FDA 483 - MD Tox Laboratory - January 28, 2025

An FDA inspection of MD Tox Laboratory in Irvine, CA, a testing laboratory for HCT/Ps, revealed significant deficiencies in its quality program, procedures, and record management. The firm failed to define and follow core CGTP requirements, maintain adequate records for equipment maintenance and quality control, and retain records for the required 10-year period. Several observations were noted as repeat findings, indicating persistent issues.