Refusal Actions by FDA as Recorded in OASIS for Costa Rica

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Glaxosmithkline Costa Rica Sa San Jose , CR ATL-DO XXX-0149700-8/1/4 66VDY99 Various Rx Creams, Rx 06-OCT-2008 PERSONALRX NO ENGLISH Exportadora P.M.T. S.A. San Jose Escazu, CR 1234 FLA-DO D97-0467782-9/4/1 16AGC42 FRESH SWORDFISH FISH 09-OCT-2008 FILTHY