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


    Rudolf Wild GmbH & Co. KG
    Heidelberg DE-NOTA, DE D-69214                 NOL-DO  112-2502330-1/1/1
    34FFT04   942780501898 CHOCOLATE
                        07-MAY-2008                        LIST INGRE
                                                           NUTRIT LBL

    Roche Pharma AG
    baden-Wuertenberg , DE                         PHI-DO  SG5-0417349-6/1/1
    66VIY99   LARIAM (MEFLOQUINE HYDROCHLORIDE) IND#76175  SPONSOR EPIX PH
                        09-MAY-2008                        UNAPPROVED

    Wavelength Laser Technologie Gmbh
    Erlangen , DE                                  CHI-DO  201-1370680-7/2/1
    86L--OI   ALLEGRETTO WAVE CONCERTO
                        09-MAY-2008                        NOT LISTED
                                                           FAILS STD

    Boehringer Ingelheim
    6507 Ingelheim, Frankfurt , DE D 6507          BLT-DO  336-7496059-9/3/1
    61KCS99   HYOSCINE SCOPOLAMINE
                        20-MAY-2008                        DIRECTIONS

    Boehringer Ingelheim
    Rhein , DE 6507                                BLT-DO  336-7493545-0/1/1
    60CCS04   EPINEPHRINE LABORATORY USE ONLY
    Partial Refusal     20-MAY-2008                        DIRECTIONS

    Brial Allergen Gmb
    Greven , DE 48268                              NOL-DO  112-0296189-5/1/1
    55QP-29   909838840849/PETROTATUM
                        27-MAY-2008                        NOT LISTED

    Bayer Schering Pha
    Berlin , DE                                    NOL-DO  112-0283774-9/1/1
    62ICB79   611798920844/FLUDARABINE PHOSPHATE 10 MG
                        27-MAY-2008                        UNAPPROVED