Refusal Actions by FDA as Recorded in OASIS for Panama

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


    Panasonic Latin America S A
    Colon , PA                                     FLA-DO  TW2-0011335-9/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        02-AUG-2007                        NON STD

    Panasonic Latin America S A
    Colon , PA                                     FLA-DO  TW2-0011396-1/1/1
    95L--31   COMPACT AUDIO SYSTEMS / FOR EXPORT ONLY
                        13-AUG-2007                        NON STD

    Novartis Consumer Health Inc.
    Parsippany, NJ  07054-2173                     SJN-DO  508-0304794-8/1/2
    60LBY01   COMTREX ND COLD/COUGH DISPENSER 45X2
                        27-AUG-2007                        NOT LISTED

    Novartis Consumer Health Inc.
    Parsippany, NJ  07054-2173                     SJN-DO  508-0304794-8/1/1
    60LBY01   COMTREX MS NT DISPENSER 45X2
                        27-AUG-2007                        NOT LISTED

    Grupo Panalang Union, Inc.
    Panama City PA-NOTA, PA 1234                   SWI-DO  FV9-7032199-1/3/1
    16AGD35   FROZEN SHARK STEAKS
                        31-AUG-2007                        SALMONELLA

    Laboartorios Prieto
    Panama , PA                                    NOL-DO  112-7397250-7/4/1
    66VCY99   857148776583 HISTACLOR NF
                        31-AUG-2007                        UNAPPROVED