Sanofi - 690604 - 01/15/2025 | FDA
Jan 21, 2025 · WARNING LETTER. Sanofi MARCS-CMS 690604 — ... Warning Letter 320-25-22. ... FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were ...
Sanofi hit with FDA warning letter at Massachusetts drug …
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. | The FDA has slapped a warning letter on Sanofi’s Genzyme ...
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
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 ...
Warning Letters | FDA - U.S. Food and Drug Administration
Learn about the types of warning letters on FDA's website. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter...
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 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 ...
Sanofi warned by FDA over 'significant' problems at a key ... - STAT
Jan 21, 2025 · In a Jan. 15 letter, the agency noted its inspectors found that 20% of bioreactor runs attempted between January 2022 and July 24 were rejected due to contamination or other quality control failures.
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 ...
Sanofi Facility Draws FDA Scrutiny Over Alleged Quality Lapses - Sanofi …
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 ...
Sanofi receives GMP warning letter for Genzyme facility - MSN
The U.S. FDA has issued a warning letter to Sanofi (NASDAQ:SNY) regarding Current Good Manufacturing Practices violations at a Genzyme plant in Framingham, Mass. The document accuses the drugmaker ...
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