FDA Warns Sanofi of Manufacturing Irregularities at Key Facility

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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.

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 failures. This was considered an “excessive” rate and the company was reprimanded for failing to adequately investigate the problem.

After visiting the plant from June 12 to July 9, 2024, the FDA cited several failures, including failure to investigate all critical production deviations, failure to meet quality and compliance measures, and failure to ensure all production deviations are reported and evaluated, that critical deviations are investigated, and that the conclusions are recorded.

“We take all inspections extremely seriously and we are fully committed to working with the FDA to resolve all findings holistically, robustly, and promptly to meet the agency’s requirements and expectations,” a Sanofi spokesperson said in a statement issued to the press, adding that there has been “no interruption” to manufacturing or the supply of drugs as a result of the FDA warning letter.

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Source: HealthDay

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