FDA WARNING_LETTER - Asfora, Wilson T. M.D. - December 27, 2007

An FDA inspection conducted from November 26 to December 27, 2007, at Dr. Wilson T. Asfora's clinical site identified serious violations of 21 CFR Part 812 concerning an Investigational Device Exemption (IDE) study for a [redacted] device. The inspection revealed a failure to conduct the investigation in accordance with the investigational plan, applicable FDA regulations, and IRB conditions (21 CFR 812.100, 812.110(b)). This included enrolling ineligible subjects, incomplete adverse event documentation, improper device use, and not reporting serious adverse events to the IRB. The firm also failed to maintain accurate, complete, and current records (21 CFR 812.140(a)), lacking documentation of eligibility evaluations, source records, and an audit trail for electronic data. Furthermore, there was a failure to ensure proper monitoring of the clinical investigation (21 CFR 812.40), as the study monitor did not verify subject eligibility or address observed protocol violations. Dr. Asfora's February 6, 2008, response was deemed unacceptable due to a lack of comprehensive corrective and preventive action plans, timeframes, and training documentation. The FDA requires a written response within fifteen working days detailing corrective actions, projected completion dates, and a list of all clinical trials participated in over the last five years. Failure to comply could result in regulatory action, including disqualification proceedings.