Refusal Actions by FDA as Recorded in OASIS for Brazil

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


    Natural Products
    Sao Paulo , BR                                 NOL-DO  112-1356347-4/1/1
    54YFY99   864084221179 MEDICAMENTS 400 MG
                        02-JUL-2008                        NO ENGLISH

    Compex - Industria e Comercio de Pesca e Exportacao Ltda.
    FORTALEZA BR-NOTA, BR 60060190                 NYK-DO  991-0162852-9/1/1
    16JFT06   FROZEN LOBSTER TAILS
                        07-JUL-2008                        SALMONELLA

    Polysuture
    Parque , BR                                    NOL-DO  112-3438923-0/1/1
    79G--AK   860761960465 SUTURES
                        21-JUL-2008                        NOT LISTED
                                                           NO 510(K)

    Compex - Industria e Comercio de Pesca e Exportacao Ltda.
    FORTALEZA BR-NOTA, BR 60060190                 FLA-DO  406-0418701-9/1/1
    16JGD06   FROZEN LOBSTER TAILS (Frozen Rock Lobster Tails)
                        22-JUL-2008                        SALMONELLA

    Visiontech Mediala Optics Ltda
    Belo Horizonte , BR                            NOL-DO  112-3209588-8/1/1
    86H--OF   861722602794  CORNEAL SEGMENT
                        31-JUL-2008                        NOT LISTED