China NMPA Drug Inspection - Lijiang Huali Biotechnology Development Co., Ltd. - honeysuckle

The Yunnan Provincial Drug Administration issued its "2019 Issue 2 Announcement on Substandard Drug Quality" on December 10, 2019. This regulatory disclosure followed province-wide drug supervision and sampling inspections aimed at reinforcing public medication safety. The inspections identified quality deficiencies across a broad range of Traditional Chinese Medicine (TCM) products from numerous manufacturers.

Key companies cited for non-compliance include Anhui Wansheng Traditional Chinese Medicine Pieces Co., Ltd., Yunnan Suiming Biotechnology Development Co., Ltd., Kunming Daodi Traditional Chinese Medicine Slices Factory, Yunnan Jinfeng Pharmaceutical Co., Ltd., Yunnan Zongshun Biotechnology Co., Ltd., and Kunming Jingtian Pharmaceutical Co., Ltd., among others. The primary regulatory framework for these assessments was the 2015 edition of the Chinese Pharmacopoeia, Part I, with some references to the 2010 edition and Yunnan Provincial Standards.

The main violations encompassed substandard physical properties such as appearance defects, improper processing, and presence of mold spots or insect eggs. Other issues included failures in specific analytical tests for total ash, impurities, sulfur dioxide, heavy metals, and incorrect content determination for active ingredients. This announcement serves as a critical regulatory measure, signaling to manufacturers and distributors the necessity to promptly address these significant quality control failures and adhere to pharmaceutical standards, ultimately strengthening drug quality supervision throughout the province.