FDA 483 - Northwest Comm Hospital IRB - December 06, 2019

The FDA inspected Northwest Community Hospital IRB in Arlington Heights, IL, and issued a Form 483 with four observations. The inspection revealed deficiencies primarily related to the IRB's written procedures for continuing review, the detail in meeting minutes, the maintenance of IRB member lists, and the retention of correspondence with investigators. These issues indicate a need for improved documentation and adherence to regulatory requirements for IRB operations.