James L. Dunnie FDA

Jim started with FDA in 1983 as an Investigator (CSO) in the Dallas District/Houston Station Office. In 1989, he was promoted and transferred to the San Juan District Office as a Drug and Biologics Specialist. In 1991, Jim was promoted and become a Supervisory Investigator and transferred to the Baltimore District Office. In 1994, he accepted a lateral transfer to FDA/ORA Headquarters – the Division of Field Investigations, as a Drug Program Expert. In 2009, Jim was promoted to a Senior Drug Program Expert. He became a member of FDA’s foreign drug inspection cadre in 1993 and has been involved with national FDA/ORA training of field drug investigators since 1996. Jim is also the ORA inspectional representative to the FDA Inter-Agency Combination Products cGMP Workgroup. Jim earned a B.S. in Environmental Science (with a Technical Writing Option) from The Pennsylvania State University in 1982. In 1989, he completed all the coursework for a M.B.A. from the University of Houston. Jim is a past recipient of FDA’s Award of Merit.