FDA 483 - Kenneth J Maverick, M.D. - May 20, 2022

An FDA inspection of Kenneth J Maverick, M.D. in San Antonio, TX, a clinical investigator, revealed significant deficiencies in the conduct of an investigational device study. Observations included failures to adhere to the investigational plan, report adverse events in a timely manner, and ensure proper Institutional Review Board monitoring. Additionally, the firm lacked complete records for the receipt and disposal of investigational devices.