Refusal Actions by FDA as Recorded in OASIS for Japan

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


    Nakagawa Shokuhin Co Ltd
    Tokyo , JP                                     NYK-DO  368-0146579-4/28/1
    25JGP07   RADISH (ROOT & TUBER VEGETABLE);PLASTIC, SYNTH;CULTURED/CURE
                        03-JAN-2008                        UNSAFE COL

    SHINSHIN CO., LTD.
    MAEBASHI-SHI JP-10, JP 379-2143                CHI-DO  677-0319637-7/93/1
    25JGP07   PICKLED RADISH
                        07-JAN-2008                        UNSAFE COL
                                                           COLOR LBLG

    Tokai Tsukemono Seizo Co Ltd
    Toyohashi Aichi, JP                            CHI-DO  677-0319637-7/101/1
    25JGP24   PICKLED GINGER
                        07-JAN-2008                        UNSAFE COL
                                                           COLOR LBLG

    Shin Nippon Commerce, Inc.
    Tokyo , JP 104                                 FLA-DO  K51-0062951-5/1/1
    86H--KY   TONOMETER
                        07-JAN-2008                        NO 510(K)

    Ajinomoto Trading Inc
    Tokyo , JP                                     FLA-DO  K51-0062951-5/1/5
    86H--JO   SLIT LAMPS --SIMILAR TO PREDICATE DEVICE
                        07-JAN-2008                        NO 510(K)

    Kaneka Corporation
    Osaka , JP 530                                 NOL-DO  112-0814120-3/1/1
    54YCE99   859956899914 Kaneka QH Capsules (DIETARY SUPPLEMENTS)
                        10-JAN-2008                        DIETARYLBL
                                                           LABELING
                                                           NUTRIT LBL

    Sumikin Bussan Kaisha. Ltd.
    Tokyo , JP                                     CHI-DO  610-3217947-7/1/1
    95L--22   SIGMA LASER POINTER
                        10-JAN-2008                        NON STD
                                                           NO REGISTR

    Kenrico LTD
    Hamamatsu JP-22, JP 433-8117                   LOS-DO  AM5-7730750-8/1/1
    66VCY99   Kenrico SAP Sheets
                        10-JAN-2008                        UNAPPROVED

    Takagi Seiko Ltd.
    Nagano City , JP 383                           FLA-DO  DM9-7011321-1/1/1
    86N--QE   OM-8 OPERATING MICROSCOPE
                        15-JAN-2008                        REGISTERED

    Sankohen Shoten Oroshibu
    Tokyo , JP 116 0009                            SEA-DO  ANP-0008899-8/7/1A
    31KGI02   GREEN TEA DRINK
                        16-JAN-2008                        FALSE
                                                           NUTRIT LBL
                                                           NEEDS FCE
                                                           NO PROCESS

    Sankohen Shoten Oroshibu
    Tokyo , JP 116 0009                            SEA-DO  ANP-0008899-8/7/1B
    31KEI02   GREEN TEA DRINK
                        16-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Sankohen Shoten Oroshibu
    Tokyo , JP 116 0009                            SEA-DO  ANP-0008899-8/7/1C
    31KEI03   GREEN TEA DRINK
                        16-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    WAKABATO SEIKA CO.,LTD.
    NAGOYA JP-23, JP 455-0874                      LOS-DO  K64-5017820-2/1/29
    03FGT99   BAKED WHEAT CRACKERS
                        17-JAN-2008                        UNSAFE COL
                                                           COLOR LBLG

    MARUZEN FOODS CORPORATION
    CHIKUMA-SHI JP-20, JP 387-8585                 LOS-DO  221-1878074-5/25/1
    02DGT99   PREPARED RICE
                        17-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    MARUZEN FOODS CORPORATION
    CHIKUMA-SHI JP-20, JP 387-8585                 LOS-DO  221-1878074-5/26/1
    02DGT99   PREPARED RICE
                        17-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Tsukushiya Co., Ltd
    Aichi-Ken, Japan , JP                          SAN-DO  597-0149762-6/7/1
    33LGT07   JELLY
                        22-JAN-2008                        FALSE

    Nestle Japan Limited
    Kobe , JP 651-0087                             SAN-DO  597-0149762-6/23/1
    30YHT99   LIQUID SOYMILK
                        22-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    MARUZEN FOODS CORPORATION
    CHIKUMA-SHI JP-20, JP 387-8585                 LOS-DO  221-1878074-5/25/2
    02DGT99   PREPARED RICE AND EGG
                        24-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    MARUZEN FOODS CORPORATION
    CHIKUMA-SHI JP-20, JP 387-8585                 LOS-DO  221-1878074-5/25/3
    02DGT99   PREPARED RICE
                        24-JAN-2008                        NEEDS FCE
                                                           NO PROCESS

    Phild Inc
    Karasuma-Dori , JP 6048152                     LOS-DO  510-7825863-2/51/1B
    80L--DQ   PHITEN AQUA METAL BRACELET
                        25-JAN-2008                        REGISTERED
                                                           NO 510(K)