China NMPA Drug Inspection - Anhui Huairentang Pharmaceutical Co., Ltd. - lotus seeds

The Hunan Province Food and Drug Administration published its 6th Drug Quality Bulletin for 2017 on November 22, 2017, detailing the outcomes of random inspections conducted to bolster drug quality oversight and safeguard public health. These inspections encompassed various drug production, distribution, and user facilities throughout the province. From a total of 903 drug batches sampled, 69 batches were identified as substandard, while 834 batches conformed to the established standards. The non-compliant batches, predominantly Traditional Chinese Medicine (TCM) raw materials and processed pieces, originated from multiple manufacturers and distributors, including entities such as Hunan Hengyue Chinese Medicine Pieces Co., Ltd., Anhui Huilong Traditional Chinese Medicine Slices Co., Ltd., and Hunan Nanguo Yaodu Traditional Chinese Medicine Pieces Co., Ltd. Key violations involved failing to meet quality specifications outlined in the *Chinese Pharmacopoeia* (2015 and 2010 editions) and the *Hunan Provincial Chinese Medicinal Materials Standard 2009*. Frequently observed issues included elevated sulfur dioxide residue, excessive moisture, improper total ash and acid-insoluble ash levels, deviations in macroscopic properties, and deficiencies in microscopic or thin-layer chromatography identification. Regulatory authorities initiated control measures, including the sealing and seizure of non-compliant products. In accordance with Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, municipal and prefectural food and drug administrations were directed to investigate the implicated enterprises, issue risk control measures within one week, and publicly announce the handling results within three months. Cases involving suspected counterfeit drugs were to be transferred to public security departments for criminal investigation.