Refusal Actions by FDA as Recorded in OASIS for New Zealand

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


    Fisher & Paykel Electronics Ltd
    Aukland , NZ                                   FLA-DO  WYQ-2019476-6/1/1
    80F--MT   Infant Warmer
                        14-JUL-2008                        REGISTERED

    Shop New Zealand
    Auckland , NZ                                  NOL-DO  112-3322317-4/1/1
    36CGN04   937417469068-BEE POLLEN
                        21-JUL-2008                        LIST INGRE
                                                           DIETARY
                                                           LACKS FIRM

    Doric Products NZ Ltd
    Auckland NZ-AUK, NZ 0751                       NOL-DO  112-3430196-1/1/1
    54FAZ99   859972864310 OMEGA CAPSULES
                        21-JUL-2008                        NUTRIT LBL

    Biocorp Nz Limited
    Blenheim FN, NZ                                CHI-DO  WV6-6005945-5/1/1
    61LCS08   CRUDE SODIUM HEPARIN (FURTHER MFG & EXPORT TO INDIA)
                        22-JUL-2008                        NOT LISTED
                                                           UNAPPROVED

    Topline International
    Auckland , NZ                                  NOL-DO  112-3600093-4/1/1
    66PBJ99   972453372966 NATURE C SUNBLOCK
                        25-JUL-2008                        NOT LISTED