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


    Mieszko S.A.
    Raciborz , PL 47-400                           NOL-DO  112-0816408-0/1/1
    33YDT99   858085027161 WRAPPED CANDIES
                        01-JUL-2008                        UNSAFE COL

    Nidaria Technology, LTD.
    Jordan Valley , IL 15132                       NYK-DO  315-5200634-3/1/1
    66PBL99    SAFE SEA SPF 0 4 OZ BOTTLE
                        02-JUL-2008                        NOT LISTED

    Nidaria Technology, LTD.
    Jordan Valley , IL 15132                       NYK-DO  315-5200634-3/2/1
    66PBL99   SAFE SEA SPF 15 4 OZ BOTTLE
                        02-JUL-2008                        NOT LISTED

    Nidaria Technology, LTD.
    Jordan Valley , IL 15132                       NYK-DO  315-5200634-3/3/1
    66PBL99   SAFE SEA SPF 30 4 OZ BOTTLE
                        02-JUL-2008                        NOT LISTED

    Nidaria Technology, LTD.
    Jordan Valley , IL 15132                       NYK-DO  315-5200634-3/4/1
    66PBL99   SAFE SEA KIDS 4 OZ BOTTLE
                        02-JUL-2008                        NOT LISTED

    Nidaria Technology, LTD.
    Jordan Valley , IL 15132                       NYK-DO  315-5200634-3/5/1
    66PBL99   SAFE SEA SPF 50 4 OZ BOTTLE
                        02-JUL-2008                        NOT LISTED

    Raje Odeh
    Jerusalem , IL                                 CIN-DO  AEK-9504271-5/1/1
    56YCB99   ANTIBIOTICS
                        21-JUL-2008                        UNAPPROVED

    Novartis
    Petach Tikva , IL                              NOL-DO  112-3559308-7/1/1
    60CAK53   865108117538/OTRIVIN SPRAY
                        21-JUL-2008                        UNAPPROVED