Genzyme Consent Decree Requires Five-Year Consultant Oversight

May 25, 2010
Genzyme would have to complete a remediation plan to correct manufacturing quality violations, followed by five years of oversight and annual reports by a third-party consultant under a consent decree it signed Monday. Genzyme expects the plan — which would include milestones for bringing its Allston, Mass., plant into compliance — to be completed in two to three years, the company said. The remediation plan, to be created with Genzyme’s third-party expert, Quantic, must be submitted to the FDA for approval.
Drug Industry Daily