China NMPA Drug Inspection - Xi"an Boai Pharmaceutical Co., Ltd. - Nifedipine tablets

On December 28, 2020, the Henan Provincial Drug Administration issued an announcement regarding 15 batches of drugs that failed to meet quality standards during provincial inspections. The report identified several companies, including Henan Shanghuatang Pharmaceutical Co., Ltd., Pingdingshan Zhonghuatang Traditional Chinese Medicine Pieces Co., Ltd., and Bozhou Zhongqiang Traditional Chinese Medicine Pieces Co., Ltd. The inspections covered various production, distribution, and clinical facilities across the province. The primary violations involved deviations from the Chinese Pharmacopoeia (2015 and 1990 editions). Specific issues included improper physical properties, excessive mineral impurities (total ash), and failure to meet the required concentration of active ingredients. Notable cases involved Nifedipine tablets with excessive impurities and an instance where a manufacturer denied producing a specific batch of herbal medicine, indicating potential counterfeiting. Following these findings, the regulatory authority mandated several immediate actions. These include the suspension of sales and use of the substandard batches, the initiation of product recalls, and an investigation into the root causes of the quality failures. The provincial administration is also pursuing legal penalties against the responsible parties and requires a thorough rectification process to ensure future compliance with national pharmaceutical safety standards.