FDA 483 - George Hon, M.D. - May 31, 2019

Kidney Wellness Institute in Long Beach, CA, was cited for significant deficiencies during a clinical investigation. The inspection revealed widespread issues with maintaining adequate and accurate case histories for study subjects, failures to adhere to the investigational plan, and critical omissions in the informed consent process, including subjects not being informed of foreseeable risks. These findings indicate a serious lack of control over study conduct and potential compromise of subject safety and data integrity.