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
Coty Pprestige Travel Retail
Essexcen , FR 55116 FLA-DO AM1-0148990-5/1/1
66PBY07 SPF 15 Sun Beauty Care
04-FEB-2008 UNAPPROVED
Coty Pprestige Travel Retail
Essexcen , FR 55116 FLA-DO AM1-0148990-5/2/1
66PBY07 Sun Beauty Stick Eyes & Lips UVA/UVB
04-FEB-2008 UNAPPROVED
Vichy Labs
Levallois , FR 92614 NOL-DO 112-1153997-1/1/1
66PAJ99 855474522352 SUNBLOCK
06-FEB-2008 NOT LISTED
N-RX INACT
DRUG NAME
Vichy Labs
Levallois , FR 92614 NOL-DO 112-1153997-1/1/2
66PAJ99 855474522352 SUNBLOCK
06-FEB-2008 NOT LISTED
N-RX INACT
DRUG NAME
Fromagerie De Saint-Urbain (Sa)
Saint Urbain Maconcourt , FR LOS-DO 595-4396008-8/14/1
12AFP56 CHEESE - BRIE
08-FEB-2008 LISTERIA
Mary Cohr
Paris , FR 75002 SWI-DO KE2-0015555-1/1/2A
66PAY99 Light Moisturising Creme - Filter UVA/UVB rays
11-FEB-2008 NOT LISTED
DIRECTIONS
INCONSPICU
Mary Cohr
Paris , FR 75002 SWI-DO KE2-0015649-2/10/2A
66PAY99 Light Moisturising Creme - Filter UVA/UVB rays
11-FEB-2008 NOT LISTED
DIRECTIONS
INCONSPICU
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/1
53YY-99 947746469361 COSMETIC PREP
14-FEB-2008 CSTIC LBLG
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/4
53YY-99 947746469361 ICY CONCENTRATE
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/5A
53YY-99 Normal skin
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/5B
53YY-99 DRY skin
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/5C
53YY-99 FOR MEN
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/6A
53YY-99 947746469361 QUICK LIFT
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/6B
53YY-99 FOR MEN
14-FEB-2008 UNSAFE COL
Icy Beauty
Forges Les , FR NOL-DO 112-1192745-7/1/6C
53YY-99 Sun Effect.
14-FEB-2008 UNSAFE COL
Societe De Production Pharmacie
Quetigny Cedex , FR NOL-DO 112-1211578-9/1/1
54ABA90 859043256759 VITAMINS
14-FEB-2008 NO ENGLISH
Derval
Derval , FR FLA-DO 793-0602905-3/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
15-FEB-2008 NEEDS FCE
Derval
Derval , FR FLA-DO 793-0602904-6/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
15-FEB-2008 NEEDS FCE
NO PROCESS
Derval
Derval , FR FLA-DO 793-0602903-8/2/1
09CYF13 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
15-FEB-2008 NEEDS FCE
NO PROCESS
Derval
Derval , FR FLA-DO 793-0602902-0/2/1
09CYF99 1932 CTNS WHIPPING CREAM FOR EXPORT ONLY
15-FEB-2008 NEEDS FCE
NO PROCESS
A.R.P.
Peschadoires , FR 63920 ATL-DO 101-7677911-3/1/1
79M--DM PHLEBECTOMY HOOKS BY MULLER
15-FEB-2008 NOT LISTED
Faye Gastronomie
Rungis Cedex , FR 94585 ATL-DO N29-0139963-5/1/1
16MEE15 SNAILS IN CAN (HELIX POMATA) FOR RESTAURANT USE ONLY
19-FEB-2008 NEEDS FCE
NO PROCESS
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/3/4
66VBL99 Sublissime UV Whitening Spot Corrector SPF 50 PA+++
19-FEB-2008 NOT LISTED
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/3/9
66VBL99 Sublissime Whitening Liquid Foundation SPF 20
19-FEB-2008 NOT LISTED
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/3/10
66VBL99 Sublissime Whitening Liquid Foundation SPF 20
19-FEB-2008 NOT LISTED
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/3/11
66VBL99 Sublissime Whitening Liquid Foundation SPF 20
19-FEB-2008 NOT LISTED
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/3/12
66VBL99 Sublissime UV Ultimate Whitening UV Base Translucent SPF 50
19-FEB-2008 NOT LISTED
Parfums Christian Dior
Paris , FR 75008 SAN-DO 597-0151182-2/5/1
66VBR99 Sublissime Whitening UV Loose Powder SPF 15
19-FEB-2008 NOT LISTED
Naja S.A.S
Chaux , FR NOL-DO 112-8238307-6/1/1
86H--QZ 861303998093 FRAMES
19-FEB-2008 REGISTERED
Smi Equipments
Coignieres , FR 78310 CIN-DO AEK-9414197-1/1/1
91N--ED MALARIA KITS
26-FEB-2008 NO PMA
NO 510(K)
Smi Equipments
Coignieres , FR 78310 CIN-DO AEK-9413192-3/1/1
91N--ED EXXON MALARIA CURATIVE KIT
26-FEB-2008 NO PMA
NO 510(K)
Biomatalante
Vigneux De Bretagne , FR 44360 NYK-DO AEK-9092323-2/1/1
87M--QV BONE FILLER
26-FEB-2008 INVDEVICE
Serp
Castelsarrasin , FR 82100 FLA-DO MA7-0629938-9/3/1
53LY-99 Aroma Ioni Corps
26-FEB-2008 COSMETLBLG
Young & Sweet Skin Care
Paris , FR SWI-DO D52-8900831-5/33/1B
53BH-01 Spa Milk Salt
28-FEB-2008 UNAPPROVED