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

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

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.

Elshoma McCoy, 49, of 176 Waverly St., Framingham, is charged with illegal possession of a firearm; illegal possession of a large capacity feeding device; improper storage of a firearm; trafficking in cocaine; and possession of cocaine with the intent to distribute.

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,

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.

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 ...

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

FRAMINGHAM — City officials announced the ... The MBTA Communities Act requires 177 communities in eastern Massachusetts to designate at least one zoning district that allows for multifamily ...

A Massachusetts doctor ... and June 2023 during medical examinations at Charles River Medical Associates in Framingham.Todd resigned from Brigham and Women's in 2023, as the hospital was moving ...

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

Some Massachusetts health experts expressed concerns about Robert F. Kennedy Jr.'s potential appointment following his Senate hearing.