Warning Letter: Genzyme’s Thymoglobulin Manufacture

Rockville, MD (Sept. 19)-The US Food and Drug Adminstration’s Center for Biologics Evaluation and Research issued a Warning Letter to Genzyme (Cambridge, MA). The citation centered on the June 2007 inspection of the manufacture of  “Thymoglobulin” (anti-thymocyte globulin [rabbit]) by Genzyme Polyclonals (Lyon, France).

The letter noted significant deviations from current good manufacturing practices (CGMP) regulations, including applicable requirements of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Specifically, the investigation revealed that the company’s ingredients had exceeded the endotoxin action limit and that these substances used in formulations were ultimately shipped to and distributed within the United States. In addition, the facility “on several occasions … continued to use components and intermediates that failed in-process limit for bioburden and presence of pathogenic microorganisms and [the facility] did not conduct sufficiently comprehensive investigations of these failures.”

The company was also cited for failure to control its purified water system used to manufacture the bulk lots and for its failure to investigate adequately reported adverse events.

The complete Warning Letter can be viewed here.