Chinese vaccine manufacturer fined for substandard product
Penalty in addition to previous fine imposed six months ago
Chinese company Jiangsu Yanshen Biological Technology Stock Co, in which US pharma manufacturer Simcere Pharmaceutical Group holds a 52.5% controlling stake, has been found liable for producing and selling inferior quality products by the People's Court of Tianning District, Changzhou City and sentenced to a fine of RMB4.6m (€531,000).
The fine consists of penalties and confiscated revenues from previous sales of substandard human-use rabies vaccine and is in addition to the RMB25.6m (€3.0m) administrative fine imposed by the Changzhou Food and Drug Administration in May 2010. Six members of Jiangsu Yanshen's former management team were also found guilty and received individual penalties.
Simcere obtained a controlling stake in Jiangsu Yanshen in November 2009, and subsequently discovered quality control problems relating to the production of its human-use rabies vaccine manufactured in 2008, prior to Simcere's stake acquisition. Last November, Simcere urged the board of Jiangsu Yanshen to replace its general manager and head of quality assurance and demanded that Jiangsu Yanshen implement a total suspension of production effective from 30 November 2009 to facilitate an internal inspection and rectification of its quality control systems.
Jiangsu Yanshen's operations remain suspended until further notice and it is uncertain when it will resume vaccine production.