St. Louis: lifting of the Warning Letter for the Virbac production site
Friday, December 16, 2016
Virbac announces that it has received from the Food and drug administration (FDA) a communication confirming the lifting of the Warning Letter received in December 2015 for its St. Louis production site (Missouri, USA).
This announcement allows the St. Louis production site to fully recover its cGMP (current Good manufacturing practice) status and beyond that, gives it the opportunity to file new registration and variation files with the FDA. This also allows Virbac to continue the transfer of production of Sentinel® Spectrum® to the St. Louis manufacturing site as originally planned. The resumption of production of historical products, requiring no variation, had started as early as mid-2015 and has continued steadily since 2016. Virbac takes advantage of this communication to indicate that, given the latest available data, net sales growth in 2016 should be around the low end of the band reported in September 2016 (4.5% to 6.5%).
"The lifting of the warning letter from our site in St. Louis reflects the work carried out over many months to improve our quality system as well as the quality of our operational teams that we have today on site. We have worked diligently and closely with the FDA throughout this period to respond to the observations that followed the inspection of December 2014 and have considerably strengthened the quality culture of our site", said Éric Marée, chairman of the Virbac executive board.