Refusal Actions by FDA as Recorded in OASIS for Hong Kong SAR

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


    Newlane Limited
    Kowloon , HK                                   NWE-DO  300-2317028-3/307/1
    95R--FW   DVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
                        02-JAN-2008                        NO REGISTR

    Newlane Limited
    Kowloon , HK                                   NWE-DO  300-2317028-3/309/1
    95R--FW   DVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
                        02-JAN-2008                        NO REGISTR

    Koon Chun Hing Kee Soy & Sauce Factory
    Au Tau Yuen Long N T, HK                       FLA-DO  BLZ-3014035-7/2/1
    37JEE11   HOISIN SAUCE
                        04-JAN-2008                        FILTHY

    BLUE STAR SEAFOOD CO.,LIMITED
    HONGKONG HK-NA, HK blank                       SWI-DO  NS7-0014227-7/1/1
    16XGD21   FROZEN COOKED SHRIMP
                        10-JAN-2008                        VETDRUGRES

    Ondo Creation Ltd
    Kowloon Tong , HK                              SAN-DO  112-0491200-3/1/1
    85H--IS   948540736842 CONDOM
                        10-JAN-2008                        NOT LISTED
                                                           REGISTERED
                                                           NO 510(K)

    Ondo Creation Ltd
    Kowloon Tong , HK                              SAN-DO  112-0495888-1/1/1
    85H--IS   948540736912 CONDOM
                        10-JAN-2008                        NOT LISTED
                                                           REGISTERED
                                                           NO 510(K)

    The Garden Company LTD.
    KOWLOON , HK 852                               SEA-DO  N16-1035351-1/7/5
    33EGT06   MIXED FRUIT BONBON
                        16-JAN-2008                        UNSAFE COL
                                                           INCONSPICU

    Zegna-Daidong Limited
    Kowloon , HK                                   FLA-DO  TW2-0011922-4/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        18-JAN-2008                        NO REGISTR

    Zegna-Daidong Limited
    Kowloon , HK                                   FLA-DO  TW2-0011922-4/2/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        18-JAN-2008                        NO REGISTR

    Wong To Yick Wood Lock Ointment Ltd.
    Kwai Chung, N.T. , HK 1234                     SAN-DO  112-0832796-8/5/1
    60LBJ99   704213517709 PAIN OINTMENT
                        22-JAN-2008                        NOT LISTED

    Solid Company Limited
    Hong Kong , HK                                 FLA-DO  TW2-0011973-7/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        30-JAN-2008                        NON STD

    Solid Company Limited
    Hong Kong , HK                                 FLA-DO  TW2-0011974-5/1/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        30-JAN-2008                        NON STD

    Solid Company Limited
    Hong Kong , HK                                 FLA-DO  TW2-0011974-5/2/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        30-JAN-2008                        NON STD

    Solid Company Limited
    Hong Kong , HK                                 FLA-DO  TW2-0011974-5/3/1
    95L--31   AUDIO SYSTEMS / FOR EXPORT ONLY
                        30-JAN-2008                        NON STD