China NMPA Drug Inspection - Anhui Fangshi Pharmaceutical Co., Ltd. - yam

On August 18, 2020, the Shanxi Provincial Drug Administration published the results of its annual drug quality sampling and inspection program, identifying ten batches of pharmaceutical products—primarily Traditional Chinese Medicine pieces—that failed to meet regulatory standards. The inspections involved multiple manufacturers, including Anhui Zhenghetang, Anhui Huadingtang, Anhui Jucaotang, Anhui Fangshi Pharmaceutical, Shanxi Guotai Traditional Chinese Medicine, Anhui Daxibei Traditional Chinese Medicine, and Anhui Zhushi Kanghao. The identified quality failures spanned several categories: substandard physical appearance, improper extractive levels, excessive total ash content, and failures in microscopic identification. Notably, several batches of products such as Kudzu root and Phellodendron bark failed content determination tests, which measure the concentration of active ingredients. These inspections were conducted under the provincial administration's regulatory framework to ensure public safety and oversee the integrity of the drug supply chain from production to clinical use. Following the findings, the regulatory authorities have launched formal investigations into the non-compliant entities. The involved companies and healthcare providers, including various local pharmacies and hospitals, are required to take immediate risk management steps. These actions include the suspension of all sales and usage of the affected batches, alongside the execution of mandatory product recalls to prevent potential harm to patients.