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


    Ost-Aqua Zao
    Chernogolovka , RU                             FLA-DO  BQL-0017148-6/1/5
    29BCT06   CARBONATED SOFT DRINK
                        03-OCT-2008                        UNSAFE COL
                                                           NO ENGLISH

    Ost-Aqua Zao
    Chernogolovka , RU                             FLA-DO  BQL-0017148-6/1/8
    29BCT06   CARBONATED SOFT DRINK
                        03-OCT-2008                        UNSAFE COL
                                                           NO ENGLISH

    RITM OKB ZAO
    TAGANROG , RU 347900                           CIN-DO  AEK-9983104-8/1/1
    84N--HI   ELECTRONIC THERAPEUTIC STIMULATOR
                        17-OCT-2008                        NOT LISTED
                                                           NO 510(K)