FDA 483 - Raymond E. Easley, D.O. - May 26, 2023

Raymond E. Easley, D.O., a clinical research facility in Snellville, GA, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the conduct of a clinical investigation, including the Principal Investigator's failure to adhere to the investigational plan, assess subject eligibility, and provide adequate oversight. Additionally, the firm failed to provide subjects with copies of approved informed consent forms and did not ensure re-consenting with updated versions.