Jan 21, 2025 · CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Warning Letter 320-25-22. January 15, 2025. AMENDED (This letter replaces Warning Letter No. 320-25-22 dated December 16, 2024.)

1 day ago · 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 inspectors, 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected due to contamination or other quality control ...

Jan 21, 2025 · The FDA, whose inspectors visited the Framingham, Mass., plant in June and July 2024, also scolded Sanofi for “multiple” instances in which the facility deviated from so-called good ...

Jan 22, 2025 · The FDA has requested Sanofi to respond to it with corrective action plans within 15 days. When contacted, a Sanofi spokesperson told us: "Patient safety and the quality of our products are our highest priorities. We take all inspections extremely seriously and we are fully committed to working with the FDA to resolve all findings holistically ...

Jan 21, 2025 · 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 U.S. drug ingredients plant tied to its longstanding subsidiary Genzyme ...

Jan 22, 2025 · 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 ...

Jan 21, 2025 · French drugmaker Sanofi received a warning letter from the US Food and Drug Administration (FDA) last week for failing to comply with its current good manufacturing (cGMP) requirements for active pharmaceutical ingredients (API). The agency said the company needs to empower its quality unit to take steps to stay in regulatory compliance.

Jan 22, 2025 · Sanofi must respond within 15 working days, outlining its corrective measures and provide the FDA with a timeline for completion. Price Action: Sanofi stock is down 0.91% at $51.22 at last check ...

Jan 22, 2025 · The FDA issues a warning letter to Sanofi over manufacturing violations at its Massachusetts site, citing contamination and inadequate quality controls. The agency demands a comprehensive review, warning of potential regulatory actions. The site, acquired with Genzyme in 2011, highlights ongoing operational challenges for Sanofi.

Jan 23, 2025 · FDA has issued a warning letter to Sanofi summarizing “significant deviations” from current good manufacturing practice (CGMP) for APIs based on inspections conducted from June 12 to July 9, 2024, at Genzyme Corporation, a subsidiary of Sanofi which acts as a company drug manufacturing facility, in Framingham, Mass. (1).