FDA 483 - Bay Area Tumor Institute IRB - December 14, 2023

The FDA inspected Bay Area Tumor Institute IRB in Oakland, CA, and issued a Form 483 citing significant deficiencies in their written procedures. The observations primarily concern the absence of adequate written procedures for conducting research reviews, reporting findings to investigators, and ensuring prompt reporting of noncompliance or study suspensions/terminations to appropriate officials and the FDA. These issues indicate a systemic lack of documented processes essential for proper IRB oversight.