FDA 483 - Jiangsu Hansoh Pharmaceutical Group Co., Ltd

JIANGSU HANSOH PHARMACEUTICAL GROUP CO.LTD in Lianyungang, China, was cited for significant deficiencies across its manufacturing and quality control operations during an FDA inspection. The observations highlight a systemic lack of adherence to aseptic processing controls, inadequate environmental monitoring, and insufficient documentation for cleaning, equipment qualification, and laboratory investigations. These issues indicate a moderate to severe risk to product quality and patient safety, particularly for sterile drug products.