FDA 483 - GlaxoSmithKline dba Human Genome Sciences Inc - July 31, 2025

The FDA inspection of Human Genome Sciences Inc. in Rockville, MD, revealed significant deficiencies across its quality control, equipment management, data integrity, and material control systems. The firm failed to adequately investigate excursions, manage out-of-service equipment, retain electronic data, verify critical component sterility, and establish proper procedures for sampling and labeling. These issues indicate a systemic lack of oversight and adherence to established procedures, potentially impacting the safety and quality of biological drug substances.