Genzyme faces more FDA scrutiny (GENZ)
Genzyme (Nasdaq: GENZ) shares are trading lower Friday afternoon after the company announced the FDA will re-inspect the company’s Allston Landing manufacturing facility.
The re-inspection is a follow-up to an inspection the agency undertook in May to verify that all corrective and preventative actions identified in a February warning letter have been implemented.
In its letter to Genzyme yesterday, the agency stated that all promised actions had not been either fully or adequately implemented at the time of the May inspection.
Genzyme will work with the FDA to schedule the re-inspection as soon as possible.
During the re-inspection, the FDA will also review Genzyme’s efforts to clean up a virus at the Allston plant.
In late June, Genzyme announced that the entire Allston Landing plant had to be shut down and sanitized to remove a viral contaminant. At the time, the company said the plant would be back up and running by the end of July, although management expected a 6-to 8-week sales hiccup for Cerezyme, an enzyme deficiency treatment that makes up about a quarter of the company’s revenue.
Genzyme also noted in its release that the sanitation of Allston is complete and production of Fabrazyme and Cerezyme has resumed. — Mike Tarsala
