Refusal Actions by FDA as Recorded in OASIS for Germany

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


    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1347214-8/1/12
    66PBL99   859042537560 AGE STOP Sun Life Sensitive 50+ SPF
                        01-JUL-2008                        NOT LISTED

    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1149145-4/1/1
    53LD-99   Power Effect Clearing Active Concentrate
                        01-JUL-2008                        CSTIC LBLG

    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1149145-4/1/2
    53LG-08   CLEAN & ACTIVE  ENZYME PEELING
                        01-JUL-2008                        CSTIC LBLG

    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1149145-4/1/3
    53LD-99   EXTREME HYDRA COMPLETE
                        01-JUL-2008                        COSM COLOR
                                                           CSTIC LBLG

    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1149145-4/1/4
    53LD-99   EXTREME LIFTING CRAEAM DAY  & NIGHT
                        01-JUL-2008                        CSTIC LBLG

    Klapp Cosmetics Gmbh
    Hessisch Lichtenau , DE                        NOL-DO  112-1149145-4/1/5
    53LD-99   IMMUN GENTLE EYE PROTECTION
                        01-JUL-2008                        COSMETLBLG

    IBL Gesellschaft fur Immunchemie Und Immunbiologie mbh
    Hamburg , DE 22335                             CIN-DO  UPS-1580447-7/1/1
    82M--LH   REAGENTS: MEDICAL DIAGNOSTICS KIT FOR THE DIAGNOSIS OF CORTI
                        03-JUL-2008                        REGISTERED

    Ibl Gesellschaft
    Hamburg , DE                                   CIN-DO  UPS-1580447-7/2/1
    82M--LH   REAGENTS: MEDICAL DIAGNOSTICS KIT FOR THE DIAGNOSIS OF THYRO
                        03-JUL-2008                        REGISTERED

    Ibl Gesellschaft
    Hamburg , DE                                   CIN-DO  UPS-1580447-7/3/1
    82M--LH   REAGENTS: MEDICAL DIAGNOSTICS KIT FOR THE DIAGNOSIS OF TESTO
                        03-JUL-2008                        REGISTERED

    Scanchemie Ltd.
    Unknown , DE                                   SWI-DO  XXX-0154562-4/1/1B
    64LAJ67   Hyprogel
                        07-JUL-2008                        DIRECTIONS
                                                           UNAPPROVED

    Bin Seena Health Limited
    London , GB W22HZ                              CIN-DO  AEK-9506847-0/1/1
    60LCA69   PERSONAL MEDICATION - ZYDOL SR 100MG 10/RX
                        21-JUL-2008                        UNAPPROVED

    Codman
    Tuttlingen , DE 78532                          NOL-DO  112-3507733-9/1/1
    79G--AD   863627234780 VAGINAL RETRACTORS
                        21-JUL-2008                        NOT LISTED

    KHK GmbH
    Koln DE-NW, DE 50996                           CIN-DO  UPS-1662288-6/1/1
    66PBJ99   LIP BALM WITH SPF 20 FOR COSMETIC USE DEL/NATURAL TRENDS PRO
                        28-JUL-2008                        NOT LISTED

    Nova Instruments
    Tuttliengen , DE                               NOL-DO  112-3198416-5/1/1
    79G--EN   861121655660 ARMITAGE FORCEPS
                        31-JUL-2008                        NOT LISTED