China NMPA Drug Inspection - Anhui Xiehecheng Pharmaceutical Pieces Co., Ltd. - Codonopsis pilosula

The Shanghai Municipal Food and Drug Administration issued an announcement on June 26, 2017, detailing findings from its 2017 Issue 3 drug supervision and sampling program. This initiative aimed to enhance quality oversight, regulate market order, and ensure the safety of drugs and pharmaceutical packaging materials within the city. The inspections revealed multiple instances of non-compliance across various traditional Chinese medicine processed slices. Key violations, identified in products from manufacturers such as Shanghai Dehua Guoyao Products Co., Ltd., Anhui Huizhongzhou Traditional Chinese Medicine Slices Co., Ltd., and Henan Juren Traditional Chinese Medicine Pieces Co., Ltd., included failures related to Total Ash, Heavy Metals and Harmful Elements, Sulfur Dioxide Residue, Appearance, Processing, Moisture, Extractives, Impurities, and Content Determination. These issues indicate deviations from established quality and safety standards. The regulatory framework underpinning these findings primarily includes the *Drug Administration Law of the People's Republic of China*, along with specific requirements from the 2015 and 2010 editions of the Chinese Pharmacopoeia and the 2008 Shanghai Processing Regulations. In response, relevant sampling units and manufacturers are mandated to implement immediate control measures. These include suspending sales and use of non-compliant products, initiating recalls, and undertaking comprehensive rectification efforts. The administration will conduct further follow-up inspections and sampling, while local market supervision bureaus are tasked with strengthening daily oversight. Enterprises are required to investigate the root causes of non-compliance, formulate and execute corrective action plans, and eliminate potential risks to public health.