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.

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.

As patient care access and safety remains under threat from a financially driven healthcare system, nurses have been recognized for their efforts to protect patients by receiving the top ranking among the nation's most honest and ethical

Massachusetts experienced the same 4.1 percent unemployment rate as the country, ending a nearly two-year streak of comparatively lower joblessness in the Bay State.

The owners of 3 Idlewile Lane in Weston admired a home they saw in Architectural Digest, so they purchased over eight acres of land in an exclusive spot in south Weston and replicated the English Arts and Crafts-style dream house on the site.

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

A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in Massachusetts.