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

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

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.

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,

Sisitsky submitted his plan to comply with the law late last month after city councilors voted to table discussing the issue until February.

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.

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. According to the inspectors, 20 percent of bioreactor runs ...

Good morning! Here are the five things you need to know in local business news to start your busy — and still very cold — Thursday, including James Beard awards, an FDA warning, Big Lots for sale, GE Vernova's success and giant pink men without pants.

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

There were unforgiveable shortcomings in management, which included critical information not reaching senior officials as well as a lack of good old-fashioned common sense.

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

Dogs can also be affected by certain pet food, but the Food and Drug Administration (FDA) has stated that their ... since 2022 - there have been none in Massachusetts," DPH spokesperson Kathleen ...