The State Food and Drug Administration's flight inspection of Changchun Changsheng found illegal acts and promptly controlled the rabies vaccine involved and did not flow to the market.


Release time:

2018-07-16

On July 15, the State Drug Administration announced: Recently, the State Drug Administration organized an inspection team based on clues to conduct unannounced inspections on the production site of Changchun Changsheng Biotechnology Co., Ltd. (hereinafter referred to as "Changchun Changsheng"). The inspection team found that Changchun Changsheng had serious violations of the "Good Manufacturing Practice for Drugs" (GMP) in the production process of freeze-dried human rabies vaccine. According to the inspection results, the State Food and Drug Administration quickly instructed the Jilin Provincial Food and Drug Administration to withdraw the relevant "Drug GMP Certificate" of Changchun Changsheng. All batches of products involved in this flight inspection have not yet been shipped and marketed, and all products have been effectively controlled.

The circular makes it clear that at present, the State Food and Drug Administration has asked the Jilin Provincial Bureau to take back Changchun Changsheng's "Drug GMP Certificate" (certificate number: JL20180024), order enterprises to stop rabies vaccine production, and instruct enterprises to strictly implement their main responsibilities, comprehensively investigate hidden risks, and take the initiative to take control measures to ensure the safety of drug use by the public. The relevant investigation team of Jilin Provincial Bureau has been stationed in Changsheng, Changchun, to investigate the relevant violations of laws and regulations. At the same time, the State Food and Drug Administration sent a special inspection team to Jilin to supervise the investigation and disposal work.

The reporter further learned from the State Food and Drug Administration that since its establishment in April this year, the State Food and Drug Administration has conscientiously implemented the decisions and arrangements of the CPC Central Committee and the State Council, adhered to the concept of people-centered development, and resolutely implemented the "four strictest" requirements of General Secretary Xi Jinping, supervise and urge enterprises to implement the main responsibility of quality and safety, and make every effort to ensure the safety and effectiveness of drug use by the people. In response to the flight inspection found that Changchun Changsheng had violated laws and regulations in the production quality management, the special inspection team of the State Food and Drug Administration clearly stated, "We will never tolerate it, and resolutely investigate and deal with it in accordance with laws and regulations. Those suspected of constituting a crime will be transferred to the public security organs. Severely punished".