FDA 483 - Shanghai Henlius Biologics Co., Ltd. - January 24, 2025

An FDA inspection of Shanghai Henlius Biologics Co., Ltd. identified significant deviations from Current Good Manufacturing Practices (CGMP) across two inspections: January 16-24, 2025, for drug substance manufacturing, and February 24-March 11, 2025, for drug product manufacturing. The primary violations centered on a deficient quality unit, which conditionally released drug substances without complete record review, failed to audit electronic data, and lacked contemporaneous documentation. The company exhibited inadequate control over electronic data systems, including unvalidated systems and unprotected original records, and failed to initiate deviations for equipment failures.

Manufacturing processes lacked assurance of control, with unapproved and unvalidated procedures, and critical aspects remaining unvalidated. Facility and equipment issues included poorly controlled areas, potential utility cross-contamination, inappropriate cleaning agents, and an inadequate environmental monitoring program. Cleaning validation studies for product-contact equipment were insufficient, missing critical sampling and risk assessments. Laboratory controls were cited for using unqualified in-house manufactured reagents. For drug product, visual inspection processes were inadequate, and HEPA filter qualification was deficient. Shanghai Henlius Biologics must implement comprehensive corrective and preventive actions to ensure compliance with CGMP regulations.