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
S.L.P. Di Cora G & C Snc
Monesiglio , IT NYK-DO 084-1042770-5/11/1
12AGO52 LA ROSSA CORA CHEESE
10-JUN-2008 INSANITARY
S.L.P. Di Cora G & C Snc
Monesiglio , IT NYK-DO 084-1042770-5/10/1
12AGO52 LA ROSSA CORA CHEESE
10-JUN-2008 INSANITARY
Bonta di Puglia s.r.l
Sannicandro di Bari IT-BA, IT 70028 NYK-DO CCT-0975340-9/2/3
21GCE09 GREEN OLIVES
12-JUN-2008 NONRSP-PRC
Phitoderm Magic Cosmetics
Roma Fn, IT SJN-DO BNO-0009585-2/1/1C
53LY-99 Caldo Gel
13-JUN-2008 CSTIC LBLG
Phitoderm Magic Cosmetics
Roma Fn, IT SJN-DO BNO-0009585-2/1/1G
53LY-99 Acneis Serum 30 ML
13-JUN-2008 NOT LISTED
R G M Snc
Pisa , IT NOL-DO 112-3039877-1/1/1
32BCP02 951238310530 RED WINE
13-JUN-2008 NO ENGLISH
R G M Snc
Pisa , IT NOL-DO 112-3039877-1/3/1
27VCT99 951238310530 VINEGAR
13-JUN-2008 NO ENGLISH
R G M Snc
Pisa , IT NOL-DO 112-3039877-1/2/1
26ACT09 951238310530 OLIVE OIL
13-JUN-2008 NO ENGLISH
NUTRIT LBL
Sapori Del Salento
73039 Tricare , IT NYK-DO DF4-0339686-7/9/1
24VCI01 ARTICHOKE SPREAD
13-JUN-2008 NO PROCESS
Spectral
Bologna , IT 40064 NOL-DO 112-3058783-7/1/1
94V--05 853032755577 CO2 LASER TUBE
17-JUN-2008 NON STD
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/1/1A
25JGH06 858393195716 Pure' al Tartufo -- Truffled Mashed Potatoes
17-JUN-2008 NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/1/1B
09ACI99 858393195716 Burro e Tartufo Bianco --Butter w/ White Truffl
17-JUN-2008 USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/1/1C
36CCT04 858393195716 Dolcissimo -- Honey with Truffle
17-JUN-2008 USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/1/1D
26DCT01 858393195716 Condimento Aromatizzato al Tartufo Bianco -- Tr
17-JUN-2008 NO ENGLISH
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/1/1E
25QCY02 858393195716 Fette di Tartufo Estivo -- Summer Truffle slic
17-JUN-2008 USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/2/1A
02GGH99 858393195716 Polenta al Tartufo -- Corn Flour w/ Truffles
17-JUN-2008 USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/2/1B
25QGH99 858393195716 Funghi Porcini Secchi -- Dried Porcini Mushroom
17-JUN-2008 NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/2/1C
25QCH02 858393195716 Tartufo Bianchetto -- Dried Spring White Truffl
17-JUN-2008 LIST INGRE
USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/2/1D
02DGH02 858393195716 Riso Carnaroli con Tartufo -- Carnaroli Rice w/
17-JUN-2008 NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/3/1A
25RCN99 858393195716 Tartufata -- Mushroom and Truffle sauce in Oil
17-JUN-2008 USUAL NAME
NUTRIT LBL
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/3/1B
25QCN99 858393195716 Funghetto -- Porcini Mushrooms sauce in Oil
17-JUN-2008 USUAL NAME
Tartufi Bianconi
Citta Di Castello , IT NOL-DO 112-3015129-5/3/1D
28KGY99 858393195716 Spicy Erbs -- Spicy Herbs
17-JUN-2008 USUAL NAME
Borgotaro Funghi & Funghi di Carretta Danilo & C snc
Borgo Val Di Taro IT-PR, IT 430043 NYK-DO DF4-0339967-1/2/1
25PCI99 MUSHROOM IN OIL
17-JUN-2008 NEEDS FCE
NO PROCESS
Sanofi Aventis Spa
Milan , IT 20158 CIN-DO UPS-1167703-4/1/2
62OCA24 DILTIAZEMHYDROCHLORIDE 200 MG, NO RX, NO ID
18-JUN-2008 UNAPPROVED
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/5/2
27YCO99 Crema Rustica an Sicilian Pesto Jar 212 G
18-JUN-2008 NEEDS FCE
NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/5/1
27YCO99 Tomato Semidry and Artichokes pate 212 G
18-JUN-2008 NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/1/3
37JCY99 FENNEL AND OLIVE PASTE
18-JUN-2008 NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/1/5
24UCO01 ARTICHOKE PASTE
18-JUN-2008 NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/1/6
24HCO01 EGG PLANTS PASTE
18-JUN-2008 NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/1/2
37JHY99 MIXED GREEN & BLACK OLIVE, ZUCCHINI PASTE
18-JUN-2008 NO PROCESS
Bisinternational di F.Bisognano
Priolo G. IT-SR, IT 96010 SAN-DO U33-0017553-6/1/7
37BCO99 FILLETS AUBERGINES AND SLICE ARTICHOKE GREEN & BLACK OLIVE
18-JUN-2008 NEEDS FCE
NO PROCESS
Farmacie Petrone Srl
Napoli , IT 80126 CIN-DO AEK-9501563-8/1/1
63XDK99 LIORESAL INTRATEC .05 ML AND 5ML FOR RE EXPORT TO COLUMBIA
20-JUN-2008 UNAPPROVED
Casre Sas
San Gennarello Di Ottav , IT NOL-DO 112-0944556-1/1/1
53EY-99 864078106858/REMOVER
25-JUN-2008 CSTIC LBLG
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/9/1
76E--IF HOSE SET FOR MACHINERY 80 MM 10-PACK
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/10/1
76E--IF GUIDED SOFT TISSUE PUNCH RP 5/PKG
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/67/1
76E--IF OMNIRRIGATOR 5-PACK (FOOT CONTROLLER)
30-JUN-2008 NOT LISTED
REGISTERED
Nobel Biocare
The Netherlands , NL LOS-DO 336-6588312-3/68/1
76D--ZA "SOFT TISSUE PUNCH 5.2 MM
30-JUN-2008 NOT LISTED
REGISTERED