FDA Warns Sanofi Genzyme of Biological Contamination Issues in Framingham Plant
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FRAMINGHAM, MA - On January 15, 2025, the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) sent a warning to French drug manufacturer Sanofi regarding issues at it's subsidiary Genzyme Corporation facilities in Framingham, MA.
Sanofi's Genzyme Corporation offices, research and manufacturing facilities occupy multiple buildings in the industrial area between Route 9 and Pleasant Street near the Southborough town line. The FDA warning cite issues at numbers 8, 31, 45, 49, 51, 55, 68, 74, 76 and 80 New York Ave, Framingham MA.
![](https://www.framingham.com/news/wp-content/uploads/2025/01/sanofi-genzyme-new-york-ave-framingham.jpg)
The warning concerned "deviations" from Current Good Manufacturing Practice (CGMP) in Sanofi/Genzyme's "active pharmaceutical ingredient" (API) processes including:
- failure to investigate all critical deviations
- high-pressure events associated with product leakage during the transfer of bulk shipping bags
- failure to document all investigational activities
- excessive percent of bioreactor runs rejected for contamination or other quality failures
- multiple microbiological contamination events
- repeated deviation from validated manufacturing processes
- failure to have equipment of the appropriate design and suitability for their intended use
The letter instructs Genzyme's Sanofi operation in Framingham to "correct any deviations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction".
Read the complete FDA Warning Letter here.
Source: U.S. Food & Drug Administration.
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