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
Sanofi Aventis
Paris , FR 75013 NOL-DO 112-3303472-0/1/1
66VAY99 861146613141 ACOMPLIA
01-AUG-2008 UNAPPROVED
Derval
Derval , FR FLA-DO 793-0603715-5/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
06-AUG-2008 NEEDS FCE
NO PROCESS
Top Respect Industrial (Shenzhen) Limited
Shenzhen , CN LOS-DO BLW-0524935-0/20/1
66VBY99 PIMPLE CREAM
07-AUG-2008 NOT LISTED
Top Respect Industrial (Shenzhen) Limited
Shenzhen , CN LOS-DO BLW-0524935-0/21/1
66VBY99 PIMPLE CREAM
07-AUG-2008 NOT LISTED
Top Respect Industrial (Shenzhen) Limited
Shenzhen , CN LOS-DO BLW-0524935-0/42/1
76E--AS Active contact gel for ADM ULTRASOUND treatments.
07-AUG-2008 NOT LISTED
REGISTERED
Top Respect Industrial (Shenzhen) Limited
Shenzhen , CN LOS-DO BLW-0524935-0/31/1
66VBY99 WHITENING MASK
07-AUG-2008 NOT LISTED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064035-5/2/1
80F--OS CATHETERS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064035-5/3/1
73B--YE C-PAP ATTACHMENTS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064035-5/4/1
80M--WV NEEDLES
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064035-5/5/1
84N--HI NERVE STIMULATORS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064258-3/2/1
73B--YE CPAP ATTACHMENTS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064258-3/3/1
84H--AS SUTURE NEEDLES
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064258-3/4/1
80F--OS CATHETERS
11-AUG-2008 REGISTERED
Vygon, S.A.
Ecouen , FR 95440 FLA-DO K51-0064258-3/6/1
79K--GZ CATHETER ACCESORY(BIONECTOR)
11-AUG-2008 REGISTERED
Onetik S.A.
Macaye , FR 64240 FLA-DO 793-0603393-1/10/1
12AGP99 300 CTNS FRENCH SAINT PAULIN FOR EXPORT ONLY
11-AUG-2008 LISTERIA
Pierre Fabre Dermo Cosmetique
Castres Cedex , FR 81106 NOL-DO 322-6278982-2/12/1
53EY-06 SHAMPOO
13-AUG-2008 CSTIC LBLG
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506327-0/2/1
64WAK99 TRIAMINIC SEAWATER NASAL SPRAY 60ML US
14-AUG-2008 NOT LISTED
UNAPPROVED
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506327-0/1/1
64WAK99 TRIAMINIC SEAWATER NASAL SPRAY 60ML US
14-AUG-2008 NOT LISTED
UNAPPROVED
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506328-8/1/1
64WAK99 TRIAMINIC SEAWATER NASAL SPRAY 60ML US
14-AUG-2008 NOT LISTED
UNAPPROVED
Sanofi Winthrop Industrie
Ambares Et Lagrave , FR 33440 SAN-DO 112-3878754-6/1/1
61LDC38 860766218280 PLAVIX
14-AUG-2008 NOT LISTED
Derval
Derval , FR FLA-DO 793-0603716-3/4/1
09CYF13 1673 CTNS WHIPPING CREAM FOR EXPORT ONLY
14-AUG-2008 NEEDS FCE
NO PROCESS
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506326-2/1/1
64WAK99 TRIAMINIC SEAWATER NASAL SPRAY 60ML US
18-AUG-2008 NOT LISTED
UNAPPROVED
Boulangerie Poilane
Bievres , FR NOL-DO 112-1037186-3/1/1
03AYT99 920106746720 bread
20-AUG-2008 LIST INGRE
NO ENGLISH
Ferton France Sa
Fere-Champenoise, France , FR 51230 NYK-DO UPS-1615562-2/1/1
34FFT02 Milk Chocolate Flavored Candy
21-AUG-2008 LACKS N/C
NUTRIT LBL
Janssen Cilag
Moulineaux , FR NOL-DO 112-1621921-5/1/1
62GCB41 857151444130/PERDOLAN
21-AUG-2008 UNAPPROVED
Lab Codepharma
Billancourt , FR NOL-DO 112-1825882-3/1/1
65JCP27 CILEST
21-AUG-2008 UNAPPROVED
Laboratoire Aventis
Paris , FR NOL-DO 112-1825882-3/1/2
64SCP29 IMOVANE
21-AUG-2008 UNAPPROVED
Laboratoire Glaxosmithkline
Cedex , FR 78163 NOL-DO 112-1503714-7/1/1
60LCA86 937012404311 NARAMIG 2.5MG
22-AUG-2008 UNAPPROVED
Nestle France
La Valle Cedex , FR NOL-DO 112-1503714-7/2/1
37JCT05 937012404311 SOY SAUCE
22-AUG-2008 NO ENGLISH
Cadbury France
Paris , FR 75014 NOL-DO 112-1503714-7/3/1
34KFT04 937012404311 CHOCOLATE
22-AUG-2008 NO ENGLISH
Sanofi Aventis Gro
Gentilly , FR 94250 NOL-DO 112-1503714-7/5/1
03RGT01 937012404311 CAKES
22-AUG-2008 NUTRIT LBL
Laboratories Adonis
Fontenay Sur Eure , FR 28630 NOL-DO 112-1452101-8/1/1
62GDJ90 830980009840 DICLOFENAC 30MG
22-AUG-2008 UNAPPROVED
Biodim
Boulugue Gillencourt , FR NOL-DO 112-1525417-1/1/1
66MCY91 862023577820 SERESTA 10MG
22-AUG-2008 UNAPPROVED
Pierre Fabre Dermo Cosmetique
Castres Cedex , FR 81106 NOL-DO 322-6278982-2/4/1
54YCE10 VITALFAN VITALITY
22-AUG-2008 UNSAFE COL
Derval
Derval , FR FLA-DO 793-0603767-6/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
25-AUG-2008 NEEDS FCE
NO PROCESS
Lipha Sa
Lyon Cedex 08 , FR 69379 NYK-DO 112-3781475-4/1/1
62KCY10 862031960823 OMEPRAZOLE 200MG
27-AUG-2008 UNAPPROVED
Mc Sas
Moulineaux , FR NYK-DO 112-3781475-4/1/2
65LCY11 862031960823 TITANOREINE
27-AUG-2008 UNAPPROVED
Pfizer
Paris , FR NYK-DO 112-3781475-4/1/3
66YCY99 862031960823 PROCTOLOG
27-AUG-2008 UNAPPROVED
Servier Laboratories
Gidy , FR 45520 NYK-DO 112-3781475-4/1/4
66YCY99 862031960823 DAFLON
27-AUG-2008 UNAPPROVED
Aventis Pharma SA
Compiegne , FR 60200 NYK-DO 112-3781475-4/1/5
66YCY99 862031960823 SURGAM
27-AUG-2008 UNAPPROVED
Adisseo France S.A.S
Commentry FR-03, FR 03600 LOS-DO 554-3961109-0/1/1
54AMY01 MICROVIT A SUPRA 1000 - VITAMIN A;ANML DIET SUPL;NEC
27-AUG-2008 NEW VET DR
Adisseo France S.A.S
Commentry FR-03, FR 03600 LOS-DO 554-3961109-0/2/1
54AMY01 MICROVIT A PROMIX - VITAMIN A;ANML DIET SUPL;NEC
27-AUG-2008 NEW VET DR
Adisseo France S.A.S
Commentry FR-03, FR 03600 LOS-DO 554-3961109-0/3/1
54AMY99 MICROVIT -VITAMIN, N.E.C.;ANML DIET SUPL;NEC
27-AUG-2008 NEW VET DR
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506592-9/1/1
66VAY99 TRIAMINIC NASAL SOLUTION 20X5ML, NON R/X NASAL DROPS
28-AUG-2008 NOT LISTED
UNAPPROVED
Goemar Laboratories
St Malo Cedex , FR 35403 NYK-DO 336-6506592-9/2/1
66VAY99 TRIAMINIC NASAL SOLUTION 20X5ML, NON R/X NASAL DROPS
28-AUG-2008 NOT LISTED
UNAPPROVED
L'Oreal Products De Luxe
Levallois Perret , FR 92300 FLA-DO F92-0029428-3/10/6
66VBJ99 MOISTURIZING CREAMS WITH SPF 50 / NO NDC / (WAREHOUSE SHORTA
28-AUG-2008 UNAPPROVED
L'Oreal Products De Luxe
Levallois Perret , FR 92300 FLA-DO F92-0029428-3/10/5
66VBJ99 SUNSCREEN WITH SPF 30 / NO NDC / (WAREHOUSE SHORTAGE CARGO)
28-AUG-2008 UNAPPROVED