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
Aceites Ybarra Sa
Dos Hermanas Sevilla, ES SEA-DO 551-6656863-9/1/1
21GCI09 STUFFED OLIVES
02-JUN-2008 FALSE
NEEDS FCE
NO PROCESS
Novartis Pharmaceutic S.A.
Barbera Del Valles , ES NOL-DO 112-2766608-1/1/1
66VCJ99 969185304920 VOLTAREN EMULGEL
09-JUN-2008 UNAPPROVED
Bcn Cosmetics 2000 S.L.
Barcelona , ES NYK-DO 276-0192822-2/1/1C
84N--FO SOLTENS TENS DEVICE
09-JUN-2008 NOT LISTED
REGISTERED
NO 510(K)
Chupa Chups Industrial Mexicana S.A. de C.V.
Toluca MX-NOTA, MX 50200 FLA-DO 408-1164843-2/1/1
33SYY06 LOLLIPOPS
09-JUN-2008 UNSAFE COL
Pasa
Barcelona , ES BLT-DO AT1-0806798-7/4/1
16JFT05 SHRIMP&PRAWNS CRUSTACEANS
12-JUN-2008 LIST INGRE
LACKS N/C
NUTRIT LBL
Industrias Videca S.A.
Villanueva De Castellon , ES FLA-DO BAO-0007604-2/2/1
20CCY09 SEEDLESS GRAPES IN LIGHT SYRUP
17-JUN-2008 NEEDS FCE
NO PROCESS
Industrias Videca S.A.
Villanueva De Castellon , ES FLA-DO BAO-0007604-2/3/1
21VCY03 FIGS WITH SYRUP
17-JUN-2008 NEEDS FCE
NO PROCESS
Industrias Videca S.A.
Villanueva De Castellon , ES FLA-DO BAO-0007604-2/4/1
20RCY03 PEAR BALLS WITH SYRUP
17-JUN-2008 NEEDS FCE
NO PROCESS
Industrias Videca S.A.
Villanueva De Castellon , ES FLA-DO BAO-0007604-2/5/1
20RCY03 MELON BALLS WITH SYRUP
17-JUN-2008 NEEDS FCE
NO PROCESS
Laboratorios Foramen Sl
Guarnizo Cantabria , ES 39611 FLA-DO BVA-0101287-7/1/1
76N--RE TOOTH PASTE ENTERED UNDER WAREHOUSE ENTRY FOR EXPORT ONLY
19-JUN-2008 UNAPPROVED
Laboratorios Foramen Sl
Guarnizo Cantabria , ES 39611 FLA-DO BVA-0101287-7/2/1
76E--FW TOOTH BRUSHES ENTERED UNDER WAREHOUSE ENTRY FOR EXPORT ONLY
19-JUN-2008 NOT LISTED
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/1/1
53KC-01 947904308620 AFTERSHAVE
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/1/2
53KC-05 947904308620 SHAVING CREAM
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/1
53LC-06 947904308620 EYECREAM
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/2
53LC-06 947904308620 CREAM DERMAQ
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/3
53MC-01 947904308620 SUNCREAM
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/4
53EC-99 947904308620 GEL HAIR
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/5
53EC-06 947904308620 SHAMPOO
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/6
53LC-06 947904308620 MASK
26-JUN-2008 CSTIC LBLG
Loreal
Madrid , ES 28007 NOL-DO 112-0989645-8/2/7
53LC-06 947904308620 MAKE-UP
26-JUN-2008 CSTIC LBLG