Refusal Actions by FDA as Recorded in OASIS for Belgium

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


    Cypress Diagnostics
    Landorp , BE                                   NOL-DO  112-0229927-0/1/1
    83M--CE   791799086894 AMEBIASIS ELISA
                        05-DEC-2007                        NOT LISTED

    Laboratoires Natural Scientific
    Marcilly En Villette , FR 45240                NOL-DO  112-0219561-9/1/1
    54ABE99   712079778231 Aliment de Vie du Cheveu (food of life for hair
                        05-DEC-2007                        UNSAFE COL

    Gray Janine
    Tervuren , BE 3080                             NOL-DO  112-0183622-1/1/1
    04AGT05   799749043854 PASTA
                        06-DEC-2007                        NO ENGLISH

    Barry Callebaut Belgium Nv
    Lebbeke-Wieze , BE B-9280                      NYK-DO  144-1374142-5/1/1
    34BVT99   BELGIAN DARK CHOCOLATE
                        19-DEC-2007                        LABELING

    Ferrero Ardennes S.A.
    Arlon , BE                                     LOS-DO  946-0603922-3/31/1
    34FFT02   KINDER FAMILY 288'S
                        19-DEC-2007                        IMBED OBJT
                                                           LACKS N/C
                                                           NUTRIT LBL

    Ferring S A
    Aalst , BE                                     NOL-DO  112-0708356-2/1/1
    64MCB05   857819928844.MENOPUR 75MG
                        20-DEC-2007                        UNAPPROVED

    Ferring S A
    Aalst , BE                                     NOL-DO  112-0708356-2/2/1
    80F--MF   857819928844.SYRINGES
                        20-DEC-2007                        NOT LISTED
                                                           NO 510(K)