FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
By Stephanie Brown HealthDay Reporter
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.
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.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted January 2025
Read this next
Thousands Laid off From NIH, FDA and CDC After Supreme Court Decision
WEDNESDAY, July 16, 2025 — Thousands of health workers lost their jobs this week after a U.S. Supreme Court ruling cleared the way for the Trump administration to move...
Loneliness Of Widowhood Isn't Diminished By Presence Of Adult Children, Study Says
WEDNESDAY, July 16, 2025 — Adult children aren’t likely to fill the void left by the loss of a spouse, a new study says. Becoming widowed might cause a stronger bond...
Consistent Physical Activity Lowers Risk Of Death
TUESDAY, July 15, 2025 — Adults who are consistently physically active have an overall lower risk of premature death, even if they pick up the habit later, a new evidence...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.