FDA 483 - ACMH Hospital IRB - November 08, 2023

ACMH Hospital IRB in Kittanning, PA, was inspected and received a Form 483 with ten observations. The observations primarily concern the lack of written procedures for various critical IRB functions, including initial and continuing review, reporting changes, and handling noncompliance. Additionally, the IRB failed to conduct reviews at convened meetings and maintain adequate meeting minutes.