Refusal Actions by FDA as Recorded in OASIS for Czech Republic

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


    Tejas, S.R.O.
    Jablonec Nad Nisoujablonec Nad Nisou , CZ 46   NYK-DO  110-0616804-7/1/1
    91D--JZ   Alcohol Breathalyzer Test
                        28-NOV-2007                        NOT LISTED
                                                           LACKS FIRM