FDA 483 - Richard J. Obiso, PhD dba Avila Herbals, LLC - July 26, 2021

Richard J. Obiso, PhD dba Avila Herbals, LLC, a sponsor-investigator in Christiansburg, VA, was inspected regarding a clinical investigation involving the investigational drug Oleander 4X. The inspection revealed significant deficiencies across multiple areas of clinical trial conduct. These include failure to submit an IND, lack of IRB review and approval, inadequate informed consent processes, and poor record-keeping for adverse events, protocol deviations, and drug accountability.