FDA 483 - Suzhou Suncadia Biopharmaceuticals Co. Ltd. - January 06, 2025

During an inspection conducted from December 30, 2024, to January 6, 2025, the U.S. Food and Drug Administration (FDA) identified significant manufacturing deficiencies at Suzhou Suncadia Biopharmaceuticals Co. Ltd. in Suzhou, Jiangsu Province, China. The inspection of this drug substance and drug manufacturer resulted in an FDA Form 483, detailing observations related to a failure to adhere to Current Good Manufacturing Practices (CGMP) for sterile drug product manufacturing. Key violations included inadequacies in procedures designed to prevent microbiological contamination. Specifically, the media fill program for validating aseptic operations was not adequately performed, failing to simulate worst-case conditions or appropriate durations. The environmental monitoring program also lacked assurance, with issues such as non-viable air monitoring not covering the full duration of critical operations and infrequent surface monitoring. Furthermore, aseptic processing systems and procedures were found to be deficient in preventing potential contamination, including concerns with equipment positioning and personnel gowning. Additional observations highlighted deficiencies in visual inspection procedures, where the testing kit used to qualify inspectors contained an unacceptable number of defective vials, and actual product appearance (haze) was not reflected in the training. Lastly, automatic and electronic equipment, including non-viable particle monitoring systems and SCADA software, were not routinely calibrated, inspected, or checked according to written programs, with software settings unverified after upgrades and validation requirements not maintained. The company is required to address these serious observations to ensure product quality and patient safety.