FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)

An FDA inspection of Qilu Pharmaceutical Co. Ltd. in Jinan, Shandong, China, revealed significant deficiencies across multiple areas of their finished drug manufacturing operations. These issues include data integrity problems, inadequate environmental monitoring and aseptic processing controls, insufficient cleaning and disinfection procedures, and failures in quality control and laboratory practices. The findings indicate a broad lack of adherence to cGMP requirements, posing potential risks to product quality and sterility.