China NMPA Drug Inspection - Hainan Zhuotai Pharmaceutical Co., Ltd. - Paclitaxel Injection

The National Medical Products Administration (NMPA) issued Announcement No. 86 on September 7, 2018, detailing non-compliance found in 15 batches of drugs from 10 different manufacturers. This regulatory action followed extensive testing by multiple drug testing institutions, revealing significant quality control failures across various product types.Key violations included dissolution issues in Cetirizine Hydrochloride Tablets from Xinhua Pharmaceutical (Gaomi) Co., Ltd., which can impact drug absorption. Hainan Zhuotai Pharmaceutical Co., Ltd. and Taiji Group Sichuan Taiji Pharmaceutical Co., Ltd. faced issues with visible foreign matter in Paclitaxel Injection, posing potential safety risks. Traditional Chinese medicine products from companies like Anhui Huilong and Huazhou Guanghua were found to contain aflatoxin in Areca Nut, a serious safety concern, while Rehmannia glutinosa from Jiangsu Taxus chinensis and Anhui Bozhou Qiancao Guoyao showed deficiencies in content determination. Other violations involved incorrect disintegration times, high total ash, improper extractives levels, and excessive moisture content, indicating manufacturing process control deficiencies that could affect drug efficacy and stability.Under the "Drug Administration Law of the People's Republic of China," regulatory authorities implemented immediate control measures such as product sealing, seizure, sales suspension, and recalls. Furthermore, the NMPA mandated provincial authorities to investigate these companies for illegal activities related to producing and selling substandard drugs. Investigations were required to be completed, and results made public, within three months of receiving the inspection reports.