Refusal Actions by FDA as Recorded in OASIS for Italy

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 231-7408047-6/3/1 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/5/2 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/16/1 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 231-7408047-6/21/1 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/33/2 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/51/4 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/57/1 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/72/3 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 231-7408047-6/74/3 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 231-7408047-6/82/2 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Gamma Croma Srl Vaiano Cremasco CR, IT 26010 SWI-DO 231-7408047-6/86/1 66PBY99 Ultimate Lip Balm SPF 12 - 01 Nude 02-JAN-2008 NOT LISTED INCONSPICU Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/1 52AIE28 PLATES FRUIT DECORATION 04-JAN-2008 CONTAINER Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/2 52AIE38 SPOONS FRUIT DECORATION 04-JAN-2008 CONTAINER Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/3 52AIE35 Bottle with Handels 04-JAN-2008 CONTAINER Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/4 52AIE37 PITCHER FRUITS DECORATION 04-JAN-2008 CONTAINER Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/5 52AIE31 SOUP DINNER FRUIT DECORATION 04-JAN-2008 CONTAINER tuscia via chiantigiana #264 Firenze , IT SWI-DO 534-1071670-7/1/1A 52AIE26 Fruits Decoration plate 04-JAN-2008 CONTAINER tuscia via chiantigiana #264 Firenze , IT SWI-DO 534-1071670-7/1/1B 52AIE26 fruits decoration spoons 04-JAN-2008 CONTAINER tuscia via chiantigiana #264 Firenze , IT SWI-DO 534-1071670-7/1/1C 52AIE26 fruits decoration centerpiece 04-JAN-2008 CONTAINER tuscia via chiantigiana #264 Firenze , IT SWI-DO 534-1071670-7/1/1D 52AIE26 fruits decoration spaghetti canisters 04-JAN-2008 CONTAINER tuscia via chiantigiana #264 Firenze , IT SWI-DO 534-1071670-7/1/1J 52AIE26 cannister spaghetti apple decor 04-JAN-2008 CONTAINER Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/3A 25RCE02 Black Winter Truffle Extra - 12g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1A 25SCE02 White Spring Truffle Extra - 25g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1B 25SCE02 White Spring Truffle Extra - 50g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1J 25SCE02 White Winter Truffle Extra - 25g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/3B 25RCE02 Black Winter Truffle Extra - 50g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/3C 25RCE02 Black Winter Truffle 1st Q. - 50g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/3D 25RCE02 Black Winter Truffle 1st Q. - 100g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6A 25PCE02 Black Summer Truffles Extra - 12.5g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6B 25PCE02 Black Summer Truffles Extra - 25g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6C 25PCE02 Black Summer Truffles Extra - 200g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6D 25PCE02 Black Summer Truffles 1st Q. - 50g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/4 25RCE02 Sliced Winter Black Truffle 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1C 25SCE02 Sliced White Spring Truffle - 90g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1D 25SCE02 Sliced White Spring Truffle - 50g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6E 25RCE02 Sliced Black Summer Truffles - 50g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/6F 25RCE02 Sliced Black Summer Truffles - 180g Jar 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1F 25SCE02 White Truffle Spread 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/1I 25SCE02 Truffle Paste 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/5A 25SCE02 Black Winter Truffle Juice - Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/5B 25SEE02 Black Winter Truffle Juice - Cans 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/7A 25SCE02 Black Summer Truffle Spread - 40g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/7B 25SCE02 Black Summer Truffle Spread - 160g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/10A 24UCE02 Asparagus Paste 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13B 25NCE25 Onion Jam 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13C 24KCE07 Pepper Jam 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13D 24KCE07 Pepper Sauce 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13E 23BCE12 Walnut Sauce 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13F 37JCE99 Genovese Pesto Sauce 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13G 37JCE99 Genovese Pesto Sauce 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13I 24KCE01 Roasted Eggplants in Olive Oil 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13J 24KCE01 Eggplant Pate 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13K 24KCE06 Roasted Zucchini 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13M 24UCE01 Artichoke Pate 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/16B 25QCE99 Sauce with Porcino Mushrooms & Zucchini 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/16C 25QCE99 Cut Porcino Mushrooms 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/12A 25RCE99 Sauce with Champignon & Truffles - 90g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/12B 25RCE99 Sauce with Champignon & Truffles - 180g Jars 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/16A 25QCE99 Porcino Mushroom Sauce 07-JAN-2008 NEEDS FCE NO PROCESS Boscovivo Arezzo , IT FLA-DO M85-0050117-5/1/13L 24KCI07 Spicy "Cherries" (Ingredients list Peppers, not Cherries) 07-JAN-2008 NEEDS FCE NO PROCESS Braco Spa Milano MI, IT 20134 NOL-DO 112-0836572-9/1/1 62TAB06 955736322758/ESOMEPRAZOLE 10-JAN-2008 UNAPPROVED Pharmacia Italia S.p.A. Milan , IT NOL-DO 112-0822635-0/1/1 65JCY21 862026651074/PROVERA 10 MG 10-JAN-2008 UNAPPROVED Menu Srl Modena , IT NYK-DO DP4-0420656-8/1/1 37JGT99 CHAMPIGNON CREAM W/TRUFFLE 14-JAN-2008 NEEDS FCE Safilo Group S.p.A. Padova , IT 35129 FLA-DO R12-0035965-0/1/1 86H--QY SUNGLASSES 15-JAN-2008 REGISTERED NO 510(K) Safilo Group S.p.A. Padova , IT 35129 FLA-DO R12-0035965-0/2/1 86H--QY SUNGLASSES 15-JAN-2008 REGISTERED NO 510(K) Safilo Group S.p.A. Padova , IT 35129 FLA-DO R12-0035965-0/3/1 86H--QY SUNGLASSES 15-JAN-2008 REGISTERED NO 510(K) Fresh Taste Produce Ltd Etobicoke ON, CA M8Y1H8 NYK-DO BGK-0918034-1/1/1 23AAN04 FRESH STERILIZED CHESTNUTS 15-JAN-2008 FILTHY Gnosis S.R.L. Cairate VA, IT 21050 LOS-DO 574-0220171-9/1/1 54FER99 SILYBIN/PHOSPHOLIPIDS 15-JAN-2008 INCONSPICU Vincenzo Padova E. Co. Ispicaispica , IT 97014 SEA-DO 551-6622760-8/22/1 23BGT01 AKMONDS, "PIZZUTA DE AVOLA" 18-JAN-2008 FILTHY NUTRIT LBL Euro Alimentari Cerignola , IT FLA-DO NL7-0104447-0/2/1 26BCE08 ONION'S IN OIL 25-JAN-2008 NEEDS FCE NO PROCESS Euro Alimentari Cerignola , IT FLA-DO NL7-0104447-0/3/1 25PCE99 MUSHOROOM IN OIL 25-JAN-2008 NEEDS FCE NO PROCESS Euro Alimentari Cerignola , IT FLA-DO NL7-0104447-0/5/1 24GCE01 EGGPLANT IN OIL 25-JAN-2008 NEEDS FCE NO PROCESS Euro Alimentari Cerignola , IT FLA-DO NL7-0104447-0/6/1 24GCE04 PEPPER'S IN OIL 25-JAN-2008 NEEDS FCE NO PROCESS Euro Alimentari Cerignola , IT FLA-DO NL7-0104447-0/7/1 28ACE07 CAPERS IN VINAGER 25-JAN-2008 NEEDS FCE NO PROCESS Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/2/6 52AIE28 PLATE LEMONS DECORATION 28-JAN-2008 UNSAFE ADD Ceramica D'Arte Tuscia Lastra A Signa FI, IT SWI-DO 534-1720040-8/3/4 52AIE34 Plates Poppy Decoration 28-JAN-2008 POISONOUS Rimpex Scs Beirut , LB NYK-DO KL1-0140028-3/1/1 53LC-06 BODY CREAM 31-JAN-2008 NOT LISTED UNAPPROVED