Refusal Actions by FDA as Recorded in OASIS for Russia

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


    Zykova Nataliya Aleksandtovna
    Moscow , RU 101000                             CIN-DO  AEK-9398249-0/1/1
    83L--IB   ELECTRICAL MEDICAL DIAGNOSTIC INSTRUMENT
                        04-FEB-2008                        NOT LISTED
                                                           NO 510(K)

    NIVEL LTD.
    MOSCOW RU-NOTA, RU NONE                        NYK-DO  548-0132277-4/1/1C
    16YVC99   Dried Okun
                        26-FEB-2008                        FILTHY

    Scan Neva Jsc
    St. Petersburg , RU                            SEA-DO  WIG-8017012-7/1/1
    25PGH07   DRIED ORGANIC MUSHROOMS
                        27-FEB-2008                        FILTHY