FDA 483 - Comanche County Memorial Hospital IRB - July 31, 2019

An FDA inspection of Comanche County Memorial Hospital IRB in Lawton, OK, identified significant deficiencies in the documentation of Institutional Review Board meeting minutes. The report details instances where meeting minutes lacked sufficient detail regarding member attendance, actions taken by the IRB, and accurate vote counts. These issues indicate a failure to maintain comprehensive records of IRB oversight activities.