FDA 483 - Bio-Thera Solutions, Ltd. - January 17, 2025

Between January 7 and January 17, 2025, the FDA inspected the Bio-Thera Solutions, Ltd. manufacturing facility in Guangzhou, China. The inspection identified several significant concerns regarding the production of sterile drug substances and products. Specifically, investigators observed poor aseptic techniques, such as operators using non-sterile tools and failing to maintain proper airflow during critical filling operations. The facility also struggled with mold control, reporting high recovery rates in cleanrooms and failing to perform timely or thorough investigations into these contamination events. Furthermore, the facility"s visual inspection process for finished products was conducted in crowded, noisy environments using statistically inadequate sampling methods.

Additional violations were noted in data management and quality oversight. The Quality Unit failed to review electronic audit trails for manufacturing equipment prior to batch release and lacked sufficient control over chromatography data systems, which could compromise data accuracy. Laboratory equipment, including a pH meter used for testing, lacked password protection. The Quality Unit also failed to follow established procedures for managing deviations and inappropriately loosened investigation thresholds for microbial growth without conducting risk assessments. To address these findings, Bio-Thera Solutions must provide a formal response to the FDA detailing its corrective and preventive actions. These observations reflect current findings and are subject to further agency review under the applicable regulatory framework for drug manufacturing.