FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - July 18, 2013

An FDA inspection conducted from July 8-18, 2013, at Qilu Pharmaceutical Co. Ltd. in Jinan, China, a finished drug manufacturer, identified numerous deficiencies in their operations, documented in a Form FDA 483. These observations revealed significant deviations from established manufacturing quality standards, primarily impacting data integrity, aseptic processing, and overall quality control. The inspection uncovered critical issues in laboratory practices, including the falsification of environmental monitoring data and the destruction of original records before investigations were complete. Procedures designed to prevent microbiological contamination were found inadequate, with improper environmental monitoring techniques, unvalidated aseptic processes, and deficiencies in critical media fill simulations. Essential components used in aseptic areas were not consistently sterilized, and environmental monitoring alert limits were not properly evaluated. Additional observations highlighted insufficient cleaning and disinfection validation for aseptic areas, creating potential cross-contamination risks. The visual inspection process for finished drug vials lacked thoroughness, and inspector qualifications were inadequate. Investigations into production and laboratory deviations were consistently insufficient, often failing to determine root causes or ensure effective corrective actions. Laboratory testing methods were also found deficient in several areas, including dissolution and weight variation, and original production data was not maintained contemporaneously or accurately. Other concerns included issues with equipment calibration, uncompleted material safety studies for stoppers, and missing laboratory testing equipment. Qilu Pharmaceutical Co. Ltd. is obligated to implement comprehensive corrective and preventive actions across its quality management system, manufacturing, and laboratory operations to ensure compliance with regulatory requirements and the safety and quality of its drug products.