FDA Requires Third Party Inspector to Meet Quality Standards

FDA Requires Third Party Inspector to Meet Quality StandardsOn Wednesday, Genzyme Corp. said that U. S. Food and Drug Administration would need a third party inspector to make sure that all the drug quality standards are met.

According to the news this afternoon, the shares of Genzyme had dropped by 4% at $55.25.

Genzyme said that on Tuesday, the FDA had informed the company's chronic production problem in Allston and regulatory action would be taken. It was also told that the plant would be under third party inspection.

Reports from Dow Jones Newswire showed that in the conference, which was held on Wednesday, executives of Genzyme said that they didn't know about the decree's financial impact until details of action have been worked out with regulators.

For many months there had been problems with the Allston plant. Last year, there was a shortage worldwide in two of Genzyme's top selling drugs, Cerezyme and Fabrazyme, because the production was temporarily ceased.

Carl Icahn said in February, at the annual meeting, that he had plans to nominate four directors at Genzym, and also said that he might push for a sale of the biotech group.

Genzyme's next annual meeting is scheduled for May 20.