China NMPA Drug Inspection - Anguo Lulutong Traditional Chinese Medicine Pieces Co., Ltd. - Astragalus

An announcement by the State Food and Drug Administration (SFDA) on June 2, 2017, detailed findings of substandard traditional Chinese medicine products. Inspections conducted by the China National Institutes for Food and Drug Control revealed that 12 batches of Astragalus membranaceus decoction pieces from 12 companies, including Xuzhou Pengzu Traditional Chinese Medicine Decoction Pieces Co., Ltd., were found to be unqualified. The primary issue identified was substandard appearance. In response, provincial food and drug administrations implemented immediate control measures, such as sealing and seizing the affected products. The implicated companies were mandated to halt sales, initiate product recalls, and implement corrective actions. The SFDA, operating under the Drug Administration Law of the People's Republic of China (specifically Articles 73, 74, and 75), further directed provincial authorities to investigate these enterprises for illegal production and sales activities. It was required that the outcomes of these investigations be publicly disclosed within three months, with reports submitted to the SFDA. The announcement also outlined a process for companies to dispute product authenticity, triggering additional investigations to trace sources and, if confirmed, result in severe penalties for manufacturers. This initiative underscores regulatory commitment to ensuring drug quality and safety in China.