The State Drug Administration launched an investigation of Changchun Changsheng Bio-tech Co, which was found fudging production records for freeze-dried rabies vaccines for human use. Those suspected of violating relative laws will be transferred to public security departments.
The Administration found that the company's freeze-dried human rabies vaccine production had record violations, such as changing the vaccine production line's technological parameter.
Such activities are in complete violation of the country's drug management law and the related regulation on drug production, an official from the administration said.
The company has stopped producing its human rabies vaccine and the administration has revoked its Drug GMP Certificate (Certificate No.: JL20180024).
The administration confirmed that the company's other vaccines available in the market have been tested and do not have quality problems. To avoid any possible loophole, the administration has launched further tests on vaccine samples kept by the company.