China NMPA Drug Inspection - Anhui Tongtai Tuozutang Pharmaceutical Co., Ltd. - Longan pulp

The Guangxi Zhuang Autonomous Region Food and Drug Administration (GFDA) issued its eighth drug quality announcement of 2018, summarizing findings from drug quality sampling inspections completed by August 31, 2018. These inspections, part of the provincial drug sampling plan, aimed to bolster drug quality oversight and ensure public medication safety. The regulatory framework for assessing drug quality primarily relied on the Chinese Pharmacopoeia (2010 and 2015 editions), supplemented by specific provincial and regional standards for traditional Chinese medicine processing.

The inspections identified 18 batches of drugs failing to meet established quality standards. This included one batch of Dextromethorphan Tablets from Guangxi Shibiao Pharmaceutical Co., Ltd., which exhibited non-compliant properties. Additionally, 17 batches of Traditional Chinese Medicine (TCM) decoction pieces from various manufacturers—including Jiangxi Zhangshu Chengfang, Xinyi Anran, Jiangxi Bairen, Huazhou City Huacong, Guangxi Jiajin, Guangxi Guigang City Lvzhiyuan, Anhui Tongtai Tuozutang, and Jiangxi Qirentang—were found to be non-compliant. Common violations for TCM products encompassed failures in "Properties," "Identification" tests (microscopic and chemical), "Appearance," "Sulfur dioxide Residue," and "Moisture content."

In response, the GFDA has instructed local food and drug administrations to implement immediate control measures, such as sealing, seizing, and suspending the sale of the substandard drugs. Furthermore, investigations will be conducted, and appropriate legal actions will be taken against the entities responsible for supplying these non-compliant products.