Refusal Actions by FDA as Recorded in OASIS for Venezuela

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


    Foreign Trade Zone#202-A3m Pharmaceuticals
    Northridge, CA  91328                          LOS-DO  336-8064699-2/2/1
    65QDB24   ORPHENADRINE CITRATE (RELAXANT);HUMAN - RX/COMBINATION INGRE
                        05-JUN-2008                        NOT LISTED
                                                           UNAPPROVED

    Zuoz Pharma Sa Pre
    Caracas , VE                                   NOL-DO  112-3011092-9/1/1
    60CAB49   929420391000/MUCORAMA
                        11-JUN-2008                        UNAPPROVED

    Sanofi Aventis
    Caracas , VE                                   NOL-DO  112-3011092-9/1/2
    61EAK06   929420391000/ALLEGRA
                        11-JUN-2008                        UNAPPROVED

    Surgilap Equipos, C.A
    Caracus , VE                                   NOL-DO  112-2857470-6/1/1
    79F--TF   852847257817-ILLUMINATOR
                        18-JUN-2008                        NOT LISTED
                                                           NO 510(K)

    Venezolanade Camarones S.A.
    Maracaibo , VE                                 FLA-DO  EJ7-0056926-5/1/1
    16JGC01   CRABMEAT
                        19-JUN-2008                        FILTHY

    Thermo Group, C.A
    Miranda , VE                                   NYK-DO  667-0091727-2/1/1A
    66VBL99   Kleravitex shampoo (anti hair loss)
                        23-JUN-2008                        NO ENGLISH
                                                           UNAPPROVED

    Thermo Group, C.A
    Miranda , VE                                   NYK-DO  667-0091727-2/1/1B
    66VBL99   Kleravitex shampoo (antidandruff shampoo)
                        23-JUN-2008                        UNAPPROVED

    Thermo Group, C.A
    Miranda , VE                                   NYK-DO  667-0091727-2/2/1A
    66VDL99   Complex vital anti hair loss ampoules
                        23-JUN-2008                        UNAPPROVED