China NMPA Drug Inspection - Gansu Xiaoling Biological Development Co., Ltd. - Dictamnus dasycarpus root bark

The Gansu Provincial Food and Drug Administration (PFDA) announced on January 29, 2018, the results of targeted supervision and sampling inspections of traditional Chinese medicine (TCM) decoction pieces. These inspections focused on products historically prone to non-compliance, adulteration, counterfeiting, or issues related to dyeing, weight-increasing, or sulfur fumigation. The regulatory framework for these actions included the "Drug Administration Law of the People's Republic of China," its implementing regulations, and the "Chinese Pharmacopoeia."Seventeen batches of TCM decoction pieces from various manufacturers, including Anhui Xiehecheng Pharmaceutical and Gansu Longmai Medicinal Materials, were found to be substandard. Common violations related to quality control parameters such as total ash content, extractive levels, content determination, physical properties, and identification, indicating issues with purity and authenticity.In response, the PFDA initiated control measures, including sealing and seizing substandard products, and mandating sampled units to suspend sales, cease use, and rectify the identified issues. Additionally, municipal and prefecture-level food and drug administration departments were instructed to investigate and prosecute illegal activities of producing and selling substandard drugs, referencing Articles 73, 74, and 75 of the *Drug Administration Law*. They are required to publicly disclose handling results for implicated enterprises within three months and report findings to the Provincial Bureau, reinforcing stringent oversight to ensure public medication safety.