China NMPA Drug Inspection - Jilin Chunbai Pharmaceutical Co., Ltd. - Fukang tablets

On September 21, 2020, the Jiangxi Provincial Drug Administration published its fourth inspection report of the year, identifying quality failures in 13 batches of 11 drug varieties. These supervision and sampling inspections were conducted under the framework of the Chinese Drug Administration Law and the 2015 Edition of the Chinese Pharmacopoeia to ensure public medication safety across the province's production and distribution networks. Several companies were cited for non-compliance, including Jilin Mizhikang Pharmaceutical, Jiangsu Pingguang Pharmaceutical, Jilin Ji'an Yisheng Pharmaceutical, and various traditional Chinese medicine producers such as Anhui Wansheng and Jiangxi Hongjie. The primary violations identified involve physical and chemical discrepancies, specifically regarding improper moisture content, failed dissolution rates, weight variations, and the presence of visible foreign matter in injections. Additionally, some herbal products failed tests for microscopic identification, total ash levels, and purity standards. Following these findings, the regulatory authority has mandated immediate corrective actions. Relevant departments are required to seal, seize, and suspend the sale of non-compliant batches, while also initiating mandatory product recalls. The Jiangxi Provincial Drug Administration has further directed that the manufacturers and distribution units involved be investigated and penalized according to relevant laws. These measures aim to remove substandard products from the market and hold responsible parties accountable for quality deviations.