FDA warns Sanofi of manufacturing irregularities at key facility
The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current ...
FiercePharma3d
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 ...
Becker's Hospital Review2d
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, ...
STAT3d
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 ...
Nature13d
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.