Biotech, FDA, Genzyme
FDA to Re-inspect Genzyme Plant
Rebecca Zacks 7/31/09
Cambridge, MA-based Genzyme (NASDAQ: 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.
