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
Derval
Derval , FR FLA-DO 793-0603200-8/2/1
09CYF13 1260 CTNS WHIPPING CREAM FOR EXPORT ONLY
02-APR-2008 NEEDS FCE
NO PROCESS
Fromagerie De La Tournette
Cedex , FR 74007 NYK-DO DP4-0429118-0/3/1
12AGP52 FLEUR DES ALPES TOURNETTE CHEESE
02-APR-2008 MFR INSAN
Derval
Derval , FR FLA-DO 793-0603221-4/2/1
09CYF13 1260 CTNS WHIPPING CREAM FOR EXPORT ONLY
07-APR-2008 NEEDS FCE
NO PROCESS
Derval
Derval , FR FLA-DO 793-0603223-0/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
07-APR-2008 NEEDS FCE
NO PROCESS
Derval
Derval , FR FLA-DO 793-0603222-2/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
10-APR-2008 NEEDS FCE
NO PROCESS
Co-Op Agricole
Thones , FR NYK-DO 165-0526477-6/51/1
12AFP52 TOMME DE SAVOIE
10-APR-2008 MFR INSAN
Boiron
Messimy , FR 69510 LOS-DO 112-0620044-9/2/7
66VCL99 CRATAEGUS OXYACANTHA
11-APR-2008 UNAPPROVED
Bayer Diagnostics
Puteaux Cedex , FR NOL-DO 112-2187217-2/1/1
66VCP99 852862512680/GLUCOR 100MG
15-APR-2008 UNAPPROVED
Bayer Diagnostics
Puteaux Cedex , FR NOL-DO 112-2187217-2/1/2
66VCP99 852862512680 Teatrois 35MG
15-APR-2008 UNAPPROVED
Stryker Spine
Cestas, Aquitane , FR 33610 CIN-DO AEK-9446519-8/1/1
87H--WE SURGICAL IMPLANTS FOR COATING AND RE EXPORT
16-APR-2008 NOT LISTED
NO 510(K)
Derval
Derval , FR FLA-DO 793-0603137-2/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
21-APR-2008 NEEDS FCE
NO PROCESS
Novafrica
Bordeaux , FR 33000 FLA-DO NL7-0104778-8/1/1A
66VDY99 Lightening Body Milk (Lait Eclaircissant)
28-APR-2008 UNAPPROVED
Novafrica
Bordeaux , FR 33000 FLA-DO NL7-0104778-8/1/1B
66VDY99 Skin Color Lightening Lotion (Lait Teint Clair)
28-APR-2008 UNAPPROVED
Novafrica
Bordeaux , FR 33000 FLA-DO NL7-0104778-8/1/1D
53LD-03 Serum Ultra White
28-APR-2008 CSTIC LBLG
Novafrica
Bordeaux , FR 33000 FLA-DO NL7-0104778-8/2/1B
64AAU20 Anti-Bacterial Lightening Exfoliating Soap
28-APR-2008 N-RX INACT
UNAPPROVED
Novafrica
Bordeaux , FR 33000 FLA-DO NL7-0104778-8/3/1A
53ED-01 Hair Nourishing Care Treatment with Jojoba
28-APR-2008 COSM COLOR
VALCREST Site de GIVORS
St Romain En Gier Fr-69, FR 69700 FLA-DO 793-0603232-1/16/1
12CGP15 560 CTNS GOAT CHEESE FOR EXPORT ONLY
28-APR-2008 LISTERIA