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


    Stam B.V.
    Am Diemen , NL 1111                            MIN-DO  M96-2073314-4/12/1
    34FET08   Chocolate Eggs, with plastic toy inside (Kindersurprise)
                        04-MAR-2008                        IMBED OBJT

    Exsilent Bv
    Amsterdam , NL 1075BX                          NOL-DO  112-0098090-5/1/1
    77E--SD   849861860324-HEARING AID
                        05-MAR-2008                        NOT LISTED

    Exsilent Bv
    Amsterdam , NL 1075BX                          NOL-DO  112-0099502-8/1/1
    77E--SD   849861860313-HEARING AID
                        06-MAR-2008                        REGISTERED

    Sun Hing Foods Inc
    Markham ON, CA L3S3T4                          NYK-DO  XXX-0153520-3/3/1
    09CEN03   Sweetened Condensed Milk
                        19-MAR-2008                        LABELING

    Perfection Foods (1991)
    Charlottetown CA-PE, CA C1A1S6                 NYK-DO  UPS-0333119-4/1/1
    09CEN03   Sweetened Condensed Milk
                        19-MAR-2008                        LABELING

    Dutch Opthalmic Research Center Int
    Zuidland , NL                                  FLA-DO  DM9-8010279-0/1/1
    86M--LZ   6010 B.A.  SILENT COMPRESSOR FOR EXPORT ONLY
                        20-MAR-2008                        REGISTERED
                                                           NO 510(K)

    Dutch Opthalmic Research Center Int
    Zuidland , NL                                  FLA-DO  DM9-8010281-6/1/1
    86H--MX   OPTHALMIC INSTRUMENTS/GUAGES FOR EXPORT ONLY  REG#9611516
                        20-MAR-2008                        REGISTERED
                                                           NO 510(K)

    Dutch Opthalmic Research Center Int
    Zuidland , NL                                  FLA-DO  DM9-8010283-2/1/1
    86H--QE   ASSOCIATE DUAL SYSTEM 110V FOR EXPORT ONLY  REG#9611516
                        20-MAR-2008                        REGISTERED
                                                           NO 510(K)