FDA 483 - Qilu Pharmaceutical Co., Ltd. (Dongjia Site) - May 24, 2024

An FDA inspection of Qilu Pharmaceutical Co., Ltd. (Dongjia Site) in Jinan, China, revealed significant deficiencies in their aseptic manufacturing operations. Observations included a lack of established procedures for preventing microbiological contamination, inadequate cleaning and maintenance protocols for equipment, and incomplete master production and control records. Additionally, the firm failed to properly qualify production equipment, raising concerns about the sterility and quality of their drug products.