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
Schering-Plough Canada Inc Kirkland QC, CA H9H4M7 NYK-DO M76-6096569-1/1/1 55EG-99 STERILE SALINE NASAL SPRAY 01-JUL-2008 NOT LISTED Glaxo Wellcome Production Evreux Cedex , FR 11827091 SAN-DO 112-2836750-7/1/1 63BCQ02 864250363500 ALBUTEROL SULFATE VENTOLIN 02-JUL-2008 NOT LISTED UNAPPROVED Bourjois Parfume Paris Neuilly Sur Seine , FR 92200 FLA-DO 408-1169503-7/4/1 62WBY17 DEODORANTS/ ANTIPERS 14-JUL-2008 UNAPPROVED Le Fedou Hures La Parade , FR 48150 FLA-DO J80-0041464-1/1/2 12CGT16 Tomme Brebis Fedou 17-JUL-2008 LISTERIA C2 Diagnostics Montferrier S , FR 34099 SAN-DO 336-6663299-0/1/1 81G--KZ CD-EMERALD ANALYZER 19-JUL-2008 NOT LISTED NO 510(K) Elvira Elle & Vire Conde Sur Vire , FR 50890 FLA-DO 793-0603660-3/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 22-JUL-2008 NEEDS FCE NO PROCESS Tatum Surgical Gaillon , FR 27600 CIN-DO UPS-1460303-7/1/1 78F--GN SURGICAL INSTRUMENTS/LINARI, STEVEN J/EVERETT, WA, 23-JUL-2008 NOT LISTED Boulangerie Poilane Bievres , FR NOL-DO 112-3583677-5/1/1 03AYT13 696182241983-WHEAT BREAD 23-JUL-2008 NO ENGLISH LABELING NUTRIT LBL Boulangerie Poilane Bievres , FR NOL-DO 112-3583677-5/2/1 03AYT99 696182241983-RYE BREAD 23-JUL-2008 NO ENGLISH LABELING NUTRIT LBL Boulangerie Poilane Bievres , FR NOL-DO 112-3583677-5/3/1 03AYT99 696182241983-WALNUT BREAD 23-JUL-2008 NO ENGLISH LABELING NUTRIT LBL Boulangerie Poilane Bievres , FR NOL-DO 112-3583677-5/4/1 03AYT99 696182241983-CURRANT BREAD 23-JUL-2008 NO ENGLISH LABELING NUTRIT LBL Fromagerie De Neufchateau Neufchateau , FR 88300 NWE-DO 004-5014847-3/1/1 12AGP56 ROULE AIL FH MINI 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Fromagerie Lincet Saligny , FR 89100 NWE-DO 004-5014847-3/5/1 12AGP56 CHAOURCE AOC SALIGNY 23-JUL-2008 LABELING Fromagerie Perrin Vernot S.A. Cleron , FR 25330 NWE-DO 004-5014847-3/6/1 12AGP56 EDEL DE CLERON 23-JUL-2008 LIST INGRE LACKS FIRM LACKS N/C USUAL NAME NUTRIT LBL Fromagerie Germain Furiani (Corsica or Corse Isl) , FR 20600 NWE-DO 004-5014847-3/7/1 12AGP56 EPOISSE AOC GERMAIN USA 23-JUL-2008 LIST INGRE USUAL NAME NUTRIT LBL Fromagerie Perrin Vernot S.A. Cleron , FR 25330 NWE-DO 004-5014847-3/8/1 12AGP56 FROMAGER CLARINES PERRIN 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Fromagerie Rouzaire S.A. Tournan En Brie , FR 77220 NWE-DO 004-5014847-3/9/1 12AGP56 GRATTE PAILLE ROUZ MINI USA 23-JUL-2008 LACKS N/C USUAL NAME NUTRIT LBL Etablissements Curtet Et Fils Vinay , FR NWE-DO 004-5014847-3/10/1 12AGP56 ST MARCELLIN 23-JUL-2008 LIST INGRE LACKS FIRM LACKS N/C USUAL NAME NUTRIT LBL Societe De Constructions Nogues Saint Estephe , FR 63820 NWE-DO 004-5014847-3/11/1 12AGP56 GAPERON FR AUVERGNE MINI 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME Sevre & Belle Celles Sur Belle , FR 79370 NWE-DO 004-5014847-3/13/1 12CGP15 CHEVRE D'OR EXPORT 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Guilloteau Fromagerie Pelussin , FR 42410 NWE-DO 004-5014847-3/14/1 12AGP56 N ROCHE LS 200G 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Guilloteau Fromagerie Pelussin , FR 42410 NWE-DO 004-5014847-3/15/1 12AGP56 N LOTS 5 MINIS FOND BOIS 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Guilloteau Fromagerie Pelussin , FR 42410 NWE-DO 004-5014847-3/16/1 12AGP56 N FROMAGER AFFINOIS 2KG 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Societe Fromagere De Raival Meuse , FR NWE-DO 004-5014847-3/17/1 12AGP56 Vignotte 23-JUL-2008 LACKS FIRM LACKS N/C USUAL NAME NUTRIT LBL Societe Fromagere De Raival Meuse , FR NWE-DO 004-5014847-3/18/1 12AGP56 SOFT RIPENED CHEESES HAXAIRE X1 23-JUL-2008 NO ENGLISH Societe Fromagere De Domfront Domfront , FR 61700 NWE-DO 004-5014847-3/19/1 12AGP56 CAMEMBERT CHATELAIN 23-JUL-2008 LIST INGRE LACKS N/C USUAL NAME NUTRIT LBL Coop Laitiere De La Haute Truyer Labouresse , FR NWE-DO 112-2198207-0/4/1 12AWO56 SWEET MARION BLEUE FOURMETTE 30-JUL-2008 LISTERIA Chantal Plasse Jassans Riottier , FR 01480 NWE-DO 112-1611502-5/2/1 12AWO02 Blue veined cheese, pasteurized cow's milk 30-JUL-2008 LISTERIA Haute Truyere Loubaresse , FR NWE-DO 112-2068285-3/3/1 12AWO56 SWEET MARION BLEUE FORMETTE 30-JUL-2008 LISTERIA Onetik S.A. Macaye , FR 64240 FLA-DO 793-0603640-5/8/1 12AGP99 250 CTNS SAINT PAULIN CHEESE FOR EXPORT ONLY 31-JUL-2008 LISTERIA