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
Dolcidea Di Ie Cristofaro
Italy , IT NYK-DO U16-4628819-5/1/1
34FGT99 CHOCOLATE EASTER EGGS
03-MAR-2008 FILTHY
Campi Di Sicilia Srl
Butera , IT NYK-DO DR9-1138013-4/2/1
24TEI01 ARTICHOKES MARINATED QUARTERED
05-MAR-2008 NO PROCESS
Campi Di Sicilia Srl
Butera , IT NYK-DO DR9-1138013-4/2/2
24TEI01 ARTICHOKES MARINATED QUARTERED
05-MAR-2008 NO PROCESS
Campi Di Sicilia Srl
Butera , IT NYK-DO DR9-1138013-4/2/3
24TEI01 ARTICHOKES MARINATED QUARTERED
05-MAR-2008 NO PROCESS
Campi Di Sicilia Srl
Butera , IT NYK-DO DR9-1138013-4/2/4
24TEI01 ARTICHOKES MARINATED QUARTERED
05-MAR-2008 NO PROCESS
Campi Di Sicilia Srl
Butera , IT NYK-DO DR9-1138013-4/2/5
24TEI01 ARTICHOKES MARINATED QUARTERED
05-MAR-2008 NO PROCESS
Crema Lombardi Snc
Roma , IT NOL-DO 112-0173128-1/1/1A
37JYT99 Vinegar
07-MAR-2008 NO ENGLISH
Crema Lombardi Snc
Roma , IT NOL-DO 112-0173128-1/1/1B
37JYT99 Pesto sauce
07-MAR-2008 NO ENGLISH
Therabel Gienne Pharma Spa
Milan , IT NOL-DO 112-0182272-6/1/1
66VCY99 862808979170 MEDICINE LEVOBREN
07-MAR-2008 UNAPPROVED
Savitar Srl
Basso , IT NOL-DO 112-8565761-7/1/1
25QCY02 848408661154 TRUFFLES mixed in glass jars, 6.3 oz
07-MAR-2008 NO PROCESS
Savitar Srl
Basso , IT NOL-DO 112-8565761-7/1/2
25QCY02 848408661154 TRUFFLES white in glass jars 6.3 oz
07-MAR-2008 NO PROCESS
Global Lab
Chennevieres Sur Marne , FR 94430 FLA-DO EQ6-0007139-1/1/1
63VAY02 PERFECTING BRITENER CREAM LABELER CODE # 16541
10-MAR-2008 N-RX INACT
LABELING
UNAPPROVED
Eus Snc Di Mannino & Zimbardo
Carini Pa , IT 90044 FLA-DO NL7-0104680-6/5/1A
16ACE45 Ventresca of Red Tuna
10-MAR-2008 LACKS FIRM
NO ENGLISH
NUTRIT LBL
NEEDS FCE
NO PROCESS
Eus Snc Di Mannino & Zimbardo
Carini Pa , IT 90044 FLA-DO NL7-0104680-6/5/1B
16MEE11 Sea Urchin
10-MAR-2008 NO ENGLISH
NUTRIT LBL
NEEDS FCE
NO PROCESS
Eus Snc Di Mannino & Zimbardo
Carini Pa , IT 90044 FLA-DO NL7-0104680-6/6/1
16ACE01 ANCHOVIES FILLET
10-MAR-2008 LACKS FIRM
NO ENGLISH
NUTRIT LBL
NEEDS FCE
NO PROCESS
Italcavi Srl
San Benedetto Del Tronto Ap , IT 663039 NYK-DO M76-4094049-1/1/1
24VEE01 ARTICHOKE, IN BRINE
11-MAR-2008 LACKS N/C
USUAL NAME
Fiab Spa
Florence , IT 50039 NOL-DO 112-8849634-4/1/1
68XYY99 818957219067/VETERINARY ACCESSORIES
12-MAR-2008 NOT LISTED
INCONSPICU
Fabri 1905 S.P.A
Bologna , IT NWE-DO 144-7480752-8/1/1
37KGT99 FRUIT DELIPASTE
12-MAR-2008 USUAL NAME
LABELING
NUTRIT LBL
Newchem Spa
Milano , IT MIN-DO DN2-0843065-7/2/1
64LDZ37 HYDROCORTISONE BASE
12-MAR-2008 DIRECTIONS
Newchem Spa
Milano , IT MIN-DO DN2-0843065-7/1/2
64LDZ67 CLOBETASOL PROPIONATE USP30 NDC# 57582-0038-5
12-MAR-2008 DIRECTIONS
Commerciale Ragozzino Srl
Caserta , IT 81057 NYK-DO J61-0020833-5/3/1
60SBY99 ANTACID
13-MAR-2008 NOT LISTED
DIRECTIONS
Commerciale Ragozzino Srl
Caserta , IT 81057 NYK-DO J61-0020833-5/11/1
60SBY99 ANTACID
13-MAR-2008 NOT LISTED
DIRECTIONS
Renna Srl
Fasano(Br) , IT 72015 NYK-DO DP4-0422384-5/9/1
24TGT02 AUBERGINES GRILLED
13-MAR-2008 INSANITARY
Renna Srl
Fasano(Br) , IT 72015 NYK-DO DP4-0422384-5/10/1
25PGT01 MUSHROOM GRILLED
13-MAR-2008 INSANITARY
Eudermic Cosmetic Line Srl
Roma , IT SEA-DO WC4-4022255-0/2/3
66VBY99 MOSQUITO DUO REPELLENT
20-MAR-2008 UNAPPROVED
Sercom Snc Di Bonino
La Morra CN, IT 12064 SEA-DO 551-6648192-4/2/1
25RCI99 MUSHROOM SAUCE
24-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/23/1
24HCI99 ARTICHOKE CREAM
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/23/2
24HCI99 ONION AND GREN APPLE CREAM
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/23/3
24HCI99 YELLOW PEPPER CREAM
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/23/4
24HCI99 RED PEPPER CREAM
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/24/1
21GCI09 PITTED WHOLE BLACK OLIVES
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/24/2
21GCI09 PITTED WHOLE BLACK OLIVES
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/27/1
24FCI08 SPICY PEPPERS IN OLIVE OIL
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/28/1
24BVI99 SUN DRIED GARBANZO BEANS
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/28/2
24BVI99 SUN DRIED VAVA BEANS
25-MAR-2008 NO PROCESS
Azienda Agraria Duca Carlo Guarini
Scorrano LE, IT 73020 BLT-DO F95-0026678-3/28/3
24BVI70 SUN DRIED LENTILS
25-MAR-2008 NO PROCESS
Fabbri 1905 S.P.A.
Bologna , IT FLA-DO D99-2089673-2/13/1
15BCE02 Pastovocrem - Pastuerized Egg Yolks
25-MAR-2008 NEEDS FCE
NO PROCESS
Spinosi Srl
Campofilonecampofilone , IT 63016 NYK-DO 164-0198253-9/5/1
21TGT03 FIG LOGS
26-MAR-2008 FILTHY
Maria F Vecchione
Genova , IT CIN-DO AEK-9429184-2/1/1
63XCA99 PERSONAL MEDICATION
27-MAR-2008 UNAPPROVED
Mucci Giovanni srl
Trani IT-BA, IT 70059 CIN-DO UPS-0513322-6/2/1
34CYT99 SWEETMEATS/ALMOND FLAVOR
27-MAR-2008 UNSAFE COL
YELLOW #5
Novartis
Origgio , IT NOL-DO 112-1844597-4/1/1
63NDP99 861478949821 BREZAL 400MG
28-MAR-2008 UNAPPROVED
Novartis
Origgio , IT NOL-DO 112-1844597-4/1/3
64RDP08 861478949821 SYNACTHEN DEPOT
28-MAR-2008 UNAPPROVED
Pliva Pharma SpA
Cinisello Balsamo, IT NOL-DO 112-1844597-4/1/2
65QDP29 861478949821 CITICOLIN 1000MG
28-MAR-2008 UNAPPROVED
Glaxosmithkline
Baranzate , IT 20021 NOL-DO 112-2329593-4/1/1
64UCE08 858054976290 AVODART
31-MAR-2008 UNAPPROVED
Glaxosmithkline
Baranzate , IT 20021 NOL-DO 112-2329543-9/1/1
64UCE08 858054976305 AVODART
31-MAR-2008 UNAPPROVED
Glaxosmithkline
Baranzate , IT 20021 NOL-DO 112-2329642-9/1/1
64UCE08 858054976408 AVODART
31-MAR-2008 UNAPPROVED
Glaxosmithkline
Baranzate , IT 20021 NOL-DO 112-2329752-6/1/1
64UCE08 858054976338 AVODART
31-MAR-2008 UNAPPROVED
Glaxosmithkline
Baranzate , IT 20021 NOL-DO 112-2329388-9/1/1
64UCE08 858054976349 AVODART
31-MAR-2008 UNAPPROVED