The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current ...

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 ...

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. 15, ...

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...

Genzyme of Cambridge, Massachusetts, faces millions in lost revenue from its top-selling specialty drugs Cerezyme and Fabrazyme as result of a viral contamination at its Allston, Massachusetts plant.

Genzyme last expanded the site in 2004. The Allston Landing facility is a highly visible landmark located between Storrow Drive and the Massachusetts Turnpike. The design and brick facade of the ...