China NMPA Drug Inspection - Bozhou Xinghe Pharmaceutical Co., Ltd. - Dictamnus dasycarpus root bark

On May 23, 2018, the Gansu Provincial Food and Drug Administration, operating under China's National Medical Products Administration (NMPA) framework, issued an announcement detailing the results of targeted supervision and sampling inspections. The inspections, conducted throughout the province, focused on traditional Chinese medicine decoction pieces with a history of non-compliance, prominent issues of adulteration, counterfeiting, or improper processing techniques such as dyeing, weight alteration, or sulfur fumigation. The regulatory framework for these inspections included the "Drug Administration Law of the Republic of China," its implementing regulations, and the "Chinese Pharmacopoeia" (2010 and 2015 editions). A total of 29 batches of traditional Chinese medicine decoction pieces, originating from various manufacturers including Gansu Longxi Baibao Pharmaceutical Co., Ltd., Taiantang (Bozhou) Traditional Chinese Medicine Pieces Co., Ltd., and Bozhou Xinghe Pharmaceutical Co., Ltd., were found to be substandard. Main violations encompassed failures in "Properties," "Inspection," "Identification," "Content Determination," "Extractives," "Characteristics," "Total Ash," and "Appearance," indicating significant quality control deficiencies. In response, relevant food and drug administration departments initiated control measures, including sealing and seizing the substandard products. Sampled units were mandated to suspend sales and use, and to rectify the issues. Additionally, municipal and prefecture-level authorities were directed to investigate and prosecute illegal activities under Articles 73, 74, and 75 of the Drug Administration Law. They are required to publicize handling results for implicated enterprises within three months and report findings to the Provincial Bureau, ensuring public safety and regulatory compliance.