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 Good Manufacturing Practice for active pharmaceutical ingredients at their ...
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 ...
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 ...
pharmaphorum5y
Sanofi opens digital biologics manufacturing site
Sanofi already has a biologics hub at the plant in Framingham, Massachusetts, which has been a global hub for the company for more than 30 years. The plant is important to Sanofi as its pipeline ...
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, ...
ENDPOINTS NEWS3d
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 ...