Framingham News - FDA Warns Sanofi Genzyme of Biological …
Jan 22, 2025 · 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 …
Sanofi - 690604 - 01/15/2025 | FDA
Jan 21, 2025 · CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Warning Letter 320-25-22. January 15, 2025. AMENDED (This letter replaces Warning Letter No. 320-25-22 dated December 16, 2024.)
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
3 days ago · Agency cites contamination at Massachusetts plant where company makes ingredients used to produce various medicines. ... about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham, Massachusetts. On Jan. 15, 2025, a warning letter was sent to ...
Sanofi hit with FDA warning letter at Massachusetts drug …
Jan 21, 2025 · Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a U.S. | The FDA has slapped a warning letter on Sanofi’s Genzyme ...
Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality …
Jan 22, 2025 · The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s SNY Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility.. After an ...
FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · In 2013, Sanofi invested $80 million to build a downstream facility at Framingham dedicated to Fabrazyme. Since then, Sanofi describes Framingham as "among the world’s first digitally enabled facilities to use continuous-biologics-production technology," in its literature. "Its end-to-end platform uses millions of points of data captured by ...
FDA warns Sanofi over manufacturing violations - Becker's …
Jan 22, 2025 · The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan ...
FDA warns Sanofi over 'inadequate' response to issues at Massachusetts …
Jan 21, 2025 · The Framingham facility came under Sanofi's control through its $20.1-billion acquisition of Genzyme in 2011. Roughly two years ago, as Sanofi unveiled a new unified corporate brand, the company said its specialty care unit …
Sanofi opens $320m continuous biologics plant in MA
Oct 15, 2019 · Framingham makes numerous products for Sanofi Genzyme, including Fabry Disease enzyme replacement therapy Fabrazyme (agalsidase beta) – production of which was moved to the site in 2012 after contamination issues at …
Genzyme Science Center Framingham, Massachusetts, USA
Nov 11, 2008 · As part of this programme Genzyme opened a new Science Center in Framingham, Massachusetts on 22 September 2008. The new research facility will now serve as a centre for early-stage research using new technology in proteins, antibodies, cell therapy and gene therapy to work on diseases such as Parkinson's disease, various …