The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
Sanofi (NYSE: SNY) acquired the Framingham facility when it bought Massachusetts-based Genzyme in a deal worth over $20 billion in 2011. Genzyme became a subsidiary of Sanofi and kept the Genzyme ...
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 facility in Framingham,
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, 2025, follows an inspection conducted from June 12 to July 9, 2024, and outlines multiple manufacturing violations for pharmaceuticals.
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.
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 ...
Massachusetts. On Jan. 15, 2025, a warning letter was sent to Sanofi stating that FDA inspectors found irregularities with the facility’s bioreactor, the vessel used to grow organisms and cells.
A fast-casual restaurant that serves Korean and Mexican food has received approval to open on Route 9 in Framingham.
Framingham High School teachers and students were honored for their immersive art exhibit they put on last year.
The 49-year-old Framingham man was arrested after a Framingham investigation into a "firearm recovery at a Waverly Street business, police said. During the arrest, police recovere
Framingham Mayor Charlie Sisitsky delivered his fourth State of the City address Monday evening at Nevins Hall.
In a press release, city officials said Framingham's community electricity program will follow an automatic enrollment model, in line with similar programs elsewhere in the state. Participation is optional, with residents having until Feb. 26 to opt out before automatic enrollment begins.