China NMPA Drug Inspection - Chen Shantang Biopharmaceutical Co., Ltd. - chrysanthemum

The State Food and Drug Administration (SFDA) announced on April 20, 2017, the discovery of 33 batches of unqualified traditional Chinese medicine (TCM) decoction pieces produced by 30 companies, including Kangmei Pharmaceutical Co., Ltd. Testing by the Anhui Provincial Institute for Food and Drug Control and the Hebei Provincial Institute for Drug Control revealed significant quality issues. Thirty-two batches of chrysanthemum from various manufacturers were found substandard regarding active component content determination and appearance (properties). Additionally, one batch of Forsythia suspensa from Beijing Yawei Traditional Chinese Medicine Pieces Co., Ltd. failed content determination tests. These violations indicate potential issues with ingredient quality, processing, or storage, impacting the efficacy and safety of the medicines. Operating under the "Drug Administration Law of the People's Republic of China" (Articles 73, 74, 75), provincial food and drug administrations initiated immediate control measures. These actions included sealing products, suspending sales and use, ordering recalls, and mandating rectifications. The SFDA further required thorough investigations into the production and sale of non-compliant drugs, demanding public disclosure of resolution within three months and severe penalties for confirmed manufacturers. Companies also maintain the right to object to product authenticity, triggering further verification. This announcement underscores the regulatory commitment to ensuring the quality and safety of traditional Chinese medicines.