dermatologyadvisor1d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.
FiercePharma9d
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 ...
STAT9d
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 ...
The Business Journals8d
Sanofi’s Framingham facility hit with FDA warning
Sanofi (NYSE: SNY) acquired the Framingham facility when it bought Massachusetts-based Genzyme in a deal worth over $20 billion in 2011. Genzyme became a subsidiary of Sanofi and kept the Genzyme ...
Becker's Hospital Review8d
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, ...
ENDPOINTS NEWS9d
Sanofi says no sup­ply in­ter­rup­tions af­ter land­ing FDA warn­ing let­ter for US site
A new FDA warning letter for French pharmaceutical company Sanofi cited a handful of issues at its biologics factory in ...
The Victoria Advocate7d
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.