FDA WARNING_LETTER - MedCentral Health System - March 31, 2010

The FDA issued a Warning Letter to MedCentral Health System following an inspection of its Institutional Review Board (IRB) from March 22-31, 2010. The inspection aimed to assess compliance with 21 CFR Part 56 (IRBs), Part 50 (Human Subjects), and Part 812 (Investigational Device Exemptions).

The letter identified several violations: 1. **Failure to follow written procedures and ensure proper IRB meetings:** The IRB lacked written procedures for reporting findings, determining review frequency, managing changes in approved research, and reporting unanticipated problems or noncompliance. Additionally, studies were approved without a convened meeting, without a majority of members present, or without a nonscientific member present, contrary to regulations. 2. **Failure to maintain adequate documentation of IRB activities:** Meeting minutes lacked documentation of continuing review, and votes for several study approvals were not recorded. 3. **Failure to advise members of expedited reviews:** There was no documentation that IRB members were notified of research proposals approved under expedited review procedures.

The IRB Chairman's April 14, 2010, response was deemed inadequate as it lacked preventative action plans for recurrence. MedCentral Health System must provide written documentation of corrective and preventative actions within fifteen working days, referencing "CTS # EC100161." Failure to respond could lead to further regulatory action.