Refusal Actions by FDA as Recorded in OASIS for Israel
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Janssen Cilag
Shefayim , IL 60990 NOL-DO 112-6772727-1/1/1
61WCO18 835528699299/DAKTARIN 15G
14-NOV-2007 UNAPPROVED
Bio Control Medical
Yehud , IL NOL-DO 112-7137484-7/1/1
74L--DF 858082137626 Cardiofit Stimulator (Neurostimulator for Hear
20-NOV-2007 NO PMA
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/1
29AGB02 GRAPEFRUIT DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/2
29AGB08 GRAPE SOFT DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/3A
29AGB04 STRAWBERRY BANANA DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/3B
29AGB04 Orange Drink
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/4
29AGB07 MANGO DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/1/5
29AGB05 CLEAR PEACH DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/2/1
21KEB13 PEACH / MAGO NECTAR DRINK
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/2/2
21VEB05 MANGO NECTAR
26-NOV-2007 NUTRIT LBL
Gat Food Canneries
Israel , IL 38100 FLA-DO BAO-0006668-8/3/1
21DEB99 STRAWBERRY BANANA NECTAR DRINK
26-NOV-2007 NUTRIT LBL
Radiancy Ltd
Yavne , IL NYK-DO 322-6089724-7/1/1
95U--20 SKIN KITS
29-NOV-2007 NO REGISTR