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


    Dalmore Products
    Vladivostok , RU 690600                        NYK-DO  BQL-0017139-5/13/1
    16AEE33   SARDINES SLICES IN OIL
                        06-AUG-2008                        NEEDS FCE
                                                           NO PROCESS

    Dalmore Products
    Vladivostok , RU 690600                        NYK-DO  BQL-0017139-5/14/1
    16AEE33   SAURY IN OWN JUICE
                        06-AUG-2008                        NEEDS FCE
                                                           NO PROCESS

    Dalmore Products
    Vladivostok , RU 690600                        NYK-DO  BQL-0017139-5/15/1
    16AEE99   YELLOW FISH  IN TOMATO SAUCE
                        06-AUG-2008                        NEEDS FCE
                                                           NO PROCESS

    Dalmore Products
    Vladivostok , RU 690600                        NYK-DO  BQL-0017139-5/16/1
    16AEE12   COD LIVER IN OWN JUICE
                        06-AUG-2008                        NEEDS FCE
                                                           NO PROCESS

    Mbe
    Moscowmoscow , RU 115035                       CIN-DO  UPS-1806193-5/1/1
    65JIY38   MIFEPREX, FOR USE IN OB/GYN DOCTORS OFFICE
                        11-AUG-2008                        UNAPPROVED

    Mbe Eurasia
    Moscowmoscow , RU 115142                       CIN-DO  UPS-1795307-4/1/1
    65JIY38   MIFEPREX, MIFOLIAN,  MEDICINE ORDERED FOR USE IN OB/GYN DOCT
                        11-AUG-2008                        UNAPPROVED

    Scio Norge As
    Hauglandshella , NO 5310                       LOS-DO  BGF-1005126-3/1/1
    80L--DQ   CELL HARMONIZER
                        21-AUG-2008                        NOT LISTED
                                                           FALSE
                                                           REGISTERED
                                                           NO 510(K)