FDA WARNING_LETTER - Centra Health Inc IRB - February 15, 2011

An FDA inspection of Centra Health, Inc.'s Institutional Review Board (IRB) from February 3-15, 2011, revealed serious violations of 21 CFR Part 56 concerning device investigations. The inspection identified two primary deficiencies. First, the IRB failed to conduct continuing review of research at least annually, as mandated by 21 CFR 56.109(f), with specific studies cited as examples of overdue reviews. Second, the IRB failed to prepare, maintain, and follow required written procedures governing its functions and operations, per 21 CFR 56.108(a)(1), 56.108(b)(1)-(3), and 56.115(a)(6). This included a lack of procedures for promptly reporting unanticipated problems, serious or continuing noncompliance, or suspension/termination of IRB approval, and a failure to follow existing procedures for renewal requests. Centra Health's March 2, 2011, response was deemed inadequate, lacking copies of proposed notices and logs for the first violation, and incomplete regarding reporting timeframes for terminations/suspensions and reporting of noncompliance for the second. The FDA requires Centra Health to provide written documentation of additional corrective actions, including revised policies, implementation dates, and training plans, within fifteen working days to prevent further regulatory action.