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


    Avi Elbaz
    Meitarmeitar , IL 85025                        CIN-DO  UPS-2353983-4/1/1
    66SDA51   CIALIS,10MG,  NO RX, NO ID, PER USE
                        03-OCT-2008                        UNAPPROVED

    Hadiklaim Date Growers Corp. Ltd.
    Tel Aviv , IL 67060                            NYK-DO  J34-0055902-0/1/1
    21GGT05   DEGLET NOUR BULK 1 KG
                        14-OCT-2008                        FILTHY

    Power Paper
    Petach Tikva , IL 49130                        BLT-DO  322-3149448-8/33/1
    89M--PH   POWER MASK MASQUE IONIQUE YEUX
                        17-OCT-2008                        REGISTERED

    Versamed Medical Systems
    Qadima , IL 60920                              FLA-DO  336-8703854-0/1/1
    73C--AI   CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE);;
                        20-OCT-2008                        REGISTERED
                                                           NO 510(K)

    Versamed Medical Systems
    Qadima , IL 60920                              FLA-DO  336-8703855-7/1/1
    73C--AI   CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE);;
                        20-OCT-2008                        REGISTERED

    Al Arz Tahini (Agas)
    Nazareth , IL                                  DET-DO  PDR-0003982-2/1/1
    23MGT01   TAHINI
                        28-OCT-2008                        NUTRIT LBL
                                                           SALMONELLA