Our Lady of Bellefonte Hospital – FDA Warning Letter, Jan 6, 2012

An FDA inspection of Our Lady of Bellefonte Hospital's Institutional Review Board (IRB) from January 3-6, 2012, revealed significant non-compliance with 21 CFR parts 50 and 56 concerning human subject protection. The IRB failed to adhere to statutory requirements, leading to six distinct violations. These included inadequate documentation of written IRB procedures (21 CFR 56.108(a), (b), 56.115(a)(6)), incomplete IRB member lists (21 CFR 56.115(a)(5)), and insufficient documentation of IRB activities like progress reports, detailed meeting minutes, and correspondence (21 CFR 56.115(a)(1), (2), (4)). Furthermore, the IRB failed to ensure proper quorum at convened meetings, including the presence of a nonscientific member (21 CFR 56.108(c)), did not consistently notify investigators in writing of IRB decisions (21 CFR 56.109(e)), and improperly used expedited review procedures for ineligible research (21 CFR 56.110(b)). The IRB's January 20, 2012, response to the Form FDA 483 was deemed inadequate due to a lack of final approval for new policies, insufficient detail on training plans, and missing completion dates. The hospital must provide a comprehensive written response within fifteen business days, detailing corrective actions, supporting documentation, and projected completion dates to prevent future regulatory action.