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 ...

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 ...

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.

THURSDAY, Jan. 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has warned ... for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham ...

The U.S. Food and Drug Administration has warned the pharmaceutical ... Practice for active pharmaceutical ingredients at their Genzyme manufacturing plant in Framingham, Massachusetts.

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, ...

Although Genzyme also produces Myozyme (alglucosidase alpha) at the plant, no runs were scheduled during the presumed period of shutdown so supplies of that drug will not be affected. With sales ...

The drug, IONIS-AZ5-2.5RX ... Developed in partnership with Sanofi's Genzyme unit, patisiran is currently under review in the US and EU. If approved Alnylam will market patisiran in the US ...