FDA issues warning letter to Sanofi's Genzyme Irish manufacturing site over quality and data integrity concerns

The U.S. Food and Drug Administration sent a warning letter late last month to the Ireland‑based manufacturing facility operated by Genzyme, which is now owned by Sanofi.

The agency highlighted serious quality problems and data‑integrity issues, pointing to shortcomings in manufacturing processes and record‑keeping at the site.

The FDA expects the company to implement corrective actions and will maintain close oversight, emphasizing the regulatory scrutiny of outsourced production in the pharmaceutical industry.