Refusal Actions by FDA as Recorded in OASIS for Spain

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


    Housediet Sl
    Barcelona , ES 08014                           FLA-DO  WIG-2046411-9/1/12
    41BGT99   APINAT CAFE INSTANT (POWDER IN BAGS)
                        05-MAY-2008                        NO ENGLISH

    Housediet Sl
    Barcelona , ES 08014                           FLA-DO  WIG-2046411-9/1/13
    41BGT99   PERTRES RELAX (PILLS)
                        05-MAY-2008                        NO ENGLISH

    Housediet Sl
    Barcelona , ES 08014                           FLA-DO  WIG-2046411-9/1/14
    62MBJ01   ANti cellulite cream with iodine
                        05-MAY-2008                        UNAPPROVED

    Alfonso Garcia Lopez, S.A. - C. Pescamar
    Poyo ES-PO, ES 36994                           FLA-DO  BIP-0012440-6/1/1
    16AEY33   PESCAMAR SARDINES IN HOT VEGETABLE OIL
                        06-MAY-2008                        NO PROCESS

    Alfonso Garcia Lopez, S.A. - C. Pescamar
    Poyo ES-PO, ES 36994                           FLA-DO  BIP-0012440-6/2/1
    16AEY33   PESCAMAR SARDINES IN TOMATO SAUCE
                        06-MAY-2008                        NO PROCESS

    Casmara Cosmetics Sa
    Alaquas(Valencia) , ES 46970                   SWI-DO  BXM-0001442-2/46/1
    53LC-06   RGENERIN ENZYME - 50ML
                        19-MAY-2008                        UNAPPROVED

    Casmara Cosmetics Sa
    Alaquas(Valencia) , ES 46970                   SWI-DO  BXM-0001442-2/52/1
    53LC-06   CASMARA FOR LEGS CREAM - 250ML
                        19-MAY-2008                        UNAPPROVED

    Nirvel Cosmetics S.L.
    Alcoi , ES                                     FLA-DO  WIG-2045123-1/3/1
    66VDY99   ANTI-HAIR LOSS TREATMENT
                        23-MAY-2008                        UNAPPROVED