Refusal Actions by FDA as Recorded in OASIS for Pakistan

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


    M.A. Pak Surgico
    Sialkot , PK                                   NYK-DO  AEK-9091703-6/1/1
    76E--IG   DENTAL RETRACTORS
                        01-MAY-2008                        STAINSTEEL

    Shan Foods Industries
    Karachi , PK 74900                             NYK-DO  BGK-0001975-3/59/1
    28BYT15   CORIANDER POWDER
                        07-MAY-2008                        SALMONELLA

    Pakistan Machine Tools (Pvt) Ltd.
    Sialkot, Punjab , PK 51310                     NYK-DO  AEK-9103291-8/1/1
    79F--ZZ   AREOLA MARKER
                        08-MAY-2008                        STAINSTEEL

    Shan Foods Industries
    Karachi , PK 74900                             LOS-DO  WUG-0142147-7/4/1
    28BGH15   CORIANDER POWDER
                        12-MAY-2008                        SALMONELLA

    Stone Instruments Company
    Sialkot, Punjab , PK 51310                     CIN-DO  UPS-0406440-6/1/1
    87H--XX   SURGICAL INSTRUMENTS-HEX SCREW DRIVER, CAP SCREW DRIVER,CROS
                        13-MAY-2008                        DE IMP GMP

    Stone Instruments Company
    Sialkot, Punjab , PK 51310                     CIN-DO  UPS-0406440-6/1/2
    87H--WJ   BONE AWL
                        13-MAY-2008                        DE IMP GMP

    Stone Instruments Company
    Sialkot, Punjab , PK 51310                     CIN-DO  UPS-0406440-6/1/3
    87H--XB   BALL TIP PROBE SS
                        13-MAY-2008                        DE IMP GMP

    Shan Foods Industries
    Karachi , PK 74900                             FLA-DO  E10-0118945-8/4/1
    28JFT99   KOFTA CURRY MIX
                        13-MAY-2008                        SALMONELLA

    Elmed Instruments Pvt. Ltd.
    Sialkot , PK 5678                              FLA-DO  EQ6-0007691-1/1/1
    80L--DQ   LAB EQ FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR EXPORT O
                        21-MAY-2008                        REGISTERED
                                                           NO 510(K)

    Meridian Express Logistics
    Dubaidubai , AE 105                            CIN-DO  UPS-1177043-3/2/1
    64LCJ03   ERR-CBP/SKIN CREAMS-PERSONAL USE
                        23-MAY-2008                        UNAPPROVED