News

Article

ePT--the Electronic Newsletter of Pharmaceutical Technology

Warning Letter: Genzyme’s Thymoglobulin Manufacture

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

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.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content