China NMPA Drug Inspection - Anhui Hongkun Pharmaceutical Co., Ltd. - Scrophularia

In December 2021, the Heilongjiang Provincial Drug Administration released Announcement No. 16, detailing results from its annual drug quality sampling inspections of manufacturers, distributors, and healthcare users. The report identified five batches of non-compliant drugs failing to meet safety and quality standards. Involved manufacturers include Bozhou Shantang Traditional Chinese Medicine Pieces Co., Ltd., Anhui Jishantang Traditional Chinese Medicine Technology Co., Ltd., Anhui Mingze Pharmaceutical Co., Ltd., Anhui Hongkun Pharmaceutical Co., Ltd., and Shaanxi Yishengtang Pharmaceutical Co., Ltd. The primary violations involved traditional Chinese medicine pieces and Berberine Hydrochloride Tablets. Inspections revealed failures in physical characteristics and appearance, with some instances of insect infestation specifically attributed to improper storage at the facility level. Additionally, certain batches failed content determination tests, which measure the presence of active ingredients. These evaluations were governed by the Chinese Pharmacopoeia 2015 Edition. In response, the administration has ordered immediate risk control measures, including the suspension of sales and use of the affected products. Companies and medical units are required to investigate the root causes of these failures and implement corrective actions. Regulatory departments are also pursuing legal penalties against entities involved in the production or sale of substandard drugs.