China NMPA Drug Inspection - Sichuan Xinrentai Pharmaceutical Co., Ltd. - Longan pulp

On August 16, 2021, the Sichuan Provincial Drug Administration issued Announcement No. 9 of 2021, identifying three batches of drugs that failed to meet national quality standards. The inspections, carried out by regional testing institutes, named three specific companies involved in the non-compliance: Shanxi Jinhua Huixing Pharmaceutical Co., Ltd., Sichuan Xinrentai Pharmaceutical Co., Ltd., and Panzhihua Xinli Traditional Chinese Medicine Pieces Co., Ltd. The primary violations included a batch of Omeprazole enteric-coated capsules failing dissolution rate tests, Longan pulp exceeding moisture content limits, and Poria cocos peel failing standards for total ash and acid-insoluble ash content. These failures indicate issues with how the drugs are absorbed by the body or their overall purity and stability. Following the framework of the Drug Administration Law of the People's Republic of China, the regulatory authority has ordered the companies to immediately suspend sales, halt use, and recall the affected batches. Additionally, the enterprises must investigate the root causes of these quality failures and implement effective rectification plans. Local regulatory departments have been instructed to conduct formal investigations into the production and sale of these substandard products and to publicly disclose their findings to ensure consumer safety and industrial accountability.