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


    Abbott Gmbh 7 Co
    Ludwigshafen , DE 57051                        SAN-DO  112-1755733-2/1/1
    60RCE19   862833234898 REDUCTIL
                        01-APR-2008                        NOT LISTED
                                                           UNAPPROVED

    Roche Diagnostics Gmbh
    Mannheim , DE D-68298                          LOS-DO  231-7289976-0/1/1
    88L--DT   CYFRA 21-1 ELECSYS REAGENT / CAL SET
                        04-APR-2008                        REGISTERED
                                                           NO 510(K)

    Ing. Buro L. Albrecht
    Heist , DE 25492                               NOL-DO  112-1929531-1/1/1B
    74J--OQ   863225982581 Normal -Zapper ZN pulse generator
                        07-APR-2008                        NOT LISTED
                                                           NO 510(K)

    Pfizer
    Berlin , DE                                    NOL-DO  112-1944504-9/1/1
    61JDA08   948125020453/LIPITOR 20MG
                        08-APR-2008                        UNAPPROVED

    Vintage Sunglasses
    Berlin , DE 14059                              NOL-DO  112-1916943-3/1/1
    86H--QY   862806926406\SUNGLASSES
                        08-APR-2008                        NOT LISTED

    Mes Medizinelektro
    Gilching , DE 82205                            NOL-DO  112-1916991-2/1/1
    94R--BW   862173189587  Ceramic Diffraction Tube/X-Ray Tube Insert (no
                        08-APR-2008                        NON STD

    Reichold Feinkost Gmbh
    Diezdiez , DE 65582                            SAN-DO  WX6-0018957-4/1/1
    25NCT21   GARLIC CLOVES
                        14-APR-2008                        NEEDS FCE
                                                           NO PROCESS

    Reichold Feinkost Gmbh
    Diezdiez , DE 65582                            SAN-DO  WX6-0018957-4/2/1
    25ECT03   GREEN PEPPERS-STUFFED WITH CREAM CHEESE
                        14-APR-2008                        NEEDS FCE
                                                           NO PROCESS

    Reichold Feinkost Gmbh
    Diezdiez , DE 65582                            SAN-DO  WX6-0018957-4/2/2
    25ECT03   RED PEPPERS-STUFFED WITH CREAM CHEESE
                        14-APR-2008                        NEEDS FCE
                                                           NO PROCESS

    Reichold Feinkost Gmbh
    Diezdiez , DE 65582                            SAN-DO  WX6-0018957-4/2/3
    25ECT03   SOUTHAFRICAN PEPPERS STUFFED WITH CREAM CHEESE
                        14-APR-2008                        NEEDS FCE
                                                           NO PROCESS

    Mikrogen Gmbh
    Neurled , DE                                   NOL-DO  112-2057250-0/1/1
    82D--FK   859043258225  RecomBlot CMV IgG
                        15-APR-2008                        NOT LISTED

    Heel Gmbh
    Baden-Baden , DE                               NOL-DO  112-2059517-0/1/1
    62UCK99   849563722222 HOMEPATHIC REMEDY FOR FLU
                        16-APR-2008                        DRUG GMPS

    Troponwerke GmbH & Co.
    Cologne , DE D-51063                           NOL-DO  112-2167500-5/2/1
    66VCE99   863826270077  PRANEX
                        21-APR-2008                        UNAPPROVED

    Andramed Gmbh
    Koblenz , DE 56068                             CIN-DO  UPS-0841684-2/1/1
    78F--GX   SNARES
                        24-APR-2008                        NOT LISTED
                                                           REGISTERED