Abington Memorial Hospital – FDA Warning Letter, Feb 15, 2019

The FDA issued a Warning Letter to Abington Memorial Hospital Institutional Review Board (IRB) on June 24, 2019, following an inspection from February 11-15, 2019. The inspection, part of the Bioresearch Monitoring Program, aimed to assess compliance with 21 CFR Parts 50, 56, and 812 regarding human subject protection and investigational device exemptions.

The letter identified serious and continuing violations of 21 CFR Part 56, Institutional Review Boards. Specifically, the IRB failed to: 1. **Review proposed research at convened meetings with a majority of members present, including at least one non-scientific member [21 CFR 56.108(c)].** Examples included a June 1, 2018 meeting where a majority was not present due to incorrect counting of a voting member and their alternative, and a January 24, 2018 meeting where an amendment was approved without a non-scientific member present. 2. **Prepare and maintain adequate documentation of IRB activities [21 CFR 56.115(a)(2) and (5)].** Discrepancies were found between meeting minutes and membership rosters from June 2017 to July 2018, failing to accurately document attendance. Additionally, minutes from a March 9, 201