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

Shanghai Henlius Biologics Co., Ltd. received a Form 483 for significant deficiencies in its drug substance manufacturing operations. Key issues include a dysfunctional quality unit, inadequate process controls, poorly maintained facilities and equipment, ineffective cleaning validation, and deficient laboratory controls for in-house media. These observations indicate a systemic lack of control over critical aspects of drug substance production and quality assurance.