FDA EIR - Kenneth S. Sharlin, MD - May 01, 2026

An FDA for-cause, high-priority Bioresearch Monitoring (BIMO) inspection of clinical investigator Kenneth S. Sharlin, MD (Sharlin Health and Neurology, Ozark, MO) was conducted from April 27 to May 1, 2026, under compliance program 7348.811 on assignment from CDER's Office of Scientific Investigations. The inspection covered two sponsor-terminated clinical trials (6 and 3 enrolled subjects) and found a Site Management Organization had taken over delegation and training from early 2025. A Form FDA 483 with two observations (10 items) was issued: the investigation was not conducted per the investigational plan (missing eligibility documentation for inclusion criteria, a serious adverse event entered into EDC late, no primary/back-up treating and examining investigators identified, a study-specific physical exam before informed consent, an incomplete screening log) and case histories were inadequate (undocumented blinded rater assessments, missing repeat eligibility test results, an unapproved track-changes consent form, no IRB notification of a sponsor screening hold, and no final disposition for two subjects). Dr. Sharlin acknowledged the observations and planned a written response; no refusals, samples or voluntary corrections.