FDA 483 - Amy Lightner MD - April 26, 2023

Amy Lightner, a sponsor-investigator in Cleveland, OH, was cited for significant deficiencies in the conduct and oversight of multiple clinical investigations involving investigational products. The inspection revealed widespread failures in adhering to study protocols, including enrolling ineligible subjects and not adequately evaluating subject eligibility, as well as critical lapses in identifying, documenting, and reporting both serious and non-serious adverse events to the sponsor and Data Safety and Monitoring Board. Additionally, the firm failed to maintain adequate and accurate case histories and did not retain records for the required duration, indicating systemic issues in clinical trial management and data integrity.