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
BELTAPHARM S.p.A. Milan , IT BLT-DO XXX-0152422-3/1/1C 66VBY99 Fashion Fair Cream 05-DEC-2007 NOT LISTED UNAPPROVED M.C.A. Medical and Chemical Agency S.p.A. MILAN , IT BLT-DO XXX-0152422-3/1/1D 66VBY99 Top-Gel 05-DEC-2007 NOT LISTED UNAPPROVED VINCO PHARMACEUTICAL MILAN , IT BLT-DO XXX-0152422-3/1/1G 66VBY99 Skin Success Gel 05-DEC-2007 NOT LISTED UNAPPROVED Esapharma S.R.L. Milano MI, IT 20134 BLT-DO XXX-0152422-3/1/1K 66VBY99 Lemonvate Antibacterial Soap 05-DEC-2007 NOT LISTED UNAPPROVED Dpc Ltd Kowloon , HK SAN-DO AW6-0072293-4/1/1G 66VBJ99 Sun Block Cream SPF 40 - 50ml 05-DEC-2007 NOT LISTED DRUG NAME Dpc Ltd Kowloon , HK SAN-DO AW6-0072293-4/1/1T 66VBJ99 Sun Block Cream Sample 05-DEC-2007 NOT LISTED LACKS FIRM LACKS N/C WARNINGS DRUG NAME Dpc Ltd Kowloon , HK SAN-DO AW6-0072293-4/1/1X 66VBJ99 Renewalo Fruit Acid Mask Sample 05-DEC-2007 FALSE LACKS FIRM LACKS N/C Leghe Leggere Lavorate Srl Buccinasco , IT 20090 NOL-DO 112-0138970-0/1/1 87H--WC 852853065870-SCREWS 06-DEC-2007 NOT LISTED NO 510(K) Sharp & Botanica Italy S.R.L. Agrate Brianzaagrate Brianza , IT 20041 NOL-DO 112-0015219-0/1/1 84M--IO 860625615912 BIOLIGHT 06-DEC-2007 NOT LISTED DIRECTIONS NO 510(K) Zambon Italia Srl Vicenza , IT 36100 NOL-DO 112-0224654-5/1/1 65BCR01 Fluimucil 06-DEC-2007 UNAPPROVED La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/1 12AGO19 BUFFALO MOZZARELLA 08-DEC-2007 SALMONELLA Zhermack S.P.A. Badia Polesine RO, IT 45021 NOL-DO 112-0278888-4/1/1 76E--BG 790383955448 DENTAL MATERIAL 10-DEC-2007 NOT LISTED NO 510(K) Gloria Maglieria Elastica SRL Menaggio CO, IT 22017 NOL-DO 112-0341308-6/1/1 80D--WL 852851116508 STOCKING 11-DEC-2007 NOT LISTED Ceramiche IMA S.R.L. aka Ceramiche Artistiche IMA SRL Montelupo , IT 50056 SAN-DO MH7-9001594-4/1/1 52AIE28 SERVING PLATE 11-DEC-2007 UNSAFE ADD Ceramiche IMA S.R.L. aka Ceramiche Artistiche IMA SRL Montelupo , IT 50056 SAN-DO MH7-9001594-4/4/1 52AIE27 PITCHER 11-DEC-2007 UNSAFE ADD Ceramiche IMA S.R.L. aka Ceramiche Artistiche IMA SRL Montelupo , IT 50056 SAN-DO MH7-9001594-4/2/1 52AIE31 DEEP BOWL 11-DEC-2007 UNSAFE ADD Leghe Leggere Lavorate Srl Buccinasco , IT 20090 NOL-DO 112-0242206-2/1/1 68XYY99 852853065848-SCREW 12-DEC-2007 NOT LISTED NO 510(K) CASEIFICIO PEZZANA 2 S.R.L. FROSSASCO IT-TO, IT 10060 NYK-DO 084-1042297-9/1/1 12ACO52 GRATELLO AL TARFUFO COWS MILK CHEESE WITH BLACK TRUFFLES 17-DEC-2007 LISTERIA Agribosco Srl Sigillo PG, IT 06028 CHI-DO 045-0248031-4/8/1 24AAE70 Canellini Beans in Vegetable Broth 17-DEC-2007 NO PROCESS Agribosco Srl Sigillo PG, IT 06028 CHI-DO 045-0248031-4/9/1 24AFE06 Organic Lentils in vegetable broth 17-DEC-2007 NO PROCESS Nuova Tradizione Srl Montecchio Maggiore (VI) IT-VI, IT 36075 BLT-DO 110-1101320-3/1/1D 45LE-99 5517 - Forest Strawberry 18-DEC-2007 UNSAFE COL LIST INGRE LACKS N/C USUAL NAME LACKS FIRM Nuova Tradizione Srl Montecchio Maggiore (VI) IT-VI, IT 36075 BLT-DO 110-1101320-3/1/1E 45LE-99 5530 - ACE 18-DEC-2007 UNSAFE COL LIST INGRE LACKS N/C USUAL NAME LACKS FIRM Nuova Tradizione Srl Montecchio Maggiore (VI) IT-VI, IT 36075 BLT-DO 110-1101320-3/2/1I 45LE-99 6003 - Crem Caramel 18-DEC-2007 UNSAFE COL LIST INGRE LACKS N/C USUAL NAME LACKS FIRM Nuova Tradizione Srl Montecchio Maggiore (VI) IT-VI, IT 36075 BLT-DO 110-1101320-3/2/1P 45LE-99 6014 - Zuppa Ingleze 18-DEC-2007 UNSAFE COL LIST INGRE LACKS N/C USUAL NAME LACKS FIRM Nuova Tradizione Srl Montecchio Maggiore (VI) IT-VI, IT 36075 BLT-DO 110-1101320-3/2/1R 45LE-99 6027 - Zabajone Reale 18-DEC-2007 UNSAFE COL LIST INGRE LACKS N/C USUAL NAME LACKS FIRM Sigma Tau Roma RM, IT 00144 NOL-DO 112-0510785-0/1/1 65CCK07 860792625270 Carnitene 18-DEC-2007 UNAPPROVED Effepi Srl Seregno , IT 20038 FLA-DO M21-0736826-0/1/1 56BAK55 OXACILLIN SODIUM FOR EXPORT ONLY, PLEASE REFUSE MERCHANDISE 19-DEC-2007 UNAPPROVED La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/2 12AGO19 BUFFALO MOZZARELLA 20-DEC-2007 SALMONELLA Dpc Ltd Kowloon , HK SAN-DO AW6-0072293-4/1/1F 66VBJ99 New Face Cream For Reddened Skin 20-DEC-2007 NOT LISTED DRUG NAME UNAPPROVED Merck Sharp & Dohme Italia S.p.A. Pavia , IT 27100 NOL-DO 112-0657118-7/5/1 61PCY99 864089213209/JANUVIA 27-DEC-2007 UNAPPROVED Leghe Leggere Lavorate Srl Buccinasco , IT 20090 NOL-DO 112-0683127-6/1/1 87H--RS 852853065631 SCREWS 27-DEC-2007 NOT LISTED NO 510(K) Emotec Srl Medollamedolla , IT 41036 NOL-DO 112-0673392-8/1/1 81K--SR 859040863243/BLOOD COLLECTION BAG 27-DEC-2007 NOT LISTED NO 510(K) La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/3 12AGO19 BUFFALO MOZZARELLA 28-DEC-2007 SALMONELLA La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/4 12AGO19 BUFFALO MOZZARELLA 28-DEC-2007 SALMONELLA La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/5 12AGO19 BUFFALO MOZZARELLA 28-DEC-2007 SALMONELLA La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/6 12AGO19 BUFFALO MOZZARELLA 28-DEC-2007 SALMONELLA La Marchesa Teverola CE, IT 81030 NYK-DO DL8-0030684-7/1/7 12AGO19 BUFFALO MOZZARELLA 28-DEC-2007 SALMONELLA Procos Spa Novara , IT 12256 NYK-DO 186-6015721-7/1/1 61NCS69 GABAPENTIN CAS#60142-96-3 31-DEC-2007 DRUG GMPS