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


    Moreno Sociedad Anonima Exportacion Importacion
    Cordoba  , ES 14006                            BLT-DO  628-0135364-0/6/1
    21GEE09   BLACK OLIVES (CHRISTMAS GIFTS NOT FOR SALE)
                        04-MAR-2008                        NO PROCESS

    Almenar Exportaciones, S.L.
    Valencia , ES                                  SJN-DO  BTL-0010451-2/19/1
    53ED-05   FACE MASK
                        05-MAR-2008                        UNAPPROVED

    Ormaza, Conservas de Pescado, S.A.
    Bermeo, Bizkaia ES-NOTA, ES 48370              BLT-DO  253-1036878-9/6/1
    16AET45   TUNA LOIN IN OLIVE OIL (EUTHYNNUS PELAMIS)
                        06-MAR-2008                        NO PROCESS

    Aceites Ybarra Sa
    Dos Hermanas Sevilla, ES                       SEA-DO  551-6633305-9/1/1
    21GET12   ANCHOVY STUFFED GREEN OLIVES
                        12-MAR-2008                        LABELING
                                                           NEEDS FCE
                                                           NO PROCESS

    Acuna T Fonbona S.A.
    Gijon-Asturias , ES                            NOL-DO  112-1572824-0/1/1
    79G--EN   862502876140-FORCEPS
                        12-MAR-2008                        NOT LISTED

    SOS Cuetara S.A
    Unknown , ES                                   ATL-DO  XXX-0151441-4/1/12
    26CY-04   Aceite de Oliva Espanol ( Olive Oil) 140 ml tin cans
                        13-MAR-2008                        NO ENGLISH
                                                           NUTRIT LBL

    Professional Cargo Service
    Guatamala City , GT                            ATL-DO  XXX-0151441-4/1/13
    26CY-04   Selecto El Olivo (Olive Oil)120ml
                        13-MAR-2008                        NO ENGLISH
                                                           NUTRIT LBL

    Inmunotek Sl
    Ssdl Reyes , ES 28700                          NOL-DO  112-1695791-3/1/1
    66VDJ99   860451506398 MOISTURIZING GEL
                        13-MAR-2008                        NOT LISTED

    Helios
    Valladolid , ES                                CHI-DO  274-0173983-7/9/1
    24ACI05   BROAD BEANS
                        19-MAR-2008                        NO PROCESS

    Helios
    Valladolid , ES                                CHI-DO  274-0173983-7/5/1
    25ECI02   PEAS AND CARROTS EXTRA FINE
                        19-MAR-2008                        NO PROCESS

    Helios
    Valladolid , ES                                CHI-DO  274-0173983-7/3/1
    25JCI01   EXTRA FINE CARROTS
                        19-MAR-2008                        NO PROCESS

    Helios
    Valladolid , ES                                CHI-DO  274-0173983-7/10/1
    24ACI51   PEAS EXTRA FINE
                        19-MAR-2008                        NO PROCESS

    Astrazeneca Farmaceutica
    Madrid , ES 28033                              NOL-DO  112-1722117-8/1/1
    60QCY86   862425085791 EMLA CREAM 30GMS
                        28-MAR-2008                        UNAPPROVED