The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

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

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 ...

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.

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.

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 ...

Framingham-based retail parent TJX Cos. has purchased two office parcels on Framingham’s Speen Street for $24.3 million.

Genzyme Corp. (Sanofi Genzyme) has disclosed sodium-dependent neutral amino acid transporter B(0)AT1 (SLC6A19) inhibitors reported to be useful for the treatment of phenylketonuria, among others.

The owner of six sandwich shop franchises located in different Central Massachusetts communities will be required to pay back wages to 12 employees after the U.S. Department of Labor filed a complaint against the stores for failing to pay the required overtime and failing to keep track of employee hours.

A fast-casual restaurant that serves Korean and Mexican food has received approval to open on Route 9 in Framingham.

Framingham Mayor Charlie Sisitsky delivered his fourth State of the City address Monday evening at Nevins Hall.