The FDA has informed Genzyme that it will visit the company's beleaguered Allston Landing manufacturing facility to follow up on a May inspection. The regulator indicated to the Boston biotech that all promised corrective and preventative actions identified in a February warning letter had not been either fully or adequately implemented at the time of the May inspection.
Genzyme said in an announcement that it will work with the FDA to schedule the visit.
During the re-inspection, the FDA will also review remediation efforts made in the wake of viral contamination that halted production of the drugs Fabrazyme and Cerezyme. As reported in late June, Genzyme expanded its vaporized hydrogen peroxide clean-up effort beyond the bioreactor involved to the entire manufacturing facility, temporarily shutting it down.
- here's the Genzyme announcement