FDA WARNING_LETTER - Bay Regional Medical Center IRB - June 04, 2010

On September 9, 2010, the FDA issued a Warning Letter to Bay Regional Medical Center (BRMC) following an inspection of its Institutional Review Board (IRB) from June 2-4, 2010. The inspection aimed to assess compliance with 21 CFR parts 50 and 56 regarding human subject protection in clinical investigations.

The FDA concluded that BRMC's IRB failed to adhere to statutory requirements and FDA regulations. A Form FDA 483, Inspectional Observations, was issued. BRMC's response, dated July 20, 2010, was received past the 15-business-day deadline.

Key violations include: 1. **Failure to follow written procedures [21 CFR 56.108(a)(1)]**: * The IRB did not assign specific members for in-depth review and presentation of studies at meetings, contrary to its Policy and Procedure Manual (PPM), observed in meetings from July 2009 to March 2010. This was a repeat observation from a March 2009 inspection. * The IRB lacked a formal tracking system for continuing review of protocols, relying solely on clinical investigators for self-reporting, despite a PPM requirement for such a system, also a result of the March 2009 inspection.

2. **Failure to conduct