Refusal Actions by FDA as Recorded in OASIS for Australia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Northwood, Melissa Coogee , AU SAN-DO AEK-6740686-4/1/1 85H--IS CONDOMS 20-MAR-2008 NOT LISTED REGISTERED NO 510(K) Vani-T Pty Ltd Lonsdalelonsdale , AU 5160 CIN-DO UPS-0523818-1/1/1 53MD-01 SUN TAN LIQUID 28-MAR-2008 COSM COLOR