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

An FDA inspection of Bio-Thera Solutions, Ltd. in Guangzhou, China, revealed significant deficiencies in their drug substance and drug product manufacturing operations. The firm failed to establish and follow adequate procedures for production controls, media fill validation, and visible particle prevention. Additionally, the Quality Unit's responsibilities were found to be inadequate, and the firm demonstrated a failure to thoroughly investigate discrepancies and ensure proper laboratory instrument qualification.