Refusal Actions by FDA as Recorded in OASIS for Turkey

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Simsek Biskuvi Ve Gida
    Karaman , TR                                   DET-DO  G17-0008733-2/3/5
    34CYT07   Milky Kid Surprise Egg
                        04-FEB-2008                        LIST INGRE
                                                           INCONSPICU
                                                           IMBED OBJT
                                                           LABELING
                                                           NUTRIT LBL

    Isik Organic
    Izmir , TR                                     DET-DO  ARA-1006947-3/2/1
    20AGH10   SULTANA RAISINS
                        05-FEB-2008                        POISONOUS
                                                           INCONSPICU
                                                           PESTICIDES

    Cash Ist07
    Istanbul , TR                                  NOL-DO  112-0996768-9/1/1
    80F--OZ   862027164993/CATHETER
                        06-FEB-2008                        RXPERSONAL

    Cash Ist07
    Istanbul , TR                                  NOL-DO  112-0996768-9/2/1
    79K--GO   862027164993/GLOVES
                        06-FEB-2008                        NOT LISTED
                                                           NO 510(K)

    Safe Spice Gida Sterilizasyon San.
    Izmir , TR                                     BLT-DO  101-7676241-6/1/1
    28BCT54   BLACK PEPPER
                        14-FEB-2008                        FILTHY

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/11/1
    87M--AT   MODULER STRAIGHT STEM
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/10/1
    87N--DJ   SIMPLEX POLLYAXIAL SCREW
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/9/1
    87M--AT   CERVICAL CAGE
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/8/1
    87N--DJ   INTERLOCKING BOLT SCREW FEMUR
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/7/1
    87N--DJ   INTERLOCKING BOLT SCREW
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/6/1
    87N--DJ   INTERLOCKING SCREW
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/5/1
    87N--DJ   SELF TAPPING CORTICAL SCREW
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/4/1
    87M--ZZ   INTERLOCKING NAIL FEMUR
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/3/1
    87N--DH   INTERLOCKING NAIL TIBIA
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/2/1
    87N--DH   INTERLOCKING NAIL TIBIA
                        20-FEB-2008                        NOT LISTED

    Astip Ortopedik Tibbi Malzelme
    Alsancak , TR IZMIR                            SWI-DO  BPX-0000065-9/1/1
    87M--ZZ   INTERLOCKING NAIL FEMUR
                        20-FEB-2008                        NOT LISTED