FDA 483 - Meharry Medical College Institutional Review Board - November 02, 2021

This FDA Form 483 documents observations from an inspection conducted on November 2, 2021. The specific company name is illegible in the provided text. The inspection revealed significant issues concerning the Institutional Review Board (IRB) operations and documentation, falling under the regulatory framework for human subject protection.

The main violations include a failure to prepare and maintain IRB meeting minutes with sufficient detail. This deficiency specifically extended to documenting actions taken, recording voting details (including members for, against, or abstaining), outlining the basis for requiring changes or disapproving research, and providing a written summary of discussions on controverted issues. Additionally, the IRB did not consistently follow its own written procedures for conducting the initial and continuing review of research studies. Meeting minutes were also found to be inadequate in documenting the presence of alternate IRB voting members, the names and specialties of any expert consultants, and consistent voting actions, particularly for members who abstained or refused to vote.

As a result of these observations, the company is required to provide a formal written response to the FDA. This response must address each observation, detailing any objections, and outlining planned or already implemented corrective actions to bring the facility into compliance with applicable FDA regulations governing human subject protection.