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
Prhoinsa Madrid , ES 28021 NOL-DO 112-8818686-1/1/1 74D--XQ 856682047580 CUFF 05-NOV-2007 NOT LISTED NO 510(K) Bio-Col S.L. Barcelona , ES FLA-DO WJD-0027503-0/1/3L 53LY-01 Cleansing Gel w/Oats 15-NOV-2007 UNSAFE COL Conserves Ferrer Sa Santpedor , ES 08251 SEA-DO 551-6598512-3/5/1 25SCE01 MUSHROOMS IN SAUCE 19-NOV-2007 NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/10/1 21GEE09 STUFFED OLIVES WITH ANCHO 21-NOV-2007 LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/10/2 21GEE09 STUFFED OLIVES WITH PEPPER 21-NOV-2007 LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/10/3 21GEE09 STUFFED OLIVES WITH ALMONDS 21-NOV-2007 LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS