China NMPA Drug Inspection - Shanghai Qingpu Traditional Chinese Medicine Pieces Co., Ltd. - peach kernel

The National Medical Products Administration (NMPA) announced on July 14, 2022, the findings of drug testing identifying 19 batches of drugs from 16 companies that failed to meet regulatory standards. Key manufacturers cited include Ruiyang Pharmaceutical Co., Ltd. (Acetylcysteine Injection), Shanghai Diran Dancheng Pharmaceutical Co., Ltd. (Erythromycin Granules), and Tonghua Zhongsheng Pharmaceutical Co., Ltd. (Longze Bear Bile Capsules), among others. These issues pertain to drugs produced between 2018 and 2021, as indicated by batch numbers. The main violations encompassed critical quality parameters such as content determination, presence of hydrogen sulfide, issues with appearance and disintegration time, content uniformity, weight uniformity, microbial limits, prohibited pesticide residues, microscopic identification discrepancies, extractives, and carbonyl value. These failures were assessed against the "Drug Administration Law of the People's Republic of China" and various editions of the "Pharmacopoeia of the People's Republic of China," along with specific drug standards. In response, regulatory authorities have mandated immediate risk control measures, including suspending sales and use, and recalling the affected drugs. Companies are required to investigate the root causes of non-compliance and implement thorough rectification plans. Provincial drug regulatory bodies have been instructed to investigate suspected illegal activities and publicly disclose their findings, ensuring accountability and patient safety.