Novartis warned as facility fails inspection
significant failures in its investigation into tracking down the
source of contamination in some of its vaccines.
In a warning letter, the received Food and Drug Administration's Center for Biologics Evaluation and Research cited failures in keeping to manufacturing standards that hark back to those that plagued Chiron (now owned by Novartis) and forced the company to withdraw a big-selling flu vaccine from the market in 2005. The latest problems have occurred at the Marburg plant in Germany in the manufacture of several vaccines including rabies vaccine (RabAvert), diphtheria and tetanus toxoid concentrates. The FDA conducted an inspection at the plant in September 2007 because problems had been flagged and found "a number of significant deviations from current good manufacturing practices (cGMP)". Problems have been highlighted in several areas including:
Production and process control (sterility failures and contamination as well as problems with media, validation and stability studies)
Sterility failure investigations being incomplete (failure to track down the source and cause of the contamination)
Problems with the maintenance and cleaning of equipment (cleaning procedures have not been validated and set in place)
Novartis has been given 15 days to respond to the Warning Letter. It has been asked to explain how they "will attain cGMP compliance with regard to bulk lot production and process controls and investigations". Through its acquisition of Chiron for $2.3bn in 2005, Novartis also now owns the Speke facility on Merseyside in the UK, which was at the centre of the flu vaccine problems. Other contamination events have also been seen (Medeva vaccines polio vaccine in 2000), but this was long before Novartis acquired the site. Recently it was reported that the Speke site had produced a record of 50m doses of flu vaccine at the plant. However this was accompanied by a 42 per cent fall in net profits for the company. This has been blamed on market conditions and the costs of restructuring. The Speke site itself is about to fall victim to restructuring with 130 of the 800 workers being made redundant by 2010. The plant has recently had $100m spent on upgrading it and so can produce more vaccines with less personnel. In the 2008-2009 season Novartis expects the facility to turn out 100 million doses of the flu vaccine for the US and UK/European markets.
