstein Chemie A.S.
    Schachen , CH                                  SAN-DO  607-5330968-5/1/1
    62GIP99   BIOTHERAPEUTIC ANTIBODY FOR CLINICAL STUDY/NON-HUMAN USE
                        19-JUL-2008                        NOT LISTED
                                                           UNAPPROVED