FDA has informed Genzyme that it will re-inspect the company’s Allston Landing manufacturing facility. The re-inspection is a follow-up to an inspection the agency conducted in May 2009, and is intended to verify that all corrective and preventative actions identified in a February warning letter have been implemented.
In its letter to Genzyme, the agency indicated that all promised actions had not been either fully or adequately implemented at the time of the May inspection. Genzyme responded that it will work with FDA to schedule the re-inspection as soon as possible.
During the re-inspection, FDA would also review Genzyme’s remediation efforts related to the recent identification of a virus at the Allston plant that required the company to temporarily halt production. The sanitization of the facility is complete and production of Fabrazyme (agalsidase beta) and Cerezyme (imiglucerase for injection) has resumed.