Refusal Actions by FDA as Recorded in OASIS for Netherlands

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


    Varian Bv
    Middelburg , NL 4338                           NOL-DO  112-0480619-7/1/1
    90K--PQ   735868161990 XRAY PARTS
                        04-JUN-2008                        NON STD

    Dsm Food Specialties
    Delft , NL                                     NYK-DO  DO7-8718166-1/1/1
    56BYL99   DELVOCID(NATAMYCIN)
                        04-JUN-2008                        NOT LISTED
                                                           UNAPPROVED

    Fortimedix Bv
    Nuth , NL 6361HC                               NOL-DO  112-3010425-2/1/1
    74N--IM   862031402530-LASER CUT STENT
                        11-JUN-2008                        NO PMA

    Klm Royal Dutch Airlines
    Schiphol Airport Amsterdam, NL NL-1118ZL       CHI-DO  208-2830846-8/1/1
    79L--RR   FIRST AID KIT
                        13-JUN-2008                        NOT LISTED
                                                           REGISTERED

    Van Uden Reibel Bv
    Rotterdam , NL 3088EC                          FLA-DO  T94-0048495-0/1/1
    56IAS40   ERYTHROMYCIN ETHYL SUCCINATE
                        18-JUN-2008                        UNAPPROVED

    N.V. Organon
    Oss , NL 5340 BH                               CHI-DO  435-2802184-3/1/1
    61LBR08   HEPARIN SODIUM-FRONTAGE LABS FOR IMPORT FOR FURTHER PROCESS
                        24-JUN-2008                        NOT LISTED
                                                           UNAPPROVED

    Essaidi Awua Tilles Therapy
    Eindhoven , NL 5644RE                          NOL-DO  112-1931821-2/1/1
    54FCF99   865333876484 HERBAL SUPPLEMENT
                        24-JUN-2008                        NOT LISTED
                                                           UNAPPROVED

    Nobel Biocare
    The Netherlands , NL                           LOS-DO  336-6588312-3/32/1
    76E--IF   DRILL STOP KIT
                        30-JUN-2008                        NOT LISTED
                                                           REGISTERED

    Nobel Biocare
    The Netherlands , NL                           LOS-DO  336-6588312-3/60/1
    76E--IF   HANDPIECE ZYGOMA 20:1
                        30-JUN-2008                        NOT LISTED
                                                           REGISTERED