Refusal Actions by FDA as Recorded in OASIS for France

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Sarl Hmd Fromagerie Saint Haon Le Chatel , FR NYK-DO DP4-0415309-1/4/1 12CGP15 TOMME DE LA CHATAIGNERAIE CHEESE 05-NOV-2007 LISTERIA Orgev Laboratoires Rambouillet , FR 78120 NOL-DO 112-8795759-3/1/1 53CD-04 862506876384 Eyes Lift Serum 07-NOV-2007 CSTIC LBLG Fabrique D'Linstruments Nogent , FR 52800 NOL-DO 112-6714565-6/3/1 79H--XD 856888279162 MEDICAL BONE CLAMPS 13-NOV-2007 NOT LISTED NO 510(K) Curtet Vinay , FR 38470 NYK-DO DP4-0412666-7/1/5 12AGP56 ST MARCELLIN CHEESE 14-NOV-2007 LISTERIA Cerp Rouen Laigneville , FR 76040 FLA-DO EQ6-0006840-5/1/1 54YBY03 PHARMACEUTICAL FDAPLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR E 19-NOV-2007 UNAPPROVED Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/14/1 37KCE99 TAPENADE GREEN OLIVES 21-NOV-2007 LACKS N/C USUAL NAME NUTRIT LBL NEEDS FCE NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/14/2 37KCE99 TAPENADE BLACK OLIVES 21-NOV-2007 LACKS N/C USUAL NAME NUTRIT LBL NEEDS FCE NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/16/2 23ECE04 CHOKOLLA NUTELLA PARVE 21-NOV-2007 LACKS N/C USUAL NAME NUTRIT LBL Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/20/1 34KFT99 BAKING CHOCOLATE 21-NOV-2007 INCONSPICU Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/8/1 27YGE99 TABASCO 21-NOV-2007 INCONSPICU Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/17/2 03TGT30 FINE PASTRY DOUGH 21-NOV-2007 INCONSPICU Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/16/1 23ECE04 CREME DE MARON 21-NOV-2007 LACKS N/C NEEDS FCE NO PROCESS Les Aliments Haut Panache Mont-royal QC, CA H4P1J3 NYK-DO 144-0735153-8/17/1 03HMT99 PALMIER EMB COOKIES 21-NOV-2007 LACKS N/C USUAL NAME NUTRIT LBL Poly Implant Protheses, S.A. La Seyne Sur Mer , FR 83500 FLA-DO K51-0062949-9/1/1 79M--RD BREAST IMPLANTS--GEL 26-NOV-2007 NOT LISTED REGISTERED