FDA EIR - Shanghai Henlius Biologics Co., Ltd. - March 11, 2025

An FDA inspection of Shanghai Henlius Biologics Co., Ltd. was conducted from February 24 to March 11, 2025, focusing on drug product manufacturing at their Songjiang Site 1 (SJ1) and Site 2 (SJ2) facilities in China. The inspection was carried out under the regulatory framework of FDA's Sterile Drug Process Inspections guidelines (CP 7356.002A).

Key violations and issues were documented in separate Form FDA 483s for each site. SJ1 received one observation concerning inadequate quality unit oversight. SJ2 received a more comprehensive list of deficiencies, including a failure to establish adequate process controls to ensure product quality and sterility, a lack of assurance for consistent aseptic filling, and insufficient procedures to prevent microbiological contamination of sterile drug products. Additionally, SJ2 also exhibited inadequate quality unit oversight. Other notable verbal observations included issues with equipment cleanliness, malfunction events, environmental monitoring practices, and documentation for water system disinfection and vial depyrogenation validation.

In response to these findings, Henlius management committed to submitting a written reply addressing all inspectional observations within 15 business days. This response is expected to outline the specific corrective and preventive actions the company will implement to resolve the identified deficiencies and ensure compliance with regulatory standards for sterile drug manufacturing.