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

An FDA inspection of Bio-Thera Solutions, Ltd. in Huangpu District, Guangzhou, revealed significant deficiencies in their drug substance and drug product manufacturing operations. The firm failed to establish and follow adequate procedures for preventing microbiological contamination, ensuring product quality through proper visual inspection and sampling, and maintaining data integrity. Furthermore, the Quality Unit's responsibilities and laboratory controls were found to be inadequate, raising concerns about the sterility and overall quality of their sterile drug products.