FDA 483 - Thomas D. Coates, M.D. - August 02, 2019

An FDA inspection of Thomas D. Coates, M.D. in Los Angeles, CA, a clinical investigator, revealed significant deficiencies in the preparation and maintenance of adequate and accurate case histories. The inspection found issues with source records, including medical histories, adverse events, and concomitant medications, which lacked completeness, attributability, and proper dating for investigator signatures. These findings indicate a failure to maintain proper documentation for clinical investigations.