Sanofi Pasteur gets warning from FDA on sterillty problems at US vaccine plant
Sanofi Pasteur, the vaccines subsidiary of leading French pharmaceutical group Sanofi-Aventis, has received a warning letter from the US Food and Drug Administration relating to sterility problems at its manufacturing plant in Swiftwater, Pennsylvania, which were discovered during an inspection over the period April 18-28.
During their inspection of the vaccines production facility, FDA investigators documented significant deviations from current Good Manufacturing Practices in the production of licensed biological agents and Fluzone monovalent concentrate batches.
However, the FDA did state that, at this time, the deficiencies noted in the inspection are not expected to significantly affect the availability of Fluzone for the 2006-7 influenza season.
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