The Chinese SFDA has found that four batches of rabies vaccine produced by Jiangsu Yanshen contained insufficient quantities of API and is investigating the conduct of some employees, according to Simcere.
A controlling stake in Jiangsu Yanshen was acquired by Simcere in October 2009. Simcere has now reported that authorities discovered illegal activities, including inadequate quality control processes and misrepresentation and avoidance of regulatory inspection, at Jiangsu Yanshen.
Failings in the quality control system led to the release between July and October 2008 of four batches of human use rabies vaccines which contained insufficient quantities of active pharmaceutical ingredients (API).
The Chinese State Food and Drug Administration (SFDA) and other authorities are investigating the issue. Simcere reported that employees responsible for the problems are under criminal investigation and Jiangsu Yanshen may be subject to administrative penalties and prosecution.
Enforcement actions could lead to material economic loss at Jiangsu Yanshen. The size of this loss is difficult to estimate but could have a negative impact on Simcere’s financial results, the company added.
Quality control issues under investigation occurred before Simcere took a controlling stake in Jiangsu Yanshen.
Acquisition by Simcere
Simcere discovered quality control problems at Jiangsu Yanshen after it acquired a controlling stake. When it found the problems Simcere urged Jiangsu Yanshen’s board to replace its general manager and head of quality assurance and demanded a suspension of production.
Jiangsu Yanshen is yet to resume production and Simcere believes it is uncertain whether it will restart vaccine manufacture. Since suspending production Jiangsu Yanshen has cooperated with authorities and the vaccine batches have not been linked to adverse events, added Simcere.