Refusal Actions by FDA as Recorded in OASIS for Turkey

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


    Pfeizer Laboratories Ltd
    Sandton , TR 2196                              NOL-DO  112-8776351-2/1/1
    66VCA99   861718685515 BITERAL  250MG
                        01-NOV-2007                        UNAPPROVED

    Roche Mustahzarlari San Ltd S
    Istanbul , TR                                  NOL-DO  112-8776351-2/1/2
    66VCA99   861718685515 MONODOK
                        01-NOV-2007                        UNAPPROVED

    Palmas Palmiye Gida San. Ve Tic.A.S.
    Izmir , TR                                     SWI-DO  655-1393454-1/2/1
    24HGH50   SUN DRIED TOMATOES
                        14-NOV-2007                        FILTHY