China NMPA Drug Inspection - Chengdu Lier Pharmaceutical Co., Ltd. - Ophiopogon japonicus

The Chongqing Municipal Food and Drug Administration (CFDA) published its 6th Drug Quality Announcement of 2017 on December 27, 2017. This bulletin details the results of city-wide drug sampling inspections conducted throughout 2017 to enhance drug quality supervision and ensure public safety. The inspection identified 32 batches of various traditional Chinese medicine pieces, from multiple manufacturers including Sichuan Kailihe Pharmaceutical Co., Ltd., Sichuan Qianfang Traditional Chinese Medicine Pieces Co., Ltd., and Chengdu Dujiangyan Chunsheng Traditional Chinese Medicine Pieces Co., Ltd., that failed to meet quality standards. Main violations encompassed a range of issues such as non-compliant appearance, properties, identification (including thin-layer chromatography and microscopic identification), content determination, and the presence of unacceptable levels of substances like magnesium/aluminum salts, total ash, moisture, and sulfur dioxide residue. The regulatory framework for these inspections was primarily the Chinese Pharmacopoeia 2015 Edition, Part I, along with supplementary inspection methods approved by the State Food and Drug Administration (SFDA). The announcement serves to inform the public and market, implicitly necessitating corrective actions by the manufacturers to address the identified quality deficiencies and ensuring rigorous regulatory follow-up to uphold drug safety and market order.