China NMPA Drug Inspection - Gansu Fuzheng Pharmaceutical Technology Co., Ltd. - traditional Chinese medicine

On March 7, 2022, the Gansu Provincial Drug Administration issued a formal suspension order against Gansu Fuzheng Pharmaceutical Technology Co., Ltd. following a surprise regulatory inspection. The inspection revealed that the company’s manufacturing processes for traditional Chinese medicine failed to comply with the Good Manufacturing Practice for Pharmaceuticals (2010 Revision). The regulatory body identified significant potential risks concerning product quality and safety during the manufacturing phase, which necessitated immediate intervention. Under the authority of Article 99, Paragraph 3 of the Drug Administration Law of the People's Republic of China, the provincial administration has mandated the immediate suspension of all production activities related to traditional Chinese medicine at this facility. This enforcement action, published on March 8, 2022, serves as a protective measure to mitigate risks to public health. The company is required to halt operations immediately to address the identified compliance gaps and ensure that all safety standards are met before production can potentially resume. This case highlights the rigorous oversight by the National Medical Products Administration (NMPA) and its provincial branches in maintaining the integrity of pharmaceutical manufacturing.