FDA 483 - Ken Y. Yoneda, M.D. - December 06, 2024

An FDA inspection of Ken Y. Yoneda, M.D., a clinical investigator in Sacramento, CA, revealed a significant failure to adhere to investigational plans and applicable FDA regulations. Specifically, the firm did not promptly report or, in some cases, failed to report at all, multiple device deficiencies observed during a clinical study. This indicates a serious lapse in compliance with study protocols and regulatory requirements for device deficiency reporting.