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
Scorcucchi Carla
Arezzoarezzo , IT 52100 CIN-DO 110-1443656-8/1/1
61WCY18 MICOTEF MICONAZOLO NITRATO VAGINAL OVULES, NO RX, NO FOR ID
01-FEB-2008 UNAPPROVED
Scorcucchi Carla
Arezzoarezzo , IT 52100 CIN-DO 110-1443656-8/1/2
61WCL18 DAKTARIN MICONAZOLO VAGINAL SOLUTION, NO RX, NO FOR ID
01-FEB-2008 UNAPPROVED
Scorcucchi Carla
Arezzoarezzo , IT 52100 CIN-DO 110-1443656-8/1/3
56BCA03 AMOXICILLINA, NO RX, NO FOR ID
01-FEB-2008 UNAPPROVED
Acqua Minerale S Benedetto
Veneto , IT 17217 LOS-DO 442-0109806-6/1/1B
31PHI02 Mint Tea (con Menta del Marocco)
01-FEB-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
NEEDS FCE
NO PROCESS
Acqua Minerale S Benedetto
Veneto , IT 17217 LOS-DO 442-0109806-6/2/1A
29BCE02 Bitter Rosso Apertivo Analcolico
01-FEB-2008 LIST INGRE
NUTRIT LBL
Acqua Minerale S Benedetto
Veneto , IT 17217 LOS-DO 442-0109806-6/2/1B
29BCE02 Bitter Blanco Apertivo Analcolico
01-FEB-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
Acqua Minerale S Benedetto
Veneto , IT 17217 LOS-DO 442-0109806-6/2/1C
29BCE02 Ginger Apertivo Analcolico
01-FEB-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
Pettenon Cosmetic Snc
San Martino Di Lupari PD, IT 35018 FLA-DO 497-1000468-8/1/2B
66VBL99 Sebum Dandruff Control Lotion
05-FEB-2008 NOT LISTED
Pettenon Cosmetic Snc
San Martino Di Lupari PD, IT 35018 FLA-DO 497-1000468-8/1/2C
66VBY99 Shampoo Prevention Anti Hairloss
05-FEB-2008 NOT LISTED
Fama Snc
Perugia , IT 06100 NOL-DO 112-0988110-4/1/1
26ACT09 649058090917 EXTRA VIRGIN OLIVE OIL
06-FEB-2008 NO ENGLISH
NUTRIT LBL
Fama Snc
Perugia , IT 06100 NOL-DO 112-0988110-4/3/1
12AVT47 649058090917 ROMANO CHEESE
06-FEB-2008 NO ENGLISH
NUTRIT LBL
Fama Snc
Perugia , IT 06100 NOL-DO 112-0988110-4/2/1
04AFT05 649058090917 DURUM WHEAT PASTA
06-FEB-2008 NO ENGLISH
tuscia via chiantigiana #264
Firenze , IT SWI-DO 534-1071670-7/1/1E
52AIE26 poppy decoration oval cannister cm30 with rings
06-FEB-2008 CONTAINER
tuscia via chiantigiana #264
Firenze , IT SWI-DO 534-1071670-7/1/1H
52AIE26 oval cannister fruits
06-FEB-2008 CONTAINER
tuscia via chiantigiana #264
Firenze , IT SWI-DO 534-1071670-7/1/1I
52AIE26 plates poppy decoration
06-FEB-2008 CONTAINER
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1A
66VBJ99 Bio Face
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1B
66VBJ99 Bio Cellu
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1C
66VBJ99 Bio Tone
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1D
66VBJ99 Bio Striae
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1E
66VBJ99 Bio Carrier
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/1F
66VBJ99 Bio Adipose
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/2
66VBJ99 Bio Breast
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/3
66VBJ99 Rejuvenase
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/4
66VBJ99 Bio Smooth
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/5
66VBJ99 Hyaluderm
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/6
66VBL99 Cleanser Plus Ceramides
07-FEB-2008 DIRECTIONS
UNAPPROVED
Microlab International
Pozzuolipozzuoli , IT 80078 DET-DO 144-1041641-9/1/7
66VBL99 Glycoderm
07-FEB-2008 DIRECTIONS
UNAPPROVED
Savelia Alessandro
Pratoprato , IT 59100 NYK-DO 110-1382687-6/1/1
62FBO99 NON PRESCRIPTION MEDICATION(BACTREN)
08-FEB-2008 NOT LISTED
Savelia Alessandro
Pratoprato , IT 59100 NYK-DO 110-1382687-6/1/2
62FBA99 NON PRESCRIPTION MEDICATION(BACTREN)
08-FEB-2008 NOT LISTED
Luongo Caterina
Florenceflorence , IT 50144 NYK-DO 110-1489318-0/1/1
56EYY20 BASSADO-DOXYCLINE(ANTIBIOTIC MEDICATION)
12-FEB-2008 NOT LISTED
DIRECTIONS
Home Art & Sales
Wollerau , CH 8832 LOS-DO MH7-3006829-2/1/1A
79M--XG BIOPTRON COMPACT III
12-FEB-2008 NO 510(K)
Home Art & Sales
Wollerau , CH 8832 LOS-DO MH7-3006829-2/1/1C
79M--XG BIOPTRON PRO 1
12-FEB-2008 NO 510(K)
Home Art & Sales
Wollerau , CH 8832 LOS-DO MH7-3006829-2/1/1B
79M--XG BIOPTRON 2 AND B2 STAND
12-FEB-2008 NO 510(K)
Canali S.P.A.
Milan FN, IT NYK-DO D99-0076572-5/1/1
56KDC99 CIPROFLOXACINA
19-FEB-2008 NOT LISTED
UNAPPROVED
Atelier Ottico Sas
Scandiano , IT NOL-DO 112-0017115-8/1/1
86H--QY 861507703971 SUNGLASSES
25-FEB-2008 NOT LISTED
Tecnimed Srl
Vedano , IT NOL-DO 112-0031343-8/1/1
84H--CB 859000440693/MOSQUITO CLICK
25-FEB-2008 NO 510(K)
Azienda Agricola Valle del Marta di Pusceddu Mario
Tarquinia IT-VT, IT 01016 NOL-DO 112-0066413-7/1/1
32BCT02 903868857551 Corneto
25-FEB-2008 NO ENGLISH
Azienda Agricola Valle del Marta di Pusceddu Mario
Tarquinia IT-VT, IT 01016 NOL-DO 112-0066413-7/2/1
32BCT02 903868857551 Ancarano
25-FEB-2008 NO ENGLISH
Azienda Agricola Valle del Marta di Pusceddu Mario
Tarquinia IT-VT, IT 01016 NOL-DO 112-0066413-7/3/1
32BCT02 903868857551 Gravisca
25-FEB-2008 NO ENGLISH
Azienda Agricola Valle del Marta di Pusceddu Mario
Tarquinia IT-VT, IT 01016 NOL-DO 112-0066413-7/4/1
32BCT02 903868857551 Foggio Ranocchio
25-FEB-2008 NO ENGLISH
Frantoio Maraldi Di Maraldi Ales
Troghi , IT 50010 NOL-DO 112-0068816-9/1/1
26AEE09 951404954290 OLIVE OIL
25-FEB-2008 NO ENGLISH
LABELING
NUTRIT LBL
Food Italia & Co.
Borgotaro , IT LOS-DO 221-1882398-2/1/1
25PGH99 DRIED PORCINI MUSHROOMS SUPER (BOLETUS EDULIS E RELATIVO GRU
28-FEB-2008 FILTHY
Food Italia & Co.
Borgotaro , IT LOS-DO 221-1882398-2/1/2
25PGH99 DRIED PORCINI MUSHROOMS EXTRA (BOLETUS EDULIS E RELATIVO GRU
28-FEB-2008 FILTHY
Food Italia & Co.
Borgotaro , IT LOS-DO 221-1882398-2/1/3
25PGH99 DRIED PORCINI MUSHROOMS STANDARD (BOLETUS EDULIS E RELATIVO
28-FEB-2008 FILTHY
Integree International Spa
Genoa , IT 16030 LOS-DO 554-3536544-4/1/1
79I--OB INFRARED RAYS, MICROMASSAGE & CHROMOTHERAPY
29-FEB-2008 REGISTERED
NO REGISTR
NO 510(K)