FDA 483 - Clinical Resolution Laboratory Inc. - September 29, 2023

Clinical Resolution Laboratory Inc. in Brea, CA, was inspected and cited for significant deficiencies in its manufacturing processes and quality control systems. The inspection revealed failures in establishing adequate production controls, thoroughly investigating discrepancies, maintaining appropriate equipment design, and ensuring reliable supplier analyses. These issues indicate a lack of robust quality assurance for drug product identity, strength, purity, and quality.