FDA EIR - Advarra IRB - May 27, 2021

An FDA "for-cause" inspection of Advarra IRB, located in Columbia, MD, took place from May 20-27, 2021. Conducted under Compliance Program 7348.809 and guided by 21 CFR Parts 50 and 56, the inspection primarily focused on assessing the IRB's compliance, particularly its determination of risk for a SARS-COV-2 Antigen Rapid Qualitative Test product.

While no formal FDA-483 "Inspectional Observations" were issued, the inspection highlighted several discussion items with Advarra management. These included ensuring sponsor compliance with 21 CFR 809.10(c), a gap in written procedures concerning the regulatory framework for conventional food products or Generally Recognized as Safe (GRAS) substances (specifically, failing to consider an Investigational New Drug application for a food product studied for disease), and a failure to report the disbanding of an acquired IRB Company (IRBCo) within the required 30 days. Additionally, inaccurate study-related contact information was noted in Informed Consent documents. Advarra management acknowledged these issues and committed to implementing corrective and preventive actions.