Sanofi Assures No Supply Disruptions Following FDA Warning Letter for US Manufacturing Site
FDA Warning Letter:
The FDA issued a warning letter to Sanofi on January 15, 2025, detailing significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs) at its US manufacturing site in Framingham, MA4.
Supply Interruptions:
Despite the warning letter, Sanofi has assured that there will be no supply interruptions due to the regulatory issues1.
CGMP Deviations:
The FDA identified several deviations, including failure to investigate critical deviations, failure to demonstrate reproducible manufacturing processes, use of unsuitable equipment, and inadequate quality unit oversight4.
Corrective Actions:
Sanofi is required to provide detailed corrective and preventive action (CAPA) plans to address the deviations, including investigations into reducing particle load, comprehensive assessments of the overall system for investigating deviations, and timelines for process performance qualification studies4.
Regulatory Impact:
Failure to promptly address these deviations may result in regulatory or legal action, including seizure and injunction, and could prevent other federal agencies from awarding contracts to Sanofi4.
Sources:
4. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sanofi-690604-01152025