Sanofi - 690604 - 01/15/2025 | FDA
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.)
Sanofi API plant hit with FDA warning letter detailing quality ...
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 ...
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
3 days 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 ...
Sanofi issued warning letter for Genzyme cGMP failures
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. @
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
THURSDAY, Jan. 23, 2025 -- 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 Genzyme manufacturing plant in Framingham, Massachusetts.
Sanofi Genzyme Facility Draws FDA Criticism Over Alleged Quality …
Jan 22, 2025 · The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s SNY Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility.. After an ...
FDA warns Sanofi over manufacturing violations - Becker's …
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 ...
Please refer to your supplemental biologics license application (sBLA), dated and received July 3, 2023, and your amendments, submitted under section 351(a) of the Public Health Service Act for...
FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · Issued on January 15, the Warning Letter followed a US Food and Drug Administration (FDA) inspection at the facility – located 30 km west of Boston, Massachusetts – in June and July last year and highlighted numerous deviations from current Good Manufacturing Practice (cGMP) for drug substance production. “FDA documented that approximately 20 percent of bioreactor runs attempted between ...
FDA Warns Sanofi Genzyme of Biological Contamination Issues in ...
Jan 22, 2025 · FRAMINGHAM, MA - On January 15, 2025, the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) sent a warning to French drug manufacturer Sanofi regarding issues at it's subsidiary Genzyme Corporation facilities in Framingham, MA.. Sanofi's Genzyme Corporation offices, research and manufacturing facilities occupy multiple buildings in the industrial area between ...
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