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
SCA Des Producteurs de Reblochon de La Vallee de Thones
THONES Fr-74, FR 74230 NYK-DO 084-1043318-2/49/1
12AGO52 TOME SAVOIE CHEESE
02-OCT-2008 MFR INSAN
Laboratoires Therabel Lucien
Levallois Perret , FR 92300 NOL-DO 112-4469956-0/1/1
64LBK50 864305646516 / DERINOX 15ML
02-OCT-2008 UNAPPROVED
Perouse Laboratoiries
Bornel Cedex , FR NOL-DO 112-4541991-9/1/1
79M--RD 864581523380/BREAST IMPLANT
02-OCT-2008 NOT LISTED
NO 510(K)
Merial
Lyon , FR 69007 NOL-DO 112-4397009-5/1/1
68YIS99 865797178891 BIODYL 50 ML
02-OCT-2008 NEW VET DR
Loreal Export
Marly La Ville,France , FR SAN-DO 427-7104565-7/1/4
66PAJ99 WHITE PERFECT DAY CREAM SPF20
03-OCT-2008 NOT LISTED
DRUG NAME
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0065277-2/1/1
80F--OS CATHETERS
06-OCT-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0065277-2/2/1
80F--OS CATHETERS
06-OCT-2008 REGISTERED
Les Laboratoires Servier
France , FR FLA-DO 112-4551897-5/1/1
64BCP48 865817675641 NATRILIX
09-OCT-2008 UNAPPROVED
Les Laboratoires Servier
Gidy , FR 45520 NOL-DO 112-4564905-1/2/1
61PCB31 864088047591/AMARYL
10-OCT-2008 UNAPPROVED
Sanofi Aventis
Vitry Sur Sei , FR NOL-DO 112-4564905-1/2/2
62OCB37 864088047591/APROVEL
10-OCT-2008 UNAPPROVED
Charabot
Grasse , FR 06130 NOL-DO 112-4521155-5/1/1
53DY-99 628365114015-CYPRES FEUILLES AND MELILOT ABS PUR
10-OCT-2008 COSMETLBLG
Charabot
Grasse , FR 06130 NOL-DO 112-4521155-5/2/1
45LE-99 628365114015-VETIVER
10-OCT-2008 LIST INGRE
USUAL NAME
Derval
Derval , FR FLA-DO 793-0603910-2/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
14-OCT-2008 NEEDS FCE
NO PROCESS
Derval
Derval , FR FLA-DO 793-0603911-0/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
14-OCT-2008 NEEDS FCE
NO PROCESS
Mesalyse
Puiseux , FR CIN-DO UPS-2495927-0/1/1
80K--ZH VETERINARY EQUIPMENT DEL TO APOTHECURE DALLAS, TX
16-OCT-2008 NOT LISTED
REGISTERED
NO 510(K)
Derval
Derval , FR FLA-DO 793-0603980-5/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
20-OCT-2008 NEEDS FCE
NO PROCESS
Vilber Lourmat
Cedex , FR 77202 FLA-DO MC2-6094234-7/1/1
95R--GW UV PHOTODOCUMENTATION SYSTEM(FOR EXPORT ONLY)
21-OCT-2008 NON STD
Gillot Sa Laiterie De St Hilaire
St Hilaire De Briouze , FR 61220 NWE-DO 112-4342696-5/1/1
12AWO56 L'ESSENCE DU FROMAGE
22-OCT-2008 NUTRIT LBL
SALMONELLA
Lamprien Provence
Senas , FR 13560 NYK-DO 084-1043325-7/1/1
28EAH99 DRIED HERBS DE PROVENCE
23-OCT-2008 SALMONELLA
SCA Des Producteurs de Reblochon de La Vallee de Thones
THONES Fr-74, FR 74230 NYK-DO 084-1043364-6/40/1
12AGO52 TOME SAVOIE CHEESE
23-OCT-2008 MFR INSAN
Delices Napoleon Europe
Marseille FR-13, FR 13006 NYK-DO 408-1181249-1/1/1
09EBT15 PASTEURIZED YOGURT LONG PRESERVATION (VARIOUS TYPES)
24-OCT-2008 NUTRIT LBL
Champs De Vie Inc
Plessisvilleplessisville , FR G6L2Y6 NYK-DO UPS-2502764-8/2/1
54FCL50 TONUS-VIE
29-OCT-2008 DIETARYLBL
LABELING
NUTRIT LBL
HEALTH C
Champs De Vie Inc
Plessisvilleplessisville , FR G6L2Y6 NYK-DO UPS-2502764-8/3/1
54FCH50 Zymdi-Vie
29-OCT-2008 DIETARYLBL
NUTRIT LBL
Champs De Vie Inc
Plessisvilleplessisville , FR G6L2Y6 NYK-DO UPS-2502764-8/4/1
54FCL50 Detox-Vie
29-OCT-2008 DIETARYLBL
LABELING
NUTRIT LBL
Champs De Vie Inc
Plessisvilleplessisville , FR G6L2Y6 NYK-DO UPS-2502764-8/5/1
54ACA90 Energi-Vie
29-OCT-2008 DIETARYLBL
LABELING
NUTRIT LBL