Sanofi’s Framingham facility hit with FDA warning
French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.
dermatologyadvisor2d
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.
FiercePharma10d
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 ...
Nature19d
Virus stalls Genzyme plant
Genzyme of Cambridge, Massachusetts, faces millions in lost revenue from its top-selling specialty drugs Cerezyme and Fabrazyme as result of a viral contamination at its Allston, Massachusetts plant.
STAT10d
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 Review9d
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, ...
The Business Journals9d
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 ...