07.31.09
The FDA informed Genzyme that it will re-inspect the company’s Allston Landing, MA 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 CAPA identified in a February warning letter have been implemented.
In a 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.During the re-inspection, the FDA will 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 and Cerezyme has resumed. Genzyme will schedule the re-inspection as soon as possible.
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In a 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.During the re-inspection, the FDA will 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 and Cerezyme has resumed. Genzyme will schedule the re-inspection as soon as possible.
Sign up today for Contracting &Outsourcing 2009!