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# ‘Objectionable Conditions’ at Hospital IRB
- URL: https://www.fdaweb.com/objectionable-conditions-at-hospital-irb/
- Published: 2024-11-05T12:00:00.000Z
- Updated: 2026-09-14T14:46:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158121

An FDA 11/2-11/8/2023 Bioresearch Monitoring Program inspection at the Armstrong County Memorial Hospital Institutional Review Board (IRB) in Kittanning, PA., found “objectionable conditions” indicating that the IRB did not adhere to applicable statutory requirements on the protection of human subjects. A 10/29 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/armstrong-county-memorial-hospital-692080-10292024?ref=fdaweb.com) emphasized these findings that the IRB:

- failed to prepare, maintain, and follow written procedures governing the functions and operations of the IRB; and
- failed to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings; and

The IRB was told to respond with a list of specific actions it has taken or plans to take to address violations and prevent their recurrence. The letter cautions that failure to address the matter adequately could lead to regulatory action.