China NMPA Drug Inspection - Bozhou Xinghe Pharmaceutical Co., Ltd. - Haijinsha

The Gansu Provincial Food and Drug Administration in China published an announcement on July 5, 2018, detailing the results of targeted supervision and sampling inspections of traditional Chinese medicine (TCM) decoction pieces. These inspections, conducted prior to the announcement date of June 22, 2018, focused on products previously identified with high non-compliance rates, concerns regarding adulteration or counterfeiting, and issues like dyeing or sulfur fumigation. Adherence was evaluated against the "Drug Administration Law of the People's Republic of China," its implementing regulations, and relevant editions of the Chinese Pharmacopoeia. Inspections revealed 26 non-compliant batches from numerous manufacturers and suppliers. Primary violations included failures in "Properties" (e.g., macroscopic or microscopic characteristics), "Content Determination" (e.g., active ingredient levels), "Identification," "Total Ash," and "Sulfur dioxide residue," indicating widespread quality and purity issues. In response, relevant food and drug administration departments implemented control measures such as sealing and seizing affected products, instructing companies to halt sales and use, and demanding rectification. Additionally, municipal authorities are mandated to investigate and prosecute these violations under the Drug Administration Law, with findings to be publicly disclosed within three months. This action reinforces the regulatory commitment to ensuring the quality and safety of TCM products for public health.