Andrea J. Bullock, MD – FDA 483, Oct 6, 2021

Andrea J. Bullock, M.D. Clinical Investigator in Boston, MA, received a Form 483 citing two significant observations during an FDA inspection. The firm failed to conduct an investigation according to its investigational plan, including enrolling an ineligible subject and not timely reporting a serious adverse event. Additionally, records for adverse device effects were found to be inaccurate, incomplete, and not current, with eCRF updates lacking supporting source documentation.