Refusal Actions by FDA as Recorded in OASIS for France
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
SNC AFFINAGE CONDITIONNEMENT
ROQUEFORT SUR SOULZON FR-12, FR 12100 NYK-DO 879-0109758-1/6/1
12AGP56 ROQUEFORT CHEESE
03-DEC-2007 SALMONELLA
SNC AFFINAGE CONDITIONNEMENT
ROQUEFORT SUR SOULZON FR-12, FR 12100 NYK-DO 084-1042147-6/9/1
12AGO49 ROQUEFORT CHEESE
03-DEC-2007 FILTHY
SALMONELLA
SNC AFFINAGE CONDITIONNEMENT
ROQUEFORT SUR SOULZON FR-12, FR 12100 NYK-DO 084-1042149-2/36/1
12AGO49 ROQUEFORT SOCIETE CHEESE
03-DEC-2007 FILTHY
SALMONELLA
Labo Derma
Paris , FR BLT-DO XXX-0152422-3/1/1B
66VBY99 Fair & White Body Clearing Milk
05-DEC-2007 NOT LISTED
UNAPPROVED
Esapharma S.R.L.
Milano MI, IT 20134 BLT-DO XXX-0152422-3/1/1V
66VBY99 Lemonvate Cream
05-DEC-2007 NOT LISTED
UNAPPROVED
Biscuiterie La Mere Poulard
St Etienne En Cogles , FR 35460 SWI-DO 101-7598124-9/1/1
33SGT06 LOLLIPOPS
06-DEC-2007 LIST INGRE
LACKS N/C
NO ENGLISH
LABELING
NUTRIT LBL
Biscuiterie La Mere Poulard
St Etienne En Cogles , FR 35460 SWI-DO 101-7598124-9/2/1
03HGT08 BUTTER SHORT BISCUITS
06-DEC-2007 NO ENGLISH
USUAL NAME
NUTRIT LBL
Laboratoires Urgo
Chenove , FR 21300 NOL-DO 112-0224654-5/2/1
61GCA56 Sulfamethizole
06-DEC-2007 UNAPPROVED
Nnovation Materiel Medical
Ss S Saint Julien , FR NYK-DO 112-8883396-7/1/1
80L--DQ 861501288177 IDROSTAR FOR HYPERHIDROSIS
11-DEC-2007 NOT LISTED
DIRECTIONS
NO 510(K)
RX DEVICE
Pronutri Activa
Carros , FR 06510 NOL-DO 112-0424675-8/1/1
54YCA99 862425578290 Proteatonic complement nutritionals
11-DEC-2007 NO ENGLISH
Abilityone Kinetec Sa
Tournes , FR NOL-DO 112-0448053-0/1/1
87N--DX 902033424236/ORTHOPEDIC SPACER
11-DEC-2007 NOT LISTED
Atelier Du Vieil Apt
Carnot , FR NOL-DO 112-0444954-3/1/1
52AIE28 SOUP BOWLS AND DESSERT PLATES
12-DEC-2007 UNSAFE ADD
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/16/1
79L--RR FIRST AID KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/33/1
79L--RR FIRST AID KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/52/1
79L--RR FIRTS AID KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/71/1
79L--RR FIRST AID KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/90/1
79L--RR FIRST AIS KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/108/1
79L--RR FIRST AID KIT
14-DEC-2007 REGISTERED
NO 510(K)
Plastimo France Sa
Lorient , FR 56100 FLA-DO AM0-0047610-2/126/1
79L--RR FIRST AID KITS
14-DEC-2007 REGISTERED
NO 510(K)
Sarl Pharmacosm
Paris , FR FLA-DO BJM-0110449-8/15/1
66VDY99 ANTISEPTIC INTIMATE GEL
14-DEC-2007 UNAPPROVED
Sarl Pharmacosm
Paris , FR FLA-DO BJM-0110449-8/31/1
66VDY99 HAIR GROWTH LOTIONS
14-DEC-2007 UNAPPROVED
Maitre Prunille
Casseneuil , FR 47440 NOL-DO 112-0511055-7/1/1
21HFE15 861304351213 PRUNES
14-DEC-2007 NO ENGLISH
NUTRIT LBL
Ets Fallot -Moutarde De Dijon Sarl Au Capital de 100.050
Beaune , FR LOS-DO 389-0038817-4/6/1
26CET11 MUSTARD OIL
18-DEC-2007 UNSAFE ADD
Greiner Bio-One France Sas
Les Ulis , FR 91940 NOL-DO 112-0553761-9/1/1
75J--KA 948141698604 TUBES FOR URINARY ANALYSIS
18-DEC-2007 NOT LISTED
NO 510(K)
Urbani Tartufi
Scheggino , IT LOS-DO 389-0038817-4/12/1
25QCT02 TRUFFLE PIECES IN GLASS JARS(WHOLE SUMMER)
18-DEC-2007 NEEDS FCE
NO PROCESS
Urbani Tartufi
Scheggino , IT LOS-DO 389-0038817-4/12/2
25QCT02 TRUFFLE PIECES IN GLASS JARS(SUMMER TRUFFLE PEELINGS)
18-DEC-2007 NEEDS FCE
NO PROCESS
Urbani Tartufi
Scheggino , IT LOS-DO 389-0038817-4/14/1
37JGE99 CHAMPAGNE & SUMMER TRUFFLE SAUCE
18-DEC-2007 NEEDS FCE
NO PROCESS
France Chirurgie I
Perigny , FR 17180 NOL-DO 112-0597120-6/1/1
79G--EX 955890871863 LACRIMAL INTUBATION
20-DEC-2007 NOT LISTED
E.B. Meyrowitzem Sa
Paris , FR NOL-DO 112-0619730-6/1/1
86H--QG 853790750669 READING GLASSES
21-DEC-2007 NOT LISTED
Sanofi Synthelabo
Gentilly , FR NOL-DO 112-0619363-6/1/1
62UBA19 860621670369/TROPHIRES/10MG
21-DEC-2007 UNAPPROVED
Laboratoires Biorga
Levallois Perret , FR 92300 NOL-DO 112-0619363-6/1/2
61XBK08 860621670369/HEXAPNEUMINE/5ML
21-DEC-2007 UNAPPROVED
Albagnac Export
Rungis Senia Cedex , FR 94517 NYK-DO DP4-0419276-8/2/1
12AGP56 CAMEMBERT CHEESE
27-DEC-2007 LISTERIA
Albagnac Export
Rungis Senia Cedex , FR 94517 NYK-DO DP4-0419276-8/2/2
12AGP56 PETIT PLAISIR CAMEMBERT CHEESE
27-DEC-2007 LISTERIA
Albagnac Export
Rungis Senia Cedex , FR 94517 NYK-DO DP4-0419276-8/2/3
12AGP56 PETIT PLAISIR SMOOTH BRICK CHEESE
27-DEC-2007 LISTERIA
Albagnac Export
Rungis Senia Cedex , FR 94517 NYK-DO DP4-0419276-8/2/4
12AGP56 PETIT PLAISIR CARRE FONDANT CHEESE
27-DEC-2007 LISTERIA
Albagnac Export
Rungis Senia Cedex , FR 94517 NYK-DO DP4-0419276-8/2/5
12AGP56 PONT EVEQUE CHEESE
27-DEC-2007 LISTERIA
Merck Sante
Semoy , FR 45400 NOL-DO 112-0657118-7/4/1
61PCY99 864089213209/GLISULIN
27-DEC-2007 UNAPPROVED
Charles Pery Et Cie S.A.
Scionzier , FR 74950 NOL-DO 112-0471668-5/1/1
68XYY99 858481417237/VETERINARY INSTRUMENT
27-DEC-2007 NOT LISTED