Changchun firm told to halt vaccine production

China's FDA has ordered major vaccine maker Changsheng Life Sciences Co to stop production after it was found to have violated standards in making rabies vaccine for humans.

China’s Food and Drug Administration issued a statement yesterday saying that it had found Changchun Changsheng Life Sciences, China’s second-biggest rabies vaccine producer, seriously violating the law by fabricating production and product inspection records, and arbitrarily changing process parameters and equipment.

CFDA’s deputy minister Xu Jinghe said the agency was investigating the company and suspected crimes would be handled by the public security department. 

Xu said that all vaccine producers would be inspected and any violations would be dealt with seriously.

The country’s watchdog has already asked Changsheng Life Sciences to terminate the production of its Vero-cell rabies vaccines, Xu added.

The announcement came after authorities carried out a snap inspection and found the company forging production data and violating the country’s drug production quality management procedures.

CFDA has also asked the provincial food and drug administration of Jilin, where the company is based, to revoke Changchun Changsheng’s certificate for Good Manufacturing Practice. The certificate is internationally recognized for drug production.

CFDA said that the batch of rabies vaccines investigated is not in the market and had been put under “effective control.” Inspectors from both state and provincial food and drug administrations have been stationed at the company for further investigation.

Shenzhen-listed Changsheng Biotechnology, the parent company of Changsheng Life Sciences, has made a public apology and voluntarily recalled all their vaccines from the market. 

The company said the recall would cost the company over 200 million yuan (around US$30 million). 

Zhao Chunzhi, secretary of Changsheng Biotechnology’s president, was quoted by China Securities Journal as saying that sales revenue from rabies vaccine products accounted for half of Changchun Changsheng’s gross revenue. This is not the first time Changsheng Biotechnology and its subsidiaries have been involved in drug safety scandals. 

Last year, a batch of vaccines for children against whooping cough, diphtheria and tetanus failed to meet the standards on biological potency. 

On July 18 this year, Jilin provincial food and drug administration announced the result of investigation into Changchun Changsheng’s DTaP vaccine. 

According to that report, 252,600 vaccines in the batch had been sold to disease control and prevention centers throughout east China’s Shandong Province.

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