St. Joseph Mercy Oakland Instiutional Review Board – FDA Warning Letter, Apr 21, 2015

The FDA issued a Warning Letter to St. Joseph Mercy Oakland Health System following an April 2015 inspection of its Institutional Review Board (IRB), which revealed objectionable conditions and repeat violations of 21 CFR Part 56. This inspection was a follow-up to a 2013 Warning Letter, highlighting persistent issues in ensuring human subject protection and data integrity. Key deficiencies included: 1) Failure to conduct continuing review of research at least annually (21 CFR 56.109(f)), with studies not reviewed before expiration and delayed renewals. 2) Failure to prepare and maintain adequate documentation of IRB activities, specifically meeting minutes detailing actions and votes (21 CFR 56.115(a)(2)), evidenced by incomplete voting records. 3) Failure to maintain an accurate list of IRB members (21 CFR 56.115(a)(5)), where a member voted before being officially listed. The IRB's responses were deemed inadequate, lacking sufficient detail, documentation of corrective actions, and a previously committed electronic management system. The FDA requires a regulatory conference within two weeks and detailed documentation of corrective and preventative actions, revised SOPs, and staff training within 15 working days to avoid further regulatory action.