FDA 483 - Abbott - June 28, 2024

An FDA inspection of Abbott in Plymouth, MN, identified significant deficiencies in its role as a sponsor-monitor for an investigational study. Observations included failures to ensure the timely return of investigational devices from non-compliant investigators and delays in recognizing and acting upon serious non-compliance. Additionally, the firm submitted incomplete and inaccurate annual progress reports to the FDA and IRBs, indicating concerns with clinical trial oversight and regulatory reporting.