Posted On:
September 16, 2009
Bayer Chastised For Bad Manufacturing Practices At YAZ Plant
It is not enough that their pills are dangerous—it now turns out that some of them may not even be effective. The FDA inspected Bayer’s Germany plant in March where drospirenone, the fourth-generation progestin, is created for Bayer’s top-selling YAZ and Yasmin birth control pills. Essentially, Bayer had been sampling their product and averaging the results, then delivering the averaged data to the FDA. Instead, Bayer should have been delivering the results of each sample of the product. Averaging increases the likelihood that the samples will pass efficacy muster.
A copy of the FDA’s letter to Bayer may be found on their website.
Comments
I have written a blog post that discusses FDA drug recall process regarding overseas production. If interested it can be found at http://drugrecalls.fda-drug-news.com/what-about-medical-device-and-drug-recalls-outside-the-us/
Posted by: Michael Thomas | October 16, 2009 3:58 PM