China NMPA Drug Inspection - Gansu Hot Spring Biotechnology Co., Ltd. - Arrowroot

The Gansu Provincial Drug Administration issued an announcement on August 7, 2019, detailing drug quality deficiencies identified through inspections by the Lanzhou Municipal Food and Drug Inspection Institute. The inspections revealed that ten batches of drugs from nine different manufacturers, including Jiangxi Guodu Traditional Chinese Medicine Pieces Co., Ltd., failed to meet established quality standards. The primary violations involved non-compliance with the Chinese Pharmacopoeia 2015 Edition, Part I. Specific issues included discrepancies in physical properties such as appearance, texture, and odor for several products, including Bupleurum, Cuttlebone, and Honey-processed Angelica dahurica. Additionally, some drugs like Eupolyphaga sinensis exhibited excessive total ash content, indicating impurity issues. A significant concern was the detection of non-compliant sulfur dioxide residue in products such as Achyranthes bidentata, Pueraria lobata, and Trichosanthes kirilowii, suggesting improper processing. In response, market supervision departments implemented control measures, including product sealing and seizure. Investigations have been launched against the implicated entities, with results slated for public release within three months. Furthermore, municipal and prefectural market supervision bureaus are tasked with intensifying oversight, compelling manufacturers to identify root causes, implement corrective actions, and mitigate all associated risks to ensure drug safety and quality.