FDA 483 - Jeffrey Ralph, M.D. - February 09, 2018

Jeffrey Ralph, M.D., a Sponsor Investigator in San Francisco, CA, was cited for deficiencies during an FDA inspection. The firm failed to conduct an investigation in accordance with the investigational plan, lacking sufficient documentation for required subject procedures. Additionally, the firm did not ensure timely Institutional Review Board (IRB) approval for a clinical study, allowing approval periods to expire on multiple occasions.