A pharmaceutical company that produced a faulty rabies vaccine had fabricated records to cover up illegal production methods, a special investigation team sent by the State Council discovered.
Changchun Changsheng Bio-tech Co, which is linked to the recent scandal over a rabies vaccine designed for human use, had mixed several batches of vaccine fluid and purified them in order to reduce costs, Xinhua News Agency reported on Friday.
Some of the vaccine liquid used in production was past its shelf life. The company was found to have fabricated the liquid's expiration date and conducted an experiment on mice with the raw liquid－a procedure that should be done on the final products.
To cover this up, it doctored production and quality test records, as well as the purchase invoices for the mice. All documents related to the case have been sealed, and the inspection team has collected 34 written testimonies.
Local police have found 60 computer hard disks that the company had intended to destroy. Top company officials, including the chairwoman surnamed Gao and 16 others, are now under criminal detention. The investigation will continue, the team said.
In another development, the Hubei Food and Drug Administration said on Friday that the production of substandard vaccines by Wuhan Institute of Biological Products Co was caused by equipment failure. The packing equipment experienced a temporary failure that led to the uneven distribution of effective elements in the doses, the administration said in a statement.
The company had produced a batch of 400,520 doses of substandard diphtheria, tetanus and whooping cough vaccine (DTaP) for infants. Health departments have arranged for children given the substandard vaccine to be revaccinated.
