FDA 483 - Florida Suncare Testing Inc. - July 24, 2025

Florida Suncare Testing Inc., a contract testing laboratory in Bunnell, FL, was cited for significant deficiencies in its quality control unit and data integrity practices. The inspection revealed a lack of appropriate controls over computer systems, including HPLC data, and widespread failures in quality unit responsibilities, such as inadequate investigations, method validation, and personnel training. These issues indicate a systemic breakdown in the firm's quality management system.