Refusal Actions by FDA as Recorded in OASIS for Ghana

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


    Tayako Enterprise
    Accra , GH                                     NYK-DO  NV3-0018166-0/9/1
    16AET33   TITUS SARDINE
                        05-NOV-2007                        NEEDS FCE
                                                           NO PROCESS

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1A
    66VCS99   Laxatative Bitters
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1B
    66VCS99   Dettol Antiseptic Solution
                        07-NOV-2007                        NOT LISTED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1C
    66VCS99   Tres Orix FORTE
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1D
    66VCS99   ZUBES Cough Mixture
                        07-NOV-2007                        NOT LISTED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1E
    66VCS99   ZUBES Childrens Cough Syrup
                        07-NOV-2007                        NOT LISTED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1F
    66VCS99   Pharma Antibacteria Soap
                        07-NOV-2007                        NOT LISTED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1G
    66VCS99   TCP Liquid Antiseptic
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1H
    66VCS99   Living Bitters Capsules
                        07-NOV-2007                        NOT LISTED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1I
    66VCS99   AMEN - WBC
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1J
    66VCS99   Adutwumwaa Capsules
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1K
    66VCS99   AMEN Blood Tonic
                        07-NOV-2007                        NO LICENSE
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1L
    66VCS99   AMEN Stomamix
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1M
    66VCS99   AMEN Cancer
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1N
    66VCS99   AMEN Rheumatism
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/2/1O
    66VCS99   ORADEX Forte
                        07-NOV-2007                        NOT LISTED
                                                           UNAPPROVED

    Amoahimaah Ent
    Adum Kumasi - Accra , GH                       NYK-DO  AGT-0003539-5/4/1
    16IFT21   SMOKED FISH
                        07-NOV-2007                        FILTHY

    Yafrims Enterprises
    Accra , GH                                     NYK-DO  AGT-0003597-3/5/1
    60FAY01   CLAY KAOLINE
                        14-NOV-2007                        NOT LISTED
                                                           DIRECTIONS