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 ...

20% of bioreactor runs at the Genzyme facility failed due to contamination or quality issues over 2.5 years. FDA identified 84 overdue deviation investigations, some exceeding 180 days ...

The US FDA has warned Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients.

French pharmaceutical giant Sanofi has received a warning letter from the U.S. Food and Drug Administration following an inspection at its drug manufacturing facility in Framingham.

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. 15, ...

Genzyme became a subsidiary of Sanofi and kept ... Related: Biggest Boston biotech news coming out of JPM 2025 Hologic gets FDA warning regarding implantable devices Related: Hologic gets FDA ...

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 ...

THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice for ...