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 ...
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 ...
The Pharma Letter8d
FDA sends Sanofi warning letter over quality violations
The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and ...
The Business Journals8d
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. French ...
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 ...
Yahoo6d
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
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. According to the ...
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, ...