The State Administration of Pharmaceutical Products announced yesterday that in July 2008, seven batches of human rabies vaccine ***2 1.58 million people produced by Hebei Fuer Biopharmaceutical Co., Ltd. and Jiangsu Yanchang Biotechnology Co., Ltd. had quality problems.
At present, the drug supervision departments in Hebei and Jiangsu have filed investigations on these two enterprises. The drug supervision department has ordered the two companies to stop the production and sale of all products such as rabies vaccine for human use, and organized experts to evaluate the possible risks caused by the problem vaccine. According to the investigation results, the drug supervision department will seriously investigate and deal with it according to law, and those suspected of committing crimes will be handed over to the public security organs for criminal responsibility.
Seven batches of vaccines involving quality problems have been identified and published on the website of the State Administration of Medical Products.
In the supervision and inspection of rabies vaccine for human use, the State Food and Drug Administration of the United States found that there were quality problems in seven batches of rabies vaccine for human use produced by Yanchang Company and Foer Company from July last year to 10, but did not explain what kind of quality problems were.
These seven batches of vaccines are the vaccines with batch numbers of 2008 10F0 1, 20080732, 20080834 and 20080837 produced by Tuo Company and the vaccines with batch numbers of 20080753, 20080758 and 200807540 10 produced by Foer Company respectively.
According to the sales flow chart of seven batches of problematic vaccines provided by the US Food and Drug Administration, * * * 2 15832 people's problematic vaccines have been sold to Chongqing, Hebei, Ningxia, Guangxi, Jiangsu, Anhui, Fujian, Sichuan and other places.
2010 may 15 the state medical products supervision and administration announced the punishment.
On June 5438+05, China State Food and Drug Administration officially notified Jiangsu Yanchang Biotechnology Co., Ltd. and Hebei Fuer Bio-pharmaceutical Co., Ltd. of the administrative punishment results of the "rabies vaccine incident among problem people"
According to the investigation by the food and drug supervision department of Jiangsu Province and the local public security department, Yanchang Company has some illegal behaviors in the process of producing rabies vaccine for human use, such as cutting corners, practicing fraud and evading supervision, which makes unqualified products flow to the market. The penalty is to confiscate the inferior rabies vaccine illegally produced and sold by Tuo Company and the illegal income, and impose a fine of three times the value of the goods, totaling 25,637,905.6 yuan. At the same time, the approval number of Tuo Company to produce rabies vaccine for human use was revoked. Seven directly responsible supervisors and other directly responsible personnel of Yanchang Company who produce and sell inferior rabies vaccine shall not engage in drug production and business activities for 10 years. Suspected of a criminal offence, criminal responsibility shall be investigated by judicial organs according to law.
According to the investigation by the food and drug supervision department of Hebei Province and the local public security department, Foer Company has illegal operation in the process of producing rabies vaccine for human use, which leads to the unqualified quality of rabies vaccine for human use.
In this regard, the punishment imposed by the food and drug supervision department is: confiscate the inferior rabies vaccine and illegal income illegally produced and sold by Foer Company, and impose a fine of 3 times the value of heavy goods according to law, totaling 5,638,284 yuan; The two persons directly responsible shall not engage in drug production and business activities within 10 years. In addition, the US Food and Drug Administration also punished the two companies, such as revoking the GMP certificate of rabies vaccine for human use, and the two companies had to bear the cost of replanting their inferior rabies vaccines.
On June 5438+February, 2009, the State Food and Drug Administration notified the quality incident of rabies vaccine for human use produced by Yanchang Company and Foer Company. China Institute for the Control of Pharmaceutical and Biological Products found that the titer of seven batches of 265438+100000 rabies vaccine products produced by the two companies was lower than the national standard.
According to reports, after the "rabies vaccine incident for people with problems", the health department and the food and drug supervision department took timely control measures and ordered the two companies to stop producing and selling all products including rabies vaccine for people and recall related products. At the same time, check the direction of the problem vaccine, take replanting measures in time, and urgently dispatch a sufficient number of vaccines to the inoculation site for free replanting. Up to now, no reports of adverse events caused by the problem vaccine have been received.