FDA 483 - Daniel Fred Goodman, M.D. - December 13, 2021

Daniel Fred Goodman, M.D., a sponsor-investigator in San Francisco, CA, was cited for multiple significant violations during an FDA inspection. The inspection revealed serious deficiencies in the conduct of a Phase 1 clinical investigation, primarily concerning informed consent procedures, protocol adherence, investigational drug accountability, and regulatory reporting. These issues indicate a severe lack of oversight and compliance with clinical trial regulations.