Shandong New Time Pharmaceutical Co. Ltd. – FDA 483, Jul 1, 2024

An FDA inspection of Shandong New Time Pharmaceutical Co., Ltd. in Linyi, China, identified critical deficiencies in aseptic processing for sterile drug products and inadequate monitoring and validation of manufacturing processes. These issues include failures in RABS operation, aseptic transfer techniques, environmental monitoring, and the establishment of process parameters, indicating a high risk of product contamination and variability. The findings suggest a significant lack of control over critical manufacturing steps.