The China Food and Drug Administration (CDFA) ordered an investigation of Changsheng Biotechnology’s vaccination facility, after inspectors observed illegal production methods during a site visit earlier this month.
According to state-run Xinhua News Agency, China’s investigators seized 1,138 pages of documents and located forged production records from Changsheng Biotechnology’s computers.
Xinhua reported the firm had violated the “approved production process” in an attempt to reduce manufacturing costs and improve the success rate of rabies vaccine production.
“Violations included blending different batches of vaccine fluid for product packaging, using expired fluid to produce some batches of products, falsifying dates of production, and conducting certain product testing before the entire production process was completed.
“To cover up such violations, the company ‘systematically’ fabricated production and inspection records and issued invoices with false dates to meet inspection requirements,” according to Xinhua.
Last week, we reported that Chinese Premier Li Keqiang had spoken out against the firm, stating it had “crossed a moral line.”
“The whole industrial chain covering vaccine production and sales must be examined thoroughly to discover the truth as quickly as possible,” he added in a statement.
The CDFA’s criticism of Changsheng Biotechnology’s practices has since prompted concern over the integrity of the nation’s domestic vaccine market.