FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - May 19, 2015

This FDA Form 483 was issued to Qilu Pharmaceuticals Co, Ltd in Jinan, Shandong Province, China, a finished dosage pharmaceutical manufacturer. The inspection revealed significant deficiencies across production, laboratory, and quality systems, including inadequate operator qualification, non-contemporaneous record-keeping, and insufficient controls for equipment, protective gear, and laboratory procedures. These observations indicate a lack of robust quality oversight and control in critical manufacturing and testing processes.