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
Aceites La Masia, S.A. Dos Hermanas - Sevilla ES-SE, ES 41700 BLT-DO 004-4765337-9/1/1 26DCN01 ESENCIAL DRESSING OIL IN GLASS 01-FEB-2008 LIST INGRE LACKS FIRM LACKS N/C USUAL NAME NUTRIT LBL Wild Valencia Sa Carcaixent , ES NOL-DO 112-1189933-4/1/1 20KGT99 799258225277 FRUIT JUICE 14-FEB-2008 LIST INGRE Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/1A 53LD-06 Clean Milk 14-FEB-2008 UNSAFE COL Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/1B 53LD-06 Base Equilibrant 14-FEB-2008 CSTIC LBLG COSMETLBLG Voe S.A. Barcelona , ES 08011 ATL-DO 101-7677911-3/3/1 74J--OW COMPRESSION GLOVES 15-FEB-2008 NOT LISTED Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/1C 53LD-06 DERMO Mask 15-FEB-2008 UNSAFE COL Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/1D 53LD-06 Peeling Gomage 15-FEB-2008 CSTIC LBLG Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/1E 53LD-06 Balance Clear 15-FEB-2008 CSTIC LBLG COSMETLBLG Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/2 53LD-01 935197740225 TONIC 15-FEB-2008 UNSAFE COL Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/3 62QBJ99 Thermmogel 15-FEB-2008 NOT LISTED DR QUALITC Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/4 53LC-02 935197740225 CELLUGEL 15-FEB-2008 CSTIC LBLG Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 112-1213130-7/1/5 53LC-99 935197740225 ANTICELUTING 200ML 15-FEB-2008 UNSAFE COL CSTIC LBLG Intermedic Arfran, S.A. Barcelona , ES 08029 NOL-DO 112-0057551-5/1/1 79G--EX 850691388118 INTERMEDIC DIODE LASER 25-FEB-2008 FAILS STD Helios Valladolid , ES CHI-DO 274-0172896-2/1/1 25ECI99 MIXED VEGETABLES 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/2 24TCI99 THISTLE 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/3 24TCI25 SPINACH 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/4 25JCI03 LEEKS 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/5 25JCI21 GARLIC BUDS 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/6 24TCI26 SWISS CHARD 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/1/7 24ECI14 GREEN BEANS 26-FEB-2008 NO PROCESS Helios Valladolid , ES CHI-DO 274-0172896-2/2/1 24TCI99 BORAGE 26-FEB-2008 NO PROCESS