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
Savini Tartufi
Forcoli , IT 56030 CHI-DO 106-0212352-2/1/3
25QCI02 SLICED BLACK TRUFFLES
03-APR-2008 NO PROCESS
Pernnigotti
Novi Ligure AL, IT 15067 NOL-DO 112-1828624-6/1/1A
13GYY99 Pernigotti Maestri gelatieri Italiani
04-APR-2008 UNSAFE COL
Pernnigotti
Novi Ligure AL, IT 15067 NOL-DO 112-1828624-6/1/1B
13GYY99 Yogurt Soft Ice
04-APR-2008 LIST INGRE
Casagiulia
Pescara , IT SAN-DO G05-1127483-2/15/1
20RCE99 VANILLA CHESTNUT CHREAM
04-APR-2008 NEEDS FCE
NO PROCESS
Commerciale Ragozzino Srl
Caserta , IT 81057 NYK-DO J61-0020833-5/17/1
60SBY99 ANTACID
07-APR-2008 NOT LISTED
DIRECTIONS
Merck Sharp & Dohme Italia Spa
Roma Rm , IT 000191 NOL-DO 112-2060144-0/1/1
64UCC06 Proscar 5mg AND FINASTERIDE
09-APR-2008 UNAPPROVED
Giusto Masiello & F.S.N.C. Industria Conserve Alimentari
Cerignola (Fg) , IT FLA-DO E41-0057030-5/3/1
21GEE09 OLIVES, WHOLE PITTED
14-APR-2008 NEEDS FCE
NO PROCESS
Giusto Masiello & F.S.N.C. Industria Conserve Alimentari
Cerignola (Fg) , IT FLA-DO E41-0057030-5/4/1
24AEE07 BEANS, WHITE
14-APR-2008 NEEDS FCE
NO PROCESS
Eugenio Brezzi & C
Grosseto GR, IT 58100 SWI-DO 101-7735714-1/1/1
25QEY02 TRUFFLE PEELINGS SLICED (BLACK SUMMER)
14-APR-2008 FILTHY
Panificio Francese Srl
Quinto De Stampiquinto De Stampi , IT 20089 NWE-DO 248-1508666-5/5/1A
03AGB03 Traditional
23-APR-2008 LIST INGRE
USUAL NAME
NUTRIT LBL
Panificio Francese Srl
Quinto De Stampiquinto De Stampi , IT 20089 NWE-DO 248-1508666-5/5/1B
03AGB03 Alle Olive
23-APR-2008 LIST INGRE
USUAL NAME
NUTRIT LBL
Panificio Francese Srl
Quinto De Stampiquinto De Stampi , IT 20089 NWE-DO 248-1508666-5/5/1C
03AGB03 Con Semi Di Lino
23-APR-2008 LIST INGRE
USUAL NAME
NUTRIT LBL
Panificio Francese Srl
Quinto De Stampiquinto De Stampi , IT 20089 NWE-DO 248-1508666-5/5/1D
03AGB03 Al Peperoncino
23-APR-2008 LIST INGRE
USUAL NAME
NUTRIT LBL
Molise Conserve S.R.L.
S. Elia A Pianisi Italy , IT 86048 NYK-DO BZK-0034666-5/3/1
24TCY01 ARTICHOKE HEARTS
24-APR-2008 NO PROCESS
Aboca Spa
Sansopolcro , IT NOL-DO 112-5573146-7/1/1
54AYY99 713692214248 VITAMINS
25-APR-2008 NO ENGLISH
Safilo Group S.p.A.
Padova , IT 35129 FLA-DO R12-0036868-5/2/1
86H--QY SUNGLASSES "FOR EXPORT ONLY"
25-APR-2008 REGISTERED
Safilo Group S.p.A.
Padova , IT 35129 FLA-DO R12-0036868-5/3/1
86H--QY SUNGLASSES "FOR EXPORT ONLY"
25-APR-2008 REGISTERED
Zach System S.P.A.
Bresso , IT NYK-DO 791-9955872-1/1/1
62GCS70 SULINDAC PHARMACEUTICAL INGERDIENT
25-APR-2008 UNAPPROVED