Sanofi - 690604 - 01/15/2025 | FDA
Jan 21, 2025 · CGMP/Active Pharmaceutical Ingredient (API)/Adulterated. Warning Letter 320-25-22. January 15, 2025. AMENDED (This letter replaces Warning Letter No. 320-25-22 dated December 16, 2024.)
FDA Warns Sanofi of Manufacturing Irregularities at Key Facility
13 hours ago · 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 manufacturing plant in Framingham, Massachusetts. On Jan. 15, 2025, a warning letter was sent to Sanofi stating that ...
FDA cites contamination concerns in warning to Sanofi MA plant
Jan 22, 2025 · Sanofi's Framingham, Massachusetts facility Image c/o Googlemaps. Issued on January 15, the Warning Letter followed a US Food and Drug Administration (FDA) ... “FDA documented that approximately 20 percent of bioreactor runs attempted between January 2022 and July 2024 were rejected for contamination or other quality failures,” the Agency ...
Sanofi hit with FDA warning letter at Massachusetts drug …
Jan 21, 2025 · 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 ...
Framingham News - FDA Warns Sanofi Genzyme of Biological …
Jan 22, 2025 · FRAMINGHAM, MA - On January 15, 2025, the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) sent a warning to French drug manufacturer Sanofi regarding issues at it's subsidiary Genzyme Corporation facilities in Framingham, MA.. Sanofi's Genzyme Corporation offices, research and manufacturing facilities occupy multiple buildings in the industrial area between ...
FDA warns Sanofi over manufacturing violations - Becker's …
Jan 22, 2025 · 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 ...
Sanofi Facility Draws FDA Scrutiny Over Alleged Quality Lapses
Jan 22, 2025 · The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s SNY Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility.. After an ...
Sanofi gets FDA warning letter for Genzyme plant, supply chain …
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. The warning letter, posted by the FDA on Tuesday, follows an inspection conducted between June 12 …
FDA warns Sanofi of manufacturing irregularities at key facility
5 days ago · Get Instant Summarized Text (Gist) The FDA has identified significant deviations from Current Good Manufacturing Practice at Sanofi's Genzyme plant in Framingham, Massachusetts.
New England Compounding Center (NECC) | FDA - U.S. Food and Drug …
NECC, Framingham, MA, EIR for Inspection Ending 4/16/2002 Persons with disabilities having problems accessing the above PDF files may call 301-796-3900 for assistance. Content current as of:
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