FDA 483 - Concentrics Research, LLC - November 26, 2024

Concentrics Research, LLC in Indianapolis was inspected by the FDA from November 18-26, 2024. The inspection revealed a significant issue with record retention, specifically the failure to collect and retain laboratory reports for clinical trial participants. This deficiency prevents the verification of critical patient data, including lipid panel measurements, impacting the reliability and accuracy of data reported to the agency.