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

An FDA inspection of Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) in Jinan, China, revealed critical deficiencies across its manufacturing operations for sterile and non-sterile drug products. The firm failed to establish and follow adequate procedures to prevent microbiological contamination, lacked proper validation of aseptic processes, and exhibited significant issues with environmental monitoring and discrepancy investigations. These widespread quality control failures indicate a high risk to product sterility and overall drug quality.