medpundit |
||
|
Saturday, July 15, 2006Sanofi pasteur’s vaccine manufacturing plant in Pennsylvania, where half of America’s influenza vaccines are made, has been served with a warning letter by the US Food and Drug Administration (FDA), asking for measures to ensure batches of its flu shot ingredients do not become contaminated again. The warning letter follows a response of sanofi pasteur to the FDA regarding its inspection of the Swiftwater facility in April, when the regulator issued the company with a "483 form," a list of observations detailing failures in sterility testing and aseptic conditions. Chiron and the FDA went through a similar dance a few years ago, resulting in a shortage. Luckily, we can look to the southern hemisphere to see how things are likely to shake out this winter for those of us in the North. It's looking even milder than last year. posted by Sydney on 7/15/2006 11:30:00 PM 1 comments 1 Comments:Why there isn't enough influenza medication? By 8:51 AM , at |
|