FDA 483 - Kent L. Wellish, M.D. - February 13, 2023

Kent L. Wellish, M.D. in Las Vegas, NV, a clinical investigator, was cited for significant deviations from a clinical study protocol during an FDA inspection. The inspection revealed multiple instances of non-compliance, including enrolling a subject who met exclusion criteria, failing to perform required examinations and vital sign measurements, and inadequate documentation and reporting of adverse events and protocol deviations. These issues indicate a lack of adherence to good clinical practice and the signed investigator statement.