FDA 483 - Center for Translational Medicine - July 11, 2025

An FDA inspection of Center for Translational Medicine in Minneapolis, MN, a nonclinical laboratory, revealed significant deficiencies in their study conduct and record-keeping practices. The firm failed to adequately document study data, adhere to approved protocols, establish necessary standard operating procedures, maintain a comprehensive master schedule, and properly archive study records. These issues indicate a lack of robust quality control and data integrity.