Refusal Actions by FDA as Recorded in OASIS for Jamaica

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


    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/2/2
    66VAL99   Red Lavender (antigas/antiflatulent)
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/5/1
    66VAL99   Aromatic Spirit of Ammonia
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/7/1
    66VAL99   CASTOR OIL
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/10/1
    66VBL99   Cocoa Butter Lotion
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/2/3
    66VBL99   INFANT GRIPE MIXTURE(FOR BABY TEETHING)
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/8/1
    66VBL99   Antacid/anti-gas (peppermint flavored)
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/3/1
    66VAL99   Eucalyptus Oil
                        16-JUN-2008                        UNAPPROVED

    P.A. Benjamin Manufacturing Co., Ltd.
    Kingston JM-01, JM 1234                        LOS-DO  JJ8-0022978-0/6/1
    66VAL99   Essence of Peppermint
                        16-JUN-2008                        UNAPPROVED