FDA WARNING_LETTER - Armstrong County Memorial Hospital - November 08, 2023

The FDA conducted an inspection of the Armstrong County Memorial Hospital (ACMH) Institutional Review Board (IRB) from November 2-8, 2023, to assess its compliance with FDA regulations (21 CFR parts 50 and 56) for the protection of human subjects in clinical investigations. The inspection revealed that the ACMH IRB did not adhere to applicable statutory requirements. Specifically, the IRB failed to prepare, maintain, and follow written procedures governing its functions and operations, as mandated by 21 CFR 56.108(a) and (b) and 21 CFR 56.115(a)(6). Additionally, the IRB failed to prepare and maintain adequate documentation of its activities, including detailed minutes of IRB meetings, a violation of 21 CFR 56.115(a)(2). While ACMH IRB stated its intent to close and transfer responsibilities to another institution, the FDA found this response inadequate due to insufficient details regarding the transfer process for currently approved research and the plan for interim review addressing the identified deficiencies. The FDA requires ACMH IRB to provide a projected timeline for the transfer, the process involved, and any written procedures for research review until the transfer is complete, specifically addressing the failures in IRB functions, operations, and meeting minute documentation within 15 business days. Failure to adequately address these violations may lead to further regulatory action.