FDA 483 - Concordia Clinical Research (IRB) - December 30, 2010

An FDA inspection of Concordia Clinical Research (IRB) in Cedar Knolls, NJ, revealed multiple deficiencies in its IRB operations. Key issues included conflicts of interest, failure to follow written procedures for review, inadequate informed consent documents, and significant lapses in maintaining detailed meeting minutes and essential study records. These findings indicate a systemic failure to ensure proper oversight and documentation of human subject research.