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
Antoine Bagno St Cyr Sur Mer , FR 83270 SWI-DO 534-1806074-4/6/12 52AIE28 Garlic Dish with lavender 02-JUN-2008 CONTAINER Derval Derval , FR FLA-DO 793-0603252-9/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 04-JUN-2008 NO PROCESS Derval Derval , FR FLA-DO 793-0603255-2/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 04-JUN-2008 NEEDS FCE NO PROCESS Boulangerie Poilane Bievres , FR NOL-DO 112-2937991-5/1/1 03AYT99 696182237259 BREAD 10-JUN-2008 NO ENGLISH LABELING NUTRIT LBL Amplitude Systems Pessacpessac , FR 33600 NYK-DO N81-0100088-1/2/1 95L--22 DERMATOLOGY LASER 10-JUN-2008 NOT LISTED REGISTERED NO REGISTR NO 510(K) Aventis Pharma S.A. Antony,France , FR LOS-DO 004-4994477-6/1/1 64LSS51 PREDNISOLONE ACETATE 11-JUN-2008 NOT LISTED UNAPPROVED Unilever International Rueil , FR 92565 BLT-DO AT1-0806798-7/14/1 27ACT02 MAYONNAISE STANDARD DRESSING 12-JUN-2008 LIST INGRE LACKS N/C NUTRIT LBL Festival De Cannes Paris , FR 75007 NOL-DO 112-3083556-6/1/1 86H--QZ 847774171154 EYEGLASSES 17-JUN-2008 NOT LISTED Vectec Clermont Ferrand , FR 63000 FLA-DO 408-1169015-2/2/2 78K--OA SURGICAL INSTRUMENTS 17-JUN-2008 REGISTERED Vectec Clermont Ferrand , FR 63000 FLA-DO 408-1169015-2/2/1 74D--RC TROCAR 17-JUN-2008 REGISTERED Derval Derval , FR FLA-DO 793-0603470-7/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 17-JUN-2008 NEEDS FCE NO PROCESS Elvira Elle & Vire Conde Sur Vire , FR 50890 FLA-DO 793-0603471-5/2/1 09CYF13 308 CTNS COOKING CREAM FOR EXPORT ONLY 17-JUN-2008 NEEDS FCE NO PROCESS Derval Derval , FR FLA-DO 793-0603471-5/4/1 09CYF13 1764 CTNS WHIPPING CREAM FOR EXPORT ONLY 17-JUN-2008 NEEDS FCE NO PROCESS Derval Derval , FR FLA-DO 793-0603472-3/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 17-JUN-2008 NEEDS FCE NO PROCESS Debauve Et Gallais Paris , FR 75007 NOL-DO 112-3100050-9/1/1 34FYY02 864581654018/CHOCOLATE CANDY 17-JUN-2008 UNSAFE COL NUTRIT LBL Uclisme Chef Du Pont , FR 50360 MIN-DO H41-1217804-5/2/1 12AMP56 SUISSE MONT ERUITS COW MILK CHEESE 18-JUN-2008 NO ENGLISH Maitres Laitiers Chef Du Pont , FR MIN-DO H41-1217804-5/2/2 12AMP56 PETIT MONTEBOURG CHOCOLAT 18-JUN-2008 NO ENGLISH Inomed La Farlede , FR 83210 NOL-DO 112-3142892-4/1/1 87L--XH 791911866321 Othopedic Intrument 19-JUN-2008 NOT LISTED NO 510(K) Inomed La Farlede , FR 83210 NOL-DO 112-3143521-8/1/1 79K--KY 799864709828 Orthopedic Instrument 19-JUN-2008 NOT LISTED NO 510(K) Innodis Sa St Quentin , FR 02100 NYK-DO UPS-1228681-9/1/1 56YBK99 EYELIGHT'S STAR ( EYE DROPS ) 20-JUN-2008 UNAPPROVED Sanofi Aventis Vitry Sur Sei , FR NOL-DO 112-2885080-9/1/1 65VCP56 057718160309 Stilnox 23-JUN-2008 UNAPPROVED Derval Derval , FR FLA-DO 793-0603526-6/2/1 09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY 23-JUN-2008 NEEDS FCE Steiner Transocean Ltd Middx , GB HA36BZ FLA-DO MA7-0683540-6/1/1 53LD-06 CREAMS, 27-JUN-2008 COSM COLOR Steiner Transocean Ltd Middx , GB HA36BZ FLA-DO MA7-0683540-6/2/1 53LD-06 GEL 27-JUN-2008 COSM COLOR Serfib S.A. Lambersart , FR NYK-DO 112-3071951-3/1/1 83L--LA 837486552691TOXOPLASMA SEROLOGICAL REAGENTS 30-JUN-2008 NOT LISTED NO 510(K) Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/22/1 27YCE99 WILD PURSLANE AND PARSLEY MOUSSE 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/23/1 27YCE99 MEDEAR AND ONION MOUSSE 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/24/1 27YCE99 CARROTS MINT AND CUMIN SPREAD 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/25/1 27YCE99 WILD NETTLES AND GARLIC SPREAD 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/26/1 27YCE99 HOKKAIDO PUMPKIN AND PERIGORD WALNUTS SPREAD 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/27/1 27YCE99 JERUSALEM ARTICHOKE AND GINGER SPREAD 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/28/1 27YCE99 SPICED EGGPLANT SPREAD 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/29/1 27YCE99 SWEET PEPPER AND BASIL MOUSSE 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/34/1 27YCE03 ONION AND MEDEAR CHUTNEY 30-JUN-2008 NEEDS FCE NO PROCESS Les Conservas Oubliees Sadirac France , FR LOS-DO 408-1161367-5/35/1 27YCE03 ONION PATTYPAN AND GINGER CHUTNEY 30-JUN-2008 NEEDS FCE NO PROCESS Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/8/1 76E--IF GUIDED TEMPLATE ABUTM W SCREW NOBRPL WP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/15/1 76N--HA ABUTMENT REPLICA BALL ATTACHMENT NP/RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/16/1 76E--IF SCREWDRIVER MANUAL UNIGRIP 20 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/26/1 76E--IF POSITION LOCATOR MODEL NOBRPL NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/27/1 76E--IF WAX-UP SLEEVE FOR ASTRA TECH 3.5ST 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/27/2 76E--IF PROCERAR W-U SL ENG NOBELACTIVE INT NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/27/3 76N--HA TEMP ABUTM PLASTIC NON-ENG BMK SYST RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/39/1 76N--HA TEMP ABUTM PLASTIC ENGAGING BMK SYST NP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/46/1 76E--IF SCREWDRIVER MANUAL UNIGRIP 36 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/46/2 76E--IF SCREWDRIVER MACHINE UNIGRIP 20 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/46/3 76E--IF CONNECTION TO HANDPIECE 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/50/1 76N--HA ABUTMENT REPLICA CERAONE NP/RP 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/51/1 76E--IF SCREWDRIVER MANUAL MULTI-UNIT 25 MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/51/2 76E--IF SCREWDRIVER MACHINE M-U BMK SYST WP 20MM 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/65/1 76E--IF IMPLANT REPLICA BMK SYST RP 5/PKG 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/66/1 76E--CT MACHINE SCREWDRIVER SLOT LONG 30-JUN-2008 NOT LISTED REGISTERED Nobel Biocare The Netherlands , NL LOS-DO 336-6588312-3/75/2 76N--HA PROCERA ABUTMENT WAX-UP KIT NOBELACTIVE 30-JUN-2008 NOT LISTED REGISTERED Boulangerie Poilane Bievres , FR NOL-DO 112-1350520-2/1/1 03AYT99 696182226012 BREAD 30-JUN-2008 LIST INGRE NO ENGLISH NUTRIT LBL