Cancer Therapy Advisor15h
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice regulations for active pharmaceutical ingredients.
STAT5d
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
Becker's Hospital Review5d
FDA warns Sanofi over manufacturing violations
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, ...
FiercePharma6d
Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs
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 ...
Five things: James Beard awards, an FDA warning, Big Lots, GE Vernova and giant pink men without pants
Good morning! Here are the five things you need to know in local business news to start your busy — and still very cold — ...
The MetroWest Daily News4d
Framingham wins 'conditional approval' for MBTA Communities Act plan. What it means
Sisitsky submitted his plan to comply with the law late last month after city councilors voted to table discussing the issue ...
Medical Xpress3d
FDA warns Sanofi of manufacturing irregularities at key facility
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.