China NMPA Drug Inspection - Anhui Haoyuan Pharmaceutical Co., Ltd. - Bupleurum

The Shandong Provincial Food and Drug Administration issued an announcement on July 25, 2017, detailing quality inspection failures for 14 batches of drugs and traditional Chinese medicine (TCM) decoction pieces. The inspections, carried out by several drug testing institutions, found significant deviations from established quality standards, primarily referencing the Chinese Pharmacopoeia.

Shijiazhuang Northern Pharmaceutical Co., Ltd. was cited for one batch of Antiviral Oral Liquid which failed an inspection for its characteristic spectrum. Additionally, thirteen batches of various TCM decoction pieces from ten different manufacturers were found substandard. These manufacturers include Anguo Tongkang Pharmaceutical Co., Ltd., Bozhou Huayun TCM Decoction Pieces Co., Ltd., Anhui Guangyintang TCM Co., Ltd., Jinan Hebao TCM Co., Ltd., Anhui Yaozhiyuan TCM Decoction Pieces Co., Ltd., Anhui Yiyuan Pharmaceutical Co., Ltd., Bozhou Hongda TCM Decoction Pieces Technology Co., Ltd., Bozhou Baishi TCM Decoction Pieces Co., Ltd., Jiuquan Peifeng TCM Ecological Planting and Processing Co., Ltd., and Shandong Shangdu Pharmaceutical Co., Ltd. Common issues among these TCM products involved failures in content determination, properties, identification, moisture levels, and the presence of impurities like sulfur dioxide residue. A notable aspect is that some manufacturers denied producing the identified substandard TCM pieces.

In response, municipal food and drug administrations initiated immediate control measures including product sealing, seizure, sales suspension, and recalls. Furthermore, regulatory bodies are conducting investigations into the implicated manufacturers and distributors. The announcement mandates strengthened ongoing supervision of these products and enterprises, urging them to identify root causes, implement corrective actions, and mitigate future risks.