FDA EIR - Abington Memorial Hospital - February 15, 2019

Abington Memorial Hospital's Institutional Review Board (IRB) underwent an FDA inspection from February 11-15, 2019, as part of a routine bioresearch monitoring surveillance under Compliance Program 7348.809. The inspection revealed several significant regulatory violations, many identified as repeat findings from a previous 2015 inspection. Key issues documented on the FDA Form 483 included inadequate meeting minutes that failed to accurately detail attendance or summarize discussions of controversial issues, insufficient communication to IRB members regarding research approved via expedited review, and non-compliance with quorum requirements, specifically regarding the mandatory presence of a nonscientific member for full board reviews. Additional concerns discussed with management highlighted recurring problems such as allowing both primary and alternate IRB members to vote and count towards quorum, misclassifying and inaccurately communicating device risk levels to investigators, incorrect use of expedited review for Humanitarian Use Devices, and a failure to adhere to the IRB's own member training Standard Operating Procedures. IRB Chairman Dr. G. Chris Christensen III acknowledged the findings. The hospital is required to implement immediate corrections, review relevant regulations and guidance, update procedures, and provide a written response to the FDA within 15 business days, detailing their corrective actions to address these persistent compliance deficiencies.