Jan 21, 2025 · The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Genzyme Corporation (a Sanofi subsidiary), FEI 1220423, at 8, 31, 45, 49, 51, 55, 68, 74, 76, 80 New...

Jan 29, 2025 · The FDA cites contamination at Massachusetts plant where Sanofi makes ingredients used to produce various medicines. HealthDay News — 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 Genzyme ...

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).

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 ...

Jan 22, 2025 · 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, at the...

THURSDAY, Jan. 23, 2025 -- 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 Genzyme manufacturing plant in Framingham, Massachusetts.

Jan 22, 2025 · The FDA has issued a warning letter to Sanofi’s Genzyme facility in Framingham, Massachusetts, citing multiple manufacturing violations. Despite the regulatory scrutiny, Sanofi confirmed that there has been no disruption to the supply of drugs from the plant.

Please refer to your supplemental biologics license application (sBLA), dated and received July 3, 2023, and your amendments, submitted under section 351(a) of the Public Health Service Act for...

May 25, 2010 · It's official: Genzyme (NASDAQ: GENZ) is now under an FDA consent decree. After repeated manufacturing snafus, the company has agreed to pay a $175 million federal fine and operate under agency...

Genzyme focuses on six areas of medicine relating to lysosomal storage diseases, renal disease, orthopedics, transplant and immune diseases, oncology, genetics, and diagnostics. The first orphan drug for Genzyme that the FDA approved was Ceredase, a …