FDA 483 - Daniel Fred Goodman, M.D. - November 25, 2024

The FDA inspected Daniel Fred Goodman, M.D., a clinical investigator in San Francisco, CA, from November 20-25, 2024. The inspection revealed that the clinical investigator failed to properly investigate and document protocol deviations, specifically neglecting to assess their impact on subject safety and data integrity. This indicates a serious lapse in adherence to investigational plans and regulatory requirements.