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
Sifavitor S.P.A.
Lodi (ITALY) , IT 26852 NOL-DO 112-3323105-2/1/1
63BCS26 642502121125 Ipratropium Bromide (Bronchodilator)
01-AUG-2008 UNAPPROVED
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/2
27YCI06 PEPPER SAUCE
01-AUG-2008 NEEDS ACID
NEEDS FCE
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/4
37JCE99 GENOVESE PESTO SAUCE
01-AUG-2008 NEEDS FCE
NO PROCESS
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/9
24KCI06 ROASTED ZUCCHINI IN OLIVE
01-AUG-2008 NEEDS ACID
NEEDS FCE
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/8
24KCI01 ROASTED EGGPLANTS IN OLIVE OIL
01-AUG-2008 NEEDS ACID
NEEDS FCE
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/10
21LCI03 SPICY CHERRIES
01-AUG-2008 NEEDS ACID
NEEDS FCE
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/11
24VCI01 ARTICHOKES PATE
01-AUG-2008 NEEDS ACID
NEEDS FCE
Boscovivo
Arezzo , IT FLA-DO M85-0050078-9/1/12
24HCI50 SUN DRIED TOMATOES PATE
01-AUG-2008 NEEDS ACID
NEEDS FCE
Savini Tartufi Di Savini Luciano
Palala Loc. Forcoli (Pi , IT 56030 CHI-DO 396-0152597-3/7/1
25SCE02 WHITE TRUFFLE PATE
05-AUG-2008 NO PROCESS
Azienda Agricola Radici
Loro Ciuffenna AR, IT 52024 SEA-DO 551-6696352-5/26/1
23FCT04 CHESTNUT SPREAD
07-AUG-2008 NO PROCESS
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323340-5/1/1
12AGP52 Burrate (fresh, soft cheese)
07-AUG-2008 LISTERIA
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323342-1/1/1
12CGP17 Burrate (soft, fresh cheese)
07-AUG-2008 LISTERIA
Paolo Farabegoli
Gambettola IT-FO, IT 47035 NYK-DO 241-9250852-1/17/2
12CVP16 PECORINO GINEPRO - SHEEP CHEESE
13-AUG-2008 LISTERIA
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1A
04AGT02 Bucaneve
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1B
04AGT02 Conchiglioni
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1C
04AGT02 Farfalle Fantasia
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1D
04AGT02 Farfalle Zebra
13-AUG-2008 LIST INGRE
NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1E
04AGT02 Galletti
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1F
04AGT02 Lingua Bia/Nera
13-AUG-2008 LIST INGRE
NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1G
04AGT02 Lingua Di Suocera
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1H
04AGT02 Lumaconi
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1I
04AGT02 Orecchiette
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1J
04AGT02 Sombrerini
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1K
04AGT02 Rigatoni
13-AUG-2008 NUTRIT LBL
Pastificio Del Colle Di Leo Antonio & C. S.N.C.
Gioia Del Colle BA, IT 70023 NWE-DO 248-1510831-1/1/1L
04AGT02 Tagliolini
13-AUG-2008 NUTRIT LBL
Azienda Agricola L Oliv Aia
Nepi , IT NWE-DO 248-1510831-1/3/1
37JBE99 CREAM VEGETABLE PEPPER SAUCE
13-AUG-2008 NEEDS FCE
NO PROCESS
Azienda Agricola L Oliv Aia
Nepi , IT NWE-DO 248-1510831-1/5/1
37JBE99 VEGETABLE CREAM SAUCE, ASPARAGUS
13-AUG-2008 NEEDS FCE
NO PROCESS
Tartuflanghe
Piobesi D'Alba CN, IT 12040 NOL-DO 600-8098171-9/6/1
25PCE02 BLACK SUMMER TRUFFLE PERSERVED IN WATER
13-AUG-2008 NO PROCESS
Eurofish Srl.
Marsala TP, IT 91025 SAN-DO H77-0111367-9/7/1
16ACN45 BELLY OF TUNA IN OLIVE OIL
13-AUG-2008 NEEDS FCE
NO PROCESS
Smeralda
09122 Cagliari , IT SAN-DO C28-0323343-9/3/1
16IGY42 swordfish, smoked, vacuum packaged, refrigerated
13-AUG-2008 POISONOUS
T & C Di Marchetti Ulderico & C Snc
Acqualagna PS, IT 61041 CHI-DO 396-0152583-3/2/1
25QCE02 SLICED SUMMER TRUFFLE IN OIL
14-AUG-2008 NO PROCESS
Cosma S.P.A.
Ciserano BG, IT 24040 LOS-DO 322-2936448-7/1/1
61TOR12 METOCLOPRAMIDE
14-AUG-2008 UNAPPROVED
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323343-9/1/2
12AGP52 stracchino (fresh, soft cheese)
15-AUG-2008 LISTERIA
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323343-9/1/1
12AGP52 Burrate (fresh, soft cheese)
15-AUG-2008 LISTERIA
Endonova
Trieste , IT NYK-DO AEK-9121462-3/1/1
87H--RX ARTHROSCOPE
19-AUG-2008 NOT LISTED
REGISTERED
Acetum Srl
Modena , IT DET-DO 231-8716478-8/2/1
27VCT99 Balsamic Vinegar of Modena
20-AUG-2008 NUTRIT LBL
Sz Tartufi Sas
Atessa CH, IT 66041 NYK-DO UPS-1431504-6/1/1
25PVH02 TRUFFLES PN#080081563505
20-AUG-2008 FILTHY
Bartolini Spa
Milano MI, IT 20158 NOL-DO 112-1413104-0/1/1
73B--WK 936463770669.POINTSELECTOR
22-AUG-2008 NOT LISTED
NO 510(K)
Nannini
Modena , IT NOL-DO 112-1538434-1/1/1
86H--QG 953296433996-LENSES
22-AUG-2008 NOT LISTED
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323344-7/1/1
12AGP52 Burrate (fresh soft cheese)
22-AUG-2008 LISTERIA
Inalco S.P.A.
Milano MI, IT 20139 NYK-DO U59-2011266-6/1/1
63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID
25-AUG-2008 DIRECTIONS
Inalco S.P.A.
Milano MI, IT 20139 NYK-DO U59-2011283-1/1/1
63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID
25-AUG-2008 DIRECTIONS
Inalco S.P.A.
Milano MI, IT 20139 NYK-DO U59-2011283-1/2/1
63HBS10 LACTULOSE SOLUTION USP GRADE WITH SORBIC ACID
25-AUG-2008 DIRECTIONS
Merck Sharp & Dohme Italia S.p.A.
Pavia , IT 27100 PHI-DO SG5-0418926-0/1/1
66VIY99 EXPIRED VYTORIN 10 & 40 MG, , SPONSOR MSP , MERCK SHERING P
26-AUG-2008 UNAPPROVED
Merck Sharp & Dohme Italia S.p.A.
Pavia , IT 27100 PHI-DO SG5-0418926-0/1/2
66VIY99 EXPIRED VYTORIN 10 & 40 MG, , SPONSOR MSP , MERCK SHERING P
26-AUG-2008 UNAPPROVED
Merck Sharp & Dohme Italia S.p.A.
Pavia , IT 27100 PHI-DO SG5-0418972-4/1/1
66VIY99 USED, RETURNED, VYTORIN 40 MG, , SPONSOR MSP , MERCK SHERIN
26-AUG-2008 UNAPPROVED
Merck Sharp & Dohme Italia S.p.A.
Pavia , IT 27100 PHI-DO SG5-0419063-1/1/1
66VIY99 VYTORIN 10 MG & 40 MG, USED SPONSOR MSP
26-AUG-2008 UNAPPROVED
Nuova Gareisa
Cuneo , IT FLA-DO AM0-0049614-2/1/1
29YGT99 NUOVA GAREISA MINERAL WATER
28-AUG-2008 NO ENGLISH
Nuova Gareisa
Cuneo , IT FLA-DO AM0-0049614-2/1/2
29YGT99 NUOVA GAREISA MINERAL WATER
28-AUG-2008 NO ENGLISH