Qilu Pharmaceutical Co., Ltd. (Dongjia Site) – FDA 483, Jun 12, 2023

An FDA inspection of Qilu Pharmaceutical Co., Ltd.'s sterile API manufacturing facility in Jinan, China, revealed significant deficiencies in aseptic processing and environmental controls. Observations included a lack of air sampling, inadequate disinfection practices, particulate shedding from cleaning cloths, and poor facility organization. Furthermore, the firm failed to conduct thorough investigations into deviations and out-of-specification results, lacking justified root causes and preventative actions.