FDA EIR - Aspire Independent Review Board LLC - June 13, 2019

The FDA conducted a routine inspection of Aspire Independent Review Board LLC (Aspire-IRB) in Santee, CA, from June 10-13, 2019. This inspection, carried out by the GCP Compliance Oversight Branch and the Center for Drug Evaluation and Research under Compliance Program 7348.809, aimed to assess the IRB's overall functions, policies, standard operating procedures, and review processes for FDA-regulated human subject research, primarily focusing on Phase I drug studies and compliance with regulations such as 21 CFR Part 50 Subpart D for vulnerable populations. The inspection concluded with no significant deficiencies identified, and no FDA Form 483 (Inspectional Observations) was issued to Aspire-IRB management. A single procedural observation was discussed at the closeout meeting: an attendee listed on the agenda for an IRB meeting on June 11, 2019, was marked as present in the generated meeting minutes report for a study, despite not attending. This was attributed to an automated reporting algorithm, which management plans to address as Aspire-IRB integrates a new electronic system in August 2019. No formal corrective actions were mandated by the FDA.