FDA WARNING_LETTER - Stephen Fallon PhD - June 13, 2025

The FDA issued a Warning Letter to Stephen J. Fallon, Ph.D., following a clinical study inspection conducted between June 2 and June 13, 2025. The study evaluated the performance and usability of the INSTI HIV Self-Test. The inspection revealed significant violations of federal regulations designed to protect research participants and ensure the reliability of clinical data. Primary issues included failures in the informed consent process, where study staff improperly recorded consent dates on behalf of subjects and failed to provide participants with copies of their signed forms. Additionally, the investigator revised compensation terms in the consent documents without obtaining required approval from an Institutional Review Board. The FDA also found a lack of proper site oversight; staff members recorded test results that the protocol required participants to record themselves, and signature logs were inconsistent. Record-keeping was further compromised by the use of correction fluid to alter data and a failure to maintain shipping records or device lot numbers. Under the regulatory framework of the Code of Federal Regulations, Dr. Fallon is required to provide a written response within 15 business days. This response must detail the corrective actions taken to address these deficiencies and prevent future occurrences, despite the investigator"s stated intention to stop conducting clinical research.