FDA 483 - Pennington Biomedical Research Center IRB - February 01, 2010

An FDA inspection of Pennington Biomedical Research Center in Baton Rouge, LA, identified significant deficiencies in their Institutional Review Board (IRB) operations. The facility failed to ensure proper IRB composition during convened meetings and improperly utilized expedited review procedures for substantial changes to research protocols. These issues indicate a lack of adequate oversight for human subject protection.