FDA 483 - Bio-Thera Solutions, Ltd. - September 26, 2025

Bio-Thera Solutions, Ltd. in Guangzhou, China, was cited for significant deficiencies across its drug substance and drug product manufacturing operations. The inspection revealed widespread issues including inadequate process controls, poor quality unit oversight, insufficient investigations into batch failures and visible particles, and unqualified laboratory methods and instruments. These findings indicate a lack of assurance in product quality and consistency.