Refusal Actions by FDA as Recorded in OASIS for Netherlands

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


    Katwijk Cmemie Bv
    Hatwijk , NL                                   NYK-DO  T77-1052334-3/1/1
    61GCS45   SULFACETAMIDE SODIUM :END USER-STIEFFEL LABS
                        05-AUG-2008                        DIRECTIONS

    Medical Measurement Systems
    Enschede , NL                                  NOL-DO  112-1411490-5/1/1
    78E--XY   736781014499 FLOWMASTER MEASUREMENT SYSTEM
                        20-AUG-2008                        NOT LISTED

    Mubio Products B.V.
    Maastricht , NL                                NOL-DO  112-1464291-3/1/1
    82L--YE   799800419727/CYTOKERATIN
                        21-AUG-2008                        NOT LISTED

    Warex Bv
    'S-Gravendeel , NL 3295BJ                      CHI-DO  W24-0117151-7/15/22
    33LGT08   Red Band English Winegums
                        22-AUG-2008                        UNSAFE COL

    Katwijk Chemie Bv
    Katwijk , NL 2222                              NYK-DO  AEK-9115524-8/1/1
    61GCS45   SULFACETAMIDE SODIUM NDC 01734-9001-01
                        27-AUG-2008                        DIRECTIONS