FDA 483 - Bay Regional Medical Center IRB - June 04, 2010

Bay Regional Medical Center IRB in Bay City, MI, was cited for failing to follow its written procedures for conducting initial and continuing review of research. The inspection revealed that the IRB did not assign studies for in-depth review, lacked a proper tracking system for protocol expiration dates, and failed to conduct continuing review of all studies at appropriate intervals, including annually. These deficiencies indicate a lack of adherence to established policies and federal requirements for human subject protection.