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

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.

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 ...

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, ...

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 ...

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Genzyme continued to drive growth for Sanofi in the first quarter, helped along by the company’s vaccines unit, but diabetes drugs are still struggling. Net sales were €8,391 million, an ...

Framingham-based retail parent TJX Cos. has purchased two office parcels on Framingham’s Speen Street for $24.3 million.

The owner of six sandwich shop franchises located in different Central Massachusetts communities will be required to pay back ...