China NMPA Drug Inspection - Hubei Zhengguang Jiuzihe Pharmaceutical Co., Ltd. - Ophiopogon japonicus

The Chongqing Municipal Drug Administration, in an announcement dated November 22, 2019, reported significant quality control failures involving 45 batches of drugs, predominantly traditional Chinese medicine products and raw materials. These non-compliant items were sourced from 28 companies, including Chengdu Jiankang Pharmaceutical Co., Ltd., Yibin Renhe Traditional Chinese Medicine Pieces Co., Ltd., and various suppliers in the Chongqing Traditional Chinese Medicine Professional Market. Inspections by five regional drug testing institutions identified a range of critical violations against established quality standards. Primary issues included "Content Determination" failures, meaning products like Mulberry leaves, Oyster, and Epimedium brevicornu lacked the specified active ingredient levels crucial for efficacy. Many products also did not meet "Appearance/Properties" standards, exhibiting issues such as mold on Anemarrhena asphodeloides, or failing "Identification" tests, raising concerns about authenticity for items like Cremastra appendiculata. Furthermore, "Inspection" criteria were violated, indicating deficiencies in purity, uniformity, or presence of excessive impurities (e.g., sulfur dioxide residue), while some products like Hydrangea macrophylla contained excessive "Extractives." The regulatory framework for these assessments primarily consisted of the Chinese Pharmacopoeia (2015 and 2010 editions) and specific provincial/municipal processing standards for traditional Chinese medicine. As a result of these findings, the Administration has mandated immediate regulatory actions. These include sealing, seizing, suspending sales, and recalling all identified non-compliant drugs, with further legal enforcement to follow.