After a site visit by FDA inspectors yielded a Form 483 for Genzyme Ireland in early 2026, the Sanofi subsidiary is facing further reprimand from the U.S. regulator. | After a site visit by FDA ...
French healthcare giant Sanofi has moved to reassure the public that all products manufactured at its Waterford Genzyme plant ...
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 ...
US drug safety inspectors have warned one of Ireland’s largest pharmaceutical plants that it is failing to meet safety ...
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, ...
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 ...
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