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
Ceramica Senatore Angelo
Cava De' Tirrenicava De' Tirreni , IT 84013 CIN-DO UPS-1023469-6/1/3B
52AIE31 Ceramic Bowl 4&3/4"
01-JUL-2008 UNSAFE ADD
Castello Monte Vibiano Vecchio Srl
Mersciano , IT 06050 NYK-DO DF4-0339575-2/1/1
27ACT03 SALAD DRESSING
01-JUL-2008 NEEDS FCE
Esapharma S.R.L.
Milano MI, IT 20134 SWI-DO XXX-0154239-9/1/1A
64LDJ67 Movate Cream
07-JUL-2008 DIRECTIONS
UNAPPROVED
vitus pharm co ltd
milan , IT SWI-DO XXX-0154239-9/1/1B
64LDJ67 Aloe Vera Cream with Clobeatsol Propionate
07-JUL-2008 DIRECTIONS
UNAPPROVED
Medical Chemical Agency
San Vittore Olona MI, IT 20028 SWI-DO XXX-0154239-9/1/1E
64LCJ28 Top Gel
07-JUL-2008 DIRECTIONS
UNAPPROVED
Beltapharm S.p.A.
Milan , IT unknown SWI-DO XXX-0154562-4/1/1A
64LAJ67 Fashion Fair Cream
07-JUL-2008 DIRECTIONS
UNAPPROVED
Beltapharm S.p.A.
Milan , IT unknown SWI-DO XXX-0154562-4/1/1F
64LDJ06 Fashion Fair Gel Plus
07-JUL-2008 DIRECTIONS
UNAPPROVED
Bertagni Industrie Alimentari Spa
Bologna Italy , IT NYK-DO 164-0200072-9/1/5
04AGT02 FROZEN CHEESE TORTELLINI PASTA
09-JUL-2008 SALMONELLA
Recordati S.P.A.
Campoverde LT, IT 04010 NYK-DO DF4-0204589-5/1/1
61XCS18 DIPHENHYDRAMINE HYDROCHLORINE
12-JUL-2008 DIRECTIONS
Recordati S.P.A.
Campoverde LT, IT 04010 NYK-DO DF4-0204575-4/1/1
61MCS24 PHENYTION MICRONIZED
14-JUL-2008 DIRECTIONS
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323339-7/1/1
12AGP52 Burrate (fresh, soft cheese)
17-JUL-2008 LISTERIA
Recordati Industria Chimica E Farmaceutica S.p.A
Milano MI, IT 20148 NOL-DO 112-3543750-9/1/1
66VIP99 862579044820 IMIDAZYL EYEDROPS
21-JUL-2008 UNAPPROVED
Acetaia Malpighi
Modena MO, IT 41100 NOL-DO 112-3429966-0/1/1
26ACT04 865232934893 OLIVE OIL
21-JUL-2008 LACKS N/C
NO ENGLISH
Acetaia Malpighi
Modena MO, IT 41100 NOL-DO 112-3429966-0/2/1
27VCP99 865232934893 VINEGAR
21-JUL-2008 LACKS N/C
NO ENGLISH
Acetaia Malpighi
Modena MO, IT 41100 NOL-DO 112-3429966-0/2/2
27VCP99 865232934893 VINEGAR
21-JUL-2008 LACKS N/C
NO ENGLISH
Esapharma S.R.L.
Milano MI, IT 20134 SWI-DO XXX-0154941-0/1/1A
64LCJ67 Esapharma Movate
24-JUL-2008 UNAPPROVED
Medical and Chemical Agency S.p.A.
Milano MI, IT 20149 SWI-DO XXX-0154941-0/1/1B
64LCJ28 Top-Gel
24-JUL-2008 UNAPPROVED
Corex S.P.A
Battipaglia It-Sa, IT 84091 NYK-DO DR9-1138468-0/1/4
04AHT01 ORECCHIETTE TRIS
31-JUL-2008 UNSAFE COL
Caseificio Voglia di latte srl
Bisceglie IT-BA, IT 70052 SAN-DO C28-0323341-3/1/1
12AGP52 burrate (fresh soft cheese)
31-JUL-2008 LISTERIA