CHANGCHUN GENESCIENCE PHARMACEUTICAL CO.,LTD – FDA 483, Apr 24, 2026

An FDA inspection of Changchun GeneScience Pharmaceutical Co., Ltd. in Changchun, China, revealed significant deficiencies in aseptic processing, quality control, and production procedures for sterile drug products. Observations included inadequate validation of aseptic processes, failure to thoroughly investigate discrepancies like mold contamination and out-of-specification results, and deficiencies in microbiological contamination prevention. The firm also lacked adequate written procedures for visual inspection and failed to establish the accuracy of test methods.