FDA 483 - Mercy Medical Center IRB - June 24, 2008

Mercy Medical Center IRB in Baltimore, MD, was cited for significant deficiencies in its operations, primarily concerning record-keeping and procedural controls. The inspection revealed a failure to maintain essential research records, improper use of expedited review, and a lack of timely continuing review for studies. Furthermore, the IRB repeatedly lacked critical written procedures for conducting reviews and for reporting unanticipated problems, noncompliance, and approval suspensions or terminations to the FDA.