FDA 483 - John Muir Medical Center IRB #1 - October 15, 2021

An FDA inspection was conducted at John Muir Medical Center IRB #1 from October 4-15, 2021, revealing two key observations related to its operational compliance. The first observation noted that the Institutional Review Board's meeting minutes were not prepared and maintained with sufficient detail, specifically failing to document all actions taken and comprehensive vote counts (for, against, and abstaining). This deficiency was exemplified by the September 2021 meeting minutes. The second observation highlighted that the IRB did not include at least one member who is independent of the institution and its immediate family members, as evidenced by the July 2021 Concord panel roster. These findings indicate that the company did not fully adhere to the regulatory requirements for IRBs overseeing clinical investigations. As part of the regulatory framework, the FDA issued a Form 483 to document these observations. John Muir Medical Center IRB #1 is now required to address these noted conditions and practices by submitting a response outlining their planned or implemented corrective actions to the FDA.