FDA 483 - Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site) - September 20, 2017

An FDA inspection of Qilu Pharmaceutical Co. Ltd. in Jinan, Shandong, China, revealed deficiencies in personnel monitoring during aseptic operations. Specifically, the procedure for taking operator finger samples after aseptic operations lacked sufficient detail, leading to inconsistent sampling practices. This indicates a concern regarding the control of aseptic processing environments.