Genzyme's Lyon plant gets FDA warning letter

The US Food and Drug Administration says that US biotechnology major Genzyme's plant in Lyon, France, is in breach of current Good Manufacturing Practice rules. The site, which manufactures bulk ingredients used to produce the firm's transplant drug Thymoglobulin (anti-thymocyte globulin [rabbit]), was subject to an FDA inspection earlier this year that identified key areas of concern. In its warning letter, the FDA detailed several violations, including that, on at least three occasions during 2006, microorganisms present in Thymoglobulin components had exceeded allowable limits and that the firm had failed to sufficiently investigate the matter. The agency also said that Genzyme had failed to adequately examine adverse events associated with Thymoglobulin bulk lot number 06TMG0080, which was produced at the facility. Genzyme spokesman Dan Quinn told the Wall Street Journal that the company "takes the FDA's concerns very seriously," and would work to address them.