Refusal Actions by FDA as Recorded in OASIS for Spain
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
NIUMA
MADRID , ES BLT-DO XXX-0152422-3/1/1H
66VBY99 Niuma Skin Lightening Lotion
05-DEC-2007 NOT LISTED
UNAPPROVED
Sillicium Espana Sl
Tineo , ES 33875 NOL-DO 112-0389144-8/1/1
54ABL99 862014176714/ ORGANIC SILICA
12-DEC-2007 LABELING
NUTRIT LBL
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/1/1
52AIE31 CERAMIC BOWLS
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/1/2
52AIE28 CERAMIC PLATES
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/1/4
52AIE28 CERAMIC EGG PLATES
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/1/5
52AIE34 CERAMIC BUTTLER KEEPERS
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/1/6
52AIE31 CERAMIC MORTARS
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/2/1
52AIE53 CERAMIC SERVING TRAYS
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/3/1
52AIE38 CERAMIC SPOON
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/3/2
52AIE34 CERAMIC CRUET
17-DEC-2007 UNSAFE ADD
Manuel De Castro Carballo
Toledo , ES 45570 SEA-DO 551-6588052-2/3/4
52AIE36 CERAMIC TUMBLERS
17-DEC-2007 UNSAFE ADD
Delaviuda Alimentacion S.A.
Toledo , ES FLA-DO 900-0051814-3/1/1A
03KHT99 Fruit nougats (30 cartons)
21-DEC-2007 UNSAFE COL
YELLOW #5
St Endoscopia S.A.R
Pozuelo De Alarcon , ES 28223 NOL-DO 112-0638926-7/1/1
78F--DS 905548043718.VIDEOGASTROSCOPE
27-DEC-2007 NOT LISTED
NO 510(K)
St Endoscopia S.A.R
Pozuelo De Alarcon , ES 28223 NOL-DO 112-0638926-7/1/2
78F--CW 905548043718.LIGHT SOURCE
27-DEC-2007 NOT LISTED
NO 510(K)
St Endoscopia S.A.R
Pozuelo De Alarcon , ES 28223 NOL-DO 112-0638926-7/1/3
87H--RX 905548043718.VIDEO SCOPE
27-DEC-2007 NOT LISTED
NO 510(K)