Sanofi Warning Letter

I think we will be evaluating the Sanofi Warning Letter of January 15th, 2025 for a while. Received at the Framingham manufacturing site, this Warning Letter will fuel case studies about the pendulum of compliance and how it can swing perhaps a bit too erratically.

This site is the sister site to the former Genzyme site (last time I checked owned by Resilience and mothballed) in Allston, MA.

The Genzyme consent decree was a significant regulatory action taken by the U.S. Food and Drug Administration (FDA) in response to ongoing manufacturing quality issues at Genzyme’s Allston Landing facility in Massachusetts. Here’s a chronological overview of the key events:

In October 2008, an FDA inspection of the Allston plant led to the issuance of an FDA Form 483, highlighting various deficiencies. In February 2009, the FDA issued a Warning Letter to Genzyme, detailing issues with microbiological contamination control procedures and bioburden monitoring. Then in June 2009, Genzyme detected a virus in one of its bioreactors, leading to a six-week production interruption and subsequent drug shortages. A follow-up FDA inspection in November 2009 revealed ongoing significant problems, resulting in a 49-item Form 483.

On May 24, 2010, Genzyme signed a consent decree with the FDA. The consent decree required Genzyme to adhere to a strict timetable to bring the Allston plant into compliance with FDA regulations.

The next few years a comprehensive remediation plan was implemented with ongoing oversight from a third-party consultant. The company then went through a certification process, FDA inspection, and surveillance by a third party for another five years before being able to request an end to the consent decree.

I believe when Sanofi sold the Allston site to Resilience (Sanofi bought Genzyme in 2011), the consent decree had pretty much finished that surveillance period, but I can find no evidence of the company petitioning the court to lift the consent decree. So I have no idea what that means.

The Framingham sites (which this Warning Letter is addressed to) here under the consent decree but to a lesser amount of oversight. So to see this new Warning Letter, for the new construction done in the mid 2010s is pretty sad for me.

There’s a lot to unpack here that is relevant to SUS biologics manufacturing facilities, but that will be a future post. I need to go get a drink.