Refusal Actions by FDA as Recorded in OASIS for Finland

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


    Biohit Oy
    Helsinki  , FI 00880                           NYK-DO  AEK-9108788-8/1/1
    57YJ-99   TENASCIN
                        30-MAY-2008                        NO LICENSE