FDA 483 - MercyOne North Iowa Medical Center IRB - June 21, 2019

An FDA inspection of MercyOne North Iowa Medical Center IRB in Mason City, IA, revealed significant deficiencies in its Institutional Review Board operations. The firm failed to maintain required records for three years, did not promptly notify investigators in writing of research approvals or modifications, and prepared meeting minutes lacking sufficient detail regarding attendance and voting. These issues indicate a lack of adherence to regulatory requirements for IRB recordkeeping and communication.