FDA 483 - Element Materials Technology Oakland-Concord - January 30, 2026

An FDA inspection of Element Materials Technology Oakland-Concord, a contract testing laboratory, revealed significant deficiencies across its operations. Findings included inadequate quality oversight of service providers, compromised sample management, and critical failures in maintaining aseptic processing areas, such as failed HEPA filters and insufficient environmental monitoring. The firm also failed to conduct thorough investigations into sterility test failures and proficiency test discrepancies, lacked proper documentation for bacterial endotoxin testing calculations, and neglected routine maintenance for critical equipment, indicating a systemic breakdown in quality control and testing integrity.