Kenneth S. Sharlin, MD – FDA 483, May 1, 2026

An FDA inspection of Sharlin Health and Neurology in Ozark, MO, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to investigational plans, such as issues with participant eligibility, late reporting of serious adverse events, and inadequate investigator staffing. Additionally, the firm failed to maintain adequate case histories, lacked proper documentation for key study procedures, and did not notify the IRB of a screening hold.