The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical
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.
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 ...
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility in Massachusetts.
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 ...
With another city election looming in November, Framingham Mayor Charlie Sisitsky said he wants to finish what he has started.
A Waltham biotech focused on cystic fibrosis and a Boston biotech led by serial founder Gary Glick are the first Massachusetts companies to set their sights on an IPO in 2025.
Some Massachusetts cities announced snow emergency ... Sisitsky announced Saturday. "Framingham Department of Public Works snow and ice preparations are already underway. The city of Framingham ...
The church is hosting the 38th edition of its Dr. Martin Luther King Jr. Day Celebration today at the Sheraton Framingham Hotel. This year's theme, which Lloyd said he selected at the beginning of last year, is based on a King quote: "We must accept finite disappointment, but never lose infinite hope."
Real estate giant Skanska has laid out plans for the first phase of its Longwood Place Project, which includes bringing more lab space to the Longwood medical area.
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