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


    Aquanova, C.A.
    San Francisco , VE                             FLA-DO  D97-0421572-9/1/1
    16JGC01   PASTEURIZED CRAB CLAWS REFRIGE
                        05-NOV-2007                        FILTHY
                                                           NUTRIT LBL

    Elaborado Por Industrias
    Caracas , VE                                   NOL-DO  112-8815529-6/1/1
    60SCE99   929420336440 OMEPRAZOL
                        07-NOV-2007                        UNAPPROVED

    Intercaps De Venezuela
    San Martin , VE                                NOL-DO  112-8815529-6/2/1
    54ACH90   929420336440 HEPA-DESICOL
                        07-NOV-2007                        UNAPPROVED