FDA 483 - Phyllis J. Gee, M.D. - December 17, 2019

An FDA inspection of Phyllis J. Gee, M.D. in Frisco, TX, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to adhere to protocol regarding subject eligibility, proper adverse event collection, treatment compliance, and study procedures. These findings indicate serious deficiencies in the conduct and oversight of clinical trials.