FDA 483 - James S. Cochran, MD - October 20, 2020

James S. Cochran, MD, a clinical investigator in Dallas, TX, was inspected regarding a clinical study. The inspection revealed that the investigation was not conducted according to the signed statement of investigator and investigational plan. This included missed and late collections of urine cytology and missed cystoscopies for study subjects, indicating significant deviations from protocol requirements.