FDA 483 - Wakai, Ronald, Ph. D., Clinical Investigator - August 22, 2014

Ronald Wakai, Ph. D., Clinical Investigator, was inspected regarding an investigational device study. The inspection revealed significant deficiencies in study conduct, monitoring, record-keeping, and informed consent processes. These issues indicate a lack of adherence to the investigational plan, signed agreements, and applicable FDA regulations, impacting subject safety and data integrity.