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
Frial S.A.
14401 Bayeux Fn, FR 144010000 LOS-DO BLS-0001598-2/3/1
24KGT01 EGGPLANT & GOAT CHEESE SAUTEE
08-JAN-2008 LISTERIA
Starvac Medic Systems
Toulouse , FR 32100 NYK-DO 551-7347872-3/1/1
74J--OW PULSTAR XI PRESSOTHERAPY
14-JAN-2008 NO 510(K)
Groupe Gm
Malakoff , FR 92240 FLA-DO T94-0047392-0/7/1
53LC-99 SUN POUCH
15-JAN-2008 NOT LISTED
Hra Pharma
Paris , FR 75003 NOL-DO 112-8581499-4/1/1
65KIA09 799208312128 GYMISO (misoprostol)
17-JAN-2008 UNAPPROVED
Lestienne Distribution
Boulogne Sur Mer FR-62, FR 62200 FLA-DO AWM-0012266-5/3/2A
33UGT99 CHUPA XXL Lollipop & Bubble Gum
18-JAN-2008 UNSAFE COL
Cadbury France
Paris , FR 75014 FLA-DO AWM-0012266-5/3/2C
33MGT05 Bubble Gum
18-JAN-2008 UNSAFE COL
NUTRIT LBL
Lestienne Distribution
Boulogne Sur Mer FR-62, FR 62200 FLA-DO AWM-0012266-5/3/2B
33MGT05 ZIP & ZAP Roudoudos
18-JAN-2008 UNSAFE COL
Fromages
Machecoul , FR 44270 NWE-DO 112-0310393-5/2/1C
12AWO52 Delice Provencal
23-JAN-2008 LISTERIA
Fromages
Machecoul , FR 44270 NWE-DO 112-0310393-5/2/1D
12AWO52 Chevre Fermier
23-JAN-2008 LISTERIA
Pascal Beillevaire
Machecoul , FR 44270 NWE-DO 112-8803958-1/2/1
12AWO64 CHEVRE FERMIER CHEESE #FR7121202CE
23-JAN-2008 LISTERIA
Pascal Beillevaire
Machecoul , FR 44270 NWE-DO 112-8803958-1/4/1
12AWO64 DELICE PROVENCAL CHEESE #FR1215002CE
23-JAN-2008 LISTERIA
Memometal Technologies
Bruz , FR NOL-DO 112-8079814-3/1/2
87J--DR 862506571086/CLIPS
28-JAN-2008 NOT LISTED
NO 510(K)
Memometal Technologies
Bruz , FR NOL-DO 112-8079814-3/2/1
87L--XH 862506571086/ORTHO.INSTRUMENTS
28-JAN-2008 NOT LISTED
Memometal Technologies
Bruz , FR NOL-DO 112-8079814-3/1/1
87N--CO 862506571086/IMPLANT
28-JAN-2008 NOT LISTED
NO PMA
Lab Dermatologies Avenue France
Paris , FR 92100 NOL-DO 112-7501451-4/1/1
65HAO01 861494707399 / DIROSEAL
28-JAN-2008 NOT LISTED
UNAPPROVED
Lab Dermatologies Avenue France
Paris , FR 92100 NOL-DO 112-7501451-4/1/2
64XAO99 861494707399 / INVATHERM
28-JAN-2008 NOT LISTED
LACKS N/C
NO ENGLISH
Lab Dermatologies Avenue France
Paris , FR 92100 NOL-DO 112-7501451-4/1/3
64XAO99 861494707399 Ruboril
28-JAN-2008 NOT LISTED
LACKS N/C
UNAPPROVED
Bagonneau Sa
Saintes , FR 17100 SWI-DO 534-1720749-4/9/2B
52AIE28 Deep Plate Magali 6025
28-JAN-2008 UNSAFE ADD
Bagonneau Sa
Saintes , FR 17100 SWI-DO 534-1720749-4/9/2C
52AIE28 Olive dish red border 6044
28-JAN-2008 UNSAFE ADD
Bagonneau Sa
Saintes , FR 17100 SWI-DO 534-1720749-4/9/2E
52AIE28 Small bowl/mug 6054
28-JAN-2008 UNSAFE ADD
Bagonneau Sa
Saintes , FR 17100 SWI-DO 534-1720749-4/9/2G
52AIE28 olive dish coquille 6080
28-JAN-2008 UNSAFE ADD