FDA to Re-inspect Genzyme Plant

Cambridge, MA-based Genzyme (NASDAQ: [[ticker:GENZ]]) announced today that the FDA will re-inspect the biotech giant’s Allston manufacturing facility, which was closed in June after a viral contaminant was spotted. Genzyme said it had finished sanitizing the plant, which produces two of its best-selling drugs, last week. In today’s press release, the company says the FDA inspection will not only review the results of the clean-up effort, but will also serve as a follow-up to an inspection of the plant conducted in May. That inspection was intended to assess whether Genzyme had completed certain “corrective and preventative actions” spelled out in a warning letter the agency sent Genzyme in February; in a letter to Genzyme yesterday, the FDA said that the May inspection found that those actions had not all been adequately implemented.

Author: Rebecca Zacks

Rebecca is Xconomy's co-founder. She was previously the managing editor of Physician's First Watch, a daily e-newsletter from the publishers of New England Journal of Medicine. Before helping launch First Watch, she spent a decade covering innovation for Technology Review, Scientific American, and Discover Magazine's TV show. In 2005-2006 she was a Knight Science Journalism Fellow at MIT. Rebecca holds a bachelor's degree in biology from Brown University and a master's in science journalism from Boston University.